Archive for September, 2017
NEW YORK, NY–(Sep 22, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring ChineseInvestors.com, Inc. (OTCQB: CIIX), a client of NNW recognizing unprecedented opportunities in the U.S. cannabis industry and laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.
The publication is titled, “Cannabinoid Consumer Market Booming as CBD Enjoys Growth in Public Sentiment.” It discusses various cannabis-based public companies determined to expand with the booming cannabis market.
To view the full publication, visit: https://www.networknewswire.com/cannabinoid-consumer-market-booming-cbd-enjoys-growth-public-sentiment/
“Branching out into the unique adaptations of the hemp oil business made perfect business sense for ChineseInvestors.com (CIIX) (www.ChineseInvestors.com), a leading financial information website for Chinese-speaking consumers and investors. CIIX has already established two wholly-owned subsidiaries based in China and the United States. CBD Biotechnology Co., Ltd., located in the free trade zone of Shanghai, China, has plans to deliver a hemp-infused skin care line in China before the end of 2017, while ChineseHempOil.com, Inc., located in the U.S., has launched its first hemp oil product line, ‘OptHemp.’
“While the demand for hemp-based cannabidiol has skyrocketed, so have the number of companies jumping into the market, Marijuana Business Daily reports (http://nnw.fm/7ENhH). There are now hundreds, if not thousands of hemp CBD companies flooding the market looking to take advantage of the profits to be made in the global cannabis industry. For companies like ChineseInvestors.com, which has been in business since 1999, capitalizing on the convergence of CBD and the nutrition and health products market in mainland China was a no-brainer.”
About ChineseInvestors.com
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail and online sales of hemp-based products and other health related products. For more information visit www.ChineseInvestors.com.
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information please visit https://www.NetworkNewsWire.com
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Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
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LOS ANGELES, Sept. 21, 2017 — Nova LifeStyle, Inc. (NASDAQ:NVFY) or (the “Company,” “Nova”), a U.S.-based innovative designer and distributor of modern LifeStyle products is pleased to announce that based upon market surveys, follow-up interviews, and performance index comparisons, US News Express has selected Diamond Sofa, a Nova LifeStyle company as one of the top 5 Asian American Brands.
Established in California in 1992, Diamond Sofa is one of the best recognized furniture brands in the United States, embracing innovative designs and urban contemporary styles.
Nova LifeStyle Anticipates Robust Profit in Third Quarter 2017
Nova LifeStyle’s third quarter profit has increased substantially compared to the prior year period. Based on a preliminary review of third quarter results, Nova anticipates robust third quarter financial performance driven by an increase in consumer demand and new product launches.
The Company also successfully completed a milestone business transformation in late 2016 when Nova divested its factories and franchise stores, thus transforming Nova’s business model from a manufacturing-oriented, asset-heavy enterprise into an asset-light operation focused on modern product design, efficient distribution and marketing.
The Company’s product stock keeping units (“SKUs”) have grown over 200% since 2016. The Company’s products have been experiencing strong ordering activity at leading online retailers Amazon.com, Wayfair Inc. and Hayneedle.com. Diamond Sofa has also maintained a long-term relationship with four furniture subsidiaries owned by Warren Buffet’s Berkshire Hathaway Inc.
For more information about Nova LifeStyle products and brands please visit http://www.novalifestyle.com or http://www.diamondsofa.com.
About Nova LifeStyle
Nova LifeStyle, Inc., a NASDAQ Global Market listed company headquartered in California, is a fast growing, innovative designer, manufacturer and distributor of modern LifeStyle furniture; primarily sofas, dining rooms, cabinets, office furniture and related components, bedrooms, and various accessories in matching collections. Visit Nova’s website: www.NovaLifeStyle.com.
Safe Harbor Statement
All statements in this press release that are not historical are forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ from the company’s expectations. You are cautioned not to place undue reliance on any forward-looking statements in this press release as they reflect Nova’s current expectations with respect to future events and are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated. Potential risks and uncertainties include, but are not limited to, the risks described in Nova’s filings with the Securities and Exchange Commission.
Company Contact:
Investor Relations:
The Equity Group Inc.
In U.S.
Adam Prior, Senior Vice President
+1 (212) 836-9606
aprior@equityny.com
BERKELEY HEIGHTS, N.J., Sept. 21, 2017 — Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, announced today that the Company will present at the Ladenburg Thalmann 2017 Healthcare Conference on September 26 at 2:30 p.m. EDT, in Track 2-Odeon at the Sofitel Hotel, New York. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs.
A live webcast of the presentation will be available through the Company’s corporate website: www.cyclacel.com. The webcast will be archived for 90 days.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel’s transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
Plans to start Coversin Phase III in PNH in Q1 2018
NEW YORK and LONDON, Sept. 21, 2017 — Akari Therapeutics (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, announces that, following advice from a recent FDA Type B End of Phase II Meeting, it plans to advance its lead investigational drug, Coversin™, towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Q1 2018.
“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.”
Akari plans to carry out two Phase III clinical studies: CAPSTONE, in naïve PNH patients where eculizumab (Soliris®; Alexion) is not the standard of care, with co-primary clinical endpoints based on hemoglobin and transfusion data, and ASSET, a Phase III clinical study switching PNH patients from eculizumab, the current standard of care treatment in PNH in the U.S., to treatment with Coversin.
The FDA indicated that providing safety and efficacy data from the Company’s clinical trials for the proposed number of unique PNH patients on Coversin for more than one year seems reasonable, subject to review of the actual data upon submission. The number proposed includes patients having C5 polymorphisms conferring eculizumab resistance.
“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin’s actions on both the complement and leukotriene (LTB4) pathways play a role. Its two leading targets in this area are atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP), a rare skin disorder,” added Solomon.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression. Akari’s lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long acting versions.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 20-F filed on March 31, 2017. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
For more information
Investor Contact:
The Trout Group
Tricia Truehart
ttruehart@troutgroup.com
+1 646 378 2953
Media Contact:
Mary-Jane Elliott / Sukaina Virji
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com
September 21, 2017
NetworkNewsWire Editorial Coverage: Medical cannabis sales are set to impress even the most timid investor, with projected sales of nearly $5 billion in 2017, or about 67% of the $7.2 billion legal cannabis market. Hemp-derived cannabidiol (CBD) product sales are also expected to be a billion-dollar business within three years, growing at a projected 55% compound annual growth rate from 2016’s $170 million in revenue, according to an article in Forbes(1). As the cannabis industry continues to flourish, many publicly traded companies are finding ample opportunities to thrive. Standout companies determined to grow with the industry include ChineseInvestors.com (CIIX) (CIIX Profile), CV Sciences, Inc. (CVSI), Terra Tech Corp. (TRTC), Medical Marijuana, Inc. (MJNA) and Hemp, Inc. (HEMP)
It’s worthwhile to note that significant changes in the acceptance of medical and recreational marijuana also includes the alternative forms of CBD-infused and hemp-derived products, which most people now understand do not contain THC, the psychoactive compound found in marijuana. A massive amount of research into the health benefits of CBD and its effect on mental health disorders is also underway in the scientific community.
Branching out into the unique adaptations of the hemp oil business made perfect business sense for ChineseInvestors.com (CIIX) (www.ChineseInvestors.com), a leading financial information website for Chinese-speaking consumers and investors. CIIX has already established two wholly-owned subsidiaries based in China and the United States. CBD Biotechnology Co., Ltd., located in the free trade zone of Shanghai, China, has plans to deliver a hemp-infused skin care line in China before the end of 2017, while ChineseHempOil.com, Inc., located in the U.S., has launched its first hemp oil product line, “OptHemp.” Customers of ChineseHempOil.com can also purchase the company’s hemp-based products, foods and beverages using bitcoin (http://nnw.fm/w3pbB). The company’s annual financial results, released Tuesday, show a 76% YoY increase in revenues along with an array of new business ventures successfully being introduced to investors.
Among its offerings is the first marijuana social media mobile app designed for Chinese-speaking customers worldwide with a beta version slated for release in November. Its direct-to-consumer e-commerce business is projecting a compound annual growth rate (CAGR) of nearly 100% through FY2020, with revenues reaching $14.8 million. CIIX is positioning itself as a global leader with a goal of becoming the largest Chinese publicly traded company in the legalized CBD market targeting the world’s Chinese-speaking communities (http://nnw.fm/yA6bN).
Another company seeking to make a difference in the rapidly expanding CBD marketplace of cannabis-related products is CV Sciences, Inc. (CVSI), a preeminent supplier and manufacturer of hemp-derived phytocannabinoids including CBD oil. The company plans to exhibit its PlusCBD Oil ™ product brand at the Natural Products Expo East September 14-16 in Baltimore, Maryland. The trade show brings together over 28,000 industry professionals and 1,400 exhibitors. CV Sciences’ product brand is sold at approximately 1,300 health food stores and continues to grow its shelf presence in various retail outlets across the county. In a news release, company spokesman Stuart Tomc said, “It’s evident that hemp-derived CBD products are doing better and growing faster than almost every other category in the supplement industry (http://nnw.fm/H2kId).”
Terra Tech Corp. (TRTC), a vertically integrated, cannabis-focused agriculture company, is also expanding its retail operations. Terra Tech Corp. operates multiple dispensaries as well as cultivation and extraction facilities in California and Nevada. Terra Tech CEO Derek Peterson said the company’s recent acquisition of Tech Center Drive Management LLC, which operates The Reserve OC medical cannabis dispensary in Santa Ana, California, represents another milestone.
“California has emerged as one of the United States’ leading legal cannabis markets, with adult-use planned to come online in 2018,” Peterson said in a news release. “Terra Tech will continue to identify opportunities to expand both its retail and cultivation capabilities in these core markets to drive forward our growth strategy and build value for shareholders (http://cnw.fm/h42vC).”
Medical Marijuana, Inc. (MJNA), the first-ever publicly traded cannabis company in the United States, announced that August 2017 was the company’s largest revenue month in its history. Its wholly owned subsidiaries Kannaway® and HempMeds® Mexico also experienced the best revenue month in their respective histories, Kannaway CEO Blake Schroeder said in a news release (http://cnw.fm/Evae6), noting the company’s plans to launch a series of new products in Q4 2017 as it gears up for its regional convention in Denver, Colorado, this fall. Expansion plans for entering the European market are expected to contribute to the company’s explosive growth, Schroeder added.
Making significant progress in its bid to be known as the world’s number one industrial hemp producer and exporter, HEMP, Inc. (HEMP) has appointed Dr. Robert Ian Bruck, director and founder of the North Carolina State University Environmental Technology Program, as Dean of Hemp, Inc.’s Hemp University. Bruck, who holds two doctorates and years of experience in the fields of plant pathology and ecology, will be responsible for the management and development of curriculum at The Hemp University. Educating not only the public but public policy makers about the business and scientific aspects of industrial hemp – from how to grow it to the many complexities of CBD – is a critical element of moving the cannabis industry forward., according to a company news release (http://cnw.fm/p1hbY).
While the demand for hemp-based cannabidiol has skyrocketed, so have the number of companies jumping into the market, Marijuana Business Daily reports (http://nnw.fm/7ENhH). There are now hundreds, if not thousands of hemp CBD companies flooding the market looking to take advantage of the profits to be made in the global cannabis industry. For companies like ChineseInvestors.com, which has been in business since 1999, capitalizing on the convergence of CBD and the nutrition and health products market in mainland China was a no-brainer.
In a news release (http://nnw.fm/OpHR2), Keevin Gillespie, newly appointed acting president of the company’s ChineseHempOil.com subsidiary, expressed his enthusiasm for the company’s future.
“As the many potential health benefits of hemp continue to be revealed through scientific research and development, I believe the Chinese community will embrace this rediscovered ancient remedy,” Gillespie stated. “I look forward to creating brand awareness and exposure for the Company’s ‘OptHemp’ product line, developing the Company’s network marketing division and generating significant new revenue streams for the Company in the coming year.”
Editorial Sources:
1) Forbes http://nnw.fm/rv2xH
For more on CIIX please visit: ChineseInvestors.com (CIIX) or www.ChineseInvestors.com
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
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WESTON, FL and PORTLAND, OR–(Sep 21, 2017) – Monaker Group (OTCQB: MKGI), a travel industry technology leader, has been invited to present at the Third Annual Robins Equity Research Roundup, being held on September 26-27, 2017 at the Shilo Inns and Suites in Portland, Oregon. The conference is sponsored by the team at Catalyst Research Management Group, RIA.
Bill Kerby, CEO of Monaker, is scheduled to present on Tuesday, September 26th at 11:15am Pacific time. He will be joined by Richard Marshall, the company’s director of corporate development, for one-on-one meetings with institutional analysts and investors the same day.
The CEO will present its Monaker Booking Engine (MBE), a new cloud-based technology platform that delivers ALR reservations that can be instantly confirmed. As recently announced, the company is nearing the first commercial launch of the cloud-based MBE by a major travel industry partner.
MBE contains over one million instantly-bookable vacation rental properties that are available on nexttrip.com or to other travel businesses using Monaker’s proprietary application program interface (API). The API supports a “white label solution” that allows travel distributors to access and customize vacation rental properties for their website — a unique capability recognized as an industry first.
About Monaker Group
Monaker Group is a technology-driven travel company focused on delivering innovation to alternative lodging rentals (ALR) market. The Monaker Booking Engine (MBE) delivers instant booking of more than 1.4 million vacation rental homes, villas, chalets, apartments, condos, resort residences and castles. MBE offers travel distributors and agencies an industry-first: a customizable, instant-booking platform for alternative lodging. For more information, visit www.monakergroup.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized and the company may not meet applicable NASDAQ Capital Market uplisting requirements and/or may not be approved for uplisting. These forward-looking statements are made only as of the date hereof, and Monaker Group undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are expressly qualified in their entirety by the “Risk Factors” and other cautionary statements included in Monaker Group’s annual, quarterly and special reports, proxy statements and other public filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the company’s Annual Report on Form 10-K for the period ended February 28, 2017 which has been filed with the SEC and is available at www.sec.gov.
Contact Information
Monaker Group
Richard Marshall – Director of Corporate Development
Tel: (954) 888-9779
rmarshall@monakergroup.com
Investor Relations Contact
Ronald Both or Grant Stude, CMA
Tel (949) 432-7557
MKGI@cma.team
Arbutus’ LNP Technology Further Validated with New Results
Arbutus to Receive Single Digit Royalties on Sales of Patisiran
VANCOUVER, British Columbia and WARMINSTER, Pa., Sept. 20, 2017 — Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, announced today that the Company’s lipid nanoparticle (LNP) licensee Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. Patisiran is enabled by Arbutus’ lipid nanoparticle (LNP) technology. The program represents the most clinically advanced application of Arbutus proprietary LNP delivery technology. Per the terms of the LNP license agreement for patisiran, Arbutus will be owed single digit royalties on sales of patisiran. Alnylam stated that it intends to file a New Drug Application (NDA) in late 2017 and a Marketing Authorisation Application (MAA) in early 2018.
Dr. Mark J. Murray, Arbutus’ President and CEO, said, “We are very pleased by the successful outcome of Alnylam’s APOLLO Phase 3 study of patisiran. This is an important achievement for patients and for the field of RNAi therapeutics. These data provide further validation of the utility of our leading LNP technology. Our LNP technology represents the most proven delivery technology for the systemic delivery of nucleic acid-based therapeutics.”
About Arbutus’ Lipid Nanoparticle Delivery (LNP) Technology
Arbutus’ LNP technology represents the most clinically validated nucleic acid delivery technology. Arbutus’ LNP formulations are manufactured by a proprietary method, which is robust, scalable, and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application. Arbutus has built a strong intellectual property portfolio directed to various aspects of LNPs and LNP formulations, including 46 patents issued in the United States alone and patent applications throughout the United States and Europe. Arbutus continues to explore opportunities to generate value from its LNP platform technology, which is well suited to deliver therapies based on RNAi, mRNA, and gene editing constructs. The broad applicability of this platform to nucleic acid therapeutic development has established Arbutus as a leader in this new area of innovative medicine.
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, and has facilities in Warminster, PA. For more information, visit www.arbutusbio.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about receiving single digit royalties on sales of patisiran; Alnylam filing a New Drug Application (NDA) in late 2017 and a Marketing Authorisation Application (MAA) in early 2018; exploring opportunities to generate value from Arbutus’ LNP platform technology; and discovering, developing and commercializing a cure for chronic hepatitis B virus (HBV) infection.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the continued demand for Arbutus’ assets, including its LNP technology; continued positive preclinical and clinical efficacy data; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: patisiran may not generate significant royalties for Arbutus, or at all; Alnylam may not file the applications on a timely basis, or at all; demand for Arbutus’ assets may lower; Arbutus’ LNP technology may not continue to produce positive preclinical and clinical efficacy data; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K and Arbutus’ continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Contact Information
Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com
Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com
Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com
CAMBRIDGE, Mass. & PARIS
– Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo –
– Alnylam Intends to File New Drug Application (NDA) in Late 2017 and Marketing Authorisation Application (MAA) in Early 2018 –
– Full Results to be Presented at 1st European ATTR Amyloidosis Meeting in November –
– Alnylam to Host Conference Call Today at 8:30 a.m. ET –
Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at 18 months. The key secondary endpoint was improvement in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN).
“We are very proud to report the first ever positive Phase 3 results for an RNAi therapeutic, marking the potential arrival of an entirely new class of medicines. This moment is the culmination of a 15-year journey of tireless work by countless contributors who have overcome enormous scientific and business challenges to make RNAi therapeutics a reality,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “This is an incredibly exciting milestone for Alnylam and RNAi, and most importantly for patients and their treating physicians and families. We extend our deepest gratitude to all the patients, investigators and study staff who participated in the APOLLO study – they made this important scientific progress possible.”
The APOLLO trial enrolled 225 hATTR amyloidosis patients with polyneuropathy, representing 39 genotypes, at 44 study sites in 19 countries around the world. Patients were randomized 2:1 to patisiran or placebo, with patisiran administered intravenously at 0.3 mg/kg once every three weeks for 18 months. For both the mNIS+7 and Norfolk QOL-DN endpoint measures provided below, a lower score indicates a better clinical result.
- At 18 months, the mean change from baseline in mNIS+7 was significantly lower in the patisiran group as compared with placebo (p less than 0.00001).
- The mean and median changes in mNIS+7 impairment scores for patisiran both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline.
- Patients in the patisiran group experienced improvement in quality of life compared to placebo, as assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) (p less than 0.00001).
- The mean and median changes in QOL scores for patisiran also both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline.
- All 5 other secondary endpoints also demonstrated statistically significant favorable differences in the patisiran arm compared to placebo (p less than 0.001). These were:
- NIS-W, the subdomain of mNIS+7 assessing muscle strength;
- Rasch-built Overall Disability Scale (R-ODS), a patient reported outcome measure of daily living and disability;
- 10-meter walk test, assessing gait speed;
- Modified body mass index (mBMI), assessing nutritional status; and
- COMPASS-31, a questionnaire to assess autonomic symptoms.
- The overall safety profile of patisiran was encouraging.
- The patisiran and placebo arms had similar frequencies of adverse events (AEs) (96.6 percent and 97.4 percent, respectively) and serious adverse events (SAEs) (36.5 percent and 40.3 percent, respectively).
- The frequency of deaths in the study was similar in the patisiran (4.7 percent) and placebo (7.8 percent) arms.
- Patisiran treatment was associated with fewer discontinuations from treatment compared with placebo (7.4 percent and 37.7 percent, respectively) and discontinuations from treatment due to AEs (4.7 percent and 14.3 percent, respectively).
- AEs reported in greater than 10 percent of patients and seen more frequently with patisiran compared with placebo were peripheral edema (29.7 percent vs. 22.1 percent, respectively) and infusion-related reactions (18.9 percent vs. 9.1 percent, respectively), both of which were generally mild-to-moderate in severity.
“Patients living with hATTR amyloidosis face an inevitable and painful advancement of their debilitating disease,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President, R&D of Alnylam. “We believe the very encouraging APOLLO data demonstrate the potential for investigational patisiran to help improve the lives of hereditary ATTR amyloidosis polyneuropathy patients. Our immediate objective is now to submit these data to global health authorities.”
Based on these positive results, Alnylam expects to file its first New Drug Application in late 2017 and first Marketing Authorisation Application shortly thereafter. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.
“This is a significant milestone that supports our belief that RNAi therapeutics have the potential to become an innovative new class of medicines for patients with rare genetic diseases,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “The APOLLO data suggest that patisiran could help improve the lives of people living with hATTR amyloidosis with polyneuropathy, a patient population in urgent need of additional treatment options. We look forward to working with Alnylam to make patisiran available around the globe as quickly as possible.”
Full results, including data from an exploratory analysis of the subgroup of patients with cardiac involvement, will be presented at the 1st European ATTR Amyloidosis Meeting for Patients and Doctors, on November 2, 2017 in Paris, France.
APOLLO is the largest randomized study ever completed in this disease. Nearly all eligible patients who completed APOLLO have rolled over to the APOLLO-Open Label Extension (OLE) study and continue to receive patisiran.
Conference Call Details
Alnylam management will discuss these results via conference call on September 20, 2017 at 8:30 a.m. ET. A slide presentation will also be available on the Investors page of the Company’s website, www.alnylam.com, to accompany the conference call. To access the call, please dial (877) 312-7507 (domestic) or (631) 813-4828 (international) five minutes prior to the start time and refer to conference ID 88881001. A replay of the call will be available beginning at 11:30 a.m. ET on September 20, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and refer to conference ID 88881001.
About the APOLLO Phase 3 Study
The APOLLO Phase 3 study is a randomized, double blind, placebo-controlled, global study designed to evaluate the efficacy and safety of patisiran in hATTR amyloidosis patients with polyneuropathy. The primary efficacy endpoint was change from baseline in the mNIS+7 composite neuropathy impairment score at 18 months. Modified NIS+7 is a composite measure of neurologic impairment that evaluates sensorimotor capabilities, nerve conduction, reflexes, and autonomic function. Secondary endpoints included the Norfolk QOL-DN quality of life score as well as measures of motor strength (NIS-W), disability (R-ODS), gait speed (10-meter walk test), nutritional status (mBMI) and autonomic symptoms (COMPASS-31). Exploratory endpoints included cardiac measures in patients with evidence of cardiac involvement at baseline as well as measures of dermal amyloid burden and nerve fiber density in skin biopsies.
About Patisiran
Patisiran is an investigational medicine that uses the body’s natural processes to lower the levels of the TTR protein that causes TTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to enable the clearance of TTR amyloid deposits in peripheral tissues and potentially restore function to these tissues. The safety and efficacy of patisiran have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About hATTR amyloidosis
Hereditary transthyretin (TTR)-mediated (hATTR) amyloidosis is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier of vitamin A. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. hATTR amyloidosis represents a major unmet medical need with significant morbidity and mortality, affecting approximately 50,000 people worldwide. hATTR amyloidosis patients have a life expectancy of 2.5 to 15 years from symptom onset, and the only approved treatment options are liver transplantation for early stage disease and tafamidis (approved in Europe, Japan and certain countries in Latin America, specific indication varies by region). There is a significant need for novel therapeutics to help treat patients with hATTR amyloidosis.
About LNP Technology
Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.
Alnylam – Sanofi Genzyme Alliance
In January 2014, Alnylam and Sanofi Genzyme, the specialty care global business unit of Sanofi, formed an alliance to accelerate the advancement of RNAi therapeutics as a potential new class of innovative medicines for patients around the world with rare genetic diseases. The alliance enables Sanofi Genzyme to expand its rare disease pipeline with Alnylam’s novel RNAi technology and provides access to Alnylam’s R&D engine, while Alnylam benefits from Sanofi Genzyme’s proven global capabilities to advance late-stage development and, upon commercialization, accelerate market access for these promising genetic medicine products. In the case of patisiran, Alnylam will advance the product in the United States, Canada and Western Europe, while Sanofi Genzyme will advance the product in the rest of the world.
About RNAi
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding protein synthesis in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, with the goal of preventing disease-causing proteins from being made.
About Alnylam Pharmaceuticals
Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including three product candidates that are in late-stage development or will be in 2017. Looking forward, Alnylam will continue to execute on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.com.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including, without limitation, Alnylam’s views with respect to the topline results from its APOLLO Phase 3 clinical trial for patisiran, its plans for and the expected timing of regulatory filings seeking approval for patisiran from regulatory authorities in the United States, Europe and ROW countries, its expectations regarding the potential for patisiran to improve the lives of hATTR amyloidosis patients with polyneuropathy and their families, its plans for the commercialization of patisiran if approved by regulatory authorities, and expectations regarding its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing, delays, interruptions or failures in the manufacture and supply of its product candidates, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.
Patisiran has not been approved by the U.S. Food and Drug Administration, European Medicines Agency, or any other regulatory authority and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.
Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the clinical development of and potential marketing approvals for the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “would be” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development of the product, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product or biological application that may be filed for the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Alnylam Pharmaceuticals, Inc.
Investors and Media
Christine Regan Lindenboom, 617-682-4340
or
Investors
Josh Brodsky, 617-551-8276
PhaseRx’s second enzyme replacement therapy to receive orphan drug designation for a Urea Cycle Disorder
SEATTLE, Sept. 20, 2017 — PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its second drug development candidate, PRX-ASL, for the treatment of argininosuccinate lyase deficiency (ASLD), has received orphan drug designation by the U.S. Food and Drug Administration (FDA).
ASLD is a rare liver disorder caused by an inherited single-gene deficiency that results in hyperammonemia (elevated ammonia in the blood), and can lead to irreversible neurological impairment, coma and death. PRX-ASL is an intracellular enzyme replacement therapy (i-ERT) designed to replace the missing or defective enzyme in patients with ASLD, thereby correcting the disease. PRX-ASL has shown therapeutic potential in a preclinical model of ASLD, including reduction in the levels of compounds whose elevation are the hallmark of ASLD including plasma citrulline, argininosuccinic acid (ASA) and blood ammonia.
“The FDA’s decision to grant PRX-ASL orphan drug designation for ASLD represents an important milestone in the development of our second therapeutic candidate,” said Robert W. Overell, Ph.D., president and chief executive officer. “PRX-ASL is our second drug to show preclinical proof of concept using our Hybrid mRNA TechnologyTM. Like our lead candidate PRX-OTC, we believe PRX-ASL also has the potential to correct the disease in children, a population that could particularly benefit from treatment for this rare disease.”
The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
About ASLD
ASLD is a rare liver disorder caused by an inherited single-gene deficiency that results in hyperammonemia (elevated ammonia in the blood), and can lead to devastating consequences, including cumulative and irreversible neurological impairment, coma and death. The only cure for ASLD is a liver transplant. Currently available drug treatments do not correct the disease, and do not eliminate the risk of life-threatening crises.
About PhaseRx
PhaseRx is a biopharmaceutical company dedicated to developing mRNA products for the treatment of children with inherited enzyme deficiencies in the liver using intracellular enzyme replacement therapy (i-ERT). PhaseRx’s initial product development focus is on urea cycle disorders, a group of rare genetic diseases that generally present before the age of twelve and are characterized by the body’s inability to remove ammonia from the blood with potentially devastating consequences for patients. The company’s i-ERT approach is enabled by its proprietary Hybrid mRNA TechnologyTM platform. PhaseRx is headquartered in Seattle. For more information, please visit www.phaserx.com.
Safe Harbor Statement
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the fact that the company has incurred significant losses since its inception and anticipates that it will continue to incur significant losses for the foreseeable future, (ii) the company being dependent on technologies it has licensed and that it may need to license in the future to develop its products, (iii) the fact that the company will need to raise substantial additional funding to bring its planned products through clinical trials, regulatory approval, manufacturing and marketing and to become profitable, (iv) the fact that the company’s Hybrid mRNA Technology has not previously been tested beyond company preclinical studies, and that mRNA-based drug development is unproven and may never lead to marketable products, (v) the fact that all of the company’s programs are in preclinical studies or early stage research, so the company cannot predict how these results will translate into results in humans, nor can it be certain that any company product candidates will receive regulatory approval or be commercialized, (vi) the fact that development of the company’s product candidates will be expensive and time-consuming, and if the development of company product candidates does not produce favorable results or is delayed, the company may be unable to commercialize these products, (vii) the company expecting to continue to incur significant research and development expenses, which may make it difficult to attain profitability, (viii) the company becoming dependent on collaborative arrangements with third parties for a substantial portion of its revenue, and its development and commercialization activities being delayed or reduced if it fails to initiate, negotiate or maintain successful collaborative arrangements, (ix) the company’s ability to adequately protect its proprietary technology from legal challenges, infringement or alternative technologies and (x) the biotechnology and pharmaceutical industries being intensely competitive, with competition from existing drugs, new treatment methods and new technologies that may prove to be more effective or marketable than the company’s products. More detailed information about the company and the risk factors that may affect the realization of forward looking statements is set forth in the company’s filings with the Securities and Exchange Commission (SEC), including the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contacts:
Corporate Communications Contact:
Jason Spark
Canale Communications
Managing Director
jason@canalecomm.com
619.849.6005
Investor Contact:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
robert.uhl@westwicke.com
858.356.5932
AUSTIN, Texas, Sept. 20, 2017 — SmallCapVoice.com, Inc. and ChineseInvestors.com (OTCQB:CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors in both the U.S. and China, and a well-known cannabidiol (CBD) health brand engaged in the development, manufacturing, marketing and distribution of consumer products containing CBD, today announce that the Company’s director of investor relations, Alan Klitenic, is featured in an audio interview at SmallCapVoice.com.
The interview outlining CIIX’s current news and efforts can be heard at http://smallcapvoice.com/blog/9-18-17-smallcapvoice-interview-with-chineseinvestors-com-inc-ciix.
Alan Klitenic, director of investor relations for ChineseInvestors.com called in to SmallCapVoice.com, Inc. to discuss the recent news for the company. Topics covered in the interview include the recent news in the Digital Currency Industry, the plans that the Company has regarding launching a Chinese Daily Video News Broadcast from the NYSE floor covering the Digital Currency Market, exciting news about its recent financial performance, and insights on all recent news including the recently announced completion of the record filing process with the Chinese FDA the soon to be launched Hemp Infused Skin Care Line in China starting in October.
During the interview Klitenic stated, “I want to emphatically state that CIIX is ready to make sales in China. We have successfully passed thru the regulatory body, the China FDA. We have manufactured this product: CBD Infused skin care products line with a design patent. This is a real milestone for us at ChineseInvestors.com. We are going to spend money and promote our CBD Hemp Oil and CBD infused skin care products in China going forward from now and thru 2018.”
About SmallCapVoice.com
SmallCapVoice.com is a recognized corporate investor relations firm, with clients nationwide, known for its ability to help emerging growth companies build a following among retail and institutional investors. SmallCapVoice.com utilizes its stock newsletter to feature its daily stock picks, audio interviews, as well as its clients’ financial news releases. SmallCapVoice.com also offers individual investors all the tools they need to make informed decisions about the stocks in which they are interested. Tools like stock charts, stock alerts, and Company Information Sheets can assist with investing in stocks that are traded on the OTC BB and Pink Sheets. To learn more about SmallCapVoice.com and its services, please visit http://smallcapvoice.com/blog/the-small-cap-daily-small-cap-newsletter/
About ChineseInvestors.com (OTCQB:CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online sales and direct sales of non-industrial hemp-based products and other health related products.
For more information visit ChineseInvestors.com
Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom
Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh
Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;
https://www.facebook.com/Chineseinvestors.com.english
Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1.214.636.2548
Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
For SmallCapVoice.com
Stuart T. Smith
512-267-2430
info@smallcapvoice.com
Drug Candidate for Alzheimer’s Shows Promise by Inhibiting Aβ Aggregation without Neuron Damage
BETHESDA, Md., Sept. 18, 2017 – India Globalization Capital, Inc. (NYSE-MKT:IGC) provides an update on compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s disease model, showing that at varying concentrations of THC, the aggregation of Aβ protein decreases by as much as 40%.
“As Alzheimer’s progresses, synaptic dysfunction and the death of neurons lead to memory loss. These study results, when combined with the earlier reported data that shows IGC-AD1 reduces Aβ40 and Aβ42 production by as much as 50%, and 40%, without any toxicity, represent a highly significant novel breakthrough that could potentially bring much needed relief from this devastating disease,” states IGC’s CEO Ram Mukunda.
It is believed that a primary cause of AD is the buildup of senile plaque composed of amyloid beta peptides (Aβ plaque) in the cerebral cortex and hippocampus. The key pathogenic event in the onset of AD is Aβ peptide monomers aggregating into prefibrillar oligomers (dimers, trimmers, tetramers and oligomers). As AD progresses Aβ oligomers directly cause synaptic dysfunction and the death of neurons, consequently leading to a loss of memory.
“A drug that (i) decreases production of Aβ, (ii) inhibits Aβ aggregation into oligomers, (iii) is not toxic to neurons, and (iv) does not cause inebriation (high), could be a powerful weapon against AD and the prevention of AD. In vitro, our product demonstrates these critical factors and we are pursuing a patent filing that protects this therapy.
AD starts 20 to 25 years before symptoms like memory loss are manifested. Statistically, there is an almost 50% chance of individuals over 80 years contracting AD and over 65% of AD patients are women. Based on the findings of these studies, our plan is two-fold. First, we will position IGC-AD1 as a drug that can be used both as a treatment for AD, and as a prophylactic treatment for the prevention of AD. Second, we will commercialize a supplement version to be sold as a medical dispensary product. This will allow our team to work through the FDA approval process for IGC-AD1, while securing market share in the medical dispensary segment. This is a very exciting time for all our shareholders and I look forward to providing updates on our progress in combatting this global disease,” concludes IGC’s CEO Ram Mukunda.
The summary in vitro data indicates that between 2.5nM and 25nM THC concentration, the formation of Aβ1-42 trimers and tetramers in N2aAPP cells are reduced by up to 40% as determined by both fluorescence and immuno blotting assays. Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.
About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia. It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion. AD currently affects more than 5.3 million Americans and over 65% of AD patients are women. Over the next 20 years, the number of those afflicted with the disease is expected to double. The forecast is staggering, considering that to date, no effective cure has been found.
About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.
For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/
Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.
Contact:
Claudia Grimaldi
301-983-0998
Leading Gunfire Detection Solution Now Live in Cincinnati, Jacksonville, Louisville, Newburgh, Pittsfield, Syracuse and St. Louis County
NEWARK, Calif., Sept. 19, 2017 — ShotSpotter (Nasdaq:SSTI), the leader in gunshot detection solutions that help law enforcement officials and security personnel identify, locate and deter gun violence, today announced that seven new cities have recently deployed ShotSpotter technology in their communities. The new cities include Cincinnati, OH; Jacksonville, FL; Louisville, KY; Newburgh, NY; Pittsfield, MA; Syracuse, NY and St. Louis County, MO – joining the more than 90 jurisdictions that already rely on ShotSpotter to ensure a fast, accurate response to gunfire incidents. Three existing ShotSpotter cities, New York City, Chicago and Birmingham have also recently expanded their coverage areas.
ShotSpotter provides real-time alerts to law enforcement of detected gunfire so that they can arrive at the precise location of a shooting event safely and quickly. With the speed of response, officers can be on the scene to aid victims, interview witnesses, and collect forensic evidence. This improves the overall effectiveness of an agency in identifying and apprehending shooters, and taking illegal guns off the streets.
“We are excited to be working with police departments in successfully implementing gunshot detection solutions as a critical component of their gun violence prevention efforts,” said Ralph Clark, CEO of ShotSpotter. “Cities are seeing positive outcomes and improved community engagement as a result of their agency’s ShotSpotter adoption and integration with best practices execution. We are thrilled with all of our customer collaborations that are making a real difference in improved public safety for all, especially in those at-risk neighborhoods who also deserve community peace.”
“After just four weeks of using ShotSpotter, we are already seeing a positive impact from the technology,” said Cincinnati Assistant Police Chief Paul Neudigate. “We have three square miles of coverage in one of our most problematic communities for shooting violence and have had over sixty activations in just a month’s time.”
“ShotSpotter is already alerting us to specific addresses that we were not aware were inundated with random gunfire incidents,” Neudigate continued. “In addition, ShotSpotter works well with our established surveillance camera system; we recently caught a running gun battle on video that we would never have known about had we not received the alert. ShotSpotter technology holds great promise for helping to reduce gun violence in the City of Cincinnati as part of an overall gun violence reduction strategy.”
According to Lieutenant Jim Cirillo, Louisville Metro Police Department, “ShotSpotter’s technology product has done exactly what they promised it to do.”
In recent months, three existing ShotSpotter cities – New York City, Chicago and Birmingham – have undergone recent expansions to their coverage areas. New York City began implementing ShotSpotter in 2015 and currently covers 57 square miles, an increase of 17.8 square miles since the beginning of 2017. In Chicago, ShotSpotter was first deployed in the 7th and 11th districts, then in the 15th and 9th. In September 2017, their sixth district also went live with ShotSpotter and the 10th district will go live soon. The city of Birmingham doubled their ShotSpotter coverage from eight to 16 square miles.
In addition, the University of Alabama (UA) Police Department has added ShotSpotter to help make its campus safer. UA becomes one of eight universities in the country to invest in the ShotSpotter gunfire detection technology.
About ShotSpotter, Inc.
ShotSpotter is the leader in gunshot detection solutions that help law enforcement officials and security personnel identify, locate and deter gun violence. ShotSpotter is based in Newark, California and offers its solutions on a SaaS-based subscription model to customers around the world, with current customers located in the United States, Puerto Rico, the U.S. Virgin Islands and South Africa.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the planned expansion and timing of covered miles. These forward-looking statements are made as of the date of this press release and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Words such as “expect,” “anticipate,” “should,” “believe,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “plan,” “could,” “intend,” variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the company’s control. The company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the availability of funding for the company’s customers to purchase the company’s solutions; the complexity, expense and time associated with contracting with government entities; the lengthy sales cycle for the company’s solutions; changes in federal funding available to support local law enforcement; and the company’s ability to deploy and deliver its solutions. Additional factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in the company’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, under the caption “Risk Factors.” ShotSpotter assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Media Contact: Liz Einbinder +1 510-794-3147 LEinbinder@ShotSpotter.com
Investor Relations Contact: Matt Glover +1 949-574-3860 matt@liolios.com
SHANGHAI, China, Sept. 19, 2017 — GDS Holdings Limited (“GDS Holdings”, “GDS” or the “Company”) (NASDAQ:GDS), a leading developer and operator of high-performance data centers in China, today announced that it has been awarded a new class of telecom license for the provision of Cloud Connect services in China. The new license allows GDS to provide connectivity services over its own network to Cloud and enterprise customers colocated in all of its data centers. GDS Cloud Connect service is currently being tested by several major customers. Full launch is planned in the next two quarters.
Mr. William Huang, Chairman and Chief Executive Officer of GDS Holdings, stated, “GDS Cloud Connect service will provide unique value proposition and create significant operational benefits for our customers through enhanced connectivity between Cloud service providers and enterprises. By leveraging our data center platform in all Tier 1 markets and the established presence of the key Cloud service providers, we will further advance our strategy to be to the home of the Cloud in China.”
About GDS Holdings Limited
GDS Holdings Limited (Nasdaq:GDS) is a leading developer and operator of high-performance data centers in China. The Company’s facilities are strategically located in China’s primary economic hubs where demand for high-performance data center services is concentrated. The Company’s data centers have large net floor area, high power capacity, density and efficiency, and multiple redundancy across all critical systems. GDS is carrier and cloud neutral, which enables customers to connect to all major PRC telecommunications carriers, and to access a number of the largest PRC cloud service providers, whom GDS hosts in its facilities. The Company offers colocation and managed services, including a unique and innovative managed cloud value proposition. The Company has a 16-year track record of service delivery, successfully fulfilling the requirements of some of the largest and most demanding customers for outsourced data center services in China. The Company’s base of customers consists predominantly of large Internet companies, financial institutions, telecommunications and IT service providers, and large domestic private sector and multinational corporations.
Safe Harbor
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “estimate,” “expect,” “future,” “guidance,” “intend,” “is/are likely to,” “may,” “ongoing,” “plan,” “potential,” “target,” “will,” and similar statements. Among other things, statements that are not historical facts, including statements about GDS Holdings’ beliefs and expectations regarding the growth of its businesses and its revenue for the full fiscal year, the business outlook and quotations from management in this announcement, as well as GDS Holdings’ strategic and operational plans, are or contain forward-looking statements. GDS Holdings may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”) on Forms 20-F and 6-K, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause GDS Holdings’ actual results or financial performance to differ materially from those contained in any forward-looking statement, including but not limited to the following: GDS Holdings’ goals and strategies; GDS Holdings’ future business development, financial condition and results of operations; the expected growth of the market for high-performance data centers, data center solutions and related services in China; GDS Holdings’ expectations regarding demand for and market acceptance of its high-performance data centers, data center solutions and related services; GDS Holdings’ expectations regarding building, strengthening and maintaining its relationships with new and existing customers; the continued adoption of cloud computing and cloud service providers in China; risks and uncertainties associated with increased investments in GDS Holdings’ business and new data center initiatives; risks and uncertainties associated with strategic acquisitions and investments; GDS Holdings’ ability to maintain or grow its revenue or business; fluctuations in GDS Holdings’ operating results; changes in laws, regulations and regulatory environment that affect GDS Holdings’ business operations; competition in GDS Holdings’ industry in China; security breaches; power outages; and fluctuations in general economic and business conditions in China and globally and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties or factors is included in the GDS Holdings’ filings with the SEC, including its registration statement on Form F-1, as amended. All information provided in this press release is as of the date of this press release and are based on assumptions that GDS Holdings believes to be reasonable as of such date, and GDS Holdings does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For investor and media inquiries, please contact:
GDS Holdings Limited
Laura Chen
Phone: +86 (21) 5119 6989
Email: ir@gds-services.com
The Piacente Group, Inc.
Ross Warner
Phone: +86 (10) 5730-6200
Email: GDS@tpg-ir.com
Alan Wang
Phone: +1 (212) 481-2050
Email: GDS@tpg-ir.com
New analysis of data shows clinically meaningful reductions in LDL-C and hsCRP across multiple trials and confirms support to advance gemcabene into Phase 3
End of Phase 2 meetings planned for early 2018
ROYAL-1 study accepted for presentation at AHA Scientific Sessions in November 2017
COBALT-1 study to be presented at the FH Foundation’s Summit meeting on Monday, September 25th
Conference call at 4:30 pm ET today
LIVONIA, Mich., Sept. 19, 2017 — Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced plans to advance its product candidate gemcabene into Phase 3 development in 2018. Gemcabene successfully achieved the primary endpoint in two recently completed Phase 2b studies, COBALT-1 and ROYAL-1, and the Company is now preparing for end of Phase 2 meetings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), anticipated to take place in early 2018. The primary focus of these meetings is to reach agreement on the design of the Phase 3 development programs for its hypercholesterolemia indications. Twenty clinical studies have shown gemcabene to be safe and effective as monotherapy or in combination with all current treatments for hypercholesterolemia, including the highest intensity statins, PCSK9 inhibitors and ezetimibe, and thus appears to be beneficial for high-risk patients that have not achieved lipid goals.
Gemphire is developing gemcabene as an add-on therapy to diet and maximally-tolerated statins for the treatment of several hypercholesterolemic populations, including atherosclerotic cardiovascular disease (ASCVD), with an emphasis on the high risk cardiometabolic subset of ASCVD patients, heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). The Company also plans to develop gemcabene as monotherapy or as add-on therapy to diet and other lipid lowering therapies for the treatment of severe hypertriglyceridemia (SHTG). Gemcabene has been shown to be safe and effective in combination with all current treatments for hypercholesterolemia, including the highest intensity statins, PCSK9 inhibitors and ezetimibe.
“I believe we have accumulated a compelling body of clinical data demonstrating the ability of gemcabene to reduce low density lipoprotein cholesterol (LDL-C) in both orphan and broad dyslipidemic conditions,” said Dr. Steven Gullans, Interim CEO of Gemphire. “Gemcabene is a unique late stage clinical asset and the only compound in development across the full spectrum of dyslipidemia that targets the triple threat of LDL-C, inflammation and triglycerides (TG). We look forward to reviewing these data with the FDA and EMA to seek agreement on the design of our comprehensive Phase 3 clinical program to confirm the benefits observed in prior studies and to support regulatory approval for the various indications and commercialization in the major markets.”
“Many high-risk patients are unable to achieve optimal LDL-C reductions and levels with the currently available therapies,” said Evan Stein, MD Director Emeritus of the Metabolic & Atherosclerosis Research Center, in Cincinnati, Ohio. “As such, physicians and patients need additional options that can be combined safely with statin therapy, which is the first therapy utilized for most patients, and can provide additional efficacy across multiple parameters associated with cardiovascular risk. Given the recent data released by Novartis Inc. establishing reduction of inflammation and hsCRP as a novel mechanism to decrease cardiovascular disease (CVD), the combined effect of gemcabene on LDL-C, apolipoprotein B and hsCRP is very promising for patients at high risk for CVD events.”
New Analysis Shows That 600 mg of Gemcabene Reduced LDL-C by 21% in Hypercholesterolemic Patients and by 25% in Mixed Dyslipidemic Patients across Multiple Clinical Trials
The Company has performed an extensive analysis of data on hypercholesterolemic patients across previously completed clinical trials for gemcabene, including the most recently completed COBALT-1 and ROYAL-1 studies. In addition to the LDL-C reduction in the overall cohorts, efficacy was assessed according to baseline LDL-C levels, and other baseline characteristics, such as the degree of obesity, magnitude of HbA1c, mixed dyslipidemia, level of inflammation, a responder analysis and combinations of these factors.
Data for the ROYAL-1 study have been accepted for presentation at the American Heart Association’s (AHA) Scientific Sessions in November 2017. Details of the ROYAL-1 data are embargoed until presentation at AHA; however, the additional analyses of ROYAL-1 showed similar trends as we will outline from the combined analysis below. As such, the announcement today is focusing on the combined analysis of the hypercholesterolemic patients involved in previously completed clinical studies.
Patients were included in the combined analysis if they were hypercholesterolemic and were on stable statin and/or other lipid lowering therapy, which represents the intended use for gemcabene in clinical practice for its hypercholesterolemic indications. The prior clinical trials included 352 hypercholesterolemic patients, composed of placebo (n=110) and gemcabene 150 mg (n=23), 300 mg (n=61), 600 mg (n=94) and 900 mg (n=64) dose groups. Data from the gemcabene 600 mg dose group are presented in the table below since this is the intended target dose for the Phase 3 trials for the reduction of LDL-C across the hypercholesterolemic patient population.
Gemphire believes gemcabene offers a unique value proposition for those patients with a high-risk cardiometabolic profile, specifically those with obesity, pre-diabetes /diabetes, inflammation and/or mixed dyslipidemia. Mixed dyslipidemia refers to a group of patients at high risk for cardiovascular disease that have elevated LDL-C, apolipoprotein B, and TGs. Cardiovascular demographics from the National Health and Nutritional Health Examination Survey (NHANES) data estimate that of the approximately 40 million patients on statins, approximately 6.1 million represent cardiometabolic patients who are not at goal and have LDL levels above 70 mg/dL with approximately 3 million of these patients being above 100 mg/dL. Cardiometabolic patients usually have several lipid abnormalities that can benefit from gemcabene’s ability to lower LDL-C, hsCRP and TGs. The LDL-C reductions for mixed dyslipidemic patients who received 600 mg of gemcabene or placebo are presented separately in the table below.
| Combined results from hypercholesterolemic patients across completed clinical studies |
| All Hypercholesterolemic Subjects |
Gemcabene 600 mg
n= 94 |
Placebo
n=110 |
p value |
| LDL-C reduction |
-21% |
-5% |
p<0.0001 |
Mixed Dyslipidemia Subset (Baseline LDL-C ≥100
and TGs ≥200 and <500 mg/dL) |
Gemcabene 600 mg
(high risk patients)
n= 24 |
Placebo
(high risk patients)
n= 30 |
p value |
| LDL-C reduction |
-25% |
-4% |
p=0.0002 |
Ability of Gemcabene to Reduce hsCRP and Inflammation is Potentially a Key Differentiator
Elevated serum C-Reactive Protein (hsCRP) is a known biomarker for patients at increased risk of a cardiovascular event. As reported previously in the ROYAL-1 study, 600 mg of gemcabene lowered serum hsCRP by 40% (n=51) compared to 6% for placebo (n=51) (p<0.0001). Note that this effect was additive to the reduction of hsCRP provided by statins, as the ROYAL-1 patients were already taking maximally tolerated doses of statins. From the combined analysis in hypercholesterolemic patients the median hsCRP reduction for patients on gemcabene 600 mg was 40% (n=90) compared with 5% in the placebo group (n=108) (p<0.0001).
CRP is a plasma protein biomarker secreted into the blood from the liver in response to inflammation. Reducing this biomarker is associated with a reduction in cardiovascular risk, as confirmed by Novartis Inc.’s Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) recently presented at the European Society of Cardiology (ESC) congress in Barcelona, Spain, in August of this year. As reported by Novartis Inc. in August 2017, in the CANTOS study, patients with a history of myocardial infarction and elevated hsCRP received treatment with an injectable anti-inflammatory monoclonal antibody to the cytokine IL-1β to determine the direct potential impact of reducing inflammation on cardiovascular events. The results demonstrated that reducing inflammation as measured by hsCRP (with a median hsCRP reduction of 37%) led to a 15% reduction in cardiovascular related MACE (combination of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death). The impact of orally administered gemcabene on hsCRP and inflammation remains a potentially key differentiator from other compounds that are approved or in development as add-on therapy to maximally tolerated statins.
Gemcabene Appears Safe for High Risk Patients in Combination with Maximally Tolerated Statins and Other Approved Treatments
The COBALT-1 and ROYAL-1 trials were designed to determine the safety, tolerability and efficacy of gemcabene as an add-on to the highest doses of statins (e.g., rosuvastatin 20 and 40 mg and atorvastatin 40 and 80 mg doses; moderate intensity therapies were also included), as well as PCSK9 inhibitors, and ezetimibe.
We believe the results from all 20 clinical studies in which 956 patients were exposed to gemcabene have demonstrated that gemcabene is well tolerated and safe. Although in practice, most patients are on low and moderate intensity statins, in our clinical trials gemcabene demonstrated a clean safety profile even when combined with the highest doses of the high intensity statins, simvastatin, atorvastatin and rosuvastatin. To date, there has been no evidence for hepatic or muscle related toxicities and no serious adverse events related to gemcabene treatment. Overall treatment emergent adverse events for gemcabene have been similar to placebo. Most adverse events have been mild to moderate in intensity and the most commonly reported adverse events have been infection and headache (based on occurrence in > 5% of subjects on gemcabene, although the rate for infection was less than placebo).
Gemphire’s Commitment to Cardiometabolic Patients, Physicians and Payors
Cardiovascular disease remains the leading cause of death globally despite the availability of statins and other therapeutics. In addition, the large recent increases in the prevalence of obesity and diabetes will result in a much greater number of individuals at risk for cardiovascular and liver diseases, including NASH. The highest risk patients would benefit from a new therapy that can be added safely to all commonly prescribed statins at any dose. Gemcabene has been given to over 950 patients to date and it appears to be a safe and effective therapeutic option for millions of cardiometabolic patients who are already on maximally-tolerated statins to reduce LDL-C, hsCRP and other potentially atherogenic lipid particles. As a once daily oral therapy at an affordable price point, gemcabene has the potential to be a valuable new approach that will provide benefits to patients, physicians and payors.
“Gemcabene has demonstrated efficacy across a broad array of important lipid parameters, such as LDL-C, non-HDL-C, total cholesterol, apolipoprotein B and triglycerides, that have been associated with cardiovascular events, such as heart attacks, stroke and death. Gemcabene has also demonstrated significant effects on reducing hsCRP, a marker of inflammation, which may be an important new target of therapy in patients with cardiovascular disease, based on the CANTOS trial results. Importantly, gemcabene has demonstrated an excellent safety profile without evidence of hepatic or muscle toxicities, even when combined with the most potent statins,” stated Dr. Lee Golden, Chief Medical Officer of Gemphire.
COBALT-1 study to be presented at the FH Foundation’s Summit
Gemphire will also be announcing full results of the COBALT-1 (HoFH) study at the FH Foundation’s Summit meeting in Miami, Florida on Monday, September 25th at 9:00 am ET. The results will be presented by Dr. Marina Cuchel, MD, PhD, Research Associate Professor at the Perelman School of Medicine at the University of Pennsylvania. The FH Summit is an invitation-only event that convenes global experts within various fields to tackle the most pressing issues facing FH populations today. The 2017 FH Global Summit will include topics on the challenges and opportunities of diverse FH subpopulations navigating diagnosis, care and access. For more information, refer to https://thefhfoundation.org/event/2017-fh-global-summit.
Gemphire to Soon Launch Proof of Concept Program in NASH
As previously announced, Gemphire will be initiating its proof of concept study in patients that suffer from fatty liver disease and nonalcoholic steatohepatitis (NASH) in the fourth quarter of 2017. Unmanaged cardiometabolic disease is the underlying cause of atherosclerosis and fatty liver disease. Gemcabene’s unique mechanism of action has demonstrated positive attributes that may be protective to both the heart and liver. Approximately 6 million patients in the U.S. are affected by NASH for which there is currently no effective treatment available.
Conference Call and Webcast
Gemphire management will host a conference call for investors at 4:30 pm ET today. To participate, please dial (844) 494-0188 (domestic) or (425) 278-9114 (international) and reference conference ID 86185879. A webcast replay will be available on the News & Events section of the Gemphire website for all interested parties following the call and will be archived and available for 90 days.
Gemcabene’s Mechanism of Action and Safety Profile Are Highly Differentiated
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. Gemcabene’s mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibition of the production of cholesterol and triglycerides in the liver. The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma non-HDL-C, VLDL-C, LDL-C, apolipoprotein B and triglycerides. In addition, gemcabene has been shown to markedly lower C-reactive protein and improve insulin sensitization. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels. Gemcabene also reduces acetyl-CoA carboxylase (ACC1) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD). Gemcabene has demonstrated proof of concept efficacy for NASH in the STAM™ model developed at SMC Laboratories in Tokyo, Japan. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 956 subjects across 20 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.
About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care especially statins that will benefit patients, physicians, and payors. Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a fourth planned trial in NASH to initiate in second half of 2017. Please visit www.gemphire.com for more information.
Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials, regulatory submissions and meetings and future expectations and plans and prospects for Gemphire, expectations regarding operating expenses and cash used in operations, and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the “Risk Factors” section of Gemphire’s Annual Report on Form 10-K for the year ended December 31, 2016, Gemphire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and in other filings Gemphire makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof. Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change. However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.
Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987
Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
(734)-245-1700
– Monaker Group inked private placement deals with prominent financial institutions and board members.- The company moves ahead with the NASDAQ listing process, as stipulated by the private placement deal.
– The company is working on finalizing its deal with Trisept.
Monaker Group Inc. (OTC: MKGI) is an emerging player in the online travel market, offering its Alternative Lodging products and services in both B2C and B2B segments. The company is well positioned to augment its position in the fast growing online travel market, which is expected to touch $1 trillion by 2022. Monaker is taking a holistic approach to boosting its visibility in the segment. The company is going full steam ahead to augment the product inventory on its Booking Engine by entering into new collaborations. It is also constantly upgrading its technology as it recently launched its apps for Android and iOS platforms. The company has taken steps to solidify its financial position, to fund its operating activities. Monaker is moving ahead with the process seeking to list its shares on NASDAQ, which is likely to be completed by the end of this year.
Monaker has taken several steps to boost its financial position as the company goes ahead with developing and marketing its new alternative lodging products and white label solutions. The company recently announced completion of a private placement of its stock. The deal yielded over $3 million for the company in gross proceeds. 21 percent of the proceeds or $635,000 from the board members and certain insiders, while remaining proceeds are attributed to prominent financial institutions including Pacific Grove Capital, an up and coming hedge fund launched by former Scout Capital Management executive Jamie Mendola. Venture capitalist Mendola has a strong pedigree behind him. A Stanford business school graduate, Mendola has worked with JPMorgan Chase and other major institutions. His latest venture Pacific Grove Capital specializes in small to midsize companies. The strategy allows the venture capital to have in-depth knowledge about its investee companies. Monaker thus stands to benefit from personalized expertise and mentoring provided by Pacific Grove Capital.
The deals entitle the purchasers to one common share and one warrant for a purchase price of $2.00. Each warrant entitles the holder to purchase one common share at an exercise price of $2.10 per share, with an expiration date five years from the date of issuance.
The deal was timely as Monaker moves ahead with making technological upgradations and other improvements in its products. The company intends to use the proceeds for augmenting its alternative lodging rentals inventory as well. The placement was also a step forward towards the company gaining listing on a stock exchange. The terms of the agreement require Monaker to apply for a listing of its common shares on the NASDAQ Capital Market within 60 days following the closing of the offering.
The company had its intention clear to seek NASDAQ membership for the stock. Monaker recently carried out a number of board appointments to comply with the requirements of NASDAQ listing. Recent appointments included Robert Post, president and CEO of Cloud5 Communications and executive chairman of The Knowland Group, to the company’s board of directors. Mr. Post has held a number of c-level positions at large hospitality and travel companies including Open Table, Micros and TravelClick. His appointment took the number of independent directors on the board to four, thus complying with NASDAQ requirement of having a majority of independent directors on the board.
Monaker also benefits from the collective expertise of its seasoned management. Among its prominent directors is Don Monaco who has nearly thirty years of high profile corporate experience with companies such as Accenture. He is the principal owner of Monaco Air Duluth, LLC a full-service, fixed-base operator aviation services business at Duluth International Airport and provides Monaker with deep understanding of the travel market. Another noteworthy director of the company is Simon Orange whose expertise lies in corporate finance and M&A. He is the co-founder of CorpAcqu, which maintains long-term investments in a diverse portfolio of successful businesses. With the recent appointments, Monaker is well positioned to harness the knowledge and skills of its directors to forge new collaborations and grow.
The company is also working on forming additional distribution channels and relationships with major players in the online travel segment. It recently reported developments about its deal with Trisept Solutions, which is a sister company to Mark Travel. The agreement pertains to Monaker’s alternative lodging product for uploading and distribution through the Trisept distribution channels and partners. Trisept’s travel distribution platforms and channels include VAX VacationAccess, Xcelerator and Synapse. The Monaker and Trisept began integration in 2016 and completion is likely to be finalized in the near-term.
Monaker’s B2B offering is centered around providing travel distributors such as agents, airlines and cruise companies access to large global inventory of alternative lodging (or commonly called “vacation rental”) properties in a white label solution. The company’s platform provides these properties on instant bookable basis, helping travel partners capture their portion of the rapidly growing segment looking for alternative stay options. More and more tourists are now exploring rental accommodations over traditional hotel or resort stays. In order to help its travel associates,Monaker is further boosting its B2B initiative by supplying ALR products, along with optional tour activities. The company also offers its partners the ability to mark listings up or down to meet their own internal requirements. A main differentiator for Monaker to other peer Vacation Rental companies, is that all the properties available in Monaker’s inventory are open for instant bookings. This feature helps in removing uncertainty for the vacationers as it also makes the booking process smoother and faster. The company also gets an edge over its peers such as Airbnb, which generally require the users to wait for the confirmation of their bookings. Monaker is all set to carve a niche for itself in online travel market on the back of its robust product, solid technological innovation and experienced management to steer it through the competition.
With technology upgrades and the recent capital infusion, Monaker is positioning to stake ground and customers with its alternative lodging white label B2B solution, while more established peers such as Airbnb, Expedia ($EXPE) and Priceline ($PCLN) continue to focus directly on the consumer with tedious request-accept B2C approach.
Disclaimer:
Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements. WFM, Inc. is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. For full disclosure, please visit: http://wwfinancial.com/legal-disclaimer/.
Contact:
Worldwide Financial Marketing, Inc.
http://wwfinancial.com/
Phone: 954.360.9998
LOS ANGELES, Sept. 18, 2017 — Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy (DMD) and other rare diseases, today announced that it will present six-month follow-up results from the randomized Phase I/II HOPE-Duchenne clinical trial of CAP-1002 in boys and young men with Duchenne muscular dystrophy (DMD) at the 22nd International Congress of the World Muscle Society. The late breaking abstract and results will be presented in the late breaking poster session starting at 10:30am CEST on Wednesday, October 4, 2017. The International Congress of the World Muscle Society will be held October 3 – 7, 2017 at the Palais du Grand Large in Saint Malo, France.
About CAP-1002
CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of progenitor cell that has been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials. The HOPE-Duchenne trial is funded in part by the California Institute for Regenerative Medicine.
About Duchenne Muscular Dystrophy
DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by an abnormality in the dystrophin complex, a structural element that plays a critical role in muscle fiber integrity, which leads to chronic muscle damage. Patients with DMD typically die in their twenties, most commonly due to heart disease. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies. Capricor’s lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; the timing of regulatory approvals; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 16, 2017, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, as filed with the Securities and Exchange Commission on August 14, 2017. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
CAP-1002 is an Investigational New Drug and is not approved for any indications. Capricor’s exosomes technology, including CAP-2003, has not yet been approved for clinical investigation.
For more information, please contact:
AJ Bergmann, Vice President of Finance
+1-310-358-3200
abergmann@capricor.com
– Lefamulin met all primary FDA and EMA endpoints with a favorable tolerability profile –
– Conference call and webcast today at 8:30 a.m. EDT to review results –
DUBLIN, Ireland and KING OF PRUSSIA, Pa., Sept. 18, 2017 — Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1) trial, which evaluated the safety and efficacy of intravenous (IV) to oral lefamulin in patients with community-acquired bacterial pneumonia (CABP). CABP is the leading cause of infectious death in the United States.
In the LEAP 1 trial, Nabriva Therapeutics’ first of two pivotal Phase 3 clinical trials of lefamulin in patients with CABP, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority (NI, 12.5% margin) compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. In the trial, ECR rates were 87.3% for lefamulin and 90.2% for moxifloxacin with or without linezolid (treatment difference -2.9 [95% confidence interval (CI) -8.5, 2.8]).
“These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. “Due to lefamulin’s flexible dosing and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy. I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone. We continue to execute on our second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017 and topline results anticipated in the spring of 2018.”
Lefamulin also met the primary endpoints for the European Medicines Agency (EMA) of non-inferiority (NI, 10% margin) compared to moxifloxacin with or without adjunctive linezolid in the modified intent to treat (mITT) and clinically evaluable at test of cure (CE-TOC) populations based on an investigator assessment of clinical response (IACR) at a test of cure visit (5 to 10 days following the completion of study therapy). IACR rates for the mITT population were 81.7% for lefamulin and 84.2% for moxifloxacin with or without linezolid (treatment difference -2.6 [95% CI -8.9, 3.9]) and for the CE-TOC population were 86.9% for lefamulin and 89.4% for moxifloxacin with or without linezolid (treatment difference -2.5 [95% CI -8.4, 3.4]). IACR is also a key secondary endpoint for the FDA.
“Community-acquired bacterial pneumonia is a common and potentially life-threatening illness for which presently available recommended antimicrobials have potential limitations often associated with resistance or safety,” said Dr. Thomas M. File Jr., M.D., MS, chair of the Infectious Disease Section, Northeast Ohio Medical University, and chair of the Infectious Disease Division, Summa Health. “With bacterial resistance continuing to increase, patients and physicians are in need of new safe and effective treatment options that adhere to the principles of antibiotic stewardship. These positive topline results evaluating the efficacy and safety of lefamulin in patients with community-acquired bacterial pneumonia are promising.”
In addition, in LEAP 1, ECR by pathogen was similar to the overall response rates and was comparable between treatment arms. Detailed results on a pathogen-by-pathogen basis in the microbiological intent to treat (microITT) population are included in Appendix A to this release.
LEAP 1 enrolled 551 patients: 276 in the lefamulin arm and 275 in the moxifloxacin with or without linezolid arm. Patients who were aged 65 or older represented 47.8% of the patients in the lefamulin arm compared to 39.3% of the patients in the moxifloxacin with or without linezolid arm. The lefamulin arm enrolled 196 (71.0%), 76 (27.5%) and 4 (1.4%) patients with a Pneumonia Outcomes Research Team (PORT) class of 3, 4 and 5, respectively. The moxifloxacin with or without linezolid arm enrolled 1 (0.4%), 201 (73.1%), 70 (25.5%) and 3 (1.1%) patients with a PORT class of 2, 3, 4 and 5, respectively.
In the LEAP 1 trial, a similar rate of treatment-emergent adverse events (TEAEs) was observed in the lefamulin arm (38.1%) and the moxifloxacin with or without linezolid arm (37.7%). In addition, the rates of TEAEs leading to study drug discontinuation were 2.9% for lefamulin versus 4.4% for moxifloxacin with or without linezolid, and the rates of withdrawal from the trial were 1.8% for lefamulin versus 4.0% for moxifloxacin with or without linezolid. Death occurred with similar frequency in both arms, with 6 patients dying in the lefamulin arm (2.2%) and 5 patients dying in the moxifloxacin with or without linezolid arm (1.8%).
Adverse events reported in greater than 2.0% of patients receiving study drug (lefamulin versus moxifloxacin with or without linezolid, respectively) were hypokalemia (2.9% versus 2.2%), nausea (2.9% versus 2.2%), insomnia (2.9% versus 1.8%), infusion site pain (2.9% versus 0%), infusion site phlebitis (2.2% versus 1.1%), alanine aminotransaminase (ALT) increase (1.8% versus 2.2%) and hypertension (0.7% versus 2.2%).
Of note, while no documented cases of Clostridium difficile infection were reported in either treatment group, diarrhea was observed in 0.7% and 7.7% of subjects receiving lefamulin and moxifloxacin with or without linezolid, respectively, with a lower overall rate of gastrointestinal TEAEs in the lefamulin arm compared to the moxifloxacin with or without linezolid arm (6.6% versus 13.0%). In addition, no meaningful differences between the lefamulin and moxifloxacin with or without linezolid arms were observed in cardiac (2.9% versus 4.0%) or hepatobiliary (0.7% versus 1.5%) TEAEs.
Elevations in liver transaminases (>3 times the upper limit of normal (ULN)) were comparable in both treatment groups: ALT (7.1% versus 6.4%) and aspartate aminotransferase (AST) (4.1% versus 2.6%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively. Elevations in liver transaminases (>5 times the upper limit of normal (ULN)) occurred in both treatment groups: ALT (2.2% versus 1.9%) and aspartate aminotransferase (AST) (0.7% versus 0.7%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively. No patient in either treatment group met Hy’s Law criteria, which is an indicator for severe liver damage.
Changes in QT interval, a measure of the heart’s electrical cycle, that were of potential clinical concern were uncommon. At steady state, maximum increases in QT interval between 30 to 60 msec occurred in 12 (4.6%) and 14 (5.4%) of patients receiving lefamulin and moxifloxacin with or without linezolid, respectively. In addition, compared to no patients in the lefamulin arm, one patient in the moxifloxacin arm had an increase in QT interval greater than 60 msec, and one patient in each treatment arm had an increase in absolute QT interval to greater than 500 msec.
Further analysis of the LEAP 1 trial results including analysis of additional patient population groups in the trial and secondary and exploratory endpoints related to these populations groups is ongoing and additional results will be presented at upcoming scientific congresses.
About LEAP 1 Trial Design
LEAP 1 was a multi-center, randomized, controlled, double-blind, global study comparing lefamulin to moxifloxacin, a fluoroquinolone antibiotic, with or without linezolid. The trial was designed to evaluate the efficacy and safety of lefamulin (IV/oral) compared to moxifloxacin (IV/oral), with or without linezolid, in 551 adults with moderate to severe CABP. Linezolid (or matching placebo for the lefamulin arm) could be added to treatment if an investigator suspected that a patient was infected with methicillin-resistant S. aureus (MRSA) prior to randomization, as moxifloxacin is not approved to treat MRSA. Lefamulin was dosed at 150 mg IV every 12 hours. The comparator drugs were dosed according to their approved labeling, with moxifloxacin dosed at 400 mg IV daily and linezolid at 600 mg IV every 12 hours. Based on pre-defined criteria, investigators had the option to switch patients to oral therapy after three days (at least six doses) of IV study medication. Study drugs were administered orally as one lefamulin 600 mg tablet every 12 hours, moxifloxacin at 400 mg daily and linezolid at 600 mg every 12 hours. All patients enrolled in this trial had a PORT class severity of at least 3 on a scale of 1 to 5 (other than one patient in the moxifloxacin with or without linezolid treatment group), which corresponds to moderate to severe clinical disease. Randomization was 1:1 and was stratified by PORT risk class, geography and exposure to prior antibiotics. Patients who received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization were excluded from participating.
For LEAP 1, the primary efficacy endpoint for the FDA was the proportion of patients in the ITT population in each treatment group achieving ECR. ECR is achieved for patients who were alive, had improvement in at least two of the four cardinal symptoms of CABP as outlined in the current FDA guidance, had no worsening in any of the four cardinal symptoms of CABP and had not received a concomitant antibiotic (other than linezolid) for the treatment of CABP up through 120 hours after the first dose of study drug. The four cardinal symptoms of CABP, as outlined in the current FDA guidance, are difficulty breathing, cough, production of purulent sputum and chest pain. A number of population groups were evaluated in LEAP 1, including an ITT population consisting of all randomized patients regardless of whether they received study medication; a modified intent to treat (mITT) population consisting of all randomized subjects who received any amount of study drug; and a microITT population consisting of all subjects in the ITT population who had at least one baseline bacterial pathogen known to cause CABP, Legionella pneumophila from an appropriate microbiological specimen, or CABP caused by Mycoplasma pneumoniae or Chlamydophila pneumoniae.
Additional Phase 3 Clinical Trial Ongoing
Nabriva Therapeutics’ second pivotal Phase 3 clinical trial, LEAP 2, is a multi-center, randomized, controlled, double-blind, global study comparing oral lefamulin to moxifloxacin. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in patients with moderate CABP. All patients enrolled in LEAP 2 have a PORT class severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease. Nabriva is targeting the enrollment of approximately 738 patients in LEAP 2. The company expects to complete enrollment in the fourth quarter of 2017, and to have topline data available in the spring of 2018.
Conference Call and Webcast
The company will host a conference call and webcast at 8:30 a.m. EDT today. The live webcast can be accessed under “Events and Presentations” in the Investor Relations section of Nabriva Therapeutics’ website at www.nabriva.com and will be accessible for 90 days. The conference call can also be accessed by dialing 1-866-411-8292 (U.S./Canada) or 1-704-908-0383 (international) and providing the passcode 86032729.
About CABP
Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than 5 million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately 3.1 million of these adult CABP patients sought treatment in a hospital setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations. Nabriva Therapeutics’ lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of TEAEs comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.
Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Nabriva’s ongoing Phase 3 clinical trial of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Nabriva’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva’s views as of any date subsequent to the date of this release.
Contact:
INVESTORS
Dave Garrett
Nabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657
MEDIA
Katie Engleman
Pure Communications
katie@purecommunications.com
910-509-3977
| Appendix A |
|
|
|
| |
Lefamulin |
Moxifloxacin
(with or without linezolid) |
| Microbiological ITT (microITT) |
N = 160 (58.0%) |
N = 159 (57.8%) |
| Baseline Pathogen |
N |
ECR (%) |
N |
ECR (%) |
| Gram Positive |
|
|
|
|
| S. pneumoniae (SP) |
82/93 |
88.2 |
% |
91/97 |
93.8 |
% |
| Penicillin-Susceptible SP (PSSP) |
17/21 |
81.0 |
% |
16/18 |
88.9 |
% |
| Penicillin-Intermediate SP (PISP) |
5/5 |
100 |
% |
2/2 |
100 |
% |
| Penicillin-Resistant SP (PRSP) |
2/2 |
100 |
% |
2/3 |
66.7 |
% |
| Multidrug-Resistant SP (MDRSP) |
6/6 |
100 |
% |
5/6 |
83.3 |
% |
| Macrolide-Resistant SP (MRSP) |
6/6 |
100 |
% |
5/6 |
83.3 |
% |
| S. aureus |
31/32 |
96.9 |
% |
13/13 |
100 |
% |
| Gram Negative |
|
|
|
|
| H. influenzae |
8/8 |
100 |
% |
6/7 |
85.7 |
% |
| M. catarrhalis |
47/52 |
90.4 |
% |
52/55 |
94.5 |
% |
| Atypicals |
|
|
|
|
| M. pneumoniae |
16/19 |
84.2 |
% |
18/20 |
90.0 |
% |
| L. pneumophila |
16/18 |
88.9 |
% |
12/14 |
85.7 |
% |
| C. pneumoniae |
10/11 |
90.9 |
% |
18/19 |
94.7 |
% |
Proposed Combination of Complementary Rare Disease Franchises Maximizes the Ability to Bring Needed New Therapies to Market
Proposal Delivers Superior Value To Dimension’s Shareholders Relative to the REGENXBIO Transaction; Provides Dimension Shareholders with Immediate Cash Premium Value of Over 358% to Unaffected Share Price
Ultragenyx to Host Conference Call Today at 10:30am ET
NOVATO, Calif., Sept. 18, 2017 — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) (“Ultragenyx” or the “Company”), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics, Inc. (NASDAQ:DMTX) (“Dimension”) for $5.50 per share, or approximately $138 million, in cash at close to be effectuated via a tender offer. The Ultragenyx offer represents a premium of over 358% to Dimension’s unaffected share price as of August 24, 2017 and premiums of 24% and 48% over the implied value of the all-stock consideration to be received by Dimension stockholders pursuant to the announced acquisition of Dimension by REGENXBIO Inc. (traded on NASDAQ under RGNX) (“REGENXBIO”), based on REGENXBIO’s last closing price and trailing 20-trading day volume-weighted average price as of September 15, 2017, respectively. As such, the proposal would provide Dimension stockholders with an immediate and certain return on their investment in Dimension and constitutes a superior alternative to the REGENXBIO transaction.
The proposal has been approved by the Board of Directors of Ultragenyx. Ultragenyx would fund the transaction from cash resources on its balance sheet and anticipates that customary closing conditions to the transaction could be satisfied so that the tender offer could complete as soon as 25 business days after merger agreement signing.
“This transaction provides a compelling opportunity to create value by leveraging Ultragenyx’s advanced clinical and regulatory expertise, as well as its rare metabolic disease commercial infrastructure to advance Dimension’s rare disease focused gene therapies and bring much needed new treatments to market,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “Based on my own experience as a scientific advisor to Dimension, I have the greatest respect for the deep expertise and knowledge of Dimension’s employees in AAV gene therapy and manufacturing. We share Dimension’s vision for bringing transformational new therapies to patients with rare genetic diseases and believe that bringing our two companies together would accelerate the process of bringing important new therapies to market for patients.”
Dr. Kakkis continued, “Our all-cash offer provides meaningfully greater value and certainty to Dimension shareholders compared to the proposed all-stock acquisition by REGENXBIO. We believe Ultragenyx and its product candidates are highly complementary to Dimension’s and present no competitive overlap, giving us confidence that we could combine our two companies quickly and seamlessly.”
Below is the text of a letter that has been sent concurrent with this announcement to Dr. Annalisa Jenkins, President and Chief Executive Officer of Dimension:
September 18, 2017
Dimension Therapeutics, Inc.
840 Memorial Drive, 4th Floor
Cambridge, Massachusetts 02139
Attention: Dr. Annalisa Jenkins, Chief Executive Officer
Dear Annalisa:
We at Ultragenyx Pharmaceutical Inc. have followed the progress of Dimension Therapeutics, Inc. (“Dimension” or the “Company”) with great interest and are impressed by the advances you have made with your product candidates. The Dimension team has built an innovative and valuable business with a strong portfolio of assets and an advanced manufacturing platform that are poised to make significant advances in the treatment of patients with rare genetic diseases.
We share your vision to expand treatment options and bring transformational therapies to patients in areas with significant unmet need and we have a strong track record of advancing rare disease focused product candidates through the clinical and regulatory processes, including submission of marketing applications for two products in both the US and EU during this last year. As we head to commercialization for two products in 2018, we are best prepared to support the advancement and eventual filing for any products successfully developed from your portfolio. As experts in the metabolic disease space, our scientific, clinical, regulatory, and commercial skills would be complementary with your technology, programs and people. As such, we believe that a combination of our respective organizations will maximize the impact we can have for patients by bringing much-needed new therapies to market.
Our vision would be to leverage our significant clinical and regulatory expertise, as well as our growing rare metabolic disease commercial infrastructure, to advance Dimension’s rare disease focused gene therapies through the clinic and to maximize their reach with patients. Furthermore, we recognize and value the deep expertise and knowledge that Dimension’s employees have developed in AAV gene therapy and manufacturing, and we believe that their collective talents would be an impressive addition to Ultragenyx. We would envision maintaining a gene therapy development unit and manufacturing development team at Dimension’s facilities in Massachusetts to continue to retain your strong team’s significant institutional knowledge and efficiently progress your critical manufacturing there.
We are pleased to submit this non-binding proposal (“Proposal”) to acquire Dimension for a value, consideration and structure that we believe represents a compelling opportunity for Dimension shareholders. In addition, this offer provides meaningfully greater value and certainty than the agreement recently reached with REGENXBIO Inc. (“REGENXBIO”).
- Price, Consideration and Structure. We are prepared to acquire 100% of the outstanding common stock of Dimension for $5.50 per share (“Purchase Price”) in cash to be effectuated via a tender offer.This represents a premium of 358% to Dimension’s unaffected share price as of August 24, 2017, and a 24% premium to the implied offer value of the REGENXBIO transaction, based upon REGENXBIO’s closing price on September 15, 2017. This also represents a 48% premium to the implied offer value of the REGENXBIO transaction, based upon REGENXBIO’s 20 trading day volume weighted average price of $23.68 per share (per Bloomberg) as of September 15, 2017.
The $5.50 per share offer implies an equity purchase price of approximately $138 million in cash at close.
- Financing. We have sufficient cash resources to fund this transaction with cash currently on our balance sheet, and our offer is not subject to any financing condition.
- Due Diligence and Timing. This Proposal is based on our current knowledge of Dimension from the Company’s public filings and disclosures and is subject to confirmatory due diligence that we expect can be addressed quickly and efficiently if we are afforded access to a customary data room and appropriate Company personnel. We are prepared to move expeditiously to complete diligence with your assistance in a two-week period.
- Merger Agreement. Concurrently with our due diligence review, we would anticipate working with you to negotiate a definitive agreement. We are prepared to accept identical or more favorable terms for Dimension than your existing merger agreement with REGENXBIO, as you will see in the enclosed version of our draft merger agreement showing changes from the existing agreement with REGENXBIO. Our draft merger agreement in fact offers greater speed and deal certainty than the pending transaction with REGENXBIO, in particular:
- We are proposing an all-cash transaction structured as a tender offer, which would expire as soon as 25 business days following entry into the merger agreement. We propose to close the deal on the business day after expiration of the tender offer. In contrast, the existing merger agreement with REGENXBIO is conditioned on SEC clearance of a registration statement by REGENXBIO and a Company shareholder approval.
- We are willing to agree to an absolute “hell or high water” covenant to demonstrate our comfort and commitment in securing antitrust clearance for our acquisition of the Company. We believe Ultragenyx and its product candidates present no competitive overlap with the Company. In contrast, the existing merger agreement with REGENXBIO specifically provides that REGENXBIO will not be obligated to sell, dispose of or hold separate any assets of REGENXBIO or the Company in order to secure antitrust clearance.
- We are proposing to bear any risk related to clinical data coming out of the Company’s ongoing trials before closing of the transaction, as reflected in our changes to the definition of “Company Material Adverse Effect” in our draft merger agreement.
The Ultragenyx board of directors has approved this Proposal. Subject to completing our due diligence and negotiating a mutually satisfactory definitive agreement to be executed upon your termination of the existing merger agreement with REGENXBIO, we will require final approval by our board of directors. No additional Ultragenyx internal approvals or shareholder approvals would be needed to consummate the transaction. Based on our current knowledge of Dimension from publicly available information, we do not believe that any other material approvals would be required for us to consummate the transaction, other than the expiration or early termination of the waiting period under the Hart-Scott-Rodino Act and, if applicable, any approvals under foreign antitrust laws.
This Proposal is not legally binding upon Ultragenyx, and no binding obligation shall arise for either party unless and until a definitive agreement has been duly executed between Ultragenyx and Dimension.
We believe that our Proposal constitutes a Superior Proposal (as defined in your existing merger agreement with REGENXBIO) and that your board of directors can and should, consistent with its fiduciary duties, make a determination to that effect. We urge you and your Board of Directors promptly to take those actions necessary under the existing merger agreement with REGENXBIO in order to afford us the opportunity to complete our due diligence and commence discussions with management and your advisors. The form of Acceptable Confidentiality Agreement (as defined in your existing merger agreement with REGENXBIO) can be provided to our General Counsel, Karah Parschauer, by email at KParschauer@ultragenyx.com. We have engaged Centerview Partners LLC and Skadden, Arps, Slate, Meagher & Flom LLP as financial and legal advisors, respectively, to assist us in this transaction and are prepared to move quickly to complete our diligence and negotiate a definitive agreement.
We have publicly disclosed this letter, simultaneously with sending it to you. We look forward to hearing from you and please do not hesitate to contact me or our advisors with any questions.
Sincerely,
Dr. Emil D. Kakkis
Chief Executive Officer and President
Ultragenyx Pharmaceutical Inc.
Advisors
Centerview Partners LLC is serving as financial advisor to Ultragenyx, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as Ultragenyx’s legal advisor.
Conference Call
Ultragenyx will host a conference call today at 10:30 a.m. Eastern (7:30 a.m. Pacific). The live and replayed webcast of the call will be available through the company’s website at www.ultragenyx.com. To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (international) and enter the passcode 86650959. The replay of the call will be available for one year.
About Ultragenyx Pharmaceutical Inc.
Ultragenyx is a biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. The Company has rapidly built and advanced a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The Company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the Company’s website at www.ultragenyx.com.
Forward Looking Statements / Additional Information
Except for the historical information contained herein, the matters set forth in this communication, including statements of anticipated changes in the business environment in which Ultragenyx operates and in Ultragenyx’s future prospects or results, statements relating to Ultragenyx’s intentions, plans, hopes, beliefs, anticipations, expectations or predictions of its future, or statements relating to Ultragenyx’s offer and the potential benefits of a transaction with Dimension Therapeutics, Inc. (“Dimension”), are forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of our regulatory filings and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of our drug candidates. There is no assurance that the potential transaction will be consummated, and it is important to note that actual results could differ materially from those projected in such forward-looking statements. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on July 28, 2017, and its subsequent periodic reports filed with the SEC.
The tender offer referred to in this communication (an “Offer”) has not yet commenced. Accordingly, this communication is for informational purposes only and does not constitute an offer to purchase or a solicitation of an offer to sell any shares of Dimension common stock or any other securities. On the commencement date of any Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related materials, will be filed with the SEC by Ultragenyx and a wholly owned subsidiary. The offer to purchase shares of Dimension common stock will only be made pursuant to the offer to purchase, letter of transmittal and related materials filed with the SEC by Ultragenyx as part of its Schedule TO. Investors and security holders are urged to read both the tender offer statement and any solicitation/recommendation statement filed by Dimension regarding the Offer, as they may be amended from time to time, when they become available, because they will contain important information about the Offer, including its terms and conditions, and should be read carefully before any decision is made with respect to the Offer. Investors and security holders may obtain free copies of these statements (when available) and other materials filed with the SEC at the website maintained by the SEC at www.sec.gov, or by directing requests for such materials to the information agent for the Offer, which will be named in the tender offer statement.
Contacts
Investor Relations:
Ryan Martins
415-483-8257
Media Relations:
Joele Frank, Wilkinson Brimmer Katcher
Tim Lynch / Trevor Gibbons / Leigh Parrish
212-355-4449
SAN JOSE, CA–(September 18, 2017) – ITUS Corporation (NASDAQ: ITUS), today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent 9,739,783, to inventors Dr. Amit Kumar, Chief Executive Officer, and John Roop, VP of Engineering, of ITUS Corporation. ITUS’s early cancer detection technology is being developed by its wholly owned subsidiary, Anixa Diagnostics Corporation.
Dr. Kumar stated, “This is the first patent to issue of several patents that we expect to issue garnering protection of our cancer detection technology. The claims of this patent were allowed in May of 2017, and now we have received the official issuance notification and patent number. We currently have one other key patent application pending at the USPTO and expect to file for additional patent protection as our research and development continues.”
Dr. Kumar added, “ITUS’s unique liquid biopsy approach utilizes flow cytometry to measure the presence and characteristics of certain circulating immune cells. We then use Artificial Intelligence to analyze the data in a manner that enables us to identify tumor bearing patients. The test utilizes a simple blood draw from the patient. To date, our technology has demonstrated its ability to identify 15 cancer types including breast, prostate, colon, lung, pancreatic, and others. Because we are measuring subtle changes in circulating immune cells, it is not surprising that our technology appears to work on multiple cancer types, and we expect the technology will eventually be able to identify all cancer types. ITUS is performing additional tests including the evaluation of benign conditions which may exist in patients but are not malignant tumors.”
ITUS Corporation
ITUS, a cancer-focused biotechnology company, through its wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the Cchek™ platform, a series of non-invasive blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. ITUS also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Drug Candidate for Alzheimer’s Shows Promise by Inhibiting Aβ Aggregation without Neuron Damage
BETHESDA, Md., Sept. 18, 2017 — India Globalization Capital, Inc. (NYSE-MKT:IGC) provides an update on compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s disease model, showing that at varying concentrations of THC, the aggregation of Aβ protein decreases by as much as 40%.
“As Alzheimer’s progresses, synaptic dysfunction and the death of neurons lead to memory loss. These study results, when combined with the earlier reported data that shows IGC-AD1 reduces Aβ40 and Aβ42 production by as much as 50%, and 40%, without any toxicity, represent a highly significant novel breakthrough that could potentially bring much needed relief from this devastating disease,” states IGC’s CEO Ram Mukunda.
It is believed that a primary cause of AD is the buildup of senile plaque composed of amyloid beta peptides (Aβ plaque) in the cerebral cortex and hippocampus. The key pathogenic event in the onset of AD is Aβ peptide monomers aggregating into prefibrillar oligomers (dimers, trimmers, tetramers and oligomers). As AD progresses Aβ oligomers directly cause synaptic dysfunction and the death of neurons, consequently leading to a loss of memory.
“A drug that (i) decreases production of Aβ, (ii) inhibits Aβ aggregation into oligomers, (iii) is not toxic to neurons, and (iv) does not cause inebriation (high), could be a powerful weapon against AD and the prevention of AD. In vitro, our product demonstrates these critical factors and we are pursuing a patent filing that protects this therapy.
AD starts 20 to 25 years before symptoms like memory loss are manifested. Statistically, there is an almost 50% chance of individuals over 80 years contracting AD and over 65% of AD patients are women. Based on the findings of these studies, our plan is two-fold. First, we will position IGC-AD1 as a drug that can be used both as a treatment for AD, and as a prophylactic treatment for the prevention of AD. Second, we will commercialize a supplement version to be sold as a medical dispensary product. This will allow our team to work through the FDA approval process for IGC-AD1, while securing market share in the medical dispensary segment. This is a very exciting time for all our shareholders and I look forward to providing updates on our progress in combatting this global disease,” concludes IGC’s CEO Ram Mukunda.
The summary in vitro data indicates that between 2.5nM and 25nM THC concentration, the formation of Aβ1-42 trimers and tetramers in N2aAPP cells are reduced by up to 40% as determined by both fluorescence and immuno blotting assays. Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.
About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia. It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion. AD currently affects more than 5.3 million Americans and over 65% of AD patients are women. Over the next 20 years, the number of those afflicted with the disease is expected to double. The forecast is staggering, considering that to date, no effective cure has been found.
About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.
For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/
Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.
Contact:
Claudia Grimaldi
301-983-0998
SAN GABRIEL, California, September 18, 2017 –
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that its wholly owned foreign enterprise, CBD Biotechnology Co. Ltd., has completed the filing process with the China Food & Drug Administration (“CFDA”) for its first line of non-industrial hemp-infused skin care products. The Company expects to launch the CBD Magic Hemp Series skin care line in October positioning CBD Biotechnology as a leader in what it believes to be an untapped segment of China’s skin care industry.
The CBD Magic Hemp Series launch will include three (3) products:
• The CBDBIO TECH Brightening and Refreshing Moisturizer – intended to balance the skin’s moisture, while forming a protective, moisturizing layer;
• The CBDBIO TECH Perfecting Shield Primer – intended to even skin tone, while covering fine lines and minimizing the look of pores; and
• The CBDBIO TECH Peptide Collagen Solution – intended to moisturize and firm the skin, while smoothing fine lines, and reducing signs of aging.
The CBD Magic Hemp Series line is different from other skin care lines currently available in China because the products are infused with hemp extract, otherwise known as cannabidiol or CBD. CBD, a powerful antioxidant and anti-inflammatory agent, has been widely used in skin care products in western countries for some time. Although a catalogue provided by the CFDA entitled “Catalogue of Cosmetics Raw Materials in Use (2015)” includes Cannabis Sativa Leaf Extract, CBD Biotechnology is not aware of any other Chinese skin care manufacturers that have entered this emerging market, setting the stage for CBD Biotechnology to proudly take the lead with its innovative product line.
“I am very pleased to announce the upcoming launch of CBD Biotechnology’s hemp-infused skin care line, the CBD Magic Hemp Series,” says Summer Yun, CEO of CBD Biotechnology Co., Ltd. “We have not only completed the filing process with CFDA, but we have also contracted with a large processing factory in Shanghai, China, with over 14-years of experience in cosmetics production.”
“China has one of the world’s largest consumer markets for skin care products. Retail sales of skincare products and make-up products in China reached 169.1 billion yuan and 28.3 billionyuan respectively in 2016, with year-over-year growth of 5% and 12% respectively. Skin care is expected to reach 223.3 billion yuan in 2021 with growth driven by rising awareness of skin health and consumption upgrading Chinese consumers. As one of the first hemp infused skin care brands in China, we are confident that CBD Biotechnology will lead Chinese market, with potential for global expansion.
About ChineseInvestors.com (OTCQB: CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online sales and direct sales of non-industrial hemp-based products and other health related products.
For more information visit ChineseInvestors.com
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Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1.214.636.2548
Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
WOBURN, Mass., Sept. 15, 2017 — Yield10 Bioscience, Inc. (NASDAQ:YTEN) announced today that it will be a subawardee on a new U.S. Department of Energy (DOE) Grant to conduct research aimed at boosting oilseed yield in Camelina, a promising biofuel crop. The 5-year, $10 million grant, which was recently recommended for funding, will be led by Michigan State University (MSU) and will involve a multidisciplinary team of researchers from MSU, North Carolina State University and Yield10 Bioscience as the industry partner. Yield10 Bioscience expects to receive approximately $3 million under the grant for research activities that are expected to begin in the fourth quarter of 2017.
Under the grant, the team of scientists will generate metabolic and gene expression models to predict in detail the gene combinations and pathways used by the Camelina plant to convert sucrose, the primary product of photosynthesis, into oil. Yield10’s work under the award will involve the use of its T3 gene discovery platform to identify novel global regulatory genes that are designed to increase oil and seed yield. The identification of new genetic targets to boost yield in Camelina may allow for the broader cultivation of Camelina for commercial use, and may have further application to other oilseed crops, such as canola and soybean.
“Current seed-oil based bioproduction relies heavily on food crop species, such as soybean, sunflower and canola oil,” said Danny Schnell, Ph.D., MSU plant biologist and grant coordinator. “Camelina doesn’t require as much water as these crops, it grows more quickly, and it has a higher resistance to pest and disease. By focusing on some key genetic control points, we’re hoping to unlock the relationship between carbon capture and increasing oil and seed production.”
“We look forward to working with Dr. Schnell and the other members of the multidisciplinary team that he has assembled to delve more deeply into the complex carbon metabolic pathways in Camelina responsible for converting the primary product of photosynthesis into seeds. We believe that this work will enable us to identify additional genes and gene combinations (or traits) to significantly improve yield in Camelina and a number of important food crops,” commented Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. “We expect our T3 gene discovery platform to contribute to this effort by identifying genes that serve as control points or master switches for increasing oil and/or seed yield.”
The Schnell Lab discovered the novel algal gene which Yield10 is developing as the C3003 trait in major food crops including canola, soybean and rice. Further work to continue to unravel the molecular mechanism by which C3003 increases seed yield in Camelina is a key part of this new grant. This work in addition to the broader research program in the grant may enable further optimization of the impact of the C3003 trait on seed yield. Receiving this funding from DOE following an extensive scientific peer review process underlines the importance not only of the discovery that led to the C3003 trait but the importance of developing multi-gene approaches to significantly increase crop yield. Under the grant, work on C3003, as well as other seed yield and oil enhancing traits, will be integrated with Yield10’s T3 Platform activities to maximize oil and/or seed yield.
Camelina is an oilseed crop in limited cultivation in North America and Europe. The crop has received recent attention as an industrial oilseed for the production of biofuels, novel industrial lipids, and oleochemicals. Research suggests that efforts to improve seed yield, oil content and fatty acid composition may expand the commercial adoption and cultivation of Camelina. In the near term Yield10 is using work in Camelina to accelerate field testing of novel yield traits for major food crops including canola, soybean and rice.
Background on Yield10’s T3 Platform
Yield10 has previously used the T3 Platform, a novel gene discovery approach, to identify novel global regulatory genes that significantly impact photosynthesis and biomass yield in switchgrass. More recently, Yield10 reported that early work in rice with one of its global regulatory genes produced rice plants with more tillers, as well as an increased aboveground biomass. Results of this work are ongoing to determine the impact on seed yield. In the new DOE subaward, Yield10 will use the T3 Platform for gene discovery in Camelina.
About Yield10 Bioscience
Yield10 Bioscience, Inc. is focused on developing new technologies to achieve step-change improvements in crop yield to enhance global food security. Yield10 has an extensive track record of innovation based around optimizing the flow of carbon in living systems. Yield10 is leveraging its technology platforms and unique knowledge base to design precise alterations to gene activity and the flow of carbon in plants to produce higher yields with lower inputs of land, water or fertilizer. Yield10 is advancing several yield traits it has developed in crops such as Camelina, canola, soybean and corn. Yield10 is headquartered in Woburn, MA and has an Oilseeds center of excellence in Saskatoon, Canada.
For more information about the company, please visit www.yield10bio.com.
(YTEN-G)
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding the Company’s ability to achieve improvements in oil content and oil yield in oilseed crops, the work to be conducted pursuant to the DOE grant described in this press release, the potential for identification of new genetic targets to boost yield in Camelina and its effect on the cultivation of Camelina for commercial use and other oilseed crops, such as canola and soybean, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including the risks and uncertainties detailed in Yield10 Bioscience’s filings with the Securities and Exchange Commission. Yield10 assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
Contacts:
Yield10 Bioscience:
Lynne H. Brum, (617) 682-4693, LBrum@yield10bio.com
Investor Relations Contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com
SANTA CLARA, Calif., Sept. 15, 2017 — Echelon Corporation (NASDAQ:ELON), the original Industrial Internet of Things (IIoT) company, announced that Andy Lovit has been granted an inducement grant under NASDAQ listing rules. Mr. Lovit joined the company as Senior Vice President of Worldwide Sales on September 11, 2017.
Equity Grants
In accordance with NASDAQ Stock Market Rules, Echelon Corporation today reported equity inducement awards granted to Andy Lovit by the Company. As an inducement to Mr. Lovit entering into employment with the Company, and in accordance with NASDAQ Listing Rule 5635(c)(4), on September 12, 2017, the Compensation Committee of the Board of Directors of the Company approved an award of 60,000 restricted stock units (the “RSU Award”) with a grant date to be effective as of October 10, 2017 to Mr. Lovit. The RSU Award was made outside of the Company’s current equity plan, but will be subject to terms and conditions generally consistent with those in the Company’s 2016 Inducement Equity Incentive Plan. The RSU Award will vest as to one-half of the shares on October 10, 2018 and one-half on the annual anniversary thereafter, subject to Mr. Lovit’s continued service through each applicable vesting date. In the event Mr. Lovit’s employment is involuntarily terminated due to and within twelve months of a Change in Control Merger of the Company, all of the unvested shares subject to the RSU Award will be accelerated and shall vest immediately.
About Echelon Corporation
For 25 years Echelon (NASDAQ:ELON) has pioneered the development of open-standard networking platforms for connecting, monitoring and controlling devices in commercial and industrial applications. With more than 110 million devices installed worldwide, Echelon’s proven, scalable solutions host a range of applications enabling customers to reduce energy and operational costs, improve safety and comfort, and create efficiencies through optimizing physical systems. Echelon focuses today on two IoT (Internet of Things) market areas: creating smart cities and smart enterprises through connected outdoor lighting systems, and enabling device makers to bring connected products to market faster via a range of IoT-optimized embedded systems. More information about Echelon can be found at www.echelon.com.
Investor Relations Contact:
Annie Leschin
StreetSmart Investor Relations
(415) 775-1788
annie@streetsmartir.com
KVM and AV/IT System Management Platform Now Supports DKM Digital KVM Matrix
PITTSBURGH, Sept. 15, 2017 — Black Box, a leading technology solutions provider of high-performance KVM, switching solutions, and professional AV signal distribution and extension, today announced enhancements to Boxilla, an enterprise-level KVM and AV/IT management system. A core new feature of Boxilla 1.1 is the ability for DKM users to seamlessly access both physical and virtual servers across an IP network. Boxilla is an integral part of Black Box’s robust services portfolio of end-to-end solutions for mission-critical control room infrastructure, smart office configurations and digital retail technology.
Originally launched in January 2017, Boxilla, which is designed to support other Black Box products, offers a comprehensive and centralized command center that manages and deploys high-performance KVM. The platform was first integrated with InvisaPC, Black Box’s IP-based KVM system, to give users a virtualization solution that can scale to hundreds of users and unlimited devices.
“After a successful integration with InvisaPC, the next phase of Boxilla allows DKM systems to grow beyond private networks by connecting across IP networks to access physical or virtual servers in the same way the user accesses servers directly connected to DKM today,” said John Hickey, senior director of KVM and ProAV at Black Box. “Users will now be able to reach any server on their network in an instant, which will greatly improve their operations across the enterprise.”
Future enhancements to Boxilla will enable it to support other premier Black Box products, including DCX, MediaCento, Coalesce and ControlBridge.
Built for everything from conference rooms to 911 call centers, Boxilla streamlines and automates communication between KVM devices so that businesses can improve efficiency and performance. Some of its key elements include:
- Centralized system management: Features a real-time, user-friendly dashboard that manages authentication, access control, accountability, troubleshooting and device monitoring.
- Improved security: Detects potential breaches and quickly identifies refused or unauthorized login attempts.
- Instant performance updates: Offers a snapshot of the entire KVM system so users can immediately assess performance, including bandwidth usage and device status.
Boxilla won its third consecutive Best of Show award in 2017 at the June InfoComm conference in Orlando, Fla. It was also recognized at ISE in February and at NAB in April.
“This is just the beginning of Boxilla’s capabilities,” said Hickey. “We’re excited to see it continue to redefine KVM and AV/IT system management across the industry.”
About Black Box
Black Box (NASDAQ:BBOX) is the trusted digital partner. With more than 40 years of experience connecting people and devices, we are dedicated to helping clients embrace the intelligent edge and enable their digital transformation. Our award winning products and service connect you with your customers, your team, and the world. Every day, our customers trust us to design, deploy, and manage their digital needs including retail IoT solutions, healthcare, and mission-critical control room infrastructures across commercial enterprises and governmental organizations. With a global presence of more than 3,400 team members, we make digital transformation possible whether at one location or hundreds.
To learn more, visit the Black Box website at http://www.blackbox.com or follow us on Twitter @blackbox_ns.
Black Box® and the Double Diamond logo are registered trademarks of BB Technologies, Inc.
For Media Inquiries:
Black Box Corporation
Melissa Ott
Marketing Manager
Phone: +1(724) 873-7033
Email: media@blackbox.com
For Investor Relations Inquiries:
Black Box Corporation
David J. Russo
Senior Vice President and Chief Financial Officer
Phone: +1(724) 873-6788
Email: investors@blackbox.com
TORONTO, Sept. 15, 2017 – The Stars Group Inc. (Nasdaq: TSG; TSX: TSGI) today updated its previously announced guidance ranges for the full year 2017 and announced the prepayment of an additional $75 million of second lien debt. All dollar ($) amounts are in U.S. dollars.
“It’s been a great three months since joining The Stars Group and the team is energized,” said Brian Kyle, Chief Financial Officer. “As I am now fully familiar with our forecasting and given our solid trends across all business lines, which reinforce our conviction and commitment to our strategy, it is now appropriate to update our financial guidance. In addition, given our progress to date, we are also able to make another meaningful prepayment of our debt.”
Full Year Guidance
Based on year-to-date performance, The Stars Group has updated its previous full year 2017 guidance and now expects:
- Revenues of between $1,285 and $1,315 million, as compared to the prior range of $1,200 and $1,260 million. The revised guidance implies 2017 revenue growth of between 11% and 14% compared to the prior year and includes an expectation that real-money online poker revenue will be slightly higher year-over-year as The Stars Group, among other things, continues to experience a very positive consumer response to Stars Rewards, which was rolled out globally in July;
- Adjusted EBITDA of between $590 and $610 million, as compared to the prior range of $560 and $580 million. The revised guidance implies 2017 Adjusted EBITDA growth of between 13% and 16% compared to prior year;
- Adjusted Net Earnings of between $445 and $469 million, as compared to the prior range of $413 and $437 million and as compared to approximately $367 million in 2016; and
- Adjusted Net Earnings per Diluted Share of between $2.17 and $2.31, as compared to the previous range of between $2.01 and $2.15 and as compared to $1.88 in 2016.
These estimates reflect management’s view of current and future market and business conditions, including assumptions of (i) anticipated negative operating conditions in Poland primarily related to constraints on processing payments in that jurisdiction, the cessation of real-money online poker in Australia on September 11, 2017, and the cessation of real-money online gaming in Colombia on July 17, 2017, (ii) the introduction of Stars Rewards, The Stars Group’s previously disclosed cross-vertical customer loyalty program, (iii) no other material adverse regulatory events and (iv) no material foreign currency exchange rate fluctuations, particularly against the Euro which is the primary depositing currency of The Stars Group’s customers, that could impact customer purchasing power as it relates to The Stars Group’s U.S. dollar denominated product offerings. Such guidance is also now based on a Euro to U.S. dollar exchange rate of 1.18 to 1.00 and all other currencies at their average exchange rate for the month of August, in each case for the remainder of 2017, unaudited expected results and certain accounting assumptions.
Debt Prepayment
Next week, The Stars Group will prepay without penalty an additional $75 million under its second lien term loan using cash on the balance sheet and cash flow from operations. Following this prepayment, The Stars Group will have repaid $115 million of its second lien debt thus far in 2017, resulting in a total reduction in annual interest expense of approximately $9.5 million, and reducing the principal balance of the second lien term loan to $95 million.
About The Stars Group
The Stars Group is a leading provider of technology-based products and services in the global gaming and interactive entertainment industries. Through its Stars Interactive division, The Stars Group ultimately owns gaming and related consumer businesses and brands, including PokerStars, PokerStars Casino, BetStars, Full Tilt, StarsDraft, and the PokerStars Championship, PokerStars Festival and PokerStars Megastack live poker tour brands (incorporating aspects of the European Poker Tour, PokerStars Caribbean Adventure, Latin American Poker Tour and the Asia Pacific Poker Tour). These brands together have more than 113 million registered customers globally and collectively form the largest poker business in the world, comprising online poker games and tournaments, sponsored live poker competitions, marketing arrangements for branded poker rooms in popular casinos in major cities around the world, and poker programming and content created for television and online audiences. The Stars Group, through certain of these brands, also offers non-poker gaming products, including casino, sportsbook and daily fantasy sports. The Stars Group, through certain of its subsidiaries, is licensed or approved to offer, or offers under third party licenses or approvals, its products and services in various jurisdictions throughout the world, including in Europe, both within and outside of the European Union, the Americas and elsewhere. In particular, PokerStars is the world’s most licensed online gaming brand, holding licenses or related operating approvals in 17 jurisdictions.
Cautionary Note Regarding Forward Looking Statements
This news release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable securities laws, including, without limitation, certain financial and operational expectations and projections, such as full year 2017 financial guidance, and certain future operational and growth plans and strategies. Forward-looking statements and information can, but may not always, be identified by the use of words such as “anticipate”, “plan”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “predict”, “potential”, “targeting”, “intend”, “could”, “might”, “would”, “should”, “believe”, “objective”, “ongoing”, “imply” and similar references to future periods or the negatives of these words and expressions. These statements and information, other than statements of historical fact, are based on management’s current expectations and are subject to a number of risks, uncertainties, and assumptions, including market and economic conditions, business prospects or opportunities, future plans and strategies, projections, technological developments, anticipated events and trends and regulatory changes that affect us, our customers and our industries. Although The Stars Group and management believe the expectations reflected in such forward-looking statements and information are reasonable and are based on reasonable assumptions and estimates, there can be no assurance that these assumptions or estimates are accurate or that any of these expectations will prove accurate. Forward-looking statements and information are inherently subject to significant business, regulatory, economic and competitive risks, uncertainties and contingencies that could cause actual events to differ materially from those expressed or implied in such statements. Specific risks and uncertainties include, but are not limited to: the heavily regulated industry in which The Stars Group carries on business; interactive entertainment and online and mobile gaming generally; current and future laws or regulations and new interpretations of existing laws or regulations with respect to online and mobile gaming; potential changes to the gaming regulatory framework; legal and regulatory requirements; ability to obtain, maintain and comply with all applicable and required licenses, permits and certifications to distribute and market its products and services, including difficulties or delays in the same; significant barriers to entry; competition and the competitive environment within The Stars Group’s addressable markets and industries; impact of inability to complete future acquisitions or to integrate businesses successfully; ability to develop and enhance existing products and services and new commercially viable products and services; ability to mitigate foreign exchange and currency risks; ability to mitigate tax risks and adverse tax consequences, including, without limitation, the imposition of new or additional taxes, such as value-added and point of consumption taxes, and gaming duties; risks of foreign operations generally; protection of proprietary technology and intellectual property rights; ability to recruit and retain management and other qualified personnel, including key technical, sales and marketing personnel; defects in The Stars Group’s products or services; losses due to fraudulent activities; management of growth; contract awards; potential financial opportunities in addressable markets and with respect to individual contracts; ability of technology infrastructure to meet applicable demand; systems, networks, telecommunications or service disruptions or failures or cyber-attacks; regulations and laws that may be adopted with respect to the Internet and electronic commerce and that may otherwise impact The Stars Group in the jurisdictions where it is currently doing business or intends to do business; ability to obtain additional financing on reasonable terms or at all; refinancing risks; customer and operator preferences and changes in the economy; dependency on customers’ acceptance of its products and services; consolidation within the gaming industry; litigation costs and outcomes; expansion within existing and into new markets; relationships with vendors and distributors; and natural events. Other applicable risks and uncertainties include, but are not limited to, those identified in The Stars Group’s Annual Information Form for the year ended December 31, 2016, including under the heading “Risk Factors and Uncertainties”, and in The Stars Group’s management’s discussion and analysis for the three and six months ended June 30, 2017 (“Q2 2017 MD&A”), including under the headings “Risk Factors and Uncertainties”, “Limitations of Key Metrics and Other Data” and “Key Metrics”, each available on SEDAR at www.sedar.com, EDGAR at www.sec.gov and The Stars Group’s website at www.starsgroup.com, and in other filings that The Stars Group has made and may make with applicable securities authorities in the future. Investors are cautioned not to put undue reliance on forward-looking statements or information. Any forward-looking statement or information speaks only as of the date hereof, and The Stars Group undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.
Non-IFRS and Non-U.S. GAAP Measures
This news release references non-IFRS and non-U.S. GAAP financial measures, including Adjusted EBITDA, Adjusted Net Earnings and Adjusted Net Earnings per Diluted Share. The Stars Group believes these non-IFRS and non-U.S. GAAP financial measures will provide investors with useful supplemental information about the financial performance of its business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating its business. Although management believes these financial measures are important in evaluating The Stars Group, they are not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with IFRS or U.S. GAAP. They are not recognized measures under IFRS or U.S. GAAP and do not have standardized meanings prescribed by IFRS or U.S. GAAP. These measures may be different from non-IFRS and non-U.S. GAAP financial measures used by other companies, limiting its usefulness for comparison purposes. Moreover, presentation of certain of these measures is provided for year-over-year comparison purposes, and investors should be cautioned that the effect of the adjustments thereto provided herein have an actual effect on The Stars Group’s operating results. The Stars Group uses the following non-IFRS and non-U.S. GAAP measures in this release:
Adjusted EBITDA means net earnings (loss) before interest and financing costs, income taxes, depreciation and amortization, stock-based compensation, restructuring and certain other items.
Adjusted Net Earnings means net earnings (loss) before interest accretion, amortization of intangible assets resulting from purchase price allocation following acquisitions, deferred income taxes, stock-based compensation, restructuring, foreign exchange, and certain other items. Adjusted Net Earnings per Diluted Share means Adjusted Net Earnings divided by Diluted Shares. Diluted Shares means the weighted average number of common shares on a fully diluted basis, including options, other equity-based awards, warrants and convertible preferred shares. The effects of anti-dilutive potential common shares are ignored in calculating Diluted Shares. See note 5 to The Stars Group’s unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2017. For the purposes of the full year 2017 financial guidance provided in this release, Diluted Shares equals between 203,000,000 and 205,000,000 for the high and low ends of the Adjusted Net Earnings per Diluted Share range, respectively.
The Stars Group has not provided a reconciliation of the non-IFRS measures to the nearest IFRS measures included in its full year 2017 financial guidance provided in this release, including Adjusted EBITDA, Adjusted Net Earnings and Adjusted Net Earnings per Diluted Share, because certain reconciling items necessary to accurately project such IFRS measures, particularly net earnings (loss), cannot be reasonably projected due to a number of factors, including variability from potential foreign exchange fluctuations impacting financial expenses, and the nature of other non-recurring or one-time costs (which are excluded from non-IFRS measures but included in net earnings (loss)), as well as the typical variability arising from the audit of annual financial statements, including, without limitation, certain income tax provision accounting, and related accounting matters.
For additional information on The Stars Group’s non-IFRS measures, see the Q2 2017 MD&A, including under the headings “Management’s Discussion and Analysis” and “Selected Financial Information—Other Financial Information”.
HINGHAM, Mass., Sept. 15, 2017 — Microbot Medical Inc. (Nasdaq:MBOT), a medical device company specializing in the design and development of transformational micro-robotic medical technologies, today announced that Intellectual Property India granted patent No. 286765, covering the Company’s TipCAT™ technology platform.
“We continue to strengthen and expand our IP portfolio,” commented Harel Gadot, Chief Executive Officer, President, and Chairman. “As a pioneer in micro-robotic surgery, this will allow us to add value to our assets as it is expected to enhance our ability to access global markets and create additional competitive advantages and barriers to entry. India is a large and emerging market and we believe having a strong IP presence in this market further builds shareholder value. In addition to India, the TipCAT™ technology platform patent has already been granted in the largest markets such as the U.S., China, Europe and several other markets, which we believe continues to show the strength of our IP assets. With this specific IP, our objective is to leverage the TipCAT platform to develop multiple products that address serious unmet needs in multiple medical applications.”
Globally, the Company now has 23 patents which are already issued and an additional 13 patent applications pending worldwide. The Company’s patents cover its ViRob™ and TipCAT™ technology platforms.
About Microbot Medical, Inc.
Microbot, which was founded in 2010 and commenced operations in 2011, became a NASDAQ listed company on November 28, 2016. The Company specializes in transformational micro-robotic medical technologies leveraging the natural and artificial lumens within the human body. Microbot’s current platforms, ViRob™ and TipCAT™, are comprised of two highly advanced micro-robotic technologies, from which the Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS™, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com.
The ViRob™ technology is a revolutionary autonomous crawling micro-robot which can be controlled remotely or within the body. Its miniature dimensions allow it to navigate and crawl in different spaces within the human body, including blood vessels, the digestive tract and the respiratory system. Its unique structure gives it the ability to move in tight spaces and curved passages as well as the ability to remain within the human body for prolonged time. To learn more about ViRob™ please visit http://www.microbotmedical.com/technology/virob/.
TipCAT™ is a transformational self-propelled, flexible, and semi-disposable endoscope providing see & treat capabilities within tubular lumens in the human body such as the colon, blood vessels, and the urinary tract. Its locomotion mechanism is perfectly suitable to navigate and crawl through natural & artificial tubular lumens, applying the minimal necessary pressure to achieve the adequate friction required for gentle, fast, and safe advancement within the human body. To learn more about TipCAT™ visit http://www.microbotmedical.com/technology/tipcat/.
Safe Harbor
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Microbot Medical Inc. particularly those mentioned in the cautionary statements found in Microbot Medical Inc.’s filings with the Securities and Exchange Commission. Microbot Medical disclaims any intent or obligation to update these forward-looking statements.
Investor Contacts:
Analysts and Institutional Investors
Michael Polyviou
EVC Group
mpolyviou@evcgroup.com
646-445-4800
Individual Investors
Jeremy Roe
Integra Consulting Group llc
jeremy@integracg.net
(925) 262-8305
NEW YORK, NY–(Sep 15, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring ChineseInvestors.com, Inc. (OTCQB: CIIX), a client of NNW recognizing unprecedented opportunities in the U.S. cannabis industry and laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.
The publication is titled, “Innovative Cannabis Players Offer Promising Entry into Explosive Market.” It highlights multiple companies racing to stake their claim in the cannabis industry.
“CIIX is focused on the research, development and distribution of legalized cannabidiol (CBD) to the global Chinese-speaking community. Already one of the fastest growing segments in the U.S. hemp and legal marijuana industry, application of CBD is also gaining traction in China. CIIX operates an online store in the free trade zone of Shanghai, China, where CBD sales are legal, though marijuana use is not.
“In December 2016, CIIX entered into a wholesale agreement with a well-known CBD health brand and formally launched a website for its subsidiary, ChineseCBDoil.com, which went live in January 2017. This launch marked the introduction of the world’s first Chinese language online store for CBD health products. At that same time, CIIX debuted the first Chinese language Yelp-style social media app where users can discuss and review cannabis services and products, as well as find locations of dispensaries.
“The company has built a widespread user base of more than 100,000 individuals, and it continues its focus on investing in both the R&D and distribution of CBD products. Corporate objectives include plans to further its study into the effectiveness of CBD for medicinal purposes in an effort to become the first company in China to employ CBD oil as a means of mitigating the suffering of epilepsy and Alzheimer’s patients.”
About ChineseInvestors.com
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail and online sales of hemp-based products and other health related products. For more information visit www.ChineseInvestors.com.
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information please visit https://www.NetworkNewsWire.com
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
MIAMI & NEW YORK
MoviePass experiences benchmark breaking growth after announcing $9.95/month subscription
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) — MoviePass Inc., a company that Helios and Matheson has agreed to buy majority stake in, announced today it has surpassed over 400,000 paying monthly subscribers in the past 30 days and achieved outstanding movie theater attendance. Up from less than 20,000 subscribers on August 14, 2017, the viral subscriber growth is due in part by the innovative and disruptive technology MoviePass and Helios & Matheson offer in combination with massive interest for the new $9.95 per month subscription plan. To test the success of the MoviePass product, 30,000 new MoviePass subscribers were surveyed. We were thrilled to find that 75.3% asserted the only reason they went to the movies was the result of being a MoviePass subscriber. Furthermore, participating theaters have reported back with increased attendance by over 400% from MoviePass subscribers.
MoviePass surpasses over 400,000 paying monthly subscribers in the last 30 days (Photo: Business Wire)
“I think it’s positive for the industry,” said Eric Wold, an analyst at B. Riley & Co. The most visible opposition has come from AMC. “The exhibitors I have spoken with are very happy.”
Additionally, MoviePass projects that it will acquire at least 2.5 million additional paying subscribers during the next twelve months, and expects to retain at least 2.1 million of those additional paying subscribers at the end of that period.
Using the Helios and Matheson Analytics resources, MoviePass Inc. analyzes consumer trends, patterns and activities to engage subscribers with movie related merchandise, advertising, and concessions relevant to their MoviePass experiences. Helios and Matheson believes its technology stack combined with the MoviePass business model will transform the movie going experience and create great value for both companies.
“MoviePass is the ‘all-you-can-eat’ movie theater experience,” said Mitch Lowe, co-founder of Netflix Inc. (NASDAQ: NFLX), former president of RedBox, and current CEO of MoviePass. “Though expensive for the company in the short-term, it’s a significant benefit and more convenient for customers. With MoviePass, there’s no movie ticket prices to think about — going to the movies will become an everyday experience rather than an occasional treat.”
Helios and Matheson’s technology learns individual moviegoer’s tastes and makes recommendations based on recorded preferences for specific genres, actors and even the opinions of friends with similar likings. There currently is no end-to-end consumer analysis from the moment someone sees a movie ad on Facebook to the moment they take their seat at the movie theater. MoviePass is bridging that gap, which should prove to be of tremendous value to production studios.
“This explains our sustainable business model: Helios and Matheson is incorporating advertising models with the MoviePass application using artificial intelligence, algorithms, and machine learning so we can provide studios with more precise data for their advertising efforts. We want to understand the data generated by the movie goers and cater directly to their needs. For example, MoviePass will understand their genre choice films: horror, action-thrillers, drama, comedy, romance, animation, etc. Through testing, we found viewership is up 18% on films we choose to market more heavily in the MoviePass app,” said Ted Farnsworth, Chairman/CEO of Helios and Matheson, about the strategic investment being made by Helios and Matheson in MoviePass. “We will seek to sell our advertising to the studios, channeling MoviePass subscribers to see certain movies. Also, we plan to use the viewing history and habit information of each user to guide them to select upcoming movies that appeal to their interests. Our goal is to serve the interests of moviegoers, movie studios and movie theaters alike,” Mr. Farnsworth concluded.
About Helios and Matheson
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) is a provider of information technology services and solutions, offering a range of technology platforms focusing on big data, artificial intelligence, business intelligence, social listening, and consumer-centric technology. Its holdings include RedZone Map™, a safety and navigation app for iOS and Android users, a community-based ecosystem that features a socially empowered safety map app that enhances mobile GPS navigation using advanced proprietary technology. Through TrendIt, Helios and Matheson has acquired technology addressing crowd and migration patterns and consumer behavior in real-time. The patented technology predicts population behavior, along with a crowd’s population size, origin and destination. HMNY is headquartered in New York, NY and listed on the Nasdaq Capital Market under the symbol HMNY. For more information, visit www.hmny.com.
About MoviePass
MoviePass is a technology company dedicated to enhancing the exploration of cinema. As the nation’s premier movie-theater subscription service, MoviePass provides film enthusiasts the ability to attend unlimited movies. The service, now accepted at more than 91% of theaters across the United States, is the nation’s largest theater network. For more information, visit www.moviepass.com.
Additional Information for Stockholders of HMNY about the Proposed Transaction between HMNY and MoviePass and Where to Find It
HMNY plans to file with the SEC and furnish its stockholders with a proxy statement in connection with the proposed transaction with MoviePass and security holders of HMNY are urged to read the proxy statement and the other relevant materials when they become available because such materials will contain important information about HMNY, MoviePass and their respective affiliates and the proposed transaction. The proxy statement and other relevant materials (when they become available), and any and all other documents filed by HMNY with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov.
In addition, investors may obtain a free copy of HMNY’s filings from HMNY’s website at www.hmny.com or by directing a request to: Helios and Matheson Analytics Inc., Attn: Secretary, Empire State Building, 350 Fifth Avenue, Suite 7520, New York, New York 10118, (212) 979-8228.
INVESTORS AND SECURITY HOLDERS OF HMNY ARE URGED TO READ THE PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BETWEEN HMNY AND MOVIEPASS.
Participants in the Solicitation
HMNY and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the security holders of HMNY in connection with the proposed transaction between HMNY and MoviePass. Information about those directors and executive officers of HMNY, including their ownership of HMNY securities, is set forth in the annual report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on April 14, 2017. Investors and security holders may obtain additional information regarding the direct and indirect interests of HMNY and its directors and executive officers in the proposed transaction by reading the proxy statement and other public filings referred to above.
Cautionary Statement on Forward-looking Statements and Other Information in this Press Release
Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements, regarding the expected completion of the acquisition of a controlling interest of MoviePass by HMNY, the time frame in which this will occur, the expected benefits to HMNY and MoviePass from completing the acquisition, and the expected financial performance of HMNY following completion of the acquisition. Statements regarding future events are based on the parties’ current expectations and are necessarily subject to associated risks related to, among other things, the conditions to the closing of the acquisition may not be satisfied (including, without limitation, the requisite equity or equity-linked financing transaction of HMNY with gross proceeds of at least $10 million upon which the MoviePass transaction is conditioned), the occurrence of any event, change or other circumstances that could give rise to the termination of the securities purchase agreement between MoviePass and HMNY, and general economic conditions. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements.
Such forward-looking statements are based on a number of assumptions. Although the parties believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning HMNY are described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other filings, including subsequent current and periodic reports, information statements and registration statements filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the parties’ current expectations and the parties do not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
Because the MoviePass $9.95 per month subscription pricing model is new, HMNY is providing the information in this press release to update investors regarding the resulting rate of increase in MoviePass subscribers in the month following the announcement of the transaction between HMNY and MoviePass. There can be no assurance that such rate of increase will continue or be sustained. Moreover, the increase in the number of MoviePass subscribers provides no assurance that the MoviePass business model will lead to profitability.
The Pollack PR Marketing Group
Stephanie Goldman, 310-556-4443
sgoldman@ppmgcorp.com
or
Mark Havenner, 310-556-4443
mhavenner@ppmgcorp.com
SAN DIEGO, Sept. 14, 2017 — Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), an ophthalmology-focused pharmaceutical company, provided an update regarding the FDA MedWatch Notice issued on August 4, 2017. The FDA’s letter dated September 5, 2017 to Imprimis Pharmaceuticals, states “non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier.” This statement is consistent with Imprimis’ previous statements in its press release on August 7, 2017. The company also confirms that upon discovery of the supplier’s mislabeling, it immediately terminated its business relationship with the supplier.
Mark L. Baum, CEO of Imprimis commented, “We are grateful for FDA’s diligence in investigating this unfortunate incident. Imprimis scrupulously follows state and federal laws and only purchases pharmaceutical ingredients from FDA registered and FDA inspected suppliers. In this case, the supplier’s mistake was exacerbated by an inaccurately written certificate to Imprimis regarding the quality of the subject ingredient. Imprimis will continue to strive to maintain the highest quality standards in our industry and will work collaboratively with the FDA and other regulatory bodies to employ best practices in order to prevent events like these from occurring again.”
Baum concluded, “Coupled with the FDA registered supplier’s misrepresentation is the fact that Imprimis never actually dispensed any medication to the patient referred to in the FDA’s MedWatch notice. This case related to the apparent improper administration of a medication to a patient by a practitioner who prescribed the medication for one patient and summarily, and without our knowledge, gave it to a completely different patient. Regardless, Imprimis will continue to review its operating procedures and make changes where appropriate to protect patient safety.”
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative medications in all 50 states. The company’s unique business model increases patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis owns and operates production and dispensing facilities located in California and New Jersey. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the outcomes of current or pending litigation, our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Other than drugs compounded at its FDA registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.
Investor Contact:
Jon Patton
jpatton@imprimispharma.com
858.704.4587
Media Contact:
Deb Holliday
deb@pascalecommunications.com
412.877.4519
NEW YORK
Offering the Veritone Platform to Dalet Galaxy Customers Will Enhance Content Production, Management and Delivery
Dalet Digital Media Systems, a leading provider of solutions and services for broadcasters and content professionals, and Veritone® Inc. (NASDAQ: VERI), a leading provider of artificial intelligence (AI) insights and solutions, today announced a new collaboration. The new alliance will allow Dalet Galaxy customers to leverage Veritone’s industry-leading AI technology for automated metadata extraction and analysis, including speech-to-text transcription, face recognition, translation, object recognition, content moderation, logo recognition and optical character recognition.
“Artificial Intelligence is one of our customers’ top priorities. They recognize the power of AI to seamlessly and automatically process, transform and analyze data.” noted Frederic Roux, vice president of sales, Americas at Dalet. “We’re pleased to collaborate with Veritone in this effort to help media organizations capture new opportunities with smart workflow services that can easily become part of their existing installation.”
The amount of multimedia content created and consumed is growing at an exponential pace in all verticals. As broadcasters and media organizations look at the best ways to tame the tsunami, streamline workflows and maximize the value of content, AI-enriched media management and workflow solutions will become a vital part for continued relevance and sustainable growth. Potential business benefits are immense and immediately tangible: augmented production workflows with smart and timely recommendations, better content insights and discovery thanks to intelligent auto-tagging features, automation of more complex tasks in the process and, in the near future, smart resource provisioning and system scaling with self-adaptive capacity planning.
However, managing artificial intelligence at scale and fielding it in relevant use cases for media organizations requires an advanced asset management and orchestration platform such as Dalet Galaxy. Leveraging on its flexible, media and business aware data model, as well as a fully featured integration framework, Dalet Galaxy offers a future-proof foundation to connect with Veritone’s open, extensible ecosystem of AI engines and applications. By taking advantage of the Veritone Platform, Dalet Galaxy users will be able to search and exploit every frame of video and every second of audio for objects, faces, brands, text, sentiment, keywords, and more. They will be able to discover unique insights, dissect and analyze content programmatically and by multivariate search, and monitor media in near real time.
“The rationale behind this collaboration is very simple: a common passion, focus and expertise in the media industry. The combination of the two complementary technologies spans across all media workflows, offering smarter services that unleash the potential of content, enhance the production experience, and reduce the complexity of content curation, ultimately enabling customers to create and deliver richer, better content to the right audience at the right time.” said Kevin Savina, Director of Product Strategy at Dalet.
“We are thrilled to team with Dalet, a leader in media asset and workflow management. The collaboration will empower Dalet Galaxy users with the new-found intelligence and impactful applications essential to remain competitive now and in the future,” added Ryan Steelberg, co-founder and president of Veritone.
Veritone makes AI accessible and actionable by combining more than 120 of the most advanced third-party engines across major cognitive functions with a suite of powerful applications and a proprietary orchestration layer, Conductor™, informed by machine learning. Deployable virtually anywhere, the Veritone Platform produces time-correlated, multi-dimensional metadata from audio and video data, unlocking new insights from linear files such as radio and TV broadcasts, call-center conversations, and CCTV footage.
This next generation of augmented media operations is a strategic focus for Dalet. The company has deep internal expertise in these topics. Michael Elhadad, co-founder and head of technology at Dalet is also a university professor and researcher in the fields of artificial intelligence and natural language processing.
A number of AI services have already been integrated with the Dalet Galaxy platform, such as automated collection and enrichment of advanced metadata. However, the unique AI capabilities of Veritone coupled with the Dalet Galaxy platform will provide broadcasters and media organizations with an end-to-end solution that will serve as an enabler to capture tomorrow’s business opportunities and generate new benefits.
Meet with us at IBC in Amsterdam
IBC Show attendees can book a private workflow consultation with a Dalet expert to learn how new product and solution enhancements can help them better create, manage and distribute content. Book a meeting via http://www.dalet.com/events/ibc-amsterdam-2017.
Veritone spokespeople are also available during IBC. Meet them at the Quantum booth (Hall 7, B27) and Microsoft booth (Hall 15, MS1) to discuss the partnership and how AI will impact the industry.
About Dalet Digital Media Systems
Dalet solutions and services enable media organizations to create, manage and distribute content faster and more efficiently, fully maximizing the value of assets. Dalet products are built on three distinct platforms that, when combined, form versatile business solutions that power end-to-end workflows for news, sports, program preparation, production, archive and radio. Individually, Dalet platforms and products offer targeted applications with key capabilities to address critical media workflow functions such as ingest, QC, edit, transcode and multiplatform distribution.
The foundation for Dalet productivity-enhancing workflow solutions, Dalet Galaxy is the enterprise orchestration and MAM platforms that unifies the content chain by managing assets, metadata, workflows and processes across multiple and diverse production and distribution systems. Specially tailored for news and media workflows, this unique technology platform helps broadcasters and media professionals increase productivity while providing operational and business visibility.
Dalet AmberFin is the high-quality, scalable transcoding platform with fully integrated ingest, mastering, QC and review functionalities, enabling facilities to make great pictures in a scalable, reliable and interoperable way. Addressing the demanding needs of studio production, multi-camera ingest, sports logging and highlights production, the innovative Dalet Brio video server platform combines density and cost-effectiveness with high reliability.
Dalet supports customers from the initial planning stages to well beyond project execution. Our global presence includes 17 offices strategically located throughout Europe, the Middle East, Asia Pacific, North America and South America, and a network of more than 60 professional partners serving 87 countries worldwide. This collective experience and knowledge enables our customers to realize potential increases in productivity, efficiency and value of their assets.
The comprehensive Dalet Care program ensures deployments remain up and running with 24/7 support 365 days a year.
Dalet systems are used around the world by many thousands of individual users at hundreds of TV and Radio content producers, including public broadcasters (ABS-CBN, BBC, CBC, DR, FMM, France TV, RAI, RFI, Russia Today, RT Malaysia, VOA), commercial networks and operators (Canal+, FOX, eTV, MBC Dubai, MediaCorp, Mediaset, Orange, Time Warner Cable, Warner Bros, Sirius XM Radio), and government organizations (Canadian House of Commons, Australian Parliament and UK Parliament).
Dalet is traded on the NYSE-EURONEXT stock exchange (Eurolist C): ISIN: FR0011026749, Bloomberg DLT:FP, Reuters: DALE.PA.
Dalet® is a registered trademark of Dalet Digital Media Systems. All other products and trademarks mentioned herein belong to their respective owners.
For more information on Dalet, visit www.dalet.com.
About Veritone
Veritone, Inc. is a leading artificial intelligence company that has developed the Veritone Platform, which unlocks the power of AI-based cognitive computing to transform and analyze unstructured public and private audio and video data for clients in the media, politics, legal and government markets. The open platform integrates an ecosystem of best-of-breed cognitive engines and powerful applications, which can be orchestrated together to reveal valuable, multivariate insights from users’ data. To learn more about Veritone, please visit Veritone.com.
Safe Harbor Statement
This news release contains forward-looking statements, including without limitation statements regarding the parties’ new business relationship and the expected benefits to Veritone, Dalet Digital Media Systems and their respective customers. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Assumptions relating to the foregoing involve judgments and risks with respect to various matters which are difficult or impossible to predict accurately and many of which are beyond the control of Dalet Digital Media Systems and Veritone. Although Dalet Digital Media Systems and Veritone believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the results contemplated in forward-looking statements will be realized. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by Dalet Digital Media Systems and Veritone or any other person that their objectives or plans will be achieved. Neither Dalet Digital Media Systems nor Veritone undertakes any obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
