Alflutinib Mesylate

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected 2H 2026 ARR-217, a CDH17 targeted ADC for gastrointestinal malignancies, advanced to Phase 1b dose optimization Dosing of first patient with ARR-002, a dual-targeting MUC16/NaPi2b tetravalent ADC with initial focus in ovarian and endometrial cancers expected Q3 2026 Cash and investments of $373.1 million as of June 30, 2026 expected to fund operations into 2028 NEWTOWN SQUARE, Pa., Aug. 12, 2026 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent Company progress. “Our FURVENT and ALPACCA global pivotal trials have the potential to establish firmonertinib as a first-line treatment option for uncommon EGFR mutations in non-small cell lung cancer (NSCLC), addressing a significant unmet need for patients who remain underserved by current therapies,” said Bing Yao, CEO of ArriVent. “In parallel, we continue to build a differentiated ADC portfolio, with ARR-217 advancing into dose optimization and ARR-002 advancing in clinical development. We look forward to presenting pivotal topline data from our global FURVENT study for firmonertinib and initial Phase 1 data for ARR-217.” Second Quarter 2026 and Recent Highlights Firmonertinib ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Phase 3 study supported by crystal structure data presented at AACR. Ongoing pivotal Phase 3 study in frontline EGFR exon 20 insertion mutant NSCLC supported by preclinical data for EGFR inhibitor firmonertinib showcased high resolution crystal structure data at the 2026 American Association for Cancer Research (AACR) Annual Meeting. Pipeline Initiated Phase 1b Dose Optimization of ADC lead ARR-217 (MRG007). ArriVent has initiated Phase 1b dose optimization for ARR-217, a CDH17 targeted ADC, in patients with gastrointestinal malignancies in partnership with Lepu Biopharma Co., Ltd. Clinically advancing ARR-002 in ovarian and endometrial cancer. ArriVent advancing ARR-002, a novel dual-target MUC16/NaPi2b tetravalent ADC, into the clinic through a first-in-human study evaluating safety, dosing, and early signals of efficacy in patients with ovarian and endometrial cancers following Investigational New Drug (IND) clearance from the Food and Drug Administration (FDA) in May 2026. Greater China license agreement with Allist for ARR-002. ArriVent entered into an exclusive licensing agreement with Shanghai Allist Pharmaceuticals Co., Ltd. (Allist) to develop and commercialize ARR-002 in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan, with all other rights retained by ArriVent. Upcoming Milestones Firmonertinib pivotal EGFR exon 20 insertion data. Top-line data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is anticipated in 2H 2026. Initial Phase 1 data for ARR-217 . Initial Phase 1 dose escalation data for ARR-217 planned to be presented at a future medical conference. Dosing of first patient with ARR-002. Dosing of first patient with ARR-002 in a Phase 1 trial expected in the third quarter of 2026. 2026 Financial Results As of June 30, 2026, the Company had cash and investments of $373.1 million, which is expected to fund operations into 2028. Net cash used in operations was $81.5 million and $94.1 million for the six months ended June 30, 2026 and 2025, respectively. Research and development expenses were $80.0 million and $89.0 million for the six months ended June 30, 2026 and 2025, respectively. General and administrative expenses were $18.8 million and $11.4 million for the six months ended June 30, 2026 and 2025, respectively. Net loss was $93.2 million and $95.8 million for the six months ended June 30, 2026 and 2025, 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 March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. 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 αC-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 the United States, Europe and certain Asian countries including Japan and China. 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. About ARR-217 ARR-217 (also known as MRG007) is a cadherin-17 (CDH17) targeted ADC, with a glycan-linked, exatecan-based antibody drug conjugate. CDH17 is a membranous cell adhesion molecule and is frequently overexpressed in colorectal cancer (CRC) and several other gastrointestinal (GI) cancers, with limited expression in normal intestinal tissue and pancreatic duct. The differential expression pro tumor versus normal tissue makes it an attractive target for antibody-drug conjugate (ADC) in GI cancers, particularly CRC. ARR-217 is currently being evaluated in a multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics in patients with unresectable locally advanced or metastatic solid tumors (NCT07066657). About ARR-002 ARR-002 (also known as AV-P138-ADC) is a first-in-class, Mucin-16 (MUC16) and sodium-dependent phosphate transport protein 2b (NaPi2b) dual-target, tetravalent (2+2 format) ADC, with site-specific conjugation to vcMMAE at a drug-to-antibody ratio (DAR) of 4. Both these cell surface antigens are expressed in solid tumors including ovarian and endometrial cancers with limited expression in normal tissues, making them ideal co-targets. 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 our product candidates 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 1a and Phase 1b study for ARR-217 in gastrointestinal tumors and the timing of presentation of data from that study, the timing of the advancement of the Phase 1 study for ARR-002, the expected benefits of the exclusive license agreement with Allist for ARR-002 in Greater China, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 5, 2026 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law. ARRIVENT BIOPHARMA, INC. BALANCE SHEETS (in thousands, except share and per share data) (Unaudited) June 30, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 154,682 $ 45,540 Short-term investments 218,437 267,281 Prepaid expenses and other current assets 21,054 20,076 Total current assets 394,173 332,897 Right of use assets – operating leases 370 13 Deferred offering costs 41 69 Other assets 134 190 Total assets $ 394,718 $ 333,169 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,217 $ 5,934 Accrued expenses 25,309 19,997 Operating lease liabilities 318 14 Total current liabilities 27,844 25,945 Operating lease liabilities, net of current amount 33 — Total liabilities 27,877 25,945 Stockholders’ equity: Preferred stock $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding — — Common stock $0.0001 par value, 200,000,000 shares authorized; 48,319,591 and 42,452,251 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 5 4 Additional paid-in capital 864,957 711,847 Accumulated deficit (497,854 ) (404,641 ) Accumulated other comprehensive income (loss) (267 ) 14 Total stockholders’ equity 366,841 307,224 Total liabilities and stockholders’ equity $ 394,718 $ 333,169 ARRIVENT BIOPHARMA, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 42,339 $ 27,720 $ 79,957 $ 89,009 General and administrative 10,352 5,903 18,844 11,386 Total operating expenses 52,691 33,623 98,801 100,395 Operating loss (52,691 ) (33,623 ) (98,801 ) (100,395 ) Interest and investment income 2,798 2,224 5,588 4,609 Net loss (49,893 ) (31,399 ) (93,213 ) (95,786 ) Unrealized gain (loss) on marketable securities 3 (1 ) (282 ) 193 Total other comprehensive gain (loss) 3 (1 ) (282 ) 193 Total comprehensive loss $ (49,890 ) $ (31,400 ) $ (93,495 ) $ (95,593 ) Share information: Net loss per share attributable to common stockholders, basic and diluted $ (1.05 ) $ (0.90 ) $ (2.01 ) $ (2.78 ) Weighted-average shares of common stock outstanding, basic and diluted 47,606,857 35,006,114 46,351,614 34,455,585 Contact: Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com

Shanghai Allist Pharmaceuticals (SSE: 688578) has licensed exclusive Greater China rights to AST12608/ARR-002, a dual-targeting MUC16/NaPi2b tetravalent antibody-drug conjugate, from Pennsylvania-based ArriVent BioPharma (Nasdaq: AVBP). The deal terms include up to USD 80.6 million in combined upfront and milestone payments, plus tiered royalties in the mid-single to low-double digit percentage range. The deal covers mainland China, Hong Kong, Macau, and Taiwan. ArriVent retains all rights outside Greater China, including the FDA investigational new drug application cleared in May 2026. ArriVent has said first-in-human dosing was planned for the second half of 2026, making this an IND-stage transaction with no human efficacy or safety data at signing. AST12608/ARR-002 is described by the companies as a potential first-in-class asset based on its tetravalent bispecific architecture, which the companies say is designed to bind MUC16 and NaPi2b simultaneously on a single construct. Preclinical data presented at the American Association for Cancer Research annual meeting in 2026 showed enhanced internalization compared with monospecific antibody controls, superior in vivo efficacy over single-target ADCs in an OVCAR-3 patient-derived xenograft model, and a tolerability profile that the companies said suggested a wider therapeutic window than comparator agents in the same class. The primary indications are ovarian cancer and endometrial cancer, with broader solid tumor applicability cited. The transaction is the second licensing deal between the two companies and structurally inverts their first. In 2021, Allist out-licensed firmonertinib, a third-generation EGFR tyrosine kinase inhibitor, to ArriVent for ex-China rights in a deal that included a USD 40 million upfront payment, equity in ArriVent, and up to USD 765 million in milestones. Here, ArriVent is the licensor and Allist the in-licensee, with a total ceiling of USD 80.6 million — a fraction of the 2021 deal's headline value, consistent with Greater China-only scope and the absence of any clinical data at signing. Allist is separately building a combination oncology portfolio around firmonertinib: in May 2026 it announced a collaboration with TransThera Sciences to evaluate the AXL/FLT3 inhibitor TT-00973 alongside firmonertinib in EGFR-mutant non-small cell lung cancer, and that combination received China Phase II approval in July 2026. The NaPi2b target class has drawn substantial attention in 2026. Gilead Sciences agreed to acquire Germany-based Tubulis GmbH for USD 3.15 billion upfront, plus up to USD 1.85 billion in contingent milestones, to gain TUB-040, a NaPi2b-directed topoisomerase I inhibitor ADC in Phase I/II for platinum-resistant ovarian cancer. Monospecific NaPi2b ADCs have also been explored previously, including lifastuzumab vedotin, which did not advance. MUC16 has been targeted by upifitamab rilsodotin, a MUC16-directed ADC in clinical development for ovarian cancer. AST12608/ARR-002's dual-targeting format is differentiated from both predecessors, though it will enter clinical development against a field that now includes a well-resourced Gilead program in the same indication and on one of the same targets. ArriVent has executed a series of ADC in-licensing deals from Chinese partners for ex-China rights — including a multi-target ADC collaboration with Alphamab Oncology for up to USD 615.5 million in June 2024, and an exclusive license to Lepu Biopharma's HER2-targeting MRG007 for up to USD 1.16 billion in January 2025. The ARR-002/Allist deal flows in the opposite direction, with ArriVent monetizing a pre-clinical asset into China while retaining the global program. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article