FREMONT, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Compensation Committee of its Board of Directors granted non-qualified stock options to purchase an aggregate of 29,000 shares of its common stock to eight new employees under Personalis’ 2020 Inducement Plan. The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee, or non-employee director, o ...

FREMONT, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries. Matching patients to their optimal cancer therapy requires a testing platform that can accurately report a broader range of clinically actionable genomic alt ...

FREMONT, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2023. Preliminary Fourth Quarter Revenue and Cash Balance Preliminary total company revenue is estimated to be $19.7 million in the fourth quarter of 2023, an increase of 18% compared with $16.7 million in the fourth quarter of 2022 Preliminary revenue from pharma tests, enterprise ...

Personalis, Inc. (NASDAQ:PSNL) Q3 2023 Earnings Conference Call November 7, 2023 5:00 PM ET Company Participants Caroline Corner - IR Chris Hall - CEO and President Aaron Tachibana - CFO and COO Rich Chen - Chief Medical Officer and EVP, Research and Development Conference Call Participants Patrick Donnelly - Citi Dan Brennan - TD Cowen Mark Massaro - VTIG Swayampakula Ramakanth - H.C. Wainwright Operator Good afternoon and welcome to Personalis Third Quarter 2023 Earnings Conference Call. All participants ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) Delaware 27-5411038 (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 00 ...

Financial Data and Key Metrics Changes - Total company revenue for Q2 2023 was $16.7 million, an 8% decrease compared to the same period last year, primarily due to timing of customer sample receipts and biopharma economic headwinds [37] - Gross margin improved to 28.7% for Q2 2023, up from 25.1% in the prior quarter and 23.5% year-over-year [38] - Net loss for Q2 2023 was $24 million, compared to a net loss of $27.5 million for the same period last year, with net loss per share at $0.50 [41] - Cash and short-term investments at the end of Q2 2023 totaled $137.2 million, with net cash usage of $11.7 million, significantly down from previous quarters [42] Business Line Data and Key Metrics Changes - The company is focusing on the MRD strategy targeting a $25 billion monitoring market with the NeXT Personal liquid biopsy test [11] - The NeXT Personal test aims for ultra-high sensitivity, detecting cancer levels down to one part per million [13] - Collaborations with AstraZeneca and TRACERx are expected to validate the technology and support reimbursement efforts [15][19] Market Data and Key Metrics Changes - The company is establishing NeXT Personal as the assay of choice for global biopharma customers, with significant collaborations in lung and breast cancer [9][21] - The TRACERx collaboration is expected to provide clinical value for early-stage lung cancer, with data presentation anticipated at a scientific conference [20] Company Strategy and Development Direction - The company is investing heavily in MRD and personalized therapies, aiming to launch NeXT Personal as a clinical laboratory developed test by the end of 2023 [27] - The strategy includes deepening evidence and pursuing coverage in early-stage lung and breast cancer, as well as immunotherapy monitoring [11][24] - The company is also focused on expanding its intellectual property portfolio to defend its market position [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in revenue growth driven by collaborations and clinical evidence generation, particularly in the second half of 2023 [61] - The company expects total revenue for 2023 to be between $70 million and $72 million, with oncology revenue projected at $61 million to $63 million [43] - Management highlighted the importance of clinical data in driving insurance coverage and revenue growth in the future [80] Other Important Information - The company has initiated a second patent infringement lawsuit against Foresight Diagnostics, asserting a total of seven patents [29] - The company is collaborating with Moderna on personalized cancer vaccines, which are expected to be significant revenue drivers in 2024 [32] Q&A Session Summary Question: Can you help us think through the personalized cancer vaccine opportunity? - Management indicated that the partnership with Moderna and Merck is expected to offset declines from other business areas, with significant revenue potential anticipated in 2024 [50][51] Question: What is driving the confidence in the revised guidance? - Management noted a growing funnel of opportunities with pharma for MRD, expecting revenue to increase in the latter half of 2023 [60][61] Question: Can you elaborate on the TRACERx trial and its significance? - Management explained that the TRACERx collaboration was chosen due to the ultra-sensitive platform, which can detect cancer that previous tests could not [69][71] Question: How will the Be Stronger trial provide interim data? - Management confirmed that the trial is designed to provide early interim data, which will help in obtaining coverage and clinical adoption [82] Question: What is the expected contribution from pharma relationships in 2023? - Management indicated that the contribution from pharma is expected to be in the range of $31 million to $32 million, with MRD being a smaller component initially [89][91]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38943 Personalis, Inc. (Exact Name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

Personalis, Inc. (NASDAQ:PSNL) Q1 2023 Earnings Conference Call May 3, 2023 5:00 PM ET Company Participants Caroline Corner – Investor Relations Chris Hall – Chief Executive Officer and President Aaron Tachibana – Chief Financial Officer and Chief Operating Officer Rich Chen – Chief Medical Officer and Executive Vice President-R&D Conference Call Participants Mike Matson – Needham & Co. Sean Lee – H.C. Wainwright Operator Greetings ladies and gentlemen. And welcome to Personalis’ First Quarter 2023 Earnings ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38943 Personalis, Inc. (Exact Name of registrant as specified in its charter) (State or other jurisdiction of incorporatio ...

Financial Data and Key Metrics Changes - For the full year of 2022, total company revenue was $65 million, a decrease of 24% compared to 2021 due to a decline in VA MVP revenue [21] - Gross margin for the fourth quarter was 13.8%, down from 38.7% in the same period of the prior year, primarily due to unabsorbed overhead costs and increased expenses [3] - Net loss for the full year of 2022 was $113.3 million, compared to a net loss of $65.2 million for 2021, with a net loss per share of $2.48 [24] - Cash and short-term investments at the end of the fourth quarter were $167.7 million, with cash usage of $25.1 million during the quarter [9] Business Line Data and Key Metrics Changes - Oncology revenue for the full year of 2022 increased by 42% compared to 2021, driven by growth in test volume with Natera [21] - Total company revenue for the fourth quarter of 2022 was $16.7 million, a 90% decrease compared to the same period of the prior year, while oncology revenue was $15.8 million, an increase of 3% [37] - R&D expenses in the fourth quarter were $16.6 million, up from $14.5 million in the same period last year, while SG&A expenses increased to $17.8 million from $13.7 million [23] Market Data and Key Metrics Changes - The company estimates that breast and lung cancer alone represents almost 1 million cases for monitoring each year [2] - The company expects to achieve a cash runway through 2025, allowing for strategic investments in key biopharma partnerships [14] Company Strategy and Development Direction - The company has defined a new strategy focused on minimal residual disease (MRD) detection, particularly in immunotherapy monitoring, breast cancer, and lung cancer [28] - The company plans to launch NeXT Personal Dx, an LDT version of its MRD offering, in the second half of 2023 [32] - The company aims to build a strong clinical evidence base to support its products and drive key indications, with collaborations planned for 2023 [35] Management's Comments on Operating Environment and Future Outlook - Management noted that 2022 was a peak year for cash usage due to one-time investments, but expects cash usage to decline each year moving forward [41] - Management expressed optimism about the potential for revenue growth in 2024, despite anticipated declines in volume from Natera [57] - The company is focused on achieving reimbursement for its NeXT Dx offering and expects to receive its first CMS reimbursement coverage decision before the end of Q3 2023 [43][90] Other Important Information - The company has pruned its biopharma business to focus on profitability, resulting in a workforce reduction of approximately 30% [29] - The company has decided to discontinue operations in China, viewing it as a permanent decision due to cost and investment challenges [78] Q&A Session Summary Question: Can you elaborate on your partnership with Moderna regarding the personalized cancer vaccine? - The company has been a strategic partner with Moderna for several years, providing genomic testing to customize therapies for patients, and is excited about the Phase 3 trials starting this year [59] Question: What are the current challenges with sample delivery? - The company is still facing headwinds in sample delivery due to issues with pharma customers obtaining samples from CROs and budget constraints amid economic conditions [61] Question: How do you view gross margins for 2023? - The company expects gross margins to improve in the latter half of 2023 as new equipment comes online, with significant savings anticipated in 2024 [50][65] Question: What is the status of the NeXT Dx reimbursement decision? - The company is committed to obtaining reimbursement for NeXT Dx this year and is actively working on the submission to MolDx [90] Question: How is the company approaching the commercialization of tests? - The company is focusing on partnerships to leverage other companies' sales forces for broader market access while developing its own capabilities in key oncology indications [72][73]