Uncategorized

(CRBP) Investigational Drug Resunab(TM) Granted Fast Track Status

NORWOOD, MA–(Aug 19, 2015) – Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has designated as a Fast Track development program the investigation of Resunab™ for systemic sclerosis (“scleroderma”).

Systemic sclerosis is a serious, life-threatening autoimmune disease that is characterized by chronic activation of the immune system, damage to blood vessels, and fibrosis (scarring) of the skin, lungs, and other internal organs. Systemic sclerosis affects predominately women in mid-life and is associated with significant morbidity and mortality. There are currently no FDA-approved drug therapies for systemic sclerosis.

Resunab is a novel synthetic oral endocannabinoid-mimic drug that preferentially binds to a receptor called CB2 on immune cells and fibroblasts. Numerous pre-clinical and ex-vivo models have demonstrated that the binding of Resunab to CB2 triggers the production of “Specialized Pro-resolving Lipid Mediators” (“SPMs”) that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis. This resolution cascade restores chronically activated immune systems back to homeostasis and halts fibrosis, without causing immunosuppression.

“We are very pleased to have achieved another significant regulatory milestone for Resunab for the treatment of systemic sclerosis, following the recently granted FDA Orphan Drug Designation in this indication,” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “With Fast Track status, we expect to have the opportunity to accelerate Resunab’s clinical development timeline to more expediently bring this potentially impactful drug therapy to individuals with systemic sclerosis.”

A Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

Corbus is scheduled to begin enrollment and dosing in its Phase 2 study of Resunab for the treatment of systemic sclerosis this quarter. For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02465437.

About Resunab
Resunab is a novel synthetic oral drug that is a preferential agonist to the CB2 receptor expressed on activated immune cells. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab triggers resolution of inflammation by increasing production of “Specialized Pro-resolving Lipid Mediators of Inflammation” and anti-inflammatory mediators, while reducing production of pro-inflammatory mediators and tissue inflammation. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn “off” chronic inflammation and fibrotic processes, without causing immunosuppression.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases. Our lead product candidate Resunab is a novel oral drug that resolves chronic inflammation and fibrotic processes. Resunab is currently in Phase 2 studies for the treatment of diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis. A Phase 2 clinical trial with Resunab for the treatment of cystic fibrosis is scheduled to commence in 2015.

For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook.

Forward-Looking Statements
This press release contains certain 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 Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: Email Contact

Media Contact
David Schull or Marissa Goberdhan
Russo Partners, LLC
Phone: +1 (858) 717-2310
Email: Email Contact
Email: Email Contact

Wednesday, August 19th, 2015 Uncategorized Comments Off on (CRBP) Investigational Drug Resunab(TM) Granted Fast Track Status

(INVE) Enters Distribution Partnership With PSA Security Network

FREMONT, Calif., Aug. 18, 2015  — Identiv, Inc. (NASDAQ:INVE) today announced it has entered into a partnership with PSA Security Network to distribute Identiv’s uTrust TS Premises Readers and credentials. PSA Security Network is the world’s largest electronic security cooperative, owned by the most progressive security integrators throughout North America. These leading security systems integrators are responsible for over $2 billion annually in security, fire, and life safety installations.

“PSA is thrilled to enter into this partnership with Identiv,” said Bill Bozeman, president and CEO of PSA Security Network. “The Identiv product line is going to be a great asset to our integrator community and will no doubt bring them an additional competitive advantage.”

Identiv’s uTrust TS Premises Readers can be specifically designed for customers to support any existing building access system (such as Identiv, Lenel, AMAG, Honeywell, or Software House). Featuring high security with an inbuilt secure processor certified to the highest standards (EAL 6+), uTrust TS Readers support all major commercial and government access credentials. Identiv has a broad credentials portfolio, offering different form factors, that is compatible with the majority of building access systems on the market today.

“PSA Security Network is an excellent partner that offers more than just product distribution. Their commitment to service combined with Identiv’s compelling product offerings delivers maximum customer value,” said Jason Hart, Identiv CEO. “We are excited to be their newest vendor, and look forward to a long-term distribution partnership offering their members Identiv’s entire advanced uTrust Reader platform and uTrust SmartID Credentials.”

About Identiv

Identiv is a global security technology company that establishes identity in the connected world, including premises, information, and everyday items. CIOs, CSOs, and product departments rely upon Identiv’s trusted identity solutions to reduce risk, achieve compliance, and protect brand identity. Identiv’s trust solutions are implemented using standards-driven products and technology, such as digital certificates, trusted authentication, mobility, and cloud services. For more information, visit identiv.com.

About PSA Security Network

PSA Security Network is the world’s largest electronic security cooperative, composed of the most progressive security integrators throughout North America. In addition to exceptional equipment selection, PSA offers industry leading education and training as well as vetted solutions and services that can enhance any security company’s operations. For more information, visit psasecurity.com.

CONTACT: Identiv Media Contact:
         Angela Lestar
         MSLGROUP
         781-684-0770
         identiv@mslgroup.com

         Investor Relations Contact:
         David Isaacs/Leah Polito
         Sard Verbinnen & Co
         415-618-8750
         identiv-IR@sardverb.com
Tuesday, August 18th, 2015 Uncategorized Comments Off on (INVE) Enters Distribution Partnership With PSA Security Network

(EVOK) Favorable Response From FDA Regarding Pediatric Study Plan for EVK-001

SOLANA BEACH, Calif., Aug. 18, 2015  — Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) indicating the agency’s concurrence with the Company’s proposed pediatric study plan for EVK-001.

Pursuant to the terms of the letter, the FDA has accepted Evoke’s EVK-001 pediatric study plan, which included a request for a full waiver of the requirement to conduct pediatric studies on the basis that diabetic gastroparesis is an adult disease. The Company expects that the pediatric study plan will be included in the Company’s anticipated New Drug Application (NDA) filing with the FDA.

“We are pleased that the FDA had a favorable response to our proposed pediatric study plan in which we have proposed a full waiver for pediatric testing of EVK-001 in all pediatric age groups,” stated Marilyn Carlson, D.M.D, M.D., RAC, Chief Medical Officer of the Company. Dr. Carlson continued, “Having received this agreement prior to data from our ongoing Phase 3 clinical trial will allow us to focus on study completion and NDA submission in a timely manner.”

“The agreed upon pediatric study plan is another positive step forward for the Company from a clinical and regulatory perspective,” stated Mr. Gonyer, R.Ph., President and Chief Executive Officer. “We believe that this agreement, along with the recent FDA guidance document that assists companies in the clinical development of drugs for the treatment of gastroparesis, specifically trial design and clinical endpoint evaluation, are consistent with the advice given by the FDA on the design of our current Phase 3 clinical development program. We continue to progress toward an NDA filing and commercialization of EVK-001 with the hope of providing a better treatment option for patients with diabetic gastroparesis.”

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through intranasal administration. Visit www.EvokePharma.com for more information.

Safe Harbor Statement

Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding the timing and completion of Evoke’s ongoing Phase 3 clinical trial of EVK-001 and the potential approval and commercialization of EVK-001 as a new and effective treatment for gastroparesis. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke’s business, including, without limitation: Evoke is entirely dependent on the success of EVK-001, for which it has commenced a Phase 3 clinical trial and male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; the FDA’s letter regarding Evoke’s pediatric study plan is not binding on the FDA, and the FDA may revise its indications regarding such plan; the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke’s Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; the inherent risks of clinical development of EVK-001, including continued delays in enrollment and completion of the Phase 3 trial as well as potential delays in any other clinical trials and studies; Evoke will require substantial additional funding to complete the Phase 3 clinical trial and potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

CONTACT: Investor Contact:
         The Ruth Group
         David Burke
         Tel: 646-536-7009
         dburke@theruthgroup.com

         Media Contact:
         The Ruth Group
         Kirsten Thomas
         Tel: 646-536-7014
         kthomas@theruthgroup.com
Tuesday, August 18th, 2015 Uncategorized Comments Off on (EVOK) Favorable Response From FDA Regarding Pediatric Study Plan for EVK-001

(KIQ) AAR Approves Field Trials For New Bottom Outlet Valve

VANCOUVER, BRITISH COLUMBIA and DOWNERS GROVE, ILLINOIS–(Aug. 18, 2015) – Kelso Technologies Inc. (the “Company” or “Kelso”) (TSX:KLS)(NYSE MKT:KIQ) –

The Company is pleased to report that the Association of American Railroads (AAR) has approved Kelso’s new bottom outlet valve (BOV) design for commercial field trial testing.

Bottom outlet valves are utilized on rail tank cars for the primary purpose of unloading the contents of the tank. The BOV must be a low-profile design as it is positioned at the lowest point of the tank so that a full discharge of the tank can be achieved. They are widely used in the transport of hazardous commodities such as crude oil, ethanol, chemicals, petrochemicals and minerals such as molten sulfur as well as many non-hazardous commodity applications.

The development of our patent pending BOV has been driven by customers’ demand for a better performing BOV due to chronic performance problems with current products in use in the market today. Kelso is dedicated to the development of “best available safety technologies” (BAST) that deliver long term reliable high performance. Our new innovative BOV design prevents valve operating stem leaks and features the use of non-corrosive ceramic materials and a seal protecting wiper. Our BOV meets the new DOT-117 tank car specifications to be implemented on October 1, 2015 and the new M1002 Tank Car Standards requiring a removable handle.

There has been no shortage of commercial interest in our BOV design. Numerous railway stakeholders have agreed to provide the required field trial testing. Testing will commence shortly and may take up to two years to complete. Once final approvals are received from the AAR the BOV represents new revenue streams that will contribute to the growth of the Company.

James R. Bond, CEO of the Company comments that, “The railroads; oil companies; tank car owners and manufacturers; provincial, state and municipal governments; along with federal and industry regulators are currently implementing plans to comply with the new DOT-117 specifications commencing on October 1, 2015. The focus of the new DOT-117 rules is that the use of BAST equipment and safe railroad operating procedures is a paramount priority, not optional and cannot be ignored. Kelso is recognized as an emerging growth company in railway equipment that has the ability to create and develop new innovative BAST products. Kelso reliably provides the market today with high quality pressure relief valves and a unique Kelso Klincher® manway both of which meet the new DOT-117 specifications. We are also innovating new patented products like the BOV and recently announced vacuum relief valve (VRV) that will further improve the safety of rail tank cars. These product development activities plus new patent activity should provide the opportunities for Kelso to continue the growth of its market share. Once the AAR approves our BOV and VRV for commercial use then Kelso can offer a full suite of commercial BAST equipment to the railway industry. These products will improve the operational safety of a tank car during transport of hazardous commodities while increasing the survivability of a tank car in a derailment involving fire.

In recent months, the global securities markets of Canada and the United States have experienced a high level of price and volume volatility. In line with the emotions of a deteriorating world economy and oil industry the market price of the common shares of Kelso has experienced wide fluctuations in price which have not been related to the operating performance, underlying asset values or business prospects of the Company. Kelso’s valuation must be determined by an open market system between shareholders and the investment community on organized daily markets as prescribed by securities law and the policies of the Toronto Stock Exchange and the NYSE Markets Exchange. Pursuant to these regulations the Company does not make a market for its common shares nor give advice on the investment worthiness of its common shares. We can give no assurance that continual price fluctuations in price will not occur. It may be anticipated that market prices for the common shares of Kelso may be subject to market trends generally, notwithstanding any potential financial success of the Company in the future. Despite diminishments in our corporate value as determined by shareholders in recent months we remain committed to our strategic direction and our positive outlook for Kelso over the next five years.”

About Kelso Technologies

Kelso is a railway equipment supplier that designs, produces and sells proprietary tank car service equipment used in the safe handling and containment of hazardous materials during transport. Products are specifically designed to provide economic and operational advantages while reducing the potential effects of human error and environmental harm during the transport of hazardous materials. The Company is recognized as a reliable supplier of AAR approved railway equipment that addresses the regulatory concerns about railroad safety in North America.

For a more complete business and financial profile of the Company, please view the Company’s website at www.kelsotech.com and public documents posted under the Company’s profile on www.sedar.com in Canada and on EDGAR at www.sec.gov in the United States.

On behalf of the Board of Directors,

James R. Bond, CEO and President

Legal Notice Regarding Forward-Looking Statements: This news release contains “forward-looking statements” within the meaning of applicable Canadian securities legislation. Forward-looking statements are indicated expectations or intentions. Forward-looking statements in this news release include the assumption that field trials of the new BOV will be successful and may take up to two years to complete; that once final product approvals are received from the AAR the BOV represents additional revenue streams that will contribute to the continued success and business growth of the Company; that we have new patented products that will further improve the safety of rail tank cars and increase their survivability in a derailment involving fire; and that these product development activities plus new patent activity should provide the opportunities for Kelso to continue the growth of its market share. Although Kelso believes its anticipated future results, performance or achievements expressed or implied by the forward-looking statements and information are based upon reasonable assumptions and expectations, they can give no assurance that such expectations will prove to be correct. The reader should not place undue reliance on forward-looking statements and information as such statements and information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Kelso to differ materially from anticipated future results, performance or achievement expressed or implied by such forward-looking statements and information, including without limitation the risk that the Company’s products may not provide the intended economic or operational advantages; or reduce the potential effects of human error and environmental harm during the transport of hazardous materials; or grow and sustain anticipated revenue streams; AAR approvals may not be attained; orders may be cancelled and competitors may enter the market with new product offerings which could capture some of our market share. Except as required by law, the Company does not intend to update the forward-looking information and forward-looking statements contained in this news release.

James R. Bond
CEO and President
bond@kelsotech.com

Richard Lee
Chief Financial Officer
lee@kelsotech.com

Corporate Address:
7773 – 118A Street
North Delta, BC, V4C 6V1
www.kelsotech.com

Tuesday, August 18th, 2015 Uncategorized Comments Off on (KIQ) AAR Approves Field Trials For New Bottom Outlet Valve

(CLTX) and Volution Announce $75 Million Private Placement

NEW YORK, NY and LONDON, UNITED KINGDOM–(August 18, 2015) – Celsus Therapeutics Plc (NASDAQ: CLTX) and Volution Immuno Pharmaceuticals SA today announced that Celsus has entered into a securities purchase agreement for a private placement with a select group of investors, led by Deerfield, and including Venrock, Vivo Capital, Foresite Capital, New Enterprise Associates, QVT Financial, RA Capital Management and certain other institutional investors.

The closing of the private placement is subject to Celsus obtaining shareholder approval of the financing transaction and the previously announced acquisition by Celsus of Volution Immuno Pharmaceuticals at Celsus’ General Shareholder Meeting on September 16, 2015, the closing of the acquisition and satisfaction of customary closing conditions. Following the closing of the acquisition, the combined company will be renamed Akari Therapeutics Plc, and the company expects to trade on the NASDAQ Capital Market under the ticker symbol ‘AKTX’.

Upon the closing of the private placement, Akari expects to receive net proceeds of approximately $70 million from the sale of ordinary shares, to be represented by American Depository Shares (ADSs). Based on yesterday’s closing bid price on NASDAQ of $0.61 per ADS, assuming an aggregate of 949,410,450 fully-diluted shares following the closing of the acquisition, the purchase price of the financing would be equal to $1.58 per the currently trading ADS (or $0.158 per ordinary share), representing a 159% premium to yesterday’s closing bid price. The actual purchase price per ADS upon closing is subject to adjustment based on the closing bid price on NASDAQ on the closing date of the acquisition which will affect the number of fully diluted ordinary shares. Currently, each ADS represents 10 ordinary shares. As of September 17, 2015, the ADS ratio will adjust, such that each ADS will represent 100 ordinary shares. The ADSs to be purchased by the investors in the financing will each represent 100 ordinary shares.

As previously announced on July 13, 2015, on a pro forma basis, prior to giving effect to the private placement, and based upon the number of ordinary shares of Celsus to be issued in the acquisition of Volution Immuno Pharmaceuticals, current Celsus security holders will own approximately 8.32% and current Volution Immuno Pharmaceutical SA security holders will own approximately 91.68% of the combined company on a fully diluted basis. The private placement values the combined entity at $150 million on a fully diluted basis prior to the completion of the private placement. The private placement is expected to close on or about September 18, 2015.

Akari plans to use the anticipated net proceeds from the private placement for clinical development of Coversin, Akari’s lead molecule, and for working capital and general corporate purposes. Coversin is a C5 inhibitor under development to treat complement-related disorders in several therapeutic areas, including hematology, nephrology, and neurology.

Citigroup Global Markets Inc. and MTS Securities, LLC acted as placement agents for the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the ADSs (and the underlying ordinary shares) sold in the private placement.

About Celsus

On July 10, 2015, Celsus entered into a Share Exchange Agreement with RPC Pharma Limited, pursuant to which privately-held Volution Immuno Pharmaceuticals will become a wholly-owned subsidiary of Celsus. The combined company will focus on development and commercialization of life-transforming treatments for a range of rare and orphan autoimmune and inflammatory diseases caused by dysregulation of complement C5, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS). Upon closing of the transaction, Celsus expects to be renamed Akari Therapeutics Plc. Coversin is a recombinant small protein derived from a protein discovered in the saliva of the Ornithodoros moubata tick, where it plays an important role in modulating the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune response. Coversin is under development to treat complement-C5 disorders in several therapeutic areas, including hematology, nephrology, and neurology. Coversin, at 17 kDa, is much smaller than an antibody and can be self-administered by subcutaneous injection, which we believe should provide considerable patient benefit over the current standard of care in several diseases.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this communication regarding the proposed business combination transaction and other contemplated transactions (including statements relating to satisfaction of the conditions to and consummation of the proposed transaction, the expected ownership of the combined company and plans with respect to financing for the combined company) constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.

Risks and uncertainties for Celsus and Volution and of the combined company include, but are not limited to: inability to complete the proposed business combination transaction or the financing; liquidity and trading market for ADSs prior to and following the consummation of the proposed business combination transaction and the financing; costs and potential litigation associated with the proposed transaction; an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the combined company’s products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; unexpected cost increases and pricing pressures; failure to obtain the necessary shareholder approvals or to satisfy other conditions to the closing of the proposed transactions; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions prior to or after the consummation of the proposed transactions; and risks associated with the possible failure to realize certain benefits of the proposed transactions, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond Celsus’, Volution’s, or the combined company’s ability to control or predict.

For a discussion of the factors that may cause Celsus, Volution or the combined organization’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, or for a discussion of risks associated with the ability of Celsus and Volution to complete the acquisition and the effect of the acquisition on the business of Celsus, Volution and the combined organization, see “Risk Factors” beginning on page 13 of the definitive proxy statement and in other filings that Celsus makes and will make with the SEC in connection with the proposed transactions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

Important Information and Where to Find It

Celsus filed the definitive proxy statement and other relevant documents with the SEC in connection with the solicitation of proxies for the General Meeting and mailed the definitive proxy statement and a proxy card to its shareholders on or about August 5, 2015. SHAREHOLDERS ARE STRONGLY ADVISED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER DOCUMENTS FILED WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Shareholders may obtain a free copy of the definitive proxy statement, any amendments or supplements to the proxy statement and other documents that Celsus files with the SEC from the SEC’s website at www.sec.gov as soon as reasonably practicable after such materials are electronically filed with, or furnished to, the SEC.

Certain Information Regarding Participants in Solicitation

Celsus, its directors and its executive officers may be deemed participants in the solicitation of proxies from shareholders in connection with the matters to be considered at the General Meeting. Information regarding the persons who may, under the rules of the SEC, be considered participants in the solicitation of Celsus shareholders in connection with the General Meeting, and their direct or indirect interests, by security holdings or otherwise, which may be different from those of Celsus’ shareholders generally, are set forth in the definitive proxy statement for the General Meeting that has been filed with the SEC and the other relevant documents filed with the SEC.

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT CELSUS MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Shareholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Celsus with the SEC in connection with the proposed transaction at the SEC’s website (http://www.sec.gov), at Celsus’ website or by writing to Dov Elefant, CFO, Celsus Therapeutics Plc. at 24 West 40th Street, 8thFloor, New York, NY 10018.

Contact:
Investor & Media Contact:
Celsus Therapeutics Plc
Gur Roshwalb, MD, CEO
646-350-0702
info@celsustx.com

Tuesday, August 18th, 2015 Uncategorized Comments Off on (CLTX) and Volution Announce $75 Million Private Placement

(OMER) Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial

— Company Plans for Phase 3 Program Based on Consistent Response in TMA Patients —

SEATTLE, Aug. 18, 2015  — Omeros Corporation (NASDAQ: OMER) today announced additional positive data in the company’s Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body’s organs, most commonly the kidney and brain. OMS721 is Omeros’ lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of TMAs, including atypical hemolytic uremic syndrome (aHUS).

The Phase 2 trial is designed to enroll primarily aHUS patients but can also enroll patients with thrombotic thrombocytopenic purpura (TTP) and hematopoietic stem cell transplant (HSCT)-related TMA. The trial has fully enrolled the first and second cohorts and is currently completing the third and final planned cohort of its dose-ranging stage. In each three-patient cohort, OMS721 is dosed for four weeks. Data from the first (low-dose) cohort were released on February 19, 2015. Today the company is releasing data from its second (mid-dose) cohort and data to date from its third (high-dose) cohort.

Three patients were treated in the second or mid-dose cohort, two of whom have aHUS and one with TTP. Both patients with aHUS were on renal dialysis prior to and at the time of study enrollment. Based on the positive data from the mid-dose cohort, the high-dose cohort was initiated and an aHUS patient has already completed the study treatment period. No patient with HSCT-related TMA has yet completed dosing with OMS721. The data referenced for all patients include measures to one week following the last dose.

A rare and devastating family of disorders, TMAs are characterized by thrombi or clumps of aggregated platelets in small blood vessels, which lead to thrombocytopenia (below-normal platelet counts) and schistocytes (fragmentation in red blood cells) that can cause dangerously low oxygen levels in organs like the brain and kidney as well as anemia. Thrombotic microangiopathies are life-threatening and can occur both in children and adults. While thrombi, thrombocytopenia and schistocytes are hallmarks of TMAs, other markers of damage within the blood vessels include an elevated plasma lactate dehydrogenase (LDH) and undetectable or reduced plasma haptoglobin levels. In addition, an elevated creatinine level – a result of the kidney damage caused by thrombi – is an indicator of impaired kidney function in patients who are not on renal dialysis.

As in Alexion’s clinical trials supporting both U.S. and European regulatory approval of Soliris® for the treatment of aHUS, this Phase 2 clinical trial, given the life-threatening nature of the disease, has no placebo arm. Soliris trials used change from baseline in platelet count as a primary endpoint to obtain approval for the treatment of aHUS. Similarly, the pre-specified primary endpoint in this Phase 2 trial is change from baseline in platelet count. In this trial, platelet counts in all three aHUS patients in the mid- and high-dose cohorts (two in the mid-dose and one in the high-dose cohort) were normal after the treatment period, with a statistically significant mean increase from baseline of approximately 68,000 platelets/mL (p = 0.0055).

In the mid-dose cohort, the two patients with plasma therapy-resistant aHUS demonstrated:

  • 47% increase in mean platelet count, resulting in both patients having counts in the normal range
  • 86% decrease in mean schistocyte count, with schistocytes disappearing in one patient
  • 71% increase in mean haptoglobin with both patients reaching the normal range during treatment, one slipping slightly below normal at one week following the last dose
  • 5% decrease in the mean levels of LDH, with levels in both patients remaining slightly elevated above normal range

The mid-dose-cohort patient with TTP required repeated plasma infusion therapy prior to entering the study. Laboratory parameters did not show consistent improvement, but the patient did not require plasma therapy during treatment with OMS721 and, to date, has not required it since completing treatment.

The first patient in the high-dose cohort – a plasma therapy-resistant aHUS patient with additional complicating disorders including hepatitis C, cryoglobulinemia and lymphoma – has also completed treatment with OMS721. Prior to OMS721 treatment, the patient required repeated dialysis. Throughout treatment and following completion of the OMS721 course, the patient to date has remained off dialysis. Hematological and renal parameters showed:

  • 63% improvement in platelet count, returning to normal levels
  • 100% decrease in schistocytes
  • Haptoglobin increased from an undetectable level and normalized
  • 43% decrease in LDH, resulting in a level just slightly above normal
  • 24% reduction in creatinine level

As expected, patients with aHUS in the mid- and high-dose cohorts demonstrated more consistent and robust improvement in efficacy measures than patients in the low-dose cohort. As in the low-dose cohort, the drug was well tolerated by all patients in the mid- and high-dose cohorts throughout the treatment period.

There have been no confirmed clinically meaningful drug-related adverse events in any clinical trials with OMS721. To date, two clinically meaningful adverse events were considered possibly related to OMS721 when first observed because an infectious etiology could not be ruled out at diagnosis, but all cultures subsequently proved negative. Specifically, one patient in the low-dose cohort was reported as possibly having an infection (as described in the company’s February 19, 2015 press release); however, all cultures were negative and no infection was identified. Another patient had significant diarrhea, but all tests for gastrointestinal pathogens were negative and the patient was receiving immunosuppressive therapy, including a drug very commonly associated with diarrhea. In addition, animal chronic toxicity studies have been completed and no notable adverse findings were observed. The FDA has cleared OMS721 for chronic dosing in clinical trials. Physician-requested compassionate use is ongoing, and all patients in the compassionate-use program are reported by their physicians to be doing well.

“We are excited by the data from this Phase 2 clinical trial with OMS721, both with respect to aHUS and TTP patients,” stated Gregory A. Demopulos M.D., chairman and chief executive officer of Omeros. “Based on clinical data, we expect that we can deliver OMS721 either subcutaneously or intravenously at a frequency and dose that are both convenient and comfortable for patients while effectively eliminating lectin-pathway activity. Compassionate use in aHUS patients has begun, and we look forward to advancing to the fixed-dose stage of the trial and discussing Phase 3 trial design with the FDA later this year.”

About Omeros’ MASP-2 Program

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into the circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. Omeros has received both Orphan Drug status and Fast Track designation from the U.S. FDA for its lead human MASP-2 antibody OMS721. An ongoing Phase 2 clinical program is evaluating OMS721 in the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome, thrombotic thrombocytopenic purpura and stem cell transplant-related TMAs. An investigator-requested compassionate use program for OMS721 is also underway. Chronic toxicity studies with systemically delivered OMS721 demonstrated no drug-related adverse events and, in addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection.

Omeros also believes that it has identified the proteins that activate the complement system’s alternative pathway in humans, which is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing the development of antibodies that block activation of the alternative pathway.

About Omeros Corporation

Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, European Commission has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has partnered its arthroscopic product, OMS103, for commercialization with Fagron Sterile Services and affiliated JCB Laboratories. Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization including with respect to Omidria® and OMS103, Omeros’ ability to partner and commercialize Omidria in Europe, Omeros’ unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Tuesday, August 18th, 2015 Uncategorized Comments Off on (OMER) Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial

(ISCOD) Announces Record Net Income in Second Quarter 2015

CARLSBAD, CA–(August 18, 2015) – International Stem Cell Corporation (OTCQB: ISCOD) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today provided a business update and announced operating results for the three and six months ended June 30, 2015.

“Stable increase in revenues from our biomedical businesses, ability to generate net income as a parent company and progress in demonstrating the safety and efficacy of our stem cells for the treatment of Parkinson’s disease and stroke position us as a leader in regenerative medicine field,” stated Andrey Semechkin, Ph.D., CEO and Co-Chairman of ISCO. “We look forward to receiving Australian TGA authorization to start clinical trials. We expect to dose the first Parkinson’s disease patients in this trial in Q4 2015.”

Second Quarter 2015 Business Highlights

  • Demonstrated in animal models that the Company’s proprietary human parthenogenetic neural stem cells (hpNSCs) can significantly reduce neurological dysfunction after a stroke.
  • Published the results of two proof of concept studies that demonstrate the safety and efficacy of the Company’s stem cell treatment of Parkinson’s disease in both non-human primate and rodent animal models in the journal “Cell Transplantation”.
  • Presented data on the Parkinson’s disease program at the American Academy Of Neurology and International Society for Cellular Therapy annual meetings.
  • Lifeline Skin Care completed development and testing of two new products, both of which have launched in Q3 of 2015.

Subsequent to the quarter end, in July, 2015, the Company completed a nine month safety study of the hpNSCs demonstrating safety elements for regulatory approval of the upcoming Parkinson’s disease clinical trial, and submitted the results to the Australian TGA.

Second Quarter 2015 Financial Highlights

  • Total revenue for the second quarter of 2015 was $1.82 million, an increase of $227,000, or 14%, compared to the second quarter in 2014; Lifeline Skin Care sales for the second quarter of 2015 increased 18%, or $138,000, and Lifeline Cell Technology sales increased 11%, or $89,000, compared to the second quarter in 2014.
  • Profit margin for the second quarter of 2015 was $1.3 million, or 72%, compared to profit margin of $1.2 million, or 74%, for the second quarter of 2014.
  • Net income for the second quarter of 2015 was $723,000, compared to net loss of $4.4 million for the second quarter in 2014. We expect our net operating loss to continue declining quarter over quarter through 2015 year-end as our research and development expenses are expected to continue decreasing due to the completion of multiple preclinical studies during the three months ended June 30, 2015.

Year-to-Date Financial Highlights:

  • Total revenue for the six months ended June 30, 2015 was $3.44 million, an increase of $200,000, or 6%, compared to the six months ended June 30, 2014; Lifeline Skin Care sales for the six months ended June 30, 2015 increased 11%, or $176,000, and Lifeline Cell Technology sales increased 1%, or $25,000, compared to the six months ended June 30, 2014.
  • Profit margin for the six months ended June 30, 2015 was $2.5 million, or 73%, compared to profit margin of $2.4 million, or 74%, for the six months ended June 30, 2014.
  • Net loss for the six months ended June 30, 2015 was $564,000 compared to net loss of $5.8 million for the six months ended June 30, 2014. We expect our net operating loss to continue declining quarter over quarter through 2015 year-end as our research and development expenses are expected to continue decreasing due to the completion of multiple preclinical studies during the six months ended June 30, 2015.

Balance Sheet Highlights:

  • The Company ended the second quarter of 2015 with cash balance of $554,000.
  • Stockholders’ equity totaled $805,000 as of June 30, 2015.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

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Safe harbor statement

Statements pertaining to anticipated developments, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
June 30, December 31,
2015 2014
Assets (Unaudited)
Cash and cash equivalents $ 554 $ 1,111
Accounts receivable, net of allowance for doubtful accounts of $18 and $19 at June 30, 2015 and December 31, 2014, respectively 361 453
Inventory, net 1,759 1,517
Prepaid expenses and other current assets 574 485
Restricted cash 50 50
Total current assets 3,298 3,616
Property and equipment, net 546 714
Intangible assets, net 2,980 2,795
Deposits and other assets 61 54
Total assets $ 6,885 $ 7,179
Liabilities and Stockholders’ Equity
Accounts payable $ 580 $ 670
Accrued liabilities 1,311 1,711
Related party payable 2,285 11
Advances 250 250
Fair value of warrant liability 1,654 4,216
Total current liabilities 6,080 6,858
Commitments and contingencies
Stockholders’ Equity
Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 300,000 issued and outstanding, with liquidation preferences of $430 and $421 at June 30, 2015 and December 31, 2014, respectively
Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and outstanding, with liquidation preference of $4,320
Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and outstanding, with liquidation preference of $5,000 5 5
Series H-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 377 and 1,482 issued and outstanding at June 30, 2015 and December 31, 2014, respectively
Series H-2 Convertible Preferred stock, $0.001 par value, 500 shares authorized, issued and Outstanding
Common stock, $0.001 par value, 720,000,000 shares authorized, 1,828,162 and 1,596,195 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively (1) 2 2
Additional paid-in capital 96,111 95,063
Accumulated deficit (95,313 ) (94,749 )
Total stockholders’ equity 805 321
Total liabilities and stockholders’ equity $ 6,885 $ 7,179
(1) All common shares reported have been adjusted for the 150-for-1 reverse stock split effected on July 29, 2015
International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2015 2014 2015 2014
Revenues
Product sales $ 1,815 $ 1,588 $ 3,437 $ 3,237
Total revenue 1,815 1,588 3,437 3,237
Expenses
Cost of sales 516 409 934 848
Research and development 567 1,411 1,685 2,369
Selling and marketing 602 679 1,256 1,348
General and administrative 1,067 1,332 2,465 2,980
Total expenses 2,752 3,831 6,340 7,545
Loss from operating activities (937 ) (2,243 ) (2,903 ) (4,308 )
Other income (expense)
Change in fair value of warrant liability 1,702 1,271 2,381 1,894
Warrant exchange inducement expense (3,445 ) (3,445 )
Interest expense (2 ) (1 ) (3 ) (2 )
Warrant modification expense (40 ) (40 )
Sublease income 8 1 16
Total other income (expense), net 1,660 (2,167 ) 2,339 (1,537 )
Income (loss) before income taxes 723 (4,410 ) (564 ) (5,845 )
Provision for income taxes
Net income (loss) $ 723 $ (4,410 ) $ (564 ) $ (5,845 )
Net income (loss) applicable to common stockholders $ 723 $ (4,410 ) $ (564 ) $ (5,845 )
Net income (loss) per common share-basic (1) $ 0.40 $ (3.88 ) $ (0.33 ) $ (5.41 )
Net income (loss) per common share-diluted (1) $ (0.52 ) $ (3.88 ) $ (1.61 ) $ (5.41 )
Weighted average shares-basic (1) 1,800 1,138 1,719 1,081
Weighted average shares-diluted (1) 1,881 1,138 1,829 1,081
(1) All common shares and per share amounts reported have been adjusted for the 150-for-1 reverse stock split effected on July 29, 2015

Contacts:

International Stem Cell Corporation
Denise Boyajian
Phone: 760-940-6383
Email: ir@intlstemcell.com

Media:

Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com

Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com

Tuesday, August 18th, 2015 Uncategorized Comments Off on (ISCOD) Announces Record Net Income in Second Quarter 2015

(ICLD) Secures a New PSC for $9M to as Much as $15M With a Tier 1 Global Com Provider

NEW YORK, Aug. 17, 2015  — InterCloud Systems, Inc. (the “Company” or “InterCloud”) (Nasdaq:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, today announced that it has been selected by one of the world’s largest Tier 1 communications service providers based in the United States as a prime vendor to deliver outsourced professional services and support for their wireline and wireless next generation voice, data, and transport infrastructure solutions.  The selection process was based on delivery capabilities, geographic reach, technology support capabilities, and performance evaluations.

The contract term is for three years with two one-year options, and is projected to be worth at least $9 million during the base term, with expansion to over $15 million. The contract award is effective immediately and transition of services is currently underway.

Mark Munro, CEO of InterCloud Systems stated: “This is the single largest contract InterCloud has ever been awarded. This is a tribute to our sales and engineering teams capabilities, our competitive products, and quality of service. Winning a multi-year agreement of this scale from a global leader in communications is a clear sign that InterCloud is positioned as a leader in our market segments. Our pipeline and backlog have grown over the past year and provide InterCloud with a strong foundation for growth.”

About InterCloud Systems, Inc.

InterCloud Systems, Inc. is a leading provider of cloud networking orchestration and automation, for Software Defined Networking (SDN) and Network Function Virtualization (NFV) cloud environments to the telecommunications service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. InterCloud’s cloud solutions offer enterprise and service-provider customers the opportunity to adopt an operational expense model by outsourcing cloud deployment and management to InterCloud rather than the capital expense model that has dominated in recent decades in IT infrastructure management. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.

CONTACT: Investor Relations
         InterCloud Systems, Inc.
         561-988-1988
Monday, August 17th, 2015 Uncategorized Comments Off on (ICLD) Secures a New PSC for $9M to as Much as $15M With a Tier 1 Global Com Provider

(OMER) Announces Plan to File Infringement Suit Against ANDA Filer

SEATTLE, Aug. 17, 2015  — Omeros Corporation (NASDAQ: OMER) today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC (Par) in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros’ commercial drug Omidria® (phenylephrine and ketorolac injection) 1%/0.3%. Omidria is approved by the U.S. Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. As reported in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015, Omeros received a notice from Par on July 27, 2015, which addresses the ANDA and Par’s request to market a generic version of Omidria pursuant to Paragraph IV of the Hatch-Waxman Act following expiration of the drug’s New Product Exclusivity and, if applicable, the subsequent Pediatric Exclusivity, but prior to the expiration of three patents published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, which have terms extending to as late as 2033. Approximately 3.8 million cataract and lens replacement procedures are projected in the U.S. in 2015.

Omeros currently owns 34 issued patents worldwide related to Omidria. The patents that are listed in the Orange Book were granted by multiple examiners in multiple art groups based on review of prior art from multiple searches. Omeros is highly confident in its patent estate protecting Omidria.

Omeros has reviewed Par’s Paragraph IV assertions and plans to file a patent infringement suit against Par within 45 days of Omeros’ receipt of Par’s notice. In this regard, Omeros has engaged a prominent Hatch-Waxman litigation team at Covington & Burling LLP. Filing of the planned lawsuit will trigger what is generally a 30-month stay of FDA action on Par’s ANDA. Issued U.S. patents are presumed to be valid, and only clear and convincing evidence presented in federal court can establish invalidity.  Independent of its patents, Omidria has also received 36-month market exclusivity through the New Product Exclusivity provided by the Federal Food, Drug, and Cosmetic Act as well as an additional six months of market exclusivity available upon successful completion of the company’s pediatric clinical plan according to the Written Request from FDA.

“Generic manufacturers challenging branded drug products is ‘business as usual’ in the pharmaceutical industry and, based on its track record this is not an uncommon activity for Par,” stated Gregory A. Demopulos M.D., chairman and chief executive officer of Omeros. “This action confirms our belief in the market potential of Omidria. We are confident in the strength of our product’s broad patent estate. We have engaged one of the premier biotech patent litigation teams in the country to pursue aggressively our case against Par, so I do not anticipate this effort becoming a distraction for Omeros. We remain focused on continuing to build on our successful launch of Omidria and on increasing the product’s market uptake.”

About Omidria®
Omeros’ PharmacoSurgery® product Omidria® contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery. The FDA has approved Omidria for use during cataract surgery or IOL replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain.

Important Risk Information for Omidria®
Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two to 24 percent are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and Omidria-treated patients. Omidria® must be added to irrigation solution prior to intraocular use. Omidria is not approved for use in children.

About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, European Commission has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has partnered its arthroscopic product, OMS103, for commercialization with Fagron Sterile Services and affiliated JCB Laboratories. Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, product commercialization including with respect to Omidria® and OMS103, risks associated with Omeros’ ability to partner and commercialize Omidria in Europe, Omeros’ unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2015. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Monday, August 17th, 2015 Uncategorized Comments Off on (OMER) Announces Plan to File Infringement Suit Against ANDA Filer

(GBT) Closing of IPO, Exercise of Over-Allotment Option

SOUTH SAN FRANCISCO, CA–(Aug 17, 2015) – Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today announced the closing of its initial public offering of 6,900,000 shares of common stock at an initial public offering price of $20.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 900,000 additional shares of common stock. All of the shares in the offering were offered by GBT. The company’s common stock is listed on the NASDAQ Global Select Market under the ticker symbol “GBT.” Global Blood Therapeutics estimates net proceeds from the offering to be approximately $126.1 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Morgan Stanley and Goldman, Sachs & Co. acted as joint book-running managers for the offering. Cowen and Company and Wedbush PacGrow acted as co-managers.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission on August 11, 2015. Copies of the final prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 803-9204 or by email at prospectus@morganstanley.com or from Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, Facsimile (212) 902-9316 or emailing prospectus.ny@ny.email.gs.com.

This press release shall not constitute an offer to sell or a 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 registration or qualification under the securities laws of any such state or jurisdiction.

About Global Blood Therapeutics

Global Blood Therapeutics, Inc. (GBT) is a clinical stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its initial product candidate, GBT440, as an oral, once-daily prophylactic therapy for sickle cell disease (SCD) and is currently evaluating GBT440 in both healthy subjects and SCD patients in a randomized, placebo-controlled, double-blind Phase 1/2 clinical trial. In addition to GBT440 for the treatment of SCD, GBT is engaged in research and development activities targeted toward hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis (IPF), and hereditary angioedema (HAE).

Contact Information:

Stephanie Diaz
(investors)
Vida Strategic Partners
415-675-7401
Email Contact

Tim Brons
(media)
Vida Strategic Partners
415-675-7402
Email Contact

Monday, August 17th, 2015 Uncategorized Comments Off on (GBT) Closing of IPO, Exercise of Over-Allotment Option

(CFRXW) (CFRX) FDA Grants Fast Track Designation to ContraFect’s CF-301

YONKERS, NY–(Aug 17, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CF-301, the first lysin in a new class of medicines, currently in a Phase 1 Clinical Trial, for the treatment of Staph aureus bloodstream infections, including MRSA.

“ContraFect is pleased that the FDA has granted Fast Track designation to CF-301, and we look forward to the opportunity to interact more frequently with the FDA as we develop a new medicine with the potential to transform the treatment paradigm for drug-resistant Staph aureus bloodstream infections, including the MRSA superbug,” said Julia P. Gregory, ContraFect’s Chief Executive Officer. “This designation may also accelerate the availability of CF-301 to patients with these serious, potentially life threatening infections, if the drug successfully completes clinical development.”

About Fast Track

Established under the FDA Modernization Act of 1997, the Fast Track Drug Development Program is intended to facilitate the development, as well as expedite the review of drugs to treat serious conditions and potentially fill an unmet medical need. The Fast Track Designation provides earlier access to and more frequent communication with the FDA regarding all aspects of a designated drug’s clinical development program. Additionally, the designated drug may be eligible for submission of the New Drug Application (NDA) on a rolling basis as well as Accelerated Approval and Priority Review if supported by clinical data at the time of the NDA submission.

About CF-301

CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.

About Lysins

Lysins are enzymes that digest the cell wall of bacteria. Once the cell wall is breached, the bacteria is killed on contact. We believe lysins are unlike standard-of-care antibiotics, especially regarding their mechanism and speed of action. Traditional antibiotics, and most cytotoxic agents, require bacterial cell division and metabolism in order to be effective. Based on in vitro and animal tests, we believe lysins, however, are fundamentally different in that they have rapid bactericidal activity, target and kill specific bacteria without impacting the good bacteria, eradicate bacteria’s protective biofilm, do not have resistance to drug resistant strains and synergize with standard of care antibiotics.

About ContraFect

ContraFect is a clinical-stage biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. ContraFect intends to address drug-resistant infections using its therapeutic product candidates from its lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “potential” or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include statements regarding the anticipated favorable impact resulting from the FDA’s fast track designation of CF-301 and the accelerated availability of CF-301 for patients, our expectation that CF-301will be the first lysin in a new class of medicines, our ability to transform the treatment paradigm for drug-resistant Staph aureus bloodstream infections, whether CF-301 successfully completes clinical development and our ability to address drug-resistant infections using our lysin and monoclonal antibody platforms, all of which are subject to certain assumptions, risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contacts

Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact

Avonelle McLean
ContraFect Corporation
Email: Email Contact

Monday, August 17th, 2015 Uncategorized Comments Off on (CFRXW) (CFRX) FDA Grants Fast Track Designation to ContraFect’s CF-301

(ESPR) Update on the ETC-1002 Development Program

Company on Track to Initiate Phase 3 Development Program in 2015 Conference Call and Webcast on Monday, August 17, 2015 at 4:30 p.m. Eastern Time

ANN ARBOR, MI–(August 17, 2015) – Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, provided an update today from the ETC-1002 (bempedoic acid) End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) last week. The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD), who are already taking maximally tolerated statins yet require additional LDL-C reduction and where there is a positive benefit/risk ratio. Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT). The Company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.

Esperion remains on track to initiate the ETC-1002 Phase 3 development program by the end of 2015. The program will support a proposed label indication for the use of ETC-1002, an oral, once-daily LDL-C lowering therapy, “as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH), or atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C.” Approximately nine million patients in the U.S. fall into these two combined categories.

The ETC-1002 Phase 3 development program will include clinical studies in patients with ASCVD and HeFH. The study designs will be finalized once minutes from the FDA meeting are received. The Company plans to continue to evaluate ETC-1002 as an add-on to statins, including at all doses.

In the fourth quarter, Esperion plans to finalize development plans for the fixed-dose combination of ETC-1002 and ezetimibe and will file a separate Investigational New Drug (IND) application with the FDA.

“After an informative and collegial meeting with the FDA, we are pleased that LDL-C remains an accepted clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patients with HeFH and/or patients with ASCVD,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We have a clear regulatory path forward for development and approval of ETC-1002, an oral, once-daily treatment option for these patients that require additional LDL-C lowering.”

Conference Call and Webcast Information

Esperion’s management will host a conference call to discuss these updates. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 15397722. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the Company’s website for two weeks.

Esperion’s Commitment to Cardiometabolic Disease

Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002), one product candidate entering into clinical evaluation (a fixed-dose combination of ETC-1002 and ezetimibe), as well as two preclinical product candidates.

About Esperion Therapeutics

Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-C lowering therapies for the treatment of patients with hypercholesterolemia. ETC-1002 (bempedoic acid), the Company’s lead product candidate, is an inhibitor of ATP Citrate Lyase, a well-characterized enzyme on the cholesterol biosynthesis pathway; the same pathway that includes HMG-CoA reductase, the enzyme target of statins. ETC-1002 and statins have a similar mechanism of action, inhibiting cholesterol biosynthesis, decreasing intracellular cholesterol, up-regulating LDL-receptors, and causing increased LDL-C clearance and reduced plasma levels of LDL-C. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of, and clinical development plan for, ETC-1002 and the fixed-dose combination of ETC-1002 and ezetimibe. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the risk that FDA may require additional studies or data prior to approval that might cause approval to be delayed, that Esperion may need to change the design of its Phase 3 program once final minutes from the FDA meeting are received, that positive results from a clinical study of ETC-1002 and the fixed-dose combination of ETC-1002 and ezetimibe may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or in all statin doses, including high doses, or the risk that other unanticipated developments or data could interfere with the scope of development and commercialization of ETC-1002 and the fixed-dose combination of ETC-1002 and ezetimibe, as well as other risks detailed in Esperion’s filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com

Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com

Monday, August 17th, 2015 Uncategorized Comments Off on (ESPR) Update on the ETC-1002 Development Program

(AVEO) Exclusive Worldwide License Agreement for AV-380

AVEO Oncology (NASDAQ:AVEO) today announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody (the “Product”).

Under the terms of the agreement, AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales and regulatory-based milestone payments totaling $311 million assuming successful advancement of the Product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs associated with the Product.

“AV-380 holds great promise as a potential treatment for cachexia secondary to multiple disease states, including cancer, chronic kidney disease, congestive heart failure and chronic obstructive pulmonary disease,” said Michael Bailey, AVEO’s president and chief executive officer. “Novartis brings resources and expertise to bear on advancing this program, which we believe provides the optimal path forward toward realizing its full potential.”

About Cachexia and GDF15

Cachexia is a complex metabolic syndrome associated with malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases. It affects some five million individuals in the United States¹.

GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Current evidence suggests that a pro-inflammatory state may be responsible for many of the symptoms associated with cachexia. Preclinical data show that inhibition of GDF15 results in a switch from catabolism to anabolism, suggesting that GDF15 inhibition with AV-380 may reverse the effects of cachexia.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.

AVEO Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about the expected benefits of AVEO’s agreement with Novartis, the amount, timing and potential receipt of payments under the Novartis agreement and AVEO’s clinical development plans for tivozanib in renal cell and colorectal cancer. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to maintain its agreement with Novartis; AVEO’s ability, and the ability of any licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

References

1 Morley et al. Cachexia: pathophysiology and clinical relevance. Am J Clin Nutr 2006;83:735–43.

Monday, August 17th, 2015 Uncategorized Comments Off on (AVEO) Exclusive Worldwide License Agreement for AV-380

(VPCO) Reports Second Quarter 2015 Results

Sales increased 105%; Gross Margins and Adjusted EBITDA Improved Compared to First Quarter of 2015

DANIA BEACH, Fla., Aug. 17, 2015  — Vapor Corp. (NASDAQ CM: VPCO, VPCOU) (“Vapor” or the “Company”), a leading U.S.-based distributor and retailer of vaporizers, e-liquids and e-cigarettes, today announced its financial and operating results for the second quarter ended June 30, 2015.

Second Quarter 2015 Financial Highlights

  • Net Sales More Than Double Q2 2015 vs Q1 2015
    Net sales for the second quarter of 2015 were $3.0 million compared to $1.5 million in the first quarter of 2015, an increase of 105%. This increase was primarily due to the Company’s retail Vape Stores expansion strategy and increased wholesale sales.
  • Gross Margins Increase
    Gross margins for the second quarter of 2015 increased to 45.2% from 25.3% the same quarter one year ago and from (-12.4)% from the first quarter of 2015. This increase was primarily related to product returns and discounts that were recognized in the previous quarters, as well as improved operating margins from the Company’s retail operations. The Company has struck new wholesale agreements with many of its retail customers to minimize the impact of future product returns and discount programs.
  • Adjusted EBITDA Loss Reduced 46% in Q2 2015 vs Q1 2015
    Adjusted EBITDA, a non-GAAP financial measure, was ($1.5) million in the second quarter of 2015 compared to ($2.8) million in the first quarter of 2015. This significant reduction was a result of the Company’s two-pronged strategy to shift its wholesale business to concentrate on smaller retail chains (generally 150 stores and less), while seeing the benefit from operating more of its vape stores for a full quarter.

“In the second quarter of 2015, we drove sequential quarterly revenue growth of 105% through our revised wholesale strategy and the strong performance of our ‘The Vape Store’ retail locations,” said Jeff Holman, CEO of Vapor Corp. “The recent completion of our $41.4 million capital raise offers us the ability to significantly expand our direct-to-consumer model, ‘The Vape Store,’ by opening new locations and acquiring existing vaporizer retailers, which will be transitioned over to our brand. We currently have 11 ‘The Vape Store’ locations, with a goal of increasing the number of company-owned retail stores by 20 to 30 locations before the end of the calendar year.”

Greg Brauser, President of Vapor Corp., stated, “Vapor Corp.’s competitive differentiator is rooted in our buying power and fast-growing network of retail locations. As we continue to acquire stores and expand our brand, our economies of scale and purchasing power will increasingly improve, further enhancing our ability to offer the industry’s highest quality e-liquids and vaporizers to customers at reduced prices. These strengths elevate our competitiveness in the approximately $3.5 billion vaporizer market and favorably position us to achieve our long-term goal of being the leading national vaporizer retailer.”

Recent Business Highlights

  • Completed an offering of 3,761,657 convertible preferred stock units at $11 per unit for gross proceeds of approximately $41.4 million and net proceeds to Vapor Corp. of approximately $38.7 million.
  • Opened 11th “The Vape Store” location in Kissimmee, FL, in response to the growing consumer demand for vaping products and in recognition of the shift in consumer preferences to shop in vape-dedicated stores.
  • Fully implemented a new point-of-sale and retail software system in all of the Company’s Vape Stores to improve efficiencies and controls as part of its expansion plan.
  • Completed overhaul and relaunch of TheVapeStoreOnline.com, Vapor Corp.’s e-commerce channel and premier destination for e-liquids, devices, tanks and coils, as well as educational resources for both new and experienced vaping customers.
  • Successfully relaunched Vapor Corp.’s affiliate program, whereby affiliates are supplied with a unique coupon code and receive commission for every product purchased online at Vapor Corp.’s e-commerce websites when a customer enters their code at checkout.
  • Rolled out a rewards program across all retail store locations and on Vapor Corp.’s e-commerce site.
  • Launched “Naked Fish”, a new, premium line of dripper e-liquids. The Naked Fish line is mixed using the highest quality USP Kosher Food Grade Vegetable Glycerin and Propylene Glycol.

“On the heels of our recent capital raise, we are in a much stronger financial position.  We are debt-free as of today and have what is likely the largest cash war chest in this segment of the industry. During the second quarter we completed the recognition of all returns and write-downs on expired e-cigarette product. In addition, we have entered new agreements with many of our larger wholesale retail customers that minimize our responsibility for the sell-through of product through their stores, mitigating our exposure to the magnitude of returns that stymied the e-cig industry in 2014,” concluded Mr. Holman.

Non-GAAP Financial Measure

This press release includes both financial measures in accordance with Generally Accepted Accounting Principles, or GAAP, as well as a non-GAAP financial measure. Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flows that either excludes or includes amounts that are not normally included or excluded in the most directly comparable measure calculated and presented in accordance with GAAP. Non-GAAP financial measures should be viewed as supplemental to, and should not be considered as alternatives to net income, operating income, and cash flow from operating activities, liquidity or any other financial measures. They may not be indicative of the historical operating results of Vapor nor are they intended to be predictive of potential future results. Investors should not consider non-GAAP financial measures in isolation or as substitutes for performance measures calculated in accordance with GAAP.

Our management uses and relies on adjusted earnings before interest, tax, depreciation and amortization, plus non-cash stock based compensation and changes in the fair value of derivatives or Adjusted EBITDA, as a non-GAAP financial measure. We believe that both management and shareholders benefit from referring to the following non-GAAP financial measure in planning, forecasting and analyzing future periods. Our management uses this non-GAAP financial measure in evaluating its financial and operational decision making and as a means to evaluate period-to-period comparison.  Our management recognizes that the non-GAAP financial measure has inherent limitations because of the excluded items described below.

We have included a reconciliation of our non-GAAP financial measure to the most comparable financial measures calculated in accordance with GAAP. We believe that providing the non-GAAP financial measure, together with the reconciliation to GAAP, helps investors make comparisons between Vapor and other companies. In making any comparisons to other companies, investors need to be aware that companies use different non-GAAP measures to evaluate their financial performance. Investors should pay close attention to the specific definition being used and to the reconciliation between such measure and the corresponding GAAP measure provided by each company under applicable SEC rules.

The following table presents a reconciliation of Adjusted EBITDA to Net loss, a GAAP financial measure:

2015
Q2
Three months ended
June 30, 2015
Q1
Three months ended
March 31, 2015
Sales, net $           3,011,303 $           1,468,621
Gross Margin 1,359,698 (182,489)
45.2% -12.4%
Advertising 67,398 105,177
Selling, general and administrative 3,534,304 3,243,189
3,601,702 3,348,366
Total other expense 2,511,251 450,341
Net Loss (4,753,255) (3,981,196)
Add Back:
Interest, net 535,001 377,459
Change in fair value derivative liabilities (214,768) 37,965
Depreciation and amortization 648,981 437,632
Stock based compensation 173,691 364,576
Other stock based expense – waivers 2,113,889
3,256,794 1,217,632
Adjusted EBITDA $        (1,496,461) $        (2,763,564)

 

About Vapor Corp.
Vapor Corp., a NASDAQ company, is a U.S. based distributor and retailer of vaporizers, e-liquids and electronic cigarettes. It recently acquired the retail store chain “The Vape Store” as part of a merger with Vaporin, Inc. The Company’s innovative technology enables users to inhale nicotine vapor without smoke, tar, ash or carbon monoxide. Vapor Corp. has a streamlined supply chain, marketing strategies and wide distribution capabilities to deliver its products. The Company’s brands include VaporX®, Krave®, Hookah Stix® and Vaporin™ and are distributed to retail stores throughout the U.S. and Canada. The Company sells direct to consumer via e-commerce and Company-owned brick-and-mortar retail locations operating under “The Vape Store” brand.

Safe Harbor Statement
This press release includes forward-looking statements including statements regarding future profitability, opening up to 20-30 new vape stores and minimizing future product returns. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. The results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include a shift in consumer preferences, contractual difficulties which adversely affect Vapor’s acquisition strategy and future federal and/or state regulation regarding vaporizers and tobacco alternatives. Further information on our risk factors is contained in our filings with the SEC, including the Prospectus dated July 23, 2015. We undertake no obligation to publicly update or revise any forward-looking statements, whether as the result of new information, future events or otherwise.

Monday, August 17th, 2015 Uncategorized Comments Off on (VPCO) Reports Second Quarter 2015 Results

(RCII) “Make a Difference Scholarship” Offers Aid amidst Skyrocketing College Costs

Rent-A-Center, Inc. (NASDAQ/NGS:RCII) today announced 60 U.S. high school and undergraduate students will share $60,000 in Rent-A-Center scholarships for distinguishing themselves academically and through civic engagement.

Having distributed $610,000 in scholarships since its establishment in 2004, Rent-A-Center’s Make A Difference scholarship provides 60 $1,000 awards annually to Rent-A-Center customers, their children, and the children of Rent-A-Center employees.

The scholarships come on the heels of a recent Gallup poll that found that college-funding worries are a top money concern for U.S. parents.

“Rent-A-Center has a long tradition of supporting education,” said Kenneth Jones, Rent-A-Center’s public affairs manager. “It’s gratifying to give back to the communities we serve and help offset tuition costs.”

Among other requirements, scholarship applicants must be pursuing their first undergraduate degree at an accredited two- or four-year college, university, vocational school or technical school in the United States or Puerto Rico.

A diverse group of students from across 12 states, this year’s awardees have a variety of academic focuses including engineering, business and psychology.

More information, including program guidelines and applications, can be found at https://www.scholarshipamerica.org/makeadifference/.

About Rent-A-Center:

A rent-to-own industry leader, Rent-A-Center is headquartered in Plano, Texas and operates more than 3,000 stores in the United States, Puerto Rico, Canada, and Mexico. The Company employs over 20,000 coworkers. Learn more at www.rentacenter.com.

 

Rent-A-Center
Kenneth Jones, 972-801-1815
media@rentacenter.com

Friday, August 14th, 2015 Uncategorized Comments Off on (RCII) “Make a Difference Scholarship” Offers Aid amidst Skyrocketing College Costs

(TTWO) Announces WWE® 2K16 Soundtrack Fit to #RaiseSomeHell

Eclectic offering features spectrum of prominent artists across multiple music genres

2K today announced the in-game soundtrack details for WWE® 2K16, the forthcoming release in the flagship WWE video game franchise. The soundtrack will feature 11 unique tracks from established and emerging artists that transcend multiple genres, including alternative, hip-hop, classic rock, heavy metal, country and electronic dance. The full WWE 2K16 soundtrack was revealed exclusively during Release on Beats 1 on Apple Music and is available now for streaming at http://apple.co/1DSFmcf. WWE 2K16 is currently scheduled for release on October 27, 2015 in North America and October 30, 2015 internationally for Xbox One and Xbox 360, as well as the PlayStation®4 and PlayStation®3 computer entertainment systems.

The WWE 2K16 soundtrack is scheduled to include the following artists and songs:

  • Billy Idol – “Rebel Yell”
  • Diplo (feat. Faustix & Imanos and Kai) – “Revolution”
  • Fashawn (feat. Nas & Aloe Blacc) – “Something To Believe In”
  • Kid Ink – “Hello World”
  • Marilyn Manson – “Deep Six”
  • MGK (feat. Victoria Monet) – “A Little More”
  • Run-DMC – “It’s Tricky”
  • Skid Row – “Youth Gone Wild”
  • Twenty One Pilots – “Heavydirtysoul”
  • Yelawolf – “Till It’s Gone” [Dan Heath Remix]
  • Zac Brown Band (feat. Chris Cornell) – “Heavy Is The Hand”
  • Zedd (feat. Logic and X-Ambassadors) – “Transmission”

“Building on the success of the in-game soundtrack curated by WWE Superstar John Cena® last year, we were enthusiastic about partnering with 2K to raise the bar higher for WWE 2K16 with a memorable list of world-renowned artists,” said Neil Lawi, Senior Vice President, WWE Music Group. “The WWE 2K16 soundtrack offers a diverse and exciting group of artists and songs including iconic tracks ‘Rebel Yell’ and ‘Youth Gone Wild,’ two of today’s most sought-after electronic dance masterminds Diplo and Zedd, and current ‘it’ artists Twenty One Pilots and Yelawolf.”

“Music plays a vital role in the WWE Universe, from WWE Superstar and Diva ring entrances to official pay-per-view themes, and inherently evokes WWE memories and emotions in all of us,” said Chris Snyder, Vice President of Marketing at 2K. “The WWE 2K16 soundtrack delivers a premium entertainment experience and is certain to raise some hell through its notable worldwide names and multiple music genres.”

Developed collaboratively by Yuke’s and Visual Concepts, a 2K studio, WWE 2K16 is not yet rated by the ESRB. WWE 2K16 is currently scheduled for release on Xbox One, Xbox 360, PS4™ and PS3™ on October 27, 2015 in North America and October 30, 2015 internationally. Consumers who pre-order WWE 2K16 at any participating retailer will receive two playable characters – each depicting global action film icon Arnold Schwarzenegger from The Terminator and Terminator 2: Judgment Day films – at no extra cost on launch day.

For more information on WWE 2K16 and 2K, visit wwe.2k.com, become a fan on Facebook, follow the game on Twitter and Instagram using the hashtags #WWE2K16 and #RaiseSomeHell or subscribe on YouTube.

2K is a wholly owned publishing label of Take-Two Interactive Software, Inc. (NASDAQ:TTWO).

T1, THE TERMINATOR, T2, TERMINATOR 2: JUDGMENT DAY, ENDOSKELETON, and any depiction of Endoskeleton are trademarks of Studiocanal S.A. All Rights Reserved. ©2015 Studiocanal S.A.®

About WWE

WWE, a publicly traded company (NYSE:WWE), is an integrated media organization and recognized leader in global entertainment. The company consists of a portfolio of businesses that create and deliver original content 52 weeks a year to a global audience. WWE is committed to family friendly entertainment on its television programming, pay-per-view, digital media and publishing platforms. WWE programming reaches more than 650 million homes worldwide in 35 languages. WWE Network, the first-ever 24/7 over-the-top premium network that includes all 12 live pay-per-views, scheduled programming and a massive video-on-demand library, is currently available in more than 170 countries. The company is headquartered in Stamford, Conn., with offices in New York, Los Angeles, London, Mexico City, Mumbai, Shanghai, Singapore, Dubai, Munich and Tokyo.

Additional information on WWE (NYSE:WWE) can be found at wwe.com and corporate.wwe.com. For information on our global activities, go to http://www.wwe.com/worldwide/.

Trademarks: All WWE programming, talent names, images, likenesses, slogans, wrestling moves, trademarks, logos and copyrights are the exclusive property of WWE and its subsidiaries. All other trademarks, logos and copyrights are the property of their respective owners.

Forward-Looking Statements: This press release contains forward-looking statements pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995, which are subject to various risks and uncertainties. These risks and uncertainties include, without limitation, risks relating to: WWE Network; major distribution agreements; our need to continue to develop creative and entertaining programs and events; a decline in the popularity of our brand of sports entertainment; the continued importance of key performers and the services of Vincent K. McMahon; possible adverse changes in the regulatory atmosphere and related private sector initiatives; the highly competitive, rapidly changing and increasingly fragmented nature of the markets in which we operate and greater financial resources or marketplace presence of many of our competitors; uncertainties associated with international markets; our difficulty or inability to promote and conduct our live events and/or other businesses if we do not comply with applicable regulations; our dependence on our intellectual property rights, our need to protect those rights, and the risks of our infringement of others’ intellectual property rights; the complexity of our rights agreements across distribution mechanisms and geographical areas; potential substantial liability in the event of accidents or injuries occurring during our physically demanding events including, without limitation, claims relating to CTE; large public events as well as travel to and from such events; our feature film business; our expansion into new or complementary businesses and/or strategic investments; our computer systems and online operations; a possible decline in general economic conditions and disruption in financial markets; our accounts receivable; our revolving credit facility; litigation; our potential failure to meet market expectations for our financial performance, which could adversely affect our stock; Vincent K. McMahon exercising control over our affairs, and his interests may conflict with the holders of our Class A common stock; a substantial number of shares which are eligible for sale by the McMahons and the sale, or the perception of possible sales, of those shares could lower our stock price; and the relatively small public “float” of our Class A common stock. In addition, our dividend is dependent on a number of factors, including, among other things, our liquidity and cash flow, strategic plan (including alternative uses of capital), our financial results and condition, contractual and legal restrictions on the payment of dividends (including under our revolving credit facility), general economic and competitive conditions and such other factors as our Board of Directors may consider relevant. Forward-looking statements made by the Company speak only as of the date made, are subject to change without any obligation on the part of the Company to update or revise them, and undue reliance should not be placed on these statements.

About Take-Two Interactive Software

Headquartered in New York City, Take-Two Interactive Software, Inc. is a leading developer, publisher and marketer of interactive entertainment for consumers around the globe. The Company develops and publishes products through its two wholly-owned labels Rockstar Games and 2K. Our products are designed for console systems and personal computers, including smartphones and tablets, and are delivered through physical retail, digital download, online platforms and cloud streaming services. The Company’s common stock is publicly traded on NASDAQ under the symbol TTWO. For more corporate and product information please visit our website at http://www.take2games.com.

About 2K

Founded in 2005, 2K develops and publishes interactive entertainment globally for console systems, handheld gaming systems and personal computers, including smartphones and tablets, which are delivered through physical retail, digital download, online platforms and cloud streaming services. 2K publishes titles in today’s most popular gaming genres, including shooters, action, role-playing, strategy, sports, casual, and family entertainment. The 2K label has some of the most talented development studios in the world today, including Firaxis Games, Visual Concepts, Hangar 13, Cat Daddy Games and 2K China. 2K’s stable of high quality titles includes the critically acclaimed BioShock®, Borderlands™, and XCOM® franchises, the beloved Sid Meier’s Civilization series, the innovative Evolve™, the popular WWE 2K franchise and NBA 2K, the #1 rated and #1 selling basketball franchise*. 2K is headquartered in Novato, California and is a wholly owned label of Take-Two Interactive Software, Inc. (NASDAQ:TTWO). For more information, please visit www.2k.com.

*According to 2008 – 2015 Metacritic.com and The NPD Group estimates of U.S. retail video game sales through July 2015.

“PlayStation” and “PS3” are registered trademarks. “PS4” is a trademark of Sony Computer Entertainment Inc.

All trademarks and copyrights contained herein are the property of their respective holders.

Cautionary Note Regarding Forward-Looking Statements

The statements contained herein which are not historical facts are considered forward-looking statements under federal securities laws and may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for the Company’s future business and financial performance. Such forward-looking statements are based on the current beliefs of our management as well as assumptions made by and information currently available to them, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may vary materially from these forward-looking statements based on a variety of risks and uncertainties including: our dependence on key management and product development personnel, our dependence on our Grand Theft Auto products and our ability to develop other hit titles, the timely release and significant market acceptance of our games, the ability to maintain acceptable pricing levels on our games, our ability to raise capital if needed and risks associated with international operations. Other important factors and information are contained in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2015, including the risks summarized in the section entitled “Risk Factors,” the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, and the Company’s other periodic filings with the SEC, which can be accessed at www.take2games.com. All forward-looking statements are qualified by these cautionary statements and apply only as of the date they are made. The Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

2K
Jaime Jensen, 415-507-7910
jaime.jensen@2k.com
or
Take-Two Interactive Software, Inc.
Alan Lewis, 646-536-2983
Corporate Press
alan.lewis@take2games.com
or
Access Communications for 2K
Erik Robertson, 415-844-6266
erobertson@accesspr.com
or
WWE
Matthew Altman, 203-352-1177
matthew.altman@wwecorp.com

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(ODP) Helps Children and Families Affected by Memorial Day Floods

Collaborative Efforts Facilitated by Feed the Children

When 11 inches of rain drenched the Greater Houston area over Memorial Day weekend, more than 12,000 homes and businesses were damaged – and countless children and families were affected.

To help some of these children start the new school year on the right foot, the Office Depot Foundation donated 2,000 colorful new sackpacks containing essential school supplies to the Greater Houston Storm Recovery Network – a collaboration of nonprofit, faith-based, local, state and national organizations that are working together to share information and resources to assist with recovery and rebuilding. The Foundation – the independent charitable giving arm of Office Depot® (NASDAQ:ODP) – announced the donations during a special Back-to-School Celebration at a Houston Office Depot store.

The Greater Houston Storm Recovery Network will distribute the sackpacks to children living in neighborhoods that were affected by the flooding. “These new sackpacks and the supplies they contain will be a valuable resource for children and families who are still feeling the impact of the floods,” said Lynae Novominsky, Vice-Chair of the Network and Volunteer Services Coordinator for Jewish Family Service of Houston. “Based upon past experience, recovery of many of these residents is expected to take from nine to 18 months, if not more.”

The Office Depot Foundation is making the donations during the 15th year of its award-winning National Backpack Program. By the end of this year, Office Depot and the Office Depot Foundation will have given away more than 3.7 million backpacks and sackpacks since the National Backpack Program began in 2001. In total, the Foundation donated 5,000 sackpacks to Houston-area schools, nonprofit organizations and government agencies this week.

“We believe that every child should have the opportunity to go to school with dignity and hope,” said Office Depot Foundation President Mary Wong. “These sackpacks and school supplies help to level the playing field.

“At the same time, this donation supports the Office Depot Foundation’s commitment to helping communities recover and rebuild after natural disasters,” Wong continued. “We are proud to support the work of the Greater Houston Storm Recovery Network as it continues to help residents of this community get back on their feet.”

The Office Depot Foundation also is supporting recovery and rebuilding efforts in Houston through its sponsorship of the National Disaster Help Desk for Business, a 24-hour toll-free hotline managed by the U.S. Chamber of Commerce Foundation’s Center for Corporate Citizenship. Businesses and nonprofit organizations can access resources and expert guidance by calling 1-888-MY-BIZ-HELP or (888) 692-4943.

The collaboration between the Office Depot Foundation and the Greater Houston Storm Recovery Network was suggested by Feed the Children, an Oklahoma City-based nonprofit organization that worked with numerous agencies in the Houston area to provide relief following the floods. “At Feed the Children we believe in championing partnerships,” said Travis Arnold, Interim President and CEO. “We know that when we unite together with other nonprofits we will have a greater impact. That is why we were excited to connect the Office Depot Foundation with the Greater Houston Storm Recovery Network and help serve these families that were impacted by the flooding.”

More information about the National Backpack Program can be found on the Office Depot Foundation’s Facebook page at www.facebook.com/officedepotfoundation. To learn more about the Office Depot Foundation and its initiatives, go to www.officedepotfoundation.org/.

About the Office Depot Foundation

The Office Depot Foundation is an independent foundation − tax exempt under IRC Sec. 501(c)(3) − that serves as the independent charitable giving arm of Office Depot, Inc. In keeping with its mission, Listen Learn Care®, the Foundation supports a variety of programs that give children tools to succeed in school and in life; build the capacity of nonprofit organizations through collaboration and innovation; and help communities prepare for disasters, as well as recovering and rebuilding afterwards. For more information, visit www.officedepotfoundation.org.

About the Greater Houston Storm Recovery Network

The Greater Houston Storm Recovery Network (the “Network”) is a collaborative of local 501(c)(3) agencies formed as a Long-Term Recovery Committee in response to the Memorial Day flooding in the Greater Houston area. The Network is pleased that it is able to start its distribution of early donations to help children start the school year off with supplies and uniforms and will be providing more resources to those families in need via its case management agencies. For more information about how to receive services, volunteer or donate, visit www.houstonfloodrecovery.org.

About Feed the Children

Feed the Children believes that it can create a world where no child goes to bed hungry. Since 1979, Feed the Children has grown into one of the largest U.S.-based charities. It is accredited by GuideStar Exchange and the BBB Wise Giving Alliance, maintain a 3-star rating from Charity Navigator, and is also a member of InterAction. Through its network agencies, Feed the Children distributed over $344 million in food, other necessities, educational supplies and medicine, impacting close to nine million individuals in the U.S. and over 4.9 million individuals globally, in fiscal year 2014.

IMAGES AVAILABLE ON REQUEST

Office Depot Foundation
Leon Rubin, 561-251-8075 (mobile)
lrubin@jkggroup.com

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(BKEPP) to Present at EnerCom, As Well As Citi Conferences

Blueknight Energy Partners, L.P. (“BKEP” or the “Partnership”) (NASDAQ: BKEP) (NASDAQ:BKEPP), a midstream energy company providing integrated services for companies engaged in the production, distribution and marketing of crude oil, asphalt and other petroleum products, announced today that Mark Hurley, Chief Executive Officer; Brian Melton, Vice-President of Business Development; and Alex Stallings, Chief Financial Officer, will present at EnerCom’s Oil and Gas Conference in Denver, Colorado at 8:25 a.m. Mountain Daylight Time, on Tuesday, August 18, 2015.

A live audio webcast of the presentation along with materials used during the conference will be accessible in the Investors section of BKEP’s website at www.bkep.com or by accessing http://www.theoilandgasconference.com on Tuesday, August 18th.

After the EnerCom Conference, Blueknight officers will conduct individual meetings with members of the investment community at the Citi MLP/Midstream Infrastructure Conference in Las Vegas, Nevada on Wednesday, August 19 and Thursday, August 20, 2015. The presentation materials used during the conference will be accessible in the Investors section of BKEP’s website at www.bkep.com on Wednesday, August 19th.

About Blueknight Energy Partners, L.P.

BKEP owns and operates a diversified portfolio of complementary midstream energy assets consisting of approximately 7.7 million barrels of crude oil storage located in Oklahoma and Texas, approximately 6.6 million barrels of which are located at the Cushing Oklahoma Interchange, approximately 900 miles of crude oil pipeline located primarily in Oklahoma and Texas, approximately 250 crude oil transportation and oilfield services vehicles deployed in Kansas, Colorado, New Mexico, Oklahoma and Texas and approximately 7.3 million barrels of combined asphalt product and residual fuel oil storage located at 43 terminals in 22 states. BKEP provides integrated services for companies engaged in the production, distribution and marketing of crude oil, asphalt and other petroleum products. BKEP is headquartered in Oklahoma City, Oklahoma. For more information, visit the Partnership’s web site at www.bkep.com.

 

BKEP
Investor Relations, 918-237-4032
investor@bkep.com
or
Media Contact:
Brent Gooden, 405-715-3232 or 405-818-1900

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(SOCB) To Be Acquired By (BNCN)

HIGH POINT, N.C., Aug. 14, 2015  — BNC Bancorp (“BNC,” NASDAQ: BNCN), the holding company for Bank of North Carolina, and Southcoast Financial Corporation (“Southcoast,” NASDAQ: SOCB), the holding company for Southcoast Community Bank, have entered into a definitive agreement pursuant to which BNC will acquire all of the common stock of Southcoast in a stock transaction valued at approximately $95.5 million, based on the closing price of BNC common stock on August 13, 2015.

Southcoast, headquartered in Mt. Pleasant, South Carolina, operates 10 branches in Mt. Pleasant, Charleston, Moncks Corner, Johns Island, Summerville, Goose Creek and North Charleston, South Carolina. As of June 30, 2015, Southcoast reported approximately $506 million in assets, $383 million in loans, and $361 million in deposits. Upon completion of the transaction, BNC is expected to have approximately $6.0 billion in assets, $4.5 billion in loans, and $4.9 billion in deposits. The transaction is expected to be immediately accretive to BNC’s fully diluted earnings per share and tangible book value per share, excluding deal costs.

Under the terms of the agreement, which has been approved by the Boards of Directors of both companies, Southcoast shareholders will receive a fixed price of $13.35 for each share of Southcoast common stock, payable in shares of BNC common stock based upon the 20-day volume weighted average price of BNC common stock prior to the closing of the merger (the
“VWAP”), subject to minimum and maximum exchange ratios. If the VWAP immediately prior to the merger is equal to or less than $19.00, then each share of Southcoast common stock will be converted into 0.7026 of a share of BNC common stock. If the VWAP immediately prior to the merger is equal to or more than $22.00, then each share of Southcoast common stock will be converted into 0.6068 of a share of BNC common stock. The transaction, which is subject to regulatory approval, the approval of the shareholders of Southcoast, and other customary conditions, is expected to close in the first quarter of 2016.

Commenting on the announcement, Rick Callicutt, President and Chief Executive Officer of BNC, said, “We are pleased to announce the combination of BNC and Southcoast. This partnership will allow us to expand our presence in one of the fastest growing and most dynamic regions in the Southeast, the Charleston and Mt. Pleasant, South Carolina markets. We are most excited about Wayne Pearson and his team joining BNC. Our combined companies will be well positioned for further growth in the Charleston and Mt. Pleasant markets with approximately $800 million in assets and a top-five deposit market share in the Charleston-North Charleston, SC MSA. The similar culture and core values of Southcoast and BNC will allow us to accelerate the integration, deepen existing customer relationships, and focus on expansion in these highly-sought after markets. The Southcoast team has built a bank that aligns with our vision of a high performing community bank that creates value for all of its stakeholders while ‘Delivering More’ than our customers expect.”

Callicutt continued, “The addition of Southcoast’s 10 offices, along with our upcoming acquisition of seven branches of CertusBank, N.A. in the Upstate Region, will allow BNC to grow our South Carolina franchise by approximately 17 office locations in the two fastest growing areas in the state.”

Wayne Pearson, Chairman and Chief Executive Officer of Southcoast, added, “We are pleased to join forces with BNC to provide enhanced and long-term value to our customers and communities. Our combination with BNC, with combined total assets of approximately $6.0 billion, will provide greater capital resources and operational scale that will allow us to grow with the robust Charleston and Mt. Pleasant economies and capture additional market share. In addition, BNC’s track record for creating and growing shareholder value will be a major plus for the Southcoast shareholder base.”

Troutman Sanders LLP provided legal counsel to BNC, while FIG Partners, LLC served as financial advisor to BNC and Sandler O’Neill + Partners LP served as a special advisor to BNC. Haynsworth Sinkler Boyd, P.A. provided legal counsel to Southcoast, while Banks Street Partners, LLC served as financial advisor to Southcoast.

INVESTOR PRESENTATION

Further information on the terms of this transaction will be included in a Form 8-K to be filed by BNC with the Securities and Exchange Commission (the “SEC”).

ABOUT BNC BANCORP

Headquartered in High Point, North Carolina, BNC Bancorp is the parent company of Bank of North Carolina, a commercial bank with total assets in excess of $5.0 billion. Bank of North Carolina provides a complete line of banking and financial services to individuals and businesses through its 57 banking offices in Virginia, North and South Carolina. The Bank currently has 12 locations in South Carolina and nine locations in Virginia that operate as BNC Bank. Bank of North Carolina is insured by the FDIC and is an equal housing lender. BNC Bancorp’s stock is traded and quoted in the NASDAQ Capital Market under the symbol “BNCN.” BNC Bancorp’s website is www.bncbancorp.com.

FORWARD-LOOKING STATEMENTS

This Current Report contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. In general, forward-looking statements usually use words such as “may,” “believe,” “expect,” “anticipate,” “intend,” “will,” “should,” “plan,” “estimate,” “predict,” “continue” and “potential” or the negative of these terms or other comparable terminology, including statements related to the expected timing of the closing of the merger, the expected returns and other benefits of the merger, to shareholders, expected improvement in operating efficiency resulting from the merger, estimated expense reductions resulting from the transactions and the timing of achievement of such reductions, the impact on and timing of the recovery of the impact on tangible book value, and the effect of the merger on BNC’s capital ratios. Forward-looking statements represent management’s beliefs, based upon information available at the time the statements are made, with regard to the matters addressed; they are not guarantees of future performance. Forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time and could cause actual results or financial condition to differ materially from those expressed in or implied by such statements.

Factors that could cause or contribute to such differences include, but are not limited to, the possibility that expected benefits may not materialize in the time frames expected or at all, or may be more costly to achieve; that the merger may not be timely completed, if at all; that prior to completion of the merger or thereafter, the parties’ respective businesses may not perform as expected due to transaction-related uncertainties or other factors; that the parties are unable to implement successful integration strategies; that the required regulatory, shareholder, or other closing conditions are not satisfied in a timely manner, or at all; reputational risks and the reaction of the parties’ customers to the merger; diversion of management time to merger-related issues; and other factors and risk influences contained in the cautionary language included under the headings “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” in BNC’s Form 10-K for the year ended December 31, 2014 and other documents subsequently filed by BNC with the SEC. Consequently, no forward-looking statement can be guaranteed. Neither BNC nor Southcoast undertakes any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For any forward-looking statements made in this Current Report on Form 8-K, the exhibits hereto or any related documents, BNC and Southcoast claim protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

ADDITIONAL INFORMATION

This communication is being made in respect of the Merger involving BNC and Southcoast. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the merger, BNC will file with the SEC a registration statement on Form S-4 that will include a proxy statement/prospectus for the shareholders of Southcoast. BNC also plans to file other documents with the SEC regarding the merger with Southcoast. Southcoast will mail the final proxy statement/prospectus to its shareholders. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS REGARDING THE MERGER AND ANY OTHER RELEVANT DOCUMENTS CAREFULLY IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE MERGER. The proxy statement/prospectus, as well as other filings containing information about BNC and Southcoast, will be available without charge, at the SEC’s website (http://www.sec.gov). Copies of the proxy statement/prospectus and other documents filed with the SEC in connection with the merger can also be obtained, when available, without charge, from BNC’s website (http://www.bncbancorp.com) and Southcoast’s website (http://www.southcoastbank.com).

Participants in the Merger Solicitation.

BNC and Southcoast, and certain of their respective directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the shareholders of Southcoast in respect of the merger. Information regarding the directors and executive officers of BNC and Southcoast and other persons who may be deemed participants in the solicitation of the shareholders of Southcoast in connection with the merger will be included in the proxy statement/prospectus for Southcoast’s special meeting of shareholders, which will be filed by BNC with the SEC. Information about BNC’s directors and executive officers can also be found in BNC’s definitive proxy statement in connection with its 2015 annual meeting of shareholders, as filed with the SEC on April 14, 2015, and other documents subsequently filed by BNC with the SEC. Information about Southcoast’s directors and executive officers can also be found in Southcoast’s Annual Report on Form 10-K, as filed with the SEC on March 12, 2015, and other documents subsequently filed by Southcoast with the SEC. Additional information regarding the interests of such participants will be included in the proxy statement/prospectus and other relevant documents regarding the merger filed with the SEC when they become available.

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(PBMD) Announces Commencement of Milestones for IMP701 Program

SYDNEY, AUSTRALIA–(Aug 14, 2015) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”) today announced it will receive an undisclosed clinical milestone payment from its collaboration and licensing agreement with Novartis relating to its Phase I IMP701 LAG-3 antibody. The antibody is being trialled for the treatment of cancer.

Immutep (which Prima Biomed acquired in December 2014) and CoStim Pharmaceuticals (which Novartis acquired in February 2014) entered into a commercial licensing and collaboration agreement in September 2012, under which CoStim obtained a licence to develop and commercialise antagonistic LAG-3 antibodies.

Novartis has full responsibility for the continued development of the antibody program and Prima is eligible to receive further potential development-based milestone payments and royalties on sales following commercialisation of the products.

Mr Marc Voigt, CEO of Prima, commented “There is strong preclinical evidence that antibodies to LAG-3 can promote an increased and sustained anti-cancer immune response. We are delighted that Novartis has now moved that concept into the clinic with help from our work in the field.”

About IMP701

IMP701 is a therapeutic antibody originally developed by Immutep to target LAG-3. This antagonist antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works to both activate effector T cells (by blocking inhibitory signals that would otherwise switch them off) and at the same time inhibit Treg function that normally prevent T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other checkpoint antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

About Prima BioMed

Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.

Prima’s original product, called CVac, is an ex vivo dendritic cell priming therapy that in May 2015 yielded favourable Phase II data in second remission ovarian cancer patients. Prima is currently seeking partners for further development of this therapy. Prima’s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is soluble LAG-3, is a T cell immunostimulatory factor for cancer chemoimmunotherapy which has completed early Phase II trials. A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.

Prima BioMed is listed on the Australian Stock Exchange and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.

For further information please contact:

Prima BioMed Ltd:
Stuart Roberts
+61 (0) 447 247 909
stuart.roberts@primabiomed.com.au

Australia Investor/Media:
Mr Matthew Gregorowski
Citadel Communications
+61 (0) 422 534 755
mgregorowski@citadelpr.com.au

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(GALT) Receives U.S. Patent Notice of Allowance

Broad Coverage Includes Use of Various Pectin Compounds for Chronic Kidney Disease Associated with the Development of Fibrosis, Established Kidney Fibrosis, Chronic Lung Disease Associated with the Development of Fibrosis and Established Lung Fibrosis

NORCROSS, Ga., Aug. 13, 2015  — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for patent application number 13/726,900, titled “Galactose-pronged polysaccharides in a formulation for antifibrotic therapies.” When issued, the patent will extend coverage of the Company’s pectin-derived compounds (including broad molecular weight ranges and other sources of pectin) to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis.

The Company’s lead compound, GR-MD-02, is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer that is comprised predominantly of galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars. GR-MD-02 is currently in a Phase 2 program in subjects with non-alcoholic steatohepatitis (NASH) with cirrhosis and NASH with advanced fibrosis.

“We are very pleased to bolster our portfolio of intellectual property with this patent and its broad coverage of pectin sources and molecular weight,” said Peter G. Traber, M.D., chief executive officer, president and chief medical officer of Galectin Therapeutics. “When issued, this patent will add to the Company’s current method of use patents for liver fibrosis, NASH, NASH with fibrosis, NASH cirrhosis and diabetic kidney disease to permit additional fibrotic disease method claims,” he added.

Claims in this new patent include administering pectin-derived compound parenterally to a patient having at least one of the four aforementioned diseases where the established fibrosis or progression of the fibrosis or cirrhosis is inhibited or slowed down. Additional specific claims encompass deriving the compound from citrus pectin, apple pectin, soybean hull pectin or sugar beet pectin with a molecular weight between 2 kDa and 400kDa. Also covered is the step of administering the modified galacto-rhamnogalacturonan compound in an admixture with a therapeutic agent, where the agent is an antifibrotic compound.

About Galectin Therapeutics

Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding patents that are expected to allow the potential expansion of Galectin’s development program for GR-MD-02 to include treatment of chronic kidney disease associated with the development of fibrosis, established kidney fibrosis, chronic lung disease associated with the development of fibrosis and established lung fibrosis. Claims in issued patents may not afford meaningful protection for our technological products. In addition, patents issued may be challenged and subsequently narrowed, invalidated or circumvented.   Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Carbohydrates are a relatively new drug class, and regulatory requirements are evolving; and we cannot assure that will be able to meet such requirements in a timely and cost effective manner in the manufacturing and characterization of our products. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc.

CONTACT: Jack Callicutt, Chief Financial Officer
         (678) 620-3186
         ir@galectintherapeutics.com

         LHA
         Kim Golodetz
         (212) 838-3777
         kgolodetz@lhai.com
Thursday, August 13th, 2015 Uncategorized Comments Off on (GALT) Receives U.S. Patent Notice of Allowance

(ONTX) Announces Submission of IND Application for Pivotal Phase 3 Trial for IV Rigosertib

Key Milestone in Positioning Rigosertib on Approval Track for HR-MDS

Pivotal Phase 3 Trial Expected to Begin in Second Half of 2015

NEWTOWN, Pa., Aug. 13, 2015  — Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy.  Upon clearance, the IND enables Onconova to initiate a randomized, controlled pivotal Phase 3 trial in patients with HR-MDS that have failed prior HMA therapy.

“We are pleased to achieve this important milestone, which positions rigosertib back on an approval track in HR-MDS,” said Ramesh Kumar, Ph.D., President and CEO of Onconova.  “We plan to submit Clinical Trial Applications (CTAs) in several European countries shortly.  Onconova anticipates initiating enrollment in the new Phase 3 study in the second half of 2015.”

The pivotal trial, designated 04-30 or “INSPIRE”, will enroll HR-MDS patients under 80 years of age who had progressed on, or failed to respond to, previous treatment with HMAs within the first nine months of initiation of HMA treatment, and had their last dose of HMA therapy within six months prior to enrollment in the trial.  The primary endpoint of this study will be overall survival, and an interim analysis is anticipated.  This randomized trial of approximately 225 patients will be conducted at about 100 sites globally.  Enrollment in this trial is expected to begin later this year, though the ability to conduct the trial as planned will require additional financing.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova’s clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company’s most advanced product candidate, two other candidates are clinical stage, and several candidates are in pre-clinical stages.  For more information, please visit http://www.onconova.com.

About Rigosertib

Rigosertib is a small molecule that inhibits cellular signaling by acting as a Ras mimetic. This is believed to be mediated by direct binding of rigosertib to the Ras-binding domain (RBD) found in many Ras effector proteins, including the Raf kinases and PI3K. The initial therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia (AML). Clinical trials with intravenous (IV) and oral formulations of rigosertib are being conducted at leading institutions in the U.S. and Europe.

Forward Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or Onconova Therapeutics, Inc.’s future operations, clinical development of Onconova’s product candidates and presentation of data with respect thereto, regulatory approvals, expectations regarding the sufficiency of Onconova’s cash and other resources to fund operating expenses and capital expenditures, Onconova’s anticipated milestones and future expectations and plans and prospects. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including our need for additional financing and current plans and future needs to scale back operations if adequate financing is not obtained, the success and timing of our clinical trials and regulatory approval of protocols, and those discussed under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.

Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT: Onconova Therapeutics

                 Benjamin Hoffman, 267-759-3036

                 bhoffman@onconova.us
Thursday, August 13th, 2015 Uncategorized Comments Off on (ONTX) Announces Submission of IND Application for Pivotal Phase 3 Trial for IV Rigosertib

(REXI) Authorizes Additional Share Repurchases

PHILADELPHIA, PA–(Aug 13, 2015) –  Resource America, Inc. (NASDAQ: REXI) (the “Company”) announced today that its Board of Directors has authorized the Company to repurchase up to $25.0 million of its common stock. This repurchase authorization replaces the Company’s previous share repurchase authorization from September 2014, pursuant to which the Company has repurchased 864,641 shares of its common stock. Share repurchases may be made from time to time through open market purchases or privately negotiated transactions at the discretion of the Company and in accordance with the rules of the Securities and Exchange Commission, as applicable. The amount and timing of any repurchases will depend on market conditions and other factors.

Resource America, Inc. is an asset management company that specializes in real estate and credit investments. The Company’s objective is to be best in class among asset managers in the real estate and credit sectors as measured by returns to investors and the quality of the funds and businesses it manages. Resource America’s investments emphasize consistent value and long-term returns with an income orientation. For more information please visit our website at www.resourceamerica.com or contact Marketing and Investor Relations at pkamdar@resourceamerica.com.

Certain matters discussed within this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ materially from expectations include financial performance, regulatory changes, changes in local or national economic conditions and other risks detailed from time to time in the Company’s reports filed with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. The Company undertakes no obligation to update or revise any forward looking statement to reflect new or changing information or events.

Contact:
Resource America, Inc.
www.resourceamerica.com
pkamdar@resourceamerica.com

Thursday, August 13th, 2015 Uncategorized Comments Off on (REXI) Authorizes Additional Share Repurchases

(OHGI) Aishuo App Wins Exclusive VoIP-Supply Contract for KeyIdea

Aishuo App Surpasses 7 Million Downloads; Approaches Halfway Milestone for 2 Year, 15 Million Subscriber Goal

LIMERICK, IRELAND–(Aug 13, 2015) – One Horizon Group, Inc. (NASDAQ: OHGI) (“One Horizon”, “We” or the “Company”), which operates its own Chinese retail VoIP service, branded Aishuo, and develops and licenses a bandwidth efficient mobile voice over Internet Protocol (“VoIP”) platform for smartphones, announced today that it has signed an agreement to be the exclusive supplier of Voice over IP services to KeyIdea Information Technology Co., Ltd (“KeyIdea”), a renowned manufacturer of satellite equipment in China. KeyIdea will commence operations of their new maritime satellite service in the fourth quarter of 2015 and will supply their crew-calling services exclusively using the Aishuo platform.

One Horizon further expands its subscriber base through the high Revenue Per User (“RPU”) crew-calling distribution channels by providing the newest entrant in the Chinese satellite operator space with a new recurring revenue stream for voice and messaging on top of the traditional equipment sales and satellite airtime rental revenues. KeyIdea will purchase pre-paid calling cards from Aishuo and resell to the crew on-board. Their fleets or crew members will have the availability to top-up online using the App. The calls will be carried through Aishuo’s Public Switched Telephone Network (“PSTN”) in China and billed to the crew on a pay-as-you-go basis.

One Horizon’s optimized technology was selected from a shortlist of platforms evaluated by KeyIdea as its unique low bandwidth usage coupled with high voice quality makes it an ideal solution for smaller capacity Internet connections such as those found on 2G, 3G and satellite. The Company’s track record of successful maritime deployments with Singapore Telecommunications (“Singtel”) and Smart Communications in the Philippines (“Smart”) were key reference deployments over satellite that KeyIdea considered as part of their selection process.

The KeyIdea maritime VoIP service supports scratch cards and all major Android mobile payment platforms including China UnionPay, Alibaba’s Alipay and Tencent’s Wechat Wallet which provides crew with convenient ways to purchase call credit.

One Horizon Group CEO Brian Collins noted, “We were delighted to be able to showcase our solution to the newest entrant in the satellite sector here in China and with our track record of success in the Philippines and Indonesia, we were confident in winning this contract. The team worked tirelessly to deliver what is going to be a truly high quality and affordable calling solution for KeyIdea’s fleets.”

Mr. Xiaogang Chen, CEO of KeyIdea, said, “The expansion of our business into providing satellite services alongside our high quality equipment is expected to deliver increased revenue and better margins for KeyIdea when linked together with a turnkey smartphone VoIP service available in all the App stores in China. We are really excited about the cooperation with One Horizon and using their unique technologies to improve the welfare of the crew on our fleets.”

Downloads of the Aishuo retail App have already surpassed 7 million across the 20 Chinese Android App stores including Baidu, Tencent, 360.CN and Xiaomi. The Aishuo rollout to Chinese smartphone users commenced in late February 2015 and the Company is seeking to acquire 15 million new subscribers over a two-year period with a view to leverage this significant user base to achieve industry average revenues per user (ARPU) for similar social media, mobile advertising and mobile VoIP apps.

Aishuo is available as a FREE download in over 25 App stores including Apple’s iTunes, Baidu’s 91.com and Baidu.com, the Tencent App store MyApp.com, 360 Qihoo store 360.cn and Xiaomi on mi.com.

About One Horizon Group, Inc.
One Horizon Group Inc.’s business is to optimize communications over the Internet through its wholly owned subsidiary, Horizon Globex GmbH, Zug, which develops and markets one of the world’s most bandwidth-efficient mobile voice over Internet Protocol (VoIP) platforms for smartphones, and also offers a range of other optimized data Applications including messaging and mobile advertising. The company controls and operates the Aishuo mobile VoIP service in China. Horizon Globex GmbH is an ISO 9001 and ISO 20000-1 certified company. The Company has operations in Ireland, Switzerland, the United Kingdom, China, India, Singapore and Hong Kong. For more information on the Company, its products and services, please visit http://www.onehorizongroup.com.

Safe Harbor Statement

This news release may contain “forward-looking” statements. These forward-looking statements are only predictions and are subject to certain risks, uncertainties and assumptions that could cause actual results to differ from those in the forward looking-statements. Potential risks and uncertainties include such factors as uncertainty of consumer demand for the Company’s products, as well as additional risks and uncertainties that are identified and described in Company’s SEC reports. Actual results may differ materially from the forward-looking statements in this press release. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company does not undertake, and it specifically disclaims, any obligation to update any forward-looking statements to reflect occurrences, developments, events or circumstances after the date of such statement.

Contact:

Ted Haberfield
MZ Group
President – MZ North America
Direct: 760-755-2716
Mobile: 858-204-5055
Email Contact
www.mzgroup.us

Thursday, August 13th, 2015 Uncategorized Comments Off on (OHGI) Aishuo App Wins Exclusive VoIP-Supply Contract for KeyIdea

(KMPH) to Report Pharmacokinetic Data From Intranasal Human Abuse Study

Conference Call and Live Audio Webcast Today at 4:30 p.m. ET

CORALVILLE, Iowa, Aug. 13, 2015  — KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that the Company will report the results from its intranasal human abuse liability study of KP201/APAP on today’s scheduled 4:30 p.m. ET call to review KemPharm’s corporate and financial results for the second quarter ended June 30, 2015.

The single-center, cross-over design pharmacokinetic study (KP201.A03) primarily measured the amount of hydrocodone released from KP201 (without acetaminophen) compared directly to hydrocodone bitartrate when both substances were insufflated (i.e. snorted).

Conference Call Information:

Interested participants and investors may access the conference call by dialing either:

  • (866) 395-2480 (U.S.)
  • (678) 509-7538 (international)

An audio webcast will be accessible via the Investor Relations section of the KemPharm website http://investors.kempharm.com/. A replay of the call will be available for 90 days beginning at approximately 5:30 p.m., ET today.

About KemPharm:

KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its LAT platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders. For more information on KemPharm, please visit www.kempharm.com.

Caution Concerning Forward Looking Statements:

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm’s financial resources and whether they will be sufficient to meet KemPharm’s business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm’s Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: For KemPharm, Inc.:	
         Gordon K. "Rusty" Johnson
         319-665-2575
         info@kempharm.com

         Media / Investor Contacts:
         Jason Rando / Joshua Drumm, Ph.D.
         Tiberend Strategic Advisors, Inc.
         212-375-2665 / 2664
         jrando@tiberend.com
         jdrumm@tiberend.com
Thursday, August 13th, 2015 Uncategorized Comments Off on (KMPH) to Report Pharmacokinetic Data From Intranasal Human Abuse Study

(SWSH) Announces Agreement to Sell Its U.S. Operations to (ECL) Ecolab

Transaction Expected to Close During the Fourth Quarter Pending Approval of the Company’s Stockholders

CHARLOTTE, N.C., Aug. 13, 2015  — Swisher Hygiene Inc. (“Swisher”) (NASDAQ:SWSH), a leading service provider of essential hygiene and sanitizing solutions, today announced that the Company agreed to sell the stock of its wholly owned U.S. subsidiary Swisher International, Inc. and other assets relating to Swisher’s U.S. operations, which comprise all of Swisher’s remaining operating interests, to Ecolab Inc. for $40.0 million in cash, of which $2.0 million is subject to a holdback for working capital adjustments. In the transaction, Swisher will retain certain debt and liabilities as set forth in the Purchase Agreement governing the sale. Completion of the transaction is subject to stockholder approval and other customary conditions.

“We believe the transaction is in the best interest of our stockholders and creates a very positive opportunity for our customers and employees. This transaction provides a broader customer base of business, additional service support, and the resources to expand our business and better service our customers. We believe Swisher International’s business model complements Ecolab’s existing institutional U.S. operations and will benefit our customers and employees,” said William M. Pierce, President and Chief Executive Officer of Swisher.

Conference Call

Swisher will host a conference call and live webcast to discuss this announcement as well as its second quarter 2015 results today at 8:30 a.m. Eastern Time.

The conference call can be accessed over the phone by dialing (855) 437-4412 or for international callers by dialing (484) 756-4295 and providing conference ID 5067258; please dial-in 10 minutes before the start of the call. A replay will be available two hours after the call and can be accessed by dialing 1-855-859-2056 or for international callers by dialing 1-404-537-3406; the conference ID is 5067258. The replay will be available until Wednesday, August 19, 2015.

Cautionary Statement on Forward-Looking Information

All statements other than statements of historical fact contained in this press release constitute “forward-looking information” or “forward-looking statements” within the meaning of the U.S. federal securities laws and the Securities Act (Ontario) and are based on the expectations, estimates and projections of management as of the date of this press release unless otherwise stated. All statements other than historical facts are, or may be, deemed to be forward looking statements. The words “plans,” “expects,” “is expected,” “scheduled,” “estimates,” or “believes,” or similar words or variations of such words and phrases or statements that certain actions, events or results “may,” “could,” “would,” “might,” or “will be taken,” “occur,” and similar expressions identify forward-looking statements.

Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Swisher as of the date of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. All of these assumptions have been derived from information currently available to Swisher including information obtained by Swisher from third-party sources. These assumptions may prove to be incorrect in whole or in part. All of the forward-looking statements made in this press release are qualified by the above cautionary statements and those made in the “Risk Factors” section of Swisher’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission, available on www.sec.gov, and with Canadian securities regulators available on Swisher’s SEDAR profile at www.sedar.com, and Swisher’s other filings with the Securities and Exchange Commission and with Canadian securities regulators available on Swisher’s SEDAR profile at www.sedar.com. The forward-looking information set forth in this press release is subject to various assumptions, risks, uncertainties and other factors that are difficult to predict and which could cause actual results to differ materially from those expressed or implied in the forward-looking information. Swisher disclaims any intention or obligation to update or revise any forward-looking statements to reflect subsequent events and circumstances, except to the extent required by applicable law.

About Swisher Hygiene Inc.

Swisher Hygiene Inc. is a NASDAQ listed service company delivering essential hygiene and sanitizing solutions to customers in a wide range of end-markets, with a particular emphasis on the foodservice, hospitality, retail and healthcare industries. These solutions are typically delivered by employees on a regularly scheduled basis and involve providing Swisher’s customers with consumable products such as detergents, cleaning chemicals, soap and hand sanitizers, paper and specialty products. Most of these offerings are coupled with the rental and servicing of dish machines, dispensing equipment and additional services such as the cleaning of restrooms and other facilities. EPA-registered disinfectants that meet the Centers for Disease Control and Prevention’s guidelines are also offered to assist customers with their need to disinfect environmental surfaces that may harbor specific viruses. Swisher is committed to service excellence, as what Swisher does matters to thousands of customers on a daily basis, helping to create the cleanest and healthiest environments.

Additional Information and Where to Find It

In connection with the proposed sale by Swisher Hygiene Inc. of its wholly owned subsidiary Swisher International, Inc. and other assets relating to Swisher Hygiene’s U.S. operations to Ecolab, Inc. (the “Sale Transaction”), Swisher Hygiene will file a proxy statement with the Securities and Exchange Commission (“SEC”). Swisher Hygiene will mail the definitive proxy statement to its stockholders.  INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION ABOUT SWISHER HYGIENE AND THE SALE TRANSACTION.  Investors and security holders may obtain a free copy of the definitive proxy statement, when it becomes available, and other documents filed by Swisher Hygiene with the SEC at the SEC’s web site at www.sec.gov.

The definitive proxy statement and such other documents also will be available for free on Swisher Hygiene’s website at www.swsh.com under the Investors page or by directing a written request to Swisher Hygiene Inc., 4725 Piedmont Row Drive, Suite 400, Charlotte, North Carolina 28210 Attention: Investor Relations.

Participants in a Solicitation

Swisher Hygiene and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from its stockholders in connection with the Sale Transaction. Information concerning the interests of Swisher Hygiene’s participants in the solicitation is set forth in Swisher Hygiene’s Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on April 1, 2015 and Amendment No. 1 to the Annual Report on Form 10-K/A for the year ended December 31, 2014, which was filed with the SEC on April 30, 2015, and in the definitive proxy statement relating to the Sale Transaction when it becomes available.

CONTACT: For Further Information, Please Contact:

         Swisher Hygiene Inc.

         Investor Contact:
         Amy Simpson
         Phone: (704) 602-7116
Thursday, August 13th, 2015 Uncategorized Comments Off on (SWSH) Announces Agreement to Sell Its U.S. Operations to (ECL) Ecolab

(EXFO) Multi-Million Dollar Order for Automatic Fiber Network Monitoring Solution

EXFO’s solution was selected based on next-generation OTDR technology and innovative software that bring the highest level of automation to monitor nearly 3,000 km of mission-critical fiber plant

QUEBEC CITY, Aug. 12, 2015 – EXFO Inc. (NASDAQ: EXFOTSX: EXF) announced today it has obtained a multi-million dollar order from a government entity in the Asia-Pacific region for a fiber monitoring system that will monitor a mission-critical, high-speed, IP/MPLS (Internet Protocol/Multiprotocol Label Switching) network spanning over nearly 3,000 kilometers.

EXFO’s fiber monitoring solution, branded as NQMSfiber, provides real-time surveillance of an optical network 24 hours per day, seven days per week. It is indispensable for detecting fiber bends, fiber cuts and fiber degradations over time, all of which can impede communications across a network.

NQMSfiber consists of optical time domain reflectometers (OTDRs), in the form of remote test units, providing high resolution and accurate loss measurements along fiber links. These units are combined with a web-based element management system (EMS), offering users a centralized access to results and an intuitive interface to analyze alarms and other events. This order is expected to be recognized into revenue in fiscal 2016.

“EXFO’s next-generation OTDR technology and innovative software, offering the highest level of automation and integration, played a major role in securing this deal, since they ensure unmatched network operation and maintenance,” said Stephane Chabot, Vice-President of EXFO’s Physical-Layer Division. “The added capabilities of our fiber monitoring system, with sophisticated functions like self-learning, programmable alarm management and dashboard reporting on fiber availability, placed our solution head-and-shoulders above the competition. In short, our fiber monitoring solution not only provides our customers with valuable, end-to-end visibility and key performance indicators (KPIs), but it also saves them precious time and money.”

About EXFO
EXFO enables extraordinary experiences on global networks. Our test, service assurance and network visibility solutions allow equipment manufacturers and network operators to deliver a wealth of services to consumers, while increasing network capacity and reducing operating costs. From a company executive holding a telepresence meeting with overseas staff to a runner transferring data from wearable technology, EXFO’s inherent expertise and powerful analytics render these events commonplace. Simply put, we have evolved over our 30-year history to ensure unmatched quality of service and quality of experience on next-generation fixed and mobile networks. EXFO has a staff of approximately 1600 people in 25 countries, supporting more than 2000 customers worldwide. For more information, visit www.EXFO.com and follow us on the EXFO Blog, Twitter, LinkedIn, Facebook, Google+ and YouTube.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and we intend that such forward-looking statements be subject to the safe harbors created thereby. Forward-looking statements are statements other than historical information or statements of current condition. Words such as may, expect, believe, plan, anticipate, intend, could, estimate, continue, or similar expressions or the negative of such expressions are intended to identify forward-looking statements. In addition, any statement that refers to expectations, projections or other characterizations of future events and circumstances are considered forward-looking statements. They are not guarantees of future performance and involve risks and uncertainties. Actual results may differ materially from those in forward-looking statements due to various factors including, but not limited to, macroeconomic uncertainty as well as capital spending and network deployment levels in the telecommunications industry (including our ability to quickly adapt cost structures with anticipated levels of business and our ability to manage inventory levels with market demand); future economic, competitive, financial and market conditions; consolidation in the global telecommunications test and service assurance industry and increased competition among vendors; capacity to adapt our future product offering to future technological changes; limited visibility with regards to timing and nature of customer orders; longer sales cycles for complex systems involving customers’ acceptances delaying revenue recognition; fluctuating exchange rates; concentration of sales; timely release and market acceptance of our new products and other upcoming products; our ability to successfully expand international operations; our ability to successfully integrate businesses that we acquire; and the retention of key technical and management personnel. Assumptions relating to the foregoing involve judgments and risks, all of which are difficult or impossible to predict and many of which are beyond our control. Other risk factors that may affect our future performance and operations are detailed in our Annual Report, on Form 20-F, and our other filings with the U.S. Securities and Exchange Commission and the Canadian securities commissions. We believe that the expectations reflected in the forward-looking statements are reasonable based on information currently available to us, but we cannot assure that the expectations will prove to have been correct. Accordingly, you should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this document. Unless required by law or applicable regulations, we undertake no obligation to revise or update any of them to reflect events or circumstances that occur after the date of this document.

Wednesday, August 12th, 2015 Uncategorized Comments Off on (EXFO) Multi-Million Dollar Order for Automatic Fiber Network Monitoring Solution

(IDN) Launches Law ID with Enhanced Functionality

Three Police Departments Pilot Law ID

Intellicheck Mobilisa, Inc. (NYSE MKT: IDN), the industry leader in identity authentication, verification and validation solutions, today announced the launch of Law ID®,the industry’s most accurate and customizable solution for immediately authenticating the identification and determining the status of an unknown and potentially dangerous contact.. The product is ideal for assisting in traffic stops, detective and undercover operations, security at outdoor events and everywhere law enforcement is on duty and immediately needs to know a contacts threat status. Law ID can be used on mobile devices at the point of contact to instantaneously access Department of Motor Vehicles, State and Federal law enforcement data sources to deliver real-time status on the contact.

Intellicheck currently has pilot agreements with police departments in three different states to install, evaluate and potentially purchase Law ID. These law enforcement agencies include departments in a major metropolitan area, a suburban unit adjacent to one of the nation’s largest cities and a sprawling, largely rural community department. Once the pilots are completed and the departments adopt Law ID, these three clients cumulatively represent annual recurring revenue potential in excess of $500K, with a total addressable market that is estimated to exceed $300M dollars annually. Having agreements with each of these distinctive size-class organizations demonstrates the scalability and effectiveness of Intellicheck’s Law ID solution for all types of law enforcement departments and agencies serving the public in a wide variety of operational environments and missions. Law ID also achieved another major milestone by passing a federal Criminal Justice Information System (CJIS) evaluation, allowing the system to access secure national law enforcement data sources.

Law ID reads embedded information on driver licenses and other government issued identification documents, while concurrently searching Department of Motor Vehicles, State, Federal and other authoritative law enforcement data sources. The real-time search results can deliver critical information, to the law enforcement officer’s smartphone including outstanding warrants, wants, and BOLOS (Be On the Look-Outs) along with photos, vehicle and weapon registration information, identification validation and additional important information. New functionality enhancements enable real-time querying and display of results from local law enforcement databases as well as providing interoperability and instantaneous access to critical information. Additionally, an upgraded interface to police records management systems (RMS) provides greater speed and accuracy in completing officer reporting forms. Better reporting accuracy coupled with less time writing reports and searching for information optimizes both the use of law enforcement officers’ time and police department resources.

Law ID offers several major safety, cost and timesaving benefits. It is an affordable SaaS solution that is scalable from small to large police departments, as well as state and federal law enforcement and criminal justice agencies. Law ID can make an important safety difference during officer-citizen encounters by quickly de-escalating potentially tense interactions. During field contacts, law enforcement officials using Law ID on a mobile device can scan a driver license for identity authentication and other law enforcement information while maintaining visibility with the contact. This eliminates the officer’s need to return to the patrol car to enter contact data or to initiate radio inquiries. Law ID can instantaneously return vital data to the palm of the officer’s hand. The Law ID solution parses the query returns and the interface highlights critical information so an officer instantly knows if there is reason for heightened awareness. By also providing an individual’s photo from a returned query, Law ID provides law enforcement officers with the visual ability to help verify a positive match on the contact. In addition, Law ID reduces third party dispatch costs and minimizes radio traffic, keeping critical communications paths open for emergency use while preventing information from being monitored using police scanners. Law ID also eliminates bulky, additional equipment with its smartphone and tablet-based capabilities.

Intellicheck CEO Dr. William Roof commented, “Law ID increases officer and citizen safety. It can help quickly de-escalate a potentially tense situation by providing rapid data access and a quick and intuitive summary of critical law enforcement information. For every police department, state and federal law enforcement and other criminal justice agencies, our feature-enhanced solution is robust, scalable and affordable. We are excited to begin deploying units to our first three representative departments and expect to have positive results.”

Intellicheck Mobilisa’s robust patent portfolio of 20 patents includes many pertaining to identification technology. Intellicheck’s identity authentication solutions support customers in the national defense, law enforcement, retail, hospitality and financial markets. The Company’s products scan, authenticate and analyze components of identity documents including driver licenses, military identification cards and other government forms of identification containing magnetic stripe, barcode and smart chip information. Once extracted from the identity card, the information can be used to provide safety, security and efficiencies throughout these markets.

About Intellicheck Mobilisa

Intellicheck Mobilisa is an industry leader in identity authentication, verification and validation systems. The Company holds over 20 patents including many pertaining to identification technology. Its identity solutions support customers in the law enforcement, national defense, hospitality, retail and financial markets. The Company’s products scan, authenticate and analyze components of identity documents including driver licenses, military identification cards and other government forms of identification containing magnetic stripe, barcode and smart chip information. For more information on Intellicheck Mobilisa and ICMOBIL, please visit www.icmobile.com.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward looking statements including, without limitation, the statements regarding Intellicheck Mobilisa’s proposed offering, that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to general market conditions, development and product commercialization activities, and the success of its research, development and expansion of sales and marketing team, plans and strategies. These and other risks and uncertainties are identified and described in more detail in Intellicheck Mobilisa’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2014, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Intellicheck Mobilisa undertakes no obligation to publicly update or revise any forward-looking statements.

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(IMDZ) Announces Phase 2 Cancer Immunotherapy Trial Collaboration

Plan to Evaluate Combination of CMB305 and Genentech’s Atezolizumab in Patients With Soft Tissue Sarcoma

SEATTLE and SOUTH SAN FRANCISCO, Calif., Aug. 12, 2015  — Immune Design (Nasdaq:IMDZ) today announced it has entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of Immune Design’s CMB305 cancer immunotherapy product candidate combined with the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) in a randomized Phase 2 trial in patients with soft tissue sarcoma.

CMB305 is a “prime-boost” cancer immunotherapy product designed to synergistically induce anti-tumor cytotoxic T lymphocytes (CTLs) to target NY-ESO-1, a tumor antigen found in a broad set of tumors. Atezolizumab is a PD-L1 antagonist and is designed to block inhibitory T-cell checkpoints and allow cytotoxic T cells to reach the tumor. The randomized, open label Phase 2 trial will evaluate CMB305 and atezolizumab in patients with locally advanced, relapsed, or metastatic synovial sarcoma or myxoid/round-cell liposarcoma, two types of sarcoma that tend to express NY-ESO-1 broadly.

“The combination of CMB305, which is designed to generate and expand tumor-specific CD8 T cells, with atezolizumab, which is designed to remove the tumor-induced blockade, makes profound sense from a mechanistic perspective,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. “We are pleased to begin this collaboration with Genentech and explore the potential synergy of these product candidates, which will hopefully bring significant benefit to patients.”

About CMB305

CMB305 is a cancer immunotherapy product candidate combining two potentially synergistic agents, LV305 and G305. LV305 is a hybrid vector from the ZVexTM discovery platform that specifically targets dendritic cells (DCs) in vivo and delivers the RNA for NY-ESO-1, enabling the DCs to express the entire tumor antigen and potentially induce a diverse set of CTLs targeting NY-ESO-1. G305, in contrast, is designed to boost the CTL response via the induction of antigen-specific CD4 “helper” T cells. G305 consists of recombinant NY-ESO-1 protein formulated with a proprietary synthetic small molecule called glucopyranosyl lipid A (GLA), the novel TLR4 agonist at the core of the GLAAS platform. CMB305 is intended to be an “off-the shelf” therapy that does not require patient-specific manufacturing or ex vivo manipulation of patient samples. Having established the safety and individual immunologic activity of LV305 and G305 in prior studies, Immune Design initiated a new Phase 1B study of the product candidate CMB305 earlier this year.

About Soft Tissue Sarcoma

Soft Tissue Sarcomas (STS) are malignancies that arise from the soft tissues of the body, such as tissues that connect, support and surround other body structures including muscle, fat, blood vessels, nerves, tendons and the lining of joints.1 In the United States, nearly 12,000 people will be diagnosed and approximately 4,870 are expected to die of STS in 2015.2 There are approximately 50 different types of STS including Liposarcomas and Synovial Sarcomas, which are subtypes effecting fat tissue and tissue around the joints, respectively.3 Myxoid/round cell is a type of liposarcoma that accounts for approximately 30% of all liposarcoma cases.4 Myxoid and round cell liposarcoma and synovial sarcomas have been shown to have high expression of NY-ESO-1, approximately 90% and approximately 50%, respectively.5

About Immune Design

Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the primary focus of Immune Design’s ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVexTM and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design’s product candidates and the reporting of clinical data regarding Immune Design’s product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Immune Design’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Immune Design’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

1 Mayo Clinic. Disease and Conditions: Soft tissue sarcoma.

Available at: http://www.mayoclinic.org/diseases-conditions/soft-tissue-sarcoma/basics/definition/con-20033386. Accessed: July 2015.

2 National Cancer Institute. SEER Stat Fact Sheets: Soft Tissue including Heart Cancer.

Available at: http://seer.cancer.gov/statfacts/html/soft.html. Accessed: July 2015.

3 American Cancer Society. What is a soft tissue sarcoma?

Available at: http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-soft-tissue-sarcoma. Accessed: July 2015

4 Orpha.net. Myxoid/round cell liposarcoma.

Available at: http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=99967. Accessed: July 2015.

5 Endo, M., et al. (April 2015). NY-ESO-1 (CTAG1B) expression in mesenchymal tumors [Abstract]. Modern Pathology, 28, 587-595.

Available at: http://www.nature.com/modpathol/journal/v28/n4/full/modpathol2014155a.html. Accessed: July 2015.

CONTACT: Media Contact
         Julie Rathbun
         Rathbun Communications
         julie@rathbuncomm.com
         206-769-9219

         Investor Contact
         Shari Annes
         Annes Associates
         sannes@annesassociates.com
         650-888-0902
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(ECTE) Non-Invasive Continuous Glucose Monitoring System Likely Class 2 Medical Device in China

ISELIN, N.J., Aug. 12, 2015  — Echo Therapeutics, Inc. (NASDAQ: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced that, after numerous consultations with the Chinese government, its strategic partner, Medical Technologies Innovation Asia (MTIA), Ltd., believes that Echo’s locally produced needle-free CGM products will be designated as a Class 2 medical device. Class 2 medical devices have a review period of 90 working days after filing submission with the Medical Device Evaluation Center of the China Food and Drug Administration (CFDA).  A formal and final designation from the CFDA is determined only at the time of submission.

As previously announced, Echo and MTIA are in the process of finalizing manufacturing assets in China and completing internal testing in support of the CFDA clinical trial and commercialization. Clinical sites for the approximately 120-patient trial have been identified and secured. Following CFDA approval, MTIA and Echo will share net sales of Echo’s CGM in the licensed territory.

“China represents the first key market for Echo and we are focused on supporting MTIA’s efforts to bring the technology to the 100 million diabetics in China. Additionally, we will build on this momentum as we move toward making our products accessible globally,” said Scott W. Hollander, Echo’s President and CEO. “In early June, I personally visited each of the manufacturing facilities in China and feel confident that MTIA has the assets in place to support their commercial efforts in the future.

“While the formal and final designation is never made until submission, my team and I continue to build a strong relationship with the CFDA while we work diligently to bring this important product to the market,” said Bai Ge, Managing Director of MTIA.

About Medical Technologies Innovation Asia

Medical Technologies Innovation Asia (MTIA) is a fully integrated medical device company focused on accelerating and delivering game-changing technologies that improve existing standards of care to meet unmet significant clinical needs and challenges, especially in oncology, diabetic, cardiovascular and other aging-related disease. Headquartered in Hong Kong, the company has manufacturing and sales facilities throughout mainland China. MTIA has established sales channels in more than 1,000 hospitals across China’s provinces, including national, top-tier regional and military institutions. MTIA is also the leading investor to pilot a number of State-Owned Enterprise giants of China in the healthcare area plus one of the potentially biggest market capitalization pharmaceutical companies who also has dramatic marketing and sales presence in the diabetic and cardiovascular disease treatment field.

About Echo Therapeutics

Echo Therapeutics is developing its non-invasive, wireless, continuous glucose monitoring (CGM) system. A significant opportunity exists for the Company’s CGM to be used in the outpatient diabetes market and in the fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the hospital settings. Echo developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s clinical studies, the safety and efficacy of Echo’s CGM System, the failure of future development and preliminary marketing efforts related to Echo’s CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell Echo’s CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2014, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(732) 549-0128

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