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Exam Code: CCSPA Practice test 2022 by Killexams.com team
Check Point Certified Security Principles Associate CCSPA
Checkpoint Principles approach
Killexams : Checkpoint Principles approach - BingNews https://killexams.com/pass4sure/exam-detail/CCSPA Search results Killexams : Checkpoint Principles approach - BingNews https://killexams.com/pass4sure/exam-detail/CCSPA https://killexams.com/exam_list/Checkpoint Killexams : Check Point Software reports significantly accelerated growth for the second quarter

Check Point Software Technologies Ltd. today posted second-quarter revenue and adjusted earnings that reached the high end of its guidance.

Check Point Software is one of the top providers of cybersecurity software for the enterprise. The company sells products that help organizations secure their cloud environments, protect employee  devices and scan network traffic for malicious requests.

Check Point Software’s revenues reached $571 million in the second quarter after growing 9% year-over-year. Compared with the second quarter of fiscal 2021, the company has more than doubled its growth rate. Deferred revenues, a measure of future sales, increased at an even faster rate of 14% to reach $1.66 billion.

Check Point Software pointed to strong demand for its Harmony suite of cybersecurity products as one factor behind its accelerated quarterly growth. 

Companies use Harmony to help employees securely log into work applications. Additionally, the product suite includes tools that block phishing campaigns and protect employee devices from malware. Check Point Software detailed today that the Harmony suite experienced more than 50% growth in the second quarter.

CloudGuard and Quantum, Check Point Software’s two other flagship product suites, both experienced double-digit growth as well during the three months ended June  30. CloudGuard is a suite of tools designed to help companies secure their public cloud environments. Quantum, in turn, is Check Point Software’s lineup of on-premises firewall appliances and related software products.

Harmony, CloudGuard and parts of the Quantum product portfolio together form Check Point Software’s security subscriptions revenue segment. The segment grew 14% year-over-year in the second quarter, to $210 million.

Check Point Software’s product and license revenues segment, which includes offerings such as its Quantum firewalls, experienced 12% growth. It accounted for $133 million of the company’s total revenue during the three months ended June 30.

The $571 million in total revenue that Check Point Software generated puts the company $11 million above the midpoint of its guidance for the second quarter. Furthermore, the company reached the high end of its adjusted earnings forecast. Check Point Software closed the second quarter with adjusted earnings of $1.64 per share, foir cents above the midpoint of its forecast and 2% more than a year ago. 

“Over the past quarter, cyber-attacks have increased by 32 percent while advanced attacks like ransomware have grown by 59 percent, underscoring why cyber-security is so critical to keep our world going,” said Check Point Software founder and Chief Executive Officer Gil Shwed. “Our strategic vision of a consolidated prevention-first security architecture is more relevant than ever to combat today’s cyber challenges.”

For the third quarter, Check Point Software is projecting revenues of $555 million to $585 million. The company expects its adjusted earnings to range between $1.6 and $1.72 per share. 

Image: Check Point Software

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Mon, 01 Aug 2022 12:53:00 -0500 en-US text/html https://siliconangle.com/2022/08/01/check-point-software-reports-significantly-accelerated-growth-second-quarter/
Killexams : University of Oxford: Oxford spinout MiroBio acquired by Gilead Sciences for $405m

MiroBio, an Oxford biotech spinout focused on therapeutics for inflammatory diseases, is set to be acquired by global biopharmaceutical company Gilead Sciences following the completion of a deal worth approximately £332m (USD$405m).

With its journey from spinning out to exit taking three years, the MiroBio team has delivered one of the fastest exits for an Oxford spinout. Underpinning its development is over 15 years of Oxford research into a fundamental principle of immune cell signalling called Kinetic-Segregation, discovered by Professor Simon Davis from the Radcliffe Department of Medicine and co-developed with Professor Richard Cornall, the Nuffield Professor of Clinical Medicine in the Nuffield Department of Medicine.

‘Once the mechanism was established it was clear we could develop antibodies that could activate inhibitory ‘checkpoint’ receptors, which exist in a wide variety of different forms on white blood cells, in order to treat human diseases involving transplant rejection, allergy, inflammation and autoimmunity. These diseases have a devastating impact on people’s lives around the world every day. Accelerating clinical trials and ultimately developing life-saving drugs will make a major difference for patients,’ said Professor Davis.

This research paved the way for the development of MiroBio’s proprietary discovery platform, I-ReSToRE (REceptor Selection and Targeting to Reinstate immune Equilibrium), and the company’s portfolio of immune inhibitory receptor agonists, both of which form the core of the deal with Gilead. MiroBio’s lead investigational antibody, MB272, entered Phase I trials this week, with the first patient dosed on 2 August. The antibody targets T, B and dendritic cells with the goal of blocking their activation and suppressing inflammatory immune responses. Through I-ReSToRE, which supports the identification and development of therapeutics for inflammatory diseases, both MiroBio and Gilead anticipate identifying and advancing further agonists.

Launched in 2019, MiroBio was co-founded by Oxford Science Enterprises (OSE), an independent investment company backing Oxford spinouts, Tim Funnell, OSE’s VP of Operations at the time, and Samsara BioCapital, a US venture capital firm, working closely with MiroBio’s scientific founders.

MiroBio has since developed as one of Oxford’s most promising university spinout companies, quickly outgrowing its first home at Oxford’s BioEscalator site and moving to its current home on the Oxford Science Park. This remarkable growth has been made possible not just because of the idea behind the company, but also the strong, collaborative network of partnerships upon which the company has been built.

‘The creation of MiroBio came through a series of friendships and partnerships, and benefitted from the rapidly evolving biotech ecosystem in Oxford, including the funding environment that has been created here,’ said Professor Cornall.

Conversations between Davis, Cornall and Srini Akkaraju, a colleague of Cornall’s from his time at Stanford, helped to initiate the company. Founder of Samsara BioCapital, Akkaraju arranged the introduction to an old friend and colleague Eliot Charles, another life sciences-focused venture capitalist who had recently moved to the UK and then came on board as the company’s launch CEO and later its Chair. At the same time, OSE’s Entrepreneur in Residence, Tim Funnell, threw himself into the day-to-day challenge of setting up MiroBio, leaving OSE to become its VP of Operations.

The company received support from Oxford University Innovation’s (OUI) Dr. Matt Carpenter and Dr. Benedicte Menn, who protected MiroBio’s assets, provided initial funding, and represented the professors in negotiations.

OSE and Samsara helped structure and co-lead MiroBio’s Series A, which was joined by the international life sciences investors SR One and Advent Life Sciences, raising £27m – a significant sum for a young spinout.

‘The final key piece of the jigsaw was Chris Paluch,’ added Professor Davis, ‘He developed several of the assets with us and decided to leave his specialist clinical training and join MiroBio as a co-founder, where he has led its basic research and drug discovery programmes.’

Speaking on the deal, Eliot Charles, Chair of MiroBio, said: ‘MiroBio has a deep understanding of checkpoint receptor signalling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.’

For Chas Bountra, Pro Vice Chancellor for Innovation at Oxford University, the origins, rapid development and exit of MiroBio underlines the potential of Oxford’s innovation ecosystem to deliver game-changing innovation from world-class ideas.

‘MiroBio was founded by two of our most brilliant academics, supported by fabulous colleagues in OUI, OSE and other investment companies,’ added Professor Bountra. ‘This new partnership with a highly innovative global pharma company is going to accelerate new life changing therapies for millions of patients. This is yet another illustration of the broad, vibrant, and growing innovation ecosystem surrounding this great university. This exciting story will undoubtedly inspire many more of our researchers and students. I know the founders are already thinking about the next big healthcare problem.’

Fri, 05 Aug 2022 00:08:00 -0500 en-US text/html https://indiaeducationdiary.in/university-of-oxford-oxford-spinout-mirobio-acquired-by-gilead-sciences-for-405m/
Killexams : Check Point Software Technologies Reports 2022 Second Quarter Financial Results

SAN CARLOS, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Check Point® Software Technologies Ltd. CHKP, today announced its financial results for the second quarter ended June 30, 2022.

Second Quarter 2022:        

  • Total Revenues: $571 million, a 9 percent increase year over year
  • Product & License Revenues: $133 million, a 12 percent increase year over year
  • Security Subscription Revenues: $210 million, a 14 percent increase year over year
  • Deferred Revenues: $1,666 million, a 13 percent increase year over year
  • GAAP Operating Income: $209 million, representing 37 percent of revenues
  • Non-GAAP Operating Income: $249 million, representing 44 percent of revenues
  • GAAP EPS: $1.36, a 1 percent decrease year over year
  • Non-GAAP EPS: $1.64, a 2 percent increase year over year

"We are pleased with our second quarter results. Total revenues achieved growth of 9 percent - more than double the rate of a year ago. This was driven by strength in products and subscriptions revenues which generated a strong increase of 12 and 14 percent respectively," said Gil Shwed, Founder and CEO of Check Point Software Technologies. "Over the past quarter, cyber-attacks have increased by 32 percent while advanced attacks like ransomware have grown by 59 percent, underscoring why cyber-security is so critical to keep our world going. Our strategic vision of a consolidated prevention-first security architecture is more relevant than ever to combat today's cyber challenges."

Financial Highlights for the Second Quarter of 2022:

  • Total Revenues$571 million compared to $526 million in the second quarter of 2021, a 9 percent increase year over year.
  • GAAP Operating Income: $209 million compared to $222 million in the second quarter of 2021, representing 37 percent and 42 percent of revenues in the second quarter of 2022 and 2021, respectively.
  • Non-GAAP Operating Income: $249 million compared to $257 million in the second quarter of 2021, representing 44 percent and 49 percent of revenues in the second quarter of 2022 and 2021, respectively.
  • GAAP Taxes on Income: $45 million compared to $47 million in the second quarter of 2021.
  • GAAP Net Income: $174 million compared to $186 million in the second quarter of 2021.
  • Non-GAAP Net Income: $209 million compared to $217 million in the second quarter of 2021.
  • GAAP Earnings Per Diluted Share: $1.36 compared to $1.38 in the second quarter of 2021, a 1 percent decrease year over year.
  • Non-GAAP Earnings Per Diluted Share: $1.64 compared to $1.61 in the second quarter of 2021, a 2 percent increase year over year.
  • Deferred Revenues: As of June 30, 2022, deferred revenues were $1,666 million compared to $1,472 million as of June 30, 2021, a 13 percent increase year over year.
  • Cash Balances, Marketable Securities and Short-Term Deposits: $3,676 million as of June 30, 2022, compared to $4,002 million as of June 30, 2021.
  • Cash Flow: Cash flow from operations of $212 million compared to $264 million in the second quarter of 2021. The second quarter of 2022 includes $47 million of expenses related to our currency hedging transactions and $30 million of tax expenses compared to $6 million of income related to our currency hedging transactions and $25 million of tax expenses in the second quarter of 2021.
  • Share Repurchase Program: During the second quarter of 2022, the company repurchased approximately 2.6 million shares at a total cost of approximately $325 million.

For information regarding the non-GAAP financial measures discussed in this release, as well as a reconciliation of such non-GAAP financial measures to the most directly comparable GAAP financial measures, please see "Use of Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information."

Conference Call and Webcast Information
Check Point will host a conference call with the investment community on August 1, 2022, at 8:30 AM ET/5:30 AM PT. To listen to the live video cast or replay, please visit the website: www.checkpoint.com/ir.

Third Quarter Investor Conference Participation Schedule:

  • KeyBanc Technology Leadership Forum
    August 7-9, 2022, Vail, CO – Fireside Chat & 1x1's
  • Oppenheimer 25th Annual Virtual Technology, Internet & Communications Conference
    August 10, 2022 – Virtual 1x1's
  • Deutsche Bank 2022 Technology Conference
    August 30 - September 1, 2022, Las Vegas, NV – Fireside Chat & 1x1's
  • Citi 2022 Global Technology Virtual Conference
    September 6-8, 2022, New York, NY – 1x1's
  • Piper Sandler 2022 Global Technology Conference
    September 12-14, 2022, Nashville, TN – 1x1's
  • Goldman Sachs 2022 Communicopia + Technology Conference
    September 15, 2022, San Francisco, CA – 1x1's

Members of Check Point's management team anticipate attending these conferences and events to discuss the latest company strategies and initiatives. Check Point's conference presentations if applicable will be available via webcast on the company's web site. To hear these presentations and access the most updated information please visit the company's web site at www.checkpoint.com/ir. The schedule is subject to change.

About Check Point Software Technologies Ltd.
Check Point Software Technologies Ltd. (www.checkpoint.com) is a leading provider of cyber security solutions to corporate enterprises and governments globally. Check Point Infinity´s portfolio of solutions protects enterprises and public organizations from 5th generation cyber-attacks with an industry leading catch rate of malware, ransomware, and other threats. Infinity comprises three core pillars delivering uncompromised security and generation V threat prevention across enterprise environments: Check Point Harmony, for remote users; Check Point CloudGuard, to automatically secure clouds; and Check Point Quantum, to protect network perimeters and datacenters, all controlled by the industry's most comprehensive, intuitive unified security management. Check Point protects over 100,000 organizations of all sizes.

Follow Check Point via:
Twitter: http://www.twitter.com/checkpointsw
Facebook: https://www.facebook.com/checkpointsoftware
Blog: http://blog.checkpoint.com
YouTube: http://www.youtube.com/user/CPGlobal
LinkedIn: https://www.linkedin.com/company/check-point-software-technologies 

©2022 Check Point Software Technologies Ltd. All rights reserved

Legal Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or our future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, statements related to our expectations regarding our products and solutions, our beliefs regarding our customers' adoption of our products and solutions, and our participation in investor conferences during the third quarter of 2022. Our expectations and beliefs regarding these matters may not materialize, and genuine results or events in the future are subject to risks and uncertainties that could cause genuine results or events to differ materially from those projected. These risks include our ability to continue to develop platform capabilities and solutions; customer acceptance and purchase of our existing products and solutions and new products and solutions; the continued effects on our business of the COVID-19 pandemic, the market for IT security continuing to develop; competition from other products and services; and general market, political, economic and business conditions. The forward-looking statements contained in this press release are also subject to other risks and uncertainties, including those more fully described in our filings with the Securities and Exchange Commission, including our Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 14, 2022. The forward-looking statements in this press release are based on information available to Check Point as of the date hereof, and Check Point disclaims any obligation to update any forward-looking statements, except as required by law.

Use of Non-GAAP Financial Information
In addition to reporting financial results in accordance with generally accepted accounting principles, or GAAP, Check Point uses non-GAAP measures of operating income, net income, and earnings per diluted share, which are adjustments from results based on GAAP to exclude, as applicable, stock-based compensation expenses, amortization of intangible assets and acquisition related expenses and the related tax affects. Check Point's management believes the non-GAAP financial information provided in this release is useful to investors' understanding and assessment of Check Point's ongoing core operations and prospects for the future. Historically, Check Point has also publicly presented these supplemental non-GAAP financial measures to assist the investment community to see the Company "through the eyes of management," and thereby enhance understanding of its operating performance. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for results prepared in accordance with GAAP. A reconciliation of the non-GAAP financial measures discussed in this press release to the most directly comparable GAAP financial measures is included with the financial statements contained in this press release. Management uses both GAAP and non-GAAP information in evaluating and operating business internally and as such has determined that it is important to provide this information to investors.

     
INVESTOR CONTACT:   MEDIA CONTACT:
Kip E. Meintzer   Gil Messing
Check Point Software Technologies   Check Point Software Technologies
+1.650.628.2040   +1.650.628.2260
ir@checkpoint.com   press@checkpoint.com
     

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
CONSOLIDATED STATEMENT OF INCOME

 (Unaudited, in millions, except per share amounts)

  Three Months Ended   Six Months Ended
  June 30,   June 30,
  2022   2021   2022   2021
Revenues:              
Products and licenses $ 133.2   $ 119.1   $ 249.1   $ 228.4
Security subscriptions   209.9     183.7     411.5     361.1
Total revenues from products and security subscriptions   343.1     302.8     660.6     589.5
Software updates and maintenance   228.0     223.3     453.2     444.2
Total revenues   571.1     526.1     1,113.8     1,033.7
               
Operating expenses:              
Cost of products and licenses   36.7     23.2     68.1     44.8
Cost of security subscriptions   9.5     8.7     19.5     16.7
Total cost of products and security subscriptions   46.2     31.9     87.6     61.5
Cost of Software updates and maintenance   25.7     25.6     51.2     50.9
Amortization of technology   2.9     1.7     6.1     3.4
Total cost of revenues   74.8     59.2     144.9     115.8
               
Research and development   86.3     67.5     172.8     135.9
Selling and marketing   170.6     148.9     329.2     288.9
General and administrative   30.6     28.2     57.9     56.0
Total operating expenses   362.3     303.8     704.8     596.6
               
Operating income   208.8     222.3     409.0     437.1
Financial income, net   9.7     10.4     16.8     23.0
Income before taxes on income   218.5     232.7     425.8     460.1
Taxes on income   44.9     46.7     82.8     91.2
Net income $ 173.6   $ 186.0   $ 343.0   $ 368.9
                       
Basic earnings per share $ 1.37   $ 1.39   $ 2.69   $ 2.74
Number of shares used in computing basic earnings per share   126.5     133.7     127.4     134.8
                       
Diluted earnings per share $ 1.36   $ 1.38   $ 2.66   $ 2.71
Number of shares used in computing diluted earnings per share   127.7     134.8     128.8     136.1

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
SELECTED FINANCIAL METRICS
(Unaudited, in millions, except per share amounts)

    Three Months Ended   Six Months Ended
    June 30,   June 30,
    2022   2021   2022   2021
                 
Revenues   $                  571.1   $                  526.1   $               1,113.8   $               1,033.7
Non-GAAP operating income     248.7     257.1     487.3     503.4
Non-GAAP net income     209.3     217.0     412.9     428.2
Diluted Non-GAAP Earnings per share   $                    1.64   $                    1.61   $                    3.21   $                    3.15
Number of shares used in computing diluted Non-GAAP earnings per share     127.7     134.8     128.8     136.1

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
RECONCILIATION OF GAAP TO NON GAAP FINANCIAL INFORMATION

(Unaudited, in millions, except per share amounts)

    Three Months Ended   Six Months Ended
    June 30,   June 30,
    2022   2021   2022   2021
                 
GAAP operating income   $                  208.8     $                  222.3     $                409.0     $                437.1  
Stock-based compensation (1)               33.7                 29.9       66.1       56.5  
Amortization of intangible assets and acquisition related expenses (2)     6.2       4.9       12.2       9.8  
Non-GAAP operating income   $                  248.7     $                  257.1     $                487.3     $                503.4  
                 
GAAP net income   $                  173.6     $                  186.0     $                343.0     $                368.9  
Stock-based compensation (1)     33.7                       29.9       66.1                56.5  
Amortization of intangible assets and acquisition related expenses (2)     6.2       4.9       12.2                  9.8  
Taxes on the above items (3)     (4.2 )                       (3.8 )                (8.4 )                (7.0 )
Non-GAAP net income   $                  209.3     $                  217.0     $                412.9     $                428.2  
                 
Diluted GAAP Earnings per share   $                    1.36     $                    1.38     $                  2.66     $                  2.71  
Stock-based compensation (1)                        0.26                          0.22                   0.51                   0.42  
Amortization of intangible assets and acquisition related expenses (2)     0.05                          0.04                   0.10                   0.07  
Taxes on the above items (3)     (0.03 )     (0.03 )                 (0.06 )                 (0.05 )
Diluted Non-GAAP Earnings per share   $                    1.64     $                    1.61     $                  3.21     $                  3.15  
                 
Number of shares used in computing diluted Non-GAAP earnings per share     127.7       134.8       128.8       136.1  
                 
(1) Stock-based compensation:                
Cost of products and licenses   $ 0.1     $ 0.1     $ 0.2     $ 0.2  
Cost of software updates and maintenance                       1.3                         1.1                  2.3                  2.0  
Research and development     10.3                         7.2                  20.8                  13.7  
Selling and marketing                       10.3                         10.5                21.4                18.8  
General and administrative                     11.7                       11.0                21.4                21.8  
      33.7       29.9       66.1       56.5  
                 
(2) Amortization of intangible assets and acquisition related expenses:                
Amortization of technology-cost of revenues     2.9       1.7                     6.1                     3.4  
Research and development     2.2       1.3       4.2       2.6  
Selling and marketing     1.1       1.9       1.9       3.8  
      6.2       4.9       12.2       9.8  
(3) Taxes on the above items     (4.2 )     (3.8 )     (8.4 )      (7.0 )
Total, net   $ 35.7     $ 31.0     $ 69.9     $ 59.3  

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited, in millions)

ASSETS

  June 30,    December 31,
  2022   2021
Current assets:      
Cash and cash equivalents $               242.8   $              271.9
Marketable securities and short-term deposits   1,428.8     1,421.8
Trade receivables, net   344.0     597.8
Prepaid expenses and other current assets   55.0     46.4
Total current assets   2,070.6     2,337.9
       
Long-term assets:      
Marketable securities   2,004.5     2,089.7
Property and equipment, net   84.3     83.4
Deferred tax asset, net   70.2     51.7
Goodwill and other intangible assets, net   1,302.1     1,257.2
Other assets   81.4     80.3
Total long-term assets   3,542.5     3,562.3
       
Total assets $            5,613.1   $           5,900.2

LIABILITIES AND
SHAREHOLDERS' EQUITY

Current liabilities:      
Deferred revenues $ 1,210.7     $ 1,257.4  
Trade payables and other accrued liabilities   457.3       454.7  
Total current liabilities   1,668.0       1,712.1  
       
Long-term liabilities:      
Long-term deferred revenues   455.2       449.7  
Income tax accrual   440.2       454.9  
Other long-term liabilities   25.2       26.4  
    920.6       931.0  
       
Total liabilities   2,588.6       2,643.1  
       
Shareholders' equity:      
Share capital   0.8       0.8  
Additional paid-in capital   2,405.6       2,276.7  
Treasury shares at cost   (11,168.0 )     (10,550.7 )
Accumulated other comprehensive gain   (87.8 )     (0.6 )
Retained earnings   11,873.9       11,530.9  
Total shareholders' equity   3,024.5       3,257.1  
Total liabilities and shareholders' equity $ 5,613.1     $ 5,900.2  
Total cash and cash equivalents, marketable securities and short-term deposits $ 3,676.1     $ 3,783.4  

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
SELECTED CONSOLIDATED CASH FLOW DATA

(Unaudited, in millions)

  Three Months Ended   Six Months Ended
  June 30,   June 30,
  2022   2021   2022   2021
Cash flow from operating activities:              
Net income $ 173.6     $ 186.0     $ 343.0     $ 368.9  
Adjustments to reconcile net income to net cash provided by operating activities:              
Depreciation of property and equipment   5.5       5.5       10.5       10.2  
Amortization of intangible assets   3.4       2.1       6.7       4.2  
Stock-based compensation   33.7       29.9       66.1       56.5  
Realized gain on marketable securities   -       (0.2 )     -       (1.5 )
Decrease (increase) in trade and other receivables, net   (6.5 )     (24.9 )     246.9       175.3  
Increase (decrease) in deferred revenues, trade payables and other accrued liabilities   1.0       63.3       (65.8 )     24.0  
Deferred income taxes, net   1.0       1.9       2.3       0.5  
Net cash provided by operating activities   211.7       263.6       609.7       638.1  
               
Cash flow from investing activities:              
Payment in conjunction with acquisitions, net of acquired cash   -       -       (48.3 )     -  
Investment in property and equipment   (6.7 )     (3.3 )     (11.4 )     (7.1 )
Net cash used in investing activities   (6.7 )     (3.3 )     (59.7 )     (7.1 )
               
Cash flow from financing activities:              
Proceeds from issuance of shares upon exercise of options   28.5       14.4       95.4       47.5  
Purchase of treasury shares   (325.0 )     (324.7 )     (650.0 )     (649.6 )
Payments related to shares withheld for taxes   (5.8 )     (4.9 )     (6.5 )     (5.8 )
Net cash used in financing activities   (302.3 )     (315.2 )     (561.1 )     (607.9 )
               
Unrealized loss on marketable securities, net   (26.9 )     (6.0 )     (96.2 )     (20.7 )
               
Increase (decrease) in cash and cash equivalents, marketable securities and short term deposits   (124.2 )     (60.9 )     (107.3 )     2.4  
               
Cash and cash equivalents, marketable securities and short term deposits at the beginning of the period   3,800.3       4,062.9       3,783.4       3,999.6  
               
Cash and cash equivalents, marketable securities and short term deposits at the end of the period $ 3,676.1     $ 4,002.0     $ 3,676.1     $ 4,002.0  

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Sun, 31 Jul 2022 21:00:00 -0500 text/html https://www.benzinga.com/pressreleases/22/08/g28282849/check-point-software-technologies-reports-2022-second-quarter-financial-results
Killexams : Whole-Exome Sequencing Predicts Response to Cancer Immunotherapy

Immunotherapies, such as immune checkpoint inhibitors, have transformed the treatment of advanced stage cancers. Unlike chemotherapies that kill cancer cells, these drugs help the body’s immune system to find and destroy cancer cells themselves. However, only a subset of patients responds long term to immune checkpoint inhibitors, and these treatments can come at a high cost and with side effects.

Researchers at New York University, Weill Cornell Medicine, and the New York Genome Center, have now developed a two-step approach, using whole-exome sequencing, to zero in on genes and pathways that predict whether cancer patients will respond to immunotherapy. The work illustrates how the use of whole-exome sequencing can better predict treatment response than current laboratory tests.

“These results suggest that the use of broader diagnostics such as whole exome or even whole genome sequencing may significantly Excellerate our ability to predict who will respond to immunotherapy—essentially, showing that more data does help to better predict treatment response,” said Marcin Imieliński, PhD, associate professor of computational genomics and associate professor of pathology and laboratory medicine at Weill Cornell Medicine, a core faculty member at the New York Genome Center. Imieliński is co-senior author of the team’s published paper in Nature Communications, which is titled “Recurrent somatic mutations as predictors of immunotherapy response.”

Immune checkpoint blockade (ICB) has transformed the treatment of metastatic cancer but is hindered by variable response rates, the authors wrote. “A key unmet need is the identification of biomarkers that predict treatment response.” Several biomarkers—including age, tumor type, and the number of mutations found in cancer cells, known as tumor mutational burden—are already known to correlate with responses to immunotherapy. Tumor mutational burden (TMB), which is calculated by analyzing a few hundred genes, is the most well-established predictor and is often used to determine a patient’s eligibility for immune checkpoint inhibitors. “TMB-high tumors are thought to be more immunogenic and hence responsive to ICB due to their increased burden of neoantigens,” the authors explained.

However, as co-senior author Neville Sanjana, PhD, asked, “Can we better predict who will benefit from immunotherapy? … Scientists have developed various biomarkers that help anticipate immunotherapy treatment response, but there’s still an unmet need for a robust, clinically practical predictive model.” Sanjana is assistant professor of biology at NYU, assistant professor of neuroscience and physiology at NYU Grossman School of Medicine, a core faculty member at New York Genome Center,

If scientists look at a much larger portion of our genes, could that help to better predict which patients will respond to immunotherapy? Whole-exome sequencing is a method for sequencing the part of the genome that codes for proteins—around 20,000 genes, or 2% of the genome—to look for mutations that may be involved in disease.

Whole-exome sequencing is not widely used in cancer treatment, although some recent studies of immunotherapies have started to include sequencing. These studies are small, but together can help illuminate the relationship between genomic factors and how patients respond to immunotherapy. However, the authors noted, “Though recent whole-exome sequencing (WES) studies have attempted to go beyond TMB to link specific DNA alterations to ICB response, they have been limited by low demo sizes and underpowered (genome-wide) analytic approaches.”

For their study the researchers combined data from six previous immunotherapy studies of patients with melanoma, lung cancer, bladder cancer, and head and neck cancer. Whole-exome sequencing was available for all participants, who were treated using either an anti-PD-1 or an anti-CTLA-4 immune checkpoint inhibitor. But even after combining the six studies, the number of patients—319 in total—was still relatively small. “ … Although we build a larger cohort by pooling several studies, the demo size is still limiting for genome-wide significance,” the team acknowledged.

“The problem with a small study of only a few hundred people is a mismatch between the number of patients and the vast number of genes sequenced in whole-exome sequencing,” said study first author Zoran Gajic, a graduate student in the Sanjana lab. “We’d ideally have a dataset with more patients than genes.”

To get around this problem, the researchers turned to a model called fishHook, which distinguishes mutations that drive cancer from background mutations, or mutations that occur by chance but are not involved in cancer. The model corrects for a range of factors that affect the rates of background mutations—for instance, adjusting for the size of a gene, since larger genes are more likely to have mutations. “To identify positively selected genes and pathways in the aggregated immunotherapy cohort, we adapted fishHook, a statistical method originally developed to study noncoding mutational recurrence in whole genome sequencing,” the team noted. “We limited the fishHook analysis to the coding regions of 19,688 genes that are consistently captured by WES.”

Using this model, the researchers employed a two-step approach: first, they looked at the sequencing from all patients to find any genes with a higher mutational burden than they would expect, adjusting for genomic factors like gene size or whether a particular piece of DNA is a known hotspot that tends to accumulate more mutations. This yielded six genes with suspiciously high mutational burdens.

Next, the researchers determined if any of these six genes were enriched in people who responded or did not respond to immunotherapy. Two of the genes—KRAS, a gene often mutated in lung cancer, and BRAF, the most commonly mutated gene in melanoma—were enriched in patients who responded to immunotherapy. In contrast, two other genes—TP53 and BCLAF1—were enriched in those who did not respond to immunotherapy. BCLAF1 is not well studied, but these findings suggest that patients with BCLAF1 mutations are less likely to respond to immune checkpoint inhibitors.” In total, we identified 4 ICB response predictive genes from our logistic regression (BCLAF1, BRAF, KRAS, and TP53),” the authors noted.

Using the same two-step approach the researchers next determined that certain pathways (MAPK signaling, p53 associated, and immunomodulatory) also predicted immune checkpoint inhibitor response.

They subsequently combined the four genes and three pathways with other predictive variables such as age, tumor type, and tumor mutational burden to create a tool they named the Cancer Immunotherapy Response CLassifiEr (CIRCLE). They found that compared to tumor mutational burden alone, CIRCLE better predicted ICB response, with a 10.5% increase in sensitivity and a 11% increase in specificity. CIRCLE was also able to accurately predict cancer survival after immunotherapy. “These results suggest that the use of broader diagnostics such as whole-exome or even whole-genome sequencing may significantly Excellerate our ability to predict who will respond to immunotherapy—essentially, showing that more data does help to better predict treatment response,” said Marcin Imieliński, associate professor of computational genomics and associate professor of pathology and laboratory medicine at Weill Cornell Medicine, a core faculty member at the New York Genome Center, and the study’s co-senior author.

Figure describing steps of CIRCLE: 1. Combine immunotherapy whole-exome sequencing datasets 2. Identify mutated genes and pathways 3. Test candidate genes and pathways for response association 4. Predictive framework for therapy response (determining Responder or Non-responder) [Sanjana and Imieliński labs]
To validate their approach, the researchers tested CIRCLE on data from 165 additional cancer patients with whole exome sequencing who underwent treatment with immunotherapy and found that CIRCLE captured predictive information beyond that obtained from tumor mutational burden alone.

“Our study focuses on biomarkers derived from existing cohorts of immunotherapy patients with paired WES and response data alongside clinically relevant metadata,” the authors summarized. “It capitalizes on the advantages of both candidate gene and genome-wide approaches to achieve optimized predictive power with a modest cohort size … “We found that the CIRCLE classifier yields improved ICB response prediction when compared to TMB,” they wrote. “Taken together, these results support broader investigations into CIRCLE and more generally recurrent somatic alterations as immunotherapy biomarkers.”

Future research will involve testing CIRCLE on larger cohorts of patient data, as the researchers anticipate that the model will Excellerate with data from thousands of patients rather than hundreds. They also hope that with larger cohorts, they can begin to tease out which patients are likely to respond to different immunotherapies, given the growing number of treatments available.

“Larger immunotherapy cohorts will be needed to validate this finding, and more broadly the principle that positively selected driver alterations can help predict immunotherapy response … Due to the cancer type specificity of driver alterations, we can expect that expanding CIRCLE to broader pan-cancer cohorts will require the classifier to be revised with additional discovery analyses.”

“We envision that this two-step approach and use of whole-exome sequencing will pave the way for better prognostic tools for cancer immunotherapy,” said Sanjana. As the authors conclude, “While panel testing is already used routinely in immuno-oncology, our results suggest that the use of broader diagnostics (including WES and whole genome sequencing) may significantly Excellerate this stratification of responders and nonresponders … We envision that CIRCLE and more broadly the analysis of recurrently mutated cancer genes will pave the way for better prognostic tools for cancer immunotherapy.”

Mon, 11 Jul 2022 20:00:00 -0500 en-US text/html https://www.genengnews.com/topics/omics/sequencing/whole-exome-sequencing/whole-exome-sequencing-predicts-patient-response-to-cancer-immunotherapy/
Killexams : Repositioning Therapeutic Cancer Vaccines in the Dawning Era of Potent Immune Interventions

Cancer Vaccines: Quo Vadis?

Contrasting results from cancer vaccine studies versus checkpoint blockade or ACT emphasized two major hurdles upstream and downstream of vaccination: the limited competence of the immune repertoire and the altered functionality of immune effector cells within the tumor microenvironment (Figure 1A). Thus, selecting clinical indications where there is a functional preexisting repertoire (either naïve or primed) and which are devoid of organized, vascular tumors with their plethora of immune-inhibiting molecules would increase the vaccines' likelihood of success (Figure 1B).

Cancer Vaccines in Minimal Residual Disease to Clear Residual Cancer & Prevent Tumor Relapse

Several groups are pursuing this concept utilizing various platform technologies. For example, van Tendeloo et al. advanced a vaccine for acute myelogenous leukemia patients previously treated with chemotherapy utilizing matured DCs transfected with mRNA that expresses WT-1 antigen.[79] Repeat immunization resulted in conversion from a partial response diagnosed as Wilm's tumor suppressor gene 1 (WT-1)-positive MRD to a complete response manifested through a WT-1-negative status. The durability of the clinical response was associated with an increase in WT-1-specific CD8+ T-cell immunity and NK activation. Clearance of residual leukemia through vaccination against WT-1 showcased this antigen as a target cancer vaccination in general.[80] Further, monitoring individual patients by using markers of residual disease could revolutionize this area of investigation by providing fairly rapid proof of principle in small-sized trials.[81]

Another study targeting residual disease was conducted in chronic myelogenous leukemia (CML) utilizing the allogeneic GVAX platform which employs a K562 leukemia cell line expressing GM-CSF.[82] CML patients on chronic treatment with the tyrosine kinase inhibitor imatinib mesylate (Gleevec®), responding to this drug, were vaccinated and monitored using the bcr/abl marker. Interestingly, about one-third of the 19 treated patients demonstrated disease clearance, illustrating the power of using potent vaccination during the minimal residual disease stage, together with molecular marker monitoring.

Another study utilized vaccination with GM-CSF and peptides spanning the bcr/abl breakpoint mixed with montanide adjuvant.[83] Interestingly, within a group of 10 CML patients who achieved stable disease after treatment with tyrosine kinase inhibitor, 50% of these witnessed either a substantial disease reduction or a major molecular response assessed by measuring the presence of the bcr/abl transcript.

Another promising disease indication is that of follicular lymphoma in remission where an individualized idiotype vaccine, based on keyhole limpet hemocyanin-coupled idiotype protein adjuvanted with GM-CSF, showed compelling evidence of clinical benefit in a Phase III randomized trial.[84] Results of this study demonstrated a substantial increase in the disease-free survival of vaccinated patients leading to some renewed efforts aimed at designing personalized vaccines.

Efforts to evaluate cancer vaccines in an adjuvant setting in solid tumors have led to mixed results. In particular, it has been difficult to accurately monitor disease burden, therefore precluding a more objective and rapid assessment of the clinical effect in small trials. Alfaro et al. outlined the importance of pursuing improvements of the vaccine platform technology in conjunction with utilizing methods to objectively assess clinical outcome on a patient-by-patient basis by quantifying the impact on both circulating tumor cells and circulating endothelial cells.[85]

Evaluation of vaccines in melanoma suggested a preferential applicability to lower disease burden. In fact, an earlier report in a sizable randomized trial, in resected advanced stage melanoma patients treated with an allogeneic cell-based vaccine (Canvaxin®), indicated a significantly improved overall survival of 5 years in vaccinated versus unvaccinated patients.[86] Nevertheless, the substantial variability in terms of vaccine characteristics and product potency (batch variation in the case of allogeneic vaccines, and patient-to-patient variability in the case of autologous cell-based vaccines) represented a significant barrier in front of vaccine development. Hence, there has been a keen interest in optimizing synthetic vaccines and exploring them in an MRD setting in solid tumors. Thus, an earlier study utilizing a recombinant NY-ESO-1 protein, combined with a saponin-based adjuvant, was conducted in melanoma patients also with resected tumors.[87] The results showed, in addition to induction of antibody and T-cell immune responses, an imbalance in terms of disease relapse. More specifically, patients assigned to the adjuvanted protein group had a several-fold lower likelihood of relapse (2 of 19 fully vaccinated patients relapsed during 2 years follow up vs 5 of 7 placebo and 9 of 16 patients vaccinated with non-adjuvanted protein). Similarly, a vaccine comprising an EGFRvIII-derived, 13-amino acid peptide that spans this specific neoepitope, conjugated to keyhole limpet hemocyanin, showed promising clinical efficacy in first-line glioblastoma, where most of the tumor bulk was previously eliminated by surgery and chemoradiation.[88] In this Phase II multicenter study, survival of vaccinated patients was directly compared to historical survival data from matched controls. In addition, tumor relapses were found to be EGFRvIII-negative, thus providing proof for the vaccine's effect in this setting.

As prevention of cancer relapse by vaccination of patients with solid tumors in complete remission is an extremely appealing opportunity, NeuVax™ is one of the most promising vaccines in Phase III clinical development. It comprises a Her-2/Neu-derived nonapeptide that stimulates CD8+ T cells in HLA-A2/A3+ patients.[89] In a previous Phase II trial, this peptide vaccine administered to node-positive patients after standard of care treatment achieved a very significant reduction of recurrence rate at 60 months of 5.6 versus 25.9% in the control arm.[201] Based on these results, the current Phase III trial seeks out to confirm the vaccine's capability to prevent recurrences in early stage node-positive breast cancer with low-to-intermediate Her-2/Neu expression, after successful utilization of standard of care leading to clinical remission.

In summary, there are compelling scientific arguments in support of MRD as a preferred indication for cancer vaccines. While there are notable examples of promising cancer vaccine trials in this indication, much more needs to be done in terms of fully tapping into the potential of cancer vaccines to clear residual disease and prevent tumor relapse.

Some Indications Associated With Measurable Tumors can Present Opportunities for Therapeutic Vaccination

Interestingly, more advanced disease indications could also represent opportunities for therapeutic vaccination, if the immune repertoire is competent and the immune environment within tumors is permissive. In particular, in situ carcinoma represents an exciting opportunity to test cancer vaccines at the interface between MRD and local progressive disease. An encouraging approach consists of adjuvanted long peptides corresponding to E6 and E7 antigens of HPV, utilized as therapeutic vaccines for cervical carcinoma with lesions confined to the epithelial layer.[38,90] This program elegantly integrates several parameters that maximize the likelihood of success for therapeutic vaccination and could represent a roadmap for adequately positioning this concept within the therapeutic armamentarium against cancer. First, a non-self-target antigen is more immunogenic and second, the use of adjuvanted peptides of optimal size results in coinduction of CD4+ and CD8+ T cell immunity through cross-presentation. Third, the synthetic nature of the vaccine results in a reduced cost of goods. Forth, an early stage yet measurable disease setting, while permissive to the activity of the T cells within lesions, is amenable to fairly rapid and objective evaluation of clinical response in individual patients. In addition, the HPV oncoprotein targets are intimately associated with the biology of this carcinoma. While a majority of patients in early stage (vulvar in situ carcinoma) showed objective and durable responses following vaccination, patients with later disease stage were fairly refractory. In addition to the association between clinical response and disease stage, there was a notable correlation between the type 1 T-cell response elicited by the vaccine and the clinical outcome.

Advanced Disease Indications Are a Difficult Target for Cancer Vaccines

Apart from early stage disease, reports of objective clinical responses measured in individual patients, have been exceedingly rare for cancer vaccines. A recent study exploring an adjuvanted NY-ESO-1 recombinant protein in melanoma showed that advanced disease patients, with metastases to internal organs, have a diminished T-cell immune response, while the antibody response was comparable to that of patients with MRD.[91] There was also a considerable increase in the percentage of Treg cells in advanced disease patients, directly highlighting one of the major hurdles.

In a Phase I trial that evaluated the outcome of an intra-lymph node prime-boost vaccine in patients with late stage metastatic melanoma with visceral lesions (stage IVc) and earlier stage with cutaneous disease and lymph node mets (stages IIIc/IVa), there was a stark discrepancy uncovered. While roughly 50% (4 of 7) of the patients with lymph node metastases showed an objective tumor reduction that qualified as a partial response under RECIST criteria, none of the 14 patients with visceral metastatic disease showed a clinical response.[92] In addition, while the immune response in both groups was similar, only patients with disease confined to lymph nodes and preexisting immunity against one of the immunizing antigens (Melan A/MART-1) showed tumor reduction.

This illustrates two important aspects. First, in the measurable disease setting, therapeutic vaccination could work through mobilizing preexisting tumor-specific T cells. Second, these findings suggest that the resulting effector T cells operate more effectively within the lymph node environment as opposed to visceral metastatic lesions where they presumably encounter a wider range of inhibitory mechanisms. This is supported by a body of evidence showing considerable variability in the tumor microenvironment. This ranges from a noninflammatory to proinflammatory microenvironment that could be permissive or inhibitory toward antitumor immune responses. Such findings also support current efforts to define tumor gene expression signatures that stratify patient populations in 'responsive' versus 'non-responsive' to active immunotherapy.[93]

Stimuvax®, a vaccine comprising liposomal-formulated Muc peptide, also illustrates the difficulty of addressing later stage, unresectable cancer. A recently completed Phase III trial in stage III non-small-cell lung carcinoma showed no survival advantage in vaccinated patients.[94] However, interestingly, a post hoc analysis showed that patients who received concurrent radiochemotherapy at the start of the vaccination regimen, showed a 10-month survival advantage over unvaccinated patients (with a medium overall survival of about 20 months). This speaks to a rational integration of vaccines with certain standard of care, but much more needs to be done to garner appropriate information to rationally design prospective studies.

Finally, an approach that resulted in objective tumor reduction in an advanced disease setting consisted of combining vaccination with cytokines such as IL-2 and IFN-α. Higher rates of objective response were seen in vaccinated patients with melanoma or RCC who received concurrent cytokine treatment, compared to patients who were being treated with cytokines alone.[95,96] While such studies are exciting, the results need to be confirmed in larger and adequately controlled trials that are quite difficult to conduct, due to the niche nature of the clinical indications and the toxicities associated with cytokine therapy.

In summary, while advanced cancer represents a very difficult indication for cancer vaccines,[97] there could be few opportunities where the immune repertoire is sufficiently preserved and metastatic lesions are still permissive for an immune mediated attack. Vaccine utilization in advanced cancer will require adequate patient stratification methods as only a minor subset of patients could be amenable to such therapeutic modality.

Integrative Immune Interventions That Leverage Vaccination

Beyond MRD or select niches consisting of measurable disease but associated with immune responsiveness, a second category of opportunities exists. This consists of vaccines adjunctive to interventions comprising restoration, amplification or engineering of the immune repertoire. In principle, while the exogenous provision of a T-cell repertoire would yield competent immune cells, vaccination would turn on, amplify or maintain their activity in vivo (Figure 1C). This could offer two advantages: a more specific post-adoptive transfer manipulation of T cells as compared to utilization of high dose cytokines and, second, a prolonged in vivo activity of the transferred T cells that face multiple negative homeostatic mechanisms.

The next objectives in the quest to treat cancer are the increase in the response rate and the durability of clinical response. There are few instances where a durable clinical response on ACT has been observed. One example is anti-leukemic CAR-T cells supra-physiologically engineered with potent costimulatory domains and directed against a renewable source of endogenous antigen such as CD19[98,99] that acts similar to an auto-vaccine.[100] The other situation where very durable clinical responses were reported in context of ACT involved TIL treatment of melanoma patients.[101] In this case, it was not clear whether TILs were capable of eliminating the 'last cancer cell' or if there was a persisting, immune-mediated containment of the disease.

The concept of integrating vaccination with ACT is anchored in earlier findings from preclinical and clinical studies.[102,103] These studies showed that the process of T-cell repertoire recovery, after chemotherapy and bone marrow transplantation, permits repertoire manipulation through vaccination. This concept yielded some encouraging results in several multiple myeloma patients immunized with idiotypic antigen.[104] Subsequently, this approach has been tested and refined in a wider range of clinical protocols some involving donor lymphocyte infusion. Other protocols explored administration of autologous peripheral T cells harvested before chemotherapy and bone marrow transplantation, in combination with subsequent vaccination during the T-cell repertoire recovery phase.[105–107] This integrated approach to immunotherapy – based on the key opportunity to manipulate a recovering T cell repertoire – was articulated in a recent review.[108]

A seminal paper was published in 2003 illustrating for the first time in a preclinical mouse model involving a TCR against the melanoma antigen gp100, the profound synergy between adoptive T-cell transfer and a gp100 vaccine. The vaccination, encompassing a pox virus expressing a gp100 peptide agonist, combined with cytokine treatment, resulted in an impressive regression of established B16 tumors without the requirement for lymphoablative conditioning.[109] Subsequently, it was shown that adoptively transferred T cells stimulated by the cognate pox virus vaccine in vivo have the capability of migrating to various tissues and non-antigen-expressing tumors but display full blown effector functions only within antigen-expressing tumors.[110] The specific T cells acquired a capability to proliferate at a much faster rate than the tumor cells.[111] Further, it was shown that a pox virus-based vaccine could be interchanged with a DC vaccine, work that also uncovered the seminal role of IL-7 during the T-cell response recovery phase.[112] Subsequently, it was also demonstrated in the same pMel preclinical model that T cells could be antigen 'primed' just before adoptive transfer, resulting into an outcome similar to the utilization of vaccination in vivo.[113] Nevertheless, it is likely that maintenance and manipulation of the T-cell repertoire over a longer interval would require additional in vivo interventions post-ACT, with vaccination possibly offering a more targeted and safer approach in contrast to high-dose cytokine treatment.

The proof-of-concept of vaccination as adjunct to ACT was also explored in other preclinical models. For example, vaccination with an adenovirus expressing the antigen 5T4 and autologous DCs, followed by local (intratumoral or peritumoral) infusion of CAR-engineered T cells against 5T4, resulted in tumor control as long as all these components of the therapy were provided.[114] DC vaccines were evaluated in combination with ACT, in models of glioblastoma and melanoma, with the specific T-cell population visualized in vivo by micro-PET analysis.[115,116] Other research outlined the importance of endogenous DCs during the recovery phase post-lymphodepletion in context of adoptive T-cell transfer, advancing the idea that the T-cell-infused recipient would be more receptive to vaccination during that critical interval.[117,118] Interestingly, several lines of evidence shed light on the importance of antigen presentation to the infused T cells, necessary for the activity of the latter. For example, in the anti-CD19 CAR T-cell model, it has been shown that continuous exposure to CD19 borne by the B-cell lineage under continuous renewal process is important in maintaining the activity of the CD8+ T cells directed against CD19.[100] Second, it was recently shown that tumor stromal cells acting as very effective professional APC cross-present tumor-derived antigen toward activating the adoptively transferred T cells to induce and support an overall antitumor effect.[119] Finally, in a model involving IL-12 co-engineered T cells adoptively transferred into mice carrying solid tumors, evidence pointed out to a role of tumor stromal macrophages, myeloid derived suppressor cells and DCs activated by local IL-12 to express Fas, in stimulating the incoming CD8+ FasL+ T cells.[120] Altogether, this evidence indicates that the adoptively transferred T cells benefit from 'auto-vaccination' by virtue of engaging resident APCs and antigen, but it is not clear to what extent this could be optimized through provision of exogenous vaccine. Reprioritization of immune interventions and aspects of the concept of combinatorial immunotherapy were critically illustrated in several reviews.[12,121–125]

Surprisingly, despite initial encouraging results in preclinical models, clinical translation of the concept of integrating ACT with vaccination yielded mixed results, thus far. A small yet randomized trial in transplanted multiple myeloma indicated that T-cell repertoire restoration with peripheral autologous T cells from patients immunized with a flu vaccine resulted in more rapid recovery of immune competency.[126] A study that pioneered this concept using a tumor-associated antigen tested peripheral T cells from melanoma patients immunized against gp100 that were expanded in vitro, followed by adoptive transfer, vaccination and IL-2 treatment.[127] Disappointingly, this trial resulted in an absence of antitumoral responses and only two instances of autoimmunity questioning the relevance of the target antigen.[127] A subsequent report on a single melanoma patient treated with TILs expanded in vitro against the same gp100 antigen and followed by fowlpox vaccination post-adoptive T-cell transfer resulted in a major clinical response.[128] The significance of this observation could be high as the same patient was previously treated unsuccessfully with TILs without vaccination.

Next, an effort to integrate vaccination against human telomerase reverse transcriptase and survivin in context of bone marrow transplantation and adoptive T-cell transfer with polyclonally stimulated autologous T cells showed that only 30% of the multiple myeloma patients treated this way developed an immune response while there was no apparent clinical improvement.[129] A variant of this approach was later tested in ovarian carcinoma patients. Instead of utilizing epitope-specific vaccines, the authors used a tumor lysate-based DC vaccine given before harvesting T cells for ex vivo polyclonal expansion and also administered after chemotherapy and T-cell infusion.[130] While the trial size was quite limited, a few patients showed some exciting signals in terms of immune response and clinical signals and there was one case associated with a durable response.

In summary, despite the excitement and support provided by preclinical evidence, the translation of the concept of integrating vaccination with ACT in humans awaits solid proof of concept. It is not clear whether integrating the two modalities could overcome the homeostatic mechanisms that limit the activity of activated T cells in vivo.

The Next Frontier: Optimization of Integrative Immune Interventions

While vaccination could help tremendously in terms of generation, amplification and/or maintenance of adoptively transferred T cells, there still seem to be substantial downstream hurdles as T cells are still facing a relatively hostile immunologic tumor microenvironment. This is reflected in the results of a preclinical study using a different melanoma antigen Trp-2, which showed that adoptive T-cell transfer combined with potent vaccination led to the accumulation of antitumor T cells within melanoma lesions but without a notable effect on the tumor.[131] In addition, extensive analysis of peripheral T cells from melanoma patients adoptively transferred with TCR-engineered T cells and followed by DC vaccination with cognate antigen, showed that the polyfunctionality of T cells was gradually lost and replaced by a regulatory-like profile in the residual antigen-specific T cells.[75,132] A more recent report showed that TCR-engineered T cells adoptively transferred to melanoma patients acquire an exhausted phenotype encompassing elevated PD-1 and CD160 expression[76] raising the question whether integration of a vaccine within this treatment protocol could counteract this phenomenon.

Altogether, these findings suggest a quite noxious impact of host-related factors, on the adoptively transferred T cells. In a mouse model, vaccination with a long polypeptide encompassing non-self antigen (human gp100), together with the potent CpG adjuvant, triggered a massive expansion of specific T cells and pronounced antitumor effects, even in the absence of a preparative regimen.[133] Another recent preclinical study showed that PD-1 blockade in conjunction with ACT, subsequent vaccination and IL-2 treatment via IL-2/anti-IL-2 antibody complexes resulted in substantial tumor regression at a much higher rate when compared to adoptive therapy or vaccination separately.[134] Finally, in a preclinical model of autovaccination by intratumoral administration of immune-stimulating CpG motifs, the authors showed that co-depletion of Treg cells by anti-CTLA4 + anti-OX40 antibodies within one tumor lesion, vastly increased the immune system's impact on injected as well as remote tumors.[135] These findings suggest that endogenously primed or adoptively transferred T cells could greatly benefit from approaches to lower rather than completely obliterate parts of the immune system such as the Treg population.

While these findings create the perspective of rationally integrating vaccination with ACT, they also suggest that one needs to overcome the inhibitory mechanisms that inherently limit the activity of T cells to fully unleash the potential of immunotherapy.

Mon, 01 Aug 2022 12:00:00 -0500 en text/html https://www.medscape.com/viewarticle/814971_4
Killexams : Ukraine war: The priest shot at a checkpoint

By Viktoriia Zhuhan
BBC Ukraine

Image caption,

Village priest Rostyslav Dudarenko (L) with fellow priests Pavlo Naydenov and Serhii Tsoma (R)

Ukraine's Prosecutor General Iryna Venediktova has said the country is in the process of documenting thousands of incidents believed to contravene its criminal code on the rules of war.

As of 24 March, there have been 2,472 cases documented by her office. On Wednesday, Ms Venediktova outlined to the media how the country is handling these cases.

"Where we see that we will be successful in Ukrainian jurisdiction, and where the perpetrator of a crime will physically be in Ukraine, we will follow one strategy," she said.

"If we understand that we are not able to have success in Ukraine, we will put our resources towards the International Criminal Court, so that a specific person, an individual, suffers the punishment."

The following is an account gathered by the BBC of just one of the incidents that have been logged as a suspected war crime.

It was just over a week into Russia's invasion of Ukraine. A group of volunteers - neighbours and friends - from the small village of Yasnohorodka, 40km west of Kyiv, had taken up their positions at a checkpoint guarding the entrance to the community.

Fighting between Russian and Ukrainian forces was already brutally fierce. Across the country, checkpoints were springing up at the entrance to towns and villages - mostly manned by local volunteers without any formal military training.

On the afternoon of 5 March, Rostyslav Dudarenko, the village priest, was at the Yasnohorodka checkpoint. His role was to check approaching vehicles. But like all military chaplains he was also there to offer the group spiritual support. He was dressed in civilian clothes.

It is not possible to establish exactly what happened, but one survivor of the attack, Yukhym (not his real name), told the BBC he had been manning the checkpoint with Dudarenko and around a dozen others when they learned three Russian tanks had driven through the village. He says the group decided to hide in the woods, ready to confront them if necessary.

As they approached the checkpoint, the Russian troops started "firing in all directions", Yukhym told the BBC. "When they realised we were hiding in the grass, they went off road to run us over with tanks."

He says the tanks had driven back to the road when Dudarenko decided to break cover.

"I saw Rostyslav raise the cross above his head, get up from his hideaway, screaming something and walking towards them. Perhaps he wanted to stop them. I tried to call him."

He says shots were then fired in the direction of the priest, and from his viewpoint at the time, they appeared to be aimed directly at Dudarenko. "And that was it. He made just a couple of steps and fell."

Yukhym, who himself was shot and injured in the attack, believes they would all have been killed if Ukraine's armed forces had not at that moment arrived to push the Russian forces back.

The voluntary group Dudarenko, 45, had joined had no military status. A couple had some military training - having previous experience in the long-running conflict with Russia in the Donbas in the east, according to another volunteer called Eduard (not his real name). Some were simply amateur hunters. Most were over the age of 50, he told the BBC.

Eduard, who was stationed at a different checkpoint, arrived just as the Russian tanks were driving away to find bodies scattered on the road. He said these included Dudarenko and his assistant - who had also been unarmed - two other defence volunteers and another person he did not know.

Dudarenko's mother Nadiia says her only son was determined to play his part.

"He wanted to be able to protect everyone," Nadiia told the BBC. "I tried to talk him out of it but I couldn't argue with him."

Image source, Tetyana Pylypchuk
Image caption,

Dudarenko and his congregation hold a memorial service for villagers killed by Nazis in 1941

The group were armed with hunting rifles plus a small number of Russian army Kalashnikovs that had come into their possession, and had just three bulletproof vests between them. But as a priest, Dudarenko refused to bear arms, his friend and fellow priest Serhii Tsoma told the BBC.

This made him particularly vulnerable when he decided to confront the tanks, but such an action was in his nature, according to eyewitness Yukhym.

"Rostyslav was a kind and optimistic person. I think that's why he went to try and stop the Russians."

He was well known in Yasnohorodka as someone always ready to help others, driving round the village to collect older congregation members before Sunday mass, says his friend Tsoma.

His services themselves were also self-sacrificing, says one of his regular congregation, Tetyana Pylypchuk.

Dudarenko belonged to the Ukrainian Orthodox Church, which was finally granted independence from the Russian Orthodox Church in 2019, in a move never recognised by Russia.

Before the formal split, the Orthodox Church in Ukraine was divided between two branches, one loyal to Moscow, and one loyal to Kyiv. Although Dudarenko served in a church aligned with Kyiv, when pro-Russian former president Viktor Yanukovych took power in Ukraine in 2010 the Moscow Patriarchate began to take over Kyiv Patriarchate churches, including the one Dudarenko served in.

So rather than betray his principles, his friends say, he left the church and conducted his services out in the open - even in the rain. He later built a makeshift church in his trailer, with the help of donations.

Image caption,

Rostyslav Dudarenko held services as a Ukrainian Orthodox priest in a makeshift church

"Our church is orphaned without you, Father," wrote Tetyana in a tribute on her Facebook page.

As has been the case with thousands of such incidents across the country over the past few weeks, the killings were swiftly logged by both the police and local and national public prosecutor's offices, with details published on their respective Facebook pages.

The cases - suspected contraventions of Ukraine's article 438: Violation of the rules of warfare - have also been uploaded on to a centralised website used by Ukraine's state institutions.

Ms Venediktova told the BBC in an interview recorded last week in English that such documentation of evidence was critical.

"In the office of prosecutor general we have a special department of war… all law enforcement agencies help us… to investigate war crimes. It's our main priority.

"Of course, we don't have enough investigators, that's why we created a common website - warcrimes.gov.ua." The website is used not just by the prosecutor general's office but by other state institutions such as Ukraine's Ministry of Foreign Affairs and Ministry of Justice, to document all evidence.

"It's very important for us," she explained. "[The evidence] should be acceptable in our Ukrainian courts, they should be acceptable in the ICC, and in other jurisdictions."

As for the 5 March incident in Yasnohorodka, once the investigation into the shooting has been concluded, a court indictment will be issued, says the Kyiv Oblast district prosecutor's office.

"The prosecution is doing everything to establish the circumstances of each and every war crime, and each and every perpetrator: from a soldier, to a general, to the high military and political leadership of the aggressor state," it said in a statement.

It added that in some cases Russian soldiers were already facing the first stage of Ukrainian prosecutions, "so we are not just talking about prospects of sentences in absentia. In each specific case war criminals will be punished in accordance with the law of Ukraine".

Svyatoslav Khomenko contributed to this report

War in Ukraine: More coverage

Thu, 24 Mar 2022 15:39:00 -0500 en-GB text/html https://www.bbc.co.uk/news/world-europe-60778909
Killexams : Checkpoint set up in Whitby as hundreds of Hells Angels members expected at gathering

A police checkpoint has been set up in Whitby, Ont., as hundreds of Hells Angels members from across Canada are expected at a gathering there this weekend.

Durham police Sgt. Joanne Bortoluss said officers have set up the checkpoint on Baldwin Street to ensure that anyone coming through is in compliance with the Highway Traffic Act.

“We’re checking for any sort of sobriety. We’re checking for people being properly class in the licence,” she added.

Baldwin Street north of Columbus Road will be closed until 9 p.m. Sunday and only local traffic is allowed access.

Hundreds of Hells Angels Motorcycle Club members from across Canada are expected in the area throughout the weekend for the “2022 Canada Run,” which is an annual gathering of Hells Angels members from throughout the country.

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They’re expected to gather at the clubhouse of the Brooklin Hells Angels chapter on Baldwin Street.

“Nothing criminal has happened. We have no indication that anything criminal will happen,” Bortoluss said.

“We are here because it’s a large-scale event. We’re expecting a lot of people and we’re here to ensure the safety of the public.”

Bortoluss added that if a member of the public does see illegal activity that is not an emergency, Durham Regional Police have a dedicated tip line and email address, which is listed on their website.

Earlier this week, Deputy Chief Dean Bertrim of the Durham Regional Police Service was among several officials who held a press conference explaining to the public what could be expected at this weekend’s event.

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“On the weekend of July 22nd to 24th, which is obviously this Friday to Sunday, the Brooklin chapter of the Hells Angels Motorcycle Club will host a site for an event they are calling the 2022 Canada Run,” Bertrim said.

“We anticipate hundreds of motorcycle club members from across Canada to converge in our region.”

He said the event will be held at a residence in Brooklin — a neighbourhood in Whitby — and up to 1,000 members could attend.

“While there’s a focus of hosting activities in the Brooklin location, we know Hells Angels members will be moving throughout the entire of the region in accommodations and the visiting of hospitality venues,” Bertrim added.

“On behalf of Chief (Todd) Rollauer and our members, I want to assure the community that our service is well aware of the event and have a comprehensive operational plan in place and is supported by the provincial biker enforcement unit and our local and national partners.”

He said officers will have “a zero-tolerance approach” to any unlawful activity.

“We have already seen the Hells Angels Motorcycle Club supporters on social media trivializing this and questioning why we’re making a big deal about this and feel that we are unfairly painting the Hells Angels Motorcycle Club in a negative light,” Bertrim said.

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“Let me be clear today: they are an organized crime group who have consistently proven to be responsible for all manners of … crimes including drug trafficking, illegal gambling, human trafficking, firearms and acts of violence perpetrated by their members and/or through support clubs.”

Bertrim said he did not want to cause panic by detailing what is expected over the weekend, but said he has “a responsibility to make sure that our community is aware and provided the accurate information.”

“Rest assured our primary focus in managing this event (is) to ensure we get through this safely and uneventfully for all,” he said.

Det. Insp. Scott Wade of the Ontario Provincial Police said normally events like the Canada Run aren’t “a significant public safety risk,” but said members of the public shouldn’t interact with “outlaw motorcycle club riders.”

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This weekend’s event in Durham Region follows a Hells Angels memorial procession that travelled from Newmarket to Toronto on Thursday in honour of Donny Petersen, the head of the Toronto Hells Angels chapter who died in December 2021.

A group of bikers gather outside an east-end storefront in Toronto following a procession to honour longtime Toronto Hells Angels member Donny Petersen, who died in late 2021, Thursday, July 21, 2022. THE CANADIAN PRESS/Cole Burston

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© 2022 Global News, a division of Corus Entertainment Inc.

Fri, 22 Jul 2022 07:01:00 -0500 en-US text/html https://globalnews.ca/news/9009220/whitby-hells-angels-gathering/
Killexams : Check Point Software Technologies Reports 2022 Second Quarter Financial Results

Check Point Software Technologies INC

SAN CARLOS, Calif., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Check Point® Software Technologies Ltd. (NASDAQ: CHKP), today announced its financial results for the second quarter ended June 30, 2022.

Second Quarter 2022:

  • Total Revenues: $571 million, a 9 percent increase year over year

  • Product & License Revenues: $133 million, a 12 percent increase year over year

  • Security Subscription Revenues: $210 million, a 14 percent increase year over year

  • Deferred Revenues: $1,666 million, a 13 percent increase year over year

  • GAAP Operating Income: $209 million, representing 37 percent of revenues

  • Non-GAAP Operating Income: $249 million, representing 44 percent of revenues

  • GAAP EPS: $1.36, a 1 percent decrease year over year

  • Non-GAAP EPS: $1.64, a 2 percent increase year over year

“We are pleased with our second quarter results. Total revenues achieved growth of 9 percent - more than double the rate of a year ago. This was driven by strength in products and subscriptions revenues which generated a strong increase of 12 and 14 percent respectively,” said Gil Shwed, Founder and CEO of Check Point Software Technologies. “Over the past quarter, cyber-attacks have increased by 32 percent while advanced attacks like ransomware have grown by 59 percent, underscoring why cyber-security is so critical to keep our world going. Our strategic vision of a consolidated prevention-first security architecture is more relevant than ever to combat today’s cyber challenges.”

Financial Highlights for the Second Quarter of 2022:

  • Total Revenues$571 million compared to $526 million in the second quarter of 2021, a 9 percent increase year over year.

  • GAAP Operating Income: $209 million compared to $222 million in the second quarter of 2021, representing 37 percent and 42 percent of revenues in the second quarter of 2022 and 2021, respectively.

  • Non-GAAP Operating Income: $249 million compared to $257 million in the second quarter of 2021, representing 44 percent and 49 percent of revenues in the second quarter of 2022 and 2021, respectively.

  • GAAP Taxes on Income: $45 million compared to $47 million in the second quarter of 2021.

  • GAAP Net Income: $174 million compared to $186 million in the second quarter of 2021.

  • Non-GAAP Net Income: $209 million compared to $217 million in the second quarter of 2021.

  • GAAP Earnings Per Diluted Share: $1.36 compared to $1.38 in the second quarter of 2021, a 1 percent decrease year over year.

  • Non-GAAP Earnings Per Diluted Share: $1.64 compared to $1.61 in the second quarter of 2021, a 2 percent increase year over year.

  • Deferred Revenues: As of June 30, 2022, deferred revenues were $1,666 million compared to $1,472 million as of June 30, 2021, a 13 percent increase year over year.

  • Cash Balances, Marketable Securities and Short-Term Deposits: $3,676 million as of June 30, 2022, compared to $4,002 million as of June 30, 2021.

  • Cash Flow: Cash flow from operations of $212 million compared to $264 million in the second quarter of 2021. The second quarter of 2022 includes $47 million of expenses related to our currency hedging transactions and $30 million of tax expenses compared to $6 million of income related to our currency hedging transactions and $25 million of tax expenses in the second quarter of 2021.

  • Share Repurchase Program: During the second quarter of 2022, the company repurchased approximately 2.6 million shares at a total cost of approximately $325 million.

For information regarding the non-GAAP financial measures discussed in this release, as well as a reconciliation of such non-GAAP financial measures to the most directly comparable GAAP financial measures, please see “Use of Non-GAAP Financial Information” and “Reconciliation of GAAP to Non-GAAP Financial Information.”

Conference Call and Webcast Information
Check Point will host a conference call with the investment community on August 1, 2022, at 8:30 AM ET/5:30 AM PT. To listen to the live video cast or replay, please visit the website: www.checkpoint.com/ir.

Third Quarter Investor Conference Participation Schedule:

  • KeyBanc Technology Leadership Forum
    August 7-9, 2022, Vail, CO – Fireside Chat & 1x1’s

  • Oppenheimer 25th Annual Virtual Technology, Internet & Communications Conference
    August 10, 2022 – Virtual 1x1’s

  • Deutsche Bank 2022 Technology Conference
    August 30 - September 1, 2022, Las Vegas, NV – Fireside Chat & 1x1’s

  • Citi 2022 Global Technology Virtual Conference
    September 6-8, 2022, New York, NY – 1x1’s

  • Piper Sandler 2022 Global Technology Conference
    September 12-14, 2022, Nashville, TN – 1x1’s

  • Goldman Sachs 2022 Communicopia + Technology Conference
    September 15, 2022, San Francisco, CA – 1x1’s

Members of Check Point's management team anticipate attending these conferences and events to discuss the latest company strategies and initiatives. Check Point’s conference presentations if applicable will be available via webcast on the company's web site. To hear these presentations and access the most updated information please visit the company's web site at www.checkpoint.com/ir. The schedule is subject to change.

About Check Point Software Technologies Ltd.
Check Point Software Technologies Ltd. (www.checkpoint.com) is a leading provider of cyber security solutions to corporate enterprises and governments globally. Check Point Infinity´s portfolio of solutions protects enterprises and public organizations from 5th generation cyber-attacks with an industry leading catch rate of malware, ransomware, and other threats. Infinity comprises three core pillars delivering uncompromised security and generation V threat prevention across enterprise environments: Check Point Harmony, for remote users; Check Point CloudGuard, to automatically secure clouds; and Check Point Quantum, to protect network perimeters and datacenters, all controlled by the industry’s most comprehensive, intuitive unified security management. Check Point protects over 100,000 organizations of all sizes.

Follow Check Point via:
Twitter: http://www.twitter.com/checkpointsw
Facebook: https://www.facebook.com/checkpointsoftware
Blog: http://blog.checkpoint.com
YouTube: http://www.youtube.com/user/CPGlobal
LinkedIn: https://www.linkedin.com/company/check-point-software-technologies

©2022 Check Point Software Technologies Ltd. All rights reserved

Legal Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or our future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, statements related to our expectations regarding our products and solutions, our beliefs regarding our customers’ adoption of our products and solutions, and our participation in investor conferences during the third quarter of 2022. Our expectations and beliefs regarding these matters may not materialize, and genuine results or events in the future are subject to risks and uncertainties that could cause genuine results or events to differ materially from those projected. These risks include our ability to continue to develop platform capabilities and solutions; customer acceptance and purchase of our existing products and solutions and new products and solutions; the continued effects on our business of the COVID-19 pandemic, the market for IT security continuing to develop; competition from other products and services; and general market, political, economic and business conditions. The forward-looking statements contained in this press release are also subject to other risks and uncertainties, including those more fully described in our filings with the Securities and Exchange Commission, including our Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 14, 2022. The forward-looking statements in this press release are based on information available to Check Point as of the date hereof, and Check Point disclaims any obligation to update any forward-looking statements, except as required by law.

Use of Non-GAAP Financial Information
In addition to reporting financial results in accordance with generally accepted accounting principles, or GAAP, Check Point uses non-GAAP measures of operating income, net income, and earnings per diluted share, which are adjustments from results based on GAAP to exclude, as applicable, stock-based compensation expenses, amortization of intangible assets and acquisition related expenses and the related tax affects. Check Point’s management believes the non-GAAP financial information provided in this release is useful to investors’ understanding and assessment of Check Point’s ongoing core operations and prospects for the future. Historically, Check Point has also publicly presented these supplemental non-GAAP financial measures to assist the investment community to see the Company “through the eyes of management,” and thereby enhance understanding of its operating performance. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for results prepared in accordance with GAAP. A reconciliation of the non-GAAP financial measures discussed in this press release to the most directly comparable GAAP financial measures is included with the financial statements contained in this press release. Management uses both GAAP and non-GAAP information in evaluating and operating business internally and as such has determined that it is important to provide this information to investors.

INVESTOR CONTACT:

MEDIA CONTACT:

Kip E. Meintzer

Gil Messing

Check Point Software Technologies

Check Point Software Technologies

+1.650.628.2040

+1.650.628.2260

ir@checkpoint.com

press@checkpoint.com

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
CONSOLIDATED STATEMENT OF INCOME

(Unaudited, in millions, except per share amounts)

 

Three Months Ended

 

Six Months Ended

 

June 30,

 

June 30,

 

2022

 

2021

 

2022

 

2021

Revenues:

Products and licenses

$

133.2

$

119.1

$

249.1

$

228.4

Security subscriptions

209.9

183.7

411.5

361.1

Total revenues from products and security subscriptions

343.1

302.8

660.6

589.5

Software updates and maintenance

228.0

223.3

453.2

444.2

Total revenues

571.1

526.1

1,113.8

1,033.7

Operating expenses:

Cost of products and licenses

36.7

23.2

68.1

44.8

Cost of security subscriptions

9.5

8.7

19.5

16.7

Total cost of products and security subscriptions

46.2

31.9

87.6

61.5

Cost of Software updates and maintenance

25.7

25.6

51.2

50.9

Amortization of technology

2.9

1.7

6.1

3.4

Total cost of revenues

74.8

59.2

144.9

115.8

Research and development

86.3

67.5

172.8

135.9

Selling and marketing

170.6

148.9

329.2

288.9

General and administrative

30.6

28.2

57.9

56.0

Total operating expenses

362.3

303.8

704.8

596.6

Operating income

208.8

222.3

409.0

437.1

Financial income, net

9.7

10.4

16.8

23.0

Income before taxes on income

218.5

232.7

425.8

460.1

Taxes on income

44.9

46.7

82.8

91.2

Net income

$

173.6

$

186.0

$

343.0

$

368.9

Basic earnings per share

$

1.37

$

1.39

$

2.69

$

2.74

Number of shares used in computing basic earnings per share

126.5

133.7

127.4

134.8

Diluted earnings per share

$

1.36

$

1.38

$

2.66

$

2.71

Number of shares used in computing diluted earnings per share

127.7

134.8

128.8

136.1

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
SELECTED FINANCIAL METRICS
(Unaudited, in millions, except per share amounts)

 

Three Months Ended

 

Six Months Ended

 

June 30,

 

June 30,

 

2022

 

2021

 

2022

 

2021

Revenues

$

571.1

$

526.1

$

1,113.8

$

1,033.7

Non-GAAP operating income

248.7

257.1

487.3

503.4

Non-GAAP net income

209.3

217.0

412.9

428.2

Diluted Non-GAAP Earnings per share

$

1.64

$

1.61

$

3.21

$

3.15

Number of shares used in computing diluted Non-GAAP earnings per share

127.7

134.8

128.8

136.1

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
RECONCILIATION OF GAAP TO NON GAAP FINANCIAL INFORMATION

(Unaudited, in millions, except per share amounts)

 

Three Months Ended

Six Months Ended

 

June 30,

June 30,

 

2022

 

2021

2022

 

2021

GAAP operating income

$

208.8

$

222.3

$

409.0

$

437.1

Stock-based compensation (1)

33.7

29.9

66.1

56.5

Amortization of intangible assets and acquisition related expenses (2)

6.2

4.9

12.2

9.8

Non-GAAP operating income

$

248.7

$

257.1

$

487.3

$

503.4

GAAP net income

$

173.6

$

186.0

$

343.0

$

368.9

Stock-based compensation (1)

33.7

29.9

66.1

56.5

Amortization of intangible assets and acquisition related expenses (2)

6.2

4.9

12.2

9.8

Taxes on the above items (3)

(4.2

)

(3.8

)

(8.4

)

(7.0

)

Non-GAAP net income

$

209.3

$

217.0

$

412.9

$

428.2

Diluted GAAP Earnings per share

$

            1.36

$

1.38

$

2.66

$

2.71

Stock-based compensation (1)

0.26

0.22

0.51

0.42

Amortization of intangible assets and acquisition related expenses (2)

0.05

0.04

0.10

0.07

Taxes on the above items (3)

(0.03

)

(0.03

)

(0.06

)

(0.05

)

Diluted Non-GAAP Earnings per share

$

1.64

$

                 1.61

$

3.21

$

3.15

Number of shares used in computing diluted Non-GAAP earnings per share

127.7

134.8

128.8

136.1

(1) Stock-based compensation:

Cost of products and licenses

$

0.1

$

0.1

$

0.2

$

0.2

Cost of software updates and maintenance

1.3

1.1

2.3

2.0

Research and development

10.3

7.2

20.8

13.7

Selling and marketing

10.3

10.5

21.4

18.8

General and administrative

11.7

11.0

21.4

21.8

33.7

29.9

66.1

56.5

(2) Amortization of intangible assets and acquisition related expenses:

Amortization of technology-cost of revenues

2.9

1.7

6.1

3.4

Research and development

2.2

1.3

4.2

2.6

Selling and marketing

1.1

1.9

1.9

3.8

6.2

4.9

12.2

9.8

(3) Taxes on the above items

(4.2

)

(3.8

)

(8.4

)

(7.0

)

Total, net

$

35.7

$

31.0

$

69.9

$

59.3

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited, in millions)

ASSETS

June 30,

December 31,

2022

2021

Current assets:

Cash and cash equivalents

$

          242.8

$

271.9

Marketable securities and short-term deposits

1,428.8

1,421.8

Trade receivables, net

344.0

597.8

Prepaid expenses and other current assets

55.0

46.4

Total current assets

2,070.6

2,337.9

Long-term assets:

Marketable securities

2,004.5

2,089.7

Property and equipment, net

84.3

83.4

Deferred tax asset, net

70.2

51.7

Goodwill and other intangible assets, net

1,302.1

1,257.2

Other assets

81.4

80.3

Total long-term assets

3,542.5

3,562.3

Total assets

$

 5,613.1

$

5,900.2

LIABILITIES AND
SHAREHOLDERS’ EQUITY

Current liabilities:

Deferred revenues

$

1,210.7

$

1,257.4

Trade payables and other accrued liabilities

457.3

454.7

Total current liabilities

1,668.0

1,712.1

Long-term liabilities:

Long-term deferred revenues

455.2

449.7

Income tax accrual

440.2

454.9

Other long-term liabilities

25.2

26.4

920.6

931.0

Total liabilities

2,588.6

2,643.1

Shareholders’ equity:

Share capital

0.8

0.8

Additional paid-in capital

2,405.6

2,276.7

Treasury shares at cost

(11,168.0

)

(10,550.7

)

Accumulated other comprehensive gain

(87.8

)

(0.6

)

Retained earnings

11,873.9

11,530.9

Total shareholders’ equity

3,024.5

3,257.1

Total liabilities and shareholders’ equity

$

5,613.1

$

5,900.2

Total cash and cash equivalents, marketable securities and short-term deposits

$

3,676.1

$

3,783.4

CHECK POINT SOFTWARE TECHNOLOGIES LTD.
SELECTED CONSOLIDATED CASH FLOW DATA

(Unaudited, in millions)

Three Months Ended

Six Months Ended

June 30,

June 30,

2022

2021

2022

2021

Cash flow from operating activities:

Net income

$

173.6

$

186.0

$

343.0

$

368.9

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation of property and equipment

5.5

5.5

10.5

10.2

Amortization of intangible assets

3.4

2.1

6.7

4.2

Stock-based compensation

33.7

29.9

66.1

56.5

Realized gain on marketable securities

-

(0.2

)

-

(1.5

)

Decrease (increase) in trade and other receivables, net

(6.5

)

(24.9

)

246.9

175.3

Increase (decrease) in deferred revenues, trade payables and other accrued liabilities

1.0

63.3

(65.8

)

24.0

Deferred income taxes, net

1.0

1.9

2.3

0.5

Net cash provided by operating activities

211.7

263.6

609.7

638.1

Cash flow from investing activities:

Payment in conjunction with acquisitions, net of acquired cash

-

-

(48.3

)

-

Investment in property and equipment

(6.7

)

(3.3

)

(11.4

)

(7.1

)

Net cash used in investing activities

(6.7

)

(3.3

)

(59.7

)

(7.1

)

Cash flow from financing activities:

Proceeds from issuance of shares upon exercise of options

28.5

14.4

95.4

47.5

Purchase of treasury shares

(325.0

)

(324.7

)

(650.0

)

(649.6

)

Payments related to shares withheld for taxes

(5.8

)

(4.9

)

(6.5

)

(5.8

)

Net cash used in financing activities

(302.3

)

(315.2

)

(561.1

)

(607.9

)

Unrealized loss on marketable securities, net

(26.9

)

(6.0

)

(96.2

)

(20.7

)

Increase (decrease) in cash and cash equivalents, marketable securities and short term deposits

(124.2

)

(60.9

)

(107.3

)

2.4

Cash and cash equivalents, marketable securities and short term deposits at the beginning of the period

3,800.3

4,062.9

3,783.4

3,999.6

Cash and cash equivalents, marketable securities and short term deposits at the end of the period

$

3,676.1

$

4,002.0

$

3,676.1

$

4,002.0

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