Alflutinib Mesylate

Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected mid-2026 Global pivotal Phase 3 first-line PACC mutant NSCLC study for firmonertinib enrollment underway ADC pipeline advancing with first ADC program, ARR-217, in Phase 1 clinical development Cash and investments of $312.8 million as of December 31, 2025 expected to fund operations into 3Q 2027 NEWTOWN SQUARE, Pa., March 05, 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 year ended December 31, 2025, and highlighted recent Company progress. “We are advancing firmonertinib toward potential registration, supported by two pivotal programs targeting uncommon EGFR mutations in non-small cell lung cancer (NSCLC), a high unmet need with limited treatment options,” said Bing Yao, CEO of ArriVent. “Our robust clinical data, including CNS activity, underscores the potential of firmonertinib to become a chemotherapy-free standard of care. We look forward to topline pivotal data for firmonertinib monotherapy in frontline EGFR exon 20 insertion mutant NSCLC expected in mid-2026. This is an event driven study, so we plan to continue sharpening our timeline as we look forward to sharing our data.” Dr. Yao continued, “Our antibody-drug conjugate (ADC) portfolio is also gaining momentum, led by ARR-217, a CDH17-targeted ADC currently in an ongoing Phase 1 trial, with best-in-class potential in gastrointestinal cancers. We expect additional ADC candidates to advance toward the clinic, broadening our pipeline beyond lung cancer into multiple additional solid tumor indications. Backed by a strong balance sheet and a projected cash runway into 3Q 2027, we are well positioned to deliver on our near-term catalysts.” Recent and Full Year 2025 Highlights Firmonertinib Dosed first in patient pivotal ALPACCA study. In December 2025, ArriVent announced dosing of the first patient in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of epidermal growth factor receptor (EGFR) PACC mutant non-small cell lung cancer (NSCLC) (NCT07185997). Positive final data in EGFR PACC mutant NSCLC. In September 2025, ArriVent presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial cohort of first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations at the 2025 World Conference on Lung Cancer (WCLC) (NCT05364073). Firmonertinib demonstrated clinically meaningful progression free survival, central nervous system (CNS) complete responses, and a manageable safety pro with previous trials. We believe this to be the first clinical dataset testing an EGFR inhibitor in a prospectively defined population of EGFR PACC mutant NSCLC. Completed enrollment for pivotal FURVENT trial . During the first quarter of 2025, we completed enrollment in the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective EGFR inhibitor, received Food and Drug Administration (FDA) Breakthrough Therapy Designation in this patient population. Received National Medical Products Administration (NMPA) approval in China in second-line EGFR exon 20 insertion mutations. In February 2026, our partner Shanghai Allist Pharmaceutical Technology Co., Ltd., received NMPA approval for firmonertinib for adults with locally advanced or metastatic NSCLC who have progressed on or after prior platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy and who have been tested for the presence of EGFR exon 20 insertion mutations. Pipeline Clinical advancement of ADC lead ARR-217 (MRG007). Ongoing Phase 1 dose escalation for ARR-217, a CDH17 targeted ADC, in gastrointestinal malignancies in partnership with Lepu Biopharma Co., Ltd. ArriVent also received FDA IND clearance for ARR-217 and dosed its first patient in March 2026. Upcoming Milestones Firmonertinib pivotal EGFR exon 20 insertions data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertions mutant NSCLC is projected to be in mid-2026. IND filing for ARR-002. U.S. IND filing for first-in-class ADC program planned for first half 2026. Plan to present preclinical data at an upcoming conference. Complete Phase 1 dose escalation for ARR-217. Plan to complete Phase 1 dose escalation and enter into dose optimization for ARR-217, a CDH17 targeting ADC program, in the second half of 2026. 2025 Financial Results As of December 31, 2025, the Company had cash and investments of $312.8 million, which is expected to fund operations into 3Q 2027. Net cash used in operations was $160.6 million and $70.2 million for the years ended December 31, 2025 and 2024, respectively. Research and development expenses were $153.4 million and $79.0 million for the years ended December 31, 2025 and 2024, respectively. The research and development expenses in 2025 include a one-time upfront payment to Lepu Biopharma Co., Ltd. General and administrative expenses were $24.2 million and $15.3 million for the years ended December 31, 2025 and 2024, respectively. Net loss was $166.3 million and $80.5 million for the years ended December 31, 2025 and 2024, 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. 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 firmonertinib 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 1 study for ARR-217 in gastrointestinal tumors and the timing of presentation of data from that study, the timing of U.S. IND filing for ARR-002, 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, to be 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) December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 45,540 $ 74,293 Short-term investments 267,281 144,570 Prepaid expenses and other current assets 20,076 8,116 Total current assets 332,897 226,979 Long-term investments — 47,683 Right of use assets – operating leases 13 154 Deferred offering costs 69 — Other assets 190 126 Total assets $ 333,169 $ 274,942 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 5,934 $ 3,782 Accrued expenses 19,997 13,330 Operating lease liabilities 14 162 Total current liabilities 25,945 17,274 Operating lease liabilities, net of current amount — 14 Total liabilities 25,945 17,288 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; 42,452,251 and 33,706,765 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively 4 3 Additional paid-in capital 711,847 496,195 Accumulated deficit (404,641 ) (238,333 ) Accumulated other comprehensive income (loss) 14 (211 ) Total stockholders’ equity 307,224 257,654 Total liabilities and stockholders’ equity $ 333,169 $ 274,942 ARRIVENT BIOPHARMA, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (Unaudited) Year Ended December 31, 2025 2024 Operating expenses: Research and development $ 153,351 $ 79,004 General and administrative 24,183 15,304 Total operating expenses 177,534 94,308 Operating loss (177,534 ) (94,308 ) Interest and investment income 11,226 13,820 Net loss (166,308 ) (80,488 ) Unrealized gain (loss) on marketable securities 225 (211 ) Total other comprehensive gain (loss) 225 (211 ) Total comprehensive loss $ (166,083 ) $ (80,699 ) Share information: Net loss per share attributable to common stockholders, basic and diluted $ (4.32 ) $ (2.56 ) Weighted-average shares of common stock outstanding, basic and diluted 38,462,600 31,469,328 Contact: Joyce Allaire LifeSci Advisors, LLC jallaire@lifesciadvisors.com

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 12, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The oncology landscape is entering a high-velocity regulatory phase as genomics in cancer care expands toward a projected $69.16 billion by 2032[1]. This massive growth is driven by the systematic integration of genotype-directed treatment pathways into standard medical practice. The precision medicine market is now on a trajectory to expand from $138.67 billion in 2026 to over $537.17 billion by 2035[2]. This strategic pivot toward registration-ready precision assets fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), CG Oncology (NASDAQ: CGON), Zentalis Pharmaceuticals (NASDAQ: ZNTL), ArriVent BioPharma (NASDAQ: AVBP), and PDS Biotechnology (NASDAQ: PDSB). The financial momentum behind expedited development pathways is reaching a fever pitch: the orphan drug market is projected to surge from $216.66 billion in 2025 to $687.47 billion by 2035[3]. Current FDA accelerated approval frameworks have already demonstrated meaningful population health gains across 65% of solid tumor indications studied[4]. This validates a new generation of registration-directed study designs that prioritize objective response rates as critical catalysts for major capital allocation in the fight against rare and resistant cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) is advancing pelareorep, an investigational immunotherapy, toward potential accelerated approval in anal cancer after reporting third-line data that nearly tripled historical response rates in a setting with no FDA-approved treatment options. The company announced updated clinical data from GOBLET Cohort 4 showing pelareorep combined with atezolizumab achieved a 29% objective response rate in patients with third-line metastatic squamous cell anal carcinoma (SCAC). These responses included two complete responses among 14 evaluable patients. Notably, the median duration of response was approximately 17 months (67 weeks). Historical third-line SCAC studies typically show objective response rates of approximately 10% or less, and when responses do occur, duration of response is generally limited. The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses. This depth and durability of responses in heavily pretreated patients address a critical unmet need. There are currently no FDA-approved therapies for patients with third-line anal cancer, making pelareorep's activity particularly significant for a patient population with virtually no options outside of chemotherapy. Based on these results and after initial encouraging feedback from the FDA, Oncolytics plans to advance pelareorep into a registration-directed clinical study in second-line and later SCAC. Oncolytics is planning a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan. If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. "As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients' lives who have no options." The company's broader gastrointestinal oncology strategy received validation through expansion of its Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. Leading the charge is CEO Jared Kelly and Chief Business Officer Andrew Aromando, who were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CG Oncology (NASDAQ: CGON) announced an expedited timeline for the topline data readout now expected in the first half of 2026 for its Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines, including HG Ta solitary lesions < 3cm, with enrollment completed early across over 90 sites. "We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment," said Arthur Kuan, Chairman and CEO of CG Oncology. "The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC." The expedited timeline represents nearly one year of advancement from the original schedule. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in more than 400 patients with NMIBC across multiple clinical trials, including the pivotal BOND-003 trial. Zentalis Pharmaceuticals (NASDAQ: ZNTL) provided a corporate update highlighting key milestones and expected momentum in the azenosertib development program for 2026, including completion of enrollment in DENALI Part 2a with dose confirmation expected in the first half of 2026. DENALI Part 2 trial topline readout is expected by year end 2026 with potential to support accelerated approval, while initiation of the ASPENOVA Phase 3 randomized confirmatory trial is planned in the first half of 2026. "2026 represents a pivotal year for Zentalis as we advance azenosertib toward potential approval in Cyclin E1-positive platinum-resistant ovarian cancer and continue to assess its role in additional indications," said Julie Eastland, Chief Executive Officer of Zentalis. "With our strong financial foundation providing an estimated runway into late 2027, we remain focused on executing our strategy to bring this potentially first-in-class, non-chemo, oral therapy to the approximately 50% of PROC patients who are Cyclin E1-positive—a population with significant unmet needs." Strong data across three trials established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer. The Company maintained a strong cash position with $280.7 million in cash, cash equivalents and marketable securities as of September 30, 2025. ArriVent BioPharma (NASDAQ: AVBP) announced the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC), with firmonertinib having the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy. The ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals with global ex-China annual incidence of NSCLC patients with EGFR PACC mutations estimated at approximately 42,000 patients. "Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. "Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. We believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum." The randomized Phase 3 study evaluates firmonertinib 240 mg once daily versus the investigator's choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. Firmonertinib was granted FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion mutations. PDS Biotechnology (NASDAQ: PDSB) announced FDA alignment on the use of progression-free survival as the primary endpoint and submitted an amended protocol for Phase 3 VERSATILE-003 trial following a constructive Type C meeting held with the FDA in December 2025. The submission follows positive final results from the Company's VERSATILE-002 trial, which showed promising median overall survival and durable PFS, with the proposed amendment changing the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power. The amendment retains median overall survival and safety as requirements for full FDA approval and is supported by dialogue with the agency, providing a pathway to potentially accelerate regulatory submission. PDS Biotech specializes in developing novel immunotherapies to transform cancer care, with PDS0101 being developed in combination with checkpoint inhibitors. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. 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