ArriVent BioPharma Q1 2024 Financial Results

ArriVent BioPharma, Inc., a clinical-stage biopharmaceutical enterprise, reported its financial outcomes for the first quarter ending March 31, 2024, and provided an update on recent corporate achievements. ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, with a focus on addressing unmet medical needs in cancer treatment.

During the initial quarter of 2024, ArriVent successfully enrolled participants for its Phase 1b cohort study targeting non-small-cell lung cancer (NSCLC) patients with EGFR PACC mutations. Additionally, the company commenced a Phase 1b combination study of firmonertinib and ICP-189, a novel SHP2 inhibitor, in NSCLC patients with classical EGFR mutations. These advancements are part of ArriVent's comprehensive development strategy to maximize the potential of firmonertinib across various EGFR mutant NSCLC profiles.

Bing Yao, Chairman and CEO of ArriVent, highlighted that the presentation of preclinical data at the 2024 AACR Annual Meeting showcased firmonertinib's broad activity across a range of uncommon EGFR mutations in NSCLC, including PACC and exon 20 insertion mutations. The company aims to continue building on these milestones to offer new treatment options for cancer patients.

Key highlights from the first quarter of 2024 include:
- Presentation of preclinical data at the AACR Annual Meeting, demonstrating firmonertinib's broad activity across uncommon EGFR mutations in NSCLC.
- Initiation of a Phase 1b combination study of firmonertinib and ICP-189, with the first patient dosed in March 2024. This study targets advanced or metastatic NSCLC patients with classical EGFR mutations.

Upcoming milestones for ArriVent in 2024 include:
- Expected proof-of-concept data from the ongoing Phase 1b FURTHER study, which fully enrolled patients with NSCLC EGFR PACC mutations.
- Selection of a next-generation antibody-drug conjugate (ADC) development candidate, in collaboration with Aarvik Therapeutics, anticipated to be completed by late 2024 or early 2025.

Corporate updates also included the strengthening of ArriVent's board leadership with the appointment of Kristine Peterson, who brings over 30 years of industry experience, including previous roles as CEO of Valeritas and Company Group Chair of Johnson & Johnson's worldwide biotech and oncology groups.

Financial results for the first quarter reflected a solid financial position with cash and cash equivalents totaling $317.4 million as of March 31, 2024, expected to fund operations into 2026. Research and development expenses grew to $17.0 million from $10.2 million in the same period the previous year, driven by increased headcount and clinical trial costs. General and administrative expenses also rose to $3.7 million from $1.9 million, primarily due to the expansion of infrastructure needed for public company operations. Net loss for the quarter was $17.4 million, compared to $12.2 million in the first quarter of 2023.

ArriVent's lead development candidate, firmonertinib, is an oral, highly brain-penetrant, and broadly active mutation-selective EGFR inhibitor. It has shown activity against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. Firmonertinib received approval in China in March 2021 for first-line advanced NSCLC with EGFR exon 19 deletion or L858R mutations, and for previously treated advanced NSCLC with EGFR T790M mutation. Additionally, the U.S. FDA granted firmonertinib Breakthrough Therapy Designation in October 2023 for previously untreated advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The drug is currently under investigation in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations and in a Phase 1b study for patients with EGFR PACC mutations. ArriVent is also exploring its use in combination therapies targeting advanced NSCLC with EGFR classical mutations in partnership with InnoCare Pharma.

Overall, ArriVent BioPharma continues to advance its mission of developing innovative cancer therapies, leveraging its robust financial position and experienced leadership to drive progress in clinical and preclinical development programs.