On August 4, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the second quarter 2026.

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"Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in treatment and the rapid expansion of our PrEP business, supporting an increase in our base business revenue expectations for 2026," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "We also made significant clinical progress with three FDA approvals and three positive Phase 3 updates. We look forward to delivering on our many opportunities in the second half of the year including another two potential launches in oncology and HIV."

Second Quarter 2026 Financial Results

•Total second quarter 2026 revenues increased 10% to $7.8 billion compared to the same period in 2025, primarily driven by:
◦Higher sales of HIV products, Trodelvy (sacituzumab govitecan-hziy) and Livdelzi (seladelpar), partially offset by lower sales of Veklury (remdesivir) as well as Cell Therapy and chronic hepatitis C virus ("HCV") products; and
◦Higher royalty, contract and other revenues related to a previous sale of intellectual property.
•Diluted (loss) earnings per share ("EPS") was $(8.45) in the second quarter 2026 compared to $1.56 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired in-process research and development ("IPR&D") expenses associated with our acquisitions of Arcellx, Inc. ("Arcellx"), Tubulis GmbH ("Tubulis") and Ouro Medicines, LLC ("Ouro Medicines"), net of the impact of our collaboration with Lakefront Biotherapeutics NV ("Lakefront") and the related taxes, as well as an IPR&D impairment related to assets previously acquired from Immunomedics, Inc. ("Immunomedics") and higher operating expenses. The decrease was partially offset by higher revenues, lower income tax expense, and higher net gains from equity securities.
•Non-GAAP diluted (loss) EPS was $(6.75) in the second quarter 2026 compared to $2.01 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired IPR&D and tax expenses discussed above, as well as higher non-GAAP selling, general and administrative ("SG&A") expenses and non-GAAP income tax expense, partially offset by higher revenues.
•As of June 30, 2026, Gilead had $3.2 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by year-to-date cash outflows of $11.3 billion related to acquisitions, $2.8 billion of debt repayments, $2.1 billion of dividend payments and $774 million of common stock repurchases, partially offset by $4.1 billion of net proceeds from debt financing and $6.1 billion of operating cash flow.
•During the second quarter 2026, Gilead generated $3.6 billion in operating cash flow.
•During the second quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $355 million of common stock.

Second Quarter 2026 Product Sales
Total second quarter 2026 product sales increased 8% to $7.6 billion compared to the same period in 2025. Total second quarter 2026 product sales excluding Veklury increased 10% to $7.6 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Cell Therapy and HCV products.
HIV product sales increased 12% to $5.7 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 7% to $3.8 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, favorable inventory dynamics and higher demand.
•Descovy (FTC 200mg/TAF 25mg) sales increased 48% to $967 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand.
The Liver Disease portfolio sales increased 10% to $877 million in the second quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as chronic hepatitis B virus ("HBV") products and Hepcludex (bulevirtide-gmod), partially offset by lower sales for HCV products.
Veklury sales decreased 81% to $23 million in the second quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations.
Cell Therapy product sales decreased 14% to $417 million in the second quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds.
•Yescarta (axicabtagene ciloleucel) sales decreased 12% to $346 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition.
•Tecartus (brexucabtagene autoleucel) sales decreased 24% to $70 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in-class competition.
Trodelvy (sacituzumab govitecan-hziy) sales increased 26% to $457 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher demand.
Second Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin remained relatively flat at 79.3% in the second quarter 2026 compared to 78.7% in the same period in 2025. Non-GAAP product gross margin also remained flat at 86.9% in the second quarter 2026 compared to the same period in 2025.
•Research and development ("R&D") expenses were $1.8 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily due to integration costs and other acquisition-related expenses, partially offset by lower oncology clinical study activity. Non-GAAP R&D expenses were $1.4 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily driven by lower oncology clinical study activity.
•Acquired IPR&D expenses were $11.2 billion in the second quarter 2026, primarily related to $7.0 billion for the Arcellx acquisition, $3.1 billion for the Tubulis acquisition and $1.0 billion for the Ouro Medicines acquisition, net of the impact of the Lakefront collaboration.
•SG&A expenses were $1.9 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by integration costs related to the acquisitions and higher HIV promotional activities. Non-GAAP SG&A expenses were $1.5 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities.

•The effective tax rate ("ETR") was (2.4)% in the second quarter 2026 compared to 19.3% in the same period in 2025. The non-GAAP ETR was (11.4)% in the second quarter 2026 compared to 18.8% in the same period in 2025. These changes primarily reflect the non-deductible acquired IPR&D expenses related to our acquisitions of Arcellx, Tubulis, and Ouro Medicines.
Guidance and Outlook
For the full year 2026, Gilead now expects:
(in millions, except per share amounts) August 4, 2026 Guidance
Low End High End Comparison to May 7, 2026 Guidance
Product sales $ 30,100 $ 30,400
Previously $30,000 to $30,400
Product sales excluding Veklury $ 29,800 $ 30,100
Previously $29,400 to $29,800
Veklury
~ $300
Previously ~ $600
Diluted loss per share $ (3.75) $ (3.40)
Previously $(3.25) to $(2.85)
Non-GAAP diluted loss per share $ (0.65) $ (0.30)
Previously $(1.05) to $(0.65)

Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.08 due to acquired IPR&D charges of $11.1 billion related to the Arcellx, Tubulis and Ouro Medicines transactions, net of the impact of the Lakefront collaboration and related taxes.
Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.
Key Updates Since Our Last Quarterly Release
Virology
•Announced U.S. Food and Drug Administration ("FDA") accepted a supplemental New Drug Application submission for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis ("PrEP"), with a Prescription Drug User Fee Act target action date of February 2, 2027.
•Announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials, in partnership with Merck, evaluating an investigational long-acting oral treatment regimen of islatravir 2 mg and lenacapavir 300 mg in adults with HIV who are virologically suppressed and switched from Biktarvy (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2) to the once-weekly combination.
•Received FDA accelerated approval for Hepcludex for the treatment of chronic hepatitis delta virus ("HDV") infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S.
•Announced a donation of 2,000 vials of remdesivir to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease ("BVD"). Remdesivir is not approved for the treatment of Ebola virus disease, including BVD, anywhere globally, and the safety and efficacy of this use is not known.
Oncology
•Received FDA approval of Trodelvy for the first-line ("1L") treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer ("mTNBC") as either a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor-based therapy or in combination with Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for patients whose tumors express PD-L1 (CPS ≥10).

•Announced European Commission marketing authorization for Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy.
•Received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Trodelvy in combination with Keytruda (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 (CPS≥10).
•Announced the discontinuation of the Phase 3 EVOKE-03 study, in partnership with Merck, evaluating Trodelvy in combination with Keytruda for the investigational treatment of 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%). The decision was based on the recommendation of the external Data Monitoring Committee, following review of data from a pre-specified final analysis of progression-free survival and interim analysis of overall survival.
•Presented new analyses at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting from the Phase 3 ASCENT-03 and ASCENT-04 studies evaluating Trodelvy with or without Keytruda in 1L mTNBC, as well as new data on investigational anitocabtagene-autoleucel ("anito-cel") clinical trial manufacturing experience in patients with newly diagnosed or relapsed/refractory multiple myeloma.
•Presented updated Phase 1 results for KITE-753, an investigational bicistronic autologous CD19/CD20 CAR T-cell therapy for relapsed or refractory B-cell lymphoma at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) meeting.
•Completed the acquisition of Tubulis for $3.15 billion in upfront consideration. This acquisition brings Gilead next-generation antibody-drug conjugate ("ADC") assets, including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, and a platform to develop novel ADCs.
Inflammation
•Completed the acquisition of Ouro Medicines for $1.675 billion in upfront consideration, which brings Gilead gamgertamig, an investigational clinical stage BCMAxCD3 T cell engager for autoimmune diseases. The acquisition was completed in collaboration with Lakefront, which equally shared the upfront payment and will equally share contingent milestone payments, subject to customary adjustments.
•Announced positive results from the Phase 3 IDEAL study, supporting the potential of Livdelzi to help people living with primary biliary cholangitis ("PBC") with elevated alkaline phosphatase ("ALP") levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with ursodeoxycholic acid ("UDCA"), or who are intolerant to UDCA.
•Presented data from the open-label Phase 3 ASSURE study at the 2026 European Association for the Study of the Liver Congress evaluating the long-term safety and tolerability profile of Livdelzi in people living with PBC with elevated ALP levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with UDCA, or who are intolerant to UDCA.
Corporate
•Issued $3.0 billion aggregate principal amount of senior unsecured notes and borrowed $1.1 billion aggregate principal amount under a one-year term loan facility.
•Announced a renewed 5-year collaboration with the World Health Organization to commit funding, strategic support and AmBisome donations toward eliminating visceral leishmaniasis.
•The Board declared a quarterly dividend of $0.82 per share of common stock for the third quarter of 2026. The dividend is payable on September 29, 2026, to stockholders of record at the close of business on September 15, 2026. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

(Press release, Gilead Sciences, AUG 4, 2026, View Source [SID1234669658])

On August 4, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX) reported that the first patient has been enrolled in the global Phase 3 DAYBreak CLL-306 study (NCT07516093) evaluating bexobrutideg, a potential best-in-class targeted protein degrader of Bruton’s tyrosine kinase (BTK), in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor. The global study is being conducted under the collaboration between Nurix and Roche and marks the first Phase 3 trial for bexobrutideg. The registrational study is designed to demonstrate the superiority of bexobrutideg versus the non-covalent BTK inhibitor pirtobrutinib, the current standard of care in this treatment setting for patients whose disease has progressed following prior covalent BTK inhibitor therapy.

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"This is an important milestone for the global bexobrutideg development program with the potential to redefine the treatment landscape for patients with CLL through a head-to-head comparison of BTK degradation versus non-covalent inhibition," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We believe targeted protein degradation offers a fundamentally differentiated approach to addressing disease targets as compared to traditional small molecule inhibition, and this trial is designed to test whether that differentiation translates into superior outcomes for patients. Together with Roche, we are committed to advancing an ambitious global development program intended to fully realize the potential of BTK degradation across oncology, immunology and neurology."

The randomized Phase 3 trial is expected to enroll approximately 620 patients with relapsed/refractory CLL/SLL who have previously progressed on a covalent BTK inhibitor. Patients will be randomized 1:1 to receive either bexobrutideg 600 mg orally once per day or pirtobrutinib. The dual primary endpoints are objective response rate (ORR) and progression free survival (PFS), as assessed by an independent review committee. The study is designed to evaluate the potential superiority of bexobrutideg relative to pirtobrutinib and support global regulatory submissions.

"Bexobrutideg has demonstrated robust clinical activity in the setting of relapsed/refractory CLL with a favorable safety and tolerability profile," said Paula O’Connor, M.D., chief medical officer of Nurix. "The initiation of DAYBreak CLL-306 reflects our commitment to bringing innovative treatment options to patients with CLL who continue to face significant unmet medical needs."

About Bexobrutideg (NX-5948)
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

​​​Bexobrutideg is currently being evaluated in a broad clinical development program in patients with chronic lymphocytic leukemia (CLL) including the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed/refractory CLL, the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed/refractory CLL, and the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed/refractory B-cell malignancies. Nurix’s plans also include the NX-5948-203 Phase 1/2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed/refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

(Press release, Hoffmann-La Roche, AUG 4, 2026, View Source [SID1234669657])

On August 4, 2026 Evexta Bio S.A., a precision oncology company, founded by Truffle Capital (founder of Abivax and Carvolix), and focused on the discovery and development of targeted therapies, reported a clinical collaboration and supply agreement with plans to initiate a Phase 1b study combining its lead investigational compound, rupitasertib, with Roche’s investigational compound giredestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer.

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Rupitasertib is a first-in-class oral dual-node PI3K/AKT/mTOR (PAM) pathway inhibitor, which selectively inhibits S6K and AKT1/3. Rupitasertib was purposefully and rationally designed to target S6K for potent PAM inhibition and AKT1/3 to block the AKT compensatory feedback loop, while sparing AKT2 to avoid hyperglycemia, which we believe will lead to a superior efficacy and safety profile compared to other PAM pathway inhibitors.

Under the terms of the agreement, Roche will supply giredestrant and Evexta Bio will conduct the Phase 1b study assessing the safety, tolerability, and preliminary anti-tumor activity of rupitasertib in combination with giredestrant in ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. The study is intended to enroll at least 15 patients and is expected to be initiated in Q4 2026.

Dr. Shawn M. Leland, PharmD, RPh, Board Chairman of Evexta Bio stated: "We are very pleased and excited to partner with Roche on Evexta Bio’s first clinical collaboration with rupitasertib. ER+, HER2-, ESR1-mutated breast cancer remains a significant unmet medical need. We are looking forward to being able to provide ER+, HER2-, ESR1-mutated breast cancer patients with the option to receive an all-oral regimen of a first-in-class, dual-node PAM pathway inhibitor and a SERD."

(Press release, Evexta Bio, AUG 4, 2026, View Source [SID1234669656])

On August 4, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum technology, reported the appointment of Dr. Amie Phinney, PhD, MBA, as the President and Chief Executive Officer, effective August 1, 2026.

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As part of the leadership transition, Mr. Sébastien Plouffe, Founder and Chief Executive Officer, will now assume the position of Executive Chairman of the Board, where he will continue to play a critical leadership role in guiding the Company’s strategic direction, financing initiatives, corporate partnerships, and long-term growth.

Since joining Defence in 2025, Dr. Phinney has played a key role in supporting Defence’s strategic evolution, strengthening its scientific and commercial positioning, and advancing the Accum technology into the next-generation intracellular drug delivery platform. She joined Defence as Strategy & Business Advisor in July 2025 and was appointed to the Board of Directors in September 2025.

"Over the past year, Amie has demonstrated exceptional leadership, strategic vision, and an unwavering commitment to Defence’s mission," said Sébastien Plouffe, Executive Chairman of Defence Therapeutics. "She has played an instrumental role in refining our corporate strategy, expanding our scientific and commercial vision, building the foundation for new strategic partnerships, and positioning Defence for its next phase of growth. The Board is confident that she is the right leader to guide the Company as we accelerate the development of the Accum platform, expand our therapeutic pipeline, and pursue strategic partnerships."

Dr. Phinney mentioned "I am honoured to be taking on the leadership of Defence Therapeutics at this exciting period of growth for the Company. Defence has built a differentiated technology platform with the potential to transform the delivery of complex biologics and targeted therapeutics. I look forward to working alongside our outstanding scientific team, Board of Directors, partners, and shareholders to accelerate the development of our pipeline, expand the applications of the Accum platform, and position Defence as a global leader in precision intracellular drug delivery."

Dr. Phinney brings more than two decades of international leadership experience spanning pharmaceutical research and development, biotechnology company creation, corporate strategy, business development, and commercialization. She previously held a range of scientific and strategic roles at Abbott and AbbVie (Chicago, USA), supporting strategic planning, alliance management, and business operations across multiple global R&D organizations. She subsequently served as Chief Scientific Officer of Lakeside Discovery, a venture-backed biotechnology company spun-out from Northwestern University in Chicago, advancing academic innovations into therapeutic programs. Most recently, she was the Senior Director of Partnerships and Business Development at adMare BioInnovations, where she helped launch and grow biotechnology companies emerging from Canadian research institutions. She is also the co-founder of Block Biosciences and served as its inaugural Chief Executive Officer, leading the academic biotechnology spinout in the development of first-in-class oncology therapeutics. Dr. Phinney holds a PhD in Biomedical Research from the University of Basel (Switzerland) and an MBA from Lake Forest Graduate School of Management (Chicago, USA). She has also completed executive education in corporate governance (Rotman School of Management, University of Toronto), private capital investment (Ivey Academy, Western University), high-performance negotiation (Kellogg School of Management, Northwestern University), and business leadership (Kenan-Flagler Business School, University of North Carolina at Chapel Hill).

As Executive Chairman, Mr. Plouffe will continue to work closely with Dr. Phinney and the Board, focusing on corporate strategy, capital markets, business development, strategic partnerships, and governance, while supporting the Company’s long-term growth objectives.

"This transition reflects the natural evolution of Defence Therapeutics," added Mr. Plouffe. "I remain deeply committed to the Company and look forward to supporting Amie and the management team as we execute on the tremendous opportunities ahead."

Under Dr. Phinney’s leadership, Defence Therapeutics will continue executing its strategy to expand the clinical and commercial potential of its proprietary Accum platform across antibody-drug conjugates (ADCs), radiotherapeutics, and other targeted biologics, while advancing strategic collaborations with biotechnology and pharmaceutical partners.

The Company wishes to announce that it has granted a total of 600,000 incentive stock options, in accordance with the terms and conditions of Defence’s omnibus incentive plan, including (i) 200,000 options to Dr. Phinney, of which 100,000 are vested immediately and 100,000 will be vested on the 1st anniversary of the date of grant, exercisable at a price of 40 cents per share for a period of five years from the date of grant, (ii) 200,000 options to an employee at the same terms; and (iii) 200,000 to the Executive Chairman vested immediately and exercisable at a price of 40 cents per share for a period of ten years from the date of grant.

(Press release, Defence Therapeutics, AUG 4, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-appoints-dr-amie-phinney-as-president-and-chief-executive-officer [SID1234669655])

On August 4, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported financial results for the second quarter 2026, and provided a corporate update.

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"Our progress during the quarter has helped position us to fully capitalize on the promise of our platform in oncology and neurology," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "The approval of VEPPANU, the first ever for a PROTAC degrader, was a significant achievement for the Company, and our subsequent licensing of VEPPANU to Rigel Pharmaceuticals promises to unlock its commercial potential and provide access to patients as efficiently as possible."

"As we move into the second half of the year, enrollment in our ongoing Phase 1 trials is strong and we have important data milestones planned over the next 12 months for ARV-393, ARV-102, and ARV-027," continued Dr. Teel. "In addition, we are initiating our first immuno-oncology Phase 1 trial with ARV-6723 – an HPK1 degrader that has shown meaningful single-agent activity in preclinical models where neither an inhibitor nor an anti-PD1 therapy has shown benefit. Altogether, our pipeline has the potential to address high unmet medical needs and maximize both clinical impact and long-term shareholder value."
Second Quarter 2026 Business Highlights and Recent Developments

Approved Product

VEPPANU (vepdegestrant): Oral PROTAC ER degrader
As part of Arvinas global collaboration with Pfizer, the companies:
•Announced the approval of VEPPANU for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
◦This approval marks the first time the U.S. Food and Drug Administration (FDA) has approved a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy.

•Entered into a license agreement with Rigel Pharmaceuticals, Inc. for the exclusive global development, manufacturing, and commercialization rights for VEPPANU.
•Announced that the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*

Pipeline

ARV-393: Oral PROTAC BCL6 degrader
•Continued dose escalation in the Phase 1 trial in patients with non-Hodgkin lymphoma (NHL).
▪Preliminary clinical activity has been observed, including responses in B- and T-cell lymphomas, in early cohorts at doses below the predicted effective exposure level.
•Continued enrollment in the Phase 1 combination trial with glofitamab in patients with diffuse large B-cell lymphoma (DLBCL).

ARV-102: Oral PROTAC LRRK2 degrader
•Joined the LRRK2 Investigative Therapeutics Exchange (LITE) program and the Parkinson’s Precision Medicine Initiative (PPMI), both supported by The Michael J. Fox Foundation for Parkinson’s Research (MJFF).

ARV-027: Oral PROTAC polyQ-AR degrader
•Completed the single-ascending dose cohorts of the first-in-human Phase 1 clinical trial in healthy volunteers and initiated enrollment in the multiple dose cohorts in healthy volunteers.

ARV-6723: Oral PROTAC HPK1 degrader
Arvinas’ first immuno-oncology clinical candidate
•Presented preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating greater antitumor activity than standard-of-care immune checkpoint inhibitors (ICIs) or an investigational HPK1 inhibitor.
◦Unlike an inhibitor and ICIs, ARV-6723 reversed T-cell exhaustion, reversed the immunosuppressive tumor microenvironment, and boosted innate cell immunity in ICI-(aPD1 and aCTLA4) resistant models.

Novel pan-KRAS degrader
•Presented preclinical data at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics.
◦Robust efficacy observed in CDX models of pancreatic, colorectal, and lung cancer.
◦Greater tumor growth inhibition than a pan-RAS (ON) inhibitor demonstrated in a KRAS G13D model.
◦Enhanced combination efficacy with immune checkpoint blockade compared with a pan-RAS (ON) inhibitor observed in a KRAS G12D syngeneic model.

ARV-806: Novel PROTAC KRAS G12D degrader

•Completed dose escalation enrollment in the Phase 1 clinical trial in patients with solid tumors harboring KRAS G12D mutations.
◦Reiterated plan to share initial data from the Phase 1 monotherapy dose escalation clinical trial in the second half of 2026.
•Announced plans to seek an out-licensing agreement for any additional clinical trials, including dose expansion or combination clinical trials.

Anticipated Upcoming Milestones and Expectations

ARV-393: Oral PROTAC BCL6 degrader
•Share data from early monotherapy cohorts in the ongoing Phase 1 dose escalation clinical trial in patients with relapsed/refractory NHL (ClinicalTrials.gov Identifier: NCT06393738) at a medical congress (2H 2026).
◦Share additional monotherapy data from the ongoing Phase 1 dose escalation trial in B- and T-cell lymphomas (mid-2027).
◦Share data from the combination cohort with glofitamab in patients with DLBCL in the ongoing Phase 1 clinical trial (mid-2027).

ARV-102: Oral PROTAC LRRK2 degrader
•Share additional biomarker data from the Phase 1 clinical trial in patients with Parkinson’s disease at the International Congress on Parkinson’s Disease and Movement Disorders (October 2026).
•Continue discussions with global health authorities on plans to initiate clinical trials in patients with progressive supranuclear palsy (2027).

ARV-027: Oral PROTAC polyQ-AR degrader
•Continue enrollment in the multiple dose cohort of the Phase 1 clinical trial in healthy volunteers and share initial data evaluating androgen receptor (AR)-degradation in muscle (1H 2027).

ARV-6723: Oral PROTAC HPK1 degrader
•Initiate enrollment of the Phase 1 clinical trial in patients with advanced solid tumors (3Q 2026).
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of June 30, 2026, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.
Second Quarter 2026 Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2026, cash, cash equivalents, and marketable securities were $567.9 million as compared with $685.4 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities of $117.5 million for the six months ended June 30, 2026, was primarily related to cash used in operations of $114.3 million (net of $35.0 million received under the Rigel License Agreement), unrealized losses on marketable securities of $2.0 million, and the purchase of lab equipment and leasehold improvements of $1.5 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) research and development (R&D) expenses were $52.6 million for the quarter ended June 30, 2026, as compared with $68.6 million for the quarter ended June 30, 2025. The decrease in R&D expenses of $16.0 million for the quarter was primarily due to a decrease in compensation and related personnel expenses of $11.0 million, which are not allocated by program, and a decrease in external expenses of $3.2 million. External expenses include (i) program-specific expenses, which decreased by $0.6 million, primarily driven by a decrease in our vepdegestrant (ARV-471) program of $10.6 million, partially offset by increases in our ARV-806, ARV-027, and ARV-393 programs of $3.9 million, $3.2 million, and $2.3 million, respectively.
Non-GAAP R&D expenses were $51.4 million for the quarter ended June 30, 2026, as compared with $59.5 million for the quarter ended June 30, 2025, excluding $0.3 million and $0.6 million of restructuring expense for the quarters ended June 30, 2026, and 2025, respectively, and $0.9 million and $8.5 million of non-cash stock-based compensation expense for the quarters ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

General and Administrative Expenses: GAAP general and administrative (G&A) expenses were $24.0 million for the quarter ended June 30, 2026, as compared with $25.3 million for the quarter ended June 30, 2025. The decrease in G&A expenses of $1.3 million for the quarter was primarily due to decreases in personnel and infrastructure related costs of $3.9 million, and costs related to developing our commercial operations of $1.4 million, partially offset by an increase in professional fees of $4.2 million, inclusive of an increase in the amortization of costs to obtain a contract related to the Pfizer Letter Agreement supplementing and amending the terms of the Original Vepdegestrant (ARV-471) Collaboration Agreement and professional fees related to the Rigel License Agreement.

Non-GAAP G&A expenses were $18.4 million for the quarter ended June 30, 2026, as compared with $18.1 million for the quarter ended June 30, 2025, excluding $1.3 million and $0.4 million of restructuring expenses for the quarters ended June 30, 2026, and 2025, respectively, and $4.3 million and $6.8 million of non-cash stock-based compensation expense for the quarter ended June 30, 2026, and 2025, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Cost of License Revenue: Cost of license revenue was $9.0 million for the quarter ended June 30, 2026, as compared with zero for the quarter ended June 30, 2025. The increase of $9.0 million was due to expenses under the Amended Yale License Agreement related to the FDA’s approval of VEPPANU and the entry into the Rigel License Agreement.
Revenue: Revenue was $249.7 million for the quarter ended June 30, 2026, as compared with $22.4 million for the quarter ended June 30, 2025. Revenue for the quarter is related to the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the research collaboration agreement with Pfizer and the Rigel License Agreement. The increase of $227.3 million was primarily due to $112.6 million of revenue from the Original Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer driven by the recognition of the remaining deferred revenue upon entry into the Rigel License Agreement of $126.4 million, partially offset by a decrease in revenue of $13.8 million for the period prior to the Rigel License Agreement. In addition, we recognized $62.5 million of revenue from the Rigel License Agreement, and $50.0 million of revenue from a development milestone payment in connection with the FDA’s approval of VEPPANU.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, August 4, 2026, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.

(Press release, Arvinas, AUG 4, 2026, View Source [SID1234669654])