First-line monotherapy data for once daily firmonertinib selected as an oral presentation in the presidential session First prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in PACC mutant non-small cell lung cancer patient population ArriVent to host virtual webinar in conjunction with 2024 WCLC NEWTOWN SQUARE, Pa., Aug. 12, 2024 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelera ...

Drug Development and Clinical Trials - Firmonertinib received Breakthrough Therapy Designation from the FDA in October 2023 for treatment of EGFRm NSCLC [63]. - In the FAVOUR trial, 79% of patients (22 out of 28) experienced a reduction in tumor size of at least 30% [67]. - The median duration of response for those patients was 15.2 months [67]. - Total firmonertinib costs rose to $12.8 million in Q1 2024, compared to $6.9 million in Q1 2023, reflecting a $5.9 million increase primarily due to the FURVENT Phase 3 clinical trial [90]. - The Allist License Agreement includes milestone payments up to $765 million based on development and sales milestones [68]. Financial Performance - The company reported a net loss of $17.4 million for Q1 2024, compared to a net loss of $12.2 million in Q1 2023 [89]. - As of March 31, 2024, the accumulated deficit was $175.3 million [71]. - Total operating expenses for Q1 2024 were $20.7 million, an increase of $8.5 million compared to Q1 2023 [89]. - Research and development expenses rose to $17.0 million in Q1 2024, up from $10.2 million in Q1 2023 [89]. - General and administrative expenses were $3.7 million for Q1 2024, up from $1.9 million in Q1 2023, marking a 94.7% increase [91]. Cash Flow and Financing - Interest income for Q1 2024 was $3.3 million, compared to $0 for Q1 2023, indicating a significant increase in cash equivalents [93]. - The company raised gross proceeds of $305.0 million from the issuance of convertible preferred stock and $183.2 million from its initial public offering in Q1 2024 [94]. - Net cash used in operating activities was $18.6 million for Q1 2024, compared to $16.9 million in Q1 2023, reflecting an increase in net loss [101][102]. - Net cash provided by financing activities was $185.6 million for Q1 2024, significantly higher than $45.0 million in Q1 2023 [104]. - As of March 31, 2024, the company had cash and cash equivalents of $317.4 million, which is expected to meet anticipated cash requirements into 2026 [96]. - The company plans to fund future operating expenses through additional public or private equity offerings, debt financings, and collaborations [95]. - The company has no long-term obligations other than operating lease obligations totaling $313,000 as of March 31, 2024 [105].

Financial Performance - As of March 31, 2024, ArriVent had cash and cash equivalents of $317.4 million, an increase from $150.4 million as of December 31, 2023[21]. - The net loss for Q1 2024 was $17.4 million, compared to a net loss of $12.2 million in Q1 2023[12]. - ArriVent's total operating expenses for Q1 2024 were $20.7 million, compared to $12.2 million in Q1 2023[23]. Research and Development - Research and development expenses for Q1 2024 were $17.0 million, up from $10.2 million in Q1 2023, primarily due to increased headcount and clinical expenses related to firmonertinib[12]. - The company fully enrolled its NSCLC EGFR PACC mutation Phase 1b cohort in the FURTHER study and initiated a Phase 1b combination study of firmonertinib and ICP-189 in March 2024[3]. - Firmonertinib was presented at the 2024 AACR Annual Meeting, demonstrating broad preclinical activity against various EGFR mutations[5]. - Proof-of-concept data for firmonertinib in patients with NSCLC EGFR PACC mutations is expected in 2024[11]. Administrative Changes - General and administrative expenses rose to $3.7 million in Q1 2024 from $1.9 million in Q1 2023, attributed to expanding infrastructure for operating as a public company[12]. - The company appointed Kristine Peterson to its Board of Directors in April 2024, bringing over 30 years of industry leadership experience[8]. Shareholder Information - The weighted-average shares of common stock outstanding increased to 25,046,531 in Q1 2024 from 1,287,574 in Q1 2023[23].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-41929 ARRIVENT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State of Other Jurisdiction of incorpo ...

Financial Performance - ArriVent reported a net loss of $69.3 million for the year ended December 31, 2023, compared to a net loss of $37.0 million in 2022, representing an increase of 87.5%[13]. - General and administrative expenses rose to $9.7 million in 2023 from $6.5 million in 2022, marking an increase of 49% primarily due to costs associated with operating as a public company[10]. - The total operating expenses for 2023 were $74.6 million, compared to $36.9 million in 2022, indicating a significant increase of 102%[17]. Research and Development - Research and development expenses increased to $64.9 million in 2023 from $30.4 million in 2022, reflecting a rise of 113% due to increased clinical spending on trials related to furmonertinib[10]. - Furmonertinib received Breakthrough Therapy Designation from the FDA for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations[6]. - The Phase 1b FURTHER trial for furmonertinib is fully enrolled, with proof-of-concept data expected in 2024[10]. - ArriVent announced a clinical development collaboration with InnoCare Pharma to investigate a novel SHP2 inhibitor in combination with furmonertinib[6]. - The company is currently enrolling patients globally for the pivotal Phase 3 FURVENT trial targeting first-line NSCLC with EGFR exon 20 insertion mutations[6]. Cash and Funding - As of December 31, 2023, ArriVent had cash, cash equivalents, and marketable securities totaling $150.4 million, which, along with IPO proceeds, is expected to fund operations into 2026[13]. - The company completed a successful IPO in January 2024, raising $201 million in gross proceeds[5].