Alflutinib Mesylate

NEWTOWN SQUARE, Pa., July 01, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (“ArriVent”) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the pricing of an underwritten public offering of 2,482,692 shares of its common stock at a price to the public of $19.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 1,363,469 shares of its common stock at a price to the public of $19.4999, which represents the per share public offering price for the shares of common stock less $0.0001 per share exercise price for each pre-funded warrant. The gross proceeds to ArriVent from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $75 million. In addition, ArriVent has granted the underwriters a 30-day option to purchase up to an additional 576,923 shares of its common stock on the same terms and conditions. All of the securities are being offered by ArriVent. Goldman Sachs & Co. LLC, Citigroup and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital and Oppenheimer & Co. are acting as lead managers, and B. Riley Securities, H.C. Wainwright & Co., and Jones are acting as co-managers for the offering. This offering is expected to close on or about July 3, 2025, subject to the satisfaction of customary closing conditions. ArriVent intends to use the net proceeds from the offering, together with its existing cash resources, to support its activities for firmonertinib and its other pipeline programs and for working capital and other general corporate purposes. An automatic shelf registration statement on Form S-3ASR relating to the securities being sold in this offering was filed with the Securities and Exchange Commission (the “SEC”) on February 3, 2025 and automatically became effective upon filing. The preliminary prospectus supplement and accompanying base prospectus relating to the offering were filed with the SEC on July 1, 2025. The final prospectus supplement and the accompanying prospectus will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement and base prospectus related to the offering may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, or via email: prospectus-ny@ny.email.gs.com; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or via telephone: (800) 831-9146; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state, province, territory or other jurisdiction. 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. Cautionary Statement Concerning Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding ArriVent’s business strategies and plans, the completion of the public offering and the use of proceeds therefrom, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” or the negative of these terms or other comparable terminology, which are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Management has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While they believe these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond management's control. These statements involve risks and uncertainties that may cause ArriVent’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements, as discussed in greater detail in its filings with the SEC, including without limitation, risks and uncertainties related to global economic or market conditions, the satisfaction of customary closing conditions related to the public offering, volatility in the share price of its common stock, changes in its operating plans or funding requirements and the risks and uncertainties described in the section entitled “Risk Factors” in its annual report on Form 10-K for the year ended December 31, 2024 that was filed with the SEC on March 3, 2025, its quarterly report on Form 10-Q for the quarter ended March 31, 2025 that was filed with the SEC on May 12, 2025 and its subsequent periodic and current reports filed with the SEC. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, ArriVent assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact for Investors & Media Joyce AllaireLifeSci Advisors, LLCjallaire@lifesciadvisors.com

16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients Robust central nervous system (CNS) activity; 41% (7/17) confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients by BICR in overall cohort Enrollment of first patient in a randomized, global pivotal Phase 3 (ALPACCA) study in first-line PACC patients expected in the second half of 2025 ArriVent to host virtual webinar today at 8 am ET June 23, 2025 -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced encouraging additional follow up proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations and a clinical development update for the firmonertinib program for the treatment of EGFR PACC mutant NSCLC. ArriVent plans to host a virtual webinar today June 23, 2025 at 8 am ET. “We are encouraged by the strong progression-free survival and durable systemic responses with long term firmonertinib treatment in frontline patients with EGFR PACC mutant NSCLC. Moreover, the generally well-tolerated safety profile is consistent with what has been clinically established,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “We believe these Phase 1b findings support the advancement of firmonertinib towards a registration study for EGFR PACC mutant NSCLC, with potential for accelerated approval. We expect to enroll the first patient in the second half of 2025 in our randomized, global pivotal ALPACCA Phase 3 trial.” Stuart Lutzker, M.D., Ph.D., Co-Founder and President of R&D of ArriVent added, “Patients with PACC mutant NSCLC represent an underserved population. We believe the interim median progression free survival of 16 months observed in the FURTHER study is clinically meaningful, and together with the compelling CNS activity and favorable safety profile underscore the potential of firmonertinib to address unmet needs across patients with PACC mutations as a once daily oral, chemo-free monotherapy.” Clinically Meaningful Progression Free Survival and Durable Responses 16.0 months mPFS with firmonertinib 240 mg by BICR with 12.5 months median follow up Majority of patients treated at 240 mg remain on study after 1 year 14.6 months median duration of response with firmonertinib 240 mg by BICR 68.2% and 43.5% confirmed ORR by BICR at 240mg and 160mg dose levels, respectively Confirmed responses at first tumor assessment in the majority of patients 41% (7/17) CNS confirmed CR and 53% (n = 9/17) CNS confirmed ORR in CNS evaluable disease patients by BICR Consistent Safety Profile with No New Safety Signals Generally well-tolerated and manageable safety profile maintained over longer treatment duration (median follow up of 12.5 months) Most frequent treatment-related adverse events (TRAEs) include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin Safety profile consistent with EGFR-TKI class and initial firmonertinib Phase1b PACC and FURTHER data ALPACCA (FURMO-006), the first randomized global Phase 3 study in first-line NSCLC in patients across PACC mutations designed with extensive regulatory input Trial design enables potential for both accelerated and full approval Firmonertinib 240 mg selected as the optimal dose for pivotal Phase 3 development Enrollment of first patient in ALPACCA (FURMO-006) is expected in the second half of 2025 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. Firmonertinib (formerly furmonertinib) 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 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. Food and Drug Administration Orphan Drug Designation for the treatment of non-small cell lung cancer with epidermal growth factor receptor (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 1b study, which includes a cohort evaluating firmonertinib in patients with EGFR PACC mutations (FURTHER; NCT05364073). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd. 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. 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