- 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 ofDecember 31, 2025 expected to fund operations into 3Q 2027
“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
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 2025World 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 inChina in second-line EGFR exon 20 insertion mutations. InFebruary 2026 , our partnerShanghai 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 endedDecember 31, 2025 and 2024, respectively. - Research and development expenses were
$153.4 million and$79.0 million for the years endedDecember 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 endedDecember 31, 2025 and 2024, respectively. - Net loss was
$166.3 million and$80.5 million for the years endedDecember 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
Firmonertinib was granted
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 aC-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
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.
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 firmonertinib 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 1 study for ARR-217 in gastrointestinal tumors and the timing of presentation of data from that study, the timing of
| ARRIVENT BIOPHARMA, INC. | ||||||||
| BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 45,540 | $ | 74,293 | ||||
| Short-term investments | 267,281 | 144,570 | ||||||
| Prepaid expenses and other current assets | 20,076 | 8,116 | ||||||
| Total current assets | 332,897 | 226,979 | ||||||
| Long-term investments | — | 47,683 | ||||||
| Right of use assets – operating leases | 13 | 154 | ||||||
| Deferred offering costs | 69 | — | ||||||
| Other assets | 190 | 126 | ||||||
| Total assets | $ | 333,169 | $ | 274,942 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,934 | $ | 3,782 | ||||
| Accrued expenses | 19,997 | 13,330 | ||||||
| Operating lease liabilities | 14 | 162 | ||||||
| Total current liabilities | 25,945 | 17,274 | ||||||
| Operating lease liabilities, net of current amount | — | 14 | ||||||
| Total liabilities | 25,945 | 17,288 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 4 | 3 | ||||||
| Additional paid-in capital | 711,847 | 496,195 | ||||||
| Accumulated deficit | (404,641 | ) | (238,333 | ) | ||||
| Accumulated other comprehensive income (loss) | 14 | (211 | ) | |||||
| Total stockholders’ equity | 307,224 | 257,654 | ||||||
| Total liabilities and stockholders’ equity | $ | 333,169 | $ | 274,942 | ||||
| ARRIVENT BIOPHARMA, INC. | ||||||||
| STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 153,351 | $ | 79,004 | ||||
| General and administrative | 24,183 | 15,304 | ||||||
| Total operating expenses | 177,534 | 94,308 | ||||||
| Operating loss | (177,534 | ) | (94,308 | ) | ||||
| Interest and investment income | 11,226 | 13,820 | ||||||
| Net loss | (166,308 | ) | (80,488 | ) | ||||
| Unrealized gain (loss) on marketable securities | 225 | (211 | ) | |||||
| Total other comprehensive gain (loss) | 225 | (211 | ) | |||||
| Total comprehensive loss | $ | (166,083 | ) | $ | (80,699 | ) | ||
| Share information: | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (4.32 | ) | $ | (2.56 | ) | ||
| Weighted-average shares of common stock outstanding, basic and diluted | 38,462,600 | 31,469,328 | ||||||
Contact:
jallaire@lifesciadvisors.com
