ArriVent BioPharma Files 8-K Report

TL;DR

ArriVent BioPharma filed an 8-K, mostly boilerplate for now.

AI Summary

On September 9, 2024, ArriVent BioPharma, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, and other events, with no specific material events or financial figures detailed in the provided text.

Why It Matters

This 8-K filing indicates ArriVent BioPharma, Inc. has submitted a report to the SEC, which may contain updates on corporate events or financial information relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without specific material disclosures of risk or significant financial events.

Key Players & Entities

• ArriVent BioPharma, Inc. (company) — Registrant
• 0001104659-24-098059 (filing_id) — Accession Number
• September 9, 2024 (date) — Date of Report

FAQ

Key Financial Figures

• $0.0001 — ge on which registered Common Stock, $0.0001 par value per share AVBP The Nasdaq

Filing Documents

• tm2423588d1_8k.htm (8-K) — 29KB
• tm2423588d1_ex99-1.htm (EX-99.1) — 21KB
• tm2423588d1_ex99-1img001.jpg (GRAPHIC) — 3KB
• 0001104659-24-098059.txt ( ) — 232KB
• avbp-20240909.xsd (EX-101.SCH) — 3KB
• avbp-20240909_lab.xml (EX-101.LAB) — 33KB
• avbp-20240909_pre.xml (EX-101.PRE) — 22KB
• tm2423588d1_8k_htm.xml (XML) — 4KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. September 9, 2024, ArriVent BioPharma, Inc. (the "Company") issued a press release announcing positive proof-of-concept global Phase 1b interim data for firmonertinib monotherapy in first-line EGFR PACC mutant non-small cell lung cancer at the 2024 World Conference on Lung Cancer. A copy of the press release is furnished as Exhibit 99.1 hereto. The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01

Item 8.01 Other Events. On September 9, 2024, the Company announced positive interim proof of concept data for firmonertinib monotherapy from a global study of firmonertinib in first-line epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) patients with P-loop and-alpha-c-helix compressing (PACC) mutations, which the Company believes represents the first clinical dataset of an EGFR inhibitor being tested in a randomized defined population of EGFR PACC mutant NSCLC. In this interim readout, 81.8% of patients treated in first-line at 240mg and 47.8% of patients treated in first-line at 160mg as of June 20, 2024 were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by blinded independent central review (BICR) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, which measurement of reduction is the threshold in this trial for a partial response and for inclusion in determination of the overall response rate (ORR). In this interim readout, 63.6% of patients treated in first-line at 240mg and 34.8% of patients treated in first-line at 160mg were observed to experience a confirmed response as measured by BICR utilizing RECIST 1.1 criteria as of June 20, 2024. Median duration of response had not yet been reached, with 90.9% (n = 20/22) of patients with confirmed responses remaining on study. In addition, 46.2% (n = 6/13) of first line patients with brain metastases at baseline were observed to experience a confirmed response utilizing modified RECIST 1.1 by BICR as of June 20, 2024. Firmonertinib was generally well-tolerated with interim safety results as of July 5, 2024 consistent with prior firmonertinib data, and the most frequent treatment-related adverse events (TRAEs) in the study were diarrhea, rash, dry skin, stomatitis, and hepatic enzyme elevation. No Grade 4 or 5 TRAEs were observed, and there were no treatment disc

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 99.1 Press Release dated September 9, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

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, MBA Winston Kung, MBA Chief Financial Officer and Treasurer Date: September 9, 2024

View Full Filing

View this 8-K filing on SEC EDGAR