ARVN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-04

• Also in the second quarter of 2026, we and Pfizer Inc., or Pfizer, entered into a license agreement with Rigel Pharmaceuticals, Inc., or Rigel, for the exclusive global development, manufacturing, and commercialization rights for VEPPANU, or the Rigel License Agreement. Under the terms of the Rigel …

• Pursuant to the terms of the Rigel License Agreement, Rigel paid to us and Pfizer a one-time, upfront payment in the aggregate amount of $70.0 million. In addition, we and Pfizer will receive an additional upfront payment in the amount of $15.0 million upon successful completion of select developmen…

• certain circumstances as provided in the Rigel License Agreement. All payments under the Rigel License Agreement will be shared equally between us and Pfizer. In connection with and to facilitate entry into the Rigel License Agreement, in the second quarter of 2026, we and Pfizer also entered into a…

• Our pipeline, which includes an overview of our clinical and preclinical programs, as well as out-licensed programs, is summarized below.

• *The agents, other than VEPPANU which has been approved by the FDA, in the pipeline graphic above are currently under investigation; their safety and effectiveness for these investigational uses have not been established.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• 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:

• •ARV-102, targeting the leucine-rich repeat kinase 2, or LRRK2, protein for the treatment of neurodegenerative diseases, including progressive supranuclear palsy, or PSP, and Parkinson's disease, or PD;

• •ARV-806, targeting Kirsten rat sarcoma, or KRAS, -G12D protein for cancers with the G12D mutation, including pancreatic, colorectal and non-small cell lung cancer;

• •ARV-393, targeting the B-cell lymphoma 6, or BCL6, protein for the treatment of relapsed/refractory non-Hodgkin lymphoma, or NHL; and

Text added vs the prior filing · source: 10-Q · 2026-08-04

• The risks listed below, versions of which were included in our Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, are replaced in their entirety by the following.

• We and Pfizer entered into the Rigel License Agreement for the commercialization and future development of VEPPANU™ (vepdegestrant), which is currently our only approved product. The success of VEPPANU will be entirely dependent on Rigel's performance of its obligations under the Rigel License Agree…

• In July 2021, we entered into a collaboration agreement with Pfizer, or the Original Vepdegestrant (ARV-471) Collaboration Agreement, pursuant to which we granted Pfizer worldwide co-exclusive rights to develop and commercialize products containing our proprietary compound vepdegestrant, or the Lice…

• Also in the second quarter of 2026, we, Pfizer and Rigel entered into the Rigel License Agreement for the exclusive global development, manufacturing, and commercialization rights for VEPPANU. Under the terms of the Rigel License Agreement, Rigel is responsible for the launch and commercialization o…

• revenue generated outside the U.S. All decisions related to pricing, access, reimbursement, sublicense and ex-U.S. regulatory plans for VEPPANU will be determined by Rigel. We will have no control over these decisions.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• In addition to the risks included in our Annual Report on Form 10-K for the year ended December 31, 2025, the following risk may also affect our business:

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-04

• 10b5-1 trading arrangement”) or (2) a “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K):

• Noah Berkowitz, M.D., Ph.D. (former Chief Medical Officer) (1)

• 10b5-1 Preset Diversification Program ("10b5-1 Plan") for sale of common stock acquired upon the vesting and settlement of restricted stock units ("RSUs") (2)Sale

• Until 8/31/2028 or earlier terminated in accordance with the terms of the 10b5-1 Plan (1)

• (1) Noah Berkowitz, M.D., Ph.D. separated from employment with the Company effective July 3, 2026. Prior to his separation, on June 30, 2026, Dr. Berkowitz terminated the 10b5-1 Plan.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• 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…

• 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…

• 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…