On May 12, 2025 Caris Life Sciences(Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported MET Immunohistochemistry (IHC) testing as standard of care for all non-squamous non-small cell lung cancer (NSQ NSCLC) patients and is poised for future drug approvals (Press release, Caris Life Sciences, MAY 12, 2025, View Source [SID1234652896]). This advanced testing protocol aims to provide deeper insights into the molecular characteristics of NSQ NSCLC, facilitating more personalized and effective treatment strategies.

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Approximately 50% of NSQ NSCLCs lack a targetable gene driver mutation, making MET protein expression an important additional personalized target. Caris is addressing these challenges by leveraging the power of MET IHC testing, which evaluates the expression of the MET protein in cancer cells. This protein is known to play a crucial role in cell proliferation, invasion, and survival, making it a vital biomarker for targeted therapies.

"To our knowledge, Caris is the only lab in the US that has historically and is currently offering the MET (SP44) RxDx assay for NSQ NSCLC," said Caris President David Spetzler, MS, PhD, MBA. "With MET IHC testing already in place, we are poised and ready to provide a detailed molecular profile to inform targeted therapies and future drug development approvals."

Key Highlights of MET IHC Testing:
Comprehensive Molecular Profiling: Caris utilizes a multi-platform approach, including immunohistochemistry (IHC) and next-generation sequencing (NGS), to provide a detailed molecular profile of NSQ NSCLC tumors.

Identification of Actionable Targets: The MET IHC testing helps identify overexpression of the MET protein, which is associated with poor prognosis and can be targeted by specific therapies.

Enhanced Treatment Personalization: By understanding the molecular makeup of NSQ NSCLC tumors, oncologists can tailor treatment plans to the individual needs of patients, potentially improving outcomes and quality of life.

Caris remains committed to advancing cancer diagnostics and treatment through innovative technologies and rigorous scientific research. Deployment of MET IHC testing for NSQ NSCLC patients underscores this commitment and highlights Caris’ dedication to improving patient care and outcomes.

Caris’ comprehensive molecular profile testing includes MI Cancer Seek and Caris Assure. Caris received FDA approval in November of 2024 for MI Cancer Seek, a tissue-based assay which is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. Caris Assure is a powerful blood-based assay that uniquely identifies somatic tumor, incidental clonal hematopoiesis and incidental germline variants by sequencing both plasma and buffy coat through a WTS and WES-based assay.

On May 12, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the first quarter ended March 31, 2025, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAY 12, 2025, View Source [SID1234652863]).

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"We continued our strong execution across our oncology-focused pipeline and are preparing for several near-term milestones. Importantly, our late-stage firmonertinib program continues to show differentiated potential to address unmet needs across EGFR-mutant non-small cell lung cancer (NSCLC)," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "ARR-217 (MRG007), our recently acquired antibody drug conjugate (ADC) targeting the gastrointestinal marker CDH17 with best-in-class potential, is expected to be the first ADC from our pipeline to enter the clinic."

Dr. Yao continued, "In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations."

First Quarter 2025 and Recent Highlights

Firmonertinib

● Completed enrollment for pivotal trial. During the first quarter of 2025, we completed enrollment in the the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
Pipeline

● Expanded our pipeline to include ARR-217 (MRG007). In January 2025, ArriVent entered into a collaboration agreement with Lepu Biopharma for ARR-217, a CDH17-targeted ADC with the potential to treat gastrointestinal cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China. In March 2025, our first IND was submitted in China with an initial clinical development focus in colorectal, pancreatic and other GI cancers. Pre-clinical data presented recently at the American Association

On May 12, 2025 ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, reported certain operational results following approval of the permanent J-code (J9028) in January 2025, as well as its financial results for the first-quarter ended March 31, 2025 (Press release, ImmunityBio, MAY 12, 2025, View Source [SID1234652881]).

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With the issuance of the permanent J-code (J9028) in January 2025, ImmunityBio has seen increased sales momentum supporting a trend of increases month-over-month as well as quarter-over-quarter, with March unit sales volume increasing 69% over February, and Q1 2025 unit sales volume exceeding unit sales volume achieved for all of fiscal year 2024.
ImmunityBio earned net product revenue of approximately $16.5 million during the three-month period ended March 31, 2025, which represented an increase of 129% over the $7.2 million of net revenue earned during the fourth quarter of 2024.
"We are seeing a steady growth in revenue as urologists increase their use of ANKTIVA to treat NMIBC carcinoma in situ (CIS) patients, particularly since we addressed the BCG shortage with the launch of our rBCG EAP in February," said Richard Adcock, President and CEO of ImmunityBio. "Nearly 200 urological practices are in early stages of implementation or have already begun administering rBCG to patients, many of them in rural areas where patients otherwise would not have access to this treatment. This not only lets us help more patients, it opens a new marketplace for ImmunityBio’s therapies."
"ANKTIVA’s increasing use by urologists shows the real-world benefits of our unique approach to immunotherapy," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, Global Chief Scientific & Medical Officer of ImmunityBio. "We’re making excellent progress in developing our pipeline, and now have multiple sites open for our second-line lung cancer study as well as having submitted an EAP protocol for ANKTIVA for the treatment of lymphopenia. We are confident that we will continue to deliver more advanced treatment candidates based on our solid science."

First-Quarter Ended March 31, 2025 Financial Summary and Comparison to Prior Year Quarter
Product Revenue, Net

Product revenue, net increased $16.5 million during the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, due to sales of ANKTIVA, which was approved in April 2024.

Research and Development Expense

Research and development (R&D) expense decreased $5.1 million to $48.2 million during the three months ended March 31, 2025, as compared to $53.3 million during the three months ended March 31, 2024. The decrease was primarily driven by lower external manufacturing costs, research agreement expenses, stock-based compensation expenses, equipment expenses, and consulting costs.

Selling, General and Administrative Expenses

Selling, general and administrative expense (SG&A) decreased $9.2 million to $32.7 million during the three months ended March 31, 2025, as compared to $41.9 million during the three months ended March 31, 2024. The decrease was due to lower costs related to litigation settlements and commercial consulting activities.

Net Loss Attributable to ImmunityBio Common Stockholders

Net loss attributable to ImmunityBio common stockholders was $129.6 million during the three months ended March 31, 2025, compared to $134.1 million during the three months ended March 31, 2024. The reduction of loss was primarily driven by product revenue, lower R&D and SG&A expense described above, lower related-party interest expense, and changes in the fair value of derivative liabilities, partially offset by changes in the fair value of our related-party convertible note and an increase in interest expense related to the revenue interest liability.

Cash and Marketable Securities Position

As of March 31, 2025, on a pro forma basis, the Company had consolidated cash and cash equivalents, and marketable securities of $136.4 million after giving effect to net proceeds of $74.8 million from an equity financing in April.

On May 12, 2025 Grit Biotechnology Co., Ltd. ("Grit Bio"), a clinical-stage biotech pioneering novel immunotherapies reported that three research programs, in collaboration with Vitalgen BioPharma Co., Ltd. ("Vitalgen"), will be showcased in one oral presentation and two poster sessions at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th annual meeting in New Orleans, LA from May 13th to 17th (Press release, Grit Bio, MAY 12, 2025, View Source [SID1234652897]).

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Grit Bio will provide the updates of three preclinical programs, including APC-targeted neoantigen cancer vaccine, non-viral-nanoparticle-directed in vivo CAR-T, and LNP-mediated gene editing in tumor infiltrating lymphocyte (TIL). The details of three presentations are:

Title: APC-Targeted LNP Enables Systemic Delivery of Neoantigen mRNA Vaccines and Enhanced Antigen-Specific T Cell Responses
Presentation Type: Oral
Time: 5:15-5:30 pm local time, Thursday, May 15th
Speaker: Pin Wang, Ph.D., CSO of Grit Biotechnology
Title: In Vivo CAR-T Therapy Powered by Novel CLAMP Technology for T cell-Targeted mRNA Delivery
Presentation Type: Poster
Time: 5:30-7:00 pm local time, Wednesday, May 14th
Poster #: 1282
Title: Enhancing Production and Functional Potential of Tumor-Infiltrating Lymphocytes via Lipid Nanoparticle-Mediated CRISPR/Cas9 Gene Editing
Presentation Type: Poster
Time: 5:30-7:00 pm local time, Thursday, May 15th
Poster #: 1776
"Through a strategic collaboration with Vitalgen, we are pioneering next-generation immunotherapies and precision delivery technologies. This synergy accelerates the development of advanced therapies with transformative improvements in safety and efficacy. We are now expanding those innovations toward global clinical implementation." said Dr. Yarong Liu, founder and Chief Executive Officer of Grit Biotechnology.

On May 12, 2025 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) reported financial results for the three months ended March 31, 2025 (Press release, Aurinia Pharmaceuticals, MAY 12, 2025, View Source [SID1234652864]).

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First Quarter 2025 Financial Results

Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024.
Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024.
License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $2.5 million, up 14% from $2.2 million in the same period of 2024.
Net Income (Loss): For the three months ended March 31, 2025, net income (loss) was $23.3 million, compared to $(10.7) million in the same period of 2024.
Cash Flow Provided by (Used in) Operating Activities: For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.
Cash Position

As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million, compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million.

Full Year 2025 Total Revenue and Net Product Sales Guidance

For 2025, Aurinia is reiterating its established total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million.

"We are pleased to report continued positive growth and momentum for LUPKYNIS in the first quarter of 2025 and are looking forward to a strong performance this year," stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Following the recent update to the American College of Rheumatology lupus nephritis treatment guideline, which recommends the incorporation of drugs like LUPKYNIS into first-line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm. We also remain on track to report initial results from our Phase 1 study of AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), later this quarter."

Webcast & Conference Call Details

A webcast and conference call will be hosted today, May 12, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.