On August 4, 2026 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery, development and commercialization of targeted therapeutics, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer. We presented the positive topline results at ASCO (Free ASCO Whitepaper) from our registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic uveal melanoma while continuing to advance our NDA submission and pre-commercial activities to support a possible commercial launch. Additionally, our clinical pipeline is poised to deliver several key updates throughout the remainder of 2026, including updated data from IDE849, our DLL3 TOP1 ADC, in SCLC and NEC and clinical progress in MTAP-deleted cancers with IDE892, our PRMT5 inhibitor, as both a monotherapy and in combination with IDE397, our proprietary MAT2A inhibitor, and RG6505, Roche’s Phase 1 pan-RAS inhibitor in NSCLC and PDAC, respectively. With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Selected Pipeline Developments and Corporate Updates

Darovasertib for Uveal Melanoma

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IDEAYA presented complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago, Illinois. Data were from a total of 313 patients with first line (1L) HLA*A2:01-negative mUM as of a January 23, 2026 cutoff date, randomized 2:1 to darovasertib in combination with crizotinib (the darovasertib combination) or an investigator’s choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1). The primary endpoint is median progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response.
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The trial met its primary endpoint, with patients receiving the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001). A similar result was observed based on investigator assessment, with the combination leading to a median PFS of 6.7 months versus 2.7 months in the ICT arm (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).
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Patients receiving the darovasertib combination also had clinically meaningful and statistically significant improvements across all key secondary endpoints.
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Overall survival (OS) data was still immature as of the January 23, 2026 cutoff date; however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027.
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Overall, the darovasertib combination was generally well-tolerated with a manageable safety profile, consistent with previous results and known side-effects of each agent.
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IDEAYA has completed enrollment of approximately 100 HLA*A2:01-positive mUM patients in the single-arm, Phase 2 OptimUM-01 trial of the darovasertib combination. The company plans to present updated ORR, PFS and OS results from approximately 85 efficacy-evaluable HLA*A2:01-positive patients, including both first line and pre-treated patients, at the 2026 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place in October in Madrid, Spain.
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Data from OptimUM-01 will be included as part of IDEAYA’s NDA submission to the U.S. Food and Drug Administration (FDA) to support regulatory discussions that have the potential to expand the labeled indication of the darovasertib combination. IDEAYA also plans to publish data from OptimUM-01 for potential inclusion in the clinical practice guidelines to support the use of the combination in certain HLA*A2:01-positive mUM patients. Inclusion in the clinical practice guidelines, if achieved, is intended to provide healthcare professionals with an evidence-based rationale to consider use of darovasertib in appropriate patients and may support payer coverage for such patients.
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Updated clinical data will also be presented at ESMO (Free ESMO Whitepaper) from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib. Based on ongoing patient recruitment considerations for the global Phase 3 OptimUM-10 trial IDEAYA is assessing optimal capital allocation across its portfolio, including accelerating its investment into other high-value programs, such as the DLL3 registrational trial and MTAP/KRAS combination studies. As part of this assessment, the Company is evaluating whether published data from the OptimUM-09 trial could provide a pathway for inclusion in clinical practice guidelines, supporting the use and payer coverage of darovasertib in the neoadjuvant setting of primary uveal melanoma.
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If successful, this approach has the potential to accelerate patient access while reducing the investment required to support clinical utility in the neoadjuvant setting, enabling increased focus on other strategic development priorities.
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Following the successful completion of a Type C meeting with the FDA earlier this year, IDEAYA and its partner, Les Laboratoires Servier (Servier), initiated a global Phase 3 registrational trial (OptimUM-11) to evaluate the darovasertib combination in the adjuvant setting of primary uveal melanoma. OptimUM-11 will enroll approximately 450 patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to 12-months of treatment with the combination or observation. The primary endpoint of the trial is relapse-free survival.
ADC / DDR combinations

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IDE849 (DLL3 TOP1 ADC): IDEAYA’s partner in China, Jiangsu Hengrui Pharmaceuticals (Hengrui), plans to provide a clinical data update from their ongoing Phase 1 trial in SCLC and NEC at ESMO (Free ESMO Whitepaper). The update will include updated ORR, PFS and safety data along with 12-month landmark OS data from approximately 100 patients enrolled in the trial. IDEAYA also plans to provide the first clinical data from its ongoing global Phase 1/2 trial of IDE849 in SCLC and NEC in the second half of 2026.
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IDEAYA is having discussions with the FDA to align on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC and plans to provide more detail on the proposed trial design with its data update in the second half of the year, with the goal of initiating the registrational trial by the end of 2026. Hengrui is also targeting to initiate a Phase 3 registrational trial for IDE849 in refractory SCLC in China by the end of 2026.
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IDE161 (PARG): IDEAYA is also conducting a Phase 1 combination trial of IDE849 with IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor in patients with DLL3-upregulated solid tumors, including SCLC, NEC and melanoma.IDEAYA has previously shared preclinical data demonstrating the mechanism of action and potential synergy of IDE161 in combination with TOP1-payload based ADCs in driving enhanced anti-tumor activity.
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IDE034 (B7H3/PTK7 bispecific TOP1 ADC): IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data. IDE034 is a potentially first-in-class B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats.
MTAP pathway

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IDE892 (PRMT5): monotherapy expansion has been initiated in the Phase 1/2 clinical trial evaluating IDE892 in MTAP-deleted solid tumors, with a focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The expansion has been initiated at projected efficacious target human exposures where 24-hour target EC90 coverage has been achieved. The IDE892 maximum tolerated dose (MTD) has not yet been reached in the ongoing dose escalation.
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IDE397 (MAT2A): a Phase 1/2 combination cohort was initiated to evaluate IDE892 with IDE397, IDEAYA’s proprietary MAT2A inhibitor, in MTAP-deleted cancers. Expansion is planned by year end 2026 or early 2027, with an initial clinical focus on MTAP-deleted NSCLC. Dual inhibition of MAT2A and PRMT5 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.
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In May, IDEAYA entered into a clinical trial collaboration with Roche to explore IDE892 in combination with RG6505, Roche’s proprietary Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC to target the genetic co-alterations of MTAP and KRAS in this indication. IDEAYA plans to begin a Phase 1 combination trial in the second half of 2026.
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Upon joint IDEAYA and Roche approval, the collaboration may also evaluate a combination triplet with IDE892, RG6505, and IDE397, IDEAYA’s proprietary Phase 1/2 MAT2A inhibitor.
KAT6/7

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IDE574 (KAT6/7): a Phase 1 dose escalation trial is underway in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation.

Corporate

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In June, IDEAYA successfully completed a public offering of 7,222,225 shares of common stock and pre-funded warrants to purchase 5,555,576 shares of common stock, inclusive of the underwriters’ full exercise of their option to purchase additional shares in the offering. Net proceeds from the offering were approximately $323.4 million, after deducting underwriting discounts, commissions and other expenses.
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IDEAYA is targeting to host an MTAP/CDKN2A, KRAS, and Pancreatic Cancer R&D Day in the fourth quarter of 2026. Topics will include rational combination strategies to target the underlying tumor heterogeneity and adaptive plasticity in PDAC and other solid tumor indications. Additional agenda details and key participants will be provided at a later date.
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As of June 30, 2026, IDEAYA had approximately $1.24 billion in cash, cash equivalents and marketable securities. IDEAYA’s cash runway guidance into 2030 is unchanged based on the current operating plan.

Financial Results for the Quarter Ended June 30, 2026
As of June 30, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.24 billion, compared to $972.9 million as of March 31, 2026. The increase was primarily attributable to $323.4 million in net proceeds from the underwritten public offering and pre-funded warrants to purchase common stock and $33.1 million from the sale of common stock shares through IDEAYA’s at-the-market offering program, partially offset by net cash used in operations.

Collaboration revenue for the three months ended June 30, 2026, totaled $8.9 million, compared to $6.6 million for the three months ended March 31, 2026. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of June 30, 2026, the remaining balance for the research and development services performance obligations is $147.0 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended June 30, 2026 totaled $108.7 million, compared to $95.7 million for the three months ended March 31, 2026. The increase was primarily driven by higher clinical trial and personnel-related expenses to support IDEAYA’s programs.

General and administrative (G&A) expenses for the three months ended June 30, 2026 totaled $22.5 million, compared to $19.4 million for the three months ended March 31, 2026. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities.

The net loss for the three months ended June 30, 2026, was $112.5 million compared to the net loss of $98.5 million for the three months ended March 31, 2026. Total stock compensation expense for the three months ended June 30, 2026, was $16.7 million compared to $14.5 million for the three months ended March 31, 2026.

(Press release, Ideaya Biosciences, AUG 4, 2026, View Source [SID1234669659])

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])