ArriVent BioPharma : Corporate Presentation May 2026
AVBP
Published on 05/11/2026 at 04:57 pm EDT
May 2026
Corporate Presentation
Accelerating a differentiated oncology pipeline built through strategic partnerships with innovative companies globally
Lead program firmonertinib with Breakthrough Therapy and Orphan designation in 1L EGFR exon 20 insertion mutant NSCLC
ArriVent BioPharma:
A Late-Stage Company With Multiple Assets in Clinical Development
Firmonertinib near-term catalysts include topline results in a global registrational 1L EGFR exon 20 insertion mutant NSCLC study expected in mid-2026
Global registrational trial for 1L EGFR PACC mutant NSCLC
Next-generation ADC portfolio advancing with ARR-217, a CDH-17 targeting ADC, in Phase 1 and US IND clearance for ARR-002, a NaPi2b x MUC16 tetravalent ADC, with plans to enter Phase 1 in
2 2H 2026
Firmonertinib: Broad-spectrum EGFR Inhibitor Structurally Differentiated to Address Underserved Uncommon EGFRm NSCLC
Active against both classical and uncommon EGFR mutations Highly brain penetrant
Orally bioavailable with pharmacokinetic properties to support convenient once a day dosing
Approved in China for patients with classical EGFR mutations and second line exon 20 insertion mutations
Proof of concept in patients with EGFR exon 20 insertion and PACC mutations
FDA Breakthrough Therapy Designation in 1L NSCLC with EGFR exon 20 insertion mutations
Anti-tumor activity against brain metastases observed across multiple clinical trials
Completed enrollment of global pivotal Phase 3 in 1L NSCLC exon 20 insertion mutation as a monotherapy
Global pivotal Phase 3 in 1L NSCLC PACC mutations ongoing
Adjuvant study in EGFR uncommon mutations initiated in China
3 Note: firmonertnib only approved in China for NSCLC EGFR classical mutations and 2L NSCLC EGFRm exon 20 insertion
Robust Pipeline to Maximize Impact Across Indications & Geographies
Program
Target Indication
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
ArriVent Rights Partner
Firmonertinib
EGFR TKI
1L NSCLC EGFR exon 20
Insertion Mutations BTD
Monotherapy
Global-Ex China
1L NSCLC EGFR PACC
Mutations
Monotherapy
Global-Ex China
Adjuvant EGFR Uncommon Mutations
Monotherapy
Global-Ex China
ARR-217
CDH17 ADC
GI Tumors
Monother
apy
Global-Ex China
ARR-002
NaPi2b x MUC16 ADC
Solid Tumors
Monotherapy
Global
ARR-421
ADC
Solid Tumors
Global-Ex China
ARR-173
ADC
Solid Tumors
Global-Ex China
4
NSCLC: non-small cell lung cancer; EGFR: epidermal growth factor receptor; PACC: P-loop and alpha-c helix compressing; Allist: Shanghai Allist Pharmaceuticals Company, Ltd.; Aarvik: Aarvik Therapeutics, Inc.; Lepu Biopharma: Lepu Biopharma Co., Ltd.; Alphamab Oncology: Jiangsu Alphamab Biopharmaceuticals, Co., LTD; 1L: First-line therapy; 1L+: Treatment naïve and previously treated with non-TKI therapies; BTD: FDA Breakthrough Therapy Designation. Firmonertnib only approved in China for NSCLC EGFR mutations and 2L NSCLC EGFRm exon 20 insertion. ARR-217, ARR-002, ARR-421, and ARR-173 are investigational products have not been approved by any regulatory authority. Global Ex-China = all countries and regions except mainland China, Hong Kong, Macau and Taiwan. Adjuvant EGFR in uncommon mutations initiated in China.
EGFR Mutant NSCLC Is One of the Most Prevalent Types of Cancer
EGFR NSCLC Mutations
Uncommon EGFR Mutations 30.8%
NSCLC Uncommon EGFR Mutations
Global Incidence (Excluding Greater China) > 100K
31K
42K
>100k Pt's
31K
PACC (incl. compound) 12.5%
Exon 20 insertions
9.1%
Other uncommon (incl. L861Q) 9.2%
Classical (incl. T790M)
69.2%
EGFR Exon 20 Insertion Mutations
EGFR PACC
Mutations
Other Uncommon EGFR Mutations
Firmonertinib Opportunity
U.S. 4.7K 6.2K 4.7K
5 Source: Globocan 2020; Adapted from Robichaux et al., Nature, 2021; Zhang et al., Oncotarget, 2016. Nilsson MB, Mounir Z, Musib L, et al. AACR 2024. PACC = P-loop and αC-helix compressing mutations.
FAVOUR Study Design: EGFR exon 20 Insertion Mutant NSCLC (NCT: 04858958)
Treatment naïve Firmonertinib 240 mg/day n=30
Previously treated Firmonertinib 160 mg/day n=30
Previously treated Firmonertinib 240 mg/day n=30
Treatment until
Disease progression
Intolerable toxicity
Death
Key Inclusion Criteria
Locally advanced or metastatic NSCLC
Presence of EGFR exon 20 insertion mutation
Measurable disease
Asymptomatic stable CNS metastases are allowed
ECOG 0-1
Follow up every 6 weeks
Randomized 1:1
Primary Endpoint: ORR by IRC assessment; Secondary Endpoint: DoR, DCR, PFS, OS, Depth of response, safety,
quality of life
6 ORR: Objective Response Rate; IRC: Independent Review Committee; DoR: Duration of Response; DCR: Disease Control Rate; PFS: Progression-free survival; OS: overall survival
Best Percent Change of Tumor Size from Baseline (%)
FAVOUR: Robust Responses to Firmonertinib Monotherapy in EGFR exon 20 Insertion NSCLC Across All Mutation Subtypes
40 Treatment Naïve 240mg
N=28
20
0 ○ □ ○ ∆ ○ ○ ○ ∆ ○ ○ ○ ∆ x ∆ ○ ∆ ○ ○ ○ ○ ∆ ○ □ ○ ∆ ∆ x ○
(20)
(40)
(60)
(80)
(100)
Confirmed ORR, % 78.6 (59.05, 91.70)
(95% CI)
Previously Treated 240mg
N=26
∆ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ □ ∆ ○ ○ x ∆ ○ ∆ ○ ○ ∆
46.2 (26.59, 66.63)
Previously Treated 160mg
N=26
○ ○ ○ ∆ x ○ □ ∆ ∆ ∆ ○ ∆ ∆ □ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ∆
38.5 (20.23, 59.43)
DoR, Median (Months) 15.2 (8.74, 24.84)
(95% CI)
13.1 (5.62, 13.80)
9.7 (5.59, NA)
Data Cut: 15 Jun 2023
Confirmed Best Overall Response EGFR exon 20 Insertion Subtype
Partial Response Stable Disease
Progressive Disease
Far Loop Mutations
Not Evaluable
exon20Ins Type Unknown
7 Source: Han B, Zhou C, Zheng W, et al., WCLC 2023
FAVOUR: Responses Were Observed to be Rapid and Durable
Most responses occur at the first tumor assessment (6 weeks)
The longest DoR is beyond 26 months with treatment ongoing
Data Cut: 15 Jun 2023
8
FURVENT: Phase 3 Global Trial in 1L EGFR exon 20 Insertion NSCLC Exceeded Target Enrollment (NCT: 05607550)
Randomized
1:1:1
Platinum Chemotherapy + Pemetrexed
Firmonertinib
240 mg QD
Firmonertinib
160 mg QD
Key Inclusion Criteria:
Non-squamous locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation
No prior systemic anticancer therapy regimens
Patients with a history of treated CNS metastases or new asymptomatic CNS metastases are eligible
N=375 (target enrollment; enrolled 398)
PFS by BICR per
RECIST v1.1
OS, ORR, DOR, PFS, CNS-PFS, PFS2, CNS-ORR, CNS-DOR, PRO,
Safety, PK
9
FURTHER: A Global Phase 1b Study Evaluating Firmonertinib Monotherapy in NSCLC EGFR PACC Mutations (NCT: 05364073)
Stage 2 Cohort 4 Dose Expansion
Stratification:
Prior Treatment (Y/N)
Contains G719X or S768I (Y/N)
N=60
Locally advanced or metastatic
NSCLC with EGFR PACC mutations
No prior EGFR TKI treatment
Asymptomatic brain metastases without prior radiation therapy allowed
Key Eligibility Criteria:
Randomized
1:1
Firmonertinib 160 mg QD
Firmonertinib
240 mg QD
Key secondary
endpoints:
Duration of response, CNS
ORR, PFS, OS
Primary endpoints:
Overall Response Rate ORR (by BICR)
Endpoints
10 Global study in 40 sites in 10 countries: Australia, Canada, China, France, Japan, Korea, Netherlands, Spain, UK, USA
FURTHER: Firmonertinib Showed Strong Confirmed Overall
Responses (BICR) for 1L PACC
160 mg QD n=23
240 mg QD n=22
Best ORR, % (95% CI)a
52.2% (30.6-73.2)
81.8% (59.7-94.8)
Confirmed ORR, % (95% CI)
43.5% (23.2-65.5)
68.2% (45.1-86.1)
Best overall response, n (%)
Complete response (CR)
1 (4.3%)
0 (0%)
Partial response (PR)
9 (39.1%)
15 (68.2%)
Stable disease (SD)
11 (47.8%)
7 (31.8%)
Progressive disease (PD)
2 (8.7%)
0 (0%)
Median Duration of Response, months
NA
14.6
DCR (CR+PR+SD), % (95% CI)
91.3% (72.0% - 98.9%)
100% (84.6% - 100%)
a includes confirmed and unconfirmed responses
Median PFS is Clinically Meaningful in 1L EGFR PACC Mutant NSCLC
PFS HR favors 240mg as the optimal dose for Phase 3
160 mg QD
(12.5, NA)
PFS Probability (%)
Final data cut as of June 3, 2025 for BICR
11.1 months (6.6, NR)
240 mg QD
16.0 months (11.0, NA)
HR (95% CI)
0.834 (0.373 - 1.863), p
= 0.6524
CNS Activity Including Complete CNS Responses in PACC Cohort
Confirmed CNS activity (CNS ORR and CNS CR by BICR) may be beneficial in delaying need for brain radiation
CNS ORR
CNS CR
Baseline MRI
Non-Target CNS Lesion
Week 12 MRI
CNS lesion not detected
47% (8/17) 41% (7/17)
In CNS evaluable disease patients from PACC cohort1
Case Study
68 yo male with newly diagnosed EGFR PACC mutant2 metastatic NSCLC
Multiple asymptomatic non-target (<1 cm) CNS
metastases detected on baseline MRI
Randomized to firmonertinib 240 mg QD
Achieved a CNS CR by BICR at cycle 4
Remains on study at cycle 18 (54 weeks) without CNS progression3
1BICR data; includes 1L and 2L at 160 mg and 240 doses
2V774M + H773L
13 3Data as of Apr 22, 2025
Firmonertinib Shows a Manageable Safety Profile in PACC Patients
No Grades 4-5 TRAEs observed
All PACC Patients All Patients in FURTHER
TRAE of Clinical Interest1 for 1L PACC Patients
PACC Cohort - 240 mg (N=29)
PACC Cohort - 160 mg (N=31)
Treatment-related adverse events (TRAEs), n (%)
160 mg (N=31)
240 mg (N=29)
160 mg (N=42)
240 mg
(N= 116)
TRAEs any grade
28 (90.3)
28 (96.6)
36 (85.7)
101 (87.1)
TRAEs Grade ≥3
8 (25.8)
6 (20.7)
9 (21.4)
25 (21.6)
Treatment-related serious AEs
(SAEs)
2 (6.5)
1 (3.4)
3 (7.1)
11 (9.5)
Dose interruption
9 (29.0)
11 (37.9)
13 (31.0)
45 (38.8)
Dose reduction
6 (19.4)
7 (24.1)
7 (16.7)
24 (20.7)
Dose discontinuation
1 (3.2)
0
2 (4.8)
8 (6.9)
Includes all patients who have received ≥1 dose
No Grades 4-5 TRAEs observed
ALPACCA (FURMO-006): First Randomized Global Phase 3 Study in 1L PACC Mutations (NCT07185997)
Key Eligibility Criteria:
Endpoints:
1:1
Randomized
Firmonertinib 240 mg QD
Investigator's choice:
osimertinib or afatinib
PACC mutation*
No prior therapy for metastatic disease and no prior EGFR-TKI
Allows untreated brain metastases if clinically stable
N=480
*Excludes Classical-like (ex. L861Q) unless compound with PACC
Primary endpoints: ORR (Interim Analysis) and PFS (Final Analysis) by BICR with RECIST v1.1
Enrolls PACC mutant patients as a distinct patient group
Control arm based on real-world EGFR-TKI usage
FDA Project FrontRunner design provides for an opportunity for accelerated approval
Our Next-Generation ADC Pipeline Advancing In Clinical Development
Improved linker-drug and conjugation technology
ARR-217 (MRG007)
Novel glyco-engineered exatecan ADC
Zeng et al., AACR 2025 Cancer Res (2025) 85 (8_Supplement_1): 2877
ARR-217 targets CDH17 which is broadly over-expressed in GI malignancies (i.e., colorectal, gastric, pancreatic)
Superior preclinical activity over conventional CDH17-DXd ADC
Phase 1 study ongoing in China and US1
Plan to complete Phase 1 dose escalation in 2H 2026
Our Second ADC Pipeline Program Also Advancing In Clinical Development
Novel Tetravalent, Dual-Targeting Antibody Drug Conjugates
ARR-002
NaPi2b
NaPi2b
MMAE
MUC16
MUC16
Novel tetravalent dual targeting ADC
AACR 2026 Poster #2660
ARR-002 targets NaPi2b and MUC16, which are highly expressed in ovarian and endometrial cancers, among other solid tumors including lung
First in class, tetravalent, dual-targeted ADC against these targets
US IND cleared and plan to initiate Phase 1 dose escalation in 2H 2026
Our Additional Dual-Targeting ADCs are Advancing Toward the Clinic
Novel Tetravalent, Dual-Targeting Antibody Drug Conjugates
ARR-421 & ARR-173 - Additional tetravalent ADC programs advancing through research partnership to provide a diversified portfolio of high value ADCs through our partnership with Jiangsu Alphamab Biopharmaceuticals, Co. LTD
Creating a pipeline of first-in-class tetravalent, dual-targeting ADCs
Designed to overcome tumor target
heterogeneity and target escape
Engineered to be superior to single target ADCs and bivalent ADCs
Near-Term Key Inflection Points Validate Approach & Drive Value Creation
Cash and Cash Equivalents as of March 31, 2026 of $326.4 million
Oral, highly CNS-penetrant TKI with broad activity and selectivity across EGFR mutations
Potential best-in-class CDH17 targeting ADC
In 1L NSCLC EGFR exon 20
In GI tumors
Novel tetravalent, dual-targeting NaPi2b x MUC16 ADC
In solid tumors
Disclaimer
ArriVent Biopharma Inc. published this content on May 11, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 11, 2026 at 20:49 UTC.