Connectivity a critical digital lifeline for Indigenous women across Canada experiencing violence and abuse during COVID-19

Rogers providing free phones and data plans to women’s shelters dedicated to helping Indigenous women and children in crisis
in remote communities

New p
artnership with National Aboriginal Circle Against Family Violence
an extension of
previously donated phones and plans
to women’s shelters across Canada

TORONTO, Dec. 03, 2020 (GLOBE NEWSWIRE) — Rogers Communications today announced a new partnership with the National Aboriginal Circle Against Family Violence (NACAFV), to provide free phones and data plans to women’s shelters across the country that support Indigenous women and children.  The COVID-19 pandemic has revealed urgent needs among Canada’s most vulnerable communities, including Indigenous women and children who may be facing the reality of being at home with an abusive family member.

“It’s unfathomable to imagine the dual crises of domestic violence and physical isolation brought on by COVID-19.  We are well into a second wave, and the need is urgent,” said Sevaun Palvetzian, Chief Communications Officer and lead for corporate social responsibility at Rogers Communications. “For women and children escaping violence and abuse, phones and connectivity provide an essential digital lifeline.  We’re proud to work with the National Aboriginal Circle Against Family Violence, which provides housing and support for Indigenous women, when home is no longer safe, and to help enable connectivity for women to safely access resources.”

Rogers is providing complimentary phones along with six months of free voice and data plans to Indigenous women’s shelters including Gignoo Transition House Inc. in New Brunswick, Ganohkwasra Family Assault Support Services, Onyota’a:ka Family Healing Lodge, Nimkii-Naabkawagan Batchewana Family Crisis Shelter, and Le Thi Nis Ten: Ha Le Thi Non Ronh Khwn in Ontario, Fisher River Healing Center in Manitoba, Qu’Appelle Haven Safe Shelter and Yorkton YTC Safe Shelter in Saskatchewan, Neepinise Family Healing Centre, Stoney Eagle’s Nest Women’s Emergency Shelter, and Ermineskin Women’s Emergency Shelter in Alberta, Okanagan Nation Emergency Transition House and Wilma’s Transition House, both in British Columbia.

“With many of our shelters in remote locations – where everyone is intimately connected – and with increased lockdowns in communities, it’s getting more difficult for Indigenous women to get away from their abusers,” said Sheila Swasson, President, National Aboriginal Circle Against Family Violence. “Once a woman does escape and finds safe haven in our shelters, she needs a phone that allows her to safely access medical and social services, to remain in touch with family and friends, and one that can’t be tracked by her abuser. We are so grateful to Rogers for helping Indigenous women and their children when they need it the most.”  

Last spring, Rogers announced a partnership with Women’s Shelters Canada to provide hundreds of free phones and six months of free voice and data plans to provide connectivity for women escaping violence and abuse. In light of the second wave of COVID-19, we have announced a six-month extension to those plans for women’s shelters across the country, in addition to those provided to organizations supporting vulnerable communities like Big Brothers Big Sisters of Canada and Pflag Canada.

If you are an Indigenous woman living in an abusive home, or you know someone who is, you can call your local shelter’s 24/7 crisis line for advice and support.  Find your local Indigenous shelter and its crisis line on www.nacafv.ca.

About Rogers

Rogers is a proud Canadian company dedicated to making more possible for Canadians each and every day. Our founder, Ted Rogers, purchased his first radio station, CHFI, in 1960. We have grown to become a leading technology and media company that strives to provide the very best in wireless, residential, sports, and media to Canadians and Canadian businesses. Our shares are publicly traded on the Toronto Stock Exchange (TSX: RCI.A and RCI.B) and on the New York Stock Exchange (NYSE: RCI). If you want to find out more about us, visit about.rogers.com.

About National Aboriginal Circle Against Family Violence

The National Aboriginal Circle Against Family Violence advocates for and supports shelters by providing practical training, culturally appropriate resources and opportunities to network in a supportive environment. For more information, please visit nacafv.ca.

For further information:                                                                                       

Rogers Communications, [email protected], 1-844-226-1338
National Aboriginal Circle Against Family Violence, [email protected] 



Lantronix Named Fifth Fastest-Growing Small Public Company by Orange County Business Journal

Lantronix achieved 31.4 percent growth, fueled by its advancements in IoT, artificial intelligence, robotics, communications and mobility

IRVINE, Calif., Dec. 03, 2020 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global provider of Software as a Service (SaaS), engineering services and intelligent hardware for the Internet of Things (IoT) and Remote Environment Management (REM), today announced that it was named the fifth fastest-growing small* public company by the Orange County Business Journal. With 31.4 percent growth in revenues over two years, Lantronix is the top-ranked software, hardware and engineering services company on the list.

“We are proud to be named among the fastest-growing small public companies in Orange County,” said Paul Pickle, president and CEO of Lantronix. “We attribute our fast-paced growth to our advancements in IoT, artificial intelligence, robotics, communications and mobility. Our hardware, software and engineering services deliver a holistic solution that empowers our customers to innovate breakthrough products and services that have the potential to change the world.”

Lantronix’s advanced artificial intelligence, robotics and IoT products and engineering services contributed to the development of two of TIME’s Best Inventions of 2020: Moxie Children’s Robot from Embodied Inc. and the HC1 Communicator smart hardhat from Guardhat. With Lantronix’s support, both companies were able to affordably jumpstart their designs and quickly get products to market.

Contributing to Lantronix’s fast growth over the past year has been its assertive and targeted acquisition strategy. Under Pickle’s leadership, Lantronix acquired IoT pioneer and Qualcomm® partner Intrinsyc Technologies Corporation in January 2020. It also acquired Maestro and FALCOM Holdings Limited, a leader in wireless IoT and connectivity technologies, in July 2019.

*OCBJ defines “small” as companies with less than $100 million in revenue.

About Lantronix

Lantronix Inc. is a global provider of software as a service (SaaS), engineering services and hardware for Edge Computing, the Internet of Things (IoT) and Remote Environment Management (REM). Lantronix enables its customers to provide reliable and secure solutions while accelerating their time to market. Lantronix’s products and services dramatically simplify operations through the creation, development, deployment and management of customer projects at scale while providing quality, reliability and security.

Lantronix’s portfolio of services and products address each layer of the IoT Stack, including Collect, Connect, Compute, Control and Comprehend, enabling its customers to deploy successful IoT and REM solutions. Lantronix’s services and products deliver a holistic approach, addressing its customers’ needs by integrating a SaaS management platform with custom application development layered on top of external and embedded hardware, enabling intelligent edge computing, secure communications (wired, Wi-Fi and cellular), location and positional tracking and environmental sensing and reporting.

With three decades of proven experience in creating robust industry and customer-specific solutions, Lantronix is an innovator in enabling its customers to build new business models, leverage greater efficiencies and realize the possibilities of IoT and REM. Lantronix’s solutions are deployed inside millions of machines at data centers, offices and remote sites serving a wide range of industries, including energy, agriculture, medical, security, manufacturing, distribution, transportation, retail, financial, environmental, infrastructure and government.

For more information, visit www.lantronix.com. Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Any statements set forth in this news release that are not entirely historical and factual in nature, including without limitation statements related to our solutions and technologies and the support of the development of wearable electronics and IoT devices utilizing Lantronix’s Lantronix Open-Q™ 626 μSOM (micro System on Module), and engineering expertise are forward-looking statements. These forward-looking statements are based on our current expectations and are subject to substantial risks and uncertainties that could cause our actual results, future business, financial condition, or performance to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. The potential risks and uncertainties include, but are not limited to, such factors as the effects of negative or worsening regional and worldwide economic conditions or market instability on our business, including effects on purchasing decisions by our customers; the impact of the COVID-19 outbreak on our employees, supply and distribution chains, and the global economy; cybersecurity risks; changes in applicable U.S. and foreign government laws, regulations, and tariffs; our ability to successfully implement our acquisitions strategy or integrate acquired companies; difficulties and costs of protecting patents and other proprietary rights; the level of our indebtedness, our ability to service our indebtedness and the restrictions in our debt agreements; and any additional factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed with the Securities and Exchange Commission (the “SEC”) on September 11, 2020, including in the section entitled “Risk Factors” in Item 1A of Part I of such report, as well as in our other public filings with the SEC. Additional risk factors may be identified from time to time in our future filings. The forward-looking statements included in this release speak only as of the date hereof, and we do not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances.

© 2020 Lantronix, Inc. All rights reserved. Lantronix is a registered trademark, and EMG, and SLC are trademarks of Lantronix Inc. Other trademarks and trade names are those of their respective owners.

Lantronix Media Contact:

Gail Kathryn Miller
Corporate Marketing &
Communications Manager
[email protected]
949-453-7158

Lantronix Analyst and Investor Contact:

Jeremy Whitaker
Chief Financial Officer
[email protected]
949-450-7241

Lantronix Sales:

[email protected]

Americas +1 (800) 422-7055 (US and Canada) or +1 949-453-3990
Europe, Middle East and Africa +31 (0)76 52 36 744
Asia Pacific + 852 3428-2338
China + 86 21-6237-8868
Japan +81 (0) 50-1354-6201
India +91 994-551-2488



Methode Electronics, Inc. Reports Fiscal Second Quarter 2021 Financial Results

  • Record Sales and Income from Operations
  • Strong Free Cash Flow
  • Electric and Hybrid Vehicle Application Growth

CHICAGO, Dec. 03, 2020 (GLOBE NEWSWIRE) — Methode Electronics, Inc. (NYSE: MEI), a global developer of custom engineered and application specific products and solutions, today announced financial results for the fiscal second quarter of 2021 ended October 31, 2020.

Fiscal
Second
Quarter 202
1
Highlights

  • Net sales were a record $300.8 million
  • Electric and hybrid vehicle applications were over 9 percent of net sales
  • Income from operations was a record $45.0 million, or 15.0 percent of net sales
  • Net income was $38.6 million, or $1.01 per diluted share, and included $3.5 million of restructuring costs, or $0.09 per diluted share, and $2.8 million of government assistance, or $0.07 per diluted share
  • Net cash provided by operating activities was $40.3 million

Consolidated
Fiscal
Second
Quarter 20
2
1
Financial Results

Methode’s net sales were a record $300.8 million, compared to $257.2 million in the same quarter of fiscal 2020. The increase in net sales was largely due to higher sales in the Automotive segment and favorable foreign currency translation. The increase was driven in part by the $32.0 million negative impact from the United Auto Workers (“UAW”) labor strike at General Motors (“GM”) in the same quarter of fiscal 2020. The quarter included $6.5 million positive impact from foreign currency translation, primarily related to the strengthening of the euro and Chinese renminbi.

Gross margin as a percentage of sales was 26.9 percent, compared to 26.7 percent in the same quarter of fiscal 2020. The increase was primarily due to the higher sales volume in all segments in the quarter, which resulted in increased overhead coverage, and was partially offset by $2.7 million of restructuring costs in cost of products sold related to actions taken to reduce overall costs and improve operational profitability.

Selling and administrative expense as a percentage of sales was 10.2 percent, compared to 12.9 percent in the same quarter of fiscal 2020. Selling and administrative expense decreased $2.4 million from the same quarter of fiscal 2020 primarily due to lower compensation expense, stock-based compensation expense, and travel expense. Partially offsetting these lower costs, the company recognized $1.5 million of restructuring costs in selling and administrative expense related to actions taken to reduce overall costs and improve operational profitability.

Income from operations was a record $45.0 million, compared to $30.7 million in the same quarter of fiscal 2020. The increase was mainly due to the higher gross profit on higher sales volume.

Other income was $2.6 million, compared to $1.0 million in the same quarter of fiscal 2020. Included in other income was $3.3 million of government assistance received by certain foreign locations with respect to the COVID-19 pandemic. There was a $0.5 million gain on a sale of a business in the same quarter of fiscal 2020.

Income tax expense was $7.6 million, compared to $5.2 million in the same quarter of fiscal 2020. The income tax expense increase was primarily due to higher pre-tax income. The effective tax rate was 16.5%, compared to an effective tax rate of 17.9% in the same quarter of fiscal 2020.

Net income was $38.6 million, or $1.01 per diluted share, compared to $23.8 million, or $0.63 per diluted share, in the same quarter of fiscal 2020.

EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization of Intangibles), a non-GAAP financial measure, was $60.2 million, compared to $43.6 million in the same quarter of fiscal 2020.

Debt, which included the $100.0 million proactive draw from the company’s revolving credit facility in March 2020 due to COVID-19, was $347.6 million at the end of the quarter, down slightly compared to $352.1 million at the end of fiscal 2020. Net debt, a non-GAAP financial measure and includes debt less cash and cash equivalents, was $105.3 million, compared to $134.8 million at the end of fiscal 2020. In November, after the end of the fiscal second quarter, the company repaid $50.0 million on its revolving credit facility from the March 2020 draw.

Free cash flow, a non-GAAP financial measure and includes cash provided by operating activities less purchases of property, plant, and equipment, was $36.7 million, compared to $35.1 million in the same quarter of fiscal 2020.

Segment
Fiscal
Secon
d
Quarter 2021 Financial Results

Comparing the Automotive segment’s quarter to the same quarter of fiscal 2020,

  • Net sales were $215.7 million, up $35.6 million, or 19.8% from $180.1 million attributable to net sales increases of $11.1 million in North America, $5.5 million in Europe, and $19.0 million in Asia. The increase was driven in part by the $32.0 million negative impact from the UAW labor strike at GM in the same quarter of fiscal 2020. The increase in Asia was primarily due to higher electric vehicle and leadframe product volume.   The segment net sales in the quarter were also positively impacted $5.3 million from foreign currency translation.
  • Gross margin as a percentage of sales was unchanged at 24.5 percent. The quarter included $2.6 million of restructuring actions, compared to $0.2 million in restructuring actions in the same quarter of fiscal 2020.
  • Income from operations was $38.8 million, up $9.9 million, or 34.3% from $28.9 million primarily resulting from the higher gross profit, partially offset by the net restructuring actions taken in the quarter.

Comparing the Industrial segment’s quarter to the same quarter of fiscal 2020,

  • Net sales were $67.9 million, up $3.0 million or 4.6% from $64.9 million primarily due to higher sales of busbar products including electric vehicle applications, partially offset by lower commercial vehicle lighting sales. The segment net sales in the quarter were also positively impacted $1.2 million from foreign currency translation.
  • Gross margin as a percentage of sales was 35.9 percent, down from 37.8 percent primarily due to the lower sales of commercial vehicle lighting solutions in the quarter.
  • Income from operations was $16.1 million, an increase from $15.1 million primarily resulting from lower selling and administrative expenses in the quarter.

Comparing the Interface segment’s quarter to the same quarter of fiscal 2020,

  • Net sales were $16.4 million, up $4.5 million or 37.8% from $11.9 million primarily due to higher sales volume of appliance products.
  • Gross margin as a percentage of sales was 22.0 percent, up from 10.1 percent also due to higher sales volume of appliance products.
  • Income from operations was $3.1 million, up from a loss of $0.2 million primarily due to higher gross profit and lower selling and administrative expense in the quarter, which was mainly due to the restructuring actions taken in the first quarter of fiscal 2021.

Comparing the Medical segment’s quarter to the same quarter of fiscal 2020,

  • Net sales were $0.8 million, up from $0.3 million. The higher net sales were due to increased product acceptance.
  • Loss from operations was $1.5 million, compared to a loss of $1.8 million.

Fiscal
Third
Quarter
2021 Guidance

For the fiscal third quarter of 2021, the company expects net sales in to be in the range of $265 to $285 million and diluted earnings per share to be in the range of $0.69 to $0.85 based on the near-term outlook, which is subject to disruption at any time due to a variety of factors including the ongoing COVID-19 pandemic situation.

Management Comments

President and Chief Executive Officer Donald W. Duda said, “I continue to express my gratitude to our employees, who have not only demonstrated incredible commitment to the company in the midst of an ongoing pandemic, but who also helped propel us to a record quarter for sales and income from operations.”

Mr. Duda added, “For our fiscal third quarter, we will continue to face market uncertainty due to the pandemic. However, the demand we experienced in the second quarter and are seeing early in the third quarter gives us the confidence to provide sales and EPS guidance for the third quarter. In addition, our order book continues to build in EV programs resulting from our three-pronged approach to EV with user interface, power distribution, and LED lighting solutions.”

Non-GAAP Financial Measures

To supplement the company’s financial statements presented in accordance with generally accepted accounting principles in the United States (“GAAP”), Methode uses certain non-GAAP financial measures, such as EBITDA, Free Cash Flow and Net Debt. Reconciliation to the nearest GAAP measures of all non-GAAP measures included in this press release can be found at the end of this release. Management believes EBITDA is useful to investors as it is a measure that is commonly used by other companies in our industry and provides a comparison for investors to the company’s performance versus its competitors. Management believes Free Cash Flow is a meaningful measure to investors because management reviews cash flows generated from operations after taking into consideration capital expenditures, which are both necessary to maintain the company’s asset base and which are expected to generate future cash flows from operations. Prior to Fiscal 2021 the definition of Free Cash Flow was net income plus depreciation and amortization less capital expenditures. Management believes Net Debt is a meaningful measure to investors because management assesses the company’s leverage position after considering available cash that could be used to repay outstanding debt. Methode’s definitions of these non-GAAP measures may differ from similarly titled measures used by others. These non-GAAP measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP.

Conference Call

The company will conduct a conference call and webcast to review financial and operational highlights led by its President and Chief Executive Officer, Donald W. Duda, and Chief Financial Officer, Ronald Tsoumas, today at 10:00 a.m. CST.

To participate in the conference call, please dial (877) 407-8031 (domestic) or (201) 689-8031 (international) at least five minutes prior to the start of the event. A simultaneous webcast can be accessed through the company’s website, www.methode.com, by selecting the Investors page.

A replay of the teleconference will be available shortly after the call through December 17, 2020, by dialing (877) 481-4010 and providing passcode 38912. A replay will also be available through the company’s website, www.methode.com, by selecting the Investors page.

About Methode Electronics, Inc.

Methode Electronics, Inc. (NYSE: MEI) is a global developer of custom engineered and application specific products and solutions with manufacturing, design and testing facilities in Belgium, Canada, China, Egypt, Germany, India, Italy, Lebanon, Malta, Mexico, the Netherlands, Singapore, Switzerland, the United Kingdom and the United States. We design, manufacture and market devices employing electrical, radio remote control, electronic, LED lighting and sensing technologies. Our business is managed on a segment basis, with those segments being Automotive, Industrial, Interface and Medical.

Our components are found in the primary end-markets of the aerospace, appliance, construction, consumer and industrial equipment, communications (including information processing and storage, networking equipment, wireless and terrestrial voice/data systems), medical, rail, consumer automotive, commercial vehicle, and other transportation industries.

Forward-Looking Statements

This press release contains certain forward-looking statements, which reflect management’s expectations regarding future events and operating performance and speak only as of the date hereof. These forward-looking statements are subject to the safe harbor protection provided under the securities laws. Methode undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in Methode’s expectations on a quarterly basis or otherwise. The forward-looking statements in this press release involve a number of risks and uncertainties. The factors that could cause actual results to differ materially from our expectations are detailed in Methode’s filings with the Securities and Exchange Commission, such as our annual and quarterly reports. Such factors may include, without limitation, the following: (1) impact from pandemics, such as the COVID-19 pandemic; (2) dependence on the automotive, appliance, commercial vehicle, computer and communications industries; (3) dependence on a small number of large customers, including two large automotive customers; (4) recognition of goodwill and long-lived asset impairment charges; (5) timing and magnitude of costs associated with restructuring activities; (6) international trade disputes resulting in tariffs and our ability to mitigate tariffs; (7) timing, quality and cost of new program launches; (8) ability to withstand price pressure, including pricing reductions; (9) failure to attract and retain qualified personnel; (10) ability to successfully market and sell Dabir Surfaces products; (11) currency fluctuations; (12) customary risks related to conducting global operations; (13) costs associated with environmental, health and safety regulations; (14) ability to withstand business interruptions; (15) ability to successfully benefit from acquisitions and divestitures; (16) investment in programs prior to the recognition of revenue; (17) dependence on the availability and price of materials; (18) dependence on our supply chain; (19) judgments related to accounting for tax positions; (20) income tax rate fluctuations; (21) adjustments to compensation expense for performance-based awards; (22) ability to keep pace with rapid technological changes; (23) breaches to our information technology systems; (24) ability to avoid design or manufacturing defects; (25) ability to compete effectively; (26) ability to protect our intellectual property; (27) success of recent acquisitions and/or our ability to implement and profit from new applications of the acquired technology; (28) ability to manage our debt levels and any restrictions thereunder; and (29) impact to interest expense from the replacement or modification of LIBOR.

For Methode Electronics, Inc.

Robert K. Cherry
Vice President, Investor Relations
[email protected]
708-457-4030

METHODE ELECTRONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

(in millions, except share and per-share data)

    Three Months Ended     Six Months Ended  
    October 31,

2020
    October 26,

2019
    October 31,

2020
    October 26,

2019
 
Net Sales   $ 300.8     $ 257.2     $ 491.7     $ 527.4  
                                 
Cost of Products Sold     220.0       188.6       365.8       383.0  
                                 
Gross Profit     80.8       68.6       125.9       144.4  
                                 
Selling and Administrative Expenses     30.8       33.2       57.4       65.6  
Amortization of Intangibles     5.0       4.7       9.7       9.5  
                                 
Income from Operations     45.0       30.7       58.8       69.3  
                                 
Interest Expense, Net     1.4       2.7       3.0       5.6  
Other Income, Net     (2.6 )     (1.0 )     (6.0 )     (0.9 )
                                 
Income before Income Taxes     46.2       29.0       61.8       64.6  
                                 
Income Tax Expense     7.6       5.2       2.5       12.5  
                                 
Net Income   $ 38.6     $ 23.8     $ 59.3     $ 52.1  
                                 
Basic and Diluted Income per Share:                                
Basic   $ 1.01     $ 0.63     $ 1.56     $ 1.39  
Diluted   $ 1.01     $ 0.63     $ 1.56     $ 1.38  
                                 
Cash Dividends per Share   $ 0.11     $ 0.11     $ 0.22     $ 0.22  
                                 
Weighted Average Number of Shares Outstanding:                                
Basic     38,106,793       37,587,742       37,971,668       37,561,098  
Diluted     38,127,538       37,739,188       38,142,978       37,703,123  







METHODE ELECTRONICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in millions, except share and per-share data)

    October 31,

2020
    May 2,

2020
 
    (Unaudited)          
ASSETS                
CURRENT ASSETS                
Cash and Cash Equivalents   $ 242.3     $ 217.3  
Accounts Receivable, Net     290.3       188.5  
Inventories     120.7       131.0  
Income Tax Receivable     10.8       12.9  
Prepaid Expenses and Other Current Assets     18.2       15.9  
TOTAL CURRENT ASSETS     682.3       565.6  
LONG-TERM ASSETS                
Property, Plant and Equipment, Net     203.2       201.9  
Goodwill     233.3       231.6  
Other Intangible Assets, Net     237.0       244.8  
Operating Lease Assets, Net     23.5       23.5  
Deferred Tax Assets     40.7       31.4  
Pre-production Costs     32.5       37.1  
Other Long-term Assets     36.8       34.7  
TOTAL LONG-TERM ASSETS     807.0       805.0  
TOTAL ASSETS   $ 1,489.3     $ 1,370.6  
                 
LIABILITIES & SHAREHOLDERS’ EQUITY                
CURRENT LIABILITIES                
Accounts Payable   $ 112.4     $ 73.8  
Accrued Employee Liabilities     23.4       19.1  
Other Accrued Expenses     31.0       18.5  
Short-term Operating Lease Liability     6.0       5.5  
Short-term Debt     15.3       15.3  
Income Tax Payable     10.6       11.6  
TOTAL CURRENT LIABILITIES     198.7       143.8  
LONG-TERM LIABILITIES                
Long-term Debt     332.3       336.8  
Long-term Operating Lease Liability     19.4       20.4  
Long-term Income Tax Payable     26.2       29.3  
Other Long-term Liabilities     18.8       15.3  
Deferred Tax Liabilities     42.5       41.6  
TOTAL LONG-TERM LIABILITIES     439.2       443.4  
TOTAL LIABILITIES     637.9       587.2  
SHAREHOLDERS’ EQUITY                
Common Stock, $0.50 par value, 100,000,000 shares authorized, 38,876,362 shares and 38,438,111 shares issued as of October 31, 2020 and May 2, 2020, respectively     19.4       19.2  
Additional Paid-in Capital     152.5       150.7  
Accumulated Other Comprehensive Loss     (7.9 )     (26.9 )
Treasury Stock, 1,346,624 shares as of October 31, 2020 and May 2, 2020     (11.5 )     (11.5 )
Retained Earnings     698.9       651.9  
TOTAL SHAREHOLDERS’ EQUITY     851.4       783.4  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY   $ 1,489.3     $ 1,370.6  







METHODE ELECTRONICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

(in millions)

    Six Months Ended  
    October 31,

2020
    October 26,

2019
 
OPERATING ACTIVITIES                
Net Income   $ 59.3     $ 52.1  
Adjustments to Reconcile Net Income to Net Cash Provided by Operating Activities:                
Depreciation and Amortization     24.7       23.7  
Stock-based Compensation Expense     1.9       4.0  
Change in Cash Surrender Value of Life Insurance     (0.7 )     (0.3 )
Amortization of Debt Issuance Costs     0.3       0.3  
Change in Deferred Income Taxes     (6.2 )     0.4  
Other     1.2       (0.5 )
Changes in Operating Assets and Liabilities:                
Accounts Receivable     (94.3 )     10.7  
Inventories     13.0       (18.1 )
Prepaid Expenses and Other Assets     7.8       (10.2 )
Accounts Payable and Other Liabilities     49.7       5.7  
NET CASH PROVIDED BY OPERATING ACTIVITIES     56.7       67.8  
                 
INVESTING ACTIVITIES                
Purchases of Property, Plant and Equipment     (15.2 )     (26.8 )
Sale of Business/Investment/Property     —       0.6  
NET CASH USED IN INVESTING ACTIVITIES     (15.2 )     (26.2 )
                 
FINANCING ACTIVITIES                
Taxes Paid Related to Net Share Settlement of Equity Awards     (3.9 )     (0.4 )
Proceeds from Exercise of Stock Options     0.1       —  
Repayments of Finance Leases     (0.2 )     (0.3 )
Cash Dividends     (9.1 )     (8.2 )
Proceeds from Borrowings     1.5       26.4  
Repayments of Borrowings     (7.6 )     (44.2 )
NET CASH USED IN FINANCING ACTIVITIES     (19.2 )     (26.7 )
Effect of Foreign Currency Exchange Rate Changes on Cash and Cash Equivalents     2.7       (2.5 )
INCREASE IN CASH AND CASH EQUIVALENTS     25.0       12.4  
Cash and Cash Equivalents at Beginning of the Year     217.3       83.2  
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD   $ 242.3     $ 95.6  
                 
SUPPLEMENTAL CASH FLOW INFORMATION                
Cash Paid During the Period For:                
Interest   $ 3.0     $ 5.6  
Income Taxes, Net of Refunds   $ 10.3     $ 10.9  
Operating Lease Obligations   $ 4.4     $ 4.3  







METHODE ELECTRONICS, INC. AND SUBSIDIARIES

RECONCILIATION OF NON-GAAP MEASURES (Unaudited)

(in millions)

    Three Months Ended     Six Months Ended  
    October 31,

2020
    October 26,

2019
    October 31,

2020
    October 26,

2019
 
EBITDA:                                
Net Income   $ 38.6     $ 23.8     $ 59.3     $ 52.1  
Income Tax Expense     7.6       5.2       2.5       12.5  
Interest Expense, Net     1.4       2.7       3.0       5.6  
Amortization of Intangibles     5.0       4.7       9.7       9.5  
Depreciation     7.6       7.2       15.0       14.2  
EBITDA   $ 60.2     $ 43.6     $ 89.5     $ 93.9  

    Three Months Ended     Six Months Ended  
    October 31,

2020
    October 26,

2019
    October 31,

2020
    October 26,

2019
 
Free Cash Flow:                                
Net Cash Provided by Operating Activities   $ 40.3     $ 48.7     $ 56.7     $ 67.8  
Purchases of Property, Plant and Equipment     (3.6 )     (13.6 )     (15.2 )     (26.8 )
Free Cash Flow   $ 36.7     $ 35.1     $ 41.5     $ 41.0  

    October 31,

2020
    May 2,

2020
 
Net Debt:                
Short-Term Debt   $ 15.3     $ 15.3  
Long-Term Debt     332.3       336.8  
Total Debt     347.6       352.1  
Less: Cash and Cash Equivalents     (242.3 )     (217.3 )
Net Debt   $ 105.3     $ 134.8  



reMYND commences first-in-human trial of ReS19-T Alzheimer’s program

Press Release

reMYND commences first-in-human trial of ReS19-T Alzheimer’s program

  • RES19-T represents a novel approach to treat Alzheimer’s at the root of the disease and restore cognition

     
  • Board and Senior Leadership team strengthened; appointment of Staph Leavenworth Bakali as Chair and Hermann Russ as Chief Medical Officer

             

Leuven Belgium, 03 December 2020: reMYND NV, a clinical stage company developing innovative treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction, today announces commencement of a first-in-human trial of its wholly owned therapeutic candidate RES19-T.

As part of its transition into a clinical stage Company, reMYND has also strengthened its Board and senior leadership team with the appointment of Staph Leavenworth Bakali as Chair of the Board and Hermann Russ as Chief Medical Officer.

RES19-T, a first-in-class small molecule, represents a novel approach to treat Alzheimer’s Disease (AD), aiming to address the disease at its root and restore cognition in patients by reducing the cellular damage associated with memory loss. ReS19-T is the first in a pipeline of candidates developed using reMYND’s proprietary drug discovery platform, which identifies disease-modifying small molecule treatments and their novel target and mechanism of action to counteract the toxicity that leads to cellular dysfunction. reMYND has a broader pipeline of novel programs in development, with a diabetes program scheduled to begin in-human trials in mid-2021.  

Prof. Philip Scheltens, MD, PhD, Neurologist and CEO of the Alzheimer Center Amsterdam commented “I am very pleased to see this program enter the clinic. The reMYND team has been meticulous in their research, focussing on fundamental cellular processes related to neurodegeneration in Alzheimer’s, resulting in this novel and differentiated approach.

“Our hope, backed by promising pre-clinical and animal data, is that restoring calcium homeostasis, a process central in the Alzheimer’s disease cascade, will result in a reduction in synaptic damage and translate into improvement in function and biomarkers in patients. This is an important line of enquiry into this devastating disease and we look forward to learning more as the study progresses.”

The trial, a phase I randomized, double-blind, placebo-controlled study with an adaptive dose design, will evaluate the safety, tolerability, and pharmacokinetics of ReS19-T in healthy subjects.

Studies in AD have shown that loss of memory is most closely linked to loss of synaptic plasticity, leading to neuronal degeneration. In four different preclinical models, ReS19-T has shown to robustly restore synaptic plasticity with an acute response and improve inflammation and AD pathology over a longer treatment duration, providing changes in recognized biomarkers for clinical translatability to symptomatic relief as well as disease modification.

Koen De Witte, Managing Director of reMYND commented “
This is an exciting time for reMYND as we enter the clinic for the first time, representing a great step forward in our journey. Our vision is to develop new medicines which go beyond symptom relief and are able to
restore function in diseases caused by cellular dysfunction, with Alzheimer’s and diabetes as our two most advanced programs. We believe our unique drug discovery platform enables us to identify novel small molecules which will allow us to address the root of these diseases, counteracting and potentially reversing the damage caused by cellular dysfunction. The exceptional group of people we have been able to rally around our platform and programs as we move into the clinic speaks volumes about the quality and potential of the work we are doing.” 


Strengthened Board and Senior Leadership Team

reMYND has strengthened its Board and senior leadership team with the appointment of Staph Leavenworth Bakali as Chair of the Board and Hermann Russ as Chief Medical Officer.

Staph Leavenworth Bakali has over 30 years of senior executive and board level experience leading, growing, and transforming large complex and start-up organizations in the global pharmaceutical, biotechnology and not-for-profit health arenas. Mr. Leavenworth Bakali has substantial experience and a proven track record in fundraising, negotiating and concluding a wide range of public and private sector agreements and partnerships, including cross border mergers and acquisitions.

He is President & Chief Executive Officer of George Health Enterprises (GHE), a London based global healthcare company. He has held senior executive and Board positions with leading pharmaceutical and biotechnology companies, including 11 years with SmithKline Beecham, living and managing businesses in established and emerging markets.

Dr. Hermann Russ is a board-certified clinical neurologist, a professor of pharmacology and a pharmacist. He holds a Ph.D. in neuro- and bio-chemistry from the University of Wurzburg, Germany. His scientific focus is on neurodegenerative diseases, including Alzheimer’s, Parkinson’s, and degenerative retina diseases. He is (co)inventor of more than 25 patents and (co)author of 50 peer-reviewed scientific publications.

Dr. Russ has over 20 years of Pharma industry experience. Before joining reMYND, he was Chief Scientific Officer of US based biotech Company Galimedix. Prior to this Dr. Russ was vice president of Neuroscience Project Leadership in Specialty R&D and Managing Officer on the Board of Directors at Teva Pharmaceuticals in Switzerland. He also worked for eight years at Merz Pharma as Head of Global R&D CNS, leading in neurology and psychiatry, spanning from early discovery to clinical development and regulatory submission. From 1999 to 2007 Dr. Russ was with Merck KGaA as Head of the Medical Center of Excellence in CNS. Dr. Russ was closely involved in 8 regulatory drug approvals, including in Alzheimer’s Disease, Huntington’s Disease and movement disorders.

About reMYND

reMYND is a clinical stage company developing treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction. It is backed by a proprietary drug discovery platform, which enables the identification of novel mechanisms-of-action, targets and first-in-class small molecules.

reMYND’s most advanced program is ReS19-T, an investigational compound for the treatment of Alzheimer’s, which entered the clinic in Q4 2020. In animal models it has shown to produce an acute response, restoring synaptic plasticity, a process central in the disease cascade leading to neuronal demise and build-up of plaques and tangles. The company is also developing a treatment for diabetes, ReS39. Animal models have demonstrated the compound’s potential to increase endogenous insulin production capacity with a sustained and durable effect on blood glucose levels and end-organ protection.

Other treatments for major health challenges are being explored using reMYND’s discovery platform, with a focus on mitochondrial dysfunction in central nervous system (CNS) disorders.

In addition, reMYND has a dedicated Contract Research Organization (CRO), which focuses on CNS disorders. The team helps clients to assess the pharmacokinetics, pharmacodynamics and efficacy of their experimental treatments in reMYND’s proprietary animal models. The CRO has a global client base, including the US, Europe and Japan.

reMYND was founded in 2002 as a spin-off from the University of Leuven and has been substantially supported by grants from VLAIO/IWT (Flanders, Belgium). Find out more at https://www.remynd.com.



Secureworks Reports Third Quarter Fiscal 2021 Results

News Summary

  • Achieved third quarter revenue of $141.6 million. GAAP gross margin increased to a record 57.9 percent during the quarter and non-GAAP gross margin increased to a record 60.7 percent.
  • Nearly 300 customers on our cloud-native Threat Detection and Response (TDR) security application.
  • Significant sequential ARR growth of 25 percent from TDR and Managed Detection and Response (MDR) security analytics offerings.
  • Offering customers a compelling alternative to legacy SIEMs through the addition of log retention and flexible reporting to our TDR application.
  • Expanded software portfolio with Vulnerability, Detection and Prioritization (VDP) application.

ATLANTA, Dec. 03, 2020 (GLOBE NEWSWIRE) — Secureworks (NASDAQ: SCWX), a leader in software-driven security solutions, today announced financial results for its third fiscal quarter, which ended on October 30, 2020. For the quarter, the company increased both GAAP and non-GAAP revenue 0.2 percent to $141.6 million from $141.3 million in the same period in the prior year. GAAP gross margin increased to 57.9 percent during the quarter, from 56.4 percent in the same period in the prior year. Non-GAAP gross margin increased to 60.7 percent from 59.2 percent in the third quarter of fiscal 2020. GAAP net loss of $3.6 million, or $0.04 per share, in the third quarter of fiscal 2021, improved from $7.9 million, or $0.10 per share, in the same period in the prior year. Non-GAAP net income was $6.7 million, or $0.08 per share, in the third quarter of fiscal 2021, compared with a non-GAAP net income of $0.8 million, or $0.01 per share, in the same period in the prior year. Adjusted EBITDA for the quarter increased to $11.3 million from $5.8 million in the third quarter of fiscal 2020.

“Our ability to outpace and outmaneuver adversaries at scale requires an integrated software platform accelerated by the power of the community,” said Michael R. Cote, Chief Executive Officer of Secureworks. “Nearly 300 customers have now chosen our cloud-native security analytics platform to transform the way they secure their environments.”

“We’re pleased with our record GAAP and non-GAAP gross margin performance in the third quarter, as well as the continued significant growth and investment in our cloud-based SaaS security analytics platform,” said Paul Parrish, Chief Financial Officer of Secureworks.

Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter fiscal 2021 results on Dec. 3, 2020, at 8:00 a.m. U.S. ET. A live audio webcast of the conference call and the related supplemental financial information will be accessible on the Company’s website at http://investors.secureworks.com. The webcast and supplemental information will be archived at the same location for one year.

Operating Metrics

The Company defines annual recurring revenue (ARR) as the value of its subscription contracts as of a particular date. Because the Company uses recurring revenue as a leading indicator of future annual revenue, it includes operational backlog. Operational backlog is defined as the recurring revenue associated with pending contracts, which are contracts that have been sold but for which the service period has not yet commenced.

Non-GAAP Financial Measures

This press release presents information about the Company’s non-GAAP revenue, non-GAAP gross margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP operating income (loss), non-GAAP net income (loss), non-GAAP earnings (loss) per share and adjusted EBITDA, which are non-GAAP financial measures provided as a supplement to the results provided in accordance with accounting principles generally accepted in the United States of America (“GAAP”). A reconciliation of each of the foregoing non-GAAP financial measures to the most directly comparable GAAP financial measure is provided below for each of the fiscal periods indicated.

Special Note 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. In some cases, you can identify these statements by such forward-looking words as “anticipate,” “believe,” “confidence,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “outlook,” “should,” “will” and “would,” or similar words or expressions that refer to future events or outcomes. Such forward-looking statements reflect the Company’s current analysis of existing trends and information. These forward-looking statements represent the Company’s judgment only as of the date of this press release.

Actual results and events in future periods may differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties and other factors, including those relating to, among others: the Company’s ability to achieve or maintain profitability; the Company’s ability to enhance its existing solutions and technologies and to develop or acquire new solutions and technologies; the rapidly evolving market in which the Company operates; the Company’s reliance on personnel with extensive information security expertise; fluctuations in the Company’s quarterly results and other operating measures; intense competition in the Company’s markets; the Company’s ability to attract new customers, retain existing customers and increase its annual contract values; the Company’s reliance on customers in the financial services industry; the Company’s ability to manage its growth effectively; the Company’s ability to maintain high-quality client service and support functions; terms of the Company’s service level agreements with customers that require credits for service failures or inadequacies; the Company’s ability to continue expansion of its sales force; the Company’s long and unpredictable sales cycles; risks associated with the Company’s international sales and operations; the effect of Brexit on the Company’s operations; the Company’s ability to expand its key distribution relationships; the Company’s technology alliance partnerships; real or perceived defects, errors or vulnerabilities in the Company’s solutions or the failure of its solutions to prevent a security breach; the risks associated with cyber attacks or other data security incidents; the effect of adverse legislative or regulatory tax changes or unfavorable outcomes in tax audits and other tax compliance matters; the ability of the Company’s solutions to interoperate with its customers’ IT infrastructure; the Company’s ability to use third-party technologies; the effect of evolving information security and data privacy laws and regulations on the Company’s business; the Company’s ability to maintain and enhance its brand; risks associated with the Company’s acquisition of other businesses; the Company’s recognition of revenue ratably over the terms of its managed security and threat intelligence contracts; estimates or judgments relating to the Company’s critical accounting policies; the Company’s exposure to fluctuations in currency exchange rates; the effect of governmental export or import controls on the Company’s business; the Company’s compliance with the Foreign Corrupt Practices Act and similar laws; the Company’s ability to maintain effective disclosure controls and procedures; the effect of natural disasters, public health issues and other catastrophic events on the Company’s ability to serve its customers, including the coronavirus (COVID-19) pandemic; the Company’s reliance on patents to protect its intellectual property rights; the Company’s ability to protect, maintain or enforce its non-patented intellectual property rights and proprietary information; claims by third parties of infringement of their proprietary technology by the Company; the Company’s use of open source technology; and risks related to the Company’s relationship with Dell Technologies Inc. and Dell Inc. and control of the Company by Dell Technologies Inc.

This list of risks, uncertainties and other factors is not complete. The Company discusses these matters more fully, as well as certain risk factors that could affect the Company’s business, financial condition, results of operations and prospects, under the caption “Risk Factors” in the Company’s annual report on Form 10-K, as well as in the Company’s other SEC filings.  Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company does not undertake to update, and expressly disclaims any obligation to update, any of its forward-looking statements, whether as a result of circumstances or events that arise after the date the statements are made, new information or otherwise.

About Secureworks

Secureworks® (NASDAQ: SCWX), a global cybersecurity leader, enables our customers and partners to outpace and outmaneuver adversaries with more precision, so they can rapidly adapt and respond to market forces to meet their business needs. With a unique combination of cloud-native, SaaS security platform and intelligence-driven security solutions, informed by 20+ years of threat intelligence and research, no other security platform is grounded and informed with this much real-world experience.
www.secureworks.com

Contact Information


Investor Inquiries:


Richie Downum
Investor Relations Director
404-235-1021
[email protected]


Media Inquiries:


Derek Delano
Corporate Communications
617-335-9516
[email protected]

SECUREWORKS CORP.
Condensed Consolidated Statements of Operations and Related Financial Highlights
(in thousands, except per share data and percentages)
(unaudited)
                       
          Three Months Ended   Nine Months Ended
          October 30,
2020
  November 1,
2019
  October 30,
2020
  November 1,
2019
Net revenue   $ 141,641     $ 141,332     $ 421,298     $ 410,779  
Cost of revenue   59,613     61,568     182,422     188,004  
  Gross margin   82,028     79,764     238,876     222,775  
  Research and development   27,608     24,095     75,790     71,600  
  Sales and marketing   34,810     40,726     107,886     116,966  
  General and administrative   24,508     25,078     73,824     73,862  
    Total operating expenses   86,926     89,899     257,500     262,428  
  Operating loss   (4,898 )   (10,135 )   (18,624 )   (39,653 ) 
Interest and other, net   (79 )   (1,257 )   944     961  
  Loss before income taxes   (4,977 )   (11,392 )   (17,680 )   (38,692 )
Income tax benefit   (1,369 )   (3,484 )   (5,309 )   (12,254 )
  Net loss   $ (3,608 )   $ (7,908 )   $ (12,371 )   $ (26,438 )
                 
Loss per common share (basic and diluted)   $ (0.04 )   $ (0.10 )   $ (0.15 )   $ (0.33 )
                 
Weighted-average common shares outstanding (basic and diluted)   81,474     80,518     81,276     80,553  
                       


Percentage of Total Net Revenue

               
Gross margin   57.9  %   56.4  %   56.7  %   54.2  %
Research and development   19.5  %   17.0  %   18.0  %   17.4  %
Sales and marketing   24.6  %   28.8  %   25.6  %   28.5  %
General and administrative   17.3  %   17.7  %   17.5  %   18.0  %
Operating expenses   61.4  %   63.6  %   61.1  %   63.9  %
Operating loss   (3.5 )%   (7.2 )%   (4.4 )%   (9.7 )%
Loss before income taxes   (3.5 )%   (8.1 )%   (4.2 )%   (9.4 )%
Net loss   (2.5 )%   (5.6 )%   (2.9 )%   (6.4 )%
Effective tax rate   27.5  %   30.6  %   30.0  %   31.7  %
Note: Percentage growth rates are calculated based on underlying data in thousands

SECUREWORKS CORP.
Condensed Consolidated Statements of Financial Position
(in thousands)
(unaudited)
               
          October 30,

2020
  January 31,

2020


Assets:

         
Current assets:          
  Cash and cash equivalents     $ 188,048      $ 181,838   
  Accounts receivable, net     107,907      111,798   
  Inventories, net     690      746   
  Other current assets     25,992      27,449   
    Total current assets     322,637      321,831   
Property and equipment, net     19,669      27,606   
Operating lease right-of-use assets, net     22,421      23,463   
Goodwill     425,314      416,487   
Intangible assets, net     164,928      180,052   
Other non-current assets     76,488      78,592   
    Total assets     $ 1,031,457      $ 1,048,031   


Liabilities and Stockholders’ Equity:

         
Current liabilities:          
  Accounts payable     $ 20,874      $ 18,690   
  Accrued and other     88,208      98,855   
  Short-term deferred revenue     173,536      175,847   
    Total current liabilities     282,618      293,392   
Long-term deferred revenue     9,930      12,690   
Operating lease liabilities, non-current     22,828      24,669   
Other non-current liabilities     48,932      50,400   
    Total liabilities     364,308      381,151   
Stockholders’ equity     667,149      666,880   
Total liabilities and stockholders’ equity     $ 1,031,457      $ 1,048,031   

SECUREWORKS CORP.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
         
    Nine Months Ended
    October 30,
2020
  November 1,
2019
Cash flows from operating activities:        
Net loss   $ (12,371 )     $ (26,438 )  
Adjustments to reconcile net loss to net cash provided by operating activities        
Depreciation and amortization   30,978       32,017    
Stock-based compensation expense   17,675       15,617    
Effects of exchange rate changes on monetary assets and liabilities denominated in foreign currencies   (1,190 )     (102 )  
Income tax benefit   (5,309 )     (12,254 )  
Other non cash impacts   150       1,830    
Provision for doubtful accounts   1,871       1,651    
Changes in assets and liabilities:        
Accounts receivable   2,296       21,689    
Net transactions with parent   5,586       (18,571 )  
Inventories   56       (438 )  
Other assets   5,593       10,838    
Accounts payable   2,668       9,086    
Deferred revenue   (4,820 )     9,848    
Accrued and other liabilities   (14,749 )     (8,921 )  
Net cash provided by operating activities   28,434       35,852    
Cash flows from investing activities:        
Capital expenditures   (2,181 )     (12,082 )  
Acquisition of business, net of cash acquired   (15,081 )     —    
Net cash used in investing activities   (17,262 )     (12,082 )  
Cash flows from financing activities:        
Taxes paid on vested restricted shares   (4,962 )     (8,197 )  
Purchases of stock for treasury   —       (6,377 )  
Net cash used in financing activities   (4,962 )     (14,574 )  
Net increase in cash and cash equivalents   6,210       9,196    
Cash and cash equivalents at beginning of the period   181,838       129,592    
Cash and cash equivalents at end of the period   $ 188,048       $ 138,788    

Non-GAAP Financial Measures

This press release presents information about the Company’s non-GAAP revenue, non-GAAP gross margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP operating income (loss), non-GAAP net income (loss), non-GAAP earnings (loss) per share and adjusted EBITDA, which are non-GAAP financial measures provided as a supplement to the results provided in accordance with GAAP. A detailed discussion of the Company’s reasons for including these non-GAAP financial measures, the limitations associated with these measures, the items excluded from these measures, and our reason for excluding those items are presented in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Non-GAAP Financial Measures” in our periodic reports filed with the SEC. The Company encourages investors to review its GAAP results in conjunction with the presentation of non-GAAP financial measures.

SECUREWORKS CORP.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data)
(unaudited)
                     
        Three Months Ended   Nine Months Ended
        October 30,

2020
  November 1,

2019
  October 30,

2020
  November 1,

2019
GAAP and non-GAAP revenue   $ 141,641       $ 141,332       $ 421,298       $ 410,779    
                     
GAAP gross margin   $ 82,028       $ 79,764       $ 238,876       $ 222,775    
  Amortization of intangibles   3,646       3,559       10,754       10,529    
  Stock-based compensation expense   255       353       1,008       1,009    
    Non-GAAP gross margin   $ 85,929       $ 83,676       $ 250,638       $ 234,313    
                     
GAAP research and development expenses   $ 27,608       $ 24,095       $ 75,790       $ 71,600    
  Stock-based compensation expense   (793 )     (996 )     (3,181 )     (3,157 )  
    Non-GAAP research and development expenses $ 26,815       $ 23,099       $ 72,609       $ 68,443    
                     
GAAP sales and marketing expenses   $ 34,810       $ 40,726       $ 107,886       $ 116,966    
  Stock-based compensation expense   (1,072 )     (691 )     (2,695 )     (2,389 )  
    Non-GAAP sales and marketing expenses   $ 33,738       $ 40,035       $ 105,191       $ 114,577    
                     
GAAP general and administrative expenses   $ 24,508       $ 25,078       $ 73,824       $ 73,862    
  Amortization of intangibles   (3,524 )     (3,524 )     (10,571 )     (10,571 )  
  Stock-based compensation expense   (3,961 )     (3,052 )     (10,791 )     (9,062 )  
    Non-GAAP general and administrative expenses $ 17,023       $ 18,502       $ 52,462       $ 54,229    
                     
GAAP operating loss   $ (4,898 )     $ (10,135 )     $ (18,624 )     $ (39,653 )  
  Amortization of intangibles   7,170       7,083       21,325       21,100    
  Stock-based compensation expense   6,081       5,092       17,675       15,617    
    Non-GAAP operating income (loss)   $ 8,353       $ 2,040       $ 20,376       $ (2,936 )  
                     
GAAP net loss   $ (3,608 )     $ (7,908 )     $ (12,371 )     $ (26,438 )  
  Amortization of intangibles   7,170       7,083       21,325       21,100    
  Stock-based compensation expense   6,081       5,092       17,675       15,617    
  Aggregate adjustment for income taxes   (2,917 )     (3,438 )     (8,998 )     (11,997 )  
    Non-GAAP net income (loss)   $ 6,726       $ 829       $ 17,631       $ (1,718 )  
                     
GAAP loss per share   $ (0.04 )     $ (0.10 )     $ (0.15 )     $ (0.33 )  
  Amortization of intangibles   0.09       0.09       0.26       0.26    
  Stock-based compensation expense   0.08       0.06       0.22       0.19    
  Aggregate adjustment for income taxes   (0.04 )     (0.04 )     (0.11 )     (0.15 )  
    Non-GAAP earnings (loss) per share *   $ 0.08       $ 0.01       $ 0.22       $ (0.02 )  
                     
* Sum of reconciling items may differ from total due to rounding of individual components
                     
GAAP net loss   $ (3,608 )     $ (7,908 )     $ (12,371 )     $ (26,438 )  
  Interest and other, net   79       1,257       (944 )     (961 )  
  Income tax benefit   (1,369 )     (3,484 )     (5,309 )     (12,254 )  
  Depreciation and amortization   10,106       10,869       30,978       32,017    
  Stock-based compensation expense   6,081       5,092       17,675       15,617    
    Adjusted EBITDA   $ 11,289       $ 5,826       $ 30,029       $ 7,981    

SECUREWORKS CORP.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands)
(unaudited)
 
 
        Three Months Ended   Nine Months Ended

Percentage of Total Net Revenue
  October 30,
2020
  November 1,
2019
  October 30,
2020
  November 1,
2019
                 
GAAP gross margin   57.9  %   56.4  %   56.7  %   54.2  %
  Non-GAAP adjustment   2.8  %   2.8  %   2.8  %   2.8  %
Non-GAAP gross margin   60.7  %   59.2  %   59.5  %   57.0  %
                     
GAAP research and development expenses   19.5  %   17.0  %   18.0  %   17.4  %
  Non-GAAP adjustment   (0.6 )%   (0.7 )%   (0.8 )%   (0.7 )%
Non-GAAP research and development expenses   18.9  %   16.3  %   17.2  %   16.7  %
                     
GAAP sales and marketing expenses   24.6  %   28.8  %   25.6  %   28.5  %
  Non-GAAP adjustment   (0.8 )%   (0.5 )%   (0.6 )%   (0.6 )%
Non-GAAP sales and marketing expenses   23.8  %   28.3  %   25.0  %   27.9  %
                     
GAAP general and administrative expenses   17.3  %   17.7  %   17.5  %   18.0  %
  Non-GAAP adjustment   (5.3 )%   (4.6 )%   (5.0 )%   (4.8 )%
Non-GAAP general and administrative expenses   12.0  %   13.1  %   12.5  %   13.2  %
                     
GAAP operating loss   (3.5 )%   (7.2 )%   (4.4 )%   (9.7 )%
  Non-GAAP adjustment   9.4  %   8.6  %   9.2  %   9.0  %
Non-GAAP operating income (loss)   5.9  %   1.4  %   4.8  %   (0.7 )%
                     
GAAP net loss   (2.5 )%   (5.6 )%   (2.9 )%   (6.4 )%
  Non-GAAP adjustment   7.2  %   6.2  %   7.1  %   6.0  %
Non-GAAP net income (loss)   4.7  %   0.6  %   4.2  %   (0.4 )%



Dgraph Labs Launches Slash Enterprise: Fully Hosted, Serverless Version of World’s Most Advanced Graph Database

Slash Enterprise is the most powerful graph database backend for GraphQL at enterprise scale, available today on AWS, Azure, or GCP

SAN FRANCISCO, Dec. 03, 2020 (GLOBE NEWSWIRE) — Go Systems Conference San Francisco – Dgraph Labs, creators of the world’s most advanced graph database, today announced the launch of Slash Enterprise, the first fully-managed, serverless solution for enterprises managing workloads with terabytes of data in production that can now run on dedicated, multi-zone clusters with high availability deployed on AWS, Azure, or GCP. Designed for mission-critical workloads at scale, and easily deployed to your cloud, Slash Enterprise can scale from zero to billions of records effortlessly with no single point of failure.

The database that powers Slash Enterprise is Dgraph — the number one rated graph database on GitHub. Dgraph was inspired by Dgraph Labs founder and CEO Manish Jain’s work at Google on the company’s Knowledge Graph infrastructure, and his efforts to unite all structured data at Google under a single graph indexing and serving system. Dgraph became the first database to natively support GraphQL, and its ability to traverse data with high throughput and low latency has led to it becoming the world’s most popular graph database.

“A native graph database is the only solution for developers who need iteration speed and flexibility within GraphQL,” Jain said. Slash Enterprise is what developers in the most demanding production environments need with that speed, scale and flexibility built in.”

SLASH ENTERPRISE SAVES MONEY AND SPEEDS TIME TO MARKET WITH HA

  • Save DevOps resources:
    Your site reliability is managed by Dgraph Labs – recognized world leaders in graph technologies and GraphQL at Google scale – but deployed in your cloud. A fully-managed solution, Slash Enterprise includes automatic full and incremental backups, encrypted EBS volumes, 24×7 strict SLA support, and other critical features required in enterprise production environments.

  • Cloud-based solution:
    Slash Enterprise deploys for you in the cloud – either AWS, Azure or GCP – with full data sovereignty for stricter compliance. Enjoy dedicated machines while you take full advantage of horizontal scalability as your data and company expand.

  • High Availability: Access all of your data, all the time. Run your mission-critical projects on dedicated, multi-zone clusters with high availability. Without a single point of failure, Slash Enterprise is fault-tolerant.

  • Production-grade Performance for your enterprise.
    Terabytes of data. Billions of records. Millisecond response time. Dedicated clusters. With high throughput and incredible scalability, Slash Enterprise shows impressive performance on terabytes of data. Get millisecond query speeds and consistently low latency.

PROVEN AT SCALE: 48 BILLION ORDERED TRIPLE DATASETS

Dgraph is used at massive scale by enterprises that include Comcast, Intuit, Siemens, Overstock, VMware and many more.

  • “When we performed a stress test on a thousand concurrent queries, Dgraph was still able to maintain a response time of 50 ms, while simultaneously achieving 15000/s QPS; the performance is excellent,” said Pan Gao, Chief Search Architect of KE Holdings, a publicly-traded online Chinese real estate broker with a market capitalization of more than $48 billion (U.S.) “We’ve shown that you can build a knowledge graph with 10 billion nodes and deliver millisecond query results and meet enterprise production environment requirements for SLAs and security,” Gao said. “We’re able to store 48 billion ordered triple datasets in Dgraph.”
  • “Within 20 minutes, I had the entire structure of the data set with all the proper interactions captured in Dgraph,” said Mike Hawkes, CTO of Capventis, an Ireland-based global digital transformation company that works with some of the largest enterprises in the world. “We solved this entire problem in one hit. It was months in the planning and minutes in the execution.”

ADD CALL TO ACTION / MORE INFORMATION / FREE DEMO / WEBINAR

ABOUT DGRAPH LABS

Dgraph Labs (@dgraphlabs) is the creator of Dgraph, the world’s first native GraphQL database with a graph backend. The company’s goal is to provide Google production-level scale and throughput to every developer working with GraphQL. With more than 14,000 GitHub stars and more than 5 million Docker pulls, Dgraph is the most popular open-source graph database in the market. Venture-backed with investors that include Redpoint and Bain Capital, Dgraph customers range from global Fortune 500 companies to emerging startups. For more information, visit https://dgraph.io/.

Editorial Contact
Lonn Johnston
+1 650.219.7764
[email protected]



(CLA) CliftonLarsonAllen LLP Named Nexia International Firm of the Year

(CLA) CliftonLarsonAllen LLP was recognized as Nexia International’s Firm of the Year, while Jeff Kvilhaug, chief global officer, was awarded Nexian of the Year.

Minneapolis, Dec. 03, 2020 (GLOBE NEWSWIRE) — (CLA) CliftonLarsonAllen LLP was named Firm of the Year by Nexia International, a global network of independent accounting and consulting firms. The award recognizes the contributions (CLA) CliftonLarsonAllen LLP has made to the development of Nexia and celebrates its success.

“Receiving this award is an incredible honor,” said CEO Denny Schleper. “Nexia is truly committed to helping its members provide international services to clients in a cohesive, personal, and customized manner.”

In addition, (CLA) CliftonLarsonAllen LLP’s chief global officer, Jeff Kvilhaug, was recognized as Nexian of the Year. This award is given to an individual who is a proactive ambassador and champion within their national, regional, or international markets and made a significant contribution to the wider Nexia network in the previous 12 months. Kvilhaug, who has enjoyed a 36-year career with the firm, also serves on the Nexia Strategy Committee.

“I’m truly humbled by this award,” said Kvilhaug. “And it’s even sweeter to win this in 2020, a year where a pandemic has increased the physical and psychological distance between people across the world. I’m so proud that my fellow teammates have been among the guiding voices throughout Nexia to help bring us all closer together.”

(CLA) CliftonLarsonAllen LLP’s independent membership with Nexia International has always been focused on the idea of global collaboration. Member firms share ideas and thought leadership materials, including webinars on U.S. relief programs and content to help global organizations navigate COVID-19 relief funding. Over the years, (CLA) CliftonLarsonAllen LLP professionals have provided leadership on Nexia International committees and groups. Jen Leary, the firm’s chief strategy officer, serves on the Nexia board of directors and its strategy committee.

“This has been a challenging year for firms of all shapes and sizes, and there’s no doubt that our connection with Nexia helped us all get through it,” said Leary. “We treasure our relationships with the member firms and look forward to them flourishing for years to come.”

Visit CLAconnect.com for more information.


About (CLA) CliftonLarsonAllen LLP

(CLA) CliftonLarsonAllen LLP exists to create opportunities for our clients, our people, and our communities through industry-focused wealth advisory, outsourcing, audit, tax, and consulting services. With more than 6,200 people, 120 U.S. locations and a global affiliation, we promise to know you and help you. For more information, visit CLAconnect.com. Investment advisory services are offered through CliftonLarsonAllen Wealth Advisors, LLC, an SEC-registered investment advisor.

Attachment



Jackie Kruger
CLA (CliftonLarsonAllen LLP)
612-376-4623
[email protected]

TG Therapeutics Recaps Schedule of Data Presentations at the Upcoming 62nd American Society of Hematology Annual Meeting and Exposition

NEW YORK, Dec. 03, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today recapped the schedule of data presentations at the upcoming 62nd American Society of Hematology (ASH) annual meeting and exposition, to be held virtually December 5 – 8, 2020.


ASH 2020 PRESENTA


T


ION DETAILS:

  • Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

    • Publication Number: 543
    • Oral Session: 642. CLL: Therapy, excluding Transplantation
    • Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
      • Presentation Time: 7:15 AM (Pacific Time)
    • Presenter: John G. Gribben, MD, D.Sc., Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom;
  • Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial

    • Publication Number: 2934
    • Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
    • Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
    • Presenter: Pier Luigi Zinzani, MD, PhD, Institute of Hematology, “L. e A. Seràgnoli”, University of Bologna, Italy
  • Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

    • Publication Number: 3137
    • Session: 642. CLL: Therapy, excluding Transplantation: Poster III
    • Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
    • Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY
  • Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies

    • Publication Number: 1130
    • Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
    • Date and Time: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
    • Presenter: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, Medical School, University of Western Australia, Crawley, Western Australia

Following each presentation during ASH 2020, the data presented will be available on TG’s corporate website at http://tgtxinc.com/publications.cfm. TG abstracts are publicly available via the ASH meeting website at www.hematology.org or on the company’s corporate website. 

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS).  Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially include the following:  the risk that interim, top-line, or other early clinical trial results, that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in final data sets or in future studies; the risk that we will not be able to meet the regulatory submission or clinical trial timelines that we project or achieve other anticipated milestones, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones; and the risk that our compounds will not receive regulatory approval or become commercially successful products.. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:
 
  Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]



Skylight Health to Enter into 15th State with Acquisition of Tennessee Clinic with $2.2 million in Revenue and $0.4 million EBITDA

  • Tennessee-based Perimeter Pain and Primary Care Clinic is an established medical practice servicing over 12,000 patients per year.
  • In 2019, the clinic generated CAD 2.2 million in revenues and CAD 400,000 in net income.
  • Forecasted annual run rate now at over $20 million combined with the last 3 announced transactions.
  • Skylight Health will pay a total cash consideration of CAD 1.03 million for the acquisition representing a 2.6x EBITDA multiple.
  • This transaction will be immediately accretive to the Company adding complementary services and insurable revenue to the existing primary care model across 15 States.

TORONTO, Dec. 03, 2020 (GLOBE NEWSWIRE) — Skylight Health Group Inc (CSE:SHG; OTCQX: CBIIF) (“SHG” or the “Company”), one of the largest multi-specialty healthcare systems in the United States, is pleased to announce that it has entered into a Letter of Intent (LOI) to purchase the assets of Healthcare Resources Management LLC (“HRM”) which operates Perimeter Pain and Primary Clinic (“Perimeter”) in Cookeville, Tennessee. The planned acquisition of HRM expands the Company’s bricks and mortar and telemedicine services to 15 States and will add 12,000 new patients to its current roster of 120,000.

HRM has been operating Perimeter in Cookeville for over 7 years with strong patient retention. Services to patients include primary care, chronic pain management, interventional procedures, weight management, regenerative medicine and aesthetics. Services provided by Perimeter are primarily reimbursed through insurance carriers including Medicare, Medicaid and other commercial payors.

The Company expects to see continued growth in patient registrations and visits as Perimeter continues to thrive among the challenges most clinics have faced due to the recent COVID-19 pandemic. Further, the Company will work quickly to expand on the current offering of services by leveraging its current telemedicine infrastructure to provide access to patients across the state of Tennessee. Upon completion, services offered by Perimeter will apply to Skylight Health’s entire patient base. These services are immediately accretive as they allow the Company to expand complementary billable services. Patients will continue to benefit from the expansion of services in-house. The Company will benefit by expanding the per patient insurable revenue share-of-wallet by retaining these services internally.

“Perimeter represents the first of complementary non-primary care acquisitions and is in direct alignment with our strategy to expand on services offered to our existing patient base nationally,” said Prad Sekar, CEO, Skylight Health. “Adding vital services like chronic pain management, interventional procedures and other from Perimeter will benefit tens of thousands of our current patients and will be deployed nationally within the existing framework of payor contracts in each state we are organically establishing over the next year.”

HRM represents the fourth announced acquisition by the Company in the last 60 days. This acquisition supports and strengthens the 3-prong growth model which includes growth from the current infrastructure, new services and acquisitions. The Company will pay as per the agreed upon terms of the LOI, a transaction value in cash of CAD 1.03 million representing an EBITDA multiple of 2.6x. Perimeter reported revenues in 2019 of CAD 2.2 million and net income of CAD 400,000. This transaction is subject to a satisfactory due diligence period by the Company and mutual agreement to an Asset Purchase Agreement and Closing Conditions. The transaction is expected to close on or before December 31, 2020.

The Company also announces the grant of 3,176,000 options to the directors and senior officers. Options have been granted as of the close of business December 2, 2020 at a strike price of $0.77 with no discount. The Company has also issued 125,000 shares at a price of $0.62 to certain consultants for services delivered.

About Skylight Health Group

Skylight Health Group (CSE:SHG OTCQX:CBIIF) is a healthcare services and technology company, working to positively impact patient health outcomes. The Company operates a US multi-state health network that comprises of physical multi-disciplinary medical clinics providing a range of services from primary care, sub-specialty, allied health and laboratory/diagnostic testing. The Company owns and operates a proprietary electronic health record system that supports the delivery of care to patients via telemedicine and other remote monitoring system integrations. healthcare services. With a patient roster of over 120,000 patients, the Company’s operations spread across 14 states and continues to expand in services and locations both organically and by way of strategic acquisitions.

The Company primarily operates a traditional insurable fee-for-service model contracting with Medicare, Medicaid and other Commercial Payors. The Company also offers a disruptive subscription-based telemedicine service for the un/under-insured population who have limited access to urgent care due to cost.

For more information please visit www.skylighthealthgroup.com or contact:

Investor Relations
Jonathan L. Robinson CFA
Oak Hill Financial
[email protected]
416-669-1001

Forward Looking Statements

Statements in this news release that are forward-looking statements are subject to various risks and uncertainties concerning the specific factors disclosed here and elsewhere in Skylight Health’s filings with Canadian securities regulators. When used in this news release, words such as “will, could, plan, estimate, expect, intend, may, potential, believe, should,” and similar expressions, are forward-looking statements.

Forward-looking statements may include, without limitation, statements regarding the Company’s unaudited financial results and projected growth.

Although Skylight Health as attempted to identify important factors that could cause actual results, performance or achievements to
differ materially from those contained in the forward-looking statements, there can be other factors that cause results, performance or achievements not to be as anticipated, estimated or intended, including, but not limited to: dependence on obtaining regulatory approvals; investing in target companies or projects which have limited or no operating history and are subject to inconsistent legislation and regulation; change in laws; reliance on management; requirements for additional financing; competition; hindering market growth and state adoption due to inconsistent public opinion and perception of the medical-use and recreational-use marijuana industry and; regulatory or political change.

There can be no assurance that such information will prove to be accurate or that management’s expectations or estimates of future developments, circumstances or results will materialize. As a result of these risks and uncertainties, the results or events predicted in these forward-looking statements may differ materially from actual results or events.

Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this release. Skylight Health disclaims any intention or obligation to update or revise such information, except as required by applicable law, and Skylight Health does not assume any liability for disclosure relating to any other company mentioned herein.

No securities regulator or exchange has reviewed, approved, disapproved, or accepts responsibility for the content of this news release.



Evelo Biosciences Completes Enrollment to Interim Target in Phase 2 Trial Evaluating EDP1815 for the Treatment of Psoriasis

CAMBRIDGE, Mass., Dec. 03, 2020 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines which act in the small intestine with systemic effects, today announced that it is recruiting ahead of schedule and has completed enrollment of the patients necessary for the interim data readout in the Phase 2 clinical trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. The interim data readout will include initial safety and efficacy data for the first 113 patients enrolled in the trial. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19.

“We are encouraged by the physician and patient interest in our Phase 2 trial, which has enabled us to complete enrollment to the interim target ahead of schedule despite the ongoing COVID-19 pandemic,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “Based on recent interactions with key opinion leaders, we see a growing understanding of the potential of SINTAX™ medicines to resolve systemic inflammation without immunosuppression, anticipating that EDP1815 may offer an improved profile over existing products and others in development as an orally-administered, safe, and effective medicine to address the needs of the millions of people with psoriasis.”

EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in 225 patients with mild to moderate psoriasis over a 16-week treatment period. The primary endpoint is mean reduction in Psoriasis Area and Severity Index (PASI) score at 16 weeks. Key secondary endpoints include other clinical measures of disease such as Physician’s Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, Psoriasis Symptom Inventory (PSI), Dermatology Life Quality Index (DLQI), and Lesion Severity Score (LSS).

About EDP1815 in Psoriasis

EDP1815 is an investigational oral biologic being developed for the treatment of inflammatory diseases. EDP1815 is a strain of Prevotella histicola, selected for its specific pharmacology. In the second and third quarter of 2019, Evelo reported positive Phase 1b interim clinical data in two cohorts of patients with mild to moderate psoriasis. EDP1815 was well tolerated at both doses, with no overall difference reported from placebo. There was a reduction in mean LSS and PASI score after 28 days of dosing in both cohorts who received EDP1815. In the high dose cohort alone, there was a continued reduction in both mean LSS (of 24% vs. placebo of 7%) and PASI score (of 21% vs. placebo of 3%) at 42 days – 14 days following the last dose of the drug. This may indicate a sustained clinical effect and dose response. EPD1815 was also observed to limit the systemic production of multiple inflammatory cytokines, including IL-6, IL-8, TNF, and IL-1, which are well-established mediators of potentially harmful effects in patients with inflammatory diseases.

About Psoriasis

Psoriasis is a common chronic immune-mediated inflammatory skin disease, affecting up to 3% of the population worldwide. The disease is driven by Th17-inflammation, which results in the formation of thickened red plaques with scaling. Psoriatic lesions can appear anywhere on the body but are most often seen on the knees, elbows, scalp, and lumbar area. There is a strong association with psoriatic arthritis, depression, and metabolic syndrome.

Patients with mild to moderate psoriasis are underserved by current treatments, including topical therapies, which do not control systemic inflammation, have low rates of compliance, or in the case of potent topical steroids, are not recommended for long-term use. The majority of novel therapies, including injectable high-cost biologics, are only approved for patients with moderate to severe disease. Even in this patient population, the majority of eligible patients do not receive biologics, instead opting for topical or oral systemic therapies, which are associated with tolerability issues and/or with monitoring requirements tied to safety concerns.  

About Evelo Biosciences

Evelo Biosciences is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic and neurological systems. The company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

Evelo currently has five product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the timing and results of any clinical trials or readouts for EDP1815, our development plans, and the promise and potential impact of EDP1815 or our other product candidates.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended
September
30, 2020, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contact

Evelo Biosciences
Jessica Cotrone, 978-760-5622
[email protected]