On August 6, 2025 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported a new study in Communications Medicine, a Nature portfolio journal, demonstrating that Caris’ AI-based image analysis model has the potential to more accurately predict cancer biomarkers and patient survival than the conventional companion diagnostic (CDx) methods (Press release, Caris Life Sciences, AUG 6, 2025, View Source [SID1234654888]). By analyzing hematoxylin and eosin (H&E) images, the study demonstrated that Caris’ AI model can improve the assessment of critical cancer biomarkers and impact patient survival outcomes in breast and colorectal cancers.

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For this study, Caris’ AI model analyzed data from over 35,000 patients in the Caris clinico-genomic database. In breast cancer, the AI model scored PD-L1 positive phenotype status using an H&E image alone and assessed overall survival of patients treated with pembrolizumab, achieving a hazard ratio (HR) for overall survival of 0.511 (p<0.001), compared to an HR of 0.882 (p>0.1) for traditionally scored PD-L1 IHCs, a result consistent with an almost doubling of overall survival for patients treated with pembrolizumab. In colorectal cancer, AI predicted mismatch repair deficiency (MMRd) and microsatellite instability (MSI) equivalent to traditional scoring.

"Traditional PD-L1 testing can undercall positive cases, especially near the 1% threshold," said Matthew Oberley, MD, PhD, SVP, Chief Clinical Officer and Pathologist-in-Chief at Caris. "Caris’ AI model enhances predictive accuracy, integrating features from both staining methods, and exhibits superior prognostic precision compared to current biomarker assessments. Clinical adoption of this tool could improve the precision and efficiency of cancer patient evaluation and aid clinical decision making."

"This study highlights how AI can significantly improve the accuracy and efficiency of tissue sample evaluation, and down the line, this has the potential to guide immunotherapy decisions and enhance patient outcomes," said George W. Sledge, Jr., MD, Caris EVP and Chief Medical Officer.

The publication can be viewed in its entirety on the Caris Life Sciences website.

On August 6, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor (Press release, Dizal Pharma, AUG 6, 2025, View Source [SID1234654887]).

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Patients with CLL/SLL treated with a BTK inhibitor or a BCL-2 inhibitor often relapse or progress due to two major resistance mechanisms: BTK C481X mutations and BTK-independent activation of BCR signaling pathway. No targeted therapy currently addresses both mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging anti-tumor activity in early CLL/SLL clinical studies, mutation-mediated resistance has already been reported, and degrader-associated toxicities may limit their long-term clinical application.

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration. It has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting both BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-cell non-Hodgkin lymphomas (B-NHLs).

The Fast Track Designation is supported by data from a pooled analysis of two phase I/II studies of birelentinib in CLL/SLL patients previously treated with covalent/non-covalent BTK inhibitors and BTK degraders. The results were presented at 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and featured in oral presentations at both the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 18th International Conference on Malignant Lymphoma (ICML).

Birelentinib demonstrated significant anti-tumor efficacy in heavily pretreated CLL/SLL patients with an objective response rate (ORR) of 84.2%, with a good safety profile. Tumor responses were observed irrespective of prior treatment with covalent/non-covalent BTK inhibitors, BTK degraders, or BCL-2 inhibitors, including in patients harboring classic BTK resistance mutations (C481X) as well as other BTK mutations, such as kinase-dead mutations. Responses were durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.

"The granting of Fast Track Designation underscores the U.S. FDA’s recognition of birelentinib’s potential to address an unmet medical need in patients with CLL/SLL," said Dr. Xiaolin Zhang, CEO of Dizal. "We look forward to working closely with the FDA to accelerate the global clinical development of birelentinib and bring this treatment option to patients as quickly as possible."

Fast Track Designation is an FDA program designed to facilitate the development and expedite the review of drugs for serious conditions that address unmet medical needs. The designation enables for frequent FDA interactions and may allow for rolling revie, priority review, or accelerated approval if criteria are met.

About Birelentinib (DZD8586)

Birelentinib is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

Birelentinib has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. In clinical studies, birelentinib exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

In August 2025, birelentinib was granted Fast Track Designation by the U.S. FDA for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

On August 6, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ending June 30, 2025 (Press release, Bio-Techne, AUG 6, 2025, View Source [SID1234654886]).

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Fourth Quarter FY2025 Highlights

Fourth quarter organic revenue increased by 3% (4% reported) to $317.0 million. Full year organic revenue increased 5% (5% reported) to $1.2 billion.
GAAP earnings per share (EPS) was $ (0.11) versus $0.25 one year ago. Delivered adjusted EPS of $0.53 compared to $0.49 one year ago. Full year GAAP EPS was $0.46 versus $1.05 one year ago. Full year adjusted EPS was $1.92 versus $1.77 one year ago.
Strong performance in our proteomic analytic and cell therapy growth pillars drove 4% organic growth (6% reported) in the Protein Sciences segment for the quarter, and 5% organic and reported growth for the full year.
Announced divestiture of the Exosome Diagnostics business including the ExoDx Prostate test (EPI) as the Company emphasizes investment and commercial priorities on non-CLIA based product lines in their growth pillars.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic revenue, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"Bio-Techne delivered a solid fourth quarter that was in-line with our expectations, despite ongoing market uncertainty," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "We achieved strong performance in our cell therapy and protein analysis instrumentation growth pillars, supported by a resilient pharma market. Our fiscal year 2025 results reflect the outstanding execution by our team and the meaningful impact our innovative solutions continue to deliver for customers, which include accelerating development timelines and driving scientific breakthroughs."

Kelderman added, "Last night, we announced the divestiture of our Exosome Diagnostics business. This strategic decision will immediately strengthen our profitability and allow us to increase our focus on high-growth areas, particularly tools for research and precision diagnostics."

Kelderman concluded, "While market uncertainties persist, I have full confidence in our team’s ability to navigate the evolving landscape and continue delivering meaningful value to all our stakeholders."

Bio-Techne will host an earnings conference call today, August 6, 2025, at 8:00 a.m. CDT. To listen, please dial 1-800-274-8461 or 1-203-518-9814 (for international callers), and reference conference ID TECHQ4. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 11159590. The replay will be available from 11:00 a.m. CDT on Wednesday, August 6, 2025, until 11:00 p.m. CDT on Saturday, September 6, 2025.

Fourth Quarter Fiscal 2025

Revenue

Net sales for the fourth quarter increased 4% to $317.0 million. Organic revenue increased 3% compared to the prior year. Foreign currency exchange had a favorable impact of 2%, and non-recurring prior year revenue from a business held-for-sale had an unfavorable impact of 1%.

GAAP Earnings Results

GAAP EPS was ($0.11) per diluted share, versus $0.25 in the same quarter last year. GAAP operating income for the fourth quarter of fiscal 2025 decreased 152% to ($23.9) million, compared to $45.8 million in the fourth quarter of fiscal 2024. GAAP operating margin was (7.5)%, compared to 15.0% in the fourth quarter of fiscal 2024. Current quarter GAAP operating margin was unfavorably impacted by impairment of the Exosome Diagnostics business.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.53 per diluted share compared to $0.49 in the same quarter last year. Adjusted operating income of $101.3 million in the fourth quarter of fiscal 2025 remained relatively consistent with fourth quarter of fiscal 2024 adjusted operating income of $101.8 million. Adjusted operating margin was 32.0% for the fourth quarter of fiscal 2025 compared to 33.5% in the fourth quarter of fiscal 2024. Adjusted operating margin was impacted by unfavorable product mix, especially within the Diagnostic Solutions segment.

Full Year Fiscal 2025

Revenue

Net sales for the full year fiscal 2025 increased 5% to $1.2 billion. Organic revenue increased 5%. Foreign currency exchange and a business held-for-sale did not have a material impact.

GAAP Earnings Results

GAAP EPS was $0.46 per diluted share, compared to $1.05 last fiscal year. GAAP operating income for full year fiscal 2025 decreased 51% to $102.3 million, compared to $206.7 million in the full year fiscal 2024. GAAP operating margin was 8.4%, compared to 17.8% in the full year fiscal 2024. GAAP operating margin was unfavorably impacted by impairment of assets held-for-sale, restructuring and restructuring-related costs, and a non-recurring arbitration award.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.92 per diluted share, compared to $1.77 last fiscal year. Adjusted operating income for fiscal 2025 increased 4% to $383.6 million, compared to $370.2 million for fiscal 2024. Adjusted operating margin for full year fiscal 2025 decreased to 31.6%, compared to 32.1% in full year fiscal 2024. Adjusted operating margin was impacted by reinstatement of incentive compensation accruals as well as unfavorable product mix.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biopharma and academic research communities. Additionally, the segment provides multiple platforms useful in various areas of protein analysis. In fiscal year 2024, a business within the Protein Sciences Segment met the criteria of held-for-sale; the held-for-sale business has been excluded from the segment’s operating results. Protein Sciences segment’s fourth quarter fiscal 2025 net sales were $226.5 million, an increase of 6% from $214.0 million for the fourth quarter of fiscal 2024. Organic revenue growth was 4% for the fourth quarter of fiscal 2025, with foreign currency exchange having a favorable impact of 2%. The Protein Sciences segment’s operating margin increased to 43.6% in the fourth quarter of fiscal 2025 compared to 43.0% in the fourth quarter of fiscal 2024. The segment’s operating margin increased primarily due to favorable volume leverage and ongoing profitability initiatives.

Protein Sciences segment’s full year fiscal 2025 net sales were $870.2 million, an increase of 5% from $830.9 million for full year fiscal 2024. Organic revenue for the segment increased 5% for the fiscal year, with foreign currency exchange and a business held-for-sale not having a material impact on revenue. Protein Sciences segment’s operating margin was 42.6% in fiscal 2025 compared to 42.7% in fiscal 2024.

Diagnostics and Spatial Biology Segment

The Company’s Diagnostics and Spatial Biology segment develops and provides spatial biology products, carrier screening and oncology kits, as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Spatial Biology segment also provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Exosome Diagnostics business met the held-for-sale criteria at June 30, 2025 and incurred an impairment loss of $83.1 million during the quarter. The Diagnostics and Spatial Biology segment’s fourth quarter fiscal 2025 net sales were $89.7 million, a decrease of 1% from $90.7 million for the fourth quarter of fiscal 2024. Organic revenue decreased 1% for the fourth quarter of fiscal 2025, with foreign exchange not having a material impact. The Diagnostics and Spatial Biology segment’s operating margin of 6.0% in the fourth quarter of fiscal 2025 compared to 12.5% in the fourth quarter of fiscal 2024. The segment’s operating margin was impacted by unfavorable product mix.

The Diagnostics and Spatial Biology segment’s full year fiscal 2025 net sales were $346.3 million, an increase of 6% from $326.4 million for full year fiscal 2024. Organic growth for the segment was 6% with foreign currency exchange not having a material impact on revenue growth. The Diagnostics and Spatial Biology segment’s operating margin was 6.2% in fiscal 2025 compared to 7.5% in fiscal 2024. The segment’s operating margin was impacted by the reinstatement of incentive compensation accruals as well as unfavorable product mix.

On August 6, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported financial results for the second quarter of 2025 and provided a corporate update (Press release, Compugen, AUG 6, 2025, View Source [SID1234654885]).

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"We continued to advance our immuno-oncology (IO) clinical and early-stage pipeline programs," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We dosed the first patient in MAIA-ovarian, our global adaptive platform trial evaluating COM701 as a single agent for maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1). In addition, we are looking forward to presenting a pooled analysis of previously presented data from our three Phase 1 trials evaluating COM701 in heavily pretreated platinum resistant ovarian cancer at ESMO (Free ESMO Whitepaper) 2025 in October. We are also progressing the Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead."

Dr. Cohen-Dayag continued, "We are excited to see the progress our partner AstraZeneca is making with its rilvegostomig program, with ten active Phase 3 trials. Rilvegostomig is an Fc reduced PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from our COM902, and which AstraZeneca has specifically designed and engineered with a unique mechanism of action to harness co-operative binding of both PD-1 and TIGIT to drive enhanced immune responses. At ASCO (Free ASCO Whitepaper) in June this year, AstraZeneca presented encouraging early data from trials evaluating rilvegostomig in combination with TROP2 ADC, Datroway, in NSCLC and in combination with chemotherapy in hepatobiliary cancer. The totality of this data along with data presented in 2024 highlight rilvegostomig as a potential IO backbone for future drug combinations. At the upcoming ESMO (Free ESMO Whitepaper) 2025 conference, AstraZeneca plans to share follow up data from ARTEMIDE-01 in NSCLC as a poster presentation and first data from TROPION-PanTumor03 in bladder cancer as a mini oral session. AstraZeneca’s broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales."

Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund operations into 2027 allows us to advance our pipeline of differentiated IO therapies and to leverage Unigen – our validated AI/ML-powered computational target discovery platform to discover novel mechanisms to activate the immune system against cancer. I look forward to transitioning leadership to Dr. Eran Ophir in September and the opportunity of stepping into the newly established role of Executive Chair. With this enhanced leadership expansion, a strategically differentiated pipeline and operational focus, Compugen is well positioned for growth."

Next Planned Milestones

ESMO 2025: poster presentation of a pooled analysis of three Phase 1 trials from previously presented data evaluating COM701 in heavily pretreated platinum resistant ovarian cancer
ESMO 2025: Compugen’s partner, AstraZeneca, plans to present:
updated data from Phase 2 ARTEMIDE-01 evaluating rilvegostomig in metastatic NSCLC as a poster presentation
first data from TROPION-PanTumor03 evaluating rilvegostomig in combination with TROP 2 ADC Datroway in bladder cancer as a mini oral session
H2 2026: data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer
Second Quarter 2025 Financial Highlights

Cash: As of June 30, 2025, Compugen had approximately $93.9 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.

Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any cash inflows. The Company has no debt.

Revenue: Compugen reported approximately $1.3 million in revenues for the second quarter ended June 30, 2025, compared to approximately $6.7 million in revenues for the comparable period in 2024. The revenues reported in the second quarter of 2025 reflect recognition of a portion of both the upfront payment and the IND milestone payment from the license agreement with Gilead. The revenues reported in the second quarter of 2024 reflect recognition of portions of the upfront payment from the license agreement with Gilead and the clinical milestone from the license agreement with AstraZeneca.

R&D expenses for the second quarter of 2025 were approximately $5.6 million compared to approximately $6.2 million for the comparable period in 2024.

G&A expenses were approximately $2.2 million for the second quarters of 2025 and 2024.

Net loss for the second quarter of 2025 was approximately $7.3 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $2.1 million, or $0.02 per basic and diluted share, in the second quarter of 2024.

Full financial tables are included below

Conference Call and Webcast Information

The Company will hold a conference call today, August 6, 2025, at 8:30 AM ET to review its second quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On August 6, 2025 Merus N.V. (Nasdaq: MRUS), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on Wednesday, August 13, 2025 at 1:30 p.m. ET (Press release, Merus, AUG 6, 2025, View Source [SID1234654884]).

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The webcast of the presentation will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.