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HERNDON, Va.–(BUSINESS WIRE)–Strategic Education, Inc. (Strategic Education) (NASDAQ: STRA) today announced that it will host a conference call to discuss its third quarter results on Thursday, November 3, 2022 at 10:00 a.m. ET. A news release outlining the results will be issued before the market opens the same day.

This call will be available via webcast. To access the live webcast of the conference call on November 3, please go to www.strategiceducation.com in the Investor Relations section 15 minutes prior to the start time of the call to register. Following the call, the webcast will be archived and available at www.strategiceducation.com in the Investor Relations section. To participate in the live call, investors should register here prior to the call to receive dial-in information and a PIN.

About Strategic Education, Inc.

Strategic Education, Inc. (NASDAQ: STRA) (www.strategiceducation.com) is dedicated to helping advance economic mobility through higher education. We primarily serve working adult students globally through our core focus areas: 1) U.S. Higher Education, including Strayer University and Capella University, each institutionally accredited, and collectively offer flexible and affordable associate, bachelor’s, master’s, and doctoral programs including the Jack Welch Management Institute at Strayer University, and non-degree web and mobile application development courses through Strayer University’s Hackbright Academy and Devmountain; 2) Education Technology Services, developing and maintaining relationships with employers to build education benefits programs providing employees access to affordable and industry-relevant training, certificate, and degree programs, including through Workforce Edge, a full-service education benefits administration solution for employers, and Sophia Learning, enabling education benefits programs through low-cost online general education-level courses that are ACE-recommended for college credit; and 3) Australia/New Zealand, comprised of Torrens University, Think Education, and Media Design School that collectively offer certificate and degree programs in Australia and New Zealand. This portfolio of high quality, innovative, relevant, and affordable programs and institutions helps our students prepare for success in today’s workforce and find a path to bettering their lives.

Contacts

Terese Wilke
Director of Investor Relations
(612) 977-6331
terese.wilke@strategiced.com

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MEMPHIS, Tenn.–(BUSINESS WIRE)–Frontdoor, Inc. (NASDAQ: FTDR), the nation’s leading provider of home service plans, today announced it will release its third-quarter 2022 financial results and hold a conference call on Thursday, November 3, 2022 at 7:30 a.m. Central time (8:30 a.m. Eastern time).

Participants may join this conference call by dialing 1-844-200-6205 (or international participants, 1-929-526-1599) and entering conference ID 780482. Additionally, the conference call will be available via webcast which will include a slide presentation highlighting the company’s results. To participate via webcast and view the presentation, visit https://investors.frontdoorhome.com.

The call will be available for replay for approximately 60 days. To access the replay of this call, please call 1-866-813-9403 and enter conference ID 925307 (international participants: +44-204-525-0658, conference ID 925307). To view a replay of the webcast, visit the company’s investor relations home page.

About Frontdoor

Frontdoor is a company that’s obsessed with taking the hassle out of owning a home. With services powered by people and enabled by technology, it is the parent company of four home service plan brands: American Home Shield, HSA, Landmark and OneGuard, as well as ProConnect, an on-demand membership service for home repairs and maintenance, and Streem, a technology company that enables businesses to serve customers through an enhanced augmented reality, computer vision and machine learning platform. Frontdoor serves 2.2 million customers across the U.S. through a network of approximately 17,000 pre-qualified contractor firms that employ an estimated 60,000 technicians. The company’s customizable home service plans help customers protect and maintain their homes from costly and unexpected breakdowns of essential home systems and appliances. With more than 50 years of home services experience, the company responds to over four million service requests annually. For details, visit frontdoorhome.com.

Forward Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations and beliefs, as well as a number of assumptions concerning future events. These statements are subject to risks, uncertainties, assumptions and other important factors. Readers are cautioned not to put undue reliance on such forward-looking statements because actual results may vary materially from those expressed or implied. The reports filed by Frontdoor pursuant to United States securities laws contain discussions of these risks and uncertainties. Frontdoor assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers are advised to review Frontdoor’s filings with the United States Securities and Exchange Commission (which are available on the SEC’s EDGAR database at www.sec.gov and via Frontdoor’s website at investors.frontdoorhome.com).

FTDR-Financial

Contacts

Investor Relations
Matt Davis
901-701-5199
IR@frontdoorhome.com

Media
Alison Bishop
901-701-5198
MediaCenter@frontdoorhome.com

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LONDON–(BUSINESS WIRE)–Endava (NYSE: DAVA), a leading next-generation technology services provider, today announced it will release results for the fourth quarter and fiscal year ended June 30, 2022, on Tuesday September 27, 2022 before the opening of regular U.S. market hours.

Following the release, John Cotterell, Endava’s CEO and Mark Thurston, Endava’s CFO, will discuss the results in a conference call beginning at 8:00 am ET.

Conference call access information is:
Participant Toll Free Dial-In Number: 1-877-270-2148
Participant International Dial-In Number: 1-412-902-6510

Conference ID: Endava Call

Webcast: https://investors.endava.com

Additionally, a replay will be available on our investor relations website after the call.

ABOUT ENDAVA PLC:

Endava is reimagining the relationship between people and technology. By leveraging next-generation technologies, our agile, multi-disciplinary teams provide a combination of product & technology strategies, intelligent experiences, and world class engineering to help clients become digital, experience-driven businesses by assisting them in their journey from idea generation to development and deployment of products, platforms and solutions. Endava collaborates with its clients, seamlessly integrating with their teams, catalysing ideation and delivering robust solutions.

Endava services clients in Payments and Financial Services, TMT, Consumer Products, Retail, Mobility and Healthcare. As of March 31, 2022, 11,001 Endavans served clients from locations in Australia, North America, Singapore and Western Europe and delivery centres in Bosnia & Herzegovina, Bulgaria, Croatia, Moldova, North Macedonia, Poland, Romania, Serbia, Slovenia, Argentina, Colombia, Mexico, Uruguay and Venezuela.

For more information, visit www.endava.com

Contacts

Investor Relations Contact:
Laurence Madsen, Endava
investors@endava.com

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Announces Management Changes

Initiates Restructuring of the Company to Include Approximately 35% Further Headcount Reduction

Secures Convertible Debt Initial Commitment of $10 Million

MCLEAN, Va.–(BUSINESS WIRE)–IronNet, Inc. (NYSE: IRNT) (“IronNet”), a leading provider of solutions Transforming Cybersecurity Through Collective Defense℠, announced today its financial results for the fiscal second quarter ended July 31, 2022.

“We encountered unexpected headwinds in our transactional business this quarter. To contain costs, we are undertaking a further restructuring of the company with the support of our new CFO Cameron Pforr,” said General (Ret.) Keith Alexander, Chairman and co-CEO of IronNet. “We have decided to forego a call with management this quarter, until we are better able to communicate on our progress.”

Fiscal Second Quarter 2023 Financial & Operating Results

  • Annual Recurring Revenue (ARR): $26.5 million at July 31, 2022, compared to $24.1 million at the end of the same quarter last year.
  • Revenue: $6.6 million compared to $6.1 million in the same quarter last year. Cloud subscription revenue was $5.2 million, or 84% of product revenue, compared to 56% in the same quarter last year.
  • Gross Margin: 62.3% compared to 70.1% in the same quarter last year.
  • Net loss: $28.4 million compared to $17.2 million in the same quarter last year. Excluding stock-based compensation expense and transaction costs and fees, net loss for the second quarter would be $20.6 million compared to $17.0 million in the same quarter last year.
  • Dollar-based average contract length: 3.2 years for the second quarter, compared to 2.8 years in the same quarter last year.
  • Cash and cash equivalents: $9.7 million at end of the second quarter. Subsequent to the end of the quarter, the company entered into an unsecured convertible debt facility with an institutional investor pursuant to which it will borrow an initial $10 million under a promissory note with an 18-month term and a 5% annual interest rate. Upon the satisfaction of certain conditions set forth in the convertible debt facility, including conditions related to the outstanding principal balance and the prevailing share price and trading volume of the company’s common stock, the company may have the ability to borrow an additional $15 million under the facility at a future date.
  • Customer Count: 78 compared to 51 at the end of the same quarter last year.

Management Update

  • Co-CEO William Welch will resign as co-CEO and from the Board of Directors in light of the restructuring of the business, and indicated he will continue to support the company in the short term. Chris Murphy, Head of Sales Operations, will lead the sales team in the interim, reporting to GEN (Ret.) Keith Alexander.
  • Experienced software and cybersecurity executive Cameron Pforr has been appointed as IronNet’s new Chief Financial Officer (CFO), replacing current CFO James Gerber who will be departing the company to join a private cybersecurity company.

Mr. Welch commented regarding his resignation: “With costs in focus, we determined that it made sense to eliminate the co-CEO position. I am a true believer in Collective Defense, and I remain firmly committed to the IronNet mission. I will continue to support the company in any way I can be of service.”

Fiscal 2023 Outlook

  • In light of the management transitions, further restructuring of the company, and the underperformance of the transactional business this quarter, the company is withdrawing its previously issued revenue and ARR guidance for fiscal 2023.

About IronNet

Founded in 2014 by GEN (Ret.) Keith Alexander, IronNet, Inc. (NYSE: “IRNT”) is a global cybersecurity leader that is transforming how organizations secure their networks by delivering the first-ever Collective Defense platform operating at scale. Employing a number of former NSA cybersecurity operators with offensive and defensive cyber experience, IronNet integrates deep tradecraft knowledge into its industry-leading products to solve the most challenging cyber problems facing the world today. For more information, visit www.ironnet.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, its ability to transform cybersecurity, execute on its business strategy and increase market share, and the expansion of the cybersecurity market and demand for IronNet’s products and services. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside IronNet’s management’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include: IronNet’s ability to execute on its plans to develop and market new products and the timing of these development programs; IronNet’s estimates of the size of the markets for its products; the rate and degree of market acceptance of IronNet’s products; the success of other competing technologies that may become available; IronNet’s ability to identify and integrate acquisitions; management changes; the performance of IronNet’s products; potential litigation; and general economic and market conditions impacting demand for IronNet’s products. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described under the heading “Risk Factors” in IronNet’s Annual Report on Form 10-K for the year ended January 31, 2022, filed with the SEC on May 2, 2022, as updated by IronNet’s Quarterly Report on Form 10-Q for the quarter ended July 31, 2022, to be filed with the SEC on September 14, 2022, and its subsequent filings with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward looking statements, and IronNet does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Certain Definitions

Annual Recurring Revenue (ARR) — Calculated at a particular measurement date as the annualized value of our then existing customer subscription contracts and the portions of other software and product contracts that are to be recognized over the course of the contracts and that are designed to renew, assuming any contract that expires during the 12 months following the measurement date is renewed on its existing terms.

Dollar-based average contract length: Calculated by multiplying the average total length of our customer contracts, measured in years or fractions thereof, by the respective revenue recognized for the last three months of each reporting period, and then dividing by the revenue attributable to software and product customers for the same three-month period used in the numerator. Because many of our customers have similar buying patterns and the average term of our contracts is more than 12 months, this metric provides a means of assessing the degree of built-in revenue repetition that exists across our customer base. Declines in average contract length are not reflective of the average lifetime of a customer.

IronNet, Inc.

Condensed Consolidated Statements of Operations

(amounts in thousands, except per share amounts, unaudited)

Three Months Ended July 31,

Six Months Ended July 31,

2022

2021

2022

2021

Product, subscription and support revenue

$

6,214

$

5,770

$

12,657

$

11,907

Professional services revenue

394

306

639

546

Total revenue

6,608

6,076

13,296

12,453

Cost of product, subscription and support revenue

2,339

1,668

4,669

3,422

Cost of professional services revenue

149

147

314

331

Total cost of revenue

2,488

1,815

4,983

3,753

Gross profit

4,120

4,261

8,313

8,700

Operating expenses

Research and development

9,715

7,571

20,442

14,462

Sales and marketing

8,754

7,687

19,420

14,836

General and administrative

13,433

5,965

29,020

11,685

Total operating expenses

31,902

21,223

68,882

40,983

Operating loss

(27,782

)

(16,962

)

(60,569

)

(32,283

)

Other income

24

8

34

16

Other expense

(664

)

(248

)

(1,044

)

(377

)

Loss before income taxes

(28,422

)

(17,202

)

(61,579

)

(32,644

)

Benefit (provision) for income taxes

7

35

(5

)

(23

)

Net loss

$

(28,415

)

$

(17,167

)

$

(61,584

)

$

(32,667

)

Basic and diluted net loss per common share

(0.28

)

(0.25

)

(0.61

)

(0.49

)

Weighted average shares outstanding, basic and diluted

101,352

67,421

100,346

67,303

IronNet, Inc.

Condensed Consolidated Balance Sheets

(amounts in thousands, except per share amounts, unaudited)

July 31,

January 31,

2022

2022

Assets

Current assets

Cash and cash equivalents

$

9,650

$

47,673

Accounts receivable

5,430

1,991

Unbilled receivables

564

4,637

Related party receivables and loan receivables

3,233

3,233

Accounts, related party and loans receivable

9,227

9,861

Inventory

6,588

4,581

Deferred costs

2,712

2,599

Prepaid warranty

1,021

829

Prepaid expenses

2,565

3,660

Other current assets

2,382

1,458

Total current assets

$

34,145

$

70,661

Deferred costs

3,413

3,243

Property and equipment, net

6,228

5,606

Prepaid warranty

1,209

1,229

Deposits and other assets

2,688

493

Total assets

$

47,683

$

81,232

Liabilities and stockholders’ equity

Current liabilities

Accounts payable

$

3,253

$

2,348

Accrued expenses

10,762

4,709

Deferred revenue

20,461

16,049

Deferred rent

159

Income tax payable

468

542

Other current liabilities

1,469

689

Total current liabilities

36,413

24,496

Deferred revenue

13,618

17,517

Deferred rent

769

Warrants

4

7

Other long-term liabilities

2,355

Total liabilities

$

52,390

$

42,789

Stockholders’ equity

Preferred stock, $0.0001 par value; 100,000 shares authorized; none issued or outstanding

Common stock; $0.0001 par value; 500,000 shares authorized; 101,649 and 88,876 shares issued and outstanding at July 31, 2022 and January 31, 2022, respectively

10

9

Additional paid-in capital

474,547

455,849

Accumulated other comprehensive income

6

271

Accumulated deficit

(479,270

)

(417,686

)

Total stockholders’ (deficit) equity

(4,707

)

38,443

Total liabilities and stockholders’ (deficit) equity

$

47,683

$

81,232

IronNet, Inc.

Condensed Consolidated Statements of Cash Flows

($ in thousands)

(unaudited)

Six Months Ended July 31,

2022

2021

Cash flows from operating activities

Net loss

$

(61,584

)

$

(32,667

)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

1,231

445

Gain on sale of fixed assets

(9

)

Employee stock based compensation

18,584

27

Change in fair value of warrant liabilities

(3

)

Non-cash interest expense

165

Changes in operating assets and liabilities:

Accounts, related party, and loans receivable

634

(1,164

)

Deferred costs

(284

)

289

Inventories

(2,007

)

(137

)

Prepaid expenses

1,095

(486

)

Other current assets

(36

)

Prepaid warranty

(172

)

234

Deposits and other assets

504

(60

)

Accounts payable

905

(200

)

Accrued expenses

(580

)

2,951

Income tax payable

(74

)

15

Other current liabilities

(2

)

Deferred rent

(67

)

Deferred revenue

512

(425

)

Operating lease liability

(582

)

Net cash used in operating activities

(41,703

)

(31,245

)

Cash flows from investing activities

Purchases of property and equipment

(1,666

)

(1,232

)

Proceeds from the sale of fixed assets

10

Net cash used in investing activities

(1,656

)

(1,232

)

Cash flows from financing activities

Exercise of stock options and vesting of restricted stock units

206

295

Statutory tax withholding related to net-share settlement of restricted stock units

(91

)

Cash received to fund employee’s tax obligation for vested RSUs

19,823

Cash remitted to fund employee’s tax obligation for vested RSUs

(12,395

)

Payment of commitment fee

(1,750

)

Payment of common stock issuance costs

(96

)

Payment of finance lease obligations

(96

)

Proceeds from issuance of debt

15,000

Proceeds from stock subscriptions

293

Payment of deferred transaction costs

(486

)

Net cash provided by financing activities

5,601

15,102

Effect of exchange rate changes on cash and cash equivalents

(265

)

(61

)

Net change in cash and cash equivalents

(38,023

)

(17,436

)

Cash and cash equivalents

Beginning of the period

47,673

31,543

End of the period

$

9,650

$

14,107

Contacts

IronNet
Nancy Fazioli – ir@ironnet.com

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MENLO PARK, Calif.–(BUSINESS WIRE)–Please replace the release with the following corrected version. A multimedia asset accompanying this release and paragraph seven have been removed.

The updated release reads:

GRAIL ANNOUNCES FINAL RESULTS FROM THE PATHFINDER MULTI-CANCER EARLY DETECTION SCREENING STUDY AT ESMO CONGRESS 2022

Adding Multi-Cancer Early Detection (MCED) Screening to Standard of Care Screening More Than Doubled the Number of Cancers Detected

71% of Participants With MCED-Detected Cancers Had Cancer Types With No Routine Screening Tests Available

Approximately Half of the MCED-Detected New Cancers Were Stage I or II

MCED-Predicted Cancer Signal Origin Had 97.1% Accuracy and Enabled Targeted Diagnostic Evaluations

MCED Screening was Implemented in Adults With Elevated Cancer Risk Without Study-Related Serious Adverse Events

Participants Reported High Satisfaction and Low Negative Psychological Impact With MCED Screening

GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection (MCED) screening using a blood test and the clinical care pathways following a “cancer signal detected” MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer. Results were presented in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.

“The PATHFINDER study is an exciting first step towards fundamental change in the approach to cancer screening. The study found cancer in about 1% of participants including types for which there is no established screening method. The study demonstrated the feasibility of this paradigm and solid test performance,” said Deb Schrag, MD, MPH, chair, Department of Medicine at Memorial Sloan Kettering Cancer Center in New York. “Although continued public health efforts to optimize adherence to existing screening strategies that have been proven effective are critical, this study provides a glimpse of what the future may hold—the opportunity for screening using blood tests to detect various types of cancers at their earliest and most treatable stages.”

PATHFINDER was a single-arm study that measured the time required to achieve diagnostic resolution (i.e., healthcare provider-defined end to the diagnostic evaluation) following a “cancer signal detected” MCED blood test result and the number and types of diagnostic tests that were used (primary endpoint). MCED test performance was a key secondary endpoint, including positive predictive value (PPV, the percent of cancer signal detected results that were confirmed to be cancer) and the accuracy of the predicted cancer signal origin (CSO). Participants were followed for 12 months after enrollment. If a participant had a negative MCED test at enrollment but developed a cancer within the 12-month follow-up, it was counted as an MCED false negative.

Test performance was measured using both an earlier version of Galleri (MCED-E) and a refined version of Galleri (MCED-Scr). The earlier version of the test was refined to reduce the detection of pre-malignant hematologic conditions, which are fairly common, and improve prediction of the cancer signal origin. The study was completed with the earlier version of the test (MCED-E) and then the blood samples were retested in a pre-specified retrospective analysis using the refined Galleri test (MCED-Scr).

“When added to standard of care screening, MCED testing more than doubled the number of cancers detected compared to standard screening alone. In fact, Galleri detected more cancers than all U.S. Preventive Services Task Force-recommended standard single cancer screenings combined. These included Stage I cancers of the liver, small intestine, and uterus, and Stage II pancreatic, bone, and oropharyngeal cancers,” said Jeffrey Venstrom, MD, chief medical officer at GRAIL. “This is particularly notable given the PATHFINDER population was heavily screened with higher-than-average rates for mammography, colonoscopy, and low-dose CT lung scans.”

A cancer signal was detected in 92 participants, two of whom began workup prior to the return of their MCED test results. Of these, 35 participants were diagnosed with 36 cancers. Among the confirmed cancers, 71% (25/35) of participants had cancer types that have no routine cancer screening available. Nearly half (48%) of the non-recurrent cancers were found in early-stages (Stage I or II). Standard of care screening identified 29 cancers, and another 56 cancers were diagnosed because symptoms appeared or tumors were found incidentally or from monitoring for cancer recurrence.

The cancer signal origin prediction had a 97% accuracy and directed physician clinical workup, leading to resolution of the cancer diagnosis in less than three months for most participants with a true positive signal (73%), and in less than two months for half of them. The median time to diagnostic resolution was longer for false positive results (162 days); 44% of these participants had scheduled follow-up imaging or procedures three or more months later, contributing to the longer time to resolution.

Most participants underwent imaging procedures, such as scans or MRIs, following true and false-positive results. As expected, most true positive participants (82%) underwent an invasive procedure to confirm a cancer diagnosis. Three underwent endoscopies triggered by the predicted cancer signal origin, and 24 had procedures triggered only by abnormal imaging, physical, or laboratory findings, including three surgical biopsies. A smaller proportion of false positive participants had invasive procedures (30%). Five had procedures triggered by CSO predictions (five endoscopies, one endometrial biopsy and one pap smear), and 12 had procedures triggered only by abnormal imaging, physical, or laboratory findings, or by their medical history. No study-related serious adverse events were reported as a result of MCED testing in the study, and there were no adverse events reported from diagnostic workups.

The PPV was 43.1% with the refined test and 38.0% with the earlier version. Specificity, or the percentage of true negatives, of the refined test was 99.5%, and 99.1% with the earlier version, and the false positive rate for both versions was less than 1%. Test performance was consistent with the interim analysis and the previous case-controlled Circulating Cell-free Genome Atlas (CCGA) study.

“The refinements we made to the earlier version of Galleri resulted in clinically expected outcomes and had the intended result of reducing false positives from hematological signals,” added Venstrom. “While PATHFINDER was not designed to determine sensitivity or the number of cancer types detected by Galleri, 11 different cancer types were detected in this study that have no standard screening today, and the false positive rate was less than 1%. In the much larger CCGA case-control study, the Galleri test detected over 50 types of cancer.”

An analysis of participant-reported outcomes of anxiety, distress, and satisfaction related to MCED testing from the study were also presented at the ESMO Congress 2022. PATHFINDER participants completed patient-reported outcomes assessments before MCED testing, after receiving MCED test results, and at the end of the study. The analysis found 97.1% of participants reported a high level of satisfaction with the test, including those who had both true positive (92%) and false-positive (82.3%) results. As expected, a higher level of anxiety was seen in participants following a positive result, but that resolved to pre-MCED test levels within 12 months.

Preliminary Real World Analysis Generally Consistent with PATHFINDER Results

GRAIL conducted an analysis of the first 38,154 Galleri commercial test results to monitor Galleri performance in a real world setting. The analysis showed a 1.1% cancer signal detection rate. As seen in clinical trials, the signal detection rate increases with age and male sex, consistent with the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) statistics. Among 326 patients with a positive cancer signal detected result and short-term follow up (as voluntarily reported by the ordering physicians), 108 cancers have been confirmed by the ordering providers to-date, representing 28 different cancer types. Of the 108 patients with a provider-confirmed cancer diagnosis, 64 had no recommended cancer screening test (59%). Provider-confirmed cancers include, among others, Stage I pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal tumor (GIST) cancers and Stage II rectal, liver, and head and neck cancers.

“Every year, we lose more than 600,000 loved ones to cancer in the U.S. alone. Unfortunately, the burden of cancer will grow with the demographic tidal wave, as the absolute risk of developing any cancer increases as we get older,” said Josh Ofman, MD, MSHS, president at GRAIL. “Bending the cancer mortality curve will require earlier detection of more cancer. However, a world with more single cancer screening tests is simply clinically and economically untenable as each single cancer screening test has a false positive rate of 5-10%. We need to expand from screening for individual cancers to also screening individuals for cancer. We believe MCED tests can enable this paradigm shift by finding more types of cancer at earlier stages with a single blood test.”

About GRAIL’s MCED Clinical Development Program

The Galleri clinical development program consists of studies that collectively include more than 335,000 participants—and what is believed to be the largest linked datasets of genomic and clinical data in the cancer field. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry. The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for a mortality reduction.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.

For more information, visit grail.com.

About Galleri®

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test is available in the U.S. and requires a prescription from a licensed healthcare provider. The Galleri test should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA, into the bloodstream. One of the “hallmarks of cancer” is when methyl groups are added to DNA. This does not alter the DNA code but it can alter gene expression. Methylation patterns on tumor-derived cell-free DNA carry cancer-specific signals and are therefore very helpful in detecting cancer and determining its origin. Galleri uses next-generation sequencing and machine learning algorithms to analyze these methylation patterns of cell-free DNA in the bloodstream.

For more information about Galleri, visit galleri.com.

Important Galleri Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information

GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Contacts

For GRAIL
Media:
Trish Rowland
Cammy Duong
pr@grail.com

Investor Relations:
Alex Dobbin
ir@grail.com

The post CORRECTING and REPLACING GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022 appeared first on Web Hosting | Cloud Computing | Datacenter | Domain News.

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AUSTIN, Texas–(BUSINESS WIRE)–E2open Parent Holdings, Inc. (NYSE: ETWO), the connected supply chain SaaS platform with the largest multi-enterprise network, today announced that it will report its fiscal second quarter 2023 financial results after the U.S. financial markets close on Tuesday, October 11, 2022. E2open management will host a conference call at 5:00 p.m. Eastern Time on that day to discuss the financial results and other business highlights.

The conference call can be accessed by dialing 888-506-0062 (domestic) or 973-528-0011 (international). The conference ID is 833680. Additionally, a live webcast of the conference call will be available in the “Investor Relations” section of the company’s website at www.e2open.com.

Following the conference call, a replay will be available through October 25, 2022, at 877-481-4010 (domestic) or 919-882-2331 (international). The replay passcode is 46495. An archived webcast of this conference call will also be available after the completion of the call in the “Investor Relations” section of the company’s website at www.e2open.com.

About e2open

E2open is the connected supply chain software platform that enables the world’s largest companies to transform the way they make, move, and sell goods and services. With the broadest cloud-native global platform purpose-built for modern supply chains, e2open connects more than 400,000 manufacturing, logistics, channel, and distribution partners as one multi-enterprise network tracking over 12 billion transactions annually. Our SaaS platform anticipates disruptions and opportunities to help companies improve efficiency, reduce waste, and operate sustainably. Moving as one.™ Learn More: www.e2open.com.

E2open and “Moving as one.” are the registered trademarks of E2open, LLC. All other trademarks, registered trademarks and service marks are the property of their respective owners.

Contacts

Media Contact:
5W PR for e2open
e2open@5wpr.com
718-757-6144

Investor Contact:
Adam Rogers
AVP Investor Relations, e2open
adam.rogers@e2open.com
515-556-1162

Corporate Contact:
Kristin Seigworth
VP Communications, e2open
kristin.seigworth@e2open.com

The post E2open to Report Fiscal 2023 Second Quarter Results appeared first on Web Hosting | Cloud Computing | Datacenter | Domain News.

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