Archive for November, 2017

$CIIX Subsidiary ChineseHempOil.com Launches OptHemp on Amazon for Singles Day

SAN GABRIEL, California, November 14, 2017 –

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announced that its wholly owned subsidiary ChineseHempOil.com, Inc. launched its OptHemp product line on Amazon.com kicking off a multi-channel campaign geared to both the US and Chinese-American markets during the 9th annual Singles Day Celebration.

This commences the e-commerce marketplace initiative that the Company set into motion in early June through a strategic partnership with Quiverr Collective (“Quiverr”), a subsidiary of Advantage Solutions. Quiverr is a top 100, platinum level partner seller on Amazon Marketplace and has agreed to include the OptHemp product line in its limited catalog for resale through the Amazon Channel.  As a wholly owned subsidiary of Advantage Solutions, Quiverr brings tremendous resources and knowledge and specified capabilities to drive sales on the Amazon channel using performance-based resale model.  Advantage Solutions is a national sales and marketing agency that specializes in providing business solutions including headquarter sales services, analytics, insights and intelligence, retail services, marketing, digital technology and business process outsourcing. The OptHemp products launched on Amazon.com represent the Company’s first use of Amazon for product sales.

“We are excited about the Amazon launch for Singles Day, 11/11/ 2017. Guanggun Jie which translated literally means “Single Sticks’ Holiday” is an entertaining festival widespread among young Mainland Chinese people,[1] to celebrate being single. This festival has become one the largest offline and online shopping days in the world, and as it has morphed into a global shopping holiday in the last several years; therefore, we thought it was the perfect day to launch with Amazon.com in advance of the holidays,” said Warren Wang CEO.

The Company also has plans to launch two new, first-of-their-kind products that will be available on Amazon.com before the Black Friday and Cyber Monday shopping extravaganzas.  With two product lines launching on Amazon.com, the Company hopes to make the most of the upcoming holiday buying season positioning itself to earn generous revenues.

The entire OptHemp line can be viewed on Amazon.com at:

https://www.amazon.com/dp/B076T9452S

https://www.amazon.com/dp/B076TQHTPJ

https://www.amazon.com/dp/B076TJZQJV

https://www.amazon.com/dp/B077BQ44YK

https://www.amazon.com/dp/B077BPFD21

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 and direct sales of hemp-based products and other health related products.

For more information visit ChineseInvestors.com

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Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh

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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

Tuesday, November 14th, 2017 Uncategorized Comments Off on $CIIX Subsidiary ChineseHempOil.com Launches OptHemp on Amazon for Singles Day

$PBIO Q3 Financials & Business Update

Record Total Revenue Reported, Led by Increases in Products & Services (+21%), Consumables (+158%), and Grant (+23%) Revenue (Y/Y); Investor Conference Call Scheduled for Tuesday, November 14, 2017 at 4:30 PM EDT

SOUTH EASTON, MA–(Nov 14, 2017) – Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” or the “Company”), a leader in the development and sale of broadly enabling, pressure-based instruments and related consumables to the worldwide life sciences industry, today announced financial results for the third quarter of 2017, provided a business update, and offered limited guidance on its expected revenue for remainder of FY 2017.

Mr. Joseph L. Damasio, Jr., VP of Finance and CFO at PBI said: “We are pleased with the strong revenue growth demonstrated in the 2017 third quarter. This growth included a record for quarterly total revenue, propelled by a 158% increase in consumable sales (also a quarterly record). Product gross profit margin remained steady at about 47%.”

Mr. Damasio continued: “We believe the revenue growth reported in the third quarter and year-to-date will not only continue in Q4 2017 and beyond, but will accelerate to an even greater rate as our new sales team begins to meet with existing and potential customers throughout the U.S. To that point, Q4 2017 Purchase Orders and Purchase Indications (90% estimated probability of closing) through early November have already exceeded products & services revenue for the full 2016 fourth quarter. We remain confident that we are on the path to future expansion, profitability and success.”

Q3 2017 Financial Highlights

  • Total Revenue increased 21%, from $535,334 in Q3 2016 to $646,061 (a new record for any quarter)
  • Products & Services Revenue increased 21%, from $500,949 in Q3 2016 to $603,726 (new quarterly record)
  • Consumable Sales increased 158%, from $32,811 in Q3 2016 to $84,594 (new quarterly record)
  • Grant Revenue increased 23%, from $34,385 in Q3 2016 to $42,335

Q3 2017 (plus October) Operational Highlights

  • Completed the staffing of our new 5-person field sales team and filled Director of Sales North America position
  • Established our first Center of Excellence in Asia, expected to significantly impact PBI’s expansion into China
  • PBI & Phasex Corp announced a strategic collaboration in nanoemulsions technology to work towards the deliverance of unprecedented shelf-stable mixtures of normally immiscible materials that address large and diverse markets in food, nutraceuticals, pharmaceuticals, cosmetics, inks, paint, lubricants and other product areas
  • Multiple scientific presentations throughout Europe expected to accelerate PBI’s penetration in Europe
  • Received first two issued patents on our widely-applicable, high pressure-based Ultra Shear Technology (UST)
  • PBI’s next-generation Barocycler 2320EXTREME named a FINALIST in the prestigious 2017 R&D 100 Awards

Mr. Richard T. Schumacher, President and CEO of PBI, said: “We have a new, multi-functional, CE Marked, award-winning Barocycler instrument that we believe can significantly expand our sales potential by filling multiple needs in the biopharma industry. We have a new six-person, experienced, and highly capable sales and marketing team that can be aggressive and proactive in its selling functions, compared to the one-person, reactive sales effort that was our capability just a few months ago. In addition, we are very excited about our new, widely-applicable patented Ultra Shear Technology (“UST”) platform that we believe will allow us to quickly expand into large new markets, such as nutraceuticals, cosmetics, and clean-label food.”

Mr. Schumacher continued: “Our goal for Q4 2017 and beyond is to continue to accelerate our sales growth and closely control expenses as we move firmly towards profitability and financial self-sufficiency. We have spent a lot of time and money over the past few years preparing for this opportunity. We believe we are ready and taking all necessary actions to grow our momentum and fully exploit the exciting growth and new markets potential that we have long envisioned.”

Financial Results: Q3 2017 vs. Q3 2016

Total revenue for the 2017 third quarter was $646,061 compared to $535,334 during the same period in 2016, an increase of $110,727 or 21%. This increase was primarily attributable to increases in both instrument and consumable sales. We believe total revenue will continue to increase on a year/year comparative basis for the remainder of 2017.

Products & Services revenue increased to $603,726 in Q3 2017 compared to $500,949 for the prior year same period, an increase of 21%. Comparing Q3 2017 to Q3 2016, instrument sales increased to $410,906 from $383,527, an increase of 7%, while consumable sales increased to a record $84,594 from $32,811, an increase of 158%. We believe products and services revenue will continue to increase on a year/year comparative basis for the remainder of 2017.

Grant revenue increased to $42,335 in the third quarter 2017 from $34,385 in the prior year period, an increase of 23%. We believe grant revenue will continue to increase in the final quarter of 2017.

Operating loss increased to $1,125,272 in Q3 2017 from $451,807 for the same period in 2016, an increase of $673,465. This increase was due primarily to a significant one-time credit of approximately $400,000 received in Q3 2016 from a former professional service provider. The remaining increase in 2017 operating loss was mostly due to headcount increases in sales and marketing and significant charges related to the registration statement process for a proposed $12.5 million financing and concomitant U.S. equities exchange up-list, which was withdrawn by the Company in August 2017.

Net loss per common share — basic and diluted — was $(2.07) for the quarter ended September 30, 2017 compared to net loss per share — basic and diluted of $(0.96) for the same period in 2016. This increase in net loss per share was due to the significant increase in Q3 2017 operating loss, which as described above, was primarily related to one-time charges stemming from the August 2017 withdrawal of a registration statement, and a one-time credit of approximately $400,000 received in Q3 2016 from a former service provider.

Financial Results: First Nine Months 2017 vs. First Nine Months 2016

Total revenue for the 2017 first nine months was $1,737,790 compared to $1,556,776 for the prior year same period, an increase of $181,014 or 12%. This increase was primarily due to higher revenue from instrument and consumable sales, as described below.

Products & Services revenue increased to $1,610,124 for the first nine months of 2017 compared to $1,429,487 for the same period in 2016, an increase of 13%. Comparing the first nine months of 2017 to the same period in 2016, instrument sales increased to $1,153,883 from $1,026,888, an increase of 12%, while consumable sales increased to $200,223 from $149,819, an increase of 34%.

Grant revenue remained steady at $127,666 in the first nine months of 2017 compared to $127,289 in the prior year period.

Operating loss was $3,328,664 for the first nine months of 2017 compared to a loss of $2,558,448 for the same period in 2016, an increase of $770,216. This increase was primarily due to the hiring of four field sales directors in 2017, costs stemming from the August 2017 withdrawal of a registration statement, the hire of a full-time CFO, and other expenses related to the growth of the business. Our Q1-Q3 2017 operating loss also increased due to the effect of approximately $400,000 in credits received in the prior year period against charges incurred with a former professional service provider.

Net loss per common share — basic and diluted — was $(7.28) for the nine months ended September 30, 2017 compared to a net loss per common share — basic and diluted — of $(6.81) for the same period in 2016.

Earnings Call
The Company will hold an Earnings Conference Call at 4:30 PM EDT on Tuesday, November 14, 2017. To attend this teleconference via telephone, Dial-in: (877) 407-8031 (North America), (201) 689-8031 (International). Verbal Passcode: PBIO Third Quarter 2017 Financial Call. Replay Number (877) 481-4010; (919) 882-2331 (International). Replay ID Number: 22751. Teleconference Replay Available for 30 days.

About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities are emerging in the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water, fluoropolymers and alcohol, etc.), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.

Forward Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” estimates,” “predicts,” “projects,” “potential” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. In evaluating these statements, you should specifically consider various factors. Actual events or results may differ materially. The Company’s financial results for first nine months ended September 30, 2017 may not necessarily be indicative of future results. These and other factors may cause our actual results to differ materially from any forward-looking statement. These risks, uncertainties, and other factors include, but are not limited to, the risks and uncertainties discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and other reports filed by the Company from time to time with the SEC. The Company undertakes no obligation to update any of the information included in this release, except as otherwise required by law.

For more information about PBI and this press release, please click on the following website link:
http://www.pressurebiosciences.com
Please visit us on Facebook, LinkedIn, and Twitter.

PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
2017 2016 2017 2016
Revenue:
Products, services, other $ 603,726 $ 500,949 $ 1,610,124 $ 1,429,487
Grant revenue 42,335 34,385 127,666 127,289
Total revenue 646,061 535,334 1,737,790 1,556,776
Costs and expenses:
Cost of products and services 328,743 262,894 852,039 727,698
Research and development 239,326 268,317 744,565 925,015
Selling and marketing 301,676 224,380 814,796 609,501
General and administrative 901,588 231,550 2,655,054 1,853,010
Total operating costs and expenses 1,771,333 987,141 5,066,454 4,115,224
Operating loss (1,125,272 ) (451,807 ) (3,328,664 ) (2,558,448 )
Other (expense) income:
Interest expense, net (1,554,379 ) (1,116,328 ) (4,431,950 ) (2,961,708 )
Other expense (200 ) (1,039 ) (1,112 )
Impairment loss on investment (6,069 )
Incentive warrants for warrant exercises (186,802 )
Gain on extinguishment of debt 90,862 90,862
Change in fair value of derivative liabilities 245,213 623,128 (26,014 ) (412,500 )
Total other expense (1,218,304 ) (493,400 ) (4,561,012 ) (3,375,320 )
Net loss (2,343,576 ) (945,207 ) (7,889,676 ) (5,933,768 )
Net loss per share attributable to common stockholders – basic and diluted $ (2.07 ) $ (0.96 ) $ (7.28 ) $ (6.81 )
Weighted average common stock shares outstanding used in the basic and diluted net loss per share calculation 1,133,791 980,846 1,084,370 871,325
PRESSURE BIOSCIENCES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
September 30, 2017 December 31, 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 18,723 $ 138,363
Accounts receivable, net of $28,169 reserve at September 30, 2017 and December 31, 2016 548,316 281,320
Inventories, net of $20,000 reserve at September 30, 2017 and December 31, 2016 1,122,782 905,284
Prepaid income taxes 7,482 7,405
Prepaid expenses and other current assets 146,278 258,103
Total current assets 1,843,581 1,590,475
Investment in available-for-sale equity securities 25,986 25,865
Property and equipment, net 19,004 9,413
TOTAL ASSETS $ 1,888,571 $ 1,625,753
LIABILITIES AND STOCKHOLDERS’ DEFICIT
CURRENT LIABILITIES
Accounts payable $ 853,173 $ 407,249
Accrued employee compensation 298,675 249,596
Accrued professional fees and other 1,352,658 956,884
Deferred revenue 313,992 159,654
Revolving note payable, net of unamortized debt discounts of $335,833 and $637,030, respectively 3,164,167 612,970
Related party convertible debt, net of debt discount of $65,240 and $0, respectively 225,894
Convertible debt, net of unamortized debt discounts of $355,375 and $2,235,839, respectively 6,315,995 4,005,702
Other debt, net of unamortized discounts of $80,747 and $380, respectively 1,952,859 238,157
Warrant derivative liability 1,685,108
Conversion option liability 951,059
Total current liabilities 14,477,413 9,266,379
LONG TERM LIABILITIES
Related party convertible debt, net of debt discount of $0 and $165,611, respectively 125,523
Convertible debt, net of debt discount of $0 and $740,628, respectively 529,742
Deferred revenue 61,592 87,527
TOTAL LIABILITIES 14,539,005 10,009,171
STOCKHOLDERS’ DEFICIT
Series D Convertible Preferred Stock, $.01 par value; 850 shares authorized; 300 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively (Liquidation value of $300,000) 3 3
Series G Convertible Preferred Stock, $.01 par value; 240,000 shares authorized; 80,570 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively 806 866
Series H Convertible Preferred Stock, $.01 par value; 10,000 shares authorized; 10,000 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively 100 100
Series H2 Convertible Preferred Stock, $.01 par value; 21 shares authorized; 21 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively
Series J Convertible Preferred Stock, $.01 par value; 6,250 shares authorized; 3,458 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively 34 35
Series K Convertible Preferred Stock, $.01 par value; 15,000 shares authorized; 6,816 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively 68 68
Common stock, $.01 par value; 100,000,000 shares authorized; 1,154,422 and 1,033,328 shares issued and outstanding on September 30, 2017 and December 31, 2016, respectively 11,544 10,333
Warrants to acquire common stock 9,721,627 6,325,102
Additional paid-in capital 29,976,405 27,544,265
Accumulated other comprehensive income 6,190
Accumulated deficit (52,367,211 ) (42,264,190 )
Total stockholders’ deficit (12,650,434 ) (8,383,418 )
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT $ 1,888,571 $ 1,625,753

Investor Contacts:
Richard T. Schumacher
President & CEO
(508) 230-1828 (T)

Joseph L. Damasio
VP of Finance and CFO
(508) 230-1828 (T)

Jeffrey N. Peterson
Chairman of the Board
(650) 812-8121 (T)

Tuesday, November 14th, 2017 Uncategorized Comments Off on $PBIO Q3 Financials & Business Update

$TCON Positive Results Phase 1 TRC102 and Fludara in Advanced Hematologic Malignancy

Overall response rate of 24% seen with no dose limiting toxicity observed

SAN DIEGO, Nov. 13, 2017 — TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today announced that positive results from a Phase 1 clinical trial of TRC102 (methoxyamine) and Fludara® (fludarabine) in patients with advanced hematologic malignancies were published in the journal Oncotarget (Volume 8, Number 45, pages 79864-79875).

The Phase 1 trial enrolled a total of 20 patients, of whom 17 had measurable disease, with chronic lymphocytic leukemia (n=10), follicular lymphoma (n=3), diffuse large B cell lymphoma (n=3), plasma cell myeloma (n=2), mantle cell lymphoma (n=1), or anaplastic large cell lymphoma (n=1). Patients received one of five levels of TRC102 (15, 30, 60, 90, or 120 mg/m2) dosed intravenously on the initial day of recurring three week cycles in combination with Fludara dosed per label at 25 mg/m2 intravenously on days 1 through 5. Dose limiting toxicity was not observed.  The most frequent toxicities were hematologic and were reversible when managed with supportive care. Four of the 17 patients (24%) experienced a partial response to treatment, and eight additional patients (8/17, 47%) had stable disease. The combination of TRC102 and Fludara produced evidence of tumor DNA damage that appeared to correlate with antitumor activity.

“We have now observed TRC102 to be well-tolerated in combination with three separate chemotherapeutics, Alimta®, Temodar® and Fludara, and we are encouraged by the responses seen to date,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “We continue to make strong progress on the program and expect to report data from multiple National Cancer Institute-sponsored Phase 2 trials of TRC102 in 2018.”

About TRC102

TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute or Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRACON

TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; TRC102, a small molecule being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule being developed for the treatment of prostate cancer. To learn more about TRACON and its product candidates, visit TRACON’s website at www.traconpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding expected timing of data from additional trials of TRC102 and other development plans and potential benefits of TRACON’s product candidates. Forward-looking statements speak only as of the date of this press release and TRACON does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, TRACON’s and NCI’s ability to identify and enroll patients in on-going and planned clinical trials, potential delays in completing on-going clinical trials, whether TRACON’s product candidates will be shown to be safe and effective in subsequent studies, and TRACON’s and NCI’s ability and willingness to fund additional clinical development of TRACON’s product candidates. For a further description of these and other risks facing TRACON, please see the risk factors described in TRACON’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and TRACON undertakes no obligation to update or revise these statements, except as may be required by law.

Company Contact:
Casey Logan
Chief Business Officer
(858) 550‐0780 ext. 236
clogan@traconpharma.com

Investor Contact:
Andrew McDonald
LifeSci Advisors LLC
646-597-6987
Andrew@lifesciadvisors.com

Monday, November 13th, 2017 Uncategorized Comments Off on $TCON Positive Results Phase 1 TRC102 and Fludara in Advanced Hematologic Malignancy

$ROKU Funai Electric Joins Roku TV Licensing Program

LOS GATOS, Calif.

Philips brand licensee expected to ship Roku TV models this year

Roku, Inc. (Nasdaq: ROKU) today announced that Funai Electric has joined the Roku TV™ licensing program. Funai Electric will leverage the Roku TV platform to build and deliver smart TVs under the Philips brand that run the Roku® OS. Philips Roku TV models are expected to be available in the U.S. this year.

“We are excited to work with Roku to deliver an exceptional streaming service on our Philips branded TVs,” said Peter Swinkels, GM, Product Planning at Funai Electric. “The Philips brand is a well-known and trusted brand in the U.S. that delivers best-in-class performance TVs. By using the Roku operating system to power Philips branded TVs, our customers will enjoy a simple-to-use interface that offers excellent streaming entertainment and discovery features for smart TVs today. We look forward to delivering new Philips Roku TVs later this year.”

“Philips is a great brand that is widely recognized by consumers,” said Chas Smith, general manager of Roku OEM. “Combined with Roku’s operating system, we can deliver a smart TV that offers value, simplicity, and entertainment.”

Building Cost Effective Smart TVs That Consumers Love

The Roku TV licensing program offers partners an easy, efficient, and cost-effective way to build smart TVs that consumers love to use. Roku provides a low-cost hardware reference design so TV brands can offer a best-in-class smart TV solution at competitive price points. The Roku operating system provides consumers with access to an ever-growing library of content as well as regular, automatic updates so they can be sure they have the latest and greatest features.

About Funai Electric

Funai Electric Co., LTD is the exclusive licensee for Philips consumer televisions and home video products in North America. Funai Electric Co., Ltd., established in 1961, is headquartered in Osaka, Japan and is listed in the Tokyo Securities Exchange First Section (6839). In addition to the consumer electronic product brands sold by Funai Corporation and the products sold by other Funai sales and marketing companies in Asia, Europe, and South America, Funai Electric Company, Ltd. is a major original equipment manufacturer (OEM) supplier for appliance, consumer electronics, computer, and computer peripheral companies at a global level.

About Roku, Inc.

Roku pioneered streaming to the TV. We connect users to the streaming content they love, enable content publishers to build and monetize large audiences, and provide advertisers with unique capabilities to engage consumers. Roku streaming players and Roku TV models are available around the world through direct retail sales and licensing arrangements with TV OEMs and service operators. The company was founded by Anthony Wood, inventor of the DVR. Roku is headquartered in Los Gatos, Calif. U.S.A.

Roku and Streaming Stick are registered trademarks of Roku, Inc. in the U.S. and in other countries.

Roku
Seana Norvell
snorvell@roku.com
or
for Funai Corp
Terry Shea
terry@brand-definiton.com

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$TST Retires Series B Preferred Stock and Closes $7.85M Common Stock Financing

TheStreet Exchanges TCV Series B Preferred Stock for Common Stock – TheStreet and 180 Degree Capital Complete Private Placement – Kevin Rendino Joins Board at TheStreet

NEW YORK, Nov. 13, 2017  — TheStreet, Inc. (NASDAQ: TST), a leading financial news and information provider, announced today that on November 10, 2017 it exchanged all shares of Series B Preferred Stock held by Technology Crossover Ventures (“TCV”) for 6,000,000 shares of the Company’s Common Stock and $20,000,000 cash. The retirement of the Series B Preferred Stock removes, among other rights of the holder and restrictions on the Company, a $55 million liquidation preference previously held by TCV.

The Company also announced that on November 10, 2017, it closed a common stock PIPE with 180 Degree Capital Corp. whereby the Company sold 7,136,363 shares of Common Stock for a total of $7,849,999.30, or, $1.10 per share. The closing bid price of the Company’s Common Stock on November 9, 2017, the day prior to signing the financing agreements, was $0.92 per share. The proceeds from the private placement were used by the Company, in part, to fund the consideration paid to TCV.

“These transactions represent another important step in the turnaround we started last year by simplifying our capital structure and cementing our relationship with two key strategic investors”, said David Callaway, President and CEO of TheStreet. “TCV has been an important supporter of TheStreet for over a decade and their conversion to common stock  serves as a strong vote of confidence in the Company’s prospects. We are also delighted to welcome to TheStreet family, Kevin Rendino and 180 Capital, who have been shareholders of TheStreet since the second quarter of 2017 when Kevin became their CEO,” Mr. Callaway continued.

In connection with the private placement, Kevin Rendino, CEO of 180 Capital, joined the Board of Directors of TheStreet. With the addition of Mr. Rendino, an independent director, the Board now has eight directors, six whom are independent, a substantial majority of the Board.

Mr. Rendino, age 51, is a financial services leader with three decades of Wall Street experience and expertise in capital markets, value investing and global equity markets.  For over twenty years (1988 – 2012), Kevin was Managing Director and a Large Cap Value Manager, overseeing 11 funds and $13B in assets. Kevin was a member of Blackrock’s Leadership Committee and a frequent contributor to CNBC, Bloomberg TV, Fox Business, The New York Times and The Wall Street Journal. From 2012 to 2016, Kevin served as Chairman and Chief Executive Officer of RGJ Capital, where he led a Graham and Dodd approach to value investing.   Since March of 2017, Mr. Rendino, has served as Chairman and Chief Executive Officer of 180 Degree Capital, a publicly traded investment management company.  In 1988, Mr. Rendino graduated from the Carroll School of Management at Boston College (B.S.).

“The retirement of the preferred stock is a seminal moment that clears the path to enhance value for all common shareholders. The turnaround at TST is well underway.  We believe the future for TST and its shareholders is bright, and we are excited to have the opportunity to be a part of it,” said Kevin Rendino, Chairman and CEO of 180 Degree Capital Corp.

“This is a watershed moment for TheStreet and its shareholders, and a giant step in the turnaround efforts we began 20 months ago,” concluded Larry Kramer, Chairman of the Board of TheStreet.

Lake Street Capital Markets served as the Company’s exclusive placement agent for the private placement with 180 Degree Capital and as the Company’s lead financial adviser on the exchange of TCV’s Series B Preferred Stock. B. Riley FBR, Inc. served as a financial advisor on the TCV exchange.

About TheStreet, Inc.

TheStreet, Inc. (NASDAQ: TST, www.t.st) is a leading financial news and information provider to investors and institutions worldwide. The Company’s namesake brand, TheStreet (www.thestreet.com), is in its third decade of producing unbiased business news and market analysis for individual investors. The Company’s portfolio of institutional brands includes The Deal (www.thedeal.com), which provides actionable, intraday coverage of mergers, acquisitions and all other changes in corporate control; BoardEx (www.boardex.com), a relationship mapping service of corporate directors and officers; and RateWatch (www.rate-watch.com), which supplies rate and fee data from banks and credit unions across the U.S.

About 180 Degree Capital Corp.

180 Degree Capital Corp. is a publicly traded registered closed-end fund focused on investing in and providing value-added assistance through constructive activism to what we believe are substantially undervalued small, publicly traded companies that have potential for significant turnarounds.  Our goal is that the result of our constructive activism leads to a reversal in direction for the share price of these investee companies, i.e., a 180-degree turn.  Detailed information about 180 and its holdings can be found on its website at www.180degreecapital.com.

Contact: Eric Lundberg, Chief Financial Officer, TheStreet, Inc., ir at thestreet.com; John Evans, Investor Relations, PIR Communications, 415-309-0230, ir at thestreet.com

Monday, November 13th, 2017 Uncategorized Comments Off on $TST Retires Series B Preferred Stock and Closes $7.85M Common Stock Financing

$CHKE Amends Credit Facility with Cerberus

SHERMAN OAKS, Cali., Nov. 13, 2017

  • New financial terms provide greater financial flexibility
  • Amendment to eliminate obligation to call equity commitments

Cherokee Global Brands (NASDAQ:CHKE), a global brand marketing platform that manages a growing portfolio of fashion and lifestyle brands, today announced the amendment, subject to the satisfaction of certain conditions, of its senior secured credit facility(the “Amendment”).

“We are pleased to announce the amendment of our credit facility with our lenders, whom we thank for their collaborative approach throughout the amendment process,” commented Henry Stupp, Chief Executive Officer of Cherokee Global Brands.  “The amendment revises the financial covenants materially to enable the company to focus on growing the business for the long term. Importantly, as part of the amendment, we have eliminated the liquidity call which could have potentially resulted in the issuance of approximately $5.5 million in additional common stock.  The amendment of our credit facility is a very positive development for the Company and important to stabilizing our balance sheet, sustaining liquidity and better positioning us for profitable future growth.”

Mr. Stupp continued, “Over the last several months, we’ve taken several actions to focus on our core business fundamentals and  high-growth brand opportunities During this time, we have made efforts to strengthen our team while addressing our financial solvency.  As a result, we are focused on  reducing operating expenses and improving cash flow.  We’re comfortable with our financial position and confident in our ability to meet our existing obligations.”

The Amendment, among other things, eliminates the requirement that the Company, under certain circumstances, exercise its rights to call the equity commitment rights under certain Common Stock Purchase Agreements dated August 11, 2017.  Upon the effectiveness of the Amendment, such commitments are expected to no longer be in effect, and none of the Company, the lenders under the senior secured credit facility or the investors under such agreements would have the right to require the investors to purchase the Company’s common stock under such agreements.  As a result, the special meeting of stockholders that had been called for November 28, 2017 to approve such issuances is expected to be cancelled.  The Amendment also provides, as a condition to the effectiveness of the Amendment, that investors purchase participations from the lenders under the senior secured credit facility in an aggregate amount of no less than $11.5 million on or before December 8, 2017.  The Company is in advanced discussions with investors who have indicated an interest in purchasing such participation interests and anticipates that it will announce a completion of that investment on or before December 8, 2017.

Additional information and a full copy of the amendment are included in the Company’s Form 8-K filed today with the Securities and Exchange Commission.

About Cherokee Inc.
Cherokee is a global brand marketing platform that manages a growing portfolio of fashion and lifestyle brands including Cherokee®, Carole Little®, Tony Hawk® Signature Apparel and Hawk Brands®, Liz Lange®, Everyday California®, Sideout®, Hi-Tec®, Magnum®, 50 Peaks®, Interceptor® and Flip Flop Shops®, a franchise retail chain, across multiple consumer product categories and retail tiers around the world. The Company currently maintains license and franchise agreements with leading retailers and manufacturers that span over 110 countries in 12,000 retail locations and digital commerce.

Safe Harbor Statement 
This news release may contain forward-looking statements regarding future events and the future performance of Cherokee. Forward-looking statements in this press release include, without limitation, express or implied statements regarding: the Company’s ability to complete the sale of participation interests in the Cerberus Credit Facility; the Company’s expectations regarding its ability to satisfy the revised financial covenants; the Company’s ability to sustain necessary liquidity and grow its business; the anticipated impact of the additions to its accounting staff; and anticipated market developments and opportunities.  A forward-looking statement is neither a prediction nor a guarantee of future events or circumstances and is based on currently available market, operating, financial and competitive information and assumptions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected, including, among others, risks that: the Company will not be able to complete the sale of the participation interests on terms acceptable to the Company or Cerberus, on a timely basis, or at all; the Company and its partners will not achieve the results anticipated in the statements made in this release; global economic conditions and the financial condition of the apparel and retail industry and/or adverse changes in licensee or consumer acceptance of products bearing the Company’s brands may lead to reduced royalties; the ability and/or commitment of the Company’s licensees to design, manufacture and market Cherokee®, Hi-Tec®, Magnum®, 50 Peaks®, Interceptor®, Carole Little®, Tony Hawk® and Hawk Brands®, Liz Lange®, Everyday California® and Sideout® branded products could cause our results to differ from our anticipations; the Company’s dependence on a select group of licensees for most of the Company’s revenues makes us susceptible to changes in those organizations; and the Company’s dependence on its key management personnel could leave us exposed to disruption on any termination of service.   The risks included here are not exhaustive. Other risks and uncertainties are described in our annual report on Form 10-K filed on May 18, 2017, its periodic reports on Forms 10-Q and 8-K, and subsequent filings with the SEC we make from time to time, including the preliminary prospectus supplement that we filed in connection with the offering described herein. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Cherokee Global Brands
Jason Boling, CFO
818-908-9868

Addo Investor Relations
Laura Bainbridge/Patricia Nir
310-829-5400

Monday, November 13th, 2017 Uncategorized Comments Off on $CHKE Amends Credit Facility with Cerberus

$IGC Announces Results of Annual Shareholders Meeting

BETHESDA, Md., Nov. 13, 2017 – India Globalization Capital, Inc. (NYSE American:IGC), announced that during its 2016-2017 Annual Meeting of Shareholders scheduled for, and convened on November 8, 2017, voting on Proposals Three and Four was adjourned due to the lack of requisite quorum.  Only stockholders of record on the record date October 5, 2017 are entitled to and are being requested to vote. At the Annual Meeting, the following proposals were approved: (i) the election of Sudhakar Shenoy and Ram Mukunda as Directors, (ii) the proposal to ratify AJSH & Company as the Company’s independent registered public accounting firm for the 2018 fiscal year, (iii) the adoption of the Company’s 2018 Omnibus Incentive Plan, (iv) a non-binding advisory resolution to approve the compensation of the Company’s named executive officers, and (v) approval to adjourn the meeting.

With respect to the matters which were not approved, the voting has been adjourned to November 22, 2017 at 11:00 a.m. (Eastern Standard Time) to allow additional time for the stockholders to vote on the proposals Three and Four set forth in the Company’s proxy statement filed with the Securities and Exchange Commission on October 10, 2017, which is available at https://www.sec.gov/Archives/edgar/data/1326205/000118518517002130/0001185185-17-002130-index.htm.

During the period of the adjournment, the Company will continue to solicit proxies from its stockholders with respect to the two proposals set forth in the Company’s proxy statement that did not pass. Proxies previously submitted in respect of the meeting will be voted at the adjourned meeting unless properly revoked.

The Company encourages all stockholders who have not yet voted to do so by November 21, 2017 at 11.59 p.m. (Eastern Standard Time). The stockholders may vote by internet at www.proxyvote.com, or by telephone at 800-454-8683, or by returning a properly executed proxy card to InvestorCom.

No changes have been made in the proposals to be voted on by stockholders at the Annual Meeting. The Company’s proxy statement and any other materials filed by the Company with the SEC remain unchanged and can be obtained free of charge at the SEC’s website at www.sec.gov.

“During the past fiscal year we simplified our corporate structure, reduced costs, and sharply focused our resources. We have two businesses, continuing legacy operations and canna-pharmaceuticals. Our most advanced and promising canna-pharmaceutical formulation addresses patients with Alzheimer’s disease. Roughly 5.3 million individuals in the U.S. and 44 million worldwide suffer from this debilitating disease.

“Our formulation, Hyalolex, has shown to reduce the primary indicators of Alzheimer’s: senile plaques and neurofibrillary tangles, as well as alleviate several end points like anxiety, sleep disorder, and care giver distress. Importantly, this is achieved without the patient getting high, or suffering long-term damage to neurons, or suffering from side effects commonly associated with cannabis.

“We believe the market for Alzheimer’s disease represents tremendous potential for our cannabis-based product Hyalolex. Our longer-term goal, with appropriate financing, is to move Hyalolex through the FDA registered pre-clinical and clinical trials. Independent of the FDA process, our near-term goal is to commercialize our liquid Hyalolex formulation for Alzheimer’s as a Complimentary and Alternative Medicine (CAM), sold through licensed medical cannabis dispensaries in the U.S., and internationally in Canada and Germany. We expect to begin marketing Hyalolex in early 2018,” states Ram Mukunda, IGC CEO.

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 and risk factors 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 at IGC:  
Claudia Grimaldi
301-983-0998

Contact at InvestorCom, Inc.
Michelle Frosch
877-972-0090

Monday, November 13th, 2017 Uncategorized Comments Off on $IGC Announces Results of Annual Shareholders Meeting

$PBIO to Discuss Q3 2017 Financial Results, Provide Business Update

SOUTH EASTON, MA–(Nov 13, 2017) –  Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”) today announced that the Company will host a teleconference to discuss its Third Quarter 2017 financial results and to provide a business update. Anyone interested may listen to the teleconference either live (by telephone) or through a replay approximately one day after the call (by telephone or via a link on the Company’s website).

The teleconference will include a Company presentation followed by a question & answer period.

  • Date: Tuesday, November 14, 2017
  • Time: 4:30 PM Eastern Standard Time (EST)

To attend this teleconference live by telephone:
Dial-in: (877) 407-8031 (North America); (201) 689-8031 (International)
Verbal Passcode (to be given to the operator): PBIO Third Quarter 2017 Financial Call

For those unable to participate in the live teleconference, a replay will be available beginning Wednesday, November 15, 2017. The replay will be accessible both by telephone and through the Company’s website for 30 days.

Replay Number: (877) 481-4010 (North America); (919) 882-2331 (Int’l); Replay ID Number: 22751

About Pressure BioSciences, Inc.
Pressure BioSciences, Inc. (“PBI”) (OTCQB: PBIO) develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or “PCT”) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions. Our primary focus is in the development of PCT-based products for biomarker and target discovery, drug design and development, bio-therapeutics characterization, soil & plant biology, forensics, and counter-bioterror applications. Additionally, major new market opportunities are emerging in the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (“UST”) to create stable nanoemulsions of otherwise immiscible fluids (such as oils and water, fluoropolymers and alcohol, etc.), and to prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies.

For more information about PBI and this press release, please click on the following link: http://www.pressurebiosciences.com

Please visit us on Facebook, LinkedIn, and Twitter.

Investor Contacts:
Richard T. Schumacher
President & CEO
(T) 508-230-1828

Monday, November 13th, 2017 Uncategorized Comments Off on $PBIO to Discuss Q3 2017 Financial Results, Provide Business Update

$ARNA Completes Full Enrollment, Etrasimod Phase 2 in Ulcerative Colitis

Data Readout Expected in Q1 2018

SAN DIEGO, Nov. 10, 2017 — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced that it has completed full enrollment in the etrasimod Phase 2 study in ulcerative colitis (UC).  Etrasimod is an investigational-stage, oral, next-generation, sphingosine-1-phosphate (S1P) receptor modulator with improved pharmacology and pharmacokinetics intended for the treatment of autoimmune diseases. The study enrolled 157 patients at sites globally.

“A significant unmet need exists across a range of autoimmune conditions including UC, and we are excited to have fully enrolled this study for etrasimod, meeting the high-end of our targeted range,” said Preston Klassen, M.D., MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena.  “We look forward to the availability of data from this Phase 2 trial in the first quarter of 2018.  Given etrasimod’s oral route of administration and optimized profile, we believe it has the potential to deliver broad clinical utility.”

The study is a 12-week, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging trial evaluating safety and tolerability. Efficacy endpoints include improvement in the Mayo clinical score (3-component, total), response, remission and mucosal healing versus placebo, and dose response. The study enrolled patients with moderate to severe UC (3-component Mayo score of 4-9 that includes endoscopic sub score >2, rectal bleeding score >1).

About Etrasimod

Etrasimod (APD334), is an oral, next generation, selective sphingosine 1-phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by selectively targeting S1P receptor subtypes 1, 4 and 5, while avoiding subtypes 2, 3. Etrasimod exhibits potentially best in class pharmacokinetics and pharmacodynamics with rapid onset of action and rapid recovery of t-lymphocytes. Selective binding with S1PR1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.  The receptor subtypes 4, 5 exhibit similar activity on additional proliferating immune cell types. Optimized pharmacology and pharmacokinetics may allow superior clinical utility across a broad range of autoimmune conditions.

Etrasimod is an investigational compound not approved for any use in any country.

About Autoimmune Diseases
Autoimmune diseases are characterized by an inappropriate immune response against substances and tissues that are normally present in the body. In an autoimmune reaction, a person’s antibodies and immune cells target healthy tissues, triggering an inflammatory response. Reducing the immune and/or inflammatory response is an important goal in the treatment of autoimmune disease.

About Ulcerative Colitis
Ulcerative colitis is a chronic disease that affects the large intestine. The innermost lining of the large intestine becomes inflamed and ulcers may form on the surface, which can cause symptoms such as frequent bowel movements, diarrhea and bloody stools. The inflammation is usually found in the rectum and can include all or a portion of the colon. Currently available treatment options have limitations in terms of side effects, patient response, efficacy and administration. We believe that an effective, oral, selective S1P receptor modulator that provides clinical benefits without current limitations has the potential to improve treatment for patients with ulcerative colitis.

About Arena Pharmaceuticals
Arena Pharmaceuticals is a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver broad clinical utility across multiple therapeutic areas. Our proprietary pipeline includes potentially first- or best-in-class programs for which we own global commercial rights. Our three most advanced investigational clinical programs are ralinepag (APD811) which has completed a Phase 2 trial for pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for multiple autoimmune indications, and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn’s disease. In addition, Arena has collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).

Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as “expected,” “intended,” “look forward to,” “believe,” “potential,” “become,” “believed to,” “may,” “can,” “focused on,” “designed to,” or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the ongoing Phase 2 program for etrasimod; the ability to complete planned trials of etrasimod; the expected timing of clinical data; the potential of etrasimod, including to improve treatment of UC patients, to deliver clinical utility across a range of autoimmune conditions and to become a disease modifying therapy; the potential of Arena’s drugs and drug candidates; and Arena’s focus, programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include the following: enrolling patients in our ongoing and intended clinical trials is competitive and challenging; clinical trials and other studies may not proceed at the time or in the manner expected or at all; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; unexpected or unfavorable new data; risks related to developing and commercializing drugs; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; the risk that Arena’s revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena’s guidance or previously reported results; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; Arena’s and third parties’ intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena’s forward-looking statements are disclosed in Arena’s filings with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K which was filed on March 15, 2017 and our Quarterly Report on Form 10-Q which was filed on November 8, 2017. These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt@lifescipublicrelations.com
646.627.8384

Friday, November 10th, 2017 Uncategorized Comments Off on $ARNA Completes Full Enrollment, Etrasimod Phase 2 in Ulcerative Colitis

$VNRX Signs MOU with National Taiwan University for Clinical Trials

ISNES, Belgium, Nov. 10, 2017 — Singapore Volition Pte. Ltd, a wholly-owned subsidiary of VolitionRx Limited (NYSE American: VNRX) (“Volition”), has entered into a Memorandum of Understanding (“MOU”) with the National Taiwan University (“NTU”) to conduct two large colorectal cancer (CRC) research studies across the Asia Pacific Region, totaling approximately 7,000 patient samples. Subject to agreement on the terms and conditions, the Parties intend to sign a binding CRC Study Agreement in the first quarter of 2018.

“The signing of this MOU is a good start for Volition in the Asia Pacific Region” commented Dr. Jasmine Kway, Volition’s Vice President of Asia. “We are fortunate and delighted to be working with a renowned institution and Professor Han-Mo Chiu, a prominent thought leader. This large-scale study will be low cost in line with Volition’s other great value studies such as the 13,500-subject study in the U.S. and the ongoing 30,000-subject prospective study in Europe and demonstrates our commitment to conducting large trials worldwide to drive the acceptance of our products.”

The first trial will be a large scale multi-country, multi-center and multi-ethnic study in the Asia Pacific Region, including 5,000 asymptomatic colorectal cancer screening subjects. The second trial will include up to 2,000 symptomatic colorectal cancer patients. These studies are being conducted to test and validate Volition’s proprietary Nu.QTM platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes.

The studies will be under the supervision of Professor Han-Mo Chiu, Clinical Professor, Department of Internal Medicine of NTU who will be the Principal Investigator for both trials. Prof. Chiu is highly regarded and widely published in this field, with many awards and achievements to his name. Professor Chiu commented, “The early detection of colorectal cancer could benefit the survival rate of patients significantly. There is a clear need for a product which not only has high accuracy but is also easy to use and affordable. I look forward to proceeding with the collaboration with Volition on these projects.”

About the National Taiwan University

NTU is one of the most prestigious universities in the world and is the top university in Taiwan. The University has a wide network of partners and collaborators and plays a leading role in education and research. The University has four university level research centers, with an overall student population of 33,000.

About Volition

Volition is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.

As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life.

Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.

For more information about Volition, visit Volition’s website (http://www.volitionrx.com) or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: http://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document.  The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

Media / Investor Contacts

Louise Day, VolitionL.day@volitionrx.com

+44 (0)7557 774620

Scott Powell, VolitionS.powell@volitionrx.com

+1 (646) 650 1351

Tirth Patel, Edison Advisorstpatel@edisongroup.com

+1 (646) 653 7035

Rachel Carroll, Edison Advisorsrcarroll@edisongroup.com

+44 (0)20 3077 5711

Safe Harbor Statement

Statements in this press release may be “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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition’s bodily-fluid-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics®, NuQ®, Nu.QTM and HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.

Friday, November 10th, 2017 Uncategorized Comments Off on $VNRX Signs MOU with National Taiwan University for Clinical Trials

$KIDS to Present at Stifel 2017 Healthcare Conference

WARSAW, Ind., Nov. 10, 2017 — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today that Mark Throdahl, President & Chief Executive Officer, and Fred Hite, Chief Financial Officer, are scheduled to present at the Stifel 2017 Healthcare Conference on Tuesday, November 14, 2017 at the Lotte New York Palace Hotel.

Details for the presentation are as follows:
Event:                   Stifel 2017 Healthcare Conference
Date:                     Tuesday, November 14, 2017
Time:                    10:15 am ET

An audio webcast of the presentation will be available online at OrthoPediatrics’ investor relations website, http://ir.orthopediatrics.com. A replay of the presentation will be available for 90 days.

Investors attending the conference who would like to schedule a one-on-one meeting with OrthoPediatrics management may do so by contacting their Stifel representative, or Emma Poalillo of The Ruth Group at epoalillo@theruthgroup.com.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market. OrthoPediatrics is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

Friday, November 10th, 2017 Uncategorized Comments Off on $KIDS to Present at Stifel 2017 Healthcare Conference

$ABCD Acquires IS3D, LLC, Provider of Cogent Education Resources

CHARLOTTESVILLE, Va., Nov. 10, 2017 — ExploreLearning announced today that it has acquired Athens, Georgia–based startup, IS3D, LLC, developers of Cogent Education™ Interactive Cases™—dynamic online experiences that put students in the role of a STEM professional tasked with solving a real-world problem.

Cogent’s award-winning Interactive Cases provide engaging and immersive contexts for learning difficult scientific concepts through authentic inquiry and problem solving. As students work through a case, embedded formative assessments give teachers real-time data that help them personalize and differentiate instruction. Research has proven Cogent’s approach effective in improving both content knowledge and critical thinking skills for students of all ability levels.

With initial availability by 2019, ExploreLearning plans to integrate Cogent Education resources into Gizmos, an award-winning online simulation library for grades 3–12 math and science. ExploreLearning also expects to retain the full Cogent development team, including the company’s co-founder and CEO, Tom Robertson, Ph.D., a former Associate Professor in the College of Veterinary Medicine at the University of Georgia.

“I am thrilled to welcome Tom and the talented Cogent team to ExploreLearning,” said David Shuster, Ph.D., founder and president of ExploreLearning. “Their Interactive Cases are a wonderful complement to Gizmos and will strengthen our ability to help STEM students develop the knowledge and skills to succeed.”

Dr. Robertson added, “This is a really natural fit. As part of Gizmos, our Interactive Cases will impact more classrooms than ever before. We look forward to expanding our concept into new topical areas and contributing to ExploreLearning’s ongoing growth and success.”

About ExploreLearning
ExploreLearning® believes all students can succeed in math and science. Our online solutions bring effective, research-proven instructional strategies to classrooms around the world. Gizmos® (www.explorelearning.com) is the world’s largest library of interactive, online simulations for math and science in grades 3–12; and Reflex® (www.reflexmath.com) is the most effective solution available for math fact fluency development. ExploreLearning is a Charlottesville, VA-based business unit of Cambium Learning® Group, Inc. (NASDAQ:ABCD), based in Dallas, Texas.

About IS3D, LLC
IS3D, LLC’s mission is to provide teachers with the tools they need to help their students succeed in their science classes. By focusing on problem-solving skills, IS3D hopes to provide all young people with the best possible chance to pursue rewarding careers in STEM disciplines. Founded in 2010, IS3D (Interactive Science in 3D) partnered with high school teachers, game designers, digital artists, computer programmers and science education researchers to create interactive worlds in which students could learn biological concepts through inquiry and problem-solving.

About Cambium Learning Group, Inc.
Cambium Learning® Group is a leading educational solutions and services company committed to helping all students reach their full potential. Cambium Learning accomplishes this goal by providing evidence-based solutions and expert professional services to empower educators and raise the achievement levels of all students. The company’s award-winning brands include: Learning A-Z® (www.learninga-z.com), ExploreLearning® (www.explorelearning.com), Kurzweil Education® (www.kurzweiledu.com), and Voyager Sopris Learning® (www.voyagersopris.com), which provide breakthrough technology solutions for students and teachers—including best-in-class intervention and supplemental instructional programs; gold-standard professional development; valid and reliable assessments; and products that enable access to learning for all students. Cambium Learning Group, Inc. (NASDAQ: ABCD), is based in Dallas, Texas. For more information, visit www.cambiumlearning.com.

Media Contacts
ExploreLearning
Tammy Weisman, Vice President, Marketing
tammy.weisman@explorelearning.com

Investor Contact
Cambium Learning Group, Inc.
Barbara Benson, Chief Financial Officer
investorrelations@cambiumlearning.com

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$TLGT Announces FDA Approval of Betamethasone Dipropionate Ointment

BUENA, N.J., Nov. 10, 2017 – Teligent, Inc. (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Betamethasone Dipropionate Ointment USP (Augmented), 0.05%.  This is Teligent’s seventh approval for 2017, and its seventeenth approval from its internally-developed pipeline of topical generic pharmaceutical medicines.

Based on recent QuintilesIMS Health data from September 2017, the total addressable market for this product is approximately $43.3 million.

“Betamethasone Dipropionate Ointment USP (Augmented), 0.05% is Teligent’s seventh FDA approval in 2017,” commented Jason Grenfell-Gardner, President and CEO of the Company. “Teligent now has twenty-two topical generic pharmaceutical products in the US portfolio, in addition to our four US injectable products. We expect to launch this product in the first quarter of 2018.”

About Teligent, Inc.
Teligent is a specialty generic pharmaceutical company.  Our mission is to be a leading player in the specialty generic prescription drug market.  Learn more on our website www.teligent.com.

Forward-Looking Statements

This press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as “plan,” “believe,” “continue,” “should” or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions.  These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption “Risk Factors” in Teligent, Inc.’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission.  Teligent, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Contact:
Jenniffer Collins
Teligent, Inc.
(856) 697-4379
www.teligent.com

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$IGC Regains NYSE Listing Compliance

BETHESDA, Md., Nov. 10, 2017 — India Globalization Capital, Inc. (NYSE American:IGC) announced that it received a letter on November 9, 2017 from NYSE Regulation stating that it is in compliance with the NYSE American LLC continued listing standards set forth in Section 704 of the NYSE American Company Guide.  Specifically, IGC held an annual meeting on November 8, 2017. As is the case for all listed issuers, the Company’s continued listing eligibility will continue to be assessed on an ongoing basis.

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

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$IDRA Positive Translational and Clinical Data, IMO-2125 at #SITC 2017

– Available Translational Data Continue to Demonstrate Correlation between Proliferation and Clonal Expansion of T-Cells to Clinical Responses –

– An additional 5th Unconfirmed RECIST v1.1 Response Observed in 10th Evaluable Patient from Ongoing IMO-2125 8mg Phase 2 Dose Expansion Cohort –

CAMBRIDGE, Mass. and EXTON, Pa., Nov. 09, 2017 — Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, today announced updated translational data from the ongoing Phase 1/2 study of intratumoral IMO-2125 in combination with ipilimumab for the treatment of anti-PD-1 refractory metastatic melanoma. These data will be presented at 4:45 P.M. E.T. on Saturday, November 11th in Maryland Ballroom A at the Gaylord National Hotel & Conference Center as part of Concurrent Session 207: Clinical Trials: Novel Combinations at the 2017 Society for Immunotherapy of Cancer Annual Meeting being held in National Harbor, MD.

In the oral presentation entitled, “TLR9 agonist harnesses innate immunity to drive tumor-infiltrating T-cell expansion in distant lesions in a Phase 1/2 study of intratumoral IMO-2125 plus ipilimumab in anti-PD-1 refractory melanoma patients,” Cara Haymaker, Ph.D., from The University of Texas, MD Anderson Cancer Center, will present an update of the essential translational findings from the Ongoing Phase 1/2 trial of IMO-2125.  Adults with anti-PD-1 refractory, unresectable stage III/IV melanoma were enrolled. IMO-2125, escalating from 4 – 32 mg is administered under image guidance, intratumorally on weeks 1, 2, 3, 5, 8, and 11 with standard ipilimumab. Biopsies were obtained in both the injected and distant tumor at baseline, 1 day and 8 weeks (W8) post injection.  Immune analyses included phenotypic, activation, and functional characterization of DC subsets and T cells. T-cell repertoire diversity was evaluated by high-throughput CDR3 sequencing and changes in gene expression signatures were assessed by nanoString.

Key Highlights to be Presented Include:

  • IMO-2125 induces a strong Type 1 interferon gene signature, macrophage influx and robust dendritic cell (DC) maturation post-injection;
  • Combination therapy induces CD8+ T-cell proliferation and activation that is preferential to the tumor;
  • The hallmark of observed tumor shrinkage appears to be the presence of Ki67+ CD8+ T-cell effector cells in the distant/un-injected tumor;
  • Major T-cell clones expanding on therapy in responding patients are shared between local/injected and distant/un-injected lesions, indicating that priming/reactivation is to a shared antigen;
  • Additionally, the company announced that since the last clinical data update provided at the European Society of Medical Oncology Conference in September, an additional (5th) unconfirmed RECIST v.1.1 response has been observed in the 10th evaluable patient to date.

“These important translational findings continue to strengthen our understanding of the critical role of intratumoral IMO-2125 therapy in the priming of T-cells and activation of the tumor microenvironment to produce durable tumor shrinkage when administered with ipilimumab in patients with anti PD-1 refractory metastatic melanoma,”  stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer.  “Our team at Idera is driving this program forward with purpose and rigor in order to bring this approach to patients rapidly.  I look forward to the initiation of the phase 3 study in the first quarter of 2018.”

A copy of the oral presentation as well as a related poster will be available Saturday, November 11, 2017 at 4:45 P.M. E.T. on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/.

About the Phase 1/2 trial of IMO-2125 in combination with ipilimumab (NCT02644967)
Study 2125-204 is a Phase 1/2 open-label study of intratumoral IMO-2125 given in combination with either ipilimumab or pembrolizumab to patients with PD-(L)1 refractory melanoma with a planned enrollment of approximately 90 patients. IMO-2125 is given in escalating dosages from 4 to 32 mg combined with either ipilimumab (3 mg/kg i.v. every 3 weeks for 4 doses) or pembrolizumab (2 mg/kg i.v. every 3 weeks).  Study endpoints are safety, tumor response, pharmacodynamics, and pharmacokinetics. Serial biopsies of both the injected and a distant tumor are being performed for translational immunologic studies.  Preliminary data, presented at SITC 2016, ASCO-SITC 2017, AACR 2017, and CRI-CIMT-EATI-AACR 2017 are available on Idera’s website (http://www.iderapharma.com/our-approach/key-publications/).

About IMO-2125 
IMO-2125 is a toll-like receptor (TLR) 9 agonist that received orphan drug designation from the FDA in 2017 for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors in refractory melanoma patients. Currently approved immuno-oncology treatments for patients with metastatic melanoma, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy making them so-called “refractory”. The combination of ipilimumab and IMO-2125 appears to activate an immune response in these patients who have exhausted all options. Intratumoral injections with IMO-2125 is designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers.  Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths.  The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016.  Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.

About Idera Pharmaceuticals
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera continues to invest in research and development, and is committed to working with investigators and partners who share the common goal of addressing the unmet needs of patients suffering from rare, life-threatening diseases. To learn more about Idera, visit www.iderapharma.com.

Forward Looking Statements
This press 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 statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera’s IMO-2125 will successfully advance through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Annual Report on form 10K for the period ended December 31, 2016. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484‐639‐7235
rdoody@iderapharma.com

Theresa Dolge
Chief Media Relations Officer
Tonic Life Communications
Office: 215-928-2748
Theresa.dolge@toniclc.com

Thursday, November 9th, 2017 Uncategorized Comments Off on $IDRA Positive Translational and Clinical Data, IMO-2125 at #SITC 2017

$ANTH Announces Completion of Recruitment in the Phase 3 RESULT Clinical Study of Sollpura

HAYWARD, Calif., Nov. 09, 2017 – Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that patient recruitment is now complete for the Phase 3 RESULT clinical study of Sollpura for the treatment of Exocrine Pancreatic Insufficiency (“EPI”) caused by cystic fibrosis. Topline data is expected in Q1 2018.

“The support from patients, the cystic fibrosis community, our clinical study investigators and sites has been tremendous and we are very pleased with how quickly and efficiently the recruitment target was achieved,” shared Dr. William Shanahan, Chief Medical Officer, Anthera Pharmaceuticals.  “We now look forward to reporting the interim futility analysis in December, followed by top line data in Q1 2018.”

The RESULT study allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase 3 SOLUTION study.  As with current practice with porcine pancreatic enzyme replacement therapies (“PERT”), the RESULT study allows for dose increases of Sollpura on an individualized basis to achieve maximum therapeutic benefit.  Sollpura has the potential to become the first non-porcine PERT, which may provide a reduction in the size and number of pills patients must consume daily due to the significantly more compact formulation of Sollpura than porcine PERTs.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing products to treat serious and life-threatening diseases, including exocrine pancreatic insufficiency and IgA nephropathy. Additional information on the Company can be found at www.anthera.com.

Safe Harbor Statement

Any statements contained in this press release that refer to future events or other non-historical matters, including statements that are preceded by, followed by, or that include such words as “estimate,” “intend,” “anticipate,” “believe,” “plan,” “goal,” “expect,” “project,” or similar statements, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.   Such statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including but not limited to those set forth in Anthera’s public filings with the SEC, including Anthera’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017.  Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

CONTACT:

Investor Relations of Anthera Pharmaceuticals, Inc.
ir@anthera.com

For Media Inquiries:
Frannie Marmorstein, 305-567-0821
frannie.marmorstein@rbbcommunications.com

www.twitter.com/antherapharma
https://www.facebook.com/antherapharma/
https://www.linkedin.com/company/anthera-pharmaceuticals

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$RILY to Acquire magicJack VocalTec $CALL for $8.71 Per Share

LOS ANGELES and WEST PALM BEACH, Fla. and NETANYA, ISRAEL, Nov. 09, 2017 — B. Riley Financial, Inc. (“B. Riley”)(NASDAQ:RILY), a diversified financial services company, and magicJack VocalTec, Ltd. (“magicJack”)(NASDAQ:CALL), a leading Voice over IP (VOIP) cloud-based communications company, have signed a definitive merger agreement, pursuant to which B. Riley will acquire magicJack for $8.71 per share, representing a 23% premium over magicJack’s 90-day average stock price and approximately $143 million in aggregate merger consideration. It is anticipated that magicJack will be held by B. Riley’s subsidiary B. Riley Principal Investments, LLC, the entity that currently owns United Online, Inc., a complementary telecommunications company. B. Riley expects to finance the transaction using cash on hand and debt financing.

“With magicJack, we look to replicate the success we’ve had with our United Online acquisition by again leveraging our operational expertise to generate significant cash flows. The synergistic potential, combined with magicJack’s subscriber base and brand name, make this an attractive investment opportunity,” said Kenny Young, CEO of B. Riley Principal Investments and a veteran telecom executive.

Bryant Riley, Chairman and CEO of B. Riley said, “Investments such as this one are the key reason we formed our Principal Investments group. We believe that magicJack is representative of the type of proprietary investment with attractive return characteristics that are often overlooked by others, but where we are uniquely qualified to leverage our balance sheet and comprehensive platform in order to maximize the investment potential. Once fully integrated, we expect magicJack to generate a meaningful contribution to B. Riley’s cash flow and, consistent with our policy of returning capital to shareholders, lead to increased dividends for our shareholders in the future.”

“This merger reflects the successful completion of our strategic alternatives process which we believe maximizes shareholder value and will benefit all our loyal customers,” said Don Bell, CEO of magicJack. “Jointly, we believe that there are significant synergistic opportunities that will result from this transaction that are complementary to magicJack’s platform.”

Closing Details
The closing of the transaction is subject to the receipt of certain regulatory approvals, the approval of the magicJack shareholders and the satisfaction of other closing conditions. The transaction is expected to close in the first half of 2018. B. Riley FBR, Inc. served as financial advisor to B. Riley. Sullivan & Cromwell LLP, Wilkinson Barker Knauer LLP and Gross Kleinhendler, Hodak, Halevy, Greenberg & Co. served as legal counsel to B. Riley. Bryan Cave LLP, Wiley Rein LLP and Yigal Arnon & Co. served as legal counsel and BofA Merrill Lynch acted as financial advisor for magicJack.

About magicJack VocalTec Ltd.
magicJack VocalTec Ltd. (NASDAQ:CALL), the inventor of magicJack and a pioneer in VOIP technology and services, is a leading cloud communications company. With its easy-to-use, low cost solution for telecommunications, magicJack has sold more than 11 million magicJack devices, which are now in their fifth generation, has millions of downloads of its calling apps, and holds more than 30 technology patents. magicJack is the largest-reaching CLEC (Competitive Local Exchange Carrier) in the United States in terms of area codes available and number of states in which it is certified.

About B. Riley Principal Investments
B. Riley Principal Investments, a wholly-owned subsidiary of B. Riley, focuses on investing in or acquiring companies or corporate assets that present attractive cash-flow driven returns and can benefit from its financial, business and operational expertise. Principal Investments addresses small to mid-cap sized opportunities with a focus on distressed situations, and companies with declining revenues that have the potential to generate material cash-flow.

About B. Riley Financial, Inc. (NASDAQ:RILY)
B. Riley Financial, Inc. is a publicly traded, diversified financial services company which takes a collaborative approach to the capital raising and financial advisory needs of public and private companies and high net worth individuals. B. Riley Financial, Inc. operates through several wholly-owned subsidiaries, including B. Riley FBR, Inc., Wunderlich Securities, Inc., Great American Group, LLC, B. Riley Capital Management, LLC (which includes B. Riley Asset Management, B. Riley Wealth Management, and Great American Capital Partners, LLC) and B. Riley Principal Investments, a group that makes proprietary investments in other businesses, such as the acquisition of United Online, Inc.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements other than statements of historical fact are forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause B. Riley’s or magicJack’s performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither B. Riley nor magicJack assume any duty to update forward looking statements. We caution readers that a number of important factors could cause actual results to differ materially from those expressed in, or implied or projected by, such forward-looking statements. Such forward-looking statements include, but are not limited to, statements about the benefits of the acquisition involving B. Riley and magicJack, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: (i) the possibility that the merger does not close when expected or at all because required regulatory, shareholder or other approvals and other conditions to closing are not received or satisfied on a timely basis or at all; (ii) the risk that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which B. Riley and magicJack operate; (iii) the ability to promptly and effectively integrate the businesses of B. Riley and magicJack; (iv) the reaction to the transaction of the companies’ customers, employees and counterparties; (v) diversion of management time on merger-related issues; and (vi) other risks that are described in B. Riley’s and magicJack’s public filings with the Securities and Exchange Commission (the “SEC”).

Additional Information and Where to Find It
This communication may be deemed to be solicitation material in respect of the proposed acquisition of magicJack by B. Riley. In connection with the proposed acquisition, magicJack intends to file relevant materials with the SEC, including magicJack’s proxy statement on Schedule 14A.  SHAREHOLDERS OF MAGICJACK ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING MAGICJACK’S PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents free of charge at the SEC’s web site, http://www.sec.gov, and magicJack shareholders will receive information at an appropriate time on how to obtain transaction-related documents free of charge from magicJack. Such documents are not currently available.

Participants in Solicitation
magicJack and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from the holders of magicJack ordinary shares in respect of the proposed transaction. Information regarding magicJack’s directors and executive officers is contained in magicJack’s annual report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 16, 2017, proxy statement for magicJack’s 2017 special meeting of shareholders filed with the SEC on June 23, 2017, and current reports on Form 8-K filed with the SEC on March 15, 2017, May 10, 2017, May 23, 2017 and June 19, 2017. Investors may obtain additional information regarding the interest of such participants by reading the proxy statement regarding the acquisition when it becomes available.

Media Contact
Joe LoBello
LoBello Communications
516-902-2684
Joe@LoBelloCommunications.com

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$SAGE Brexanolone Achieves Primary Endpoints, Phase 3 Clinicals in Postpartum Depression

CAMBRIDGE, Mass.

Statistically significant mean reduction in the HAM-D score compared to placebo at 60 hours demonstrated in both trials

Brexanolone provided a rapid and durable reduction over 30 days in depressive symptoms as measured by HAM-D in both placebo-controlled multi-center trials

Positive results support planned regulatory submissions; Company to host conference call today at 8:00 A.M. ET

Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone (USAN; formerly SAGE-547); Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD. Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score compared to placebo at 60 hours (Study 202B: p=0.0242 for 90 µg/kg/h dose and p=0.0011 for 60 µg/kg/h dose; Study 202C: p=0.0160 for 90 µg/kg/h dose). Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials. Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.

PPD is a common biological complication of childbirth affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. It is estimated that PPD affects approximately 10 to 20 percent of women giving birth in the U.S. and up to half of these cases may go undiagnosed without proper screening. There are no approved therapies for PPD and there is a clear unmet medical need for treatment.

“PPD is commonly viewed as a disorder solely experienced by the mother, but it also seriously impacts the child and family members – both immediate and extended,” said Dr. Samantha Meltzer-Brody, M.D., M.P.H., associate professor and director of UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator of the studies. “Symptoms of PPD should not be overlooked by new moms or those in their support networks and the healthcare community should encourage discussion and appropriate action. These data meaningfully advance our understanding of PPD and may prompt medical professionals to evaluate how PPD is perceived, identified and treated within their practices in the future. In these studies, brexanolone provided a profound and durable effect over the study period that could be an important step in potentially changing the way health care providers think about treating this disorder.”

The Hummingbird Phase 3 program included two Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled trials designed to evaluate the safety and effectiveness of brexanolone in women with moderate and severe PPD. Entry criteria for participants included depressed mood and/or loss of interest and associated symptoms of depression, including appetite problems, sleep problems, motor problems, lack of concentration, loss of energy, poor self-esteem and suicidality that began no earlier than the third trimester and no later than the first four weeks following delivery.

“This is the first Phase 3 program conducted specifically in women with PPD and these results exemplify the value of Sage’s distinct approach to clinical research,” said Jeff Jonas, M.D., chief executive officer of Sage. “We are pleased with the findings, specifically the rapid onset of action and duration of effect observed in all arms of the Hummingbird program. We believe the data represent an unprecedented opportunity in the development of treatments for PPD, and may serve as the catalyst for a paradigm shift in how the disease is approached and, if approved, may change how PPD is treated.”

“Today illustrates what an exciting time it is in CNS research and drug development,” said Steve Kanes, M.D., Ph.D., chief medical officer of Sage. “Sage is deliberately pursuing a translational clinical strategy that can expedite medical innovation and potentially transform the lives of patients. This strategy begins with open label trials in a carefully selected disease indication, such as PPD, where patients are in need of transformative treatment options. Our approach seeks to establish signals for safety and activity and if a signal is observed, we move efficiently into later stage development. Our brexanolone research for a treatment in PPD followed this path, resulting in the successful data we are announcing today.”

Summary of Top-line Brexanolone Phase 3 Results

Effect on Postpartum Depressive Symptoms:

  • In both trials at all doses, brexanolone achieved the primary endpoint, a significant mean reduction from baseline in the HAM-D total score at 60 hours compared to placebo.
    • Study 202B – Patients with severe PPD (n=122):
      • Patients were randomized to one of three treatment groups (brexanolone 90 μg/kg/hour, brexanolone 60 μg/kg/hour, or placebo) on a 1:1:1 basis.
      • Brexanolone 90 μg/kg/hour treatment was associated with a statistically significant mean reduction in HAM-D total score of 17.7 points from baseline compared with a 14.0 point mean reduction in HAM-D total score associated with placebo (p=0.0242).
      • Brexanolone 60 μg/kg/hour treatment was associated with a statistically significant mean reduction in HAM-D total score of 19.9 points from baseline compared with a 14.0 point mean reduction in HAM-D total score associated with placebo (p=0.0011).
      • Statistically significant differences in the reduction in HAM-D total score of brexanolone versus placebo were first observed at 48 hours and the effect at 60 hours was maintained through the 30-day follow-up with statistical significance for both brexanolone dose groups.
      • Improvement in the Clinical Global Impression – Improvement scale (CGI-I) at 60 hours was consistent with the primary endpoint (p=0.0096 for 90 µg/kg/h dose and p=0.0124 for 60 µg/kg/h dose).
    • Study 202C – Patients with moderate PPD (n=104):
      • Patients were randomized to one of two treatment groups (brexanolone 90 μg/kg/hour or placebo) on a 1:1 basis.
      • Brexanolone treatment was associated with a statistically significant mean reduction in HAM-D total score of 14.2 points from baseline at 60 hours (p=0.0160) compared with a 12.0 point mean reduction in HAM-D total score associated with placebo.
      • Statistical significance was first observed at 48 hours and remained through Day 7, but not at Day 30. However, the effect observed at 60 hours in the brexanolone group was maintained through the 30-day follow-up.
      • Improvement in the Clinical Global Impression – Improvement scale (CGI-I) at 60 hours was consistent with the primary endpoint (p=0.0005).

Safety and Tolerability:

  • Brexanolone was generally well tolerated in both studies with similar rates of adverse events across all treatment groups.
  • In each trial, there was one patient who experienced a serious adverse event; neither required hospitalization and one of which was deemed by the investigator not to be study-drug related.
  • The most common adverse events in the studies were headache, dizziness, and somnolence.

Detailed study results, including additional secondary endpoints, will be submitted for presentation at an upcoming medical meeting and for publication. Sage believes these data will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD. Sage plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.

About the Hummingbird Program: 202B and 202C

The Hummingbird program included two Phase 3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trials (Study 202B and Study 202C), designed to evaluate the safety and effectiveness of brexanolone in women with moderate and severe postpartum depression (PPD), aged between 18 and 45 years (inclusive) who were ≤6 months postpartum at screening in the United States.

  • Patients enrolled in both trials (202B; 202C) were required to have had a Major Depressive Episode that began no earlier than the third trimester and no later than the first four weeks following delivery, and to also be less than six months postpartum at the time of enrollment.
  • Trial participants in 202B were required to have a HAM-D score of 26 or above prior to treatment. These patients were randomized to one of three treatment groups (brexanolone 90 μg/kg/hour, brexanolone 60 μg/kg/hour, or placebo) on a 1:1:1 basis.
  • Trial participants in 202C were required to have a HAM-D score of between 20 and 25 prior to treatment. These patients were randomized to one of two treatment groups (brexanolone 90 μg/kg/hour or placebo) on a 1:1 basis.

For more information about these trials, please visit https://thehummingbirdstudy.com/.

Conference Call Information

Sage will host a conference call and webcast today at 8:00 A.M. ET to discuss the top-line results from the Phase 3 brexanolone Hummingbird trials in PPD. The live webcast can be accessed on the investor page of Sage’s website at investor.sagerx.com. The conference call can be accessed by dialing 866-450-8683 (toll-free domestic) or 281-542-4847 (international) and use the conference ID 7592007. A replay of the webcast will be available on Sage’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

About Postpartum Depression

Postpartum depression (PPD) is a distinct and readily identified major depressive disorder that is a biological complication of childbirth, affecting a subset of women typically commencing in the third trimester of pregnancy or within four weeks after giving birth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Suicide is the leading cause of maternal death following childbirth. It is estimated that PPD affects approximately 10 to 20 percent of women giving birth in the U.S. and up to half of these cases may go undiagnosed without proper screening. There are no approved therapies for PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.

About the Hamilton Rating Scale for Depression (HAM-D)

HAM-D is a validated rating scale used to provide an assessment of depression, and as a guide to evaluate recovery. This scale is an accepted regulatory endpoint for depression. The scale is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation, anxiety, weight loss, and somatic symptoms.

About Brexanolone (SAGE-547)

Brexanolone (SAGE-547) is an allosteric modulator of both synaptic and extrasynaptic GABAreceptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor. Sage’s proprietary i.v. formulation of brexanolone is being developed for the treatment of postpartum depression (PPD) and has been granted Breakthrough Therapy designation by the FDA and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) in PPD.

About Sage Therapeutics

Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage’s lead program, a proprietary i.v. formulation of brexanolone (SAGE-547), is in Phase 3 clinical development for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders. For more information, please visit www.sagerx.com.

Forward-Looking Statements

Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation: our expectations regarding the potential for brexanolone in the treatment of PPD; our view as to the unmet need for additional treatment options in PPD and how brexanolone might address the needs of PPD patients and families, if successfully developed and approved; our estimate as to the number of patients with PPD; our plans and expectations with respect to future regulatory submissions and activities related to brexanolone and ongoing development; our views as to the potential for approval of brexanolone and future commercialization and the impact on our company; and our expectations regarding development, planned activities and the potential for success of our other product candidates. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the clinical and non-clinical data we have generated to date may be determined by regulatory authorities, despite prior advice, to be insufficient to file for or gain regulatory approval to launch and commercialize our proprietary formulation of brexanolone and regulatory authorities may determine that additional trials or data are necessary in order to file for or obtain approval; regulatory authorities may find fault with the data generated at particular clinical site or sites or with the activities of our trial monitor or may disagree with our analyses of the results of our trials or identify issues with our manufacturing or quality systems, and any such findings or issues could require additional data or analyses or changes to our systems that could delay or prevent us from gaining approval of brexanolone; we may encounter unexpected safety or tolerability issues with brexanolone or any of our product candidates in ongoing or future development; the number of patients with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may not be able to successfully demonstrate the efficacy and safety of any of our other product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies; the efficacy data generated in ongoing or future clinical trials may be negative or less robust than we expect; ongoing or future clinical trials may not support further development of our other product candidates or be sufficient to gain regulatory approval to market any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress, number, size and cost of clinical trials, and our ability to proceed with further clinical trials of a product candidate in a particular indication, or at all, or our ability to obtain marketing approval; we may decide that a development pathway for a product candidate in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates; as well as those risks more fully discussed in the section entitled “Risk Factors” in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

 

Investor Contact:
Sage Therapeutics
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media Contact:
Suda Communications LLC
Maureen L. Suda, 585-355-1134
maureen.suda@sagerx.com

Thursday, November 9th, 2017 Uncategorized Comments Off on $SAGE Brexanolone Achieves Primary Endpoints, Phase 3 Clinicals in Postpartum Depression

$RTNB Soar Triggers $NDAQ Halt

NEW YORK, Nov. 09, 2017 — The Nasdaq Stock Market® (Nasdaq:NDAQ) announced that trading was halted today in root9B Holdings, Inc. (Nasdaq:RTNB) at 15:32:55 Eastern Time for “additional information requested” from the company at a last sale price of $1.32.

Trading will remain halted until root9B Holdings, Inc. has fully satisfied Nasdaq’s request for additional information.

For news and additional information about the company, please contact the company directly or check under the company’s symbol using InfoQuotesSM on the Nasdaq® Web site.

For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at http://www.nasdaq.com.

NDAQO

Nasdaq Media Contact:
Christine Barna
Christine.Barna@nasdaq.com

Thursday, November 9th, 2017 Uncategorized Comments Off on $RTNB Soar Triggers $NDAQ Halt

$SNES Signs a Distribution Agreement with Target Specialty Products for ContraPest®

FLAGSTAFF, Ariz., Nov. 8, 2017 — SenesTech, Inc. (NASDAQ: SNES), a developer of proprietary technologies for managing animal pest populations through fertility control, today announced a national distribution agreement with Target Specialty Products for ContraPest®.  In addition to distribution, Target Specialty Products will be marketing and selling ContraPest throughout its network.

“Target Specialty Products is an excellent sales and distribution partner for SenesTech, with their direct connection with the pest control operators, with their extensive breadth and depth of coverage throughout the U.S., and their commitment to a vision of protecting the environment. They will provide us with a more extensive nationwide sales coverage in the pest management sector,” said Dr. Loretta P. Mayer, Chair, CEO and co-founder of SenesTech. “As they have assured us, that consistent with their core values, they will work hard to embrace innovation and provide their customers with access to quality products. ContraPest is a clear example of such innovation and quality.”

About SenesTech 

SenesTech has developed an innovative technology for managing animal pest populations through fertility control as opposed to a lethal approach.

ContraPest’s novel technology and approach targets the reproductive capabilities of both sexes in rat populations, inducing egg loss in female rats and impairing sperm development in males. Using a proprietary bait delivery method, ContraPest is dispensed in a highly palatable liquid formulation that promotes sustained consumption by rat communities. ContraPest is designed, formulated and dispensed to be low hazard for handlers and non-target species such as wildlife, livestock and pets, where the active ingredients break down rapidly, unlike rodenticides. In contrast, the historical approach to managing rat pest populations, rodenticides, carries a high risk of environmental contamination and the poisoning of non-target animals, pets and children. ContraPest is a Restricted Use product.

We believe our innovative non-lethal approach, targeting reproduction, is more humane, less harmful to the environment, and more effective in providing a sustainable solution to pest infestations than traditional lethal pest management methods.  We believe ContraPest® will establish a new paradigm in rodent control, resulting in improved performance in rodent control over rodenticides, without the negative environmental effects of rodenticides.  For more information visit the SenesTech website at www.senestech.com.

About Target Specialty Products

With over 80 years of industry experience, Target Specialty Products is proud to be a leading national wholesale distributor of pest management and turf and ornamental (T&O) products, application equipment, supplies, services, education and training programs.

Serving the entire United States and Canada from conveniently located branch locations, Target Specialty Products provides products, services and equipment to the following industries, in both the private and public sectors: Aquatic, Forestry, and Vector Control, Golf Course and Turfgrass Maintenance, Landscape Maintenance, Nursery, Pest Management, Fumigation and Vegetation Management.

Safe Harbor Statement
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 and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may,” “future,” “plan” or “planned,” “will” or “should,” “expected,” “anticipates,” “draft,” “eventually” or “projected.” You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors and other risks identified in our filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACT:
Investor: Robert Blum, Joe Dorame, Joe Diaz, Lytham Partners, LLC, 602-889-9700, senestech@lythampartners.com
Company: Tom Chesterman, Chief Financial Officer, SenesTech, Inc., 928-779-4143

Wednesday, November 8th, 2017 Uncategorized Comments Off on $SNES Signs a Distribution Agreement with Target Specialty Products for ContraPest®

$DGLY Exploring Strategic Alternatives

Roth Capital Partners Engaged to Assist in the Process

Lenexa, KS, Nov. 08, 2017 — Digital Ally, Inc. (NASDAQ: DGLY) today announced that its Board of Directors has initiated a process to explore a full range of strategic alternatives to best position the Company for the future including, but not limited to, monetizing its patent portfolio and related patent infringement litigation against Axon Enterprise, Inc. (“Axon,” formerly known as TASER International, Inc.) and Enforcement Video, LLC d/b/a WatchGuard Video (“WatchGuard”), the sale of the Company as a whole, or the sale of select properties or groups of properties or individual businesses. The result of the strategic review may also include the continued implementation of the Company’s business plan.  The Company has retained Roth Capital Partners LLC (“Roth”) to assist in this process. There can be no assurance a transaction will result from this process and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction.

The Company has recently received several unsolicited inquiries from parties involving a variety of alternatives including, but not limited to, 1) seeking distribution and/or licensing rights to the Company’s patented VuLink® auto-activation technology, 2) seeking distribution and/or licensing rights to the Company’s suite of patents other than the VuLink; 3) full sale of the Company; and 4) partial sale of its law enforcement or commercial divisions.  In addition, the Company has recently entered into an exclusive distribution agreement with VieVU, LLC regarding the Company’s patented VuLink product line. The Company believes the unsolicited inquiries are being driven by the recent and important wins it received in the U.S. Patent Office (the “Patent Office”) that confirm the validity of our VuLink and related auto-activation technologies.  Digital’s Board of Directors and management engaged Roth to ensure that the Company and its shareholders consider all reasonable alternatives to maximize shareholder value, given the multiple inquiries.

On July 6, 2017, the Patent Office denied Axon’s petition for inter partes review (“IPR”) of Digital’s Patent No. 9,253,452 (the “’452 Patent”). And on August 3, 2017, the Patent Office denied Axon’s final petition for IPR of the ‘452 Patent. This was Axon’s final attempt to invalidate the ‘452 Patent before the Patent Office.

With the Patent Office determining that Axon failed to demonstrate even a reasonable likelihood of invalidating the ‘452 Patent in its IPR petition, an IPR status update was submitted to the District Court of Kansas. The Court can now decide whether to maintain the stay of the litigation that was implemented pending the results of the IPR petitions. The Company believes that there will be no reason to maintain the stay and, if lifted, it will request an expedited schedule for trial.

On May 27, 2016, Digital filed a complaint against WatchGuard in the U.S. District Court for the District of Kansas alleging patent infringement based on WatchGuard’s VISTA Wifi and 4RE In-Car product lines. In May 2016, WatchGuard filed an IPR petition with the Patent Office challenging the validity of the ‘950 Patent and filed a motion to stay litigation, pending at least a preliminary decision from the PTAB regarding the IPR petition filed challenging the ‘950 Patent and four additional IPR petitions filed by Axon challenging the ‘292 Patent and the ‘452 Patent. In doing so, WatchGuard agreed to be bound by the Patent Office’s decision in connection with the four IPR petitions filed by Axon against the ‘292 Patent and the ‘452 Patent. A compromise was subsequently reached under which the court stayed the case, and ordered the parties to submit a report by January 5, 2018 notifying the court about the status of the pending IPR petitions. The Patent Office subsequently denied institution of all of Axon’s IPR petitions against the ‘452 Patent, which means these requests will not proceed. The Company expects Patent Office to render its decision in the near future regarding  whether it will grant institution of WatchGuard’s IPR regarding the ‘950 Patent.

“We are excited to pursue the cases and now focus on the significant damages associated with Axon’s infringement of the ‘452 Patent,” said Digital’s CEO, Stanton E. Ross. “With the defeat of Axon’s IPRs for the ‘452 Patent, we will request an expedited path to trial where a jury can assess Axon’s willful infringement of the ‘452 Patent and award Digital Ally appropriate damages. We also seeking the Court to enjoin all further sales of Axon’s non-SPPM Signal technology.”

About Digital Ally
Digital Ally®, headquartered in Lenexa, KS, specializes in the design and manufacturing of the highest quality video recording equipment and video analytic software. Digital Ally pushes the boundaries of technology in industries such as law enforcement, emergency management, commercial fleets, and consumer use. Digital Ally’s complete product solutions include in-car and body cameras, cloud and local management software, and automatic recording technology. These products work seamlessly together and are simple to install and operate. Digital Ally products are sold by domestic direct sales representatives and international distributors worldwide.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. A wide variety of factors that may cause actual results to differ from the forward-looking statements include, but are not limited to, the following: whether a transaction will result from the initiative with Roth Capital Partners; whether the Company will achieve positive outcomes in its patent litigation with various parties, including Axon Enterprise, Inc. and WatchGuard; whether the Patent Office rulings will curtail, eliminate or otherwise have an effect on the actions of Axon, WatchGuard and other parties respecting the Company, its products and customers; competition from larger, more established companies with far greater economic and human resources; its ability to attract and retain customers and quality employees; the effect of changing economic conditions; and changes in government regulations, tax rates and similar matters. These cautionary statements should not be construed as exhaustive or as any admission as to the adequacy of the Company’s disclosures. The Company cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”, “should”, or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. The Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Additional information respecting factors that could materially affect the Company and its operations are contained in its annual report on Form 10-K for the year ended December 31, 2016 and quarterly report on Form 10-Q for the three and six months ended June 30, 2017, as filed with the Securities and Exchange Commission.

 

Contact Information
Stanton Ross, CEO
Tom Heckman, CFO
Digital Ally, Inc
913-814-7774

info@digitalallyinc.com
Wednesday, November 8th, 2017 Uncategorized Comments Off on $DGLY Exploring Strategic Alternatives

$CVO Awarded 2020 U.S. Census Printing and Mailing Contract

STAMFORD, Conn., Nov. 8, 2017 — Cenveo, Inc. (NASDAQ: CVO), a global leader in digital manufacturing and fulfillment of envelopes, labels, print and related communication resources, has been awarded the 2020 Census Printing and Mailing Contract from the U.S. Census Bureau.  The two-year $61 million contract is one of the largest contracts for printing and mailing ever awarded by the U.S. Government Publishing Office.

“Cenveo’s award of the 2020 U.S. Census is a reflection of our core capabilities and expertise, manufacturing and fulfillment,” said Robert G. Burton, Sr., Cenveo’s Chairman and Chief Executive Officer.  “We are well-positioned to execute and manage all aspects of this program successfully and with the level of quality and security expected.  We are honored to be a part of this program that will achieve a lasting impact to the future of our country.”

The contract will involve the manufacturing and fulfillment of 1.6 billion pieces, including letters, envelopes, inserts, questionnaires and postcards.  The majority of the work will be performed at Cenveo’s printing and binding facilities located in Southern California (Los Angeles) locations and other work performed across the United States.

“The U.S. Census is a massive manufacturing and fulfillment program that requires the utmost degree of precision and operational planning,” said Michael Burton, Chief Operating Officer of Cenveo.  “We are excited and committed to partner with the U.S. Census team and confident in our ability to deliver this program.”

Visit www.census.gov to learn more about the 2020 U.S. Census Printing and Mailing Contract.

Cenveo (NASDAQ: CVO), world headquartered in Stamford, Connecticut, is a leading global provider of print and related resources, offering world-class solutions in the areas of custom labels, envelopes, commercial print, content management and publisher solutions. The company provides a one-stop offering through services ranging from design and content management to fulfillment and distribution. With a worldwide distribution platform, we pride ourselves on delivering quality solutions and service every day to our customers. For more information please visit us at www.cenveo.com.

Statements made in this release, other than those concerning historical financial information, may be considered “forward-looking statements,” examples of which include statements relating to our 2017 outlook and future financial condition and operating results, as well as any other statement that does not directly relate to any historical or current fact.  These forward-looking statements are based upon current expectations and involve a number of assumptions, risks and uncertainties that could cause actual results to differ materially from such forward-looking statements.  In view of such uncertainties, investors should not place undue reliance on our forward-looking statements.  Such statements speak only as of the date of this release and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Factors which could cause actual results to differ materially from management’s expectations include, without limitation: (i) our substantial level of indebtedness could materially adversely affect our financial condition, liquidity and ability to service or refinance our debt, and prevent us from fulfilling our business obligations; (ii) our ability to pay the principal of, or to reduce or refinance, our outstanding indebtedness; (iii) the terms of our indebtedness imposing significant restrictions on our operating and financial flexibility; (iv) additional borrowings available to us could further exacerbate our risk exposure from debt; (v) United States and global economic conditions have adversely affected us and could continue to adversely affect us; (vi) our ability to successfully integrate acquired businesses with our business; (vii) a decline in our consolidated profitability or profitability within one of our individual reporting units could result in the impairment of our assets, including goodwill and other long-lived assets; (viii) the industries in which we operate our business are highly competitive and extremely fragmented; (ix) a general absence of long-term customer agreements in our industry, subjecting our business to quarterly and cyclical fluctuations; (x) factors affecting the United States Postal Service’s impacting demand for our products; (xi) the availability of the Internet and other electronic media adversely affecting our business; (xii) increases in paper costs and decreases in the availability of raw materials; (xiii) increases in energy and transportation costs; (xiv) our labor relations; (xv) our compliance with environmental laws; (xvi) our dependence on key management personnel; (xvii) any failure, interruption or security lapse of our information technology systems and (xviii) there can be no assurances that our profitability plan will satisfy the NASDAQ or result in achieving compliance with its listing standards.  This list of factors is not exhaustive, and new factors may emerge or changes to the foregoing factors may occur that would impact our business.  Additional information regarding these and other factors can be found in Cenveo, Inc.’s periodic filings with the SEC, which are available at www.cenveo.com.

Inquiries from analysts and investors should be directed to Ayman Zameli at (203) 595-3063.

Wednesday, November 8th, 2017 Uncategorized Comments Off on $CVO Awarded 2020 U.S. Census Printing and Mailing Contract

$ONCS Positive Updated Long-Term Follow-Up Data, Phase 2 ImmunoPulse® IL-12, Melanoma

Updated Phase 2 Efficacy and Durability Findings to Be Presented at the 2017 Society for Immunotherapy of Cancer Annual Meeting OncoSec to Host Analyst and Investor Event During the 2017 Society for Immunotherapy of Cancer Annual Meeting in National Harbor, MD

SAN DIEGO, Nov. 8, 2017 — OncoSec Medical Incorporated (“OncoSec” or “Company”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse® IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy. The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.

The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting “cold” tumors to “hot,” potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.

“Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma,” said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Dan O’Connor, CEO of OncoSec noted: “The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy.”

The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.

Analyst Event in National Harbor, MD

OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial.  The event will be held in-person and via live webcast.

Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: https://edge.media-server.com/m6/p/aj3vpts5. An archived version of the presentation will be available for 90 days on the “Investors” section of OncoSec’s website: http://ir.oncosec.com/events-presentations.

For those interested in attending this event in person, please contact media@oncosec.com. Please RSVP in advance as seating is limited.

Peer-Reviewed Publication  

The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.

For the full-article please visit, https://www.ncbi.nlm.nih.gov/pubmed/29064334.

About the SITC Annual Meeting

The Society for Immunotherapy of Cancer (SITC) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.  Currently, SITC has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to http://www.sitcancer.org/2017.

About PISCES/KEYNOTE-695

PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or “tavo”) delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

About OncoSec Medical Incorporated

OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12 (tavokinogene telseplasmid [pIL-12] or “tavo”). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.

University of California Disclaimer

The information stated above was prepared by OncoSec Inc. and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of OncoSec, or any of its products, by The Regents of the University of California, its officers, agents and employees.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements about OncoSec’s business strategies, including advancement of its lead melanoma program and its broader clinical portfolio and plans to pursue collaborations with industry partners, as well as the potential contributions and impact of new directors on these strategies. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of these terms or other comparable terminology.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause OncoSec’s results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: the status, progress and results of clinical programs; ability to obtain regulatory approvals for, and the level of market opportunity for, OncoSec’s product candidates; OncoSec’s business plans, strategies and objectives, including plans to pursue collaboration, licensing or other similar arrangements or transactions; expectations regarding OncoSec’s liquidity and performance, including expense levels, sources of capital and ability to maintain operations as a going concern; the competitive landscape of OncoSec’s industry; and general market, economic and political conditions; and the other factors discussed in OncoSec’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended July 31, 2017.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any 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.

CONTACT:

Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com

Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com

Wednesday, November 8th, 2017 Uncategorized Comments Off on $ONCS Positive Updated Long-Term Follow-Up Data, Phase 2 ImmunoPulse® IL-12, Melanoma

$OTIC Positive Results from AVERTS-2 Phase 3 Trial of OTIVIDEX

  • Achieved primary endpoint (p value = 0.029)
  • Company plans to meet with FDA to discuss results and clinical requirements for registration
  • Management will review results during third quarter conference call at 4:30 p.m. EST today

SAN DIEGO, Nov. 08, 2017 – Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the AVERTS-2 Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease achieved its primary efficacy endpoint (p value = 0.029). Otonomy plans to review these results with the U.S. Food and Drug Administration (FDA) and discuss clinical requirements for registration of OTIVIDEX for patients with Ménière’s disease. The company expects to provide an update from discussions with the FDA during the first quarter of 2018.

Top-line results for the AVERTS-2 trial are as follows:

  • The clinical trial achieved its primary endpoint of count of definitive vertigo days (DVD) by Poisson Regression analysis in Month 3 for OTIVIDEX vs. placebo (p value = 0.029) based on analysis of all 174 patients enrolled in the trial.
  • The OTIVIDEX group demonstrated a 6.2 day reduction in the mean reported number of DVD from baseline to Month 3 with a 2.5 day mean difference between OTIVIDEX and placebo in Month 3.
  • For subjects who completed daily diaries through Month 3 (n=105), there was a 68% reduction in vertigo frequency from baseline to Month 3 in the OTIVIDEX group vs. 40% for placebo.

“The success of the AVERTS-2 trial clearly demonstrates the treatment benefit of OTIVIDEX in patients with Ménière’s disease, and these results are consistent with our expectations based on the Phase 2b trial,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We will complete analysis of this trial and prepare for discussions with the FDA which we expect to occur during the first quarter of 2018. We will also further assess the AVERTS-1 trial to identify factors that might explain the different outcome in that trial and inform the design of our clinical program to support an NDA filing.”

The AVERTS-2 Phase 3 trial was a four month, prospective, randomized, double-blind, placebo-controlled trial of patients with unilateral Ménière’s disease conducted in Europe. Following an initial one month lead-in period, eligible subjects were randomized 1:1 to a single intratympanic injection of OTIVIDEX or placebo. Subjects continued in the trial for up to an additional three months of observation. A total of 174 patients were randomized into the study with 105 patients completing daily diaries through three months of post-treatment observation before the trial was terminated on August 31, 2017. OTIVIDEX was generally well-tolerated with no drug-related serious adverse events observed.
 
Webcast and Conference Call

Otonomy management will review the results during the third quarter webcast and conference call today at 4:30 p.m. EST. A slide presentation for the call will be available shortly before the event on Otonomy’s website on the “Events and Presentations” page at http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-calendar. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 4495749. A live webcast of the call will be available online in the investor relations section of Otonomy’s website at www.otonomy.com and will be archived there for 30 days.

About Otonomy

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO® (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, an sNDA has been accepted for filing by the FDA for acute otitis externa (AOE) and a successful End-of-Phase 2 review has been completed with the FDA for acute otitis media with tympanostomy tubes (AOMT). OTIVIDEXTM is a steroid in development for the treatment of Ménière’s disease. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial. Multiple programs targeting sensorineural hearing loss including age-related hearing loss are in preclinical development. These programs involve the anatomical and functional restoration of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, plans to meet with the FDA regarding the clinical development requirements for OTIVIDEX and the timing of any such meeting, timing of future pipeline updates from Otonomy, and statements by Otonomy’s president and CEO. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTIVIDEX and OTO-311, and label expansion indications for OTIPRIO; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 8, 2017, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com

Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

Wednesday, November 8th, 2017 Uncategorized Comments Off on $OTIC Positive Results from AVERTS-2 Phase 3 Trial of OTIVIDEX

$KBSF Announces Senior Management and Board of Directors Changes

SHISHI, China, Nov. 7, 2017  — KBS Fashion Group Limited (NASDAQ: KBSF) (“KBS” or the “Company”), a vertically-integrated casual menswear company in China, today announced changes to its senior management and Board of Directors (the “Board”).

On November 1, 2017, Mr. Keyan Yan resigned from his positions as Chief Executive Officer (“CEO”) and President of the Company. Mr. Yan will continue to serve as Chairman of the Board. The Board has appointed Mr. Xiaowen Zheng (“Mr. Zheng”) as its new CEO and President, effective immediately. The Board also voted to appoint Xiaowen Zheng as director of the company and the size of board increased to eight. Additionally, Ms. Lixia Tu, who currently serves as Chief Financial Officer of the Company, was appointed as Secretary of the Company, effective immediately.

Mr. Zheng has extensive experience in China’s advertising and media industries. Prior to this appointment, as the founder, Mr. Zheng has served as Chairman and CEO of Shancangzi (Xiamen) Culture Communications Co. Ltd. (“SCZ”), a China-based advertising and branding agency, since its inception in 2007. Mr. Zheng currently also serves as a board director of Advertising Association of Fujian Province and Advertising Association of Xiamen City, a member of China Public Relations Association. Mr. Zheng attended Executive Development Program in Economics at Xiamen University and holds a Bachelor Degree in Information Management and Systems from Yang-En University.

Mr. Yan, Chairman of KBS, welcomed Mr. Zheng to his new positions, “Xiaowen is an expert in advertising and branding and has successfully led his SCZ team in promoting leading brands, such as Coca-Cola, Mercedes-Benz, Uni-President, Wanda Plaza, in the Fujian market where we have the strongest presence. The Board is thrilled that Xiaowen has agreed to take up the torch and lead KBS’ next chapter.”

Mr. Zheng, the new CEO of KBS, added, “KBS is a truly differentiated brand in the garment industry and has a solid foundation to excel in the long run. I feel privileged to join KBS and look forward to working closely with the Board and other senior management members to take the Company to the next level.”

About KBS Fashion Group Limited

Headquartered in Shishi, China, KBS Fashion Group Limited, through its subsidiaries, is engaged in the business of designing, manufacturing, selling and distributing its own casual menswear brand, KBS, through a network of 50 KBS branded stores (as of June 30, 2017) and over a number of multi-brand stores. To learn more about the Company, please visit its corporate website at www.kbsfashion.com.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of KBS Fashion Group Limited, and its subsidiary companies. All statements, other than statements of historical fact included herein, are “forward-looking statements” in nature within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

For further information, please contact:

Lisa Tu
Chief Financial Officer
T: +86 158-5972-2469
E: lingsantu@hotmail.com

Tony Tian, CFA
Weitian Group LLC
T: +1 732-910-9692
E: tony.tian@weitian-ir.com

Tuesday, November 7th, 2017 Uncategorized Comments Off on $KBSF Announces Senior Management and Board of Directors Changes

$GSV Intersects 136m of 2.67 g Au/t at the Dark Star Oxide Gold Deposit

Infill core hole DS17-20 extends the high-grade oxide zone with an intercept of 22.1m of 6.89 g Au/t

VANCOUVER, British Columbia, Nov. 07, 2017 — Gold Standard Ventures Corp. (TSX:GSV) (NYSE AMERICAN:GSV) (“Gold Standard” or the “Company) today announced results from 11 exploration and infill holes at the Dark Star oxide gold deposit on its 100%-owned/controlled Railroad Project in Nevada’s Carlin Trend.  These drill holes are a portion of Gold Standard’s 2017 US$15.5 million program which includes up to 48,800 m of reverse-circulation (RC) and core drilling in 117 holes (see February 2, 2017 news release).  The infill drilling is designed to reduce drill spacing in critical portions of Dark Star to 30m.  Recent results either confirm or outperform the current resource block model.

Infill core hole DS17-20 intersected 136.0m of 2.67 g Au/t approximately 30m north of DS16-03B (101.2m of 1.54 g Au/t) and approximately 90m south of DS16-08 (126.2m of 4.07 g Au/t).  These new results are expected to significantly improve the grade of the current block model in the northern portion of Dark Star (please go to the following link – https://goldstandardv.com/lp/dark-star-nov2017-map).

Jonathan Awde, CEO and Director of Gold Standard commented: “The Dark Star oxide deposit continues to surprise us to the upside. First, the high-grade zone to the north is expanding laterally beyond our modeling, which is likely to increase grade and ounces in our next resource estimate. Second, this drilling has confirmed that Dark Star remains wide open both to the east and the west. We suspect that it may also continue further to the north and this year’s drilling is testing this direction as well. Third, and perhaps most intriguing, we are seeing evidence that higher grade oxide material may reoccur at deeper levels of the deposit than originally thought. Overall, we think the Dark Star deposit is going to look very different at the end of this program than it did a year ago.”

Mr. Awde also noted that the positive Dark Star drill results, coupled with the high gold recovery rates averaging 86.5% on material in column testing (see October 25, 2017 news release), further establish Dark Star as a high-quality oxide gold deposit.

Key Highlights

  • In the northern portion of Dark Star, infill core hole DS17-20 intersected 136.0m of 2.67 g Au/t, including 3 higher-grade zones of 15.7m of 3.02 g Au/t, 22.1m of 6.89 g Au/t and 14.3m of 3.80 g Au/t respectively.  The DS17-20 intercept is approximately 30m north of DS16-03B (101.2m of 1.54 g Au/t as announced on April 18, 2017) and approximately 90m south of DS16-08 (126.2m of 4.07 g Au/t as announced on April 18, 2017).  Gold mineralization in DS17-20 appears to outperform the resource block model in this portion of the oxide deposit, and confirm the lateral continuity of a +2.0g Au/t gold zone located in the immediate hanging wall of the Ridgeline fault (please go to the following link – https://goldstandardv.com/lp/dark-star-nov2017-map).
  • In the southern portion of Dark Star, infill core hole DS17-22 intersected 55.8m of 0.94 g Au/t including 16.8 of 1.28 g Au/t.  This hole confirms the tenor and grade of the block model in this location and enhances and upgrades the geological understanding of wide-spaced RC drill holes.
  • Two RC exploration holes have extended the Dark Star deposit to the east. DS17-26 intersected 47.3m of 0.52 g Au/t, and DS17-27 intersected two mineralized zones including 51.8m of 0.76 g Au/t and 53.4m of 0.74 g Au/t.  DS17-27 ended in 2.19 g/t gold at a depth of 183m, extending the oxide gold mineralization 45m deeper than the current Dark Star resource model. This intercept may reflect the occurrence of previously unknown deeper horizons of better grade oxide material which could have important implications for the deposit as a whole.
  • Two other RC exploration holes have extended the Dark Star deposit to the west. DS17-21 intersected 13.7m of 1.24 g Au/t and DS17-23 intersected 12.2m of 1.41 g Au/t west of the existing Dark Star block model and towards the Pinion deposit. Additional exploration drilling is planned to test targets to the west of Dark Star.

Dark Star drill results are as follows:

Drill Hole Method Azimuth Incl. TD (m) Intercept (m) Thickness (m) Grade (g Au/t)
DS17-17 RC 090 -45 471.0 15.2 – 18.3 3.1 0.21
21.3 – 24.4 3.1 0.29
32.0 – 33.5 1.5 0.43
DS17-18 RC 090 -45 318.6 6.1 – 29.0 22.9 0.57
DS17-19 RC -90 446.6 236.3 – 242.4 6.1 0.51
350.6 – 358.2 7.6 0.50
393.2 – 396.3 3.1 0.56
DS17-20 Core -90 197.9 37.8 – 173.8 136.0 2.67
Including
Including
Including
42.8 – 58.5 15.7 3.02
103.8 – 125.9 22.1 6.89
157.9 – 172.2 14.3 3.80
DS17-21 RC -90 591.5 271.3 – 274.4 3.1 2.69
300.3 – 303.4 3.1 0.21
387.2 – 388.7 1.5 0.23
393.3 – 397.9 4.6 0.22
431.4 – 440.5 9.1 0.20
455.8 – 457.3 1.5 0.24
468.0 – 481.7 13.7 1.24
DS17-22 Core -90 91.5 0 – 55.8 55.8 0.94
Including
Including
20.0 – 26.2 6.2 2.63
33.5 – 50.3 16.8 1.28
56.4 – 57.9 1.5 0.27
89.9 – 91.4 1.5 0.25
DS17-23 RC 180 -65 118.9 106.7 – 118.9 12.2 1.41
DS17-24 RC 360 -63 167.7 54.9 – 64.0 9.1 0.30
DS17-25 RC 090 -65 167.7 120.4 – 128.0 7.6 0.41
DS17-26 RC 090 -80 122.0 3.1 – 9.2 6.1 0.35
 Including 16.7 – 64.0 47.3 0.52
42.7 – 48.8 6.1 1.00
DS17-27 RC 090 -80 182.9 65.5 – 117.3 51.8 0.76
IncludingIncluding 85.3 – 89.9 4.6 2.38
122.0 – 123.5 1.5 0.32
129.5 – 182.9 53.4 0.74
160.1 – 166.2 6.1 1.75

** Gold intervals reported in this table were calculated using a 0.20 g Au/t cutoff.  Weighted averaging has been used to calculate all reported intervals.  True widths are estimated at 70-90% of drilled thicknesses.

Mac Jackson, Gold Standard’s Vice President of Exploration stated: “Infill development and step out exploration drilling continue to grow the Dark Star deposit, making significant additions to the high-grade oxide core of the deposit.  With the confirmation of the geologic model and controls on the high-grade oxide mineralization, we are able to target and add high quality, readily leachable oxide ounces.  We continue to drill at Dark Star and also test new targets in the same Pennsylvanian-Permian host rocks along the Dark Star corridor and at Jasperoid Wash with additional results pending.”

Gold Standard would also like to welcome Mr. Mark Laffoon to the Company as a Senior Engineer.  Mr. Laffoon brings over 38 years of management and successful mine engineering experience to Gold Standard from his work in the western United States.  Mr. Laffoon will lead the engineering work to develop the Dark Star and Pinion oxide gold deposits.

Sampling Methodology, Chain of Custody, Quality Control and Quality Assurance
All sampling was conducted under the supervision of the Company’s project geologists and the chain of custody from the project to the sample preparation facility was continuously monitored. Core was cut at the company’s facility in Elko and one quarter was sent to the lab for analysis and the remaining material retained in the original core box.  A blank or certified reference material was inserted approximately every tenth sample.  The core and RC samples were delivered to either ALS Minerals or Bureau Veritas Mineral Laboratories preparation facility in Elko, NV where they were crushed and pulverized.  Resulting sample pulps were shipped to either ALS Minerals or Bureau Veritas certified laboratory in Sparks, NV or Vancouver, BC.  Pulps were digested and analyzed for gold using fire assay fusion and an atomic absorption spectroscopy (AAS) finish on a 30 gram split.  Over limit gold assays were determined using a fire assay fusion with a gravimetric finish on a 30 gram split. All other elements were determined by ICP analysis.  Data verification of the analytical results included a statistical analysis of the standards and blanks that must pass certain parameters for acceptance to insure accurate and verifiable results.

Drill hole deviation was measured by gyroscopic down hole surveys that were completed on all holes by International Directional Services of Elko, NV.  Final collar locations are surveyed by differential GPS by Apex Surveying, LLC of Spring Creek, Nevada.

The scientific and technical content contained in this news release have been reviewed, verified and approved by Steven R. Koehler, Gold Standard’s Manager of Projects, BSc. Geology and CPG-10216, a Qualified Person as defined by NI 43-101, Standards of Disclosure for Mineral Projects.

ABOUT GOLD STANDARD VENTURES – Gold Standard is an advanced stage gold exploration company focused on district scale discoveries on its Railroad-Pinion Gold Project, located within the prolific Carlin Trend. The 2014 Pinion and Dark Star gold deposit acquisitions offer Gold Standard a potential near-term development option and further consolidates the Company’s premier land package on the Carlin Trend. The Pinion deposit now has an NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 31.61 million tonnes grading 0.62 g/t Au, totaling 630,300 ounces of gold and an Inferred Resource of 61.08 million tonnes grading 0.55 g/t Au, totaling 1,081,300 ounces of gold, using a cut-off grade of 0.14 g/t Au.  The Dark Star deposit, 2.1 km to the east of Pinion, has a NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 15.38 million tonnes grading 0.54 g/t Au, totaling 265,100 ounces of gold and an Inferred Resource of 17.05 million tonnes grading 1.31 g/t Au, totaling 715,800 ounces of gold, using a cut-off grade of 0.2 g Au/t. The North Bullion deposit, 7 km to the north of Pinion, has a NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 2.92 million tonnes grading 0.96 g/t Au, totaling 90,100 ounces of gold and an Inferred Resource of 10.97 million tonnes grading 2.28 g/t Au, totaling 805,800 ounces of gold, using a cut-off grade of 0.14 g Au/t for near surface oxide and 1.25 to 2.25 g Au/t for near surface sulfide and underground sulfide respectively.

Neither the TSX nor its regulation services provider  nor the NYSE AMERICAN accepts responsibility for the adequacy or accuracy of this news release.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. All statements, other than statements of historical fact, included herein including, without limitation, statements about our potential near term development option are forward looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Risk factors affecting the Company include, among others: the results from our exploration programs, global financial conditions and volatility of capital markets, uncertainty regarding the availability of additional capital, fluctuations in commodity prices; title matters; and the additional risks identified in our filings with Canadian securities regulators on SEDAR in Canada (available at www.sedar.com) and with the SEC on EDGAR (available at www.sec.gov/edgar.shtml). These forward-looking statements are made as of the date hereof and, except as required under applicable securities legislation, the Company does not assume any obligation to update or revise them to reflect new events or circumstances.

CAUTIONARY NOTE FOR U.S. INVESTORS REGARDING RESERVE AND RESOURCE ESTIMATES

All resource estimates reported by the Company were calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission for descriptions of mineral properties in SEC Industry Guide 7 under Regulation S-K of the U. S. Securities Act of 1933. In particular, under U. S. standards, mineral resources may not be classified as a “reserve” unless the determination has been made that mineralization could be economically and legally produced or extracted at the time the reserve determination is made. Accordingly, information in this press release containing descriptions of the Company’s mineral properties may not be comparable to similar information made public by US public reporting companies.

On behalf of the Board of Directors of Gold Standard,

“Jonathan Awde”

Jonathan Awde, President and Director

FOR FURTHER INFORMATION PLEASE CONTACT:
Jonathan Awde
President
Tel: 604-669-5702
Email: info@goldstandardv.com
Website: www.goldstandardv.com

Tuesday, November 7th, 2017 Uncategorized Comments Off on $GSV Intersects 136m of 2.67 g Au/t at the Dark Star Oxide Gold Deposit

$NKTR Presents Preclinical Data on Regulatory T Cell Stimulator NKTR-358

SAN FRANCISCO, Nov. 7, 2017 — Nektar Therapeutics (Nasdaq: NKTR) today announced it is presenting preclinical data on NKTR-358, a potential first-in-class resolution therapeutic that may address the underlying immune system imbalance in patients with many immune conditions, at the 2017 American College of Rheumatology (ACR/ARHP) Annual Meeting in San Diego from November 3-8, 2017.

NKTR-358 is a novel immunological therapy designed to target the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 can act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

“Data from these studies show that NKTR-358 drives the proliferation and sustained preferential activation of regulatory T cells, both of which are critically important to restore balance to the immune system,” said Jonathan Zalevsky, Ph.D., Senior Vice President of Biology and Preclinical Development at Nektar Therapeutics. “NKTR-358 also produces antigen-specific Treg memory to suppress inflammatory responses in experimental mouse models of hypersensitivity, and showed strong efficacy in a mouse model of systemic lupus erythematosus. We are very excited about the potential for NKTR-358 to restore the body’s natural self-tolerance mechanisms and resolve the immune system dysfunction associated with autoimmune disorders.”

More than 23 million Americans have an autoimmune disease – nearly eight percent of the U.S. population – and the prevalence is continuing to rise.i,ii There are more than 80 known types of autoimmune diseases, including lupus, Crohn’s disease, psoriasis and rheumatoid arthritis.iii

In July 2017, Nektar entered into a strategic collaboration with Eli Lilly and Company to develop and commercialize NKTR-358 in multiple autoimmune conditions.

Details of the preclinical data presentation at ACR are as follows:

Abstract 2715:NKTR-358: A Selective, First-in-Class IL-2 Pathway Agonist Which Increases Number and Suppressive Function of Regulatory T Cells for the Treatment of Immune Inflammatory Disorders.”
Presenter: John Langowski, Ph.D.
Poster Session and Title: ACR Poster Session C, T Cell Biology and Targets in Autoimmune Disease Poster II
Date and Time: Tuesday, November 7, 2017 from 9:00-11:00 a.m. PT

  • NKTR-358 delivers sustained, preferential activation of regulatory T cells.
  • In non-human primates, a single administration of NKTR-358 led to increases in Treg mobilization for over 14 days.
  • In a mouse model of cutaneous hypersensitivity, NKTR-358 significantly suppressed antigen-induced inflammatory responses, an effect which was antigen-specific and associated with establishment of Treg memory.
  • NKTR-358 was efficacious in a spontaneous mouse model of systemic lupus erythematosus (SLE).

The poster will be available for download on the Nektar website: http://www.nektar.com/pipeline/rd-pipeline/nktr-358.

The ACR/ARHP Annual Meeting is the premier educational event for physicians, health professionals, and scientists who treat or research those with or at risk for arthritis and rheumatic and musculoskeletal diseases.

About NKTR-358
NKTR-358 is being developed as a once or twice-monthly self-administered injection for a number of autoimmune diseases. In March of 2017, Nektar began the first Phase 1 dose-finding trial of NKTR-358 to evaluate single-ascending doses of NKTR-358 in approximately 50 healthy subjects. The study will measure Treg mobilization, functional activity, pharmacokinetics and safety, with the goal of establishing a range of dose levels to be advanced into a multiple-ascending dose trial in patients with an autoimmune condition (such as psoriasis or systemic lupus erythematosus (SLE) or others). In July 2017, Nektar entered into a strategic collaboration with Eli Lilly and Company to develop and commercialize NKTR-358 in multiple autoimmune conditions.

About Nektar
Nektar Therapeutics is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: “potential,” “can,” “plan,” “expect,” “could,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-358, the timing and availability of clinical data for NKTR-358, the future clinical development plans for NKTR-358, the commercial and therapeutic potential of NKTR-358, and the potential of our technology and drug candidates in our research and development pipeline.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of NKTR-358 are based on findings and observations from preclinical findings; (ii) NKTR-358 is in early-stage clinical development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors even after positive findings in previous preclinical studies; (iii) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-358) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (v) patents may not issue from our patent applications for NKTR-358, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q with the Securities and Exchange Commission on August 9, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585

Jodi Sievers of Nektar Therapeutics
415-482-5593

For Media:
Jennifer Paganelli
347-658-8290
jpaganelli@purecommunications.com

i The American Autoimmune Related Diseases Association. Autoimmune Statistics. https://www.aarda.org/news-information/statistics/
ii Johns Hopkins University. Autoimmune Disease Research Center. http://autoimmune.pathology.jhmi.edu/faqs.cfm
iii The American Autoimmune Related Diseases Association. Autoimmune Statistics. https://www.aarda.org/news-information/statistics/

Tuesday, November 7th, 2017 Uncategorized Comments Off on $NKTR Presents Preclinical Data on Regulatory T Cell Stimulator NKTR-358

$IZEA All-Time Record Revenue of $8.2 Million in Q3

ORLANDO, Fla.

First Adjusted EBITDA Positive Quarter Since Becoming a Public Company

IZEA, Inc. (NASDAQ: IZEA), operator of IZEAx, the premier online marketplace connecting brands and publishers with influential content creators, reported financial results for the third quarter ended September 30, 2017.

Q3 2017 Financial Highlights Compared to Same Year-ago Quarter

  • Adjusted EBITDA was $221,000, compared to $(886,000), an improvement of $1.1 million.
  • Total revenue up 9% to $8.2 million, compared to $7.5 million.
  • Managed Services revenue increased 20% to $7.0 million, compared to $5.8 million.
  • Content Workflow revenue decreased 28% to $1.1 million, compared to $1.6 million.
  • Revenue backlog, which includes unbilled bookings and unearned revenue, was $11.0 million at the end of the quarter.
  • Net bookings increased 2% to $7.9 million compared to $7.7 million.
  • Gross profit increased 23% to $4.4 million, with gross margin of 54%.

Trailing Twelve Months Ended September 30, 2017 Compared to Same Year-ago TTM

  • Revenue up 10% to $28.8 million, compared to. $26.1 million.
  • Managed Services Revenue up 21% to $22.9 million, compared to $19.0 million.
  • Gross Profit up 21% to $14.6 million, compared to $12.1 million.
  • Adjusted EBITDA improved 46% to $(3.7) million, compared to $(5.8) million.

Management Commentary

“This was a milestone quarter for the company. We crossed $8M in quarterly revenue for the first time, and posted our first EBITDA positive quarter since becoming a public company,” said Ted Murphy, IZEA’s Chairman and CEO. “We have made meaningful progress towards our goal of reaching sustainable, profitable growth, and I am excited by what our team has accomplished to date. Our goal was to have our first EBITDA positive quarter in the second half of 2018 and we are full year ahead of schedule.”

“Our managed sales team continues to deliver impressive results. In addition to all-time record revenue, we delivered all-time record bookings for managed services, the core of our business. Our focus on managed services and the improved margins on those services helped propel us to an EBITDA positive quarter. Custom Content sales were particularly strong, and we are heading into what we expect to be an even stronger Q4 for Managed Services with annual renewals for 2018.”

“We continue to invest in technology to benefit our clients and improve our own operational efficiency. Artificial intelligence and machine learning are being integrated in areas throughout the organization. This technology surfaces new insights, automates processes, and ultimately allows us to accomplish more with less ongoing expense. Our revenue per employee in Q3 increased from $197,000 to $267,000 year over year and remains an efficiency metric we are focused on. Looking forward, we will be announcing additional innovations that leverage big data and artificial intelligence to make us even more effective.”

Q3 2017 Financial Results

Revenue in the third quarter of 2017 increased 9% to $8.2 million compared to $7.5 million in the same year-ago quarter. The increase in our Q3 2017 revenue is primarily due to organic growth in our Managed Services revenue.

Gross profit in the third quarter of 2017 increased 23% by approximately $826,000, as compared to the third quarter of 2016. The increase in gross profit was primarily attributable to a favorable shift to higher margin Managed Services revenue versus lower margin self-service Content Workflow revenue.

Operating expenses in the third quarter of 2017 and 2016 were $5.0 million. Cash-based Opex in the third quarter of 2017 was approximately $4.2 million, compared to $4.5 million in the third quarter of 2016, a decrease of 5% year over year.

Net loss in the third quarter of 2017 was approximately $(559,000), or $(0.10) per share, as compared to a net loss of $(1.5) million, or $(0.28) per share, in the same year-ago quarter. Adjusted EBITDA was approximately $221,000 compared to $(886,000) during the same period of 2016, an improvement of $1.1 million year over year.

Cash and cash equivalents at September 30, 2017 totaled $3.5 million. Receivables at the end of the quarter were $5.3 million, up from $4.1 million at the end of Q2 2017. As of September 30, 2017, the company has accessed $810,000 of a $5.0 million credit line for cash management purposes.

Updated 2017 Outlook

The company expects annual revenue in 2017 will be approximately $29-$30 million, compared to $27.3 million in 2016. The company has increased its gross margin guidance by 200 basis points. Gross margins are now expected to range between 50% to 51% compared to 48% in 2016. Guidance for adjusted EBITDA has improved by $1.0 million and adjusted EBITDA is expected to be approximately $(3.0-3.25) million compared to $(5.2) million in 2016.

Conference Call

IZEA will hold a conference call to discuss its third-quarter 2017 results today at 5:00 p.m. Eastern time. Management will host the call, followed by a question and answer period.

Date: Tuesday, November 7, 2017
Time: 5:00 p.m. Eastern time
Toll-free dial-in number: 1-877-407-4018
International dial-in number: 1-201-689-8471

The conference call will be webcast live and will be available for replay via the investors section of the company’s website at https://izea.com/investors.

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. A replay of the call will be available after 8:00 p.m. Eastern time on the same day through November 14, 2017.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13672388

About IZEA

IZEA operates IZEAx, the premier online marketplace that connects marketers with influential content creators. IZEAx automates influencer marketing and custom content development, allowing brands and agencies to scale their marketing programs. IZEA creators range from leading social media influencers to accredited journalists. Creators are compensated for producing and distributing unique content on behalf of marketers including long form text, videos, photos and status updates. Marketers receive influential consumer content and engaging, shareable stories that drive awareness. For more information about IZEA, visit https://izea.com.

Use of Non-GAAP Financial Measures “EBITDA” is a non-GAAP financial measure under the rules of the Securities and Exchange Commission. IZEA defines EBITDA as earnings or loss before interest, taxes, depreciation and amortization. IZEA defines “Adjusted EBITDA,” also a non-GAAP financial measure, as earnings or loss before interest, taxes, depreciation and amortization, non-cash stock related compensation, gain or loss on asset disposals or impairment, changes in acquisition cost estimates, and all other non-cash income and expense items such as gains or losses on settlement of liabilities and exchanges, and changes in fair value of derivatives, if applicable. We believe that EBITDA and Adjusted EBITDA provide useful information to investors as they exclude transactions not related to the core cash operating business activities including non-cash transactions. We believe that excluding these transactions allows investors to meaningfully trend and analyze the performance of our core cash operations.

All companies do not calculate EBITDA and Adjusted EBITDA in the same manner, and EBITDA and Adjusted EBITDA as presented by IZEA may not be comparable to those presented by other companies. Moreover, EBITDA and Adjusted EBITDA have limitations as analytical tools, and you should not consider them in isolation or as a substitute for an analysis of our results of operations as reported under GAAP. A reconciliation of GAAP to non-GAAP results is included in the financial tables included in this press release.

Safe Harbor Statement

All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding, expectations concerning IZEA’s ability to increase bookings for Managed Services and maintain the margins thereon; anticipated declines in Content Workflow revenue; expectations with respect to operational efficiency; and expectations concerning IZEA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: competitive conditions in the content and social sponsorship segment in which IZEA operates; failure to popularize one or more of the marketplace platforms of IZEA; inability to finance growth initiatives in a timely manner; changing economic conditions that are less favorable than expected; and other risks and uncertainties described in IZEA’s periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and IZEA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

IZEA, Inc.
Justin Braun, 407-215-6218
Manager, Corporate Communications
Justin.braun@izea.com

Tuesday, November 7th, 2017 Uncategorized Comments Off on $IZEA All-Time Record Revenue of $8.2 Million in Q3

$MYO Issues November 2017 Shareholder Letter

CAMBRIDGE, Mass.

Provides an Update on Third Quarter 2017 and Ongoing Commercial Activities

Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today issued a letter to shareholders to give an update on third quarter 2017 and ongoing MyoPro® commercial activities.

An accompanying digital shareholder letter can be viewed at: shareholderletters.myomo.com/q3-17.

Dear Fellow Shareholders:

Welcome to the first edition of our Investor Relations digital shareholder letter, whose purpose is to keep you informed about Myomo’s progress. Since completing our IPO in June, we have been implementing various sales and marketing programs to grow the company. We established additional MyoPro Centers of Excellence to distribute our products to patients around the country; increased our Marketing presence online and begun our international expansion. We are leveraging our FDA registered, CE Marked, and only commercial, proprietary technology to restore function to the millions of patients with upper limb paralysis.

We believe we have the strategic focus, business model, and an expanding operational footprint to ably serve this market, facilitating our growth.

Thank you for your investment in MYO shares, which provides us the resources to grow the business and create shareholder value over time.

Sincerely;

Paul R. Gudonis
Chairman & Chief Executive Officer

About Myomo
Myomo, Inc. is a commercial stage medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.

Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s future business expectations, including the launch of MyoPro for Veterans, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Our actual results could differ materially from those anticipated in these forward looking statements for many reasons, including, without limitation, risks related to regulatory approval and market acceptance of our products, and the other risk factors contained in our filings made with the Securities and Exchange Commission. More information about factors that potentially could affect Myomo’s financial results is included in Myomo’s filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

 

For Myomo:
ir@myomo.com
or
Investor Relations:
PCG Advisory
Vivian Cervantes, 212-554-5482
vivian@pcgadvisory.com
or
Public Relations:
Greenough
Rachel Robbins, 617-275-6521
rrobbins@greenough.biz

Tuesday, November 7th, 2017 Uncategorized Comments Off on $MYO Issues November 2017 Shareholder Letter

$CIIX Diversity Drives Success, Company Aims Even Higher for FY2018

November 7, 2017

  • Launching its Chinese Daily Video News Broadcast from NYSE on cryptocurrency news in 1Q2018
  • CIIX sets FY2018 goals of greater than 100% sales increase, reduced costs, and profitability
  • Consilium Global Research projects CIIX to reach revenues of $14.8 million by FY2020 at a compounded annual growth rate (CAGR) of nearly 100%
  • CIIX reports FY2017 YOY operating sales gain of 76%

ChineseInvestors.com, Inc. (OTCQB: CIIX) is a diverse company with goals set by Warren Wang, company founder and CEO, of a 100% gain in sales in FY2018 after achieving a 76% YOY increase in operating revenues in FY2017. The goal in FY2018 is not only the large sales gain, but a reduction in costs and profitability.

CIIX is targeting its goal of becoming the primary medical cannabis Chinese community oriented publicly-traded company. It has diverse offerings to the global Chinese-speaking population. These include financial education and market analysis, in addition to R&D and distribution of legalized, hemp-based cannabidiol (CBD). It now also offers Chinese Daily Video News Broadcast on cryptocurrencies and blockchain news from the NYSE, along with its line of CBD-infused skin care products.

At the same time, CIIX is generating subscription revenue and advertising sales. It also offers public relations and investor relations consulting services to Chinese companies.

Recently, it expanded its board by three individuals who have extensive financial and industry experience: Patrick Leung, Keevin Gillespie and Delray Wannemacher. The goal, according to CEO Wang, is to add to the company’s board individuals who can help grow the company’s Consumer Retail and Financial Services/Media divisions.

For more information, visit the company’s website at www.ChineseInvestors.com

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Tuesday, November 7th, 2017 Uncategorized Comments Off on $CIIX Diversity Drives Success, Company Aims Even Higher for FY2018