Press Release: ArriVent BioPharma Reports Full Year 2025 Financial Results

Dow Jones
Mar 06
   -- Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR 
      exon 20 insertion mutant NSCLC expected mid-2026 
 
   -- Global pivotal Phase 3 first-line PACC mutant NSCLC study for 
      firmonertinib enrollment underway 
 
   -- ADC pipeline advancing with first ADC program, ARR-217, in Phase 1 
      clinical development 
 
   -- Cash and investments of $312.8 million as of December 31, 2025 expected 
      to fund operations into 3Q 2027 

NEWTOWN SQUARE, Pa., March 05, 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 year ended December 31, 2025, and highlighted recent Company progress.

"We are advancing firmonertinib toward potential registration, supported by two pivotal programs targeting uncommon EGFR mutations in non-small cell lung cancer (NSCLC), a high unmet need with limited treatment options," said Bing Yao, CEO of ArriVent. "Our robust clinical data, including CNS activity, underscores the potential of firmonertinib to become a chemotherapy-free standard of care. We look forward to topline pivotal data for firmonertinib monotherapy in frontline EGFR exon 20 insertion mutant NSCLC expected in mid-2026. This is an event driven study, so we plan to continue sharpening our timeline as we look forward to sharing our data."

Dr. Yao continued, "Our antibody-drug conjugate $(ADC)$ portfolio is also gaining momentum, led by ARR-217, a CDH17-targeted ADC currently in an ongoing Phase 1 trial, with best-in-class potential in gastrointestinal cancers. We expect additional ADC candidates to advance toward the clinic, broadening our pipeline beyond lung cancer into multiple additional solid tumor indications. Backed by a strong balance sheet and a projected cash runway into 3Q 2027, we are well positioned to deliver on our near-term catalysts."

Recent and Full Year 2025 Highlights

Firmonertinib

   -- Dosed first in patient pivotal ALPACCA study. In December 2025, ArriVent 
      announced dosing of the first patient in the global pivotal Phase 3 
      ALPACCA study evaluating firmonertinib monotherapy for first-line 
      treatment of epidermal growth factor receptor (EGFR) PACC mutant 
      non-small cell lung cancer (NSCLC) (NCT07185997). 
 
   -- Positive final data in EGFR PACC mutant NSCLC. In September 2025, 
      ArriVent presented positive final proof-of-concept data from the 
      randomized global Phase 1b FURTHER trial cohort of first-line 
      firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC 
      mutations at the 2025 World Conference on Lung Cancer (WCLC) 
      (NCT05364073). Firmonertinib demonstrated clinically meaningful 
      progression free survival, central nervous system $(CNS)$ complete 
      responses, and a manageable safety profile consistent with previous 
      trials. We believe this to be the first clinical dataset testing an EGFR 
      inhibitor in a prospectively defined population of EGFR PACC mutant 
      NSCLC. 
 
   -- Completed enrollment for pivotal FURVENT trial. During the first quarter 
      of 2025, we completed enrollment in the global pivotal Phase 3 FURVENT 
      study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 
      insertion mutations (NCT05607550). Firmonertinib, an oral, highly 
      brain-penetrant, and broadly active mutation-selective EGFR inhibitor, 
      received Food and Drug Administration (FDA) Breakthrough Therapy 
      Designation in this patient population. 
 
   -- Received National Medical Products Administration (NMPA) approval in 
      China in second-line EGFR exon 20 insertion mutations.   In February 
      2026, our partner Shanghai Allist Pharmaceutical Technology Co., Ltd., 
      received NMPA approval for firmonertinib for adults with locally advanced 
      or metastatic NSCLC who have progressed on or after prior platinum-based 
      chemotherapy or who are intolerant to platinum-based chemotherapy and who 
      have been tested for the presence of EGFR exon 20 insertion mutations. 

Pipeline

   -- Clinical advancement of ADC lead ARR-217 (MRG007). Ongoing Phase 1 dose 
      escalation for ARR-217, a CDH17 targeted ADC, in gastrointestinal 
      malignancies in partnership with Lepu Biopharma Co., Ltd. ArriVent also 
      received FDA IND clearance for ARR-217 and dosed its first patient in 
      March 2026. 

Upcoming Milestones

   -- Firmonertinib pivotal EGFR exon 20 insertions data. Top-line 
      firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 
      (NCT05607550) study for first-line EGFR exon 20 insertions mutant NSCLC 
      is projected to be in mid-2026. 
 
   -- IND filing for ARR-002. U.S. IND filing for first-in-class ADC program 
      planned for first half 2026.   Plan to present preclinical data at an 
      upcoming conference. 
 
   -- Complete Phase 1 dose escalation for ARR-217. Plan to complete Phase 1 
      dose escalation and enter into dose optimization for ARR-217, a CDH17 
      targeting ADC program, in the second half of 2026. 

2025 Financial Results

   -- As of December 31, 2025, the Company had cash and investments of $312.8 
      million, which is expected to fund operations into 3Q 2027. 
 
   -- Net cash used in operations was $160.6 million and $70.2 million for the 
      years ended December 31, 2025 and 2024, respectively. 
 
   -- Research and development expenses were $153.4 million and $79.0 million 
      for the years ended December 31, 2025 and 2024, respectively. The 
      research and development expenses in 2025 include a one-time upfront 
      payment to Lepu Biopharma Co., Ltd. 
 
   -- General and administrative expenses were $24.2 million and $15.3 million 
      for the years ended December 31, 2025 and 2024, respectively. 
 
   -- Net loss was $166.3 million and $80.5 million for the years ended 
      December 31, 2025 and 2024, 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 <ALPHA>C-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

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March 05, 2026 16:01 ET (21:01 GMT)

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