ARVN 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• We are a biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, protein degradation platform, we are pioneering the development of a new class of therapeutics designed to harn…

• In the past five years, seven of the programs developed using our PROTAC protein degradation platform have progressed to clinical trials in oncology and neurology indications after demonstrating potent and selective protein degradation in our preclinical studies. We believe favorable clinical trial …

• In the second quarter of 2026, the U.S. Food and Drug Administration, or FDA, approved VEPPANU™ (vepdegestrant) for the treatment of adults with estrogen receptor-positive, or ER+,/human epidermal growth factor receptor 2-negative, or HER2-, estrogen receptor 1, or ESR1, -mutated advanced or metasta…

• In September 2025, we and Pfizer, Inc. announced our plan to jointly select a third party for the commercialization and potential further development of vepdegestrant. We and Pfizer, remain on track to announce selection of a third party to commercialize VEPPANU.

• We are currently also progressing the following product candidates through clinical development programs:

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• We are a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through our PROteolysis TArgeting Chimera, or PROTAC, degrader platform, we are pioneering the development of protein degradation therapies designed t…

• •Defined terms used in the graphic above include: AR, androgen receptor; BCL6, B-cell lymphoma 6; ER, estrogen receptor; HPK1, Hematopoietic Progenitor Kinase 1; I-O, immuno-oncology; KAT6, lysine acetyltransferase 6; KRAS, Kirsten rat

• sarcoma viral oncogene homolog; LRRK2, leucine-rich repeat kinase 2; mCRPC, metastatic castration resistant prostate cancer; mHSPC, metastatic hormone sensitive prostate cancer; NDA, new drug application; NHL, non-Hodgkin lymphoma; polyQ, expanded polyglutamine.

• Clinical Stage Programs: ARV-102, ARV-393, ARV-806 and vepdegestrant

• ARV-102 is an investigational, orally bioavailable and brain-penetrant investigational PROTAC designed to specifically target and degrade LRRK2, which is a large, multidomain scaffolding kinase with GTPase activity. ARV-102 is our first oral PROTAC protein degrader in development to treat neurodegen…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. The term “disclosure controls…

• No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial repo…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our

• disclosure controls and procedures as of September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to en…

• No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended September 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial …

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• We currently have only one approved product, VEPPANU™ (vepdegestrant), and the success of VEPPANU will depend on our and Pfizer’s ability to identify and successfully execute a commercialization arrangement with a third party and on the terms of any such deal.

• In the second quarter of 2026, we announced that the FDA approved our new drug application for VEPPANU™ (vepdegestrant) for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least o…

• In the third quarter of 2025, we announced that we and our collaborator, Pfizer, have agreed to jointly select a third party for the commercialization and potential future development of vepdegestrant. In the second quarter of 2026, we announced that, we and Pfizer remain on track to announce select…

• While we believe we are on track to announce selection of a third party, there is no assurance that we actually will be able to identify a suitable partner for VEPPANU or that, if we are able to identify such a partner, we will be able to enter into a definitive agreement with that partner on accept…

• The commercial success of VEPPANU will be dependent upon our ability to enter into an agreement, and close any transaction, with a third party. Failure to enter into an agreement or close a transaction or entering into an agreement where the third party does not perform its obligations, may mean tha…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

• In April 2025, we committed to and approved a reduction in our workforce by approximately 33% across all areas of our company, as part of our decision to streamline operations across the organization and enable the efficient progression of our portfolio. In addition, in September 2025, we announced …

• Disruptions at the U.S. Food and Drug Administration, or FDA, and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other

• developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.

• The FDA and comparable regulatory agencies in foreign jurisdictions, such as the European Medicines Agency, or EMA, play an important role in the development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including inves…

相对上期新增的文字 · 来源:10-Q · 2026-05-11

• The following table describes, for the first quarter of 2026, each trading arrangement for the sale or purchase of Company securities adopted or terminated by our directors and officers that is either (1) a contract, instruction or written plan intended to satisfy the affirmative defense conditions …

• Name (Title)Action Taken (Date of Action)Type of Trading ArrangementNature of Trading ArrangementDuration of Trading Arrangement

• Randy Teel, Ph.D. (President, Chief Executive Officer, and Director)

• 2/27/2026Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that were granted on or after February 26, 2026; and all equity awards granted prior to February 26, 2026 that vest after the relevant cooling off periodSaleUntil final settlement of any res…

• 2/27/2026Durable Rule 10b5-1 trading arrangement for sell-to-cover transactions relating to all equity awards that were granted on or after February 26, 2026; and all equity awards granted prior to February 26, 2026 that vest after the relevant cooling off periodSaleUntil final settlement of any RSU…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• our securities in a manner that avoids concerns about initiating transactions while in possession of material nonpublic information.

• None of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this Quarterly Report on Form 10-Q.

• On November 4, 2025, we entered into amended and restated employment agreements with each of Angela Cacace, Ph.D., our Chief Scientific Officer, and Randy Teel, Ph.D., our Chief Business Officer. Each of Dr. Cacace and Dr. Teel is a named executive officer in our definitive proxy statement for our 2…

• The original employment agreements with each of Dr. Cacace and Dr. Teel were each entered into with us on January 2, 2019. The employment agreements for Dr. Cacace and Dr. Teel were amended and restated primarily so that the agreements would appropriately reflect the current title and level of compe…