Market Newsdesk

MISSISSAUGA, ON, Nov. 16, 2020 /CNW/ – “It’s like watching a child taking its first steps,” are the words that come to mind when Gordon Reed is asked how he feels about seeing UPS Canada’s largest package sorting and delivery facility up and running. As the director for special projects in UPS’s industrial engineering department, Gordon has spent a lot of work and long hours getting the massive, 850,000 square foot facility in Caledon, Ontario online. “This project is close to my heart and our whole team is so proud that we could get this facility operational in time when it is most needed.”

The new hub has begun operations in anticipation for the annual increase in volume that will start around Cyber Week and continue through January 2021. Part of a $500 millionCanada investment plan announced in 2018, the facility features advanced scanning and sortation technology, integrated with data-driven tools to increase efficiency and reliability for UPS’s customers in one of the fastest growing provinces in Canada.

“This year has not been without its challenges and we want to make sure we do our part to reduce the stress of the coming holidays as much as possible for all Canadians,” said Dominic Porporino, president of UPS Canada.  “We anticipate a record breaking holiday season, but this new hub – our flagship facility – and the dedicated people that operate it, are ready to serve Canadians when they need it the most. It is a testament to our company’s purpose of keeping the world moving forward by delivering what matters.”

To further help successfully deliver the holidays this year, UPS expects to hire over 100,000 seasonal employees globally. In Canada, more than 5,000 new employees will be hired to provide additional support. Full and part-time positions will be filled and many past seasonal hires have landed permanent jobs at UPS.

Earlier this year, UPS also opened a 180,000 square foot expansion at its Montreal facility and, in November 2018, the company unveiled a new facility in Kanata, Ontario and has expanded its package centres in Brampton and London, Ontario and Edmonton, Alberta.

To prepare your business for the busy holiday season or plan your online shopping, visit ups.com to view the UPS Canada Holiday calendar.

About UPS

UPS (NYSE: UPS) is a global leader in logistics, offering a broad range of solutions including transporting packages and freight; facilitating international trade, and deploying advanced technology to more efficiently manage the world of business. Headquartered in Atlanta, UPS serves more than 220 countries and territories worldwide. UPS’s international expansion took its first steps north and entered the Canadian market on February 28, 1975. Over the past four decades, UPS in Canada has expanded to approximately 12,000 employees serving Canada from coast-to-coast.  Headquartered in Mississauga, Ontario, UPS Canada operates a delivery fleet of over 3,000 (package cars, tractors, trailers and shifters) of which more than 41% run on alternative fuels. Today, UPS is customer first, people led, innovation driven. UPS was awarded America’s Best Customer Service company for Shipping and Delivery services by Newsweek magazine; Forbes Most Valuable Brand in Transportation; and top rankings on the JUST 100 list for social responsibility, the Dow Jones Sustainability World Index, and the Harris Poll Reputation Quotient, among other prestigious rankings and awards. The company can be found on the web at ups.com or pressroom.ups.com and its corporate blog can be found at ups.com/longitudes The company’s sustainability eNewsletter, UPS Horizons, can be found at ups.com/sustainabilitynewsletter. To get UPS news direct, follow @UPS_News on Twitter. To ship with UPS, visit ups.com/ship.

SOURCE UPS Canada Ltd.

HARBIN, China, Nov. 16, 2020 /PRNewswire/ — China XD Plastics Company Limited (NASDAQ: CXDC) (“China XD,” the “Company” or “we”), one of China’s leading specialty chemical companies engaged in the development, manufacture and sale of polymer composite materials primarily for automotive applications, today announced its financial results for the third quarter ended September 30, 2020.

Third Quarter 2020 Financial Highlights         

• Revenue was $290.1 million, a decrease of 22.3% YoY and an increase of 2.4% sequentially
• Gross profit was $34.6 million, a decrease of 42.4% YoY and a decrease of 13.3% sequentially
• Gross margin was 11.9%, decrease of 4.2% YoY and a decrease of 2.2% sequentially
• Net loss was $38.0 million, compared to net income of $17.0 million in the same period last year and net income of $17.6  million sequentially
• EBITDA was negative $0.07 million, a decrease of 100.2% YoY and a decrease of 100.2% sequentially. A description of the adjustments from GAAP  net loss to EBITDA is detailed in the table captioned “Reconciliation of GAAP and Non-GAAP Results” following this press release.
• Total volume shipped was 83,855 metric tons, down 8.9% YoY and an increase of 48.4% sequentially

Third Quarter 2020 Results

Revenues

Revenues were US$290.1 million in the third quarter ended September 30, 2020, a decrease of US$83.1 million, or 22.3%, compared to US$373.2 million in the same period of last year. This was due to the decrease of 8.9% in sales volume and a decrease of 16.5% in the average RMB selling price of our products, as compared with those of the same period of last year, partially offset by an appreciation of RMB against USD by 1.8%.

(i) Domestic market

For the three-month period ended September 30, 2020, revenue from domestic market decreased by US$62.4 million or 17.7% compared with that in the same period of last year, as a result of (i) a decrease of 6.6% in sales volume; and (ii) a decrease of 13.8% in the average RMB selling price of our products, as compared with those of last year; partially offset by (iii) an appreciation of RMB against USD by 1.1%.

According to the China Association of Automobile Manufacturers, automobile production and sales in China decreased by 6.7% and 6.9%, respectively, for the first nine months of 2020 as compared to the same period of 2019.

The weakening in macroeconomic conditions since the outbreak of COVID-19 pandemic in January 2020 continued to exacerbate auto business environment. The Company’s business was negatively impacted and has generated lower revenue. Thanks to our positive efforts to expand our customer bases and to meet their new requirements, the Company has begun to recover slowly after May 2020. We had increase in sales by 43.9% in Southwest China and 19.3% in East China, except a decrease in sales by 71.2% in Northeast China, 45.7% in Central China , 27.7% in North China  and 0.8% in South China for the three-month period ended September 30, 2020 as compared to the same period of 2019.

 As for the RMB selling price, the decrease of 13.8% was mainly due to Company’s marketing strategy to offer discount sales  to receive more orders  in order to accelerate inventory turnover and replenish operating funds  in domestic market during the three-month period ended September 30, 2020.

(ii) Overseas market

For the three-month period ended September 30, 2020, revenues from overseas market US$0.2 million as compared to US$20.9 million of the same period of 2019. The Dubai facility was temporarily shut down since late February and has not resumed its operation till the current period, which has negatively impacted operations in Dubai facility.

Premium products (PA66, PA6, POM, PPO, Plastic Alloy and PLA) in total accounted for 85.3% of revenues from sales of finished goods in the third quarter of 2020, compared to 86.7% in the prior year period. The Company continued to shift production mix from traditional lower-end products such as PP to higher-end products such as PA66 and PA6, primarily due to (i) greater growth potential of advanced modified plastics in luxury automobile models in China, (ii) the stronger demand as a result of promotion by the Chinese government for clean energy vehicles and (iii) better quality demand from and consumer recognition of higher-end cars made by automotive manufacturers from Chinese and Germany joint ventures, Sino-U.S. and Sino-Japanese joint ventures, which manufacturers tend to use more and higher-end modified plastics in quantity per vehicle in China.

Gross profit was US$34.6 million in the third quarter ended September 30, 2020, compared to US$60.1 million in the same period of 2019, representing a decrease of US$25.5 million or 42.4%. Our gross margin decreased to 11.9% during the third quarter ended September 30, 2020 from 16.1% during the same quarter of 2019 primarily due to more sales of higher-end products and more  sales of semi-finished goods during the third quarter of 2019, and the increased cost for idle capacity as a result of shutdown.

General and administrative (G&A) expenses were US$11.0 million for the quarter ended September 30, 2020 compared to US$6.0 million in the same period in 2019, representing an increase of 83.3%, or US$5.0 million. The increase was primarily due to the US$4.19 million of share based compensation cost recognized in the third quarter of 2020.

Provision for doubtful accounts was US$6.8 million for the quarter ended September 30, 2020 compared to nil in the same period of 2019. As of September 30, 2020, accounts receivable of US$2.0 million from the Company’s two customers in UAE and US$4.8 million from the Company’s customer in PRC was overdue for more than 12 months. Based on assessment of the collectability of the amounts due from the customers, the Company provided an allowance for doubtful accounts of US$6.8 million for the period ended September 30, 2020.

Provision for long-term prepayments to equipment and construction suppliers was US$21.8 million for the quarter ended September 30, 2020 compared to nil in the same period of 2019. On October 20, 2016, Sichuan Xinda entered into an equipment purchase agreement purchase contract with Peaceful for a total consideration of RMB89.8 million (equivalent to US$12.7 million), and on May 31, 2019, Dubai Xinda entered into an equipment purchase contract with Peaceful for a total consideration of US$18.8 million to purchase production and testing equipment. As of September 30, 2020, Peaceful failed to deliver the equipments under the purchase agreements. Based on the assessment of the realizability of the prepayments, the Company recognized a provision of US$21.8 million for the period ended September 30, 2020.

Research and development expenses were US$4.4 million in the quarter ended September 30, 2020 compared with US$19.9 million in the same period in 2019, representing a decrease of US$15.5 million, or 77.9%. This decrease was due to (i) a decrease of US$14.9 million in raw materials consumption, (ii) a decrease of US$0.4 million in depreciation, and (iii) a decrease of US$0.2 million in salary and welfare for R&D personnel. As of September 30, 2020, the number of ongoing research and development projects was 347.

Total operating income was negative US$9.7 million in the third quarter ended September 30, 2020 compared to US$33.8 million in the same period of 2019, representing a decrease of 128.7% or US$43.5 million. This decrease is primarily due to the lower gross profit and the higher operating expenses. 

Net interest expenses were US$22.3 million for the three-month period ended September 30, 2020, compared to US$16.7 million in the same period of 2019, representing a increase of 33.5% or US$5.6 million, primarily due to (i) the increase of average loan interest rate from 4.70% of the same period in 2019 to 6.41% for the three-month period ended September 30, 2020 and (ii) the increase of average short-term and long-term loan balance in the amount of US$1,326.3 million for the three-month period ended September 30, 2020 compared to US$915.6 million of the same period in 2019.

The effective income tax rates for the three-month periods ended September 30, 2020 and 2019 were negative 4.5% and 24.8%, respectively. The decrease of effective income tax rate was primarily due to the increased loss before income taxes from Dubai Xinda and decreased income before taxes from HLJ Xinda Group and Sichuan Xinda.  

Net loss was US$38.0 million in the third quarter of 2020 compared to a net income of US$17.0 million in the same quarter of 2019, representing a decrease of US$55.0 million, or 323.5%. Basic and diluted losses per share for the third quarter of 2020 were both US$0.56, compared to US$0.25 earnings per share per share for the same period of 2019.

The average number of shares used in the computation of basic and diluted earnings per share for the three months ended September 30, 2020 was 67.9 million, compared to 51.8 million shares for earnings per share in the prior year period.

Earnings before interest, tax, depreciation and amortization (EBITDA) was negative $0.07 million for the third quarter of 2020, compared of $54.6 million for the same period of 2019, representing a decrease of $54.7 million, or 100.2%. For a detailed reconciliation of EBITDA, a non-GAAP measure, to its nearest GAAP equivalent, please see the financial tables at the end of this release.

Financial Condition

As of September 30, 2020, the Company had US$385.2 million in the total amount of cash and cash equivalents, restricted cash and time deposits, representing an increase of US$156.8 million or 68.7% as compared to US$228.4 million as of December 31, 2019, mainly due to the financing activity cash inflows. As of September 30, 2020, working capital was US$307.5 million (current assets minus current liabilities) and the current ratio (current assets divided by current liabilities) was 1.2, as compared to the current ratio of 1.0 as of December 31, 2019. Stockholders’ equity as of September 30, 2020 was US$877.3 million, increased by 4.8% as compared to US$836.4 million as of December 31, 2019, primarily due to the increase of US$48.0 million noncontrolling interests.

Prepaid expenses and other current assets increased by 113.2% or US$194.5 million primarily because (i) receivables due from third parties increased by US$278.2 million, partially offset by (ii) a decrease of US$42.6 million of receivables from Hong Kong Grand Royal Trading Co., Ltd., and (iii) a decrease of US$40.0 million of advances to suppliers for purchasing raw materials. The aggregate short-term and long-term bank loans increased by 39.5% due to using the line of credits to support operating and investing activities in HLJ Xinda Group and Sichuan Xinda. We define the manageable debt level as the sum of aggregate short-term and long-term loans over total assets.

Recent Development

On November 5, 2020, the Company held a special meeting of stockholders, at which the Company’s stockholders voted, among other things, in favor of the proposal to adopt the previously announced agreement and plan of merger (the “Merger Agreement”), dated as of June 15, 2020, by and among the Company, Faith Dawn Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands (“Parent”), and Faith Horizon Inc., a Nevada corporation and wholly owned subsidiary of Parent (“Merger Sub”), providing for the merger of the Merger Sub with and into the Company, with the Company continuing as the surviving corporation and as a wholly-owned subsidiary of Parent (the “Merger”).

The Merger remains subject to various customary closing conditions as set forth in the Merger Agreement. If and when completed, the proposed merger would result in the Company becoming a privately-held company and the common stock of the Company would no longer be listed on the NASDAQ Global Market or any other stock exchange, and price quotations with respect to shares of Company common stock in the public market will no longer be available

Financial Guidance and Business Outlook

As a result of the outbreak of COVID-19 in the PRC, China Auto Industry production and sales drastically decreased by 6.7% and 6.9% for the first nine months of  2020, according to the China Association of Automobile Manufacturers. It has a ripple effect and impact throughout China auto supply chain, including the Company. 

Due to the fact that the Company had temporarily closed some of its manufacturing facilities and offices in the PRC in accordance with the requirement of the PRC government, the ongoing COVID-19 pandemic has an ongoing material adverse effect on our business operations. In light of these circumstances and continuing uncertainties, the Company will not be able to forecast its financial guidance for fiscal 2020 until further notice.

About Non-GAAP Financial Measure

To supplement the Company’s consolidated financial results presented in accordance with United States Generally Accepted Accounting Principles (“GAAP”), the Company uses in this press release the following measure defined as non-GAAP financial measures by the United States Securities and Exchange Commission: EBITDA. The presentation of the non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. For more information on this non-GAAP financial measure, please see the table captioned “Reconciliation of GAAP and non-GAAP Results” set forth at the end of this press release. The Company’s management believes that this adjusted measure provides investors with a better understanding of how the results relate to the Company’s historical performance. This adjusted measure should not be considered an alternative to net income (loss), or any other measure of financial performance presented in accordance with U.S. GAAP, and is not necessarily comparable to a similarly titled measure of any other company. The accompanying tables have more details on the reconciliation between non-GAAP financial measure and its most directly comparable GAAP financial measure.

About China XD Plastics Company Limited

China XD Plastics Company Limited, through its wholly-owned subsidiaries, develops, manufactures and sells polymer composites materials, primarily for automotive applications. The Company’s products are used in the exterior and interior trim and in the functional components of 31 automobile brands manufactured in China, including without limitation, Audi, Mercedes Benz, BMW, Toyota, Buick, Chevrolet, Mazda, Volvo, Ford, Citroen, Jinbei and VW Passat, Golf, Jetta, etc. The Company’s wholly-owned research center is dedicated to the research and development of polymer composites materials and benefits from its cooperation with well-known scientists from prestigious universities in China. As of September 30, 2020, 644 of the Company’s products have been certified for use by one or more of the automobile manufacturers in China. For more information, please visit the Company’s English website at http://chinaxd.irpass.com/, and the Chinese website at http://www.xdholding.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the U.S.  Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to, the Company’s growth potential in international markets; the effectiveness and profitability of the Company’s product diversification strategy; the impact of the Company’s product mix shift to more advanced products and related pricing policies;  the effectiveness, profitability, and the marketability of the Company’s ongoing mix shift to more advanced products; the prospect of the Company’s facilities in various regions.   These forward-looking statements can be identified by terminology such as “will,” “expect,” “project,” “anticipate,” “forecast,” “plan,” “believe,” “estimate” and similar statements. Forward-looking statements involve inherent risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company and the industry. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to, the global economic uncertainty, the fluctuation in automotive sales and productions, the development of Company’s expansion plans, the slowdown of China’s automotive industry, the concentration of the Company’s distributors, customers and suppliers,  and other risks detailed in the Company’s filings with the Securities and Exchange Commission and available on its website at http://www.sec.gov. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in its expectations, except as may be required by law.  Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results.

– Financial Tables Follow –

 

 

 

 

 

 

 

 

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SOURCE China XD Plastics Company Limited

GURUGRAM, India and NEW YORK, Nov. 16, 2020 /PRNewswire/ — Yatra Online, Inc. (“Yatra”) (NASDAQ: YTRA) (OTCQX: YTROF), India’s leading Corporate Travel Services provider, today announced its participation in the following virtual conferences during November and December 2020.

Sidoti & Co Microcap Virtual Investor Conference on Thursday November 19, 2020. CEO Dhruv Shringi’s  presentation will begin at 8:30am EST. A live webcast of the presentation will be available to the public at http://investors.yatra.com/. Management will also participate in virtual one-on-one meetings.

Benzinga Global Small Cap Conference on December 9, 2020. CEO Dhruv Shringi will be presenting at the conference.  Management will also participate in virtual one-on-one meetings. A live webcast of the presentation will be available to the public at http://investors.yatra.com/.

A replay of all the webcasts will be available for 90 days following each presentation.

About Yatra Online, Inc.

Yatra Online, Inc. is the parent company of Yatra Online Pvt. Ltd. which is based in Gurugram, India and is India’s leading Corporate Travel services provider with over 700+ Corporate customers and one of India’s leading online travel companies and operates the website https://www.yatra.com/. The company provides information, pricing, availability, and booking facility for domestic and international air travel, domestic and international hotel bookings, holiday packages, buses, trains, in city activities, inter-city and point-to-point cabs, homestays and cruises. As a leading platform of accommodation options, Yatra provides real-time bookings for more than 103,000 hotels in India and over 1,500,000 hotels around the world.

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SOURCE Yatra Online, Inc.

FREMONT, Calif., Nov. 16, 2020 /PRNewswire/ — Aerkomm Inc. (“Aerkomm” or “the Company”) (Euronext Paris: AKOM; OTCQX: AKOM), a development stage service provider of In-Flight Entertainment and Connectivity solutions for the airline industry using Ka-band technology, today announced that on November 9, 2020, the Company filed its quarterly report on Form 10-Q for the quarter ended September 30, 2020 with the U.S. Securities and Exchange Commission (the “SEC”). The quarterly report is available in the “Regulatory” section of Aerkomm’s website at https://ir.aerkomm.com/quarterly-reports as well as on the SEC’s website at https://www.sec.gov/Archives/edgar/data/1590496/000121390020035939/0001213900-20-035939-index.htm.

About Aerkomm Inc.

Aerkomm Inc. (Euronext Paris: AKOM; OTCQX: AKOM), operating through its wholly owned subsidiary, Aircom Pacific, Inc., is a development stage service provider of in-flight entertainment and connectivity solutions for the airline industry. The Company strives to become a leading provider of a wide range of in-flight broadband entertainment and connectivity services, including Wi-Fi connectivity, cellular networks, movies, gaming, live television, and music. Aerkomm aims to reshape the market for in-flight entertainment and connectivity services by offering on-board connectivity to its airline partners and passengers for free, generating revenue through advertising and on-board transactions.

More information about Aerkomm is available at www.aerkomm.com.

Safe Harbor Statement

This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our periodic filings with the Securities and Exchange Commission (the “SEC”) under the Securities Exchange Act of 1934, as amended, as well as in our Registration Statement on Form S-1 filed with the SEC (SEC File No. 333-237942) on April 30, 2020, as amended to date. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

William Zima

ICR Inc.
[email protected]
+1 (203) 682-8233

 

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SOURCE Aerkomm Inc.

SAN ANTONIO, Texas, Nov. 16, 2020 /PRNewswire/ — Biglari Capital Corp. (together with its affiliates, “Biglari Capital”), one of the largest and longest-standing shareholders of Cracker Barrel Old Country Store, Inc. (the “Company” or “Cracker Barrel”) (NASDAQ:CBRL), beneficially owning approximately 8.7% of the Company’s outstanding common stock, today issued the following statement in support of its nominee for election to the Cracker Barrel board of directors (the “Board”) at the Company’s upcoming annual meeting of shareholders, scheduled for November 19, 2020. 

For weeks now, Cracker Barrel has tried to mislead investors into believing the election of directors at its 2020 annual shareholders meeting is not about Cracker Barrel, but rather about Biglari Capital. But Biglari is not running for a Board seat, nor is any individual who has any relationship with Biglari Capital or is otherwise beholden to it in any way. Rather, we have nominated Raymond P. (“Rick”) Barbrick, a highly qualified restaurant industry executive with over 30 years of experience, whose independence has been affirmed by Institutional Shareholder Services Inc. (“ISS”). 

Why Cracker Barrel needs a director with relevant restaurant experience

The Company has failed to achieve its three-year plan, failed to increase customer traffic, lagged in total shareholder return, and botched its investment in Punch Bowl Social, which cost shareholders over $137 million in eight months. It is inconceivable to us that, despite the ongoing downturn in its business, the Company has eschewed putting an experienced industry executive on the Board who could bring expertise to these matters. The four directors the Company has added in the past three years have absolutely no relevant expertise, including the two directors brought on after the Punch Bowl Social debacle, which, according to ISS, “exposed the lack of appropriate restaurant experience on the board.” [1]

Clearly, if the Company had directors with the right experience, then management would not have been allowed to run rampant with undisciplined spending on capital expenditures, acquisitions, and investments, which have all gone unchecked precisely because the Board lacks relevant restaurant expertise. It is not surprising that management wants to preserve the status quo, considering the current Board went out of its way to pay the Company’s executives bonuses when none was earned, eliminate the performance-vesting requirements of 2019 and 2020 equity awards, and gift CEO Sandy Cochran over $6 million in compensation in the midst of a global pandemic. It is time for these excesses to stop and for the Board to return its full attention to enhancing the core Cracker Barrel brand, overseen by a new director with extensive experience in both restaurant operations and capital allocation. 

Why it is urgent to add a director with relevant experience

It is during crises such as the current pandemic that a company’s leaders must have the relevant skill set to navigate through key strategic decisions. Much as it would be absurd to fill an investment management company with directors lacking any financial market expertise, it is misguided to fill the board of a casual dining restaurant chain with directors possessing no casual dining expertise.

Adding to this urgency is the Board’s extreme mishandling of its initial investment in, and subsequent exit from, the Punch Bowl Social project. To be sure, we were opposed to the Punch Bowl Social investment, for we thought the price paid was sky-high and that entering into the nightlife business was a strategic mistake. But once the investment was made, through equity and debt positions, we thought the Board’s decision to exit Punch Bowl Social without becoming an unsecured creditor was also a poor demonstration of judgment, as it meant the Company would be unable to salvage any value from its investment. In an act of inexplicable recklessness, the Board determined to exit Punch Bowl Social before the passage of the CARES Act, when it was impossible to know what would be contained in it.

Yet what makes the current situation most urgent is that just weeks ago, the Board and management affirmed their intention to maintain their strategy of acquisitions in unrelated and untested concepts. CEO Sandy Cochran, in her October 1, 2020 letter to shareholders, insisted that Cracker Barrel will continue to “Extend our Brand by seeking opportunities where we can leverage our scale and expertise and either create or invest in other concepts.” Statements such as this should cause alarm in shareholders, as they further demonstrate the critical need for a director on the Board who can ask the right questions and hold management accountable for its actions, before the Board compounds its past errors and destroys even more value for shareholders. If the Board contemplates other acquisitions, shareholders should welcome a director with relevant experience who has navigated restaurant acquisitions and has no prior relationship with any other director.

Rick Barbrick, highly qualified independent Board nominee

Fortunately, we have done the work that the Company left undone and, through our own efforts, have identified and recruited an independent and highly qualified candidate, Rick Barbrick, to rectify what ISS called the “shortage of relevant restaurant industry experience on the board.” Mr. Barbrick has over 30 years of restaurant experience in casual dining and fast food businesses, most recently as President, Co-Chief Executive Officer, and Chief Operating Officer of the Briad Group, the owner-operator of one of the largest Wendy’s franchises in North America. Prior to March 2020, Briad was a TGI Fridays franchisee as well, and at one point was the largest TGI Fridays operator. Mr. Barbrick has also led and operated a number of restaurant concepts, including Avado Brands, Inc. (d/b/a Don Pablo’s Restaurant) (formerly NASDAQ: AVDO) and Bertucci’s. In fact, if he is elected at the upcoming annual meeting, Mr. Barbrick would be the only director on the Board who has experience in managing a freestanding restaurant chain. 

Mr. Barbrick’s experience is ideally suited to Cracker Barrel’s primary strategic initiative to “enhance the core” because, in stark contrast to the incumbent directors, he has been involved in all operations of a restaurant company. Thus, he would know the right questions to ask in board deliberations, including those concerning capital allocation, succession planning, and other governance matters. As a leader of restaurant companies, Mr. Barbrick has: 

• Spearheaded Bertucci’s transformation from “pizzeria” to a full-service casual dining concept
• Executed strategic plans, marketing and operating initiatives, menu enhancements, and the reimaging of units
• Acquired and divested various restaurant companies
• Evolved a corporate culture in which staff is highly motivated to attend to every detail of the restaurant environment and guest experience
• Focused on creating community goodwill by partnering with local charities and building relationships to support the opening of new restaurants
• Created unique family dining experiences

Based on his extended and accomplished career, including his work for a number of private equity sponsors, no one can plausibly deny that Mr. Barbrick would bring his own perspective and expertise to the Board, would work constructively with the other directors, and would serve as an independent voice for the benefit of all shareholders.  It is without dispute that Mr. Barbrick has been a productive, rather than a disruptive, force on every board on which he has previously served.

Compare Mr. Barbrick’s experience with that of the Company’s nominee, Norman Johnson.
Mr. Johnson has:

• Had absolutely no restaurant experience, having previously served as an executive of a filtration company and on the boards of a valve manufacturer and a provider of transportation and trucking services
• Not been listed in the Company’s proxy statement as having any financial experience, despite Ms. Cochran’s claim that he is a “financial expert” serving on the audit committee
• Been purported to have “intimate knowledge of…acquisitions and growth strategies,” yet has presided over a failed acquisition strategy that has caused substantial value destruction for shareholders
• Overseen a Board “refreshment” process that appears to have been more about “who you know,” considering the backstory of Mr. Johnson’s own election to the Board back in 2012

The $5 Million Question

We nominated one individual with exactly the experience the Board desperately needs, which we thought would avoid a proxy contest. The question shareholders must ask is: Why is Cracker Barrel wasting more than $5 million of shareholders’ money simply to fight Mr. Barbrick’s candidacy? The Board’s unreasonableness has forced us into a proxy contest. We believe one Board seat not only sends the right message, but also changes the dynamics in the boardroom to avoid poor compensation plans, poor acquisition strategies, and poor expansion initiatives. But the Board would rather fight Mr. Barbrick’s nomination during a pandemic than expand the Board with an experienced restaurant executive. The Company would have you believe that its current directors already possess relevant backgrounds, but shareholders should see right through this hollow claim, just as ISS has: “The independent directors do possess substantial experience in the food service sector, just not with independent dining brands and diners who have come to venues primarily for a dining experience.” ISS also noted “they have only incidental and captive-dining expertise.”

The Company failed to bring in someone with relevant restaurant experience, we believe, because the Board did not know its importance. A similar breakdown occurred when it pursued and exited Punch Bowl Social, another governance failure from a lack of relevant restaurant experience on the Board. We identified a serious skill-set gap on the Board and then presented someone who has the expertise no other director on the Board possesses. There is no reason to give the Board a pass on its governance failures. The Board has had its opportunity to make the necessary changes — yet it has failed in its refreshment process.

Accordingly, as one of the Company’s largest shareholders, we urge our fellow shareholders to support the election of the highly qualified and independent restaurant executive Rick Barbrick to the Board and vote the GOLD proxy card today.

[1] Permission to quote ISS was neither sought nor obtained.

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SOURCE Biglari Capital Corp.

 

– Q3 2020 Adjusted Total Revenue – $16.7 million –
– Q3 2020 Adjusted EBITDA – $6.6 million –
– Blexten Canadian Prescriptions Increased 30% Year-Over-Year –
– Cambia Canadian Prescriptions Increased 13% Year-Over-Year –

  Nuvo to Host Conference Call/Audio Webcast November 16 at 8:30 a.m. ET

MISSISSAUGA, ON, Nov. 16, 2020 /PRNewswire/ – Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX: NRI) (OTCQX: NRIFF), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, today announced its financial and operational results for the three and nine months ended September 30, 2020.  For further details on the results, please refer to Nuvo’s Management, Discussion and Analysis (MD&A) and Condensed Consolidated Interim Financial Statements for the three and nine months ended September 30, 2020 which are available on the Company’s website (www.nuvopharmaceuticals.com).  All figures are in Canadian dollars, unless otherwise noted.

Key Developments
Three months ended September 30, 2020 include the following:

• Adjusted total revenue⁽¹⁾ was $16.7 million, a decrease of 12% compared to $18.9 million for the three months ended September 30, 2019.
• Adjusted EBITDA⁽¹⁾ was $6.6 million, a decrease of 15% compared to $7.8 million for the three months ended September 30, 2019. 
• The Company’s Commercial Business segment includes the promoted products – Blexten^® and Cambia ^®.  Revenue related to these products was $6.4 million, an increase of 21% compared to revenue of $5.3 million for the three months ended September 30, 2019.  Canadian prescriptions of Blexten and Cambia increased by 30% and 13%, respectively compared to the three months ended September 30, 2019.
• Principal loan repayments of $3.7 million (US$2.8 million).

Nine months ended September 30, 2020 include the following:

• Adjusted total revenue⁽¹⁾ was $53.6 million, a decrease of 3% compared to $55.1 million for the nine months ended September 30, 2019.
• Adjusted EBITDA⁽¹⁾ was $22.2 million, an increase of 19% compared to $18.7 million for the nine months ended September 30, 2019. 
• Revenue related to Blexten and Cambia was $18.7 million, an increase of 34% compared to revenue of $13.9 million for the nine months ended September 30, 2019.  Canadian prescriptions of Blexten and Cambia increased by 37% and 13%, respectively compared to the nine months ended September 30, 2019.
• Principal loan repayments of $18.8 million (US$14.0 million).

Business Update

• As a result of the COVID-19 pandemic, the Company has made changes to operations to ensure our employees are safe and healthy, while the business continues to supply global partners, wholesalers, pharmacies, and ultimately patients, with our healthcare products. The Commercial Business segment had continued organic growth of its key promoted products – Blexten and Cambia. The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic which increased revenue in the three months ended March 31, 2020 and reduced revenue in the three months ended June 30, 2020 as the pandemic progressed. Buying patterns stabilized in the three months ended September 30, 2020. It is anticipated that the COVID-19 pandemic may continue to impact the timing of revenue in future quarters and the Company will monitor market dynamics accordingly.
• In September 2020, Aralez Pharmaceuticals Canada, Inc. (Aralez Canada) received notice that Health Canada had issued a medical device license for two new line extensions of NeoVisc^®. NeoVisc is a viscosupplement used to replenish the synovial fluid in the joints of patients with osteoarthritis. NeoVisc One contains the lowest injection volume (only 4ml) available for single-dose viscosupplements in Canada. Neovisc Plus consists of a three injection dosing system that is administered to a patient over the course of a few weeks. In some patients, a three dose treatment may provide longer relief.
• In September 2020, Aralez Canada launched Suvexx^® into the approximately $130 million Canadian prescription acute migraine market. Suvexx (sumatriptan succinate and naproxen sodium tablets) is a fixed-dose combination prescription medication, indicated for the acute treatment of migraine attacks with or without aura in adults. Suvexx helps patients manage acute migraine attacks using a combination of sumatriptan succinate and naproxen sodium in a single tablet.
• In August 2020, the Blexten pediatric dossier was accepted for review by Health Canada. If approved, Blexten pediatric will be available in both an oral syrup formulation (2.5mg/ml) and an orally dispersible tablet formulation (10mg tablets). A regulatory decision from Health Canada is anticipated by mid-2021.
• During the three months ended September 30, 2020, the Company made a $3.7 million (US$2.8 million) principal repayment on the Amortization Loan, included within the loans held by Deerfield Management Company, L.P and its related entities (the Deerfield Loans). Since January 1, 2020, the Company has repaid $18.8 million (US$14.0 million) of the Deerfield Loans – $4.5 million (US$3.5 million) to discharge the Bridge Loan which bore interest at 12.5% and $14.2 million (US$10.5 million) against the Amortization Loan which bears interest at 3.5%. As of September 30, 2020, the total remaining balances of the Deerfield Loans consisted of: US$49.5 million on the Amortization Loan and US$52.5 million on the Convertible Loan both of which bear interest at 3.5%.

“In September, we launched our innovative treatment for acute migraine attacks, Suvexx, into the Canadian market.  Thus far, the Suvexx launch has been well received with encouraging feedback from physicians and patients who now have access to this new medicine.  Despite the COVID-19 pandemic, our key promoted products, Blexten and Cambia, have continued to grow both in terms of total prescriptions and market share versus 2019.  The loss of the guaranteed minimum royalty for Vimovo in the U.S. has negatively impacted our top-line sales revenue; however, the restructuring we implemented in Q2 2019 has helped to improve both our adjusted EBITDA and cash from operating activities during the quarter and year-to-date,” said Jesse Ledger, Nuvo’s President & CEO.  “In Q3, we made continued progress in repaying our debt to Deerfield and have now repaid over $18 million year-to-date.  We continue to meet our growth strategy objectives and look forward to a strong finish to the year.”

Third Quarter 2020 Financial Results 
Total revenue is comprised of product sales, license revenue and contract revenue.  Total revenue was $16.6 million and $56.5 million for the three and nine months ended September 30, 2020 compared to $18.8 million and $50.0 million for the three and nine months ended September 30, 2019.

Adjusted total revenue was $16.7 million and $53.6 million for the three and nine months ended September 30, 2020 compared to $18.9 million and $55.1 million for the three and nine months ended September 30, 2019.  The $2.2 million decrease in adjusted total revenue in the current quarter was primarily attributable to a decrease of $1.6 million of revenue in the Licensing and Royalty Business segment, combined with a decrease of $0.4 million of revenue in the Production and Service Business segment and a $0.1 million decrease in revenue from the Commercial Business segment. The Commercial Business segment revenue had continued organic growth of its key promoted products – Blexten and Cambia.  The possibility of future supply disruptions resulted in forward buying linked to the COVID-19 pandemic which increased revenue in the three months ended March 31, 2020 and reduced revenue in the three months ended June 30, 2020 and stabilized in the three months ended September 30, 2020 as the pandemic progressed and buying patterns returned to normal.  The COVID-19 pandemic may impact the timing of revenue in future quarters and the Company will continue to monitor market dynamics accordingly.  For the three months ended September 30, 2020, the Licensing and Royalty Business segment revenue decreased primarily due to a reduction in both U.S. and rest of world net sales of Vimovo. The Production and Service Business segment revenue decreased as a result of a decrease in the Company’s Pennsaid product sales. 

Adjusted EBITDA was $6.6 million and $22.2 million for the three and nine months ended September 30, 2020 compared to $7.8 million and $18.7 million for the three and nine months ended September 30, 2019.  The decrease in the current quarter was primarily attributable to the decrease in gross profit of $2.4 (net of revenue recognized upon recognition of contract assets, amounts billed to customers for existing contract assets and inventory-step up expenses, partially offset by a decrease in general and administrative (G&A) expenses (net of amortization).  This decline in gross profit was due to a decrease in adjusted total revenue, partially offset by an increase in gross margin percentage on product sales due to the receipt of the Canada Emergency Wage Subsidy, as well as changes in product mix.

Gross profit on total revenue was $10.2 million or 61% and $39.1 million or 69% for the three and nine months ended September 30, 2020 compared to a gross profit of $11.3 million or 60% and $30.0 million or 60% for the three and nine months ended September 30, 2019.  The decrease in gross profit for the current three was primarily attributable to a decrease in license revenue, partially offset by an increase in gross margin on product sales (See Total Revenue above).  The increase in gross profit for the current nine-month period was primarily attributable to an increase in license revenue and gross margin on product sales (See Total Revenue above).

Non-IFRS Financial Measures
The Company discloses non-IFRS measures (such as adjusted total revenue, adjusted EBITDA and adjusted EBITDA per share) that do not have standardized meanings prescribed by IFRS.  The Company believes that shareholders, investment analysts and other readers find such measures helpful in understanding the Company’s financial performance and in interpreting the effect of the Aralez Transaction and the Deerfield Financing on the Company.  Non-IFRS financial measures do not have any standardized meaning prescribed by IFRS and may not have been calculated in the same way as similarly named financial measures presented by other companies.

The following is a summary of how adjusted total revenue is calculated:

Adjusted EBITDA
EBITDA refers to net income (loss) determined in accordance with IFRS, before depreciation and amortization, net interest expense (income) and income tax expense (recovery).  The Company defines adjusted EBITDA as net income before net interest expense (income), depreciation and amortization and income tax expense (recovery) (EBITDA), plus amounts billed to customers for existing contract assets, inventory step-up expenses, stock-based compensation expense, Other Expenses (Income), less revenue recognized upon recognition of a contract asset and other income.  Managexment believes adjusted EBITDA is a useful supplemental measure to determine the Company’s ability to generate cash available for working capital, capital expenditures, debt repayments, interest expense and income taxes.

The following is a summary of how EBITDA and adjusted EBITDA are calculated:

Management to Host Conference Call/Webcast
Management will host a conference call to discuss the results today (Monday, November 16, 2020) at 8:30 a.m. ET.  To participate in the conference call, please dial 416 764 8688 or 1 888 390 0546.  Please call in 15 minutes prior to the call to secure a line.  You will be put on hold until the conference call begins.

A taped replay of the conference call will be available two hours after the live conference call and will be accessible until midnight on November 23, 2020 by calling 416 764 8677 or 1 888 390 0541 / replay passcode: 499774#.

A live audio webcast of the conference call will be available through www.nuvopharmaceuticals.com.  Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to hear the webcast.

About Nuvo Pharmaceuticals Inc
Nuvo (TSX: NRI; OTCQX: NRIFF) is a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products.  The Company’s products target several therapeutic areas, including pain, allergy and dermatology.  The Company’s strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets.  Nuvo’s head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and its manufacturing facility is located in Varennes, Québec, Canada.  The Varennes facility operates in a Good Manufacturing Practices (GMP) environment respecting the U.S, Canada and E.U. GMP regulations and is regularly inspected by Health Canada and the U.S. Food and Drug Administration.  For additional information, please visit www.nuvopharmaceuticals.com.

Forward-Looking Statements

This press release contains “forward-looking information” as defined under Canadian securities laws (collectively, “forward-looking statements”). The words “plans”, “expects”, “does not expect”, “goals”, “seek”, “strategy”, “future”, “estimates”, “intends”, “anticipates”, “does not anticipate”, “projected”, “believes” or variations of such words and phrases or statements to the effect that certain actions, events or results “may”, “will”, “could”, “would”, “should”, “might”, “likely”, “occur”, “be achieved” or “continue” and similar expressions identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking statements. 

Forward-looking statements are not historical facts but instead represent management’s expectations, estimates and projections regarding future events or circumstances, including the anticipated receipt of certain milestone and royalty payments, the anticipated launch of certain products and the potential impact of COVID-19. Such forward-looking statements are qualified in their entirety by the inherent risks, uncertainties and changes in circumstances surrounding future expectations which are difficult to predict and many of which are beyond the control of the Company. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic and competitive uncertainties and contingencies and may prove to be incorrect. Material factors and assumptions used to develop the forward-looking statements, and material risk factors that could cause actual results to differ materially from the forward-looking statements, include but are not limited to, the validity of the ‘907 and ‘285 Patents claims, the outcome of ongoing patent litigation, the potential impact of COVID-19 on the Company’s operations, business and financial results and other factors, many of which are beyond the control of Nuvo.  Additional factors that could cause Nuvo’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo’s most recent Annual Information Form dated February 24, 2020 under the heading “Risks Factors”, and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo’s forward-looking statements. Forward-looking statements should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not the times at or by which such performance or results will be achieved.

All forward-looking statements are based only on information currently available to the Company and are made as of the date of this press release. Except as expressly required by applicable Canadian securities law, the Company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements in this press release are qualified by these cautionary statements.

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SOURCE Nuvo Pharmaceuticals Inc.

FREMONT, Calif., Nov. 16, 2020 /PRNewswire/ — Aerkomm Inc. (“Aerkomm” or “the Company”) (Euronext Paris: AKOM; OTCQX: AKOM), a development stage service provider of In-Flight Entertainment and Connectivity solutions for the airline industry using Ka-band technology, today announced that on November 5, 2020. it filed an S-1/A3 registration statement amendment with the Securities and Exchange Commission (the “SEC”) relating to a proposed offering of up to Euro 40 million in new shares of its common stock. The price for the shares of common stock to be offered is expected to be €20.50 per share.

The Company plans to use the proceeds from this offering for general corporate purposes, including working capital, product development, marketing activities, expanding its internal organization and other capital expenditures including the building of the Company’s first ground station and data center in the Asia region.

The offering will be made only by means of a prospectus filed with the SEC. A copy of the preliminary prospectus relating to the offering is available, for free, on the SEC’s website at https://www.sec.gov/Archives/edgar/data/1590496/000121390020035203/0001213900-20-035203-index.htm. A copy also may be obtained from the Company. A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Aerkomm Inc.

Aerkomm Inc. (Euronext Paris: AKOM; OTCQX: AKOM), operating through its wholly owned subsidiary, Aircom Pacific, Inc., is a development stage service provider of in-flight entertainment and connectivity solutions for the airline industry. The Company strives to become a leading provider of a wide range of in-flight broadband entertainment and connectivity services, including Wi-Fi connectivity, cellular networks, movies, gaming, live television, and music. Aerkomm aims to reshape the market for in-flight entertainment and connectivity services by offering on-board connectivity to its airline partners and passengers for free, generating revenue through advertising and on-board transactions.

More information about Aerkomm is available at www.aerkomm.com.

Safe Harbor Statement

This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our periodic filings with the Securities and Exchange Commission (the “SEC”) under the Securities Exchange Act of 1934, as amended, as well as in our Registration Statement on Form S-1 filed with the SEC (SEC File No. 333-237942) on April 30, 2020, as amended to date. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

William Zima

ICR Inc.
[email protected]
+1 (203) 682-8233

 

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SOURCE Aerkomm Inc.

FREMONT, Calif., Nov. 16, 2020 /PRNewswire/ — Aerkomm Inc. (“Aerkomm” or “the Company”) (Euronext Paris: AKOM; OTCQX: AKOM), a development stage service provider of In-Flight Entertainment and Connectivity solutions for the airline industry using Ka-band technology, today announced the United States Securities and Exchange Commission (the “SEC”) has declared the Company’s registration statement on Form S-1 effective (File No. 333-233674) as of November 6, 2020.

This S-1 Registration Statement relates to the Company selling maximum of 1,951,219 shares, or €40,000,000, of common stock at a €20.50 offering price per share. The Company plans to use the proceeds from this offering for general corporate purposes, including working capital, product development, marketing activities, expanding its internal organization and other capital expenditures including the building of the Company’s first ground station and data center in the Asia region.

The SEC’s Notice of Effectiveness may be accessed through the SEC’s website at https://www.sec.gov/Archives/edgar/data/1590496/999999999520003093/9999999995-20-003093-index.htm.  A copy also may be obtained from the Company. A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Aerkomm Inc.

Aerkomm Inc. (Euronext Paris: AKOM; OTCQX: AKOM), operating through its wholly owned subsidiary, Aircom Pacific, Inc., is a development stage service provider of in-flight entertainment and connectivity solutions for the airline industry. The Company strives to become a leading provider of a wide range of in-flight broadband entertainment and connectivity services, including Wi-Fi connectivity, cellular networks, movies, gaming, live television, and music. Aerkomm aims to reshape the market for in-flight entertainment and connectivity services by offering on-board connectivity to its airline partners and passengers for free, generating revenue through advertising and on-board transactions.

More information about Aerkomm is available at www.aerkomm.com.

Safe Harbor Statement

This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our periodic filings with the Securities and Exchange Commission (the “SEC”) under the Securities Exchange Act of 1934, as amended, as well as in our Registration Statement on Form S-1 filed with the SEC (SEC File No. 333-237942) on April 30, 2020, as amended to date. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Investor Relations Contact:

William Zima

ICR Inc.
[email protected]
+1 (203) 682-8233

 

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SOURCE Aerkomm Inc.

Project Lucy Submits Pre-IND Briefing Package to the FDA; Agrees Q1 Interim Analysis of Swiss Phase 2a Trial of LSD Assisted Therapy for Anxiety Disorders

NEW YORK and BASEL, Switzerland, Nov. 16, 2020 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, has received a positive response on its protocol design for a Phase 2a clinical trial evaluating microdoses of LSD in the treatment of adult ADHD from the Swiss and Dutch health authorities. MindMed has also successfully submitted a pre-IND briefing package to the FDA for its Project Lucy, a potential Phase 2b Efficacy Trial evaluating LSD Assisted Therapy in anxiety disorders. In addition, the company has now reached an agreement with University Hospital Basel Liechti Lab to conduct an interim analysis anticipated in Q1 2021 for its Phase 2a clinical trial of LSD assisted therapy for anxiety disorders currently ongoing in Switzerland.

Microdose LSD Positive Regulatory Response

MindMed’s Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities. MindMed is working with our site coordinators in Switzerland and the Netherlands on our patient recruitment strategy and will provide updates on recruitment progress in due course. MindMed anticipates dosing to begin in patients in the second half of next year at both of our sites in Basel, Switzerland and Maastricht, Netherlands. MindMed’s clinical and technical operation teams are in the process of producing and preparing the GMP LSD material necessary to begin dosing for the Phase 2a commercial drug trial.

J.R. Rahn, MindMed co-founder and co-CEO said: “We are very pleased with the positive response from the Swiss and Dutch regulators on our protocol design evaluating microdoses of LSD for Adult ADHD in our planned Phase 2a trial. Our team has been working diligently to prepare this trial and we are very excited to begin recruitment and plan on dosing ADHD patients in the second half of 2021.”

MindMed’s microdosing division is now evaluating the potential for additional microdosing technologies as part of our R&D efforts and growing its portfolio of microdose-related clinical trials.

Submission of Pre-IND Briefing Package to the FDA

MindMed’s clinical and regulatory team has recently completed a pre-IND briefing package and submitted it last week to the FDA in preparation for a pre-IND call with the FDA in December. Data from a recently completed Phase 1 dose range finding study by the Liechti Lab together with multiple other Phase 1 studies conducted both in patients and healthy volunteers over the past 10 years helped define the dosing regimen proposed by MindMed to the FDA for the proposed Phase 2b clinical trial.

These efforts at FDA and our clinical strategy for LSD are being led by MindMed President Dr. Miri Halperin Wernli and her team of drug development experts and scientific collaborators. Dr. Halperin Wernli added: “Our team worked very diligently throughout the third quarter to prepare the pre-IND briefing package, drawing on support from many of our scientific collaborators and domain experts. We hope to open the IND for this Phase 2b trial and to begin treating patients in 2021.”

Swiss Phase 2a Study Interim Analysis

MindMed was able to agree with the Liechti Lab and receive approval from the ethics committee at the University Hospital Basel to undertake an interim readout and analysis of the Phase 2a study using LSD assisted therapy for anxiety disorders being conducted in Switzerland by Dr. Matthias Liechti and Dr. Peter Gasser. MindMed in partnership with the Liechti Lab will conduct this interim analysis of the Phase 2a clinical trial data in Q1 2021. The study has been ongoing for close to four years and MindMed eagerly awaits the analysis and results from the interim readout of the study.

MindMed maintains an exclusive license to this Phase 2 study as part of our license agreement with the University Hospital Basel. More info on the trial can be found here:

https://clinicaltrials.gov/ct2/show/NCT03153579?term=Basel+lsd&draw=2&rank=7

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, ” Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities of the Company will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons except in certain transactions exempt from the registration requirements of the U.S. Securities Act)

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SOURCE Mind Medicine (MindMed) Inc.