On November 4, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the third quarter ended September 30, 2025. The quarter was distinguished by significant operational momentum in its "Win-in-MRD" strategy, headlined by increasing clinical tests delivered and robust clinical evidence generation.

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Third Quarter 2025 and Recent Business Highlights

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Accelerated Clinical Adoption: Delivered 4,388 clinical tests, demonstrating robust 26% sequential increase over Q2 2025 and a 364% year-over-year growth fueled by increasing physician adoption of the NeXT Personal platform for cancer monitoring.
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Submitted for Medicare Lung Cancer Coverage: Submitted a third dossier for Medicare coverage. The Company has three pending indications and remains confident its evidence will meet the standard for coverage.
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Presented New Lung Cancer Data: Presented positive new data from AstraZeneca’s Phase 3 NeoADAURA trial in lung cancer. The findings show NeXT Personal is a strong predictor of patient outcomes and a more sensitive and accurate measure of MRD in the neoadjuvant setting. Data from the LAURA trial was also presented at ESMO (Free ESMO Whitepaper) that showed NeXT Personal could detect recurrence 5 months ahead of blinded expert review and NeXT Personal could be utilized for treatment response monitoring in adjuvant lung cancer.
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Launched Prospective Breast Cancer Utility Study: Launched the CATE clinical trial in collaboration with Yale Cancer Center. The study aims to demonstrate the utility of NeXT Personal in guiding treatment decisions for patients with HR+/HER2- breast cancer to prevent metastatic relapse.
"Our third-quarter results demonstrate clear progress in our strategy to Win-in-MRD," said Chris Hall, Chief Executive Officer and President of Personalis. "The 364% year-over-year growth in our clinical test volume is a powerful indicator of physician enthusiasm for NeXT Personal. We believe the compelling data from the AstraZeneca NeoADAURA and LAURA studies and the launch of our CATE trial with Yale are helping to build an unimpeachable evidence base for our technology. With our third indication submitted for Medicare coverage, we are well positioned for success in this large market."

Third Quarter 2025 Financial Results Compared with 2024

Revenue of $14.5 million for the third quarter of 2025 compared with $25.7 million. The decrease of 44% was primarily due to the expected decline of $4.6 million in revenue from Natera, a decrease in population sequencing revenue of $4.2 million, and a decrease in revenue from pharma tests and services, and other customers of $2.5 million.

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Pharma tests and services, and other customers of $13.2 million for the third quarter of 2025 compared with $15.7 million, a decrease of 16%.

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Population sequencing of $0.2 million for the third quarter of 2025 compared with $4.4 million, a decrease of 95%.

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Gross margin of 13.2% for the third quarter of 2025 compared with 34.0%. The decrease was primarily due to a reduction in fixed cost absorption from the lower revenue volume and increased unreimbursed clinical test costs demonstrating the interest in our tests as we await reimbursement.

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Net loss of $21.7 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 88.7 million in the third quarter 2025, compared with a net loss of $39.1 million, and net loss per share of $0.64 based on a weighted-average basic and diluted share count of 61.1 million; the prior year net loss included a $26.0 million non-cash expense from warrants which were exercised in the third quarter of the prior year.

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Cash, cash equivalents, and short-term investments of $150.5 million as of September 30, 2025; cash usage of $23.4 million from operations and capital equipment additions in the third quarter of 2025.

Fourth Quarter and Full Year 2025 Outlook

Personalis expects the following for the fourth quarter of 2025:

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Total company revenue to be in the range of $15.7 to $20.7 million
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Revenue from pharma tests and services, and all other customers to be in the range of $12.0 to $17.0 million
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Revenue from population sequencing and enterprise sales of approximately $3.7 million

Personalis now expects the following for the full year of 2025 (updated guidance):

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Total company revenue in the range of $68.0 to $73.0 million (reduced range from prior guidance of $70.0 to $80.0 million)
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Revenue from pharma tests and services, and all other customers in the range of $50.0 to $54.0 million (reduced range from prior guidance of $52.0 to $58.0 million)
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Revenue from population sequencing and enterprise sales in the range of $16.5 to $17.0 million (increased range from prior guidance of $15.0 to $16.0 million)
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Revenue from clinical tests reimbursed in the range of $1.5 to $2.0 million (reduced range from prior guidance of $3.0 to $6.0 million to account for reimbursement milestone later in 2025)
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Gross margin in the range of 22% to 24% (no change from prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement
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Net loss of approximately $85 million (no change from prior guidance)
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Cash usage of approximately $75 million (no change from prior guidance)

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results, as well as plans for the remainder of 2025, after market close on Tuesday, November 4, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

(Press release, Personalis, NOV 4, 2025, View Source [SID1234659366])

On November 4, 2025 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, reported activation of a new U.S. clinical trial site at the University of Alabama at Birmingham ("UAB") for its ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.

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The UAB site joins the list of clinical centers participating in the Company’s global Phase 1/1b trial, which is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients. Enrollment at the UAB site is expected to begin immediately.

"We are pleased to activate UAB as a clinical site for our ongoing Phase 1/1b PAS-004 trial," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "UAB brings deep clinical expertise in NF1 and a strong commitment to advancing care for patients with NF1 neurofibromas. Alongside our continued engagement with the NF community, including our recent platinum sponsorship of the NF Caregivers Symposium, we remain focused on advancing PAS-004 through clinical development with urgency and purpose."

In parallel with the site activation, Pasithea will serve as Platinum Sponsor of the 2025 NF Caregivers Symposium that will be hosted at UAB on November 8, 2025. The symposium gathers caregivers, clinicians, researchers, and advocates to discuss patient care, caregiver support, emerging research, and quality-of-life considerations for families affected by NF1.

"Collaborations between academia, industry, caregivers, and patient advocates improve outcomes and support for NF1 patients," said Dr. Rebecca Brown, Director of NF Clinical Programs at UAB. "We look forward to participating in this clinical trial and supporting other activities that promote resources for the NF community."

About the Phase 1/1b Study of PAS-004

The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ("RPBD") or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology.

The trial will be conducted in two parts. In Part A (dose escalation phase), following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B (expansion phase), approximately 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D).

The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S.

(Press release, Pasithea Therapeutics, NOV 4, 2025, View Source [SID1234659365])

On November 4, 2025 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter 2025 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our activity in the third quarter focused on advancing the clinical work required to support our ambitious Phase 1b program for NXP900, which recently commenced." Mr. Bentsur continued, "Our goal for the Phase 1b program is to showcase NXP900’s therapeutic potential, both as a single agent and in combination with certain market-leading therapies with the aim of reversing acquired resistance to these drugs. With the Phase 1b monotherapy component already underway, and the expected upcoming initiation of the combination component, we continue to make strides towards achieving this goal." Mr. Bentsur added, "To support and inform the Phase 1b program, we completed the NXP900 Phase 1a dose escalation study and the drug-drug interaction study in healthy volunteers and are pleased with NXP900’s emerging clinical profile, especially with the deep pharmacodynamic response observed at clinically relevant doses." Mr. Bentsur concluded, "We believe that our cash position and focus on efficient operations will enable us to achieve the key milestones and potential value inflection points for the NXP900 Phase 1b program."

Third Quarter 2025 Financial Results

Cash and cash equivalents were $35.4 million as of September 30, 2025, compared to $18.5 million as of December 31, 2024. The increase of $16.9 million in the cash balance as of the end of the third quarter of 2025 is a result primarily of our public offering in February 2025 and the utilization of our At-the-Market facility, partially offset by the operating expenses for the first nine months of 2025.

The Company’s net loss was $7.5 million for the three months ended September 30, 2025, compared to $4.2 million for the three months ended September 30, 2024, an increase in net loss of $3.4 million. The increase in net loss in the third quarter of 2025 was primarily due to a one-time $2.0 million milestone achievement expense for NXP900 and $0.7 million related to the clinical drug-drug interaction study. The three months ended September 30, 2025 also includes $1.5 million of non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation, were $5.8 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, an increase of $3.0 million.

General and administrative expenses, including non-cash stock-based compensation, were $2.0 million for the three months ended September 30, 2025, compared to $1.5 million for the three months ended September 30, 2024, an increase of $0.5 million.

Interest income was $0.3 million for the three months ended September 30, 2025, compared to $0.2 million for the three months ended September 30, 2024.

(Press release, Nuvectis Pharma, NOV 4, 2025, View Source [SID1234659364])

On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company has entered into an agreement to receive funds managed by Blackstone Life Sciences ("Blackstone") for the development of sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global Phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers.

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"This agreement positions Merck to harness the potential of sac-TMT, a promising ADC candidate targeting TROP2, while we continue to advance our broad and expansive pipeline," said Caroline Litchfield, chief financial officer, Merck. "We are making important investments to drive patient impact and revenue growth, and to sustain our business for the future while remaining disciplined towards maintaining an appropriate financial profile."

Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs for sac-TMT expected to be incurred throughout 2026. In return, Blackstone is eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT across all approved indications in Merck’s marketing territories contingent upon receipt of regulatory approval in the U.S. for first-line treatment of triple-negative-breast cancer based on findings of the TroFuse-011 clinical trial.

"Sac-TMT is an innovative asset that has the potential to improve patient care across many forms of cancer," said Dr. Nicholas Galakatos, global head, Blackstone Life Sciences. "We are excited to be collaborating with Merck to realize the full value of this high priority product and contribute to our partner’s revenue growth by leveraging our scale capital and expertise."

Sac-TMT is being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Sichuan Kelun Pharmaceutical Co, Ltd. ("Kelun-Biotech"), which is unchanged by this agreement with Blackstone. Merck will retain decision-making authority and control over the development, manufacturing, and commercialization of sac-TMT; Blackstone will not receive any rights to sac-TMT.

About sacituzumab tirumotecan (sac-TMT)

Sac-TMT is an investigational ADC that consists of three components: 1) a TROP2-targeting monoclonal antibody, sacituzumab, 2) a cytotoxic payload from the topoisomerase 1 inhibitor class, and 3) a novel, irreversible but hydrolyzable linker, which joins the monoclonal antibody and the cytotoxic payload leveraging proprietary linker conjugation technology. The average drug-to-antibody ratio of sac-TMT is 7.4. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion and metastasis. TROP2 ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects and have shown encouraging anti-tumor activity in clinical studies.

Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659363])

On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company, through a subsidiary (Prometheus BioSciences), has reached an agreement with Dr. Falk Pharma GmbH (Falk) to discontinue an existing contract concerning co-development and co-commercialization rights in certain territories for MK-8690 (formerly PRA-052), and for Merck to assume full responsibility for the development program going forward. MK-8690 is an investigational anti-CD30 ligand monoclonal antibody being evaluated by Merck in an early-stage clinical trial.

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Under the terms of the agreement, Prometheus BioSciences (Prometheus) and Falk have discontinued their collaboration based on their existing co-development contract resulting in Prometheus having secured global rights to MK-8690. In exchange, Falk will receive a $150 million upfront payment and is eligible to receive a payment associated with a development milestone as well as royalties on sales in certain territories. The original contract between Falk and Prometheus was signed in 2020. Merck subsequently acquired Prometheus in 2023.

As a result of the transaction with Falk, Merck will record a pre-tax charge to research and development expenses of $150 million, or approximately $0.05 per share, in both its GAAP and non-GAAP fourth quarter results.

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659362])