PSNL Personalis Inc.
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the EACR Liquid Biopsies Virtual Event, November 18-19, including a poster presentation and satellite symposia.
The company will showcase both their platforms, ImmunoID NeXT™ and NeXT Liquid Biopsy™.
ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample, thus maximizing the biological information that can be generated from a precious tumor specimen.
NeXT Liquid Biopsy, a first-of-its-kind, high-performance exome-wide liquid biopsy assay, provides a unique ability to evaluate the cancer ecosystem and advance the development of next-generation therapies. While solid tumor biopsies remain the standard for the interrogation of the cancer genome, the advent of liquid biopsies has demonstrated there can be more to a cancer's genotypic profile than that found in a single tissue biopsy. Therefore, the combination of NeXT Liquid Biopsy and ImmunoID NeXT delivers the most comprehensive view of a cancer's mutational landscape by evaluating both the tissue and blood. NeXT Liquid Biopsy enables investigation into key applications such as spatial and temporal heterogeneity of the tumor, clonal evolution and tumor dynamics in response to therapies, and mechanisms of acquired resistance. In this presentation, we'll highlight data demonstrating the genomic profiling and assay performance enabled by NeXT Liquid Biopsy through the evaluation of reference standards and patient samples.
Following are details for the Personalis presentations.
Scientific Poster Presentation
Poster Number
Title & Presenter
Dates
40
Sensitive detection and monitoring of genetic alterations in circulating cfDNA with an enhanced whole-exome approach
Presenter: Simo V. Zhang, PhDNOV 18-19 | Online
Following are details of an industry-sponsored symposium which will be presented at the meeting.
Satellite Symposia
Title
Title & Presenter
Dates
Sponsored Symposia
NeXT Liquid Biopsy, A High Performance, Exome-Wide Liquid Biopsy Assay to Study Tumor Dynamics
Presenters: Erin N. Newburn, PhD and Dan Norton, MBANOV 18-19 | On Demand
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 U.S. Department of Veterans Affairs Million Veteran Program (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 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 ImmunoID NeXT Platform, Personalis' services for the VA MVP, 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 the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201118005479/en/
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that the company will present data from its clinical test - NeXT DxTM - at the virtual AMP Annual Meeting from Nov 16-20, 2020.
The poster presentation, titled "An exome and transcriptome based NeXT DxTM test enables therapy selection for cancer patients and offers insights into emerging composite biomarkers for immunotherapy" will be presented on Tuesday, Nov 17th between 1-2pm EST. The NeXT Dx test utilizes Personalis' ImmunoID NeXT Platform®, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The Personalis NeXT Dx Test provides a diagnostic report to the ordering provider which includes genomic alterations identified in 247 cancer-related genes, therapy recommendations, clinical trial matching and results from immunotherapy-related biomarkers such as microsatellite instability (MSI) status and exome-wide tumor mutational burden (TMB). Research data supporting identification of novel biomarkers from tumor exome and transcriptome can be provided upon physician's request.
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 U.S. Department of Veterans Affairs Million Veteran Program (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 our biopharmaceutical customers with information on 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 ImmunoID NeXT Platform, Personalis' services for the VA MVP, 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 the company's most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption "Risk Factors." Personalis disclaims any obligation to update such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005468/en/
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today announced that the company will participate in the Society for Immunotherapy of Cancer (SITC) Annual Meeting online, November 11-14, including poster presentations on November 11th – 13th.
The company will showcase ImmunoID NeXT™, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT™ 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 is a list of abstracts that will be presented at the meeting.
Scientific Poster Presentations
Poster Number & Category
Title & Presenter
Day & Time
29
Biomarkers, Immune Monitoring, and Novel Technologies
Profiling Tumor Circulating Cell-Free DNA with an Enhanced Whole-Exome to Enable Sensitive Assessment of Somatic Mutations
Presenter: Simo V. Zhang, PhD
NOV 11 | 5:15 – 5:45 PM EST
andNOV 13 | 4:40 – 5:10 PM EST
57
Biomarkers, Immune Monitoring, and Novel Technologies
Precision neoantigen discovery using novel algorithms and expanded HLA-ligandome datasets
Presenter: Dattatreya Mellacheruvu, PhD
NOV 11 | 5:15 – 5:45 PM EST
andNOV 13 | 4:40 – 5:10 PM EST
67
Biomarkers, Immune Monitoring, and Novel Technologies
B-cell receptor heavy chain repertoire profiling using an augmented transcriptome
Presenter: Eric Levy, Ph.D.
NOV 11 | 5:15 – 5:45 PM EST
andNOV 13 | 4:40 – 5:10 PM EST
73
Biomarkers, Immune Monitoring, and Novel Technologies
Orthogonally and functionally validated algorithm for detecting HLA loss of heterozygosity
Presenter: Rachel M. Pyke, PhD
NOV 11 | 5:15 – 5:45 PM EST
andNOV 13 | 4:40 – 5:10 PM EST
Following are details of an industry-sponsored symposium which will be presented at the meeting.
Industry Sponsor Symposium
Presentation Category
Title & Presenter
Day & Time
Sponsored Symposia
Maximizing immunotherapy biomarker discovery with a multidimensional tumor immunogenomics platform
Presenter: Erin N. Newburn, PhD
NOV 12 | 12:30 – 12:50 PM EST
Personalis will also be exhibiting during the online conference. Representatives will be available to answer questions about the company's cancer immunogenomics services.
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 U.S. Department of Veterans Affairs Million Veteran Program (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 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).
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109006091/en/
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for population sequencing and cancer, today reported financial results for the third quarter ended September 30, 2020.
Third Quarter Highlights
- Reported record revenues of $19.8 million in the third quarter of 2020 versus $17.2 million in the third quarter of 2019, an increase of 15.5%
- A total of 39 customers have placed orders for NeXT as of September 30, 2020, with 7 of those customers placing their first orders in the third quarter of 2020
- Received a new task order with an approximate value of up to $31 million from U.S. Department of Veterans Affairs Million Veterans Program (VA MVP), increasing the contracted to date value to approximately $175 million
- Achieved milestone of completing more than 90,000 whole human genomes sequenced under the VA MVP contract
- Completed a follow-on public offering and sold 6.6 million shares of common stock at a price of $19.00 per share; received net proceeds of $117.1 million after discounts, fees, and expenses
"I'm proud to say that we were able to report record revenues once again this quarter, with our team delivering strong execution across both our population sequencing and biopharma businesses, despite the impact from the COVID-19 pandemic. We continued to see strong ordering levels from both our existing and new customers, and year-to-date, our biopharma orders were twice the amount compared with last year," said John West, Chief Executive Officer. "In addition, we further strengthened our balance sheet by raising $117.1 million with an equity financing in the quarter."
Third Quarter 2020 Financial Results
Revenues were $19.8 million in the three months ended September 30, 2020, up 15.5% from $17.2 million in the same period of the prior year. In the third quarter, the VA MVP accounted for $14.1 million of the company's total revenues, and the remaining $5.7 million was from biopharmaceutical and all other customers.
Gross margin was 26.9% for the three months ended September 30, 2020, compared with 32.8% in the same period of the prior year.
Operating expenses were $15.0 million for the three months ended September 30, 2020, compared with $11.4 million in the same period of the prior year.
Net loss was $9.5 million for the three months ended September 30, 2020 and net loss per share was $0.27 based on a weighted-average basic and diluted share count of 35.5 million, compared with a net loss of $6.9 million and a net loss per share of $0.22 based on a weighted-average basic and diluted share count of 31.1 million in the same period of the prior year.
Cash, cash equivalents, and short-term investments were $206.1 million as of September 30, 2020.
Guidance and COVID-19
Due to continued uncertainty surrounding the COVID-19 pandemic, Personalis will not provide guidance for fiscal 2020 at this time.
Webcast and Conference Call Information
Personalis will host a conference call to discuss the third quarter financial results after market close on Thursday, November 5, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using conference ID: 9697771. 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 company, 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 as an indication of future performance. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "hope," "intend," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or similar expressions and the negatives of those terms. 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; the launch of new products and product features; the timing of tissue and blood 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 will increase; the success of Personalis' collaborations and partnerships; 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 COVID-19 pandemic, which may significantly impact the company's business and operations and the business and operations of our customers. 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 September 30, 2020, that will be filed following this earnings release. 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
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Revenues
$
19,816
$
17,153
$
58,472
$
47,053
Costs and expenses
Costs of revenues
14,483
11,524
44,428
31,538
Research and development
7,193
5,303
20,048
15,045
Selling, general and administrative
7,793
6,056
22,772
15,692
Total costs and expenses
29,469
22,883
87,248
62,275
Loss from operations
(9,653
)
(5,730
)
(28,776
)
(15,222
)
Interest income
117
756
873
1,040
Interest expense
—
(204
)
(2
)
(1,133
)
Loss on debt extinguishment
—
(1,704
)
—
(1,704
)
Other (expense) income, net
(4
)
(2
)
5
(1,415
)
Loss before income taxes
(9,540
)
(6,884
)
(27,900
)
(18,434
)
Provision for income taxes
(5
)
(1
)
(39
)
(5
)
Net loss
$
(9,545
)
$
(6,885
)
$
(27,939
)
$
(18,439
)
Net loss per share, basic and diluted
$
(0.27
)
$
(0.22
)
$
(0.85
)
$
(1.35
)
Weighted-average shares outstanding, basic and diluted
35,460,092
31,133,683
32,845,583
13,613,444
PERSONALIS, INC.
SUPPLEMENTAL REVENUE INFORMATION (unaudited)
(in thousands)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
VA MVP
$
14,092
$
12,912
$
43,598
$
29,791
All other customers
5,724
4,241
14,874
17,262
Total
$
19,816
$
17,153
$
58,472
$
47,053
PERSONALIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands, except share and per share data)
September 30,
December 31,
2020
2019
Assets
Current assets
Cash and cash equivalents
$
133,245
$
55,046
Short-term investments
72,818
73,243
Accounts receivable, net
5,903
3,300
Inventory and other deferred costs
6,268
4,606
Prepaid expenses and other current assets
5,359
3,383
Total current assets
223,593
139,578
Property and equipment, net
12,735
14,106
Operating lease right-of-use assets
10,632
1,845
Other long-term assets
1,852
1,762
Total assets
$
248,812
$
157,291
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable
$
6,514
$
7,337
Accrued and other current liabilities
8,797
6,648
Contract liabilities
20,593
35,977
Total current liabilities
35,904
49,962
Long-term operating lease liabilities
8,897
639
Other long-term liabilities
471
—
Total liabilities
45,272
50,601
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; 38,790,189 and 31,243,029 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
4
3
Additional paid-in capital
372,027
247,282
Accumulated other comprehensive income (loss)
37
(6
)
Accumulated deficit
(168,528
)
(140,589
)
Total stockholders' equity
203,540
106,690
Total liabilities and stockholders' equity
$
248,812
$
157,291
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105006109/en/
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Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for cancer, today announced that company management will participate in the following upcoming investor conferences.
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29th Annual Credit Suisse Virtual Healthcare Conference
Presenting on Tuesday, November 10, 2020 at 4:15 p.m. Eastern Time
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Oppenheimer Fall MedTech Summit
Participating on Thursday, November 12, 2020
About Personalis, Inc.
Personalis, Inc. is a growing cancer genomics company 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. Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over two million veteran genomes. 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).
View source version on businesswire.com: https://www.businesswire.com/news/home/20201027005148/en/
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29th Annual Credit Suisse Virtual Healthcare Conference