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 ...

Revenue Performance - Total revenue increased by 24%, or $3.6 million, in Q1 2023 compared to Q1 2022, reaching $18.86 million[107]. - Revenue from pharma tests, enterprise, and other customers rose by 35% to $15.9 million in Q1 2023, driven by higher sales to Natera[107]. - Revenue from population sequencing decreased by 14% to $3.0 million in Q1 2023 due to reduced task orders from the VA MVP[107]. - Natera accounted for 50% of total revenue in Q1 2023, up from 27% in Q1 2022[122]. - Revenue from pharma tests and services decreased by 16%, or $1.2 million, in Q1 2023 due to non-recurring projects and variability in clinical trial spending[123]. - Revenue from enterprise sales increased by 130%, or $5.3 million, in Q1 2023, driven by a 150% increase in samples processed for Natera[124]. - Other revenue increased by 33%, or less than $0.1 million, in Q1 2023 due to higher revenue from university research projects[127]. Financial Outlook - The company expects to reduce cash usage to approximately $75 million in 2023, down from $119 million in 2022, following a 30% workforce reduction and closure of operations in China[111]. - Net loss for Q1 2023 was $28.66 million, compared to a net loss of $28.21 million in Q1 2022, with a net loss per share of $0.61[121]. - Total costs and expenses increased by 12%, or $5.2 million, in Q1 2023, with cost of revenue rising by 29%, or $3.2 million[128]. - Research and development expenses decreased by 3%, or $0.5 million, in Q1 2023, primarily due to workforce reduction[131]. - Selling, general and administrative expenses decreased by 9%, or $1.4 million, in Q1 2023, also due to workforce reduction[133]. - Restructuring and other charges amounted to $3.9 million in Q1 2023, related to workforce reduction and closure of China operations[135]. - Interest income increased by 770% to $1.253 million in Q1 2023 due to higher yields on investments[138]. - As of March 31, 2023, cash and cash equivalents totaled $148.9 million, down from $167.7 million at the end of 2022[141]. Corporate Developments - The company announced a partnership with Moderna to support personalized cancer vaccine development, including for a Phase 3 melanoma trial[111]. - The new corporate headquarters in Fremont, California, is approximately three times larger than the previous location, allowing for expanded laboratory and R&D capabilities[106]. - The company aims to focus on immunotherapy monitoring, breast cancer, and lung cancer over the next 2-3 years, collaborating with leading cancer centers and academic institutions[104]. Accounting Policies - The company considers revenue recognition, stock-based compensation, and leases as critical accounting policies and estimates due to their potential impact on financial statements[155]. - There have been no material changes to critical accounting policies and estimates compared to the previous fiscal year ended December 31, 2022[156].

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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) Delaware 27-5411038 (State or other jurisdiction ...

Financial Data and Key Metrics Changes - Total company revenue for Q3 2022 was $14.9 million, a decrease of 33% compared to the same period last year, primarily due to a $13.7 million decline in VA MVP revenue [29] - Oncology business revenue increased by 73% year-over-year, driven mainly by volume increases from Natera, which accounted for half of the oncology revenue in the quarter [29] - Gross margin was 16.7% for Q3 2022, down from 36.2% in the same period last year, primarily due to under absorbed overhead costs from decreased VA MVP revenue and increased expenses to support growing oncology revenue [30] - Net loss for Q3 was $26.5 million, compared to a net loss of $17.7 million for the same period last year, with a net loss per share of $0.58 [33] Business Line Data and Key Metrics Changes - All revenue in Q3 2022 came from the oncology business, which saw a significant increase in revenue [29] - The company recognized approximately $1.5 million from an exome-scale liquid biopsy project for a leading global pharmaceutical company [23] Market Data and Key Metrics Changes - The company has seen growing interest in its NeXT Personal platform from pharmaceutical companies in the U.S., Europe, and China, with two pharma placing orders over $1 million each [19] - The Veterans Administration Million Veterans Program (VA MVP) has begun to enroll veterans again, with a goal of reaching 1 million enrollees in 2023 [24] Company Strategy and Development Direction - The centerpiece of the company's oncology business is the NeXT Personal MRD test, which aims to provide highly sensitive and informative cancer monitoring [6] - The company plans to launch its MRD test as a lab-developed test (LDT) in 2023 and has been building a commercial team to support this initiative [20] - The company is focused on personalized diagnostics, integrating tumor characterization capabilities into its MRD test to provide actionable insights for oncologists [12] Management's Comments on Operating Environment and Future Outlook - Management noted a slowdown in biopharma demand due to budget concerns and macroeconomic conditions, particularly affecting smaller biotechs [40] - The company anticipates that the current challenging environment may continue into early 2023, but remains optimistic about the long-term need for cancer solutions [40] - Management expects gross margins to improve in the long term as oncology revenue scales up [31] Other Important Information - The company has a strong balance sheet with cash and short-term investments of $192.8 million, providing more than two years of cash runway [34] - The company has initiated a brand evolution to align with its strategy of creating highly personalized cancer diagnostic tests [22] Q&A Session Summary Question: Concerns about tightening budgets among large pharma customers - Management acknowledged a slowdown in biopharma demand due to budget concerns, particularly affecting smaller biotechs, and anticipates this trend may continue into early 2023 [40] Question: Impact of staffing shortages on sample shipments - Management confirmed that sample shipments are slower due to staffing shortages affecting patient enrollments and sample collections [44] Question: Implications of FDA requests for additional clinical data on MRD efforts - Management believes their test's performance and data from extensive collaborations will position them favorably compared to competitors facing similar FDA scrutiny [46] Question: Timing and strategy for refreshing sequencing infrastructure - Management indicated that new sequencing technologies could significantly reduce costs, with expectations for improvements in gross margins beginning in early 2024 [50] Question: Revenue expectations from the new Shanghai facility - Management does not anticipate revenue from the Shanghai facility in 2022, with expectations for moderate revenue in 2023 [59] Question: Factors driving gross margin changes - Management attributed the decline in gross margin primarily to decreased VA MVP volume, with expectations for recovery as the program resumes [68] Question: Cash burn expectations for 2023 - Management expects operating cash burn to be below $85 million in 2023, with significant expenditures related to the new facility accounted for in 2022 [78]

PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's nine-month revenue fell 25% to $48.3 million, driving a net loss of $82.2 million and a significant cash decrease [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $317.9 million, driven by a reduction in cash and investments, leading to lower stockholders' equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $83,522 | $105,585 | | Short-term investments | $109,234 | $181,479 | | Total current assets | $221,908 | $318,231 | | Total assets | $317,861 | $396,528 | | Total current liabilities | $33,739 | $31,313 | | Total liabilities | $75,462 | $86,227 | | Total stockholders' equity | $242,399 | $310,301 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Nine-month revenue fell 25% to $48.3 million, and net loss nearly doubled to $82.2 million due to higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $14,858 | $22,261 | $48,325 | $64,812 | | Cost of revenue | $12,379 | $14,195 | $37,287 | $41,151 | | Research and development | $14,957 | $13,617 | $48,343 | $34,800 | | Selling, general and administrative | $14,781 | $12,140 | $46,141 | $33,989 | | Loss from operations | $(27,259) | $(17,691) | $(83,446) | $(45,128) | | Net loss | $(26,492) | $(17,670) | $(82,247) | $(45,027) | | Net loss per share | $(0.58) | $(0.40) | $(1.81) | $(1.03) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $53.5 million, with a net cash decrease of $22.1 million for the nine-month period Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(53,471) | $(55,554) | | Net cash provided by (used in) investing activities | $30,686 | $(99,980) | | Net cash provided by financing activities | $855 | $168,353 | - The significant difference in financing activities between 2022 and 2021 is due to the **$162.3 million net proceeds from a follow-on equity offering in January 2021**[28](index=28&type=chunk)[158](index=158&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight significant customer concentration shifts, a patent infringement lawsuit, and stock-based compensation expenses - The company operates as a single reportable segment: the sale of sequencing and data analysis services[31](index=31&type=chunk) Revenue Concentration by Major Customer (Nine Months Ended Sep 30) | Customer | 2022 Revenue % | 2021 Revenue % | | :--- | :--- | :--- | | Natera, Inc. | 38% | <10% | | VA MVP | 16% | 62% | | Merck & Co., Inc. | 12% | <10% | - On August 2, 2022, the company filed a complaint for patent infringement against Foresight Diagnostics Inc, who has filed counterclaims alleging non-infringement and invalidity of the patents[96](index=96&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Q3 revenue decline due to the VA MVP contract completion, offset by growth from other customers - The company is strategically shifting towards the clinical diagnostic market with its NeXT Dx and NeXT Personal tests, anticipating initial revenue from NeXT Dx in Q4 2022[109](index=109&type=chunk)[110](index=110&type=chunk) - In September 2022, Personalis secured a new contract with the VA MVP, but it is **currently under protest by a competitor, leading to an immediate work stoppage**[115](index=115&type=chunk) Revenue by Customer Type (Q3, in thousands) | Customer Type | Q3 2022 | Q3 2021 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | VA MVP | $0 | $13,650 | $(13,650) | (100%) | | All other customers | $14,858 | $8,611 | $6,247 | 73% | | **Total revenue** | **$14,858** | **$22,261** | **$(7,403)** | **(33%)** | - The company is relocating its headquarters to a new 100,000 sq ft facility in Fremont, CA, with expected capital expenditures of **$40-$43 million in 2022** for the expansion[118](index=118&type=chunk)[161](index=161&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from this disclosure as a "smaller reporting company" - As a "smaller reporting company," Personalis is exempt from providing quantitative and qualitative disclosures about market risk[170](index=170&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - The CEO and CFO concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[171](index=171&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[172](index=172&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in a patent infringement lawsuit with Foresight Diagnostics Inc - The company is involved in a patent infringement lawsuit with Foresight Diagnostics Inc, as detailed in Note 9 of the financial statements[175](index=175&type=chunk)[96](index=96&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of losses, customer concentration, supplier reliance, and regulatory uncertainty - **Operational Risk:** The company has a history of losses and expects to incur significant future losses, with **substantial customer concentration** in the VA MVP and Natera[185](index=185&type=chunk)[199](index=199&type=chunk) - **VA MVP Contract Risk:** The new contract with the VA MVP is under protest, requiring an immediate work stoppage, and **may be terminated if the protest is not resolved favorably**[202](index=202&type=chunk) - **Supplier Risk:** The company relies on **Illumina as the sole supplier** for its sequencers and associated reagents, posing a significant operational risk[211](index=211&type=chunk) - **Regulatory Risk:** The company's tests are marketed as Laboratory Developed Tests (LDTs), which could be subject to **more onerous FDA oversight** under future legislative changes like the VALID Act[252](index=252&type=chunk)[254](index=254&type=chunk) - **Litigation Risk:** The company is involved in **expensive and time-consuming patent infringement litigation** with Foresight Diagnostics, with an uncertain outcome[345](index=345&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None[399](index=399&type=chunk) [Other Information](index=74&type=section&id=Item%205.%20Other%20Information) The company amended its bylaws to align with new SEC universal proxy rules - The company amended its bylaws on October 26, 2022, to align with the SEC's new universal proxy rules (Rule 14a-19)[402](index=402&type=chunk) [Exhibits](index=75&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q

Personalis, Inc. (NASDAQ:PSNL) Q2 2022 Earnings Conference Call August 3, 2022 5:00 PM ET Company Participants Caroline Corner - Investor Relations John West - President & Chief Executive Officer Aaron Tachibana - Chief Financial Officer Conference Call Participants Stephanie Iannetta - Cowen Joseph Conway - Needham & Company Mark Massaro - BTIG Derik De Bruin - Bank of America Arthur He - H.C. Wainwright & Company. Operator Good day, and thank you standing by. Welcome to the Q2 2022 Personalis Earnings Con ...