On July 30, 2026 CEL-SCI Corporation (NYSE American: CVM) reported that a manuscript highlighting the latest findings from its Phase 3 study titled "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," has been accepted for publication in Oral Oncology, one of the world’s leading peer-reviewed journals dedicated to head and neck cancer research and treatment.

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The manuscript, authored by Eyal Talor, Ph.D. (CEL-SCI Chief Scientific Officer, the developer of Multikine) and colleagues, is based on data from CEL-SCI’s landmark Phase 3 IT-MATTERS clinical trial evaluating Multikine (Leukocyte Interleukin, Injection)* in the treatment of newly diagnosed treatment naïve, resectable, locally advanced head and neck cancer patients. In accordance with the journal’s publication policies, CEL-SCI will disclose the scientific findings following publication in Oral Oncology.

"The acceptance of this manuscript by Oral Oncology represents another important validation of the quality and significance of our clinical data," said Geert Kersten, CEO of CEL-SCI. "Publication in leading peer-reviewed journals expands awareness of Multikine among oncologists, head and neck surgeons and cancer researchers around the world. As we prepare to begin patient enrollment in our Confirmatory Registration Study, we believe growing recognition within the scientific community will further strengthen the foundation supporting Multikine’s potential to become an important new treatment option for patients with low PD-L1 head and neck cancer."

In CEL-SCI’s Phase 3 study, a well-defined population of newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low tumor PD-L1 expression and no lymph node involvement treated with Multkine before receiving standard of care had a 73% five-year overall survival rate compared to 45% in patients receiving standard of care alone.

Unlike currently available immune checkpoint inhibitor therapies that primarily target patients with higher PD-L1 expression, Multikine is being developed specifically for patients with low PD-L1 tumor expression—an underserved patient population with limited treatment options and a recognized unmet medical need.

CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which is designed to confirm the previously observed overall survival benefit in this predefined target patient population. The registration study aims to enroll patients globally at clinical centers across the United States, Europe and Asia and is designed based on the approximately 97% statistical power to detect the previously observed overall survival hazard ratio of 0.34 in the same selected population of the completed Phase 3 study.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study in the same selected population, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, JUL 30, 2026, View Source [SID1234669555])

On July 30, 2026 One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, reported data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap.

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The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv.

"Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes," said Helena Yu, MD, thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. "Until now that type of analysis required different types of samples and workflows than we deploy in clinical care. This study shows we can do that analysis from the same samples we already collect, paving the way to more deeply explore how we can leverage this technology to guide treatment."

The study included multiple institutions from multiple regions and varied sample and tumor types to reflect the diversity encountered in real world clinical care. The data include findings from 88 single-nucleus experiments spanning bladder, breast, colon, lung, ovarian, and pancreatic cancers, including 36 core biopsies. The assay produced reproducible measurements of cellular composition and cell-type-resolved gene expression. Technical reproducibility was high (median correlation > 0.92 in cell-type proportions across replicates), and automated estimates of immune infiltration closely matched pathologists’ assessments of tumor-infiltrating lymphocytes. The workflow succeeded on archival blocks up to roughly a decade old and on ultra-low-input biopsies, and it quantified clinically relevant antibody-drug-conjugate targets.

The assay uses single-nucleus RNA sequencing to measure gene activity inside individual cells present in thin slices of tissue prepared for standard pathologic analyses. OneMap, an A.I.-powered software engine, identifies which cells are present and measures what each type is doing. OneMap then produces a single standardized report for each sample, eliminating the batch processing that older single-cell methods required.

"Single-cell analysis is a valuable addition to current molecular profiling, revealing important information about a tumor that standard tests cannot. Previously, it required the wrong kind of samples, too much tissue and analysis that only worked in large batches, making it impractical for real-world patient care," said Vincent Miller, executive chairman of One Biosciences. "This study validates our approach, which runs on ordinary pathology slides every hospital already produces, needs only a fraction of the tissue, and returns a standardized report for one patient at a time, creating a true sample-to-report solution that can enable more targeted clinical trials and ultimately improve patient care."

Standard tumor diagnostics average signal across millions of cells, potentially obscuring subpopulations of cells that might drive resistance, including immune cells. Single-cell profiling analyzes tumors one cell at a time, providing critical insights for both researchers and clinicians. Ongoing studies will explore whether single cell profiles can better select patients. In the clinic, single cell profiles offer an important addition to standard bulk profiling that grounds treatment decisions in the composition of a patient’s own tumor.

(Press release, One Biosciences, JUL 30, 2026, View Source [SID1234669554])

On July 30, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported financial results for the quarter ended June 30, 2026.

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"Q2 was another exceptional quarter for us," said Eric Lefkofsky, Founder and CEO of Tempus. "Our strategy is working given the investments we have made in AI over the past several years are driving some of the best growth rates we have seen in our two largest businesses – Oncology Diagnostics and Data Licensing."

Second Quarter 2026 Highlights

Total revenue of $382.5 million, up 22% year-over-year
Oncology volume growth of 31% year-over-year, up from 28% last quarter
Molecular residual disease (MRD) volume was 9,000 tests, up from 6,500 last quarter
Data Licensing & Modeling (Insights) revenue up 36% year-over-year
Signed ~$200 million in new Data and Applications licenses
FDA approved xT Tumor Only which will migrate tissue testing to ADLT pricing
Successfully delivered our first oncology foundation model to AstraZeneca
Completed a $460 million offering of 0.0% convertible senior notes due 2032
GAAP net income of $5.6 million and Adjusted EBITDA of $8.0 million
Cash and marketable securities of $820.7 million as of June 30, 2026
Increasing revenue guidance to $1.595 to $1.605 billion for 2026 and expect full year Adjusted EBITDA of ~$65 million
On July 20, 2026, Tempus also announced an agreement to acquire Personalis, a leader in the tumor-informed MRD space. "Through our existing collaboration with Personalis, we have already demonstrated the strength of combining highly sensitive MRD technology with our commercial infrastructure," said Mr. Lefkofsky. "With clinical adoption and reimbursement momentum building, we believe we are collectively well positioned to capture this opportunity, which makes this acquisition particularly exciting."

Second Quarter 2026 Summary Results

Revenue increased 22% year-over-year to $382.5 million.
Diagnostics generated $289.3 million of revenue, representing 20% year-over-year growth, driven by Oncology volume growth of 31%, offset by Hereditary revenue growth of 5%.
Data and Applications generated $93.2 million of revenue, representing 28% year-over-year growth, with Insights growing 36%.
Gross profit increased 26% year-over-year to $246.5 million, led by growth in Data and Applications.
Net income was $5.6 million, which included $55.6 million of stock compensation expense and related employer payroll taxes and $98.5 million in unrealized gains on marketable securities, compared to a net loss of $(42.8 million) in Q2 of 2025.
Adjusted EBITDA was $8.0 million, compared to ($5.6 million) in Q2 of 2025.
$820.7 million in cash and marketable securities as of June 30, 2026.
Recent Operational Highlights

Entered into a definitive agreement to acquire Personalis for $16.25 per share (~$1.5 billion enterprise value), tightly integrating its ultrasensitive NeXT Personal MRD technology into Tempus’ diagnostic platform
Received FDA approval for tumor-only xT CDx assay, becoming the first laboratory to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling
Launched digital pathology IMS Open-Source Consortium along with Yale New Haven Hospital (YNHH) and Memorial Sloan Kettering Cancer Center (MSK) to accelerate the democratization and standardization of digital pathology
Introduced Tempus Preview to provide preliminary results for high impact biomarkers within ~24 hours of tissue receipt
Announced a strategic collaboration with the Keck School of Medicine of USC to integrate Tempus’ AI platform, molecular diagnostics, and clinical trial matching across more than 1.5 million annual patient visits to accelerate precision oncology care
Introduced initial results from and successfully delivered the first version of our foundation model to AstraZeneca
Signed large deals with BioNTech, Daiichi Sankyo, Level Set Bio, and Incyte Pharmaceuticals, contributing to ~$200 million in total bookings this quarter
Second Quarter Financial Results

Three Months Ended June 30,

2026

2025

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

382,486

$

314,635

22

%

Gross profit

$

246,498

$

195,039

26

%

Loss from operations

$

(75,913

)

$

(61,774

)

23

%

Non-GAAP loss from operations

$

(2,708

)

$

(17,036

)

(84

)%

Net income (loss)

$

5,642

$

(42,843

)

113

%

Non-GAAP net loss

$

(7,726

)

$

(37,327

)

(79

)%

Adjusted EBITDA

$

8,044

$

(5,580

)

244

%

Net income (loss) per share, basic

$

0.03

$

(0.25

)

112

%

Non-GAAP net loss per share, basic

$

(0.04

)

$

(0.22

)

(82

)%

Financial Outlook and Guidance

Tempus is increasing its full year 2026 revenue guidance to $1.595 to $1.605 billion, which represents ~25% annual growth. We continue to expect 2026 Adjusted EBITDA to be ~$65 million. Guidance assumes no impact from the Personalis transaction, which is expected to close in late Q4 2026 or early 2027.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, July 30, 2026 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 9053038
United States – New York: (646) 307-1963
USA & Canada – Toll-Free: (800) 715-9871
Live webcast can be accessed here

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO, and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, JUL 30, 2026, View Source [SID1234669553])

On July 30, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that a new indication application of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱) has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or have recurred after prior programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy in the early stage. This marks the sixth indication application accepted by the NMPA for sac-TMT.

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The acceptance for review is based on the positive results from the randomized, open-label, multicenter Phase III registrational OptiTROP-Breast03 study evaluating the efficacy and safety of sac-TMT versus investigator’s choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who have not received prior systemic therapy for advanced disease. The enrolled population included patients with PD-L1 CPS <10, as well as those who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage. The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvements in key efficacy profile compared with investigator’s choice of chemotherapy, showing a clear clinical benefit.

Previously, sac-TMT was granted Breakthrough Therapy Designation (BTD) by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC. This new indication application has also been included in the priority review and approval process, becoming the sixth application for sac-TMT to enter this process. Inclusion in this process is expected to further expedite the review and approval, allowing this innovative treatment to benefit patients sooner.

Dr. Michael Ge, CEO of Kelun-Biotech, said, "Following the approval of sac-TMT for second-line or later treatment of TNBC based on results from the Phase III OptiTROP-Breast01 study, we are delighted to see another important milestone in the same disease area. For patients with PD-L1-negative advanced TNBC, the efficacy of traditional chemotherapy is limited, and there is an urgent clinical need for more effective and safer first-line treatment options. The positive results from the OptiTROP-Breast03 study demonstrate a clear and clinically meaningful improvement in efficacy with sac-TMT compared to chemotherapy and support the continued evaluation of sac-TMT as the first-line treatment for TNBC. We look forward to the early approval of this indication to bring a new and more effective first‑line treatment option to a broader population with advanced TNBC."

About sac-TMT(佳泰莱)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six BTDs by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. Two new indication applications have been accepted for review by the NMPA and have been included in the priority review and approval process: 1) sac-TMT in combination with pembrolizumab (KEYTRUDA[1]) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative; and 2) sac‑TMT as first‑line treatment for patients with recurrent or metastatic TNBC who have a PD‑L1 CPS <10 or have recurred after prior PD‑1/PD‑L1 inhibitor therapy in the early stage. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JUL 30, 2026, View Source [SID1234669552])

On July 30, 2026 Astrin Biosciences, a cancer intelligence company transforming how cancer is detected and treated through deep proteomics and AI, reported the publication of a landmark peer-reviewed study, "Development and Validation of a Machine-Learning Deep Plasma Proteome Classifier for Early Stage Breast Cancer Detection." The study demonstrates high sensitivity and specificity of the first blood test for early breast cancer detection.

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This research, initially presented in December 2025 at the San Antonio Breast Cancer Symposium, reflects the validation of Astrin’s novel proteome-based liquid biopsy test for early-stage breast cancer detection. In this paper published in Breast Cancer: Targets and Therapy, Astrin demonstrates that Certitude, which leverages mass spectrometry and machine learning, achieves high accuracy in identifying breast cancer, particularly in its earliest and most treatable stages.

For decades, liquid biopsies have leaned on DNA-based blood tests — an approach that has struggled for breast cancer for a simple biological reason: early breast tumors shed only about a tenth of the DNA compared to other cancers, including colorectal. That is why DNA-based multi-cancer tests have shown low sensitivity in breast disease, and why even the most sensitive tests leave early breast cancer off their panels entirely. Certitude reads a different signal in proteins rather than DNA. Cancer cells don’t grow in isolation — they constantly signal to immune and stromal cells, and that protein crosstalk appears in the blood long before a tumor is large enough to image. By profiling the proteome in depth, Certitude surfaces those faint early signals, closing a gap that imaging and DNA-based blood tests have never fully solved.

Astrin’s patent-pending proteomics approach captures a deep profile of over 9,000 proteins to identify cancer-specific signals. In the validation arm of 397 women, the test achieved a sensitivity of 92.6% and a specificity of 92.3%, with a remarkably high negative predictive value (NPV) of 99.87%. These results were consistent across all breast cancer stages (0-IV) and across various molecular and pathological subtypes, including the notoriously difficult-to-detect Invasive Lobular Carcinoma (ILC).

"Our proteomic assay demonstrates high sensitivity and specificity in women with breast cancer, especially at early stages," said Justin Drake, Ph.D., Corresponding Author and Chief Science Officer at Astrin Biosciences. "By reducing false positives more than 10-fold compared to MRIs or contrast enhanced mammograms, Certitude represents a promising path forward as a supplemental screening option that is convenient and accessible."

For women with dense breasts, Certitude offers more clarity than ever before. Dense tissue appears white on a mammogram — and so can abnormalities, including some cancers — which can make it more difficult for radiologists to detect changes or suspicious areas. In addition to identifying cancers in pathological stages 0, I, and II with high accuracy, Certitude detected 93% of breast cancers in women with dense breast tissue across a simulated population, many of which could have been missed by traditional mammography. The study validates a high-throughput pipeline capable of processing hundreds of samples weekly with exceptional reproducibility.

"Breast cancer screening has relied on the same imaging techniques for decades. The research published today represents a real step forward for women, showing that a proteomic-based blood test can detect earliest signals of breast cancer with high confidence," said Dr. Pooja Advani, Medical Oncologist and Director of the Multidisciplinary Breast Clinic at Mayo Clinic.

Certitude is intended for women following screening mammography who require additional risk stratification before further imaging. The test is most appropriate for:

Women ages ≥40 with dense breasts (BI-RADS C or D) and a negative mammogram
Patients with inconclusive or indeterminate mammographic findings (e.g., BI-RADS 0 or 3)
High-risk patients with negative or equivocal mammogram, used as part of high-risk screening rotation
Suspicious or positive findings (BI-RADS 3 or 4)
To learn more or request the test, go to www.certitudetest.com.

(Press release, Astrin Biosciences, JUL 30, 2026, View Source [SID1234669551])