ArriVent BioPharma: FURVENT misses primary endpoint
Cash and investments totaled $393.2 million at quarter-end, which ArriVent expects to fund operations through mid-2028.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
ArriVent BioPharma, Inc. (AVBP) reported third-quarter collaboration revenue of $5.000 million and a net loss of $40.313 million, compared with a $34.978 million net loss in the same quarter of 2025. Cash and investments were $393.2 million as of September 30, 2026, which the company expects to fund operations to mid-2028. ArriVent said FURVENT did not meet its primary endpoint and that it is conducting a detailed review of the study data; enrollment in the Phase 3 ALPACCA study remained on track.
Stuart Lutzker, M.D., Ph.D. notified ArriVent of his intention to retire as President, Research and Development and as a director, effective December 1, 2026. The company intends to enter a retirement agreement under which it would pay him $428,438.21 for, among other things, duties requested through that date, compliance with restrictive covenants and a release of claims. Chief Medical Officer Priti Patel, M.D., will lead research and development effective December 1, 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash runway: $393.2 million is expected to fund operations to mid-2028.
Negative
- Major pointFURVENT did not meet its primary endpoint; ArriVent is reviewing the study data.
- Moderate pointThird-quarter net loss was $40.313 million, versus $34.978 million in 2025.
Filing Explained
The balance sheet reports 42,452,251 common shares issued and outstanding at
8-K Event Classification
Key Figures
Key Terms
antibody-drug conjugate (ADC) medical
Breakthrough Therapy Designation regulatory
Orphan Drug Designation regulatory
drug-to-antibody ratio (DAR) technical
P-loop and αC-helix compressing (PACC) mutations medical
Earnings Snapshot
Cash and investments of $393.2 million as of September 30, 2026 expected to fund operations to mid-2028.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were AVBP's third-quarter 2026 results?
How long will AVBP's cash fund operations?
What did ArriVent report about FURVENT?
What is the ALPACCA trial evaluating?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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).
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with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On November 9, 2026, ArriVent BioPharma, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On November 6, 2026, Stuart Lutzker, M.D., Ph.D. notified the Company of his intention to retire from the position of President, Research and Development of the Company and as a director of the Company, effective as of December 1, 2026 (the “Retirement Date”). Dr. Lutzker’s departure was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies, or practices.
In connection with Dr. Lutzker’s retirement from the Company, the Company intends to enter into a retirement agreement with Dr. Lutzker (the “Retirement Agreement”). Under the terms of the Retirement Agreement, the Company would pay Dr. Lutzker, in consideration for, among other things, his performance of duties requested by the Company until the Retirement Date, his compliance with certain restrictive covenants, and a typical release of claims, a one-time payment of $428,438.21.
In connection with Dr. Lutzker’s departure, the Company also announced that Priti Patel, M.D., the Company’s Chief Medical Officer, will be assuming the role and responsibility of leading the Company’s research and development function, effective as of December 1, 2026.
Dr. Patel, age 51, is an experienced biopharmaceutical executive with extensive expertise in clinical development, oncology, and hematology drug development. She brings a strong track record of leadership in advancing clinical development programs and shaping medical and clinical strategies across biotechnology and pharmaceutical organizations.
Prior to joining the Company in January 2026, Dr. Patel served as an independent consultant to biotechnology companies from April 2023 until January 2026, as Chief Medical Officer of Neoleukin Therapeutics from May 2021 to April 2023, as well as Vice President and Head of Hematology Clinical Development at AstraZeneca, following earlier roles at Acerta Pharma B.V., an AstraZeneca group company.
Dr. Patel holds a Bachelor of Arts in Public Health from The Johns Hopkins University, a Master of Public Health from the Johns Hopkins Bloomberg School of Public Health, and a Doctor of Medicine from the University of Vermont College of Medicine.
There are no transactions to which we are a party and in which Dr. Patel has a material interest that are required to be disclosed under Item 404(a) of Regulation S-K. Except as discussed above, Dr. Patel has not previously held any positions with us, and Dr. Patel has no family relationship with any of our directors or executive officers.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release dated November 9, 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: November 9, 2026
Exhibit 99.1
ArriVent BioPharma Reports Third Quarter 2026 Financial Results
| · | Continued enrollment in pivotal Phase 3 ALPACCA study in EGFR PACC-mutant NSCLC |
| · | Presented encouraging Phase 1 data for ARR-217, a CDH17-targeted ADC for gastrointestinal malignancies at ESMO |
| · | Dosed first patient in U.S. Phase 1a/1b study of ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC, with initial focus in ovarian and endometrial cancers |
| · | Strengthened clinical leadership with announcement of Priti Patel, M.D., M.S., as Chief Medical Officer, bringing extensive oncology development experience |
| · | Cash and investments of $393.2 million as of September 30, 2026 expected to fund operations to mid-2028 |
NEWTOWN SQUARE, PA, November 9, 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 third quarter ended September 30, 2026, and highlighted recent Company progress.
“Enrollment remains on track for our global Phase 3 ALPACCA trial in first line EGFR PACC mutant NSCLC patients. While FURVENT did not meet its primary endpoint, firmonertinib demonstrated clear antitumor activity, with an efficacy and safety profile consistent with prior studies. We are conducting a detailed review of the FURVENT study to better understand the totality of the data.,” said Bing Yao, Ph.D., CEO of ArriVent. “Our antibody-drug conjugate (ADC) portfolio is also advancing, with initial ARR-217 data showing promising antitumor activity and a manageable safety profile in colorectal cancer. In addition, we dosed the first patient in a Phase 1 study of ARR-002. We are encouraged by the momentum across our pipeline and excited about the opportunity to advance these programs toward new potential treatment options for patients with significant unmet needs.”
Third Quarter 2026 and Recent Highlights
Firmonertinib
| · | Continued Enrollment in Global Pivotal Phase 3 ALPACCA in PACC-Mutant NSCLC. The ALPACCA study is evaluating firmonertinib 240 mg against investigator’s choice of osimertinib or afatinib in first line patients with EGFR PACC mutant NSCLC. The study builds on encouraging Phase 1b FURTHER findings and includes an interim analysis of objective response rate to support a potential accelerated approval pathway, with PFS assessed for potential full approval. |
| · | Reported Phase 3 FURVENT Results and Evaluating Next Steps. FURVENT did not meet its primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR). At 240 mg, firmonertinib demonstrated median PFS of 11.0 months versus 9.5 months with chemotherapy (HR 0.75; p=0.0654), a confirmed objective response rate by BICR of 60% versus 33%, and a safety profile consistent with prior studies. The Company is reviewing the full dataset, including differences between BICR and investigator-assessed PFS in the chemotherapy arm, to inform potential next steps. |
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ADC Pipeline
| · | Presented Phase 1 ARR-217 Data at ESMO. Preliminary Phase 1 data for ARR-217 (MRG007), a CDH17-targeted ADC being developed in partnership with Lepu Biopharma, was presented in a late breaking rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026. In evaluable patients with colorectal cancer treated at 6 mg/kg, the objective response rate, including confirmed and unconfirmed responses, was 44.8% and the disease control rate was 93.1%. Adverse events were predominantly low-grade gastrointestinal and hematologic toxicities. Phase 1b dose optimization and expansion are ongoing. |
| · | Advanced ARR-002 into Clinical Development. Dosed the first patient in the U.S. Phase 1a/1b first-in-human study of ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC. The dose-escalation and expansion study is evaluating safety, dosing and early signals of efficacy in patients with advanced or metastatic ovarian or endometrial cancer. |
Corporate
| · | Strengthened Clinical Leadership. Announced Dr. Priti Patel, M.D., M.S., as Chief Medical Officer. Dr. Patel brings extensive experience, in particular late-stage development experience, in both large pharmaceutical and emerging biotech in global oncology development including AstraZeneca, Acerta and Onyx Pharmaceuticals. Prior to joining ArriVent, Dr. Patel served as Chief Medical Officer at Neoleukin Therapeutics and Vice President, Head of Hematology Clinical Development at AstraZeneca. |
| · | Retirement of Dr. Stuart Lutzker. Stuart Lutzker, M.D., Ph.D., a co-founder of ArriVent, announced his retirement. Over the past five years, Dr. Lutzker served as the President of Research and Development and Board member. During his tenure, Dr. Lutzker led the research and development team and was the architect of our ADC pipeline including advancing ARR-217 and ARR-002 into the clinic. “Dr. Lutzker has been the driving force behind our R&D vision,” said Dr. Yao. “We are deeply grateful for his unwavering commitment and passion in advancing new therapies for patients. We thank him for all his contributions.” |
Upcoming Milestones
| · | Firmonertinib update. We plan to provide an update on firmonertinib in the first quarter of 2027 around the review of the FURVENT study. |
| · | Phase 1b Data for ARR-217. Phase 1b dose optimization data for ARR-217 in late line colorectal cancer are expected in the first half of 2027, and ARR-217 combination data with bevacizumab as well as combination data with chemotherapy are expected in the second half of 2027. |
| |
2026 Financial Results
| · | As of September 30, 2026, the Company had cash and investments of $393.2 million, which is expected to fund operations to mid-2028. |
| · | Net cash used in operations was $122.2 million and $129.9 million for the nine months ended September 30, 2026 and 2025, respectively. |
| · | Research and development expenses were $118.9 million and $121.2 million for the nine months ended September 30, 2026 and 2025, respectively. |
| · | General and administrative expenses were $28.3 million and $17.5 million for the nine months ended September 30, 2026 and 2025, respectively. |
| · | Net loss was $133.5 million and $130.8 million for the nine months ended September 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 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. Firmonertinib is 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 is also
approved in China for NSCLC with EGFR exon 20 insertion mutations in patients who had progressed during/after platinum chemotherapy or
were intolerant to platinum 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 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA; NCT07185997).
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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 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 payload. 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. ARR-002 is currently being evaluated in a multi-center, Phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics in patients with ovarian and endometrial cancers (NCT07755436).
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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 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 1 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, 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.
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ARRIVENT BIOPHARMA, INC.
BALANCE SHEETS
(in thousands, except share and per share data)
(Unaudited)
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 113,583 | $ | 45,540 | ||||
| Short-term investments | 279,640 | 267,281 | ||||||
| Prepaid expenses and other current assets | 23,392 | 20,076 | ||||||
| Total current assets | 416,615 | 332,897 | ||||||
| Right of use assets – operating leases | 302 | 13 | ||||||
| Deferred offering costs | 38 | 69 | ||||||
| Other assets | 134 | 190 | ||||||
| Total assets | $ | 417,089 | $ | 333,169 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,615 | $ | 5,934 | ||||
| Accrued expenses | 20,742 | 19,997 | ||||||
| Operating lease liabilities | 256 | 14 | ||||||
| Total liabilities | 23,613 | 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; 51,212,170 and 42,452,251 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively | 5 | 4 | ||||||
| Additional paid-in capital | 932,104 | 711,847 | ||||||
| Accumulated deficit | (538,167 | ) | (404,641 | ) | ||||
| Accumulated other comprehensive income (loss) | (466 | ) | 14 | |||||
| Total stockholders’ equity | 393,476 | 307,224 | ||||||
| Total liabilities and stockholders’ equity | $ | 417,089 | $ | 333,169 | ||||
| |
ARRIVENT BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration revenue | $ | 5,000 | $ | — | $ | 5,000 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 38,897 | 32,167 | 118,853 | 121,176 | ||||||||||||
| General and administrative | 9,479 | 6,149 | 28,324 | 17,535 | ||||||||||||
| Total operating expenses | 48,376 | 38,316 | 147,177 | 138,711 | ||||||||||||
| Operating loss | (43,376 | ) | (38,316 | ) | (142,177 | ) | (138,711 | ) | ||||||||
| Interest and investment income | 3,063 | 3,338 | 8,651 | 7,947 | ||||||||||||
| Net loss | (40,313 | ) | (34,978 | ) | (133,526 | ) | (130,764 | ) | ||||||||
| Unrealized gain (loss) on marketable securities | (199 | ) | 226 | (480 | ) | 419 | ||||||||||
| Total other comprehensive gain (loss) | (199 | ) | 226 | (480 | ) | 419 | ||||||||||
| Total comprehensive loss | $ | (40,512 | ) | $ | (34,752 | ) | $ | (134,006 | ) | $ | (130,345 | ) | ||||
| Share information: | ||||||||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.81 | ) | $ | (0.83 | ) | $ | (2.82 | ) | $ | (3.54 | ) | ||||
| Weighted-average shares of common stock outstanding, basic and diluted | 49,526,356 | 41,912,905 | 47,425,424 | 36,968,978 | ||||||||||||
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com