On August 6, 2025 XtalPi (2228.HK), a leading global technology company in integrating artificial intelligence (AI) and robotics for drug and materials discovery, reported a transformative strategic collaboration with DoveTree Medicines, a biotechnology pioneer founded by renowned drug developer Dr. Gregory Verdine (Press release, XtalPi, AUG 6, 2025, View Source [SID1234654892]). The collaboration, worth up to $5.99 billion, represents one of the largest commitments to date for AI- and robotics-driven pharmaceutical R&D.

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Under the agreement, DoveTree gains exclusive global rights to develop and commercialize a portfolio of innovative therapeutics generated through the partnership. XtalPi has received an upfront payment of $51 million and is eligible for $49 million in additional near-term payments, plus development and commercial milestones, as well as tiered royalties totaling up to $5.89 billion.

This collaboration merges XtalPi’s integrated drug discovery capabilities with DoveTree’s deep biological expertise in selecting and validating novel targets of high therapeutic potential. Together, the companies will focus on developing first-in-class candidates across oncology, immunology and inflammatory diseases, neurological disorders, and metabolic dysregulation with significant unmet needs. The partnership will advance DoveTree’s selected pipeline of projects targeting historically challenging mechanisms, with plans to expand joint R&D capabilities in emerging modalities like molecular glue.

DoveTree Medicines was founded by Dr. Gregory Verdine, an internationally esteemed scientist, entrepreneur, and seasoned investor in the biopharmaceutical field, with outstanding achievements in both academia and industry. He has co-founded over a dozen biopharmaceutical companies, including more than five publicly listed firms such as Enanta Pharmaceuticals (NASDAQ: ENTA), Rein Therapeutics (NASDAQ: RNTX), and WaVe Life Sciences (NASDAQ: WVE). Credited with originating the "drugging the undruggable" concept, Dr. Verdine has pioneered unique molecular glue and peptide technology platforms, successfully applying them to the drug development against "undruggable" proteins such as RAS, Myc, and β-catenin. He has co-developed three FDA-approved drugs, with over a dozen additional candidates currently in clinical development.

XtalPi has developed an intelligent de novo drug discovery platform that spans small molecules, biologics, antibody-drug conjugates (ADCs), and molecular glues. This multimodal capability enables the efficient exploration of parallel drug development approaches against single targets and unlocks broader chemical space. By integrating quantum physics predictions, AI-driven molecular design, and a large-scale robotic lab-in-the-loop, XtalPi significantly accelerates the drug discovery workflow—from target analysis and molecular generation to affinity prediction, ADMET assessment, and synthesis design—with enhanced accuracy and efficiency. Through extensive partnerships with innovative pharmaceutical companies, XtalPi’s platform has been rigorously validated in real-world projects, accumulating vast datasets of standardized experimental data and high-precision computational data to continuously optimize models within a closed feedback loop.

Dr. Gregory Verdine, Founder and Chief Executive Officer of DoveTree, stated: "XtalPi’s unique platform has the potential to transform the profound uncertainties of drug discovery into quantifiable engineering solutions. Their demonstrated ability to innovate at scale makes them a valuable partner in pursuing drug targets that are beyond conventional methods. By merging DoveTree’s biological insights and extensive R&D expertise with XtalPi’s powerful platform, we aim to deliver transformative therapies for patients globally."

Dr. Shuhao Wen, Chairman of XtalPi, commented: "Dr. Verdine and DoveTree bring exceptional biological acumen, business vision, and a proven track record of translational success, perfectly complementing our platform’s strengths in high-throughput molecule generation, design, and validation. This partnership positions us to accelerate breakthroughs against complex diseases while expanding the frontiers of AI-driven drug discovery. XtalPi remains committed to advancing our core technologies and working closely with leading innovators to help build diverse pipelines of impactful medicines."

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

•
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)
•
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)
•
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

•
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
o
Mechanistic and translational data for AlloNK in autoimmune diseases
o
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
o
Disclosure of lead indication for AlloNK development in autoimmune diseases
•
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
•
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
•
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

On August 6, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported financial results for the second quarter ended June 30, 2025 (Press release, Veracyte, AUG 6, 2025, View Source [SID1234654874]).

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"Testing growth continues to exceed our expectations, driven by Decipher which achieved its thirteenth consecutive quarter of over 25% year-over-year volume growth," said Marc Stapley, Veracyte’s chief executive officer. "This strong result, combined with Afirma volume meeting our expectations and the resolution of the French subsidiary proceedings, has positioned us for incremental investment in our strategic portfolio in the second half of 2025 and beyond, strengthening our confidence in delivering sustained long-term revenue growth. Backed by our differentiated platform and a growing body of clinical evidence, we are deeply committed to improving outcomes for patients around the world."

Key Financial Highlights

For the three-month period ended June 30, 2025, as compared to the same period in 2024:

Increased total revenue by 14% to $130.2 million and testing revenue by 14% to $122.3 million.
Increased total volume by 15% to 44,966 tests and testing volume by 18% to 42,441 tests.
Grew Decipher revenue by 24% to $76.3 million and Afirma revenue by 5% to $43.4 million.
Grew Decipher volume by 28% to approximately 25,500 tests and Afirma volume by 8% to approximately 16,950 tests.
Recorded GAAP net loss of $1.0 million, or (0.8%) of revenue, including $20.5 million of one-time impairment charges, and adjusted EBITDA of $35.8 million, or 27.5% of revenue.
Generated $33.6 million of cash from operations to end the quarter with $320.7 million of cash, cash equivalents, and short-term investments as of June 30, 2025.
Provided full year revenue guidance of $496 million to $504 million; raised testing revenue guidance to $477 million to $483 million or 14% to 15% year-over-year growth.
Key Business Highlights

Kicked off our high risk and metastatic growth strategy with the full launch of Decipher for use in the metastatic population in June, engaging physicians in understanding the utility of Decipher in aiding decision making on treatment intensification.
Demonstrated utility of Decipher Prostate and Decipher Bladder Genomic Classifiers as well as the Decipher GRID research capabilities through 29 abstracts presented and nine new publications.
Supported the presentation of seven different abstracts covering clinical Afirma GSC data and research with Afirma GRID at scientific and medical conferences, and saw the publication of the first study detailing the development and validation of tumor behavior classifiers offered on the Afirma GRID research report, in Frontiers in Endocrinology.
Added to the clinical data demonstrating that Prosigna accurately classifies patients’ risk of recurrence with the presentation of 10-year clinical outcomes data from the OPTIMA Prelim study at ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress.
Completed the French entity restructuring process as it relates to the sale of the Veracyte SAS product manufacturing business and deconsolidation of the Veracyte SAS operations (see below).
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

Second Quarter 2025 Financial Results

Total revenue for the second quarter of 2025 was $130.2 million, an increase of 14% compared to $114.4 million reported in the second quarter of 2024. Testing revenue was $122.3 million, an increase of 14% compared to $107.0 million in the second quarter of 2024, driven by our Decipher Prostate and Afirma tests. Product revenue was $3.6 million, a decrease of 8% compared to $3.9 million in the second quarter of 2024. Biopharmaceutical and other revenue was $4.3 million, an increase of 21% compared to $3.6 million in the second quarter of 2024.

Total gross margin for the second quarter of 2025 was 69%, compared to 68% in the second quarter of 2024. Non-GAAP gross margin was 72%, compared to 71% in the second quarter of 2024.

Operating expenses were $95.0 million for the second quarter of 2025 including $20.5 million of impairment given the partial sale and subsequent liquidation proceedings of our French subsidiary. Non-GAAP operating expenses grew 2% to $60.3 million compared to $59.0 million in the second quarter of 2024.

Net loss for the second quarter of 2025 was $1.0 million, a decrease of 117% compared to the second quarter of 2024. Diluted net loss per common share was $0.01, a decrease of $0.08 compared to the second quarter of 2024. Non-GAAP diluted net earnings per common share was $0.44, an increase of $0.14 compared to the second quarter of 2024. Net cash provided by operating activities in the first six months of 2025 was $39.0 million, an improvement of $18.4 million compared to the same period in 2024.

Adjusted EBITDA for the second quarter of 2025 was $35.8 million, an improvement of 49% compared to the second quarter of 2024, representing 27.5% of revenue compared to 21.0% of revenue in the same period of 2024.

Update on Marseille Operations

As previously communicated, on May 7, 2025, the Commercial Court of Marseille opened restructuring proceedings related to Veracyte SAS, Veracyte Inc.’s French subsidiary. These proceedings allowed the court-appointed representative to evaluate opportunities for sale of all or part of the Veracyte SAS business, including Veracyte’s immune-oncology biopharma business, contract IVD development and manufacturing and support for Veracyte’s IVD product development and manufacturing.

On July 16, 2025, the Marseille Commercial Court published a decision approving the sale of the manufacturing operations of Veracyte SAS to Helio Diagnostics SAS. The sale closed on August 1, 2025. Following the sale, the remaining Veracyte SAS assets will continue to be managed by the court-appointed administration until formal liquidation proceedings are opened, at which point the proceeding will be managed solely by a court-appointed judicial liquidator. Given the sale and subsequent liquidation proceedings we took a $20.5 million impairment charge on related assets in Q2 and have deconsolidated the entity as of August 1, 2025, the effective date of the sale.

Management will provide further details on the potential impact to Veracyte’s 2025 financial outlook during the conference call this afternoon.

2025 Financial Outlook

The company is raising full-year 2025 testing revenue guidance to $477 million to $483 million, or 14% to 15% year-over-year growth, from prior guidance of $470 million to $480 million. Adjusting for the impact of the paused Envisia test, the guidance implies 16% to 17% year-over-year testing revenue growth. Given the resolution of the French subsidiary proceedings, the company is initiating full-year 2025 total revenue guidance of $496 million to $504 million, or 11% to 13% year-over-year growth.

Additionally, the company is raising guidance for adjusted EBITDA as a percentage of revenue in 2025 to 23.5% from 22.5%.

The company is unable to provide a quantitative reconciliation of expected adjusted EBITDA as a percentage of revenue to the most directly comparable forward-looking GAAP measure without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, that are dependent on various factors, are out of the company’s control, or that cannot be reasonably predicted. Such adjustments include, but are not limited to, acquisition-related expenses, and other adjustments. Any associated estimate of these items and their impact on GAAP performance for the guidance period could vary materially. For more information on the non-GAAP financial measures, please refer to the section titled "Note Regarding Use of Non-GAAP Financial Measures" at the end of this press release.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: View Source

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 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the second quarter ended June 30, 2025 and provided recent business and clinical program updates (Press release, Xencor, AUG 6, 2025, View Source [SID1234654875]).

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"Xencor is focused on execution of our clinical studies, evaluating four wholly owned XmAb drug candidates in cancer and advanced autoimmune-driven diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In oncology, these include two T-cell engager (TCE) programs, XmAb819 and XmAb541, which continue to progress through dose-escalation studies. We are on-track to present preliminary safety and efficacy from XmAb819 in advanced clear cell renal cell carcinoma later this year."

"In our autoimmune portfolio, we recently initiated the Phase 2b XENITH-UC study of XmAb942, our potential best-in-class antibody targeting TL1A for inflammatory bowel disease, to rapidly identify a pivotal dose regimen for those with moderately to severely active ulcerative colitis. Also, in June we were granted regulatory authorization to proceed with the proof-of-concept study of plamotamab, our CD20 B-cell depleting TCE, in rheumatoid arthritis. For the remainder of the year, we expect to continue our global rollout of the XENITH-UC and plamotamab studies, and we also remain on-track to start a proof-of-concept study of XmAb657, our novel CD19 B-cell depleting TCE for the treatment of patients with autoimmune disease."

Clinical Program Updates

Oncology

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025.

XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with advanced solid tumors expressing CLDN6. Like XmAb819, XmAb541 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing CLDN6. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer, germ cell tumors, and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025.
Autoimmune & Inflammatory Diseases

Plamotamab (CD20 x CD3), a clinical stage, B-cell depleting bispecific T-cell engager for development in rheumatoid arthritis (RA). Xencor is evaluating plamotamab in a Phase 1b/2a proof-of-concept study, for patients with RA have progressed through prior standard-of-care treatment. In June 2025, Xencor received regulatory authorization to proceed with the study.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. In the first half of 2025, Xencor presented initial data from a Phase 1 study of XmAb942 in healthy volunteers. The results showed that XmAb942 was well tolerated at single and multiple doses and had a greater than 71-day half-life, which supports an every 12-week dosing in maintenance. Xencor recently initiated the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy.
Recent Partnership Developments

Incyte Corporation: In June 2025, Incyte announced that Monjuvi was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma in combination with rituximab and lenalidomide. The approval was based on data from Incyte’s pivotal Phase 3 inMIND trial. Xencor earned a $25 million regulatory milestone payment in addition to non-cash royalty revenue from sales of Monjuvi/Minjuvi for the second quarter of 2025. Monjuvi and Minjuvi are registered trademarks of Incyte.
Additional Corporate Updates

In July, Xencor appointed Raymond Deshaies, Ph.D., to its board of directors. Dr. Deshaies is a pioneering biochemist and cell biologist with more than 25 years of experience in biotechnology and drug development. He recently served as senior vice president of global research at Amgen Inc., where he oversaw all research activities, including the nomination of over 50 clinical candidates, expansion of Amgen’s capabilities for discovering and optimizing multispecific drug candidates, and application of generative protein design to biologics discovery.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $555 million and $585 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the Second Quarter Ended June 30, 2025

Cash, cash equivalents and marketable debt securities totaled $663.8 million as of June 30, 2025, compared to $706.7 million as of December 31, 2024.

Revenue for the second quarter ended June 30, 2025 was $43.6 million, compared to $23.9 million for the same period in 2024. Revenue earned in the second quarter of 2025 was primarily milestone revenue from Incyte and non-cash royalty revenue from Alexion and Incyte, compared to the same period in 2024, which was primarily non-cash royalty revenue from Alexion and Incyte and licensing revenue from multiple licensees.

Research and development (R&D) expenses for the second quarter ended June 30, 2025 were $61.7 million, compared to $61.5 million for the same period in 2024. R&D spending for the second quarter of 2025 compared to 2024 reflects increased spending on XmAb819, XmAb541 and XmAb657 (CD19 x CD3), offset by reduced wind-down costs on terminated programs.

General and administrative (G&A) expenses for the second quarter ended June 30, 2025 were $15.1 million, compared to $17.7 million for the same period in 2024. Decreased G&A spending for the second quarter of 2025 compared to 2024 is primarily due to lower stock compensation expense.

Other income (expense), net, for the second quarter ended June 30, 2025 was $2.1 million, compared to $(13.4) million for the same period in 2024. The increase for the second quarter of 2025, compared to 2024, is primarily driven by unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the second quarter ended June 30, 2025 was $30.8 million, or $(0.41) on a fully diluted per share basis, compared to net loss of $67.3 million, or $(1.09) on a fully diluted per share basis, for the same period in 2024.