PSNL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-11-04

• Key business accomplishments and financial updates in the third quarter of 2026 include:

• Launched NeXT Personal® Real-Time Variant Tracker™: Commercially launched optional Real-Time Variant Tracker supplemental results in the NeXT Personal molecular residual disease (MRD) test report, which identify clinically relevant resistance and therapeutically targetable variants over time, during…

• Reported pre-interim results from prospective Triple Negative Breast Cancer (TNBC) B-STRONGER-1 study: Personalis’ study is a multi-site, prospective study evaluating ctDNA dynamics in stage I-III TNBC patients receiving neoadjuvant therapy (NAT). Results showed high sensitivity, achieving a 96% ctD…

• Demonstrated the value of ultrasensitive ctDNA for predicting early immunotherapy response: A study conducted with The University of California, San Diego (UCSD) for 55 patients across 8 metastatic cancer types showed that an ultrasensitive assay may provide resolution in cases of heterogeneous resp…

• Specific components of the increase in the third quarter of 2026 were a $4.3 million increase in fees payable to Tempus for the volume of tests sold and results delivered to physicians and commercial-related expenses associated with higher NeXT Personal Dx testing volume, a $4.7 million increase in …

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• increases were partially offset by (i) the expected revenue decline from Enterprise sales due to the completion of the project with Natera, and (ii) planned lower population sequencing revenue from the VA MVP.

• Key business accomplishments and financial updates in the second quarter of 2026 include:

• Secured Medicare Coverage for IO Monitoring: Received Medicare coverage approval for NeXT Personal® for immunotherapy monitoring for patients with late-stage solid tumors;

• Secured Medicare Coverage for Neoadjuvant Therapy Monitoring for Breast Cancer: Received Medicare coverage approval for NeXT Personal for monitoring treatment response to NAT in patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC) or HER2-positive (HER2+) breast cancer;

• Presented Compelling Colorectal Cancer Recurrence Detection: The prospective VICTORI study led by the University of British Columbia showed NeXT Personal detected 100% of all patient relapses, including all distant metastases in historically difficult-to-detect regions like the lung. Notably, just f…

相对上期新增的文字 · 来源:10-Q · 2026-11-04

• Certain conditions to completion of the Merger have been satisfied, including the expiration of the waiting period under the HSR Act and the effectiveness of the registration statement on Form S-4. Completion of the Merger remains subject to other conditions set forth in the Merger Agreement, includ…

• materially and adversely affect our business operations and financial condition, which in turn would materially and adversely affect the price of our common stock.

• in a more patient-friendly, efficient, or cost-effective manner than is currently possible. If we cannot compete successfully against current or future competitors, or if we cannot maintain successful customer or supply relationships with Moderna, Illumina or other present or potential competitors, …

• enrollment and also may have needed to divert resources to respond to the pandemic. Another health epidemic or pandemic may negatively impact the value of any potential new VA MVP contract or order.

• In January 2024, we announced that we received a final Medicare coverage determination for our NeXT Dx offering, extended retroactively to August 29, 2023. In November 2025, we announced that we received Medicare coverage for NeXT Personal Dx for post-treatment surveillance of cancer recurrence in p…

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• The completion of the Merger is subject to a number of conditions set forth in the Merger Agreement, including: (i) the approval of the Merger and adoption of the Merger Agreement by the affirmative vote of the holders of a majority of the outstanding shares of our common stock entitled to vote ther…

• We expect that biopharmaceutical companies will increasingly focus attention and resources on the targeted and personalized cancer diagnostic sector as the potential and prevalence of molecularly targeted oncology therapies approved by the FDA along with

• In January 2024, we announced that we received a final Medicare coverage determination for our NeXT Dx offering, extended retroactively to August 29, 2023. In November 2025, we announced that we received Medicare coverage for NeXT Personal Dx for

• post-treatment surveillance of cancer recurrence in patients with Stage II and III breast cancer, with an effective date of October 7, 2025. In February 2026, we announced that we received Medicare coverage for NeXT Personal Dx for surveillance of patients with Stage I to III NSCLC with an effective…

• We are pursuing a partner-centric strategy and have key relationships with Tempus, Myriad, Moderna and Merck, among others. These and any other partnering and/or collaboration arrangements that we have entered into or may enter into in the future may not be successful, or may terminate, which could …

相对上期新增的文字 · 来源:10-Q · 2026-11-04

• During our last fiscal quarter, certain of our officers (as defined in Rule 16a-1(f) under the Exchange Act) terminated written plans for the sale of our securities as set forth in the table below.

• Aaron Tachibana, Chief Financial Officer and Chief Operating Officer

• * Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

• **Non-Rule 10b5-1 trading arrangement as defined in Item 408(c) of Regulation S-K under the Exchange Act.

相对上期删除的文字 · 来源:10-Q · 2026-08-04

• There are no disclosures required by this Item 5, including those relating to “Rule 10b5-1 trading arrangements” and “non-Rule 10b5-1 trading arrangements” as those terms are defined in Item 408 of Regulation S-K.