PSNL Personalis Inc.

22.75
+1.23  (+6%)
Previous Close 21.52
Open 22.07
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Market Cap $995,763,769
Shares 43,769,836
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Enterprise Value $728,613,349
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  1. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.

    First Quarter Highlights

    • Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
    • Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
    • Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
    • Announced a collaboration…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the first quarter ended March 31, 2021.

    First Quarter Highlights

    • Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
    • Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
    • Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
    • Announced a collaboration with MapKure, LLC, a company jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., LLC for use of the NeXT PlatformTM for clinical trials and companion diagnostic development
    • Added approximately $162 million of cash to balance sheet from public offering of common stock financing in the first quarter of 2021; ended the quarter with cash, cash equivalents, and short-term investments of $353.4 million as of March 31, 2021

    "I'm proud to say that we were able to report record revenue once again this quarter and achieved our nineteenth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Biopharma and all other customer revenue grew 74% year-over-year, and orders from customers exceeded revenues reported once again this quarter," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera in the field of personalized oncology, and a companion diagnostics collaboration with MapKure. Both collaborations further validate our NeXT platform as a leading front end tissue-sequencing platform, capable of detecting cancer cell mutations that conventional exome tests often miss. Our tissue offering complements our whole exome liquid biopsy product that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct revenue opportunities in the rapidly growing cancer monitoring market."

    First Quarter 2021 Financial Results

    Revenues were $20.9 million in the three months ended March 31, 2021, up 9% from $19.2 million in the same period of the prior year.

    Gross margin was 35.6% in the three months ended March 31, 2021, compared with 21.1% in the same period of the prior year.

    Operating expenses were $19.9 million in the three months ended March 31, 2021, compared with $13.7 million in the same period of the prior year.

    Net loss was $12.4 million in the three months ended March 31, 2021 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 42.3 million, compared with a net loss of $9.1 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.3 million in the same period of the prior year.

    Business Outlook

    Personalis expects the following for the second quarter of 2021:

    • Total Company revenues to be approximately $21.3 million
    • Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $7.3 million to $7.7 million
    • Net Loss to be in the range of $16 million to $17 million; estimated outstanding shares of 43 million

    Personalis expects the following for the full year of 2021:

    • Total Company revenues to be approximately $85 million
    • Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $30 million to $32 million
    • Net Loss to be in the range of $70 million to $75 million; estimated outstanding shares of 44 million

    Webcast and Conference Call Information

    Personalis will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 5, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 6587766. The live webinar can be accessed at https://investors.personalis.com.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "estimate," "expect," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements regarding the company's expectations for revenues and net loss for the second quarter and full year of 2021. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks, uncertainties and other factors relate to, among others: the timing and pace of new orders from customers, including from the U.S. Department of Veterans Affairs Million Veteran Program, which was the company's largest customer in 2018, 2019, and 2020; the launch of new products and new product features, such as NeXT Personal; the market adoption of offerings launched in 2020, such as Personalis' whole exome liquid biopsy product; the timing of tissue, blood, and other specimen sample receipts from customers, which can materially impact revenue quarter over quarter and year over year; whether orders for the NeXT Platform and revenues from biopharmaceutical customers increase in future periods; the success of Personalis' collaborations, and including those with Natera and the MapKure; the success of the company's international expansion plans; the evolution of cancer therapies and market adoption of the company's services; the company's expectations regarding future performance; and the ongoing COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers and suppliers. In addition, other potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 that will be filed after this earnings release, and risk factors included within the Annual Report on Form 10-K filed on February 25, 2021. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

     

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

    (in thousands, except share and per share data)

     

     

     

     

     

     

    Three Months Ended March 31,

     

     

    2021

     

    2020

    Revenues

     

    $

    20,881

     

     

    $

    19,161

     

    Costs and expenses

     

     

     

     

     

     

     

     

    Costs of revenues

     

     

    13,454

     

     

     

    15,122

     

    Research and development

     

     

    9,496

     

     

     

    6,390

     

    Selling, general and administrative

     

     

    10,421

     

     

     

    7,274

     

    Total costs and expenses

     

     

    33,371

     

     

     

    28,786

     

    Loss from operations

     

     

    (12,490

    )

     

     

    (9,625

    )

    Interest income

     

     

    95

     

     

     

    510

     

    Interest expense

     

     

     

     

     

    (2

    )

    Other income (expense), net

     

     

    (12

    )

     

     

    8

     

    Loss before income taxes

     

     

    (12,407

    )

     

     

    (9,109

    )

    Provision for (benefit from) income taxes

     

     

    (3

    )

     

     

    30

     

    Net loss

     

    $

    (12,404

    )

     

    $

    (9,139

    )

    Net loss per share, basic and diluted

     

    $

    (0.29

    )

     

    $

    (0.29

    )

    Weighted-average shares outstanding, basic and diluted

     

     

    42,265,596

     

     

     

    31,345,029

     

    PERSONALIS, INC.

    SUPPLEMENTAL REVENUE INFORMATION (unaudited)

    (in thousands)

     

     

     

    Three Months Ended March 31,

     

     

     

    2021

     

     

    2020

     

    VA MVP

     

    $

    13,210

     

     

    $

    14,756

     

    All other customers

     

     

    7,671

     

     

     

    4,405

     

    Total

    $

    20,881

     

    $

    19,161

    PERSONALIS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)

    (in thousands, except share and per share data)

     

     

     

    March 31,

     

     

    December 31,

     

     

     

    2021

     

     

    2020

     

    Assets

     

     

     

     

     

     

     

     

    Current assets

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    137,089

     

     

    $

    68,525

     

    Short-term investments

     

     

    216,340

     

     

     

    134,765

     

    Accounts receivable, net

     

     

    8,053

     

     

     

    6,349

     

    Inventory and other deferred costs

     

     

    5,579

     

     

     

    5,639

     

    Prepaid expenses and other current assets

     

     

    5,607

     

     

     

    5,441

     

    Total current assets

     

     

    372,668

     

     

     

    220,719

     

    Property and equipment, net

     

     

    11,152

     

     

     

    11,834

     

    Operating lease right-of-use assets

     

     

    9,899

     

     

     

    10,271

     

    Other long-term assets

     

     

    1,787

     

     

     

    2,018

     

    Total assets

     

    $

    395,506

     

     

    $

    244,842

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    6,522

     

     

    $

    8,301

     

    Accrued and other current liabilities

     

     

    13,805

     

     

     

    11,301

     

    Contract liabilities

     

     

    18,237

     

     

     

    21,034

     

    Total current liabilities

     

     

    38,564

     

     

     

    40,636

     

    Long-term operating lease liabilities

     

     

    8,162

     

     

     

    8,541

     

    Other long-term liabilities

     

     

    360

     

     

     

    720

     

    Total liabilities

     

     

    47,086

     

     

     

    49,897

     

    Commitments and Contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity

     

     

     

     

     

     

     

     

    Preferred stock, $0.0001 par value — 10,000,000 shares authorized; none issued

     

     

     

     

     

     

    Common stock, $0.0001 par value — 200,000,000 shares authorized; 43,798,661 and 39,105,548 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively

     

     

    4

     

     

     

    4

     

    Additional paid-in capital

     

     

    542,694

     

     

     

    376,788

     

    Accumulated other comprehensive income (loss)

     

     

    (5

    )

     

     

    22

     

    Accumulated deficit

     

     

    (194,273

    )

     

     

    (181,869

    )

    Total stockholders' equity

     

     

    348,420

     

     

     

    194,945

     

    Total liabilities and stockholders' equity

     

    $

    395,506

     

     

    $

    244,842

     

     

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  2. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  3. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, announced today it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

    Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company's website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency and quality. Personalis operates one of the largest sequencing programs globally and is currently the sole sequencing provider to the U.S. Department of Veterans Affairs Million Veterans Program. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis® ImmunoID NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue or blood sample. The Personalis® Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited.

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  4. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021.

    These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present new data in scientific posters to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, which will be held online, April 10-15, 2021 and May 17-21, 2021.

    These abstracts showcase data from ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The ImmunoID NeXT Platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

    Following are details and links to the scientific posters that will be presented at the online meeting.

    Poster Number, Session Category and Session Title

     

    Title & Presenter

     

    Date

     

    Location

    399

    Clinical Research (Excluding Trials)

     

    Biomarkers Predictive of Therapeutic Benefit

    Pan-cancer survey of HLA loss of heterozygosity using a robustly validated NGS-based machine learning algorithm

     

    Presenter: Rachel Marty Pyke, PhD

     

    April 10, 2021

    Online

    555

    Clinical Research (Excluding Trials)

     

    Liquid Biopsies: Circulating DNA

    Longitudinal exome-scale liquid biopsy monitoring of evolving therapeutic resistance mechanisms in head and neck squamous cell carcinoma patients receiving anti-PD-1 therapy

     

    Presenter: Charles Abbott, PhD

    April 10, 2021

    Online

    1898

    Immunology

    Tumor

     

    Antigenicity/Processing and Presentation

    Accurate modeling of antigen processing and MHC peptide presentation using large-scale immunopeptidomes and a novel machine learning framework

     

    Presenter: Rachel Marty Pyke, PhD

    April 10, 2021

    Online

    2227

    Molecular and Cellular Biology / Genetics

     

    Genomic Profiling of Tumors

    Pan-cancer shedding patterns of tumor circulating cell free DNA

     

    Presenter: Fábio Navarro, PhD

     

    April 10, 2021

    Online

    2241

    Molecular and Cellular Biology / Genetics

     

    Genomic Profiling of Tumors

    Profiling tumor-infiltrating immune cells using an augmented transcriptome

     

    Presenter: Eric Levy, PhD

    April 10, 2021

    Online

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform, Personalis' business opportunities, leadership, plans, vision or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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  5. Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.

    As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure's Phase 1a/1b dose escalation and expansion clinical trial…

    Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced a collaboration with MapKure, LLC, a clinical-stage company focusing on genetically defined disease drivers and jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., to use a clinical trial assay (CTA) based on the Personalis® NeXT Platform™, an exome/transcriptome scale NGS-based assay, to support development of BGB-3245, an investigational next-generation B-RAF inhibitor, in patients with advanced or refractory solid tumors.

    As part of this collaboration MapKure will be working with Personalis to utilize the NeXT Platform as a confirmatory test for patients enrolled into MapKure's Phase 1a/1b dose escalation and expansion clinical trial. Additionally, MapKure will benefit from the breadth of the NeXT Platform, which enables broad tumor immunogenomic profiling of the tumor and consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample, which will help MapKure understand if other biomarkers are clinically relevant to BGB-3245.

    "With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer treatment. Our NeXT Platform provides biotechnology companies, like MapKure, with comprehensive genomic information from the entire exome and transcriptome, and provides information that can support the identification of new, advanced biomarkers. Once these biomarkers have been selected by MapKure, we expect to develop them as a companion diagnostic for regulatory submission and approval. We look forward to working with MapKure to accelerate the development of their cancer therapy in the clinic by utilizing the results from our NeXT Platform," said John West, CEO at Personalis.

    Financial terms of the collaboration were not disclosed.

    About Personalis, Inc.

    Personalis, Inc. is a leader in population sequencing and cancer genomics, with a focus on data, scale, efficiency, and quality. Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to the VA MVP. In oncology, Personalis is transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient's cancer and immune response. The Personalis NeXT Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. The Personalis Clinical Laboratory is GxP aligned as well as CLIA'88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).

    About MapKure

    MapKure is a clinical-stage company created in 2019 to develop precision medicines for patients with life-threatening diseases, with an initial focus on cancer. By focusing on genetically defined disease drivers, MapKure is positioned to advance the development of transformative medicines to patients whose unmet medical needs are largely unaddressed. MapKure is jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., and is currently developing BGB-3245 under an exclusive license from BeiGene in solid tumor patients harboring specific B-RAF driver mutations and fusions, as well as in patients who have developed resistance to first-generation B-RAF inhibitors.

    Forward-Looking Statements

    All statements in this press release that are not historical are "forward-looking statements" within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the Personalis NeXT Platform or the NeXT Dx Test, the expected benefits (including the potential for clinical trial use, companion diagnostic development and regulatory filings based on the company's NeXT Platform or the NeXT Dx Test) of the company's collaboration with MapKure, the company's business opportunities, leadership or growth, or other future events. Such forward-looking statements involve risks and uncertainties, including those related to the COVID-19 pandemic, that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis' filings with the U.S. Securities and Exchange Commission, including Personalis' most recent reports on Forms 8-K, 10-K and 10-Q, the company's registration statement on Form S-3 filed on December 30, 2020, and the company's prospectus supplement filed on January 27, 2021, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.

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