Uncategorized

$SHIP Prices $4.9 Million #Registered #DirectOffering

ATHENS, GREECE–(Aug 5, 2016) – Seanergy Maritime Holdings Corp. (the “Company”) (NASDAQ: SHIP) announced today that it has entered into a Securities Purchase Agreement with one institutional investor, pursuant to which the Company will sell 1,180,000 shares of common stock at a purchase price of $4.15 per share for gross proceeds of $4.9 million in a registered direct offering. No warrants were issued to investors in the offering. The closing of the transaction is expected to occur on or about August 10, 2016, subject to the satisfaction of customary closing conditions.

Maxim Group LLC acted as the exclusive placement agent for the offering.

The Company estimates that the net proceeds from the sale of the securities, after deducting fees and expenses, will be approximately $4.5 million. The net proceeds of this offering are expected to be used for general corporate purposes.

The shares of common stock are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333- 205301) previously filed and declared effective by the United States Securities and Exchange Commission (“SEC”). A prospectus supplement relating to the offering will be filed by the Company with the SEC. When filed, copies of the prospectus supplement, together with the accompanying base prospectus, can be obtained at the SEC’s website at http://www.sec.gov or from the offices of Maxim Group LLC, 405 Lexington Avenue, New York, New York 10174, Attn: Prospectus Department, or by telephone at (800) 724-0751.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Any offers of securities will be made only by means of a prospectus supplement and accompanying base prospectus.

About Seanergy Maritime Holdings Corp.

Seanergy Maritime Holdings Corp. is an international provider of marine dry bulk shipping services through the ownership and operation of dry bulk vessels. The Company is registered in the Marshall Islands with executive offices in Athens, Greece and an office in Hong Kong. The Company currently owns a modern fleet of a total of eight dry bulk carriers, consisting of six Capesizes and two Supramaxes, with a combined cargo-carrying capacity of approximately 1,145,553 DWT and an average fleet age of about 7.6 years.

The Company’s common stock trades on the Nasdaq Capital Market under the symbol “SHIP.”

Forward-Looking Statements

This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may,” “should,” “expects,” “intends,” “plans,” “believes,” “anticipates,” “hopes,” “estimates,” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the Company’s ability to continue as a going concern; the Company’s operating or financial results; the Company’s liquidity, including its ability to pay amounts that it owes and obtain additional financing in the future to fund capital expenditures, acquisitions and other general corporate activities; competitive factors in the market in which the Company operates; shipping industry trends, including charter rates and factors affecting vessel supply and demand; future, pending or recent acquisitions and dispositions, business strategy, areas of possible expansion or contraction, and expected capital spending or operating expenses; risks associated with operations outside the United States; and other factors listed from time to time in the Company’s filings with the SEC, including its most recent annual report on Form 20-F. The Company’s filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information please contact:

Capital Link, Inc.
Paul Lampoutis
230 Park Avenue Suite 1536
New York, NY 10169
Tel: (212) 661-7566
E-mail: seanergy@capitallink.com

Friday, August 5th, 2016 Uncategorized Comments Off on $SHIP Prices $4.9 Million #Registered #DirectOffering

$IMGN Announces #Webcasts of #Presentations at Upcoming #Investor #Conferences

ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the following presentations by Company management at upcoming investor conferences will be webcast:

  • Canaccord Genuity Growth Conference
    1:30pm ET, August 10, 2016
  • Morgan Stanley Global Healthcare Conference
    2:50pm ET, September 12, 2016

The webcasts will be accessible live through the “Investors” section of the Company’s website, www.immunogen.com; a replay will be available at the same location for approximately a week.

About ImmunoGen, Inc.

ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen’s lead product candidate, mirvetuximab soravtansine, is being advanced to a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche’s marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

 

ImmunoGen, Inc.
Carol Hausner, 781-895-0600
info@immunogen.com

Friday, August 5th, 2016 Uncategorized Comments Off on $IMGN Announces #Webcasts of #Presentations at Upcoming #Investor #Conferences

$OCUL Will Be @ #OphthalmologyInnovationSummit, #AmericanSocietyofRetinaSpecialists #ASRS

Presentation to highlight preclinical data supporting the Company’s proprietary sustained release technology for intravitreal injections

Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced that Jonathan Talamo, M.D., Chief Medical Officer, will present at the Ophthalmology Innovation Summit (OIS) at the American Society of Retina Specialists (ASRS) on Monday, August 8, 2016, in San Francisco, CA.

Dr. Talamo will provide an update on the Company’s ongoing preclinical development programs for its sustained release hydrogel technology being developed to treat wet age-related macular degeneration (wet AMD) and other retinovascular diseases. The Company is developing sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small and large molecule pharmaceuticals, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues for 4-6 months.

“We at Ocular Therapeutix continue to be encouraged by the results emerging from work with our proprietary delivery platforms for high molecular weight protein VEGF inhibitors and small molecule Tyrosine Kinase Inhibitors,” stated Dr. Talamo. “I look forward to sharing these interesting findings with my colleagues in San Francisco next week.”

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. (OCUL) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™ (dexamethasone insert), is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis, and in Phase 2 clinical development for dry eye disease. A third Phase 3 clinical trial is being conducted for post-surgical ocular inflammation and pain. For glaucoma and ocular hypertension, the Company plans to initiate the first of two OTX-TP (sustained release travoprost) Phase 3 clinical trials in the third quarter of 2016. Ocular Therapeutix is evaluating sustained-release injectable drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the development and regulatory status of the Company’s product candidates, such as the Company’s expectations and plans regarding regulatory submissions for and the timing and conduct of clinical trials of DEXTENZA for post-surgical ocular inflammation and pain, including our expectations regarding the pending NDA filed with the FDA, DEXTENZA™ for the treatment of allergic conjunctivitis, DEXTENZA for dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel depot technology and the advancement of the Company’s other product candidates, the potential utility of any of the Company’s product candidates, the sufficiency of the Company’s cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

 

Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief Financial Officer
bsmith@ocutx.com
or
Burns McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular Therapeutix, Inc.
Scott Corning
Vice President of Sales and Marketing
scorning@ocutx.com

Friday, August 5th, 2016 Uncategorized Comments Off on $OCUL Will Be @ #OphthalmologyInnovationSummit, #AmericanSocietyofRetinaSpecialists #ASRS

$EGLE Announces #Reverse #StockSplit

STAMFORD, Conn., Aug. 5, 2016  — Eagle Bulk Shipping Inc. (Nasdaq: EGLE) (the “Company”) today announced that it has effected a 1-for-20 reverse stock split of its issued and outstanding shares of common stock.  The reverse stock split, which was previously approved by the Company’s Board of Directors and shareholders, took effect as of 5:00 p.m., Eastern Time, August 4, 2016. Upon the effectiveness of the reverse stock split, every 20 shares of issued and outstanding common stock were combined into one issued and outstanding share of common stock, with no change in par value per share.

The reverse stock split is intended to bring the Company into compliance with the $1.00 minimum average closing share price requirement for continued listing on the Nasdaq Global Select Market (the “NASDAQ”). In addition, the effectiveness of the reverse stock split is also (i) a requirement under the Company’s previously announced Second Lien Loan Agreement, dated March 30, 2016, and (ii) a condition to the consummation of each of the Company’s previously announced Common Stock Purchase Agreements, dated July 1, 2016 and July 10, 2016, respectively.

The Company’s common stock is expected to begin trading on a split-adjusted basis on the NASDAQ at the market open on August 5, 2016.  The Company’s common stock will continue to trade under the symbol “EGLE” but will have a new CUSIP number (Y2187A 143).

The reverse stock split reduced the number of shares of the Company’s outstanding common stock from approximately 376.1 million shares to approximately 18.8 million shares. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would have resulted will be settled in cash. Shareholders holding share certificates will receive information from Computershare, Inc., the Company’s transfer agent, regarding the process for exchanging their shares of common stock. Shareholders who hold their shares in brokerage accounts or in “street name” will not be required to take any action to effect the exchange of their shares.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on July 13, 2016, a copy of which is available at www.sec.gov.

About Eagle Bulk Shipping

Eagle Bulk Shipping Inc. is a Marshall Islands corporation headquartered in Stamford, Connecticut. We own one of the largest fleets of Supramax dry bulk vessels in the world. Supramax dry bulk are vessels which are constructed with on-board cranes, ranging in size from approximately 50,000 to 65,000 dwt and are considered a sub-category of the Handymax segment, typically defined as 40,000 to 65,000 dwt. We transport a broad range of major and minor bulk cargoes, including but not limited to coal, grain, ore, pet coke, cement and fertilizer, along worldwide shipping routes.

Forward-Looking Statements

Matters discussed in this release may constitute forward-looking statements. Forward-looking statements reflect management’s current expectations and observations with respect to future events and financial performance. Where the Company expresses an expectation or belief as to future events or results, such expectation or belief is expressed in good faith and believed to have a reasonable basis. However, the Company’s forward-looking statements are subject to risks, uncertainties, and other factors, which could cause actual results to differ materially from future results expressed, projected, or implied by those forward-looking statements.

The Company’s actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors which could include the following: (i) changes in demand in the dry bulk market, including, without limitation, changes in production of, or demand for, commodities and bulk cargoes, generally or in particular regions; (ii) greater than anticipated levels of dry bulk vessel new building orders or lower than anticipated rates of dry bulk vessel scrapping; (iii) changes in rules and regulations applicable to the dry bulk industry, including, without limitation, legislation adopted by international bodies or organizations such as the International Maritime Organization and the European Union or by individual countries; (iv) actions taken by regulatory authorities; (v) changes in trading patterns significantly impacting overall dry bulk tonnage requirements; (vi) changes in the typical seasonal variations in dry bulk charter rates; (vii) changes in the cost of other modes of bulk commodity transportation; (viii) changes in general domestic and international political conditions; (ix) changes in the condition of the Company’s vessels or applicable maintenance or regulatory standards (which may affect, among other things, our anticipated drydocking costs); (x) the outcome of our discussions with the agent of our credit facility regarding the calculation of collateral covenants, (xi) the outcome of legal proceedings in which we are involved and (xii) other factors listed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission.

The Company disclaims any intent or obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact:

Investor Relations:

Adir Katzav
Chief Financial Officer
Eagle Bulk Shipping Inc.
Tel. +1 212-785-2500

Media:

Jonathan Morgan
Perry Street Communications, New York
jmorgan@perryst.com
Tel. +1 212-741-0014

Friday, August 5th, 2016 Uncategorized Comments Off on $EGLE Announces #Reverse #StockSplit

$OPCO Reports #Q2 #FY16 #Financial #Results

OurPet’s Company (OTCQX: OPCO) (“the Company”) (www.ourpets.com), a leading proprietary pet supply company, today reports its second-quarter results for the three-month period ended June 30, 2016, which were impacted by a temporary reduction of purchase orders from a major retail customer clearing out its existing private-label inventory to make room for soon-to-launch OurPet’s branded products.

Second-quarter 2016 revenue decreased 2.7% to $5.4 million compared to $5.6 million for the same period a year ago. Net income for the 2016 second quarter decreased 41% to $154,634 compared to $262,076 the prior year. Earnings per share remained steady at $0.01 for the second quarter of 2016 and 2015.

Dr. Steven Tsengas, president and CEO of OurPet’s, says, “While we were disappointed with the decline in revenues and net income, the decreases are directly attributable to a major pet specialty retailer’s decision to transition out of its private label stainless steel rubber bonded bowls and toys and accessories, which we previously supplied, to make room in its inventory for OurPet’s branded products that will be rolled out during Q3 and Q4 of this year. This planned depletion of the customer’s private label inventory resulted in a temporary OurPet’s revenue disruption of approximately $521,000 for the second quarter of this year. Had this customer’s inventory reduction not occurred, we believe we would have shown strong revenue growth for the 2nd quarter instead of the revenue decline and obviously greater sales growth for the first six months of 2016. Overall, we are very pleased with the growing acceptance of our branded products: ‘OurPet’s’ in the Pet Specialty channel and ‘PetZone’ in the ‘Food, Drug, Mass’ (FDM) channel. As of June 30, 2016, we had a record order pipeline of approximately $1.9 million with over $1 million of it from our previously mentioned major pet specialty retailer. Additionally, despite the temporary setback in sales, we were able to reduce our inventory to less than $7.2 million compared to $8 million at end of 2015. We have used the proceeds to reduce our line of credit from $3.3 million to $2.4 million.”

Second-quarter net income decreased by $107,442 to $154,634 from $262,076 for the same quarter a year ago. The Company attributes the decrease to the lower gross profit ($146,000) and increased Selling, General and Administrative expenses of $49,000 primarily related to major new product launches, all of which were offset by a decrease of $104,000 in income tax expense.

Based on historical performance, new products and overall market, the Company anticipates a solid performance in the last six months of 2016.

“We recently attended the SuperZoo National trade show in Las Vegas where we presented another very strong showing of innovative products led by our Intelligent Pet Care BlueTooth® line; our Switchgrass Natural Cat Litter™; our newest generation of electronic cat toys that will simply drive cats wild; and a new very stylish 3-height Store-N-Feed. Due to the seasonal nature of the pet industry, we typically experience our strongest sales in the second half of the year. We have no reason to believe this year will be any different,” Dr. Tsengas concludes.

2016 Second-Quarter Results

Net revenue declined 2.7% to $5,436,902 for the 2016 second quarter from $5,586,828 for the same period last year. The decrease of approximately $150,000 is attributable to a major pet specialty customer clearing out their inventory of private label products to allow for the purchase of OurPet’s branded products. We also offered additional promotions, discounts and allowances to other customers switching over to our new brands.

Second-quarter sales for every other channel were up over the same period a year ago with e-commerce up 21%, FDM retail up over 12%, and value retail up over 78%. International sales were down 8.1% primarily due to the strong dollar. With respect to product categories, sales of toys and accessories were up over 33% over last year’s second quarter as well as waste management and odor control were up 14%.

Gross profit was down approximately $146,000 to $1,571,844 for the 2016 second quarter compared to $1,718,069 for the period last year. Gross profit margin decreased 1.9 percentage points to 28.9% for the 2016 second quarter from 30.8% for the same period a year ago due to a heavier than usual sales mix of slow moving and excess inventory and unfavorable overhead absorption.

Income from operations decreased to $227,702 for the 2016 second quarter from $422,463 a year ago. This approximate $195,000 decrease was primarily due to the lower gross profit combined with about $49,000 in higher Selling, General and Administrative expenses.

Net income decreased 41% to $154,634 for the 2016 second quarter from $262,076 last year. Earnings per share were $0.01 for the second quarter of 2016 and 2015.

2016 First Six Months Results

Net revenue increased 3.8% to $11,612,887 for the first half of 2016 from $11,184,150 for the same period a year ago. The $428,737 year-over-year increase was due to strong first half revenue growth in all channels except for Pet Specialty as noted above. Food, Drug, Mass increased 11%, E-Commerce increased 17% and Value increased 168%.

Gross profit decreased .3% to $3,403,701 for the first six months of 2016 versus $3,412,414 for the first half of last year due to the lower sales volume. Gross profit margin decreased 1.2 percentage points to 29.3% for the first six months of 2016 from 30.5% the prior year due to the same factors that adversely impacted the 2016 second quarter results.

Income from operations decreased 17% to $642,972 for the 2016 first half, which was attributable to lower gross profit and higher selling, general, and administrative expenses.

Other income increased to $34,468 for the first six months of 2016 from $26,000 for the same period last year.

Income before taxes decreased 18.4% to $616,684 for the first half of 2016 versus $755,474 for the same period a year ago.

Income tax expense was $195,470 for the first six months of 2016 compared to $279,606 the prior year.

Net income for the first six months of 2016 decreased 11.5% to $421,214 from $475,868 for the same period in 2015. Earnings per share remained at $0.02 for the first six months of both 2016 and 2015.

About OurPet’s Company

OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investors and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.

Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.

OURPET’S COMPANY AND SUBSIDIARIES
CONSOLIDATED OPERATING RESULTS
For the Three Months Ended For the Six Months Ended
June 30, June 30,
2016 2015 2016 2015
Net revenue $ 5,436,902 $ 5,586,828 $ 11,612,887 $ 11,184,150
Cost of goods sold 3,865,058 3,868,759 8,209,186 7,771,736
Gross profit on sales 1,571,844 1,718,069 3,403,701 3,412,414
Selling, general and administrative expenses 1,344,142 1,295,606 2,760,729 2,633,638
Income from operations 227,702 422,463 642,972 778,776
Other income (7,463) (21,277) (34,468) (26,000)
Interest expense 27,920 24,795 60,756 49,302
Income before taxes 207,245 418,945 616,684 755,474
Income Tax expense 52,611 156,869 195,470 279,606
Net Income $ 154,634 $ 262,076 $ 421,214 $ 475,868
Basic and Diluted Net Income Per Common
Share After Dividend Requirements For Preferred
Stock $ 0.01 $ 0.01 $ 0.02 $ 0.02
Weighted average number of common shares
outstanding used to calculate 17,657,516 17,558,838 17,643,936 17,555,973
basic earnings per share
Weighted average number of common and
equivalent shares outstanding used to 18,277,335 19,201,418 18,250,885 19,172,847
calculate diluted earnings per share
OURPET’S COMPANY AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, December 31,
2016 2015
ASSETS
Cash and equivalents $ 168,635 $ 100,000
Receivables, net 3,325,003 4,294,810
Inventories, net 7,181,216 7,914,613
Prepaid expenses 645,076 582,676
Total current assets 11,319,930 12,892,099
LONG TERM ASSETS
Property and equipment, net 1,962,490 1,873,260
Amortizable Intangible Assets, net 375,792 357,341
Intangible Assets 461,000 461,000
Goodwill 67,511 67,511
Deposits and Other assets 18,003 18,003
Total long term assets 2,884,796 2,777,115
Total assets $ 14,204,726 $ 15,669,214
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current maturities of long-term debt 248,153 276,890
Accounts payable 716,122 1,582,849
Accrued expenses 531,200 571,858
Total current liabilities 1,495,475 2,431,597
LONG TERM LIABILITIES
Long-term debt – less current portion above 759,794 876,248
Revolving line of credit 2,405,032 3,267,170
Deferred income taxes 320,955 333,834
Total long term liabilities 3,485,781 4,477,252
Total liabilities 4,981,256 6,908,849
Stockholders’ Equity 9,223,470 8,760,365
Total liabilities and stockholders’ equity $ 14,204,726 $ 15,669,214

 

OurPet’s Company
Dr. Steven Tsengas, CEO, 440-343-6500, x111
or
Investor Relations
Dream Team.
Michael McCarthy, 512-758-8877

Friday, August 5th, 2016 Uncategorized Comments Off on $OPCO Reports #Q2 #FY16 #Financial #Results

$RWLK German Court Ruling Deems #ReWalk #Exoskeleton #MedicallyNecessary in #SCI

Social Welfare Court Decision in Germany: Reimbursement Approved on Appeal

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Aug. 4, 2016  — ReWalk Robotics (NASDAQ: RWLK), the leading developer and manufacturer of exoskeletons, announced the first ruling by the Social Welfare Court of Speyer declaring the ReWalk exoskeleton system was medically necessary and should be covered by insurance for an individual with spinal cord injury (SCI).  The ruling, which was delivered in late July, overturned the original denial of the claim by the payor, a statutory health insurance entity.

The claimant, Philip Hollinger, is a 44 year old father of two who suffered a spinal cord injury in a car accident in 2006 that left him paralyzed with a T6 level injury.  Mr. Hollinger has been relegated to the use of a wheelchair in the 10 years since the accident.  He was introduced to ReWalk’s exoskeleton technology at the Rehacare trade show in Dusseldorf in September 2013 and he successfully completed the trial and training process at Asklepios Klinik in Falkenstein.

In August 2014, Hollinger submitted a claim to his statutory health insurance for coverage of a ReWalk Personal System to help him stand and walk at home and in his community.  When the insurer denied his claim, Mr. Hollinger appealed to the Social Welfare Court of Speyer, which overturned the insurer’s denial.

“Only an individual with a spinal cord injury can fully appreciate the moment of pure happiness when you are able to stand up and walk again,” said Philip Hollinger. “The decision of the Social Welfare Court of Speyer offers hope to other people with SCI, and confirms what I and other ReWalk users have experienced: this technology returns to me many of the things I have lost with my disability.  Now, I am able to stand and walk again independently, and to see the world at eye level.”

The ruling delivered by the Social Welfare Court of Speyer1 included several key decisions regarding exoskeleton technology for spinal cord injured individuals that will serve as precedent for future cases.  The Court determined:

  • ReWalk is a medical aid that compensates the malfunction of the body directly.  As such, it does not require a positive recommendation by the German Joint National Committee (GBA) or a listing in the German catalogue of medical aids (Hilfsmittelverzeichnis).
  • The ReWalk exoskeleton technology is not comparable to wheelchairs as only ReWalk enables the insured to walk again. Therefore, the principle of efficiency pursuant to Section 12 of Book V of the German Social Security Code (SGB V) is not applicable.
  • The reimbursement of a ReWalk Personal Exoskeleton System cannot be denied based upon the argument that the supply of a wheelchair is sufficient because a wheelchair does not compensate the malfunction of the body completely.
  • The fact that the insured still needs assistance when using the ReWalk Personal System does not justify the denial of the payor to cover the cost of the system.
  • The insured still needing a wheelchair in addition to a ReWalk does not qualify as a basis for denial because exoskeleton technology gives the insured the possibility to stand up for a few hours per day.

“This ruling is a milestone for insurance coverage of exoskeleton technology, both in Germany and around the world,” said ReWalk Robotics CEO Larry Jasinski.  “With each decision approving coverage of the ReWalk, we make key advances in the effort to ensure every eligible ReWalk user has access to and coverage of their system.”

ReWalk Robotics Personal 6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. ReWalk is the first exoskeleton system to receive FDA clearance for use in the home as well as in the rehabilitation setting.  ReWalk received FDA clearance in June 2014, and a CE mark in June 2010.

About ReWalk Robotics Ltd.

ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany. For more information on the ReWalk systems, please visit http://www.rewalk.com.

ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.

Forward Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk’s future performance and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek” and similar terms or phrases.  The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk’s control.  Important factors that could cause ReWalk’s actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and to expand to new markets; ReWalk’s ability to maintain and grow its reputation and to achieve and maintain market acceptance of its products; ReWalk’s ability to achieve reimbursement from third-party payors for its products; ReWalk’s expectations as to its clinical research program and clinical results; ReWalk’s ability to improve its products, develop new products; ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk’s ability to repay its secured indebtedness; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the U.S. Securities and Exchange Commission on February 29, 2016 and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission.  Any forward-looking statement made in this press release speaks only as of the date hereof.  Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them.  Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

Thursday, August 4th, 2016 Uncategorized Comments Off on $RWLK German Court Ruling Deems #ReWalk #Exoskeleton #MedicallyNecessary in #SCI

$TTOO to Present at the #CanaccordGenuityGrowthConference

LEXINGTON, Mass., Aug. 04, 2016  — T2 Biosystems, Inc. (NASDAQ:TTOO) today announced that John McDonough, president and chief executive officer, and Shawn Lynch, chief financial officer, are scheduled to attend and present at the Canaccord Genuity Growth Conference on Thursday, August 11, 2016, at 8:30 a.m. ET in Boston.

A live, listen-only webcast of the presentation may be accessed by visiting the Investors/Events & Presentations section of the Company’s website at www.t2biosystems.com.  A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the Company’s website for 30 days.

About T2 Biosystems

T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.

Media Contact:
Susan Heins, 
Pure Communications
susan@purecommunicationsinc.com
864-286-9597

Investor Contact:
Matt Clawson,
Pure Communications
matt@purecommunicationsinc.com
949-370-8500
Thursday, August 4th, 2016 Uncategorized Comments Off on $TTOO to Present at the #CanaccordGenuityGrowthConference

$ABEO European Regulatory Approval Phase 1/2 #Gene #Therapy #Clinical #Study

NEW YORK, NY and CLEVELAND, OH–(August 04, 2016) – Abeona Therapeutics, Inc. (NASDAQ: ABEO)

  • Approval of clinical trial for ABO-102 (AAV-SGSH) in European Union marks 3rd regulatory approval for the company, 2nd for ABO-102
  • Approval following encouraging safety profile and early biopotency signals observed in 2 low dose patients through 30 Days post-injection in ongoing US trial

Abeona Therapeutics, Inc. (NASDAQ: ABEO), a leading clinical-stage biopharmaceutical company focused on delivering gene and plasma-therapies for life-threatening rare diseases, today announced European regulatory approval for a Phase 1/2 Gene Therapy Clinical Trial utilizing ABO-102 (AAV-SGSH) for patients with Sanfilippo syndrome type A (MPS IIIA). The clinical study was approved by the Agencia Espanola de Medicamentos y Productos Sanitarios, and the Company is conducting the Phase 1/2 clinical study at Cruces University Hospital (Bilbao, Spain).

“We are encouraged by the recently reported early clinical data suggesting ABO-102 is well tolerated, with early biopotency signals showing reduced urinary and CSF GAG (heparan sulfate). This is the second clinical trial approval supporting the advancement of ABO-102 as a potential treatment for patients with Sanfilippo syndrome type A, or MPS IIIA. We thank the foundations and regulatory agencies for helping advance these potentially life-changing therapies into global clinical trials,” stated Timothy J. Miller, Ph.D, President & CEO.

The clinical study is supported by a 25-subject MPS III Natural History Study, which included potential efficacy assessments consisting of neurocognitive evaluations, biochemical assays and MRI data generated over 1 year of follow up assessments.

“Sanfilippo syndromes are devastating and progressive lysosomal storage diseases that affect children around the world. These gene therapies, delivered as a single, non-invasive intravenous injection, offer a new and promising treatment paradigm for patients with this relentless disease,” commented Luis Aldámiz-Echevarría, M.D., PhD., Principal Investigator of the clinical trials and Associate Professor in the Faculty of Medicine at the University of the Basque Country (Spain), Paediatrician in the Department of Paediatrics at Cruces University Hospital (Spain) and Principal Investigator of the Metabolic Inherited Disorders Group and the Metabolomics and Proteomics Platform at BioCruces Health Research Institute (Spain).

“Today we consider that a period of hard work ends and a period full of hope for other children affected by Sanfilippo begins. None of this would have been possible without the help of thousands of people who rely on us, so we want to thank the volunteers, all the people that have supported us financially, our scientific committee, the AEMPS, Abeona, the research team that developed this program, and all parents of children affected for their integrity and dedication,” said Emilio Lopez Alvarez, President, Stop Sanfilippo Foundation, Spain.

Sanfilippo syndromes (or mucopolysaccharidosis (MPS) type III) are a group of four inherited genetic diseases each caused by a single gene defect, described as type A, B, C or D, which cause enzyme deficiencies that result in the abnormal accumulation of glycosaminoglycans (sugars) in body tissues. MPS III is a lysosomal storage disease, a group of rare inborn errors of metabolism resulting from deficiency in normal lysosomal function. The incidence of MPS III (all four types combined) is estimated to be 1 in 70,000 births. Mucopolysaccharides are long chains of sugar molecule used in the building of connective tissues in the body. There is a continuous process in the body of replacing used materials and breaking them down for disposal. Children with MPS III are missing an enzyme which is essential in breaking down the used mucopolysaccharides called heparan sulfate. The partially broken down mucopolysaccharides remain stored in cells in the body causing progressive damage. Babies may show little sign of the disease, but as more and more cells become damaged, symptoms start to appear. In MPS III, the predominant symptoms occur due to accumulation within the central nervous system (CNS), including the brain and spinal cord, resulting in cognitive decline, motor dysfunction, and eventual death. Importantly, there is no cure for MPS III and treatments are largely supportive care.

About ABO-102 (AAV-SGSH) ABO-102 is an adeno-associated viral (AAV)-based gene therapy for patients diagnosed with MPS IIIA (Sanfilippo syndrome). ABO-102 is delivered as a one-time intravenous injection of a normal copy of the defective gene (SGSH) for delivery to cells of the central nervous system (CNS) and peripheral organs with the aim of correcting the underlying genetic errors that cause the disease. In Sanfilippo preclinical models, a single dose of ABO-102 induced cells in the CNS and peripheral organs to produce the missing enzyme, and repaired the underlying cell pathology that causes the disease. ABO-102 significantly restored normal cell and organ function, corrected cognitive deficits, increased neuromuscular function and normalized the lifespan of animals with MPS IIIA over 100% for more than one year after treatment compared to untreated control animals. These results are consistent with studies from several laboratories suggesting AAV treatment to replace the defective SGSH gene could potentially benefit patients with Sanfilippo syndrome. In addition, safety studies conducted in animal models of Sanfilippo syndrome have demonstrated that delivery of ABO-102 is well tolerated with minimal side effects. Clinical studies are ongoing and have demonstrated that ABO-102 has a strong safety profile through 30 Days post-injection and early biopotency signals are being observed.

About Abeona: Abeona Therapeutics Inc. is a leading clinical stage company developing gene therapy and plasma-based therapies for severe and life-threatening rare genetic diseases. Abeona’s lead programs are ABO-102 (AAV-SGSH) and ABO-101 (AAV-NAGLU), adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome (MPS IIIA and IIIB), respectively. We are also developing ABO- 201 (AAV-CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, Abeona is developing plasma protein therapies, including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD, using our proprietary SDF™ (Salt Diafiltration) ethanol-free process. For more information, visit www.abeonatherapeutics.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, our plans for continued development and internationalization of our clinical programs, that AAV treatment to replace the defective SGSH gene could potentially benefit patients with Sanfilippo syndrome, that early clinical data suggest that ABO-102 is well tolerated with early biopotency signals showing reduced urinary and CSF GAG (heparan sulphate), management plans for the Company, and general business outlook. These statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the success of our clinical trials, the impact of competition, the ability to develop our products and technologies; the ability to achieve or obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10- K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Company and Media Contact:

Andre’a Lucca
Vice President, Communications & Operations
Abeona Therapeutics Inc.
+1 (212)-786-6208
alucca@abeonatherapeutics.com

Christine Berni-Silverstein
Vice President, Investor Relations
Abeona Therapeutics Inc.
+1 (212)-786-6212
csilverstein@abeonatherapeutics.com

Thursday, August 4th, 2016 Uncategorized Comments Off on $ABEO European Regulatory Approval Phase 1/2 #Gene #Therapy #Clinical #Study

$CLIR Announces First Major Order in Flare Application

The Company Announces Significant Follow-On Order While Nearing Completion of Initial Wellhead Flare Testing

SEATTLE, Aug. 4, 2016  — ClearSign Combustion Corporation (NASDAQ: CLIR), an emerging provider of industrial combustion technologies that help to reduce emissions and improve efficiency, announced today that they have received a multi-flare contract from a major California oil producer to retrofit their enclosed wellhead ground flares with its Duplex™ technology to ensure compliance with air district emission requirements. This contract, which includes the previously disclosed initial test unit and is through the producer’s contractor, Advanced Combustion & Process Controls, Inc. (ACPC), is valued at over $1,000,000. It is expected to be completed over the next 6 to 12 months depending on the customer’s schedule.

This first major order for ClearSign comes as it nears completion of the retrofit of the customer’s high output, enclosed ground flare used for flaring wellhead gas which was originally announced in February.

While there are over one million flares associated with production wells in North America, only a small portion of these flares are currently regulated. California currently regulates flare emissions and it is expected that other states will follow over time to comply with the Clean Air Act.

The Clean Air Act, as administered by the Environmental Protection Agency (EPA), regulates six common criteria air pollutants, including ground-level ozone. These regulations are enforced by state and local air quality districts as part of their compliance plans. As a precursor to ozone, nitrogen oxide (NOx) are regulated emissions by local air quality districts. Although NOx emissions from refineries and other oil production and processing operations are highly regulated as they are historically a significant source of stationary NOx emissions, enclosed ground flares have not historically been viewed as a source requiring the same level of regulation.  However, with EPA mandated 8-hour ground-level ozone regulations being reduced from 84 ppb in 1997, to 75 ppb in 2008, and 70 ppb in 2015, we believe that local regulators are in search for other means to comply with the impending standards. ClearSign’s Duplex technology is uniquely able to address the emissions challenges being faced by the oil field /production industry.

Steve Pirnat, ClearSign Chairman and CEO, said, “We are very pleased with the excellent results to date from our installation of Duplex in an enclosed wellhead flare. The positive performance of our technology and our customer’s confidence in that technology has led to this major, new contract for additional installations. I believe that this is a seminal endorsement of Duplex from a significant oil producer.”

About ClearSign Combustion Corporation
ClearSign Combustion Corporation designs and is developing products and technologies that strive to improve key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the chemical, petrochemical, refinery, power and commercial boiler industries. For more information, please visit www.clearsign.com.

Cautionary note on forward-looking statements
This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. Forward-looking statements may be identified by words such as “expect”, “anticipate”, “believe”, “intend”, “hope”, “could”, “plans” and other comparable or similar terminology as well as the negative of such terminology. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Annual Report on Form 10-K and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.

Thursday, August 4th, 2016 Uncategorized Comments Off on $CLIR Announces First Major Order in Flare Application

$CHEK Announces Agreement w/ $GE #Healthcare #XRay Capsule Manufacturing

ISFIYA, Israel and BOSTON, Aug. 4, 2016  — Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK, CHEKW), a clinical stage medical diagnostics company engaged in the development of an ingestible capsule for preparation-free, colorectal cancer screening, today announced it has entered into an agreement with GE Healthcare to develop and validate high-volume manufacturing for X-ray source production and assembly into Check-Cap’s capsule. Upon successful completion, the parties may discuss collaboration on execution of a high-volume manufacturing facility and distribution of the Check-Cap system.

“We are very excited to commence this strategic relationship with GE Healthcare as we continue our efforts to optimize the supply chain for the Check-Cap system,” said Bill Densel, CEO of Check-Cap. “GE Healthcare is a global leader in the development, manufacturing, and distribution of diagnostic imaging agents and radio-pharmaceutical drugs and devices. We believe that leveraging their experience and expertise provides us with a significant opportunity to meet our goal of increasing the time and cost efficiencies of production of our capsule for use in future clinical trials and commercialization.”

Colorectal cancer is the second leading cause of cancer death in the U.S., with an estimated 134,000 diagnoses and 49,000 deaths in 2016.  Despite compelling evidence that screening can detect colorectal cancer and precancerous polyps, nearly one-third of the recommended adult population has never been screened.  The Check-Cap system was designed to improve the patient experience by eliminating the features of existing screening methods, such as bowel preparation, invasive procedure, and stool handling, that pose a barrier to test completion.

Check-Cap is currently conducting a multi-center clinical feasibility study and expects to file a CE Mark submission for the Check-Cap system in the first half of 2017.

About Check-Cap

Check-Cap is a clinical-stage medical diagnostics company developing the world’s first ingestible capsule system for preparation-free, less-invasive colorectal cancer screening.

The capsule utilizes innovative ultra-low dose X-ray and wireless communication technologies to scan the inside of the colon as it moves naturally, while the patient follows his or her normal daily routine.   After passage, the system generates a 3D map of the inner surface of the colon which enables detection of polyps and cancer.  Designed to increase the willingness of individuals to participate in recommended colorectal cancer screening, the Check-Cap system addresses many frequently-cited barriers, including laxative bowel preparation, invasiveness, and sedation. The Check-Cap system is currently not cleared for marketing in any jurisdiction.

Legal Notice Regarding Forward-Looking Statements

This press release contains “forward-looking statements.” Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. For a discussion of these and other risks that could cause such differences and that may affect the realization of forward-looking statements, please refer to the “Special Note On Forward-looking Statements” and “Risk Factors” in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

CONTACT:
Investors
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com

Vivian Cervantes
PCG Advisory
212-554-5482
vivian@pcgadvisory.com

Media
Rob Sawyer
Lazar Partners Ltd.
212-843-0209
rsawyer@lazarpartners.com

Thursday, August 4th, 2016 Uncategorized Comments Off on $CHEK Announces Agreement w/ $GE #Healthcare #XRay Capsule Manufacturing

$ANTH Completion of Dosing #CHABLIS-SC1 #Phase3 #Clinical w/ #Blisibimod

HAYWARD, Calif., Aug. 03, 2016  — Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that the last patient in the Phase 3 CHABLIS-SC1 clinical study, evaluating blisibimod for the treatment of systemic lupus erythematosus, received their final study dose on July 27th.  As described in the protocol, patients are followed for eight weeks after their last dose at which time the final safety data is collected. Due to timing of this final visit, the company expects topline efficacy and safety data will be available prior to the annual American College of Rheumatology Annual Meeting in November.

“We are very pleased that we have had our last patient dosed in this 52-week active dosing study,” said James Pennington, MD, Anthera’s Interim Chief Medical Officer. “We continue to aggressively collect, analyze and finalize the CHABLIS-SC1 database as the final patients suffering from lupus complete the study. To date, the mean baseline SELENA-SLEDAI score, a measure of lupus disease activity, is 13.6 and in-line with our hypothesis of studying people with more severe disease.”

Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, a six-point reduction in the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study.

About CHABLIS-SC1

CHABLIS-SC1 is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with seropositive, clinically-active lupus (SELENA-SLEDAI ≥ 10) who require corticosteroid therapy in addition to standard-of-care for treatment of their disease.  The study enrolled 442 patients in 12 countries across Asia, Eastern Europe and Latin America.  Patients received either 200mg of blisibimod or placebo in addition to their standard-of-care medication for 52 weeks. The primary endpoint of the CHABLIS-SC1 study will be clinical improvement in the SRI-6 response at 52 weeks. With 442 evaluable patients, the study is powered at 89% to detect a 14% treatment difference assuming a 25% placebo response rate.  Key secondary outcomes from the study, including SRI-8, reduction in the number of lupus flares and steroid use, are intended to further differentiate blisibimod from currently available therapies. For more information on the CHABLIS-SC1 study, please visit http://www.anthera.com/clinical-studies/chablis_sc/.

About Blisibimod

Blisibimod is a selective peptibody antagonist of the B-cell activating factor (BAFF) cytokine that is initially being developed as a treatment for lupus. BAFF is a tumor necrosis family member and is critical to the development, maintenance and survival of B-cells. It is primarily expressed by macrophages, monocytes and dendritic cells and interacts with three different receptors on B-cells including BAFF receptor, or BAFF-R, B-cell maturation, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI. The BAFF-R receptor is expressed primarily on peripheral B-cells. Blisibimod consists of a novel BAFF binding domain fused to the N-terminus of the Fc region of human antibody. Blisibimod binds to BAFF and inhibits the interaction of BAFF with its receptors. The role of BAFF in lupus has recently been clinically validated in multiple late-stage clinical studies with an anti-BAFF antibody. We intend to advance the development of our BAFF antagonist, blisibimod, to exploit its broad potential clinical utility in autoimmune diseases, with initial focus on lupus. Blisibimod demonstrates anti-BAFF activity and has been shown to be safe and effective in selectively modulating and reducing B-cells in two Phase 1 clinical studies in lupus patients.

About Anthera Pharmaceuticals, Inc.

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious and life-threatening diseases, including lupus, lupus with glomerulonephritis, IgA nephropathy, and exocrine pancreatic insufficiency due to cystic fibrosis. 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.  These forward-looking statements include statements about Anthera’s expectations with respect to its public offering, including statements about its intended use of proceeds from the offering.  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 March 31, 2016.  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: 
Nikhil Agarwal of Anthera Pharmaceuticals, Inc.
nagarwal@anthera.com or 510-856-5600 x5621
Wednesday, August 3rd, 2016 Uncategorized Comments Off on $ANTH Completion of Dosing #CHABLIS-SC1 #Phase3 #Clinical w/ #Blisibimod

$NMIH #ClaudiaMerkle Named to #WomenOfInfluence List

Executive Vice President Recognized for Her Noteworthy Accomplishments in the Private Mortgage Insurance Business

EMERYVILLE, CA–(August 03, 2016) – National Mortgage Insurance Corporation (National MI), a subsidiary of NMI Holdings, Inc. (NASDAQ: NMIH), announces that Claudia Merkle, executive vice president, chief of insurance operations, is named as one of HousingWire’s Women of Influence. The Women of Influence awards recognize the outstanding efforts of women in driving the U.S. housing economy forward, and are given to women who are making notable contributions to their businesses and to the industry at-large — with a specific focus on contributions made in the most recent 12 months.

“I’m extremely honored to be named to HousingWire’s Women of Influence list,” Merkle said. “I’m proud to have the opportunity to make a difference at National MI, and to serve as a mentor to both female and male employees.”

A highly respected leader with more than 25 years of experience in the mortgage industry, Merkle leads National MI’s insurance operations and its sales and marketing functions. As chief of insurance operations, she played a key role in almost doubling National MI’s lender clients in the past two years alone, to over 1,000 clients today.

“Claudia’s contributions to National MI and to the private mortgage insurance industry have been outstanding,” said Bradley Shuster, CEO of National MI. “This recognition by HousingWire is well-deserved. Claudia’s strong leadership and guidance leading the front lines of sales and operations have been crucial to National MI’s success.”

One of Merkle’s most notable accomplishments was developing an innovative way to perform National MI’s underwriting, which enabled the company to provide competitive rescission relief for a majority of its loans, and served as the basis for the National MI SafeGuard® product. National MI’s insurance product made 12-month rescission relief feasible and started a trend in the industry.

Merkle has also been instrumental in National MI’s expansion: the company tripled its market share in 2015 and reached profitability in the second quarter of 2016.

About National MI

National Mortgage Insurance Corporation (National MI), a subsidiary of NMI Holdings, Inc. (NASDAQ: NMIH), is a U.S.-based, private mortgage insurance company enabling low down payment borrowers to realize home ownership while protecting lenders and investors against losses related to a borrower’s default. To learn more, please visit www.nationalmi.com.

 

Press Contact
Mary McGarity
Strategic Vantage Mortgage Public Relations
http://strategicvantage.com/
(203) 513-2721
MaryMcGarity@StrategicVantage.com

Investor Contact

John M. Swenson
Vice President, Investor Relations and Treasury
john.swenson@nationalmi.com
(510) 788-8417

Wednesday, August 3rd, 2016 Uncategorized Comments Off on $NMIH #ClaudiaMerkle Named to #WomenOfInfluence List

$KOOL Promising #Results 40-Month Follow-Up Critical Limb #Ischemia Study

RANCHO CORDOVA, Calif., Aug. 03, 2016  — Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced 40-month follow-up results for a number of patients that participated in the Company’s earlier feasibility study using Cesca’s proprietary SurgWerks™ system for the treatment of late stage, “no option” critical limb ischemia (CLI).

The feasibility study was conducted in 2011 at Fortis Escorts Heart Institute in New Delhi, India, where seventeen patients with late stage CLI, all of whom had exhausted available surgical options short of a major limb amputation, were treated with autologous bone marrow derived stem cells. The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longer-term safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.

Results from the original study reported successful limb salvage for twelve of the seventeen patients after twelve months. In the 40-month follow-up, three of the 12 patients that were amputation-free at 12 months could not be contacted, but the remaining nine were clinically assessed. The results reported favorable clinical outcomes, including a significant overall reduction in rest pain and improvements in quality of life. All nine patients still had their limbs and exhibited no sign of disease progression, though two of the nine had in the interim undergone additional SurgWerks treatments to relieve mild to moderate rest pain. There were no adverse or serious adverse events reported at the 40 month follow-up, and there were no safety concerns attributed to the treatment procedure.

“These longer-term, post-study follow-up results not only reinforce our belief that autologous bone marrow derived stem cell therapy using our SurgWerks-CLI system is effective, they also suggest that it is durable”, said Dr. Venkatesh Ponemone, Study Director and Executive Director of TotipotentRX, a subsidiary of Cesca Therapeutics Inc. “We look forward to starting the Phase III pivotal clinical trial recently approved by the FDA and to ultimately making the SurgWerks-CLI procedure available to patients,” he added.

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.  These include:

  • The SurgWerks™ System (in development) – a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure  Kits  for use in regenerative stem cell therapy at the point-of-care for  vascular and orthopedic diseases.
  • The CellWerks™ System (in development) – a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
  • The AutoXpress® System (AXP®) – a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
  • The MarrowXpress™ System (MXP™) – a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
  • The BioArchive® System – an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
  • Manual bag sets for use in the processing and cryogenic storage of cord blood.


Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change.  Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” “belief,” “suggest,” “look forward to” and similar expressions and include, but are not limited to, statements regarding research and product commercialization, our belief concerning the efficacy and durability of our SurgWerks-CLI procedure, the start, if at all, of the Phase III pivotal clinical trial for SurgWerks-CLI, and the ultimate commercial availability of the procedure to patients.  These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption “Risk Factors” in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.  We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

 

Company Contact: Cesca Therapeutics Inc. 
ir@cescatherapeutics.com

Investor Contact: The Ruth Group 
Lee Roth / Tram Bui 
646-536-7012 / 7035 
lroth@theruthgroup.com / tbui@theruthgroup.com
Wednesday, August 3rd, 2016 Uncategorized Comments Off on $KOOL Promising #Results 40-Month Follow-Up Critical Limb #Ischemia Study

$APHB Completes #Enrollment Phage Therapy in #StaphylococcusAureus

AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced it has completed enrollment of its Phase 1 clinical trial to evaluate the safety of AB-SA01, its proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Army Institute of Research (Walter Reed) Clinical Trials Center in Silver Spring, Maryland. AmpliPhi expects to report topline results by the end of the third quarter of 2016.

Bacteriophages, or, more simply, “phages”, are naturally-occurring viruses that have evolved to be highly selective for the bacterial species they must infect in order to replicate. Successful infection enables a single phage to hijack a bacterial host’s protein production machinery to rapidly produce hundreds of progeny phages, at which point the phage instructs the bacterial cell to burst, scattering the highly selective progeny into the surrounding environment to attack nearby bacteria and repeat the reproduction process until the bacterial population is depleted. Throughout this process the phages maintain their bacterial species selectivity, enabling a phage-based therapeutic to precisely target a pathogenic bacterial population while sparing the beneficial microbiota. Phage can infect and kill bacteria, whether they are antibiotic-resistant or not and even when they have formed protective biofilms. Such biofilms are a major line of defense for bacteria, sometimes rendering them impervious to conventional antibiotics.

Despite vigorous eradication efforts, S. aureus is one of the most common causes of hospital-acquired infections. It can cause pneumonia, infect prosthetic joints, skin and other soft tissues and is a leading cause of bloodstream infections – typically as a consequence of traumatic injury, surgery or use of catheters or injectable drugs – where it can go on to infect and damage the heart, joints and bones.

The double-blinded, placebo-controlled study began on May 24, 2016 and was designed to evaluate the safety of AB-SA01 administered topically to the skin of 12 healthy adult volunteers between the ages of 18 and 60. Volunteers were split into two cohorts of six participants each, and received either the low-dose (1 x 108 PFU/mL) or high-dose (1 x 109 PFU/mL) of AB-SA01, administered topically to the forearm under an occlusive bandage. Placebo was similarly administered to the volunteer’s opposite forearm, allowing each participant to serve as their own control. Participants received AB-SA01 and placebo daily for three consecutive days and were monitored following treatment.

“Successfully enrolling the first U.S.-based trial of AB-SA01 marks a signal achievement by the AmpliPhi team and our partners at Walter Reed as we work to pioneer the first rigorous human efficacy studies of phage therapy in the United States,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Phage therapy holds the potential to play a critical role in humanity’s fight against the looming and ever-evolving threat of antibiotic-resistant bacteria by exploiting a predator-prey relationship that has been raging since the dawn of life on Earth. We look forward to completing the necessary follow-up visits and providing more results soon, and expect to have complete study reports for both this trial as well as our Phase 1 AB-SA01 trial in patients with chronic rhinosinusitis later this year.”

For more information, visit www.ampliphibio.com.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation (NYSEMKT:APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi’s product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.

Forward Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements about the expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

 

Company and Investor Relations:
AmpliPhi Biosciences
Matt Dansey, +1 858-800-4869
md@ampliphibio.com
or
Media Relations (USA)
Lazar Partners
Danielle Lewis/Glenn Silver, + 1 212-867-1762
ampliphi@lazarpartners.com
or
Media Relations (Europe and ROW)
Instinctif Partners
Gemma Howe/Sue Charles, +44 (0)20 7866 7860
ampliphi@instinctif.com

Wednesday, August 3rd, 2016 Uncategorized Comments Off on $APHB Completes #Enrollment Phage Therapy in #StaphylococcusAureus

$MPET Announces #Strategic #Merger and Enters the #LNG Business

Tellurian Co-founders Charif Souki to Become Chairman, Martin Houston President

DENVER, CO–(August 03, 2016) – Magellan Petroleum Corporation (NASDAQ: MPET) (“Magellan”) today announced that it has entered into a definitive merger agreement with Tellurian Investments Inc. (“Tellurian”), a recently formed private company focused on the development of a mid-scale liquefied natural gas (“LNG”) facility on the U.S. Gulf Coast. Tellurian is led by Charif Souki, former founder, Chairman, and CEO of Cheniere Energy, Inc. and Martin Houston, former COO of BG Group plc.

J. Thomas Wilson, President and CEO of Magellan, commented, “This transaction concludes our strategic alternatives review process and we believe offers a unique opportunity for Magellan’s shareholders to participate at an early stage in an investment potentially similar to Cheniere Energy’s remarkable success, under the leadership of Charif Souki. He and Martin Houston are proven leaders in the LNG industry.”

Martin Houston, co-founder of Tellurian, also commented, “Our experienced team leading Driftwood LNG, a 26-millon tonnes liquefaction project in Louisiana, and our deep relationship with Bechtel and its sub-contractors, GE and Chart Industries, are key factors that we believe will drive the successful development of one of the most cost-competitive LNG projects globally. With this transaction, we will be able to access more attractive financing in order to develop Driftwood LNG, which should come on stream in 2022, just as the markets for new LNG open up.”

The board of directors of each company has unanimously approved the terms of the agreement and has recommended that its shareholders approve the transaction. Completion of the merger is subject to approval of the Magellan and Tellurian shareholders and certain regulatory approvals and customary conditions.

The transaction is expected to close in the fourth quarter of 2016. Upon closing, pursuant to the terms of the merger agreement, each share of Tellurian will be converted into the right to receive 1.30 shares of Magellan. Magellan will issue approximately 122 million shares of common stock to Tellurian shareholders, representing approximately 95% of Magellan’s pro forma outstanding common stock.

Petrie Partners Securities, LLC acted as financial advisor to Magellan. Davis, Graham & Stubbs LLP acted as legal advisor to Magellan. Gray Reed & McGraw, P.C. acted as legal advisor to Tellurian.

CAUTIONARY INFORMATION ABOUT FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. The words “believe”, “expect”, “intend”, “plan”, “potential”, and similar expressions are intended to identify forward-looking statements, and these statements may relate to the merger transaction. These statements involve a number of known and unknown risks, which may cause actual results to differ materially from expectations expressed or implied in the forward-looking statements. These risks include uncertainties about Magellan’s ability to complete the merger; the development of the Driftwood project following completion of the merger and other matters discussed in the “Risk Factors” section of Magellan’s Annual Report on Form 10-K for the fiscal year ended June 30, 2015, and any updates thereto in subsequent reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak as of the date of this release. Although Magellan may from time to time voluntarily update its prior forward-looking statements, it disclaims any commitment to do so except as required by securities laws.

IMPORTANT INFORMATION FOR INVESTORS AND SHAREHOLDERS
This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed business combination between Magellan and Tellurian.

In connection with the proposed transaction, Magellan intends to file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 that will include a joint proxy statement of Magellan and Tellurian that also constitutes a prospectus of Magellan. Each of Magellan and Tellurian also plan to file other relevant documents with the SEC regarding the proposed merger. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. Any definitive joint proxy statement(s)/prospectus(es) for Magellan and/or Tellurian (if and when available) will be mailed to shareholders of Magellan or Tellurian, as applicable. INVESTORS AND SECURITY HOLDERS OF MAGELLAN AND TELLURIAN ARE URGED TO READ THE PROXY STATEMENT(S), REGISTRATION STATEMENT(S), PROXY STATEMENT(S)/PROSPECTUS(ES) AND OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.

Investors and security holders will be able to obtain free copies of these documents (if and when available) and other documents containing important information about Magellan and Tellurian, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Magellan will be available free of charge on Magellan’s internet website at www.magellanpetroleum.com or by contacting Magellan using the contact information below.

PARTICIPANTS IN SOLICITATION
Magellan and Tellurian and their respective directors, executive officers and other members of their management and employees may be deemed to be participants in the solicitation of proxies from the companies’ shareholders in connection with the merger. Shareholders are urged to carefully read the proxy statement regarding the merger when it becomes available, because it will contain important information. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the companies’ shareholders in connection with the merger will be set forth in the proxy statement when it is filed with the SEC. You can find information about Magellan’s executive officers and directors in its definitive proxy statement filed with the SEC on June 6, 2016. You can obtain free copies of these and other documents containing relevant information at the SEC’s web site at www.sec.gov or by directing a request to the address or phone number set forth below.

ABOUT MAGELLAN
Magellan Petroleum Corporation is an independent oil and gas exploration and production company. Following the closing of the transactions contemplated by the Exchange Agreement on August 1, 2016, the company disposed of its CO2-EOR activities and continues to own exploration acreage in the Weald Basin, onshore U.K., and an exploration block, NT/P82, in the Bonaparte Basin, offshore Northern Territory, Australia. Magellan routinely posts important information about the company on its website at www.magellanpetroleum.com.

ABOUT TELLURIAN INVESTMENTS
Tellurian Investments is a private company founded by Charif Souki and Martin Houston. It is underpinned by a group of experienced industry experts developing a low-cost, mid-scale liquefied natural gas (LNG) project (Driftwood LNG) in Louisiana on United States Gulf Coast. The team delivers results by focusing on cost and simple design, using world-scale components but within a modular and multiple, mid-scale unit design. The team has delivered cost-leading LNG projects over more than 50 years with its deep collective knowledge and expertise. This enables Tellurian to be confident about establishing a new global standard for low-cost LNG manufacturing. For more information, please see the company’s website at www.tellurianinvestments.com.

For further information, please contact:

Magellan Petroleum Corporation
Antoine Lafargue
Senior Vice President — CFO, Treasurer, and Corporate Secretary
720.484.2404
IR@magellanpetroleum.com

Tellurian Investments
Joi Lecznar
Public Affairs and Communication
832.962.4044
joi.lecznar@tellurianinvestments.com

Wednesday, August 3rd, 2016 Uncategorized Comments Off on $MPET Announces #Strategic #Merger and Enters the #LNG Business

$EXPI #Brokerage Division Surpasses 1,500 Agents; Significant #Changes & #Growth

eXp World Holdings, Inc. (EXPI) Brokerage Division Surpasses 1,500 Agents

Earlier today, eXp World Holdings, Inc. (OTCQB: EXPI) announced that eXp Realty, its real estate brokerage division, has surpassed 1,500 agents across all of its operating markets in the United States and Canada. This growth milestone continues to build on an impressive start to 2016 for the company, with overall agent count expanding by more than 57 percent since January 1, when EXPI reported 864 agents.

“eXp Realty continues to attract Increasing numbers of top agents who are entrepreneurial in their approach to the business and who recognize agent ownership as a fundamental shift in the way in which real estate professionals are valued as partners,” Glenn Sanford, founder and chief executive officer of EXPI, stated in today’s news release. “The Company is excited about its current growth trajectory and is continually looking to attract high quality professionals to the brokerage.”

eXp Realty’s growth is particularly compelling when studying the company’s recent history. Originally launched in October 2009, the Agent-Owned Cloud Brokerage™ introduced an aggressive revenue sharing program that offers agents a percentage of the gross commission income earned by professionals they recruit to the company. While this idea represented an innovative take on the traditional real estate brokerage business model, EXPI uncovered a formula for accelerated growth and retention in 2014. After listing as a public company in 2013, EXPI instituted an equity-sharing initiative with its agents and brokers that has helped it establish a sizable foothold in major real estate markets across North America.

In late June, the benefits of eXp Realty’s high-engagement, low overhead business model were on display when Sally and Stephen Koss, founders of Greater Boston’s Landmark Group, decided to join the eXp team after more than three decades within the RE/MAX (NYSE: RMAX) system. When interviewed about the change, Sally Koss pointed toward EXPI’s ownership opportunities as a real game changer in the real estate industry.

“With eXp we have access to ground-breaking real estate technology to better serve our agents and clients,” she stated in a news release. “Most importantly though, we are able to thank our agents by providing them with the very same opportunities that we have — ownership as fellow shareholders able to build organizations within and across markets. While there are other companies in the industry that are publicly held, the driving force behind eXp’s public company status is to give direct ownership to its agents and brokers.”

In recent weeks, EXPI has continued to build on its success in growing the eXp Realty brand. The company added brokerage operations in both Utah and New Jersey in mid-July, expanding its national network to include 43 states, in addition to the District of Columbia. EXPI also recently announced the additions of Rick Miller and Randall Miles as independent members of its board of directors, and industry veteran Russ Cofano was introduced as the company’s chief strategy officer and general counsel. All three of these individuals are expected to play key roles in EXPI’s continued development, both within the public financial markets and as a rapidly-growing organization.

For more information, visit the company’s website at http://investors.exprealty.com

eXp World Holdings, Inc. (EXPI) Reports Significant Changes and Growth for the Month of July

Xp World Holdings, Inc. (OTCQB: EXPI) is the holding company for eXp Realty LLC, the Agent-Owned Cloud Brokerage™. The company is a cloud-based real estate brokerage service for residential homing in North America. With this cloud platform, agents and brokers build their businesses from the comforts of their own homes. As a result, they can work, attend classes, strategize, and innovate, no matter where they are in the world.

With recent advances in technology, the 21st century consumer is even more equipped to make an informed decision when buying a home. Through EXPI’s cloud environment, prospective buyers can see more images, read more information on properties, and have more overall context, while still enjoying the ongoing support of a professional real estate team.

The month of July proved especially successful for EXPI. The company recently announced the appointment of three new, key members of the team. These include Russ Cofano, who has been appointed as chief strategy officer and general counsel, along with Rick Miller and Randall Miles, who have joined the company as part of the board of directors. Between them, these new members bring over 75 years of experience and expertise in the fields of real estate, brokerage, sales, leadership, finance, financial technology, and much more.

Aside from new appointments to the management and directors teams, EXPI will now operate in both New Jersey and Utah. The two new expansions will be led by Jeanne Borgers and Rick Southwick, two recognized leaders in the areas. As a result of this, EXPI is now operational in 43 States, as well as Alberta, Canada, and the District of Columbia, and is featured in more than 105 different Multiple Listing Services.

To top off the good news for July, eXp Realty has officially reached more than 1,400 real estate professionals, a number that grew by 67 between the 1st and 15th of July, and one that has grown from 862 since the beginning of 2016. In addition, at the beginning of the month, EXPI had a revamp of the eXp World cloud environment, enabling the company to leverage systems and tools that allow them to continue to provide consumers with efficient and quality services without the added expenses and burdens of brick and mortar facilities.

For more information, visit the company’s website at http://investors.exprealty.com

Wednesday, August 3rd, 2016 Uncategorized Comments Off on $EXPI #Brokerage Division Surpasses 1,500 Agents; Significant #Changes & #Growth

$HRTX Enters into #LoanAgreement for Up to $100 Million

Heron Therapeutics, Inc. (NASDAQ:HRTX), has entered into an agreement with Tang Capital Partners, LP whereby Tang Capital will lend the Company up to $100 million. The loan will have a two-year term and bear interest of 8% per annum. The first close of $50 million is expected to occur within five business days. The second close of an additional $50 million is subject to the achievement of a corporate milestone. There are no fees, no warrants and no equity conversion feature associated with this transaction.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain. For more information, visit www.herontx.com.

Forward-Looking Statements

This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release, and involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, those associated with: the projected sufficiency of our capital position for future periods, our ability to repay any indebtedness, and other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as Investor Relations and Media Contact:
Heron Therapeutics, Inc.
Jennifer Capuzelo, 858-703-6063
Associate Director, Investor Relations
jcapuzelo@herontx.com

Tuesday, August 2nd, 2016 Uncategorized Comments Off on $HRTX Enters into #LoanAgreement for Up to $100 Million

$TCMD Announces Closing of #IPO

MINNEAPOLIS, Aug. 02, 2016  — Tactile Systems Technology, Inc. (“Tactile Medical”) (Nasdaq:TCMD), a medical technology company that develops innovative medical devices for the treatment of chronic diseases at home, announced today the closing of its initial public offering of 4,120,000 shares of common stock at a public offering price of $10.00 per share, before underwriting discounts and commissions.  All shares of the common stock in this offering are being sold by Tactile Medical.  Tactile Medical’s common stock began trading on The NASDAQ Global Market on July 28, 2016 under the ticker symbol “TCMD.”

Piper Jaffray & Co., William Blair & Company, L.L.C, and Canaccord Genuity Inc. acted as joint book-running managers for the offering. BTIG, LLC acted as co-manager for the offering.

A registration statement relating to the securities being sold in this offering was declared effective by the U.S. Securities and Exchange Commission on July 27, 2016. This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained by contacting: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@pjc.com, or William Blair & Company L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, by telephone at (800) 621-0867, or by email at prospectus@williamblair.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Investor Inquiries:

Mike Piccinino
Managing Director
Westwicke Partners 
(443) 213-0500
investorrelations@tactilemedical.com

Media Inquiries:

Kristen Weaver
Director of Marketing Communications 
Tactile Medical
(612) 355-5116
Tuesday, August 2nd, 2016 Uncategorized Comments Off on $TCMD Announces Closing of #IPO

$SKYS Announces #Acquisition of 164 MW of #Solar Project #Permits in the #US

HONG KONG and SAN MATEO, Calif., Aug. 02, 2016  — Sky Solar Holdings, Ltd. (NASDAQ:SKYS) (“Sky Solar” or the “Company”), a global developer, owner and operator of solar parks, today announced that Sky Capital America Inc. (“Sky Capital”), Sky Solar’s wholly-owned U.S. subsidiary, has completed an acquisition of 22.5MW development stage permits for the solar projects in California and Vermont from a California-based solar energy development company.

The Company aims to enter into definitive documents for the acquisition of an additional approximately 140MW of development stage solar project permits primarily in California, from the same solar energy development company within the third quarter of 2016. Sky Solar expects to complete the development and construction of these projects in the next 18-24 months.

Mr. Sanjay Shrestha, President of Sky Capital, commented, “Over the last few months, we have substantially expanded our US portolio by acquiring high-quality assets with attractive returns. This acquisition represents another example of our commitment to our long-term growth strategy as well as our efforts to strengthen our presence in the US market. We look forward to expanding our presence in the Americas region by adding high-quality projects with investment grade offtakers.”

About Sky Solar Holdings, Ltd.

Sky Solar is a global independent power producer (“IPP”) that develops, owns and operates solar parks and generates revenue primarily by selling electricity. Since its inception, Sky Solar has focused on the downstream solar market and has developed projects in Asia, South America, Europe, North America and Africa. The Company’s broad geographic reach and established presence across key solar markets are significant differentiators that provide global opportunities and mitigate country-specific risks. Sky Solar aims to establish operations in select geographies with highly attractive solar radiation, regulatory environments, power pricing, land availability, financial access and overall power market trends. As a result of its focus on the downstream photovoltaic segment, Sky Solar is technology agnostic and is able to customize its solar parks based on local environmental and regulatory requirements. As of March 31, 2016, the Company had developed 276 solar parks with an aggregate capacity of 259.1 MW and owned and operated 133.1 MW of solar parks.

Safe-Harbor Statement

This press release contains forward-looking statements. These statements constitute “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 as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to the following: the reduction, modification or elimination of government subsidies and economic incentives; global and local risks related to economic, regulatory, social and political uncertainties; resources we may need to familiarize ourselves with the regulatory regimes, business practices, governmental requirements and industry conditions as we enter into new markets; global liquidity and the availability of additional funding options; the delay between making significant upfront investments in the Company’s solar parks and receiving revenue; expansion of the Company’s business into the U.S. and China; risk associated with the Company’s limited operating history, especially with large-scale IPP solar parks; risk associated with development or acquisition of additional attractive IPP solar parks to grow the Company’s project portfolio; and competition. Further information regarding these and other risks is included in Sky Solar’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

For investor and media inquiries, please contact:

Sky Solar:

IR@skysolarholding.com

SKYS Investor Relations:

ICR, LLC
Vera Tang
(646) 277-1215
Vera.tang@icrinc.com
Tuesday, August 2nd, 2016 Uncategorized Comments Off on $SKYS Announces #Acquisition of 164 MW of #Solar Project #Permits in the #US

$VECO Announces Upcoming Investor Events

PLAINVIEW, NY–(August 02, 2016) – Veeco Instruments Inc. (NASDAQ: VECO) today announced that management is scheduled to present at the following webcasted investor conferences:

  • Canaccord Growth Conference at the InterContinental Hotel in Boston, MA on Wednesday, August 10, 2016 at 1:00 PM ET
  • Deutsche Bank Technology Conference at the Encore at Wynn Las Vegas in Las Vegas, NV on Wednesday, September 14, 2016 at 5:40 PM ET

The presentations will be broadcast live and can be accessed on the investor relations section of Veeco’s website at ir.veeco.com. A webcast replay will be made available on the website for a minimum of two weeks following the original dates.

Veeco management is also scheduled to participate in the following non-webcasted investor conferences:

  • Needham Advanced Industrial Technologies Conference at Needham’s Corporate Headquarters in New York, NY on Thursday, August 4, 2016
  • Pacific Crest Global Technology Leadership Forum at the Sonnenalp Hotel in Vail, CO on Monday, August 8, 2016

About Veeco

Veeco’s process equipment solutions enable the manufacture of LEDs, displays, power electronics, compound semiconductors, hard disk drives, semiconductors, MEMS and wireless chips. We are the leader in MOCVD, MBE, Ion Beam, Wet Etch single wafer processing and other advanced thin film process technologies. Our high performance systems drive innovation in energy efficiency, consumer electronics and network storage and allow our customers to maximize productivity and achieve lower cost of ownership. For information on our company, products and worldwide service and support, please visit www.veeco.com.

To the extent that this news release discusses expectations or otherwise makes statements about the future, such statements are forward-looking and are subject to a number of risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include the risks discussed in the Business Description and Management’s Discussion and Analysis sections of Veeco’s Annual Report on Form 10-K for the year ended December 31, 2015 and in our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K and press releases. Veeco does not undertake any obligation to update any forward-looking statements to reflect future events or circumstances after the date of such statements.

Veeco Contacts:
Investors:
Shanye Hudson
516-677-0200 x1272
shudson@veeco.com

Media:
Jeffrey Pina
516-677-0200 x1222
jpina@veeco.com

Tuesday, August 2nd, 2016 Uncategorized Comments Off on $VECO Announces Upcoming Investor Events

$ADXS & $AMGN Enter #Global #Cancer #Immunotherapies #Collaboration

Collaboration Will Advance Highly Targeted, Patient-Specific Treatment Approach Advaxis Will Hold a Teleconference at 9:30 a.m. ET Today

THOUSAND OAKS, Calif. and PRINCETON, N.J., Aug. 2, 2016  — Amgen (NASDAQ:AMGN) and Advaxis, Inc. (NASDAQ:ADXS) today announced a global agreement for the development and commercialization of Advaxis’ ADXS-NEO, a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient’s tumor. This collaboration brings together Amgen’s development expertise in immuno-oncology with Advaxis’ MINE™ (My Immunotherapy Neo-Epitopes) program, which is uniquely positioned to develop a customized approach to cancer treatment.

Under the terms of the agreement, Amgen receives exclusive worldwide rights to develop and commercialize ADXS-NEO. Amgen will make an upfront payment to Advaxis of $40 million and purchase $25 million of Advaxis common stock. Amgen will be fully responsible for funding clinical and commercial activities. Advaxis will lead the clinical development of ADXS-NEO through proof-of-concept, retain manufacturing responsibilities, and receive development, regulatory and sales milestone payments of up to $475 million and potential high single digit to mid-double digit royalty payments based on worldwide sales.

“Amgen’s collaboration with Advaxis leverages and enhances our development and commercialization expertise in novel immuno-oncology treatments,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to partnering with Advaxis to advance this highly targeted and patient-specific treatment option for patients.”

“Amgen is a pioneer in the science of using living cells to develop biologic medicines, making them an incredibly strong partner to develop and commercialize Advaxis’ MINE,” said Daniel J. O’Connor, president and chief executive officer at Advaxis. “With Amgen’s resources, worldwide reach and a culture that embraces science and innovation, we are positioned to accelerate the clinical development program for ADXS-NEO to improve the lives of those who suffer from cancer.”

The Advaxis Lm Technology™ utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. For ADXS-NEO, DNA from each patient’s primary tumor and/or metastases as well as normal cells, is sequenced and compared to identify mutations in genes coding for potential neo-antigens in the cancer. Advaxis then engineers and manufactures patient-specific Lm-LLO (listeriolysin O) vectors capable of immunizing them against neoepitopes exclusive to their cancer. After the ADXS-NEO infusion, neoepitope peptides corresponding to each patient’s cancer-associated mutations are delivered directly into their antigen presenting cells by Lm-LLO, where they can stimulate cellular immune responses against multiple neoepitopes simultaneously. Clinical trials for ADXS-NEO are expected to begin in 2017.

About MINE™ (My Immunotherapy Neo-Epitopes) / ADXS-NEO
MINE™ (My Immunotherapy Neo-Epitopes) and ADXS-NEO are designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in each individual patient’s tumor. This strategy, using massive parallel sequencing, eliminates the need for predictive algorithms and enables the development of truly personalized immunotherapies that can be manufactured in a manner that is cost-effective and timely for patients.

MINE™ will evaluate the immunologic and anti-tumor activity of this patient tumor-specific, neoepitope-based immunotherapy. Advaxis and Amgen will use learnings from MINE to identify and target neoepitopes using Lm Technology™ and later develop patient specific immunotherapy constructs that incorporate the neoepitope sequences identified in the patient’s tumor cells. Clinical studies using ADXS-NEO are in development.

Conference Call and Webcast
Advaxis will host a conference call today, Aug. 2, 2016, beginning at 9:30 a.m. ET. Please see below for details.

Conference call numbers:
Domestic/Canada: 888-466-4442
International: 719-325-2480
Conference ID: 2246109
Webcast: http://public.viavid.com/index.php?id=120644

Accessible via the Investor Relations section of Advaxis’ website: http://ir.advaxis.com/

A replay of the conference call and webcast will be available beginning approximately one hour after the completion of the call. Access numbers for this replay are 1 (877) 870-5176 (U.S./Canada) and 1 (858) 384-5517 (international); conference ID: 2246109.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer-fighting T cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapy, axalimogene filolisbac (AXAL), targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation for each of these three clinical settings, as well as a Special Protocol Assessment for the Phase 3 AIM2CERV trial in patients with high risk, locally advanced cervical cancer. AXAL has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies. Advaxis has two additional immunotherapy products in human clinical development: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2-expressing solid tumors. Advaxis has received Fast Track Designation for ADXS-HER2 for the treatment of patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma and for AXAL for the treatment of high-risk locally advanced cervical cancer.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and 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.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with its products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen’s stock price may be volatile and may be affected by a number of events. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Advaxis Forward-Looking Statement
This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’ proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’ SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2015, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Amgen, Thousand Oaks
Kristen Neese, 805-313-8267 (media)
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609-250-7515

JPA Health Communications (media)
David Connolly
dconnolly@jpa.com
617-543-3915

Tuesday, August 2nd, 2016 Uncategorized Comments Off on $ADXS & $AMGN Enter #Global #Cancer #Immunotherapies #Collaboration

$TRXC Announces First Sale of ALF-X #Surgical #Robotic System

TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the first global sale of its ALF-XⓇ Surgical Robotic System to Humanitas Hospital in Milan, Italy.

“We are pleased to announce the first global sale of our ALF-X System,” said Todd M. Pope, President and CEO of TransEnterix. “Humanitas is an outstanding academic hospital with a respected multi-specialty surgical program. The ALF-X enables an enhanced surgical program through the use of advanced robotic technology with responsible procedural economics.”

“The initiation of sales of ALF-X represents an important milestone towards realizing our vision to transform surgical robotics,” continued Mr. Pope. “We have made substantial progress building out our global commercial, distribution and service capabilities throughout 2016.”

The ALF-X System is CE Marked and is indicated for use in general surgery, gynecology, urology and thoracic surgery. We are actively preparing a submission for U.S. FDA Clearance for the ALF-X System.

About Humanitas

Humanitas is a highly specialized research and teaching hospital partnered with Humanitas University Medical School. Humanitas University trains globally-oriented healthcare professionals through state-of-the-art interactive teaching methods and close integration with their clinical and research community. Humanitas believes that it is essential to unite organizational efficiency and clinical quality. For this reason, it was the first Italian general hospital and one of the few in Europe, to be certified for quality by the International Joint Commission.

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the ALF-X Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The company is also developing the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The ALF-X Surgical System has been granted a CE Mark but is not available for sale in the US. For more information, visit the TransEnterix website at www.transenterix.com.

Forward Looking Statements

This press release includes statements relating the ALF-X® System and SurgiBot™ System and our current regulatory and commercialization plans for these products. These statements and other statements regarding our future plans and goals constitute “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, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K filed on March 3, 2016, our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, 443-213-0501
invest@transenterix.com
or
Media Contact:
Mohan Nathan, 919-765-8400
media@transenterix.com

Monday, August 1st, 2016 Uncategorized Comments Off on $TRXC Announces First Sale of ALF-X #Surgical #Robotic System

$MCEP Announces #Permian Bolt-On #Acquisition

TULSA, Aug. 01, 2016  — Mid-Con Energy Partners, LP (NASDAQ:MCEP) (“Mid-Con Energy” or the “Partnership”) through its wholly owned subsidiary, Mid-Con Energy Properties, LLC, announces that on July 28, 2016 it has entered into a definitive agreement to acquire oil and natural gas properties in Nolan County, Texas, for an aggregate purchase price of approximately $19.5 million.  The acquisition is subject to customary post-closing adjustments and is expected to close on or before August 12, 2016, with an effective date of June 1, 2016.  The acquisition will be funded through private financing from investors including affiliates of Bonanza Capital, Investor John Goff, and Swank Capital.  Effective upon the closing of the asset purchase, the Partnership also announces that it has received unanimous lender support to increase the pro forma conforming borrowing base of its revolving credit facility to $140 million subject to execution of Amendment No. 10 to the credit agreement.

“Since announcing the results of our spring 2016 redetermination, we made a concerted effort to re-establish a conforming borrowing base without exclusively relying on a rebound in commodity price,” commented Jeff Olmstead, Mid-Con Energy’s Chief Executive Officer.  “We believe that the strategy announced today enhances the Partnership’s outlook on multiple fronts.  The equity-weighted acquisition allows us to bolt-on multiple low operating cost, oil producing properties adjacent to our existing Permian position, while improving our overall debt metrics, collateral coverage, and financial flexibility.  We are grateful for the efforts of all parties involved, and look forward to focusing on opportunities to grow in this challenged commodity price environment.”

PERMIAN ACQUISITION HIGHLIGHTS

  • Mid-Con Energy acquires ~96% average working interest and will assume operatorship upon closing
  • Properties include 27 producing wells, 11 injection wells, and 3 inactive wells
  • Net proved reserves of ~1.5 MMBoe audited by Cawley, Gillespie and Associates, Inc.
  • Reserves ~57% proved developed producing and ~99% oil with a reserve-to-production ratio of ~11.2 years
  • Average net daily production of 368 Boe/d (~96% oil) calculated based on trailing three-month average ended June 30, 2016
  • Historical lease operating expenses average approximately $12/Boe based on trailing three-month period ended June 30, 2016
  • Production taxes approximate 4.6%

ABOUT MID-CON ENERGY PARTNERS, LP
Mid-Con Energy is a publicly held Delaware limited partnership formed in July 2011 to own, acquire, exploit and develop producing oil and natural gas properties in North America, with a focus on Enhanced Oil Recovery.  Mid-Con Energy’s core areas of operation are located in Southern Oklahoma, Northeastern Oklahoma, the Gulf Coast, and the Permian.  For more information, please visit Mid-Con Energy’s website at www.midconenergypartners.com.

FORWARD-LOOKING STATEMENTS
This press release includes “forward-looking statements” — that is, statements related to future, not past, events within meaning of the federal securities laws. Forward-looking statements are based on current expectations and include any statement that does not directly relate to a current or historical fact. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as “anticipate,” “believe,” “estimate,” “intend,” “expect,” “plan,” “project,” “should,” “goal,” “forecast,” “guidance,” “could,” “may,” “continue,” “might,” “potential,” “scheduled,” or “will” or other similar words. These forward-looking statements involve certain risks and uncertainties and ultimately may not prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. For further discussion of risks and uncertainties, you should refer to Mid-Con Energy’s filings with the Securities and Exchange Commission (“SEC”) available at www.midconenergypartners.com or www.sec.gov. Mid-Con Energy undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement and our SEC filings. Please see the risks and uncertainties detailed in the “Forward-Looking Statements” of our public filings.

INVESTOR RELATIONS CONTACT
IR@midcon-energy.com
(918) 743-7575
Monday, August 1st, 2016 Uncategorized Comments Off on $MCEP Announces #Permian Bolt-On #Acquisition

$IONS & $BIIB #Nusinersen Meets Primary Endpoint

— Biogen Intends to File Marketing Applications for Nusinersen with Regulatory Authorities in the Coming Months —

— Biogen Exercises Option to Develop and Commercialize Nusinersen Globally —

— Companies to Host Webcast Today at 9:00 a.m. EDT to Provide Program Update —

Biogen (NASDAQ:BIIB) and Ionis Pharmaceuticals (NASDAQ:IONS) today announced that nusinersen, their investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint pre-specified for the interim analysis of ENDEAR, the Phase 3 trial evaluating nusinersen in infantile-onset (consistent with Type 1) SMA. The analysis found that infants receiving nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment. Nusinersen demonstrated an acceptable safety profile in the trial. As a result of these findings, Biogen has exercised its option to develop and commercialize nusinersen globally and paid Ionis a $75 million license fee. Biogen will initiate regulatory filings globally in the coming months.

“We are grateful to the families participating in the clinical trials, who continue to inspire us. We want to thank them, along with the investigators who have worked tirelessly on this program and the broader SMA community, for their partnership. Without their contributions, we would not be here today,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “We share the community’s sense of urgency as we strive to bring the first treatment for SMA, the leading genetic cause of infant mortality, to families facing this devastating disease. We remain committed to understanding the potential of nusinersen in the broader SMA population and will continue to focus on the rapid completion of our ongoing studies.”

Based on the results of the pre-specified interim analysis, the ENDEAR study will be stopped and participants will be able to transition into the SHINE open-label study in which all patients receive nusinersen. Data from the other endpoints of ENDEAR will be analyzed when the full data set is available. Results will be presented at future medical congresses. Additionally, participants enrolled in the sham-controlled arm of EMBRACE, a Phase 2 study which also included infantile-onset patients, will have the opportunity to receive nusinersen.

The other studies in the nusinersen program, including CHERISH (later-onset consistent with Type 2) and NURTURE (pre-symptomatic infants), will continue as planned in order to collect the data to demonstrate the safety and efficacy of nusinersen in these populations.

“We are hopeful that nusinersen, if approved, will make a meaningful difference in the lives of patients and families affected by SMA. We look forward to working with Biogen on completing the clinical program and preparing for what we hope is a positive regulatory review,” said B. Lynne Parshall, chief operating officer at Ionis Pharmaceuticals. “Nusinersen is the first antisense drug from our neurological disease franchise to advance to regulatory review, and it illustrates the potential of our antisense technology to address severe diseases that other therapeutic modalities are unable to address adequately.”

Biogen is working to open a global expanded access program (EAP) for eligible patients with infantile-onset SMA (consistent with Type 1) in the coming months. The EAP can be initiated at existing nusinersen clinical trial sites in countries where EAPs are permitted according to local laws and regulations, can be operationalized, and where there is a path that can support long-term availability of nusinersen. Once the EAP is operational and required local approvals are in place, individual participating sites may start enrollment after they have transitioned ENDEAR study participants to the open-label extension study.

“Today is a hopeful day for the SMA community, which has worked tirelessly to support research and development for this terrible disease. Many of our families have participated in this and other clinical trials in order to advance our understanding of SMA. We are excited about reaching this important milestone, and the opportunity these results create to potentially bring the first treatment option for SMA to patients and families. We will continue to relentlessly support research into SMA until we have therapies for all and, ultimately, a cure,” commented Kenneth Hobby, President, Cure SMA.

Biogen is now responsible for all nusinersen development, regulatory and commercialization activities and costs. Ionis will complete the Phase 3 studies and work with Biogen on regulatory filings. The two companies will also work together to transition the clinical programs that Ionis is conducting to Biogen. Ionis is eligible to receive tiered royalties on any potential sales of nusineren up to a percentage in the mid-teens, in addition to up to $150 million in milestone payments based on regulatory approvals.

Webcast

The companies will host a live webcast to discuss the results of the Phase 3 ENDEAR interim results for nusinersen today, August 1, 2016, from 9:00 to 9:30 a.m. EDT. Participants may access the webcast through the Investors section of www.biogen.com or www.ionispharma.com. Following the live webcast, an archived version of the call will be available at the same URLs for one month.

The Nusinersen Clinical Trial Program

The nusinersen Phase 3 program is comprised of two registrational studies, ENDEAR and CHERISH. ENDEAR is a thirteen-month study investigating nusinersen in 122 patients with infantile-onset SMA; the onset of signs and symptoms of SMA less than or equal to 6 months and age less than or equal to 7 months at screening. Based on insights gained from earlier-stage studies and discussions with regulators, a primary endpoint was added to ENDEAR earlier this year that evaluates the proportion of motor milestone responders from the motor component of the Hammersmith Infant Neurological Examination (HINE).

CHERISH is a fifteen-month study investigating nusinersen in 126 non-ambulatory patients with later-onset SMA; onset of signs and symptoms greater than 6 months and age 2 to 12 years at screening. CHERISH was fully enrolled in May 2016.

Additionally, the SHINE open-label extension study for patients who previously participated in ENDEAR and CHERISH is open and is intended to evaluate the long-term safety and tolerability of nusinersen.

Two additional Phase 2 studies, EMBRACE and NURTURE, were designed to collect additional data on nusinersen. The EMBRACE study is designed to collect additional data on a small subset of patients with infantile or later-onset SMA who do not meet the age and other criteria of ENDEAR or CHERISH. NURTURE is an ongoing study in pre-symptomatic infants who are less than or equal to 6 weeks of age at time of first dose to determine if treatment before symptoms begin would prevent or delay the onset of SMA symptoms. All studies are being conducted on a global scale.

About SMA1-5

Spinal Muscular Atrophy (SMA) is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic functions of life, like breathing and swallowing.

Due to a loss of, or defect in the SMN1 gene, people with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with Type 1 SMA, the most severe life-threatening form, produce very little SMN protein and do not achieve the ability to sit without support or live beyond 2 years without respiratory support. People with Type 2 and Type 3 produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA.

Currently, there is no approved treatment for SMA.

About Nusinersen

Nusinersen is an investigational, potentially disease-modifying therapy6 for the treatment of SMA. Nusinersen is an antisense oligonucleotide (ASO) that is designed to alter the splicing of SMN2, a gene that is nearly identical to SMN1, in order to increase production of fully functional SMN protein. 7

ASOs are short synthetic strings of nucleotides designed to selectively bind to target RNA and regulate gene expression.Through use of this technology, nusinersen has the potential to increase the amount of functional SMN protein in infants and children with SMA.

Both the U.S. and EU regulatory agencies have granted special status to nusinersen in an effort to expedite the review process, including Orphan Drug Status and Fast Track Designation in the U.S. and Orphan Drug Designation in the EU.

We acknowledge support from the following organizations for nusinersen: Muscular Dystrophy Association, SMA Foundation, Cure SMA and intellectual property licensed from Cold Spring Harbor Laboratory and the University of Massachusetts Medical School.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

About Ionis Pharmaceuticals Inc.

Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases. Using its proprietary antisense technology, Ionis has created a large pipeline of first-in-class or best-in-class drugs, with over a dozen drugs in mid- to late-stage development. Drugs currently in Phase 3 development include volanesorsen, a drug Ionis is developing and plans to commercialize through its wholly owned subsidiary, Akcea Therapeutics, to treat patients with either familial chylomicronemia syndrome or familial partial lipodystrophy; IONIS-TTRRx, a drug Ionis is developing with GSK to treat patients with all forms of TTR amyloidosis; and nusinersen, a drug Ionis is developing with Biogen to treat infants and children with spinal muscular atrophy. Ionis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Ionis is available at www.ionispharma.com.

Biogen Safe Harbor

This press release contains forward-looking statements, including statements relating to the safety and efficacy of nusinersen, as well as clinical trial results and plans, potential regulatory filings and expected timelines, including expanded access for nusinersen, including the transition of the ENDEAR and EMBRACE clinical trial study participants to an open label study and the timing thereof, the submission of applications to regulatory authorities and the timing thereof, and the opening of an EAP and the timing thereof. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from our current expectations include the actual timing and content of submissions to and decisions made by the regulatory authorities regarding marketing authorization applications for nusinersen, the actual timing and final results of the nusinersen clinical trials and the uncertainties involved in operationalizing an EAP. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

Ionis Forward-looking Statement

This press release includes forward-looking statements regarding Ionis’ strategic relationship with Biogen and the development, activity, therapeutic potential, safety and commercialization of nusinersen. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2015, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

BIOGEN and the BIOGEN logo are registered trademarks of BIOGEN.

Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark of Ionis Pharmaceuticals, Inc.

1. Darras B, Markowitz J, Monani U, De Vivo D. Chapter 8 – Spinal Muscular Atrophies. In: Vivo BTD, ed. Neuromuscular Disorders of Infancy, Childhood, and Adolescence (Second Edition). San Diego: Academic Press; 2015:117-145.
2. Lefebvre S, Burglen L, Reboullet S, et al. Identification and characterization of a spinal muscular atrophy-determining gene. Cell. 1995;80(1):155-165.
3. Mailman MD, Heinz JW, Papp AC, et al. Molecular analysis of spinal muscular atrophy and modification of the phenotype by SMN2. Genet Med. 2002;4(1):20-26.
4. Monani UR, Lorson CL, Parsons DW, et al. A single nucleotide difference that alters splicing patterns distinguishes the SMA gene SMN1 from the copy gene SMN2. Hum Mol Genet. 1999;8(7):1177-1183.
5. Peeters K, Chamova T, Jordanova A. Clinical and genetic diversity of SMN1-negative proximal spinal muscular atrophies. Brain. 2014;137(Pt 11):2879-2896.
6. Rigo F, Hua Y, Krainer AR, Bennett CF. Antisense-based therapy for the treatment of spinal muscular atrophy. J Cell Biol. 2012;199(1):21-25
7. Hua Y, Sahashi K, Hung G, Rigo F, Passini MA, Bennett CF, Krainer AR. Antisense correction of SMN2 splicing in the CNS rescues necrosis in a type III SMA mouse model. Genes Dev. 2010 Aug 1;24(15):1634-44

 

Media:
Biogen
Todd Cooper, +1 781-464-3260
public.affairs@biogen.com
or
Ionis Pharmacuticals
Wade Walke, +1 760-603-2741
CorpComm@ionisph.com
or
Investor:
Biogen
Ben Strain, +1 781-464-2442
IR@biogen.com
or
Ionis Pharmaceuticals
Wade Walke, +1 760-603-2741
CorpComm@ionisph.com

Monday, August 1st, 2016 Uncategorized Comments Off on $IONS & $BIIB #Nusinersen Meets Primary Endpoint

$OGEN Receipt of Payment in Full, #Sale of Consumer #Probiotic Business

Oragenics, Inc. (NYSE MKT: OGEN.BC) (the “Company”), a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis, today announced it has received payment in full of the $450,000 promissory note issued to the Company in connection with the previously announced sale of its Consumer Probiotic Business to ProBiora Health, LLC, an entity owned by Ms. Christine L. Koski. The receipt of this payment finalizes the payment to the Company of the $1,700,000 purchase price of which $1,250,000 was previously paid to the Company at closing and, as previously announced, ProBiora Health, LLC will also be obligated to pay the Company contingent consideration annually over a 10 year period based on a percentage of sales of products using the Purchased Assets, with a maximum obligation to the Company of $2,000,000.

About Oragenics, Inc.

We are focused on becoming a leader in novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon Corporation, a synthetic biology company. The collaborations allow Oragenics access to Intrexon’s proprietary technologies toward the goal of accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus.

For more information about Oragenics, visit www.oragenics.com.

Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect management’s current views with respect to future events and performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, our current need for financing to meet our operational needs and to be able to move our product candidates forward through pre-clinical and clinical development, our inability to obtain sufficient financing to conduct our business; any inability to obtain or delays in the Food and Drug Administration approval for future clinical studies and testing, the future success of our studies and testing and any inability to also achieve favorable results in human studies, our ability to successfully develop and commercialize products, the financial resources available to us to continue research and development, any inability to regain compliance with the NYSE MKT continued listing requirements and those other factors described in our filings with the U.S. Securities and Exchange Commission. Any responsibility to update forward-looking statements is expressly disclaimed.

 

Oragenics, Inc.
Michael Sullivan, 813-286-7900 x232
Chief Financial Officer
msullivan@oragenics.com
or
Investor/Media Contact:
The Ruth Group
David Burke, 646-536-7009
dburke@theruthgroup.com

Monday, August 1st, 2016 Uncategorized Comments Off on $OGEN Receipt of Payment in Full, #Sale of Consumer #Probiotic Business

$GRC Declares #Cash #Dividend

The Board of Directors of The Gorman-Rupp Company (NYSE MKT: GRC) has declared a quarterly cash dividend of $0.105 per share on the common stock of the Company, payable September 9, 2016, to shareholders of record August 15, 2016. This marks the 266th consecutive quarterly dividend paid by The Gorman-Rupp Company.

Brigette A. Burnell
Corporate Secretary
The Gorman-Rupp Company
Telephone (419) 755-1246
NYSE MKT: GRC

 

The Gorman-Rupp Company
Wayne L. Knabel, Chief Financial Officer, 419-755-1397

Friday, July 29th, 2016 Uncategorized Comments Off on $GRC Declares #Cash #Dividend

$AVXL Confirms #Phase2a Study of #ANAVEX 2-73 in #Alzheimer’s

NEW YORK, July 29, 2016 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), confirms the information in the July 27, 2016 press release announcing positive results from the Phase 2a Alzheimer’s trial for ANAVEX 2-73.

Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, commented:  “To interpret the ANAVEX 2-73 results presented at the 2016 AAIC meeting, it is important to keep in mind the stated goals of this first in Alzheimer’s patients study.  This was a Phase 2a study, primarily designed to determine which ANAVEX 2-73 dosages are safe to administer to mild to moderate stage Alzheimer’s patients.  The study was successful in establishing the maximum tolerated dose and in revealing the range of ANAVEX 2-73 doses that are well-tolerated by Alzheimer patients. It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks.  However, this analysis was based on pooled data from a relatively small number of subjects receiving a variety of doses.  It is therefore unlikely that these findings reflect the full potential ANAVEX 2-73 in treating Alzheimer’s disease.  It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive.  Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.“

Anavex confirms that there has been no change with regards to its science, data or the fundamentals of the Company. Anavex remains dedicated to advancing ANAVEX 2-73 and will be reporting new data to investors as it becomes available.

Anavex confirms the data included in its news release dated July 27, 2016.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email:  info@anavex.com

Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com 

Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
Friday, July 29th, 2016 Uncategorized Comments Off on $AVXL Confirms #Phase2a Study of #ANAVEX 2-73 in #Alzheimer’s

$KGJI Sells Jewelry Park for Approximately $171 Million

Company will Focus on Expansion of its Core Jewelry Business; Will Relocate Its Headquarters to the Jewelry Park

WUHAN CITY, China, July 29, 2016 — Kingold Jewelry, Inc. (“Kingold” or “the Company”) (NASDAQ: KGJI), one of China’s leading manufacturers and designers of high quality 24-karat gold jewelry, ornaments and investment-oriented products, today announced that Wuhan Kingold Jewelry Company Limited (“Wuhan Kingold”), the controlled subsidiary of the Company, has sold all of its interest in the Shanghai Creative Industry Park, or the Kingold Jewelry Cultural Industry Park (the “Jewelry Park”) to Wuhan Lianfuda Investment Management Co., Ltd. (“Wuhan Lianfuda”) for RMB 1.14 billion (approximately US$ 171 million). In connection with the sale, Kingold leased space in the Jewelry Park for its new headquarters for an annual rent of RMB 1,718,400 (approximately US$ 256,800).

Wuhan Lianfuda has paid Wuhan Kingold the total consideration of RMB 1.14 billion (approximately US$ 171 million), pursuant to a contract to transfer the contractual rights and obligations (the “Transfer Contract”) entered between Wuhan Kingold and Wuhan Lianfuda. In addition, Kingold transfers and Wuhan Lianfuda receives, all the rights and obligations in an acquisition agreement (the “Acquisition Agreement”) signed among Kingold, Wuhan Wansheng and Wuhan Huayuan Science and Technology Development Limited Company (“Wuhan Huayuan”) on October 23, 2013, including 60% stock rights of Wuhan Huayuan. Wuhan Lianfuda will undertake the remaining payment obligation of RMB 360 million (approximately US$ 54 million) stipulated in the Acquisition Agreement. According to an evaluation report issued by an independent evaluation agency, the evaluated value of the Jewelry Park on June 18, 2016 was approximately RMB 1.48 billion (approximately US$ 221 million).

Background on Development of the Jewelry Park

On October 29, 2013, the Company filed a current report on Form 8-K disclosing the Acquisition Agreement. Pursuant to the Acquisition Agreement as amended, the Company acquired the operating rights for 66,667 square meters (approximately 717,598 square feet, or 16.5 acres) of industrial land for use in the development of the Jewelry Park for approximately RMB 1.0 billion (approximately US$ 150 million) from Wuhan Wansheng, and authorized Wuhan Wansheng, as an agent, to complete construction of the Jewelry Park. Upon completion of the whole project, the Company would have 100% ownership of the properties situated on the land.

Before the Transfer Contract was signed, the project was in the process of final inspection, acceptance and filing for the record. The Company had paid RMB 640 million (approximately US$ 96 million) for the share acquisition fees and the construction fees to Wuhan Wansheng and Wuhan Wansheng had transferred 60% of the stock rights of Wuhan Huayuan to the Company. Wuhan Wansheng and Wuhan Huayuan issued the consent of Jewelry Park transfer to the Company on the day when the Transfer Contract was signed.

Relocation of Kingold’s Headquarters

On June 27, 2016, The Company signed two leases with Wuhan Huayuan to rent certain space at the Jewelry Park as its new headquarter office and store:

i) The Company’s office located in Floor 10, Tower A, Building 7 of the Jewelry Park with 1,200 square meters

ii) The Company’s store will be located in No. 6 store, Building 1 of the Jewelry Park with 340 square meters

The aggregate monthly rent is RMB 143,200 (approximately US$ 21,400) and the aggregate yearly rent is RMB 1,718,400 (approximately US$ 256,800). The Company will relocate its corporate offices to the Jewelry Park in August 2016, and plans to move the store to the Jewelry Park in October 2016. The Company’s current headquarters will be used as a factory.

Management Commentary

Mr. Zhihong Jia, Chairman and CEO of the Company, commented, “We were pleased to complete a transaction that provides Kingold with a positive return on investment on our development in the Jewelry Park.  Ultimately, our management team decided that it was in the best interest of our Company to focus our capital and personal resources towards expanding our core jewelry design and manufacturing business.  We expect to utilize the proceeds to continue to grow both within China and internationally.  We also will be pleased to work with Wuhan Lianfuda as the Jewelry Park develops into what our Company envisioned, a robust market serving as a bridge between upstream and downstream companies within the jewelry industry, and we are excited to be part of this ongoing collective market activity.”

About Kingold Jewelry, Inc.

Kingold Jewelry, Inc. (NASDAQ: KGJI), centrally located in Wuhan City, one of China’s largest cities, was founded in 2002 and today is one of China’s leading designers and manufacturers of 24-karat gold jewelry, ornaments, and investment-oriented products. The Company sells both directly to retailers as well as through major distributors across China. Kingold has received numerous industry awards and has been a member of the Shanghai Gold Exchange since 2003. For more information, please visit www.kingoldjewelry.com.

Business Risks and Forward-Looking Statements

This press release contains forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended. You can identify these forward-looking statements by words such as “expects,” “believe,” “project,” “anticipate,” or similar expressions. The forward-looking statements in this release include statements regarding Kingold’s outlook with respect to its 2016 outlook for gold processing, its expectations with respect to completion of construction of the Jewelry Park and planned grand opening, as well as its ability to engage in presales and finance the remaining construction.  Readers are cautioned that actual results could differ materially from those expressed in any forward-looking statements. Forward-looking statements are subject to a number of risks, including those contained in Kingold’s SEC filings available at www.sec.gov, including Kingold’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. Kingold undertakes no obligation to update or revise any forward-looking statements for any reason.

Company Contact
Kingold Jewelry, Inc.
Bin Liu, CFO
Phone: +1-847-660-3498 (US) / +86-27-6569-4977 (China)
bl@kingoldjewelry.com

INVESTOR RELATIONS
The Equity Group Inc.
Katherine Yao, Senior Associate
Phone: +86-10-6587-6435
kyao@equityny.com

Friday, July 29th, 2016 Uncategorized Comments Off on $KGJI Sells Jewelry Park for Approximately $171 Million

$OPCO #Switchgrass #BioChar #Natural #Cat Litter Launches at #SuperZoo

OurPet’s Company (OPCO) Has a New Natural Solution to Your Cat Litter Woes

FAIRPORT HARBOR, OH–(Jul 29, 2016) – Every cat-owner’s dream has finally come true with the introduction of a litter that is all natural, highly absorbent and eliminates that dreaded litter box smell.

After years of extensive product development and testing, OurPet’s Company (OTCQX: OPCO) is introducing Switchgrass Natural Cat Litter™ with BioChar that has been top ranked amongst competitors through third party testing. OurPet’s will be showcase the cat litter at their SuperZoo booth, #10219, in Las Vegas, NV.

OurPets® Switchgrass Natural Cat Litter™ with BioChar is biodegradable, all natural, sustainable, and is a non-food alternative to the other corn or wheat based natural cat litters in the marketplace. Switchgrass is a hardy, natural grass native to North America that does not require fertilization or the use of chemicals during growth. Historically, switchgrass has been used for flood control, not for feedstock.

Biochar is made using the pyrolysis process to convert natural wood chips to an activated, non-marking carbon that is proven to be highly odor and moisture absorbent. During pyrolysis, the volatile gases are collected and used as clean burning fuel while the CO2 is trapped in the pine wood with minimal CO2 release into the atmosphere.

Together, switchgrass and biochar combine to make a strong clumping cat litter that is safe, highly moister and odor absorbent, biodegradable, lightweight, and made in the U.S.A. from sustainable ingredients. OurPets® Switchgrass Natural Cat Litter™ will be sold in 10 and 20 pound bags and will be available for retail August 2016.

For more information on OurPet’s and their new products, visit www.ourpets.com or stop by their SuperZoo booth #10219.

About The OurPet’s Company

The OurPet’s Company (OTCQX: OPCO) designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets® and Pet Zone® brands domestically and internationally. OurPets® and Pet Zone® products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. Since its founding in 1995, the OurPet’s Company has been building an extensive intellectual property portfolio with more than 160 patents in either issued or pending status all devoted to solving problems related to the human/pet bond. OurPet’s was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, the OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.

Media Contact:

Peter Ostapowicz
Marketing Communications Specialist
440-354-6500 x141
Email Contact

Friday, July 29th, 2016 Uncategorized Comments Off on $OPCO #Switchgrass #BioChar #Natural #Cat Litter Launches at #SuperZoo

$EXPI #RussCofano Joins eXp World Holdings and eXp Realty

Industry Veteran Named Chief Strategy Officer and General Counsel

BELLINGHAM, WA–(July 29, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI) today announced that industry veteran Russ Cofano has joined the Company as Chief Strategy Officer and General Counsel.

Cofano brings more than twenty-five-years of industry experience to eXp. He most recently served as senior vice president of industry relations for MOVE, Inc. operator of REALTOR.com® developing strategy and building relationships with the real estate industry’s leading organizations, MLSs and technology companies. Cofano has also served as chief executive officer for the Missouri REALTORS®, the largest trade association in the state of Missouri, and as vice president and general counsel for John L. Scott Real Estate, consistently ranked as one of the largest real estate brokerage companies in the nation. He has also served as an advisor to a number of REALTOR® associations and MLSs and as CEO of a real estate CRM technology company.

“I have been looking for ‘the next great opportunity’ within the industry, and I’m certain that I’ve found that opportunity at eXp,” said Cofano. “Unlike other new entrants, eXp is redefining the brokerage model of the future from within. Glenn Sanford has assembled a fantastic team and I’m excited to join them and use my various industry experiences to help the company chart its course of success.”

“Russ brings a wealth of experience and industry knowledge to the Company from multiple perspectives,” said Company founder and CEO, Glenn Sanford. “We’re fortunate to be able to add Russ to our team and believe he will have an immediate and lasting impact on the Company as we continue to grow.”

Contact information for Russ Cofano: russ.cofano@exprealty.com

About eXp World Holdings, Inc.

eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

eXp World Holdings, Inc. also owns 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, Virginia and New Mexico. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.

For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.com.

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.

 

Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426

Trade and Media Contact Information:
Jason Gesing
CEO
eXp Realty
jason@exprealty.com
617-970-8518

Friday, July 29th, 2016 Uncategorized Comments Off on $EXPI #RussCofano Joins eXp World Holdings and eXp Realty