On August 6, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, and Freenome, a biotechnology company pioneering an early cancer detection platform, reported they have entered into an agreement under which Exact Sciences will acquire exclusive rights in the United States to current and future versions of Freenome’s blood-based, single indication, colorectal cancer (CRC) screening tests (Press release, Exact Sciences, AUG 6, 2025, View Source [SID1234654862]).

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Complete findings from the prospective PREEMPT study were recently published in JAMA, a high-quality peer-reviewed journal. U.S. Census adjusted results as reported in JAMA show Freenome’s first version test achieved sensitivities of 81% for CRC and 14% for advanced precancerous lesions (APL) at specificity of 90%. The Freenome team recently submitted the last module of the pre-market application to the FDA. Freenome then plans to submit a supplement to the FDA for its next-generation test once final clinical validation data are available.

"This exclusive license expands our leadership in cancer screening with the addition of blood-based options," said Kevin Conroy, Chairman & CEO. "Cologuard Plus is the most accurate guideline-included non-invasive colorectal cancer screening test. We’re now able to offer a complementary blood-based option to the over 50 million unscreened Americans, supported by our broad commercial reach, ExactNexus technology platform, and deep relationships with health systems and payers."

"The test performance represents an important step toward closing the screening gap in the United States," said Aaron Elliott, Ph.D., Chief Executive Officer at Freenome. "Exact Sciences brings the scale, reach, and proven track record to maximize its impact and deliver this technology to patients faster and with greater certainty."

In addition, Exact Sciences shared initial results from an internal version of its CRC blood test, showing sensitivities of 73% for CRC and 14% for APL at 90% specificity. These results do not include the additional marker class presented at the ESMO (Free ESMO Whitepaper) 2024 congress. Internal testing and evaluation of the assay are ongoing.

Transaction terms and additional information

Under the terms of the agreement, Freenome will receive $75 million in cash payable by November 2025. Additional potential payments of up to $700 million are based on the achievement of certain milestones for Freenome’s blood-based CRC screening tests, including:

$100M upon first-line FDA approval for the first version test
$100M upon first-line FDA approval for the next-generation test contingent on performance benchmarks such as ≥19% APL sensitivity and ≥83% overall CRC sensitivity, provided a reduced payment would be payable for certain performance levels below such benchmarks
$500M if rated as a first-line A or B test in the United States Preventive Services Taskforce (USPSTF) guidelines or meeting certain payer contracted coverage requirements, provided a reduced payment would be payable based on second-line A or B USPSTF guidelines inclusion
Freenome may be eligible to receive royalty rates ranging from 0% to 10% based on the test’s profitability and subject to customary royalty stacking provisions. If certain criteria are not met, Exact Sciences will have the right to terminate the agreement.

Exact Sciences committed $20M annually over the next three years in joint R&D development expenses leveraging the technology.

Exclusivity is subject to receipt of FDA approval and expiration or termination of the applicable Hart-Scott-Rodino waiting period. Prior to the exclusive license, Exact Sciences can co-exclusively commercialize a lab-developed version of the test.

Additionally, Exact Sciences agreed to purchase from Freenome a senior convertible note with an aggregate principal amount of $50M with a 5.0% coupon rate due in 2030.

On August 6, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the second quarter ended June 30, 2025 (Press release, Delcath Systems, AUG 6, 2025, View Source [SID1234654861]).

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Second Quarter 2025 Financial Results

Total revenue of $24.2 million, compared with $7.8 million in the second quarter of 2024
HEPZATO KIT revenue of $22.5 million, compared to $6.6 million in the second quarter of 2024
CHEMOSAT revenue of $1.7 million, compared to $1.2 million in the second quarter of 2024
Gross margins of 86%, compared to 80% in the second quarter of 2024
Net income of $2.7 million, compared to a net loss of $13.7 million in the second quarter of 2024
Non-GAAP positive adjusted EBITDA in the second quarter of $9.8 million, compared to a loss of $0.8 million in the second quarter of 2024
Cash provided by operations of $7.3 million in the quarter
Cash and investments of $81.0 million as of June 30, 2025
Business Highlights

Activated three new U.S. centers in the second quarter, which brings the current total to 20 active centers, with an additional 10 centers accepting referrals
Announced its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access beginning July 1, 2025
Received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease
"The consistent utilization of HEPZATO at treating sites and continued positive feedback from treating physicians has increased our confidence in HEPZATO’s long term growth prospects," said Gerard Michel, Chief Executive Officer of Delcath. "Physicians are sharing positive results, which is expanding interest at sites not yet activated as well as interest in participating in the future development of HEPZATO. With growing physician engagement and a strong financial outlook, the company is well prepared to pursue additional indications for HEPZATO."

2025 Full Year Financial Guidance
The Company updates its financial outlook for fiscal year 2025:

Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $93 to $96 million, an increase of more than 150% over 2024
Gross margins in the range of 83% to 85%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Second Quarter 2025 Results
Total revenue for the quarter ending June 30, 2025 was $24.2 million compared to $7.8 million for the same period in the prior year. Revenue in the quarter includes sales of $22.5 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending June 30, 2025, were $6.9 million compared to $3.4 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer and Phase 2 clinical trial in metastatic breast cancer. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ended June 30, 2025, were $11.4 million compared to $6.8 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net income for the quarter ended June 30, 2025 was $2.7 million compared to net loss of $13.7 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended June 30, 2025 was $9.8 million compared to adjusted EBITDA loss of $0.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of June 30, 2025, the Company had $81.0 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Wednesday, August 6, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=fbe0333159

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

On August 6, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the second quarter of 2025 (Press release, BeOne Medicines, AUG 6, 2025, View Source [SID1234654860]).

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"Our strong second quarter performance reinforces our trajectory as a global oncology powerhouse and underscores our proven ability to deliver sustainable, long-term growth," said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. "We are executing with purpose and advancing our mission to deliver transformative medicines to more patients worldwide. BRUKINSA, the backbone of our hematology franchise, continues to set the standard as the best-in-class BTK inhibitor with the most approved indications and market leader in the US, a position earned from superior efficacy, favorable safety, and positive patient outcomes across its five indications. Building on this momentum, our two additional Phase 3 hematology assets, BCL2 inhibitor sonrotoclax and BTK CDAC BGB-16673, have the potential to further expand our franchise leadership with pivotal data readouts and new trial initiations anticipated in the near-term. At our recent Investor R&D Day, we outlined a bold path forward with more than 20 expected R&D milestones in the next 18 months. This includes potentially promising advances across our expansive solid tumor pipeline, where we are building future global franchises targeting a range of highly prevalent cancers."

(Amounts in thousands of U.S. dollars and unaudited)
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 % Change 2025 2024 % Change
Net product revenues $ 1,302,076 $ 921,146 41 % $ 2,410,606 $ 1,668,064 45 %
Net revenue from collaborations $ 13,224 $ 8,020 65 % $ 21,973 $ 12,754 72 %
Total revenue $ 1,315,300 $ 929,166 42 % $ 2,432,579 $ 1,680,818 45 %
GAAP income (loss) from operations $ 87,885 $ (107,161) 182 % $ 98,987 $ (368,509) 127 %
Adjusted income (loss) from operations* $ 274,945 $ 48,464 467 % $ 414,302 $ (98,877) 519 %

GAAP net income (loss) $ 94,320 $ (120,405) 178 % $ 95,590 $ (371,555) 126 %
Adjusted net income (loss)* $ 252,822 $ 23,294 985 % $ 388,959 $ (122,602) 417 %
GAAP basic EPS per ADS $ 0.87 $ (1.15) 176 % $ 0.89 $ (3.56) 125 %
Adjusted basic EPS per ADS* $ 2.33 $ 0.22 959 % $ 3.61 $ (1.17) 409 %
GAAP diluted EPS per ADS $ 0.84 $ (1.15) 173 % $ 0.85 $ (3.56) 124 %
Adjusted diluted EPS per ADS* $ 2.25 $ 0.22 923 % $ 3.48 $ (1.17) 397 %
Free Cash Flow* $ 219,772 $ (205,538) 207 % $ 207,447 $ (670,688) 131 %

Second Quarter 2025 Financial Results
Revenue for the second quarter of 2025 was $1.3 billion, compared to $929 million in the prior-year period driven primarily by growth in BRUKINSA (zanubrutinib) product sales in the U.S. and Europe.
Product Revenue totaled $1.3 billion for the second quarter of 2025 compared to $921 million in the prior-year period. The increase in product revenue was primarily attributable to increased sales of BRUKINSA. The U.S. continued to be the Company’s largest market, with product revenue of $685 million compared to $479 million in the prior-year period. In-licensed products from Amgen and TEVIMBRA (tislelizumab) also contributed to product revenue growth.
•U.S. sales of BRUKINSA totaled $684 million in the second quarter of 2025, representing growth of 43% over the prior-year period driven primarily by robust demand growth across all indications and modest benefit due to net pricing. BRUKINSA continues to maintain its leading new patient share across the BTKi class due to its differentiated, best-in-class clinical profile. BRUKINSA sales in Europe totaled $150 million in the second quarter of 2025, representing growth of 85% compared to the prior-year period, driven by increased market share across all major European markets, including Germany, Italy, Spain, France and the UK.
•Sales of TEVIMBRA totaled $194 million in the second quarter of 2025, representing growth of 22% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the second quarter of 2025 was 87.4% compared to 85.0% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in our portfolio. Gross margin also benefited from cost of sales productivity improvements for both BRUKINSA and TEVIMBRA. On an adjusted basis, which does not include depreciation and amortization, gross margin as a percentage of product sales increased to 88.1% for the second quarter of 2025, compared to 85.4% in the prior-year period.
Operating Expenses
The following table summarizes operating expenses for the second quarter of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 2025 Q2 2024 % Change Q2 2025 Q2 2024 % Change
Research and development $ 524,896 $ 454,466 15 % $ 444,057 $ 382,509 16 %
Selling, general and administrative $ 537,913 $ 443,729 21 % $ 441,655 $ 363,922 21 %
Total operating expenses $ 1,062,809 $ 898,195 18 % $ 885,712 $ 746,431 19 %

The following table summarizes operating expenses for the first half of 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q2 YTD 2025 Q2 YTD 2024 % Change Q2 YTD 2025 Q2 YTD 2024 % Change
Research and development $ 1,006,783 $ 915,104 10 % $ 865,252 $ 787,949 10 %
Selling, general and administrative $ 997,201 $ 871,156 14 % $ 837,166 $ 736,068 14 %
Total operating expenses $ 2,003,984 $ 1,786,260 12 % $ 1,702,418 $ 1,524,017 12 %

Research and Development (R&D) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage, and offset by lower development upfront and milestone fees. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $0.5 million and $12 million in the second quarter of 2025 and 2024, respectively.
Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2025 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in global commercial expansion, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 41% for the second quarter of 2025, compared to 48% in the prior-year period.
Net Income/(Loss) and GAAP/Non-GAAP Earnings Per Share
GAAP net income for the second quarter of 2025 was $94 million, an increase of $215 million over the prior-year period loss, primarily attributable to revenue growth and improved operating leverage.
For the second quarter of 2025, basic and diluted earnings per share was $0.07 and $0.06 per share and $0.87 and $0.84 per American Depositary Share (ADS), respectively, compared to basic loss of $0.09 per share and $1.15 per ADS in the prior-year period.
Free Cash Flow for the second quarter of 2025 was $220 million, an increase of $425 million over the prior-year period.
For further details on BeOne’s Second Quarter 2025 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2025 filed with the U.S. Securities and Exchange Commission.

Full Year 2025 Guidance
BeOne has updated its full year 2025 revenue guidance and maintained its expense guidance. Guidance is summarized below:
Prior FY 2025 Guidance1
Current FY 2025 Guidance1
Total Revenue $4.9 – $5.3B $5.0 – $5.3B
GAAP Operating Expenses
(R&D and SG&A) $4.1 – $4.4B $4.1 – $4.4B
GAAP Gross Margin % Mid-80% range Mid to high-80% range
GAAP Operating Income Positive FY 2025 Positive FY 2025
Cash Flow Positive FY 2025
cash flow from operations Positive FY 2025
free cash flow

1 Does not assume any potential new, material business development activity or unusual/non-recurring items. Assumes June 30, 2025, foreign exchange rates.
BeOne’s total revenue guidance for full year 2025 of $5.0 billion to $5.3 billion includes expectations for strong revenue growth driven by BRUKINSA’s U.S. leadership position and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the mid- to high- 80% range due to mix and production efficiencies as compared to 2024. BeOne’s guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth in both commercial and research at a pace that continues to deliver meaningful operating leverage. Non-GAAP operating expenses, which exclude costs related to share-based compensation, depreciation and amortization expense, are expected to track with GAAP operating expenses, with reconciling items unchanged from existing practice. Operating expense guidance does not assume any potential new, material business development activity or unusual/non-recurring items.
Second Quarter Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•BRUKINSA is now approved in 75 markets globally with five new or expanded reimbursements in the quarter.
•Received U.S. Food and Drug Administration (FDA) approval and a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of a new film-coated tablet formulation for all approved indications.

TEVIMBRA (tislelizumab)
•TEVIMBRA is now approved in 47 markets globally with 20 new reimbursements in the quarter, including in Japan, Europe and Australia.
•Received European Commission (EC) approval in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma.
•Received EC approval for the treatment of first-line extensive-stage small cell lung cancer.
•Received a positive CHMP opinion recommending approval of TEVIMBRA in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
•Received FDA approval of alternative dosing regimens of 150 Q2W and 300 Q4W for the treatment of first-line gastric cancer and second-line esophageal squamous cell carcinoma.

Select Clinical-Stage Programs
Hematology
•Sonrotoclax (BCL2 inhibitor):
◦Achieved acceptance of submissions in China with priority reviews for the treatment of relapsed refractory (R/R) chronic lymphocytic leukemia (CLL) and R/R mantle cell lymphoma (MCL).
◦Achieved first subject enrolled in global Phase 3 trial in combination with CD20 antibody for the treatment of R/R CLL.
•BGB-16673 (BTK CDAC):
◦Received EMA PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.
◦Achieved first subject enrolled for global Phase 3 BGB-16673-302 trial for the treatment of R/R CLL.
◦Achieved first subject enrolled for China Phase 3 BGB-16673-303 trial for the treatment of R/R/ CLL.
◦Initiated enrollment of potentially registration enabling Phase 2 trial for the treatment of R/R WM.
Lung Cancer
•Tarlatamab (AMG 757):
◦Achieved acceptance of BLA and priority review in China for the treatment of 3L+ small cell lung cancer (SCLC).
◦Achieved acceptance of BLA in China for the treatment of 2L SCLC.
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody): Received regulatory approval and achieved commercial launch in China for the treatment of second-line HER2-high-expression biliary tract cancer.
Inflammation & Immunology
•BGB-45035 (IRAK4 CDAC): Achieved first subject enrolled in Phase 1b trial for the treatment of atopic dermatitis and prurigo nodularis.
•BGB-16673 (BTK CDAC): Achieved first subject enrolled in Phase 1 trial for the treatment of chronic spontaneous urticaria.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•EC approval of tablet formulation.
2H 2025
•Interim analysis of Phase 3 MANGROVE trial for the treatment of treatment-naïve MCL.
2H 2025
TEVIMBRA
•EU approval for the treatment of neoadjuvant and adjuvant early stage NSCLC.
2H 2025
•Initiate Phase 3 trial for subcutaneous formulation.
2H 2025
Hematology
•Sonrotoclax: Data readout of Phase 2 trial and potential global accelerated approval submissions for the treatment of R/R MCL.
2H 2025
•BGB-16673: Initiate Phase 3 head-to-head trial compared to noncovalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL.
2H 2025
Breast Cancer
•BGB-43395 (CDK4 inhibitor):
◦Initiate Phase 3 trial for the treatment of second-line hormone receptor-positive, HER2-negative metastatic breast cancer.
2026
◦Initiate Phase 3 trial for the treatment of first-line hormone receptor-positive, HER2-negative metastatic breast cancer.
2026
Lung Cancer
•BGB-58067 (PRMT5 inhibitor) and BG-89894 (MAT2A inhibitor): Anticipate first subject enrolled in combination trial.
2H 2025
GI Cancers
•Zanidatamab (HER2-targeting bispecific antibody): Readout of primary progression-free survival data from Phase 3 trial in collaboration with Zymeworks/Jazz for the treatment of first-line HER2-positive gastroesophageal adenocarcinoma.
2H 2025
Inflammation and Immunology
•BGB-45035 (IRAK4 CDAC):
◦Anticipate first subject enrolled in Phase 2 trials.
2H 2025
◦Proof-of-concept data for tissue IRAK4 degradation.
2H 2025

Other Highlights
•Completed renaming to BeOne Medicines Ltd., and redomiciliation to Switzerland.
Conference Call and Webcast
The Company’s earnings conference call for the second quarter 2025 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 6, 2025, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation and a replay of the webcast will also be available.

On August 6, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Arvinas, AUG 6, 2025, View Source [SID1234654859]).

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"It was an eventful and exciting quarter at Arvinas, with significant clinical and regulatory progress across our pipeline of PROTAC degraders," said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. "The recent submission of a New Drug Application to the U.S. Food and Drug Administration for vepdegestrant represents a truly significant first for Arvinas – the first PROTAC degrader to enter clinical trials and have a positive readout in a Phase 3 clinical trial, and the first ever new drug application submitted for a PROTAC. We also continued to advance our early-stage programs, presenting compelling first in human data from ARV-102, our LRRK2 degrader, and preclinical data for our BCL6 degrader, ARV-393, as well as initiating a Phase 1 clinical trial with our KRAS G12D degrader, ARV-806. We have multiple near-term clinical and regulatory milestones, and our programs offer a rich set of catalysts over the next 12 months."

2Q 2025 Business Highlights and Recent Developments

Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies:

Submitted a New Drug Application to the U.S. Food and Drug Administration for vepdegestrant.
Presented results from the VERITAC-2 Phase 3 clinical trial in a late-breaker oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), with simultaneous publication of results in the New England Journal of Medicine.
Pivotal Phase 3 VERITAC-2 clinical trial results demonstrated 2.9-month improvement in median progression-free survival (PFS) when compared to fulvestrant in previously treated patients with an estrogen receptor 1 mutation; the trial did not reach statistical significance in improvement in PFS in the intent-to-treat population.
Vepdegestrant was generally well tolerated, with few discontinuations and low rates of gastrointestinal-related adverse events
Added a combination cohort of vepdegestrant plus Pfizer’s KAT6 inhibitor (PF-07248144) to Pfizer’s ongoing Phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT04606446).
The trial is currently evaluating Pfizer’s KAT6 inhibitor in combination with endocrine therapies following CDK4/6 inhibitor treatments; the trial is being operationalized and funded by Pfizer.
ARV-102: Oral PROTAC LRRK2 degrader

Presented single ascending dose (SAD) and multiple ascending dose (MAD) data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference and at the International Association of Parkinsonism and Related Disorders demonstrating blood-brain barrier penetration, central and peripheral LRRK2 degradation, and reduction of pathway biomarkers:
At a single oral dose of at least 60 mg, and once daily repeated oral doses of at least 20 mg, ARV-102 achieved greater than 50% LRRK2 reduction in the cerebral spinal fluid (CSF) and greater than 90% LRRK2 reduction in the peripheral blood mononuclear cells (PBMCs), indicating substantial central and peripheral LRRK2 protein degradation.
Inhibition of Rab10 phosphorylation in PBMCs and reduction of bis(monoacylglycerol)phosphate (BMP) in urine following single doses of ARV-102, signifying downstream LRRK2 pathway engagement.
Bioavailable and brain penetrant with dose dependent exposure in the CSF.
ARV-102 was generally safe and well tolerated with no serious adverse events reported after single or multiple doses.
Completed enrollment in the SAD cohort of the ongoing Phase 1 clinical trial in patients with Parkinson’s disease.
Activated site in preparation for multiple dose cohort initiation in patients with Parkinson’s disease.

ARV-393: Oral PROTAC BCL6 degrader

Continued recruiting patients in the first-in-human Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) (ClinicalTrials.gov Identifier: NCT06393738).
Presented new preclinical data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress:
Data presented at AACR (Free AACR Whitepaper) demonstrated that ARV-393 had broad and significant combinability with standard of care chemotherapy, standard of care biologics and investigational small molecule inhibitors targeting clinically validated oncogenic drivers of lymphoma.
Data presented at EHA (Free EHA Whitepaper) demonstrated:
Significant single-agent activity of ARV-393 in models of nodal T-follicular helper cell lymphoma, angioimmunoblastic-type (also known as AITL) and transformed follicular lymphoma.
Enhanced tumor growth inhibition, including tumor regressions, with ARV-393 in combination with small molecule inhibitors in models of aggressive diffuse large B-cell lymphoma (DLBCL).
Overall, current preclinical data suggest that ARV-393 has the potential to be an attractive combination partner for development of novel therapies for lymphoma, including chemo-free combination regimens and/or "all oral" treatment options.

ARV-806: Novel PROTAC KRAS G12D degrader

Initiated enrollment in the Phase 1 clinical trial evaluating ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).

Corporate updates:

Announced that John Houston, Ph.D., Chairperson, Chief Executive Officer (CEO) and President at Arvinas, informed the Board of Directors of his plans to retire from his role as CEO and President following a search for, and the appointment of, a new CEO.
The Arvinas Board of Directors has begun a search for a new CEO, and Dr. Houston will remain Chairperson of Arvinas’ Board of Directors upon retiring as CEO and President.
Anticipated Upcoming Milestones and Expectations

Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

Continue market preparations for vepdegestrant in advance of the PDUFA action date.
Revise our vepdegestrant collaboration with Pfizer with the goal of maximizing the value of vepdegestrant.
Present patient reported outcomes data from the VERITAC-2 clinical trial evaluating vepdegestrant versus fulvestrant for previously treated patients with ESR1 mutated- ER+/HER2- advanced or metastatic breast cancer at the European Society for Medical Oncology 2025 Congress (October 2025).
Present results of the TACTIVE-N trial, a Phase 2 clinical trial of neoadjuvant vepdegestrant, in a mini oral session at European Society for Medical Oncology 2025 Congress (ClinicalTrials.gov Identifier: NCT05549505) (October 2025).
ARV-102: Oral PROTAC LRRK2 degrader

Share final data from the SAD/MAD cohorts of the Phase 1 clinical trial in healthy volunteers (2H 2025).
Share initial data from the SAD cohort of the ongoing Phase 1 clinical trial in patients with Parkinson’s disease (2H 2025).
Initiate enrollment in the multiple dose cohort of the Phase 1 clinical trial in patients with Parkinson’s disease (2H 2025); present initial data from multiple dose cohort (2026).
Initiate Phase 1b clinical trial in patients with progressive supranuclear palsy (1H 2026).
ARV-393: Oral PROTAC BCL6 degrader

Share preclinical data in combination with glofitamab in models of aggressive high grade DLBCL (2H 2025).
Share preliminary clinical data from the ongoing Phase 1 clinical trial in patients with NHL (ClinicalTrials.gov Identifier: NCT06393738) (2H 2025).
ARV-806: Novel PROTAC KRAS G12D degrader

Continue enrollment in the Phase 1 clinical trial of ARV-806 in patients with solid tumors harboring KRAS G12D mutations (ClinicalTrials.gov Identifier: NCT07023731).
Share preclinical data from the clinical stage ARV-806 program (2H 2025).
Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, and marketable securities as of June 30, 2025, is sufficient to fund planned operating expenses and capital expenditure requirements into the second half of 2028.

Second Quarter Financial Results
Cash, Cash Equivalents, and Marketable Securities Position: As of June 30, 2025, cash, cash equivalents and marketable securities were $861.2 million, as compared with $1,039.4 million as of December 31, 2024. The decrease in cash, cash equivalents and marketable securities of $178.2 million for the six months ended June 30, 2025 was primarily related to cash used in operations of $177.0 million, the purchase of lab equipment and leasehold improvements of $1.6 million and $0.1 million of long-term debt repayments, partially offset by proceeds from the issuance of shares under the ESPP of $0.5 million.

Research and Development Expenses: Generally Accepted Accounting Principles (GAAP) Research and development (R&D) expenses were $68.6 million for the quarter ended June 30, 2025, as compared with $93.7 million for the quarter ended June 30, 2024. The decrease in research and development expenses of $25.1 million for the quarter was primarily due to a decrease in external expenses of $18.3 million and a decrease in compensation and related personnel expenses of $7.9 million, which are not allocated by program. External expenses include (i) program-specific expenses, which decreased by $15.9 million, primarily driven by decreases in our vepdegestrant (ARV-471) and luxdegalutamide (ARV-766) programs of $10.0 million and $9.5 million, respectively, partially offset by increases in our ARV-102 and ARV-806 programs of $2.1 million and $1.5 million, respectively, and (ii) our non-program specific expenses, which decreased by $2.4 million.

Non-GAAP R&D expenses were $59.5 million for the quarter ended June 30, 2025, as compared with $83.0 million for the quarter ended June 30, 2024, excluding $0.6 million of restructuring expense for the three months ended June 30, 2025, and $8.5 million and $10.7 million of non-cash stock-based compensation expense for the three months ended June 30, 2025 and 2024, 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 $25.3 million for the quarter ended June 30, 2025, as compared with $31.3 million for the quarter ended June 30, 2024. The decrease in general and administrative expenses of $6.0 million for the quarter was primarily due to a decrease in personnel and infrastructure-related costs of $4.8 million and professional fees of $2.2 million, partially offset by an increase in costs related to developing our commercial operations of $1.1 million.

Non-GAAP G&A expenses were $20.2 million for the quarter ended June 30, 2025, as compared with $20.4 million for the quarter ended June 30, 2024, excluding $0.4 million of restructuring expense for the quarter ended June 30, 2025, and $4.7 million and $10.9 million of non-cash stock-based compensation expense for the quarter ended June 30, 2025 and 2024, 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.

Revenue: Revenue was $22.4 million for the quarter ended June 30, 2025 as compared with $76.5 million for the quarter ended June 30, 2024. Revenue for the quarter is related to the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer and the collaboration and license agreement with Pfizer. The decrease of $54.1 million was primarily due to $45.6 million of decreased revenue from the Novartis License Agreement and the Novartis Asset Agreement, both of which were entered into during the three months ended June 30, 2024 and were completed by December 31, 2024 as the technology transfer of our ongoing and planned clinical trials of luxdegalutamide (ARV-766) were transitioned to Novartis. Revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer decreased by $6.8 million related to the removal of the first-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib, and the removal of the second-line Phase 3 combination trial with a CDK4/6 inhibitor from the development plan during the first quarter of 2025 and revenue from the Bayer Collaboration Agreement decreased by $1.6 million as a result of the termination of the Bayer Collaboration Agreement in August 2024.

Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, August 6, 2025, at 8:00 a.m. ET to review its second quarter 2025 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.

On August 6, 2025 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the second quarter ended June 30, 2025, and highlighted recent progress (Press release, Artiva Biotherapeutics, AUG 6, 2025, View Source [SID1234654858]).

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"We are making meaningful progress across our ongoing clinical trials exploring AlloNK in autoimmune disease. We now have over a dozen sites enrolling across our trials in the US and have already treated over a dozen patients with AlloNK in combination with monoclonal antibodies across rheumatoid arthritis, SLE, lupus nephritis, Sjögren’s disease, and systemic sclerosis," said Fred Aslan, M.D., Chief Executive Officer of Artiva. "By the end of 2025, we look forward to sharing initial translational data supporting AlloNK’s mechanism of action, and safety data, supporting the potential of our therapy, which includes the use of cyclophosphamide and fludarabine, to be administered and managed in an outpatient setting across multiple autoimmune indications. We also look forward to announcing our lead indication by the end of 2025, setting the stage to share initial clinical response data in that indication in the first half of next year."

Recent Business Highlights

AlloNK (also known as AB-101) Updates

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Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN)
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First patient treated with AlloNK + rituximab in recently initiated global Phase 2a company-sponsored basket clinical trial for refractory rheumatoid arthritis (RA), Sjögren’s disease (SjD), idiopathic inflammatory myopathies (myositis, or IIM), and systemic sclerosis (scleroderma, or SSc)
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Over a dozen patients treated with AlloNK + monoclonal antibody (mAb) across refractory RA, SLE, LN, SjD, and SSc in the company-sponsored trials and an investigator-initiated basket trial
Upcoming Milestones

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By Year-End 2025: Initial safety and translational data for AlloNK + mAb across multiple autoimmune diseases from ongoing clinical trials and disclosure of lead indication for further development
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Mechanistic and translational data for AlloNK in autoimmune diseases
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Insights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabine
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Disclosure of lead indication for AlloNK development in autoimmune diseases
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1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy

Second Quarter 2025 Financial Results

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Cash, Cash Equivalents and Investments. As of June 30, 2025, Artiva had cash, cash equivalents, and investments of $142.4 million, which is expected to fund operations into Q2 2027
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Research and Development Expenses. Research and development expenses were $17.9 million for the three months ended June 30, 2025, compared to $12.3 million for the three months ended June 30, 2024
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General and Administrative Expenses. General and administrative expenses were $4.9 million for the three months ended June 30, 2025, compared to $3.9 million for the three months ended June 30, 2024
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Other Income (expense), net. Other income, net, was $1.6 million for the three months ended June 30, 2025, compared to other expense, net, of $1.7 million for the three months ended June 30, 2024
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Net Loss. Net loss totaled $21.3 million for the three months ended June 30, 2025, as compared to net loss of $17.8 million for the three months ended June 30, 2024, with non-cash stock-based compensation expense of $1.5 million for the three months ended June 30, 2025, and June 30, 2024