Archive for August, 2015

(ABGB) Will Build a New Port Terminal in Uruguay

The contract exceeds $93 million
The development of engineering will begin in the fourth quarter of 2015.

SEVILLE, Spain, Aug. 24, 2015  — Abengoa (MCE: ABG.B/P SM /NASDAQ: ABGB), the company that applies innovative technology solutions for sustainability in the energy and environment sectors, has been awarded the construction of the new port terminal located in Capurro, Montevideo.

This project aims at having an exclusive area for the transfer and re-embarkation of fishery products to major international markets and in turn relieve the central docks of the port, seen the increasing activity.

Abengoa, with a 50% stake in the winning consortium, will be responsible for drawing up the final design and construction of approximately 1,000 meters of quays for industrial fishing vessels, with the corresponding protection, berthing and defense works. Also, it will fill an area of 2.5 hectares, and will carry out the paving, drainage, power distribution of drinking water and fuel, as well as the dredging of the basin and its final location against the promenade, on an area up to 20 hectares. In this latter work, stands out the use of geocontainer technology.

The engineering works are expected to begin in the fourth quarter of 2015, with a deadline of nine months for the drafting and 30 months for its execution. Direct work for 140 people is foreseen.

The implementation of this project is aligned with the company’s diversification strategy and reaffirms Abengoa’s leadership in the Uruguayan market, where it has been participating for 35 years in major projects in the country. The company’s experience in the execution of major infrastructure projects stands out.

About Abengoa

Abengoa (MCE: ABG.B/P SM /NASDAQ: ABGB) applies innovative technology solutions for sustainability in the energy and environment sectors, generating electricity from renewable resources, converting biomass into biofuels and producing drinking water from sea water. (www.abengoa.com)

Communication Department:
Patricia Malo de Molina Meléndez.
Tel. +34 954 93 71 11
E-mail: communication@abengoa.com
Investor relations:
Ignacio García Alvear.
Tel. +34 954 93 71 11
E-mail: ir@abengoa.com

 

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(BLIN) FatWire Co-Founder Ari Kahn Joins Bridgeline as CEO

BURLINGTON, Mass., Aug. 24, 2015  — Bridgeline Digital, Inc. (NASDAQ:BLIN), The Digital Engagement Company™, today announced that digital engagement veteran Ari Kahn has joined Bridgeline as Chief Operating Officer. Kahn will lead Bridgeline’s operations – including sales, marketing and service delivery.

“Ari has an impressive track record of growing a leading company in our marketplace and building significant shareholder value,” said Thomas Massie, Chief Executive Officer of Bridgeline Digital. “Ari’s robust operational experience will play a critical role in driving growth via stronger executional discipline. We are building a winning team, and Ari brings essential skills and leadership capabilities that will improve our performance.  It is exciting to see an industry expert express confidence by joining the Company and with a meaningful investment as Ari has done by investing above market value last week to secure $250,000 in Bridgeline common stock.”

Kahn was the co-founder of FatWire, a leading content management and digital engagement company.  As the General Manager and Chief Technology Officer of FatWire, Kahn built FatWire to a global corporation with offices in 13 countries, top industry analyst rating, and after winning many of the Global-2000 as customers, FatWire had annual revenues of over $40 Million and was acquired by Oracle for $160 Million. Kahn received his Ph.D. in Computer Science and Artificial Intelligence from the University of Chicago.

“As a founder of the Web Content Management and Digital Engagement category I see Bridgeline’s technical advantages and market position. Bridgeline’s digital engagement platform iAPPS provides tremendous value for its customers and the marketplace. iAPPS is ready to support more than 10 times its current customer base, and Bridgeline, through its dynamic and scalable platform iAPPS, consistently wins the majority of time in competitive situations. It is time to get the word out; Bridgeline is ready for serious growth!”

Kahn’s appointment follows a series of industry accolades for iAPPS. In the past six months, leading analyst firm Forrester named iAPPS a strong performer in their Through-Channel Marketing Automation report and The SIIA awarded iAPPS with the 2015 CODiE for Best Web Content Management Platform.

About Bridgeline Digital

Bridgeline Digital, The Digital Engagement Company™, enables its customers to maximize the performance of their mission critical websites, intranets, and online stores. Bridgeline’s iAPPS platform deeply integrates Web Content Management, eCommerce, eMarketing, Social Media management, and Web Analytics to help marketers deliver online experiences that attract, engage and convert their customers across all digital channels.  Bridgeline provides end-to-end Digital Engagement solutions and boasts an award-winning team of interactive services professionals. Headquartered in Burlington, Mass., with nine additional locations throughout the United States and a .NET development center in Bangalore, India. Bridgeline has thousands of quality customers that range from small- and medium-sized organizations to Fortune 1000 companies. To learn more, please visit www.bridgeline.com or call (800) 603-9936.

CONTACT: Becki Dilworth
         Senior Vice President of Marketing
         Bridgeline Digital, Inc.
         303.785.3858
         bdilworth@bridgeline.com
Monday, August 24th, 2015 Uncategorized Comments Off on (BLIN) FatWire Co-Founder Ari Kahn Joins Bridgeline as CEO

(OCAT) Receives SBIR Grant from NIH

Ocata Therapeutics, Inc. (NASDAQ:OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to fund further preclinical development of Ocata’s proprietary Hemangio-derived Mesenchymal Cell (HMC™) product for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN).

“Ocata has demonstrated potential therapeutic activity of a pluripotent stem cell-derived product for the treatment of autoimmune diseases such as lupus nephritis and Crohn’s disease,” said Robert Lanza, M.D., Chief Scientific Officer at Ocata, and Principle Investigator of the grant. “Our studies in highly regarded pre-clinical models of lupus nephritis provided proof of concept that our HMC’s increased the lifespan of the lupus-prone mice and inhibited the progression of otherwise fatal glomerulonephritis.”

Systematic lupus erythematosus (SLE) is a systemic autoimmune disease that presents significant disease management challenges, as there is currently no known cure. While treatment to relieve symptoms is sometimes available for patients with mild to moderate SLE, a subset of SLE patients resist all forms of current interventions and develop LN, a severe and debilitating disease. The HMC product developed by Ocata has shown to have immune-modulatory and anti-inflammatory activity to help treat these diseases.

“This grant from the NIH, a preeminent research agency, recognizes the promise of our HMC product as a potential new treatment for disabling autoimmune diseases like lupus nephritis, where there is no cure available today,” said LeRoux Jooste, Chief Commercial Officer and SVP Business Development. “Our preclinical research and patent estate firmly anchors our leading position in the development of our novel Restorative Immunology™ platform and expands Ocata’s potential to partner the non-ophthalmic uses of its technology for the treatment of devastating autoimmune diseases.”

About Ocata Therapeutics, Inc.

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of regenerative ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.

Forward-Looking Statements

All statements, other than historical facts, contained in this news release, including statements regarding Ocata’s belief regarding the continued development of its HMC product, the ability to produce and the potential effectiveness of a pluripotent stem cell-derived product to treat auto immune diseases, the effect of Ocata’s pre-clinical research and patent estate on the development of its product platforms, and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history; Ocata’s need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.

 

Investors:
Westwicke Partners
John Woolford, 443-213-0506
john.woolford@westwicke.com
or
Press:
Russo Partners
David Schull, 858-717-2310
david.schull@russopartnersllc.com

Monday, August 24th, 2015 Uncategorized Comments Off on (OCAT) Receives SBIR Grant from NIH

(EPZM) Acceptance of IND for Tazemetostat

Phase 2 study in adults and phase 1 study in pediatric patients with INI1-negative tumors or synovial sarcoma to begin in the second half of 2015

Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for patients with cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application for tazemetostat for the treatment of adults and pediatric patients with INI1-negative tumors or synovial sarcoma. In the second half of 2015, Epizyme plans to initiate a multi-center phase 2 study in adults and a multi-center phase 1 study in children to evaluate tazemetostat in patients with relapsed or refractory INI1-negative tumors or synovial sarcoma.

“Patients with INI1-negative tumors have a life-threatening disease and few treatment options. Our development approach reflects Epizyme’s strategy for aggressively advancing tazemetostat for indications with high unmet need,” said Peter Ho, M.D., Ph.D., Chief Development Officer. “These clinical studies and our IND enable the expansion of our clinical development program, as we aim to establish tazemetostat’s benefit globally in multiple therapeutic areas where it has shown promise in early research.”

“We believe the treatment of INI1-negative tumors offers an opportunity for us to establish a strong clinical profile for tazemetostat in multiple patient populations and reinforces Epizyme’s leadership position in the field of targeted epigenetic therapeutics,” added Robert Gould, Ph.D., President and Chief Executive Officer. “These new registration-supporting studies in INI1-negative tumors and synovial sarcoma will complement our ongoing 5-arm phase 2 study of tazemetostat in non-Hodgkin lymphoma, which is actively enrolling patients.”

INI1 is a critical component of the SWI/SNF regulatory complex, a chromatin remodeler that acts in opposition to EZH2. INI1-negative tumors have altered SWI/SNF function, resulting in aberrant and oncogenic EZH2 activity. This activity can be targeted by small molecule inhibitors of EZH2 such as tazemetostat. INI1-negative tumors are generally aggressive and are poorly served by current treatments. For example, current treatment of MRT, a well-studied INI1-negative tumor, consists of surgery, chemotherapy and radiation therapy, which are associated with limited efficacy and significant treatment-related morbidity. The annual incidence of patients with INI1–negative tumors and synovial sarcoma in major markets, including the U.S., E.U. and Japan, is approximately 2,400.1

The adult phase 2 multicenter study will enroll up to 90 patients in three cohorts. The first cohort will be comprised of patients with malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK) and atypical teratoid / rhabdoid tumor (ATRT). The second cohort will be comprised of patients with other INI1-negative tumors including epithelial sarcoma, epithelioid malignant peripheral nerve sheath tumor, extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, and renal medullary carcinoma. The third cohort will be comprised of patients with synovial sarcoma. Dosing in all three cohorts will be at the recommended phase 2 dose of 800 mg twice per day (BID) with a tablet formulation, which Epizyme is also using in its ongoing phase 2 trial in non-Hodgkin lymphoma. The primary endpoint is overall response rate (ORR) for patients with INI1-negative tumors and progression-free survival (PFS) for patients with synovial sarcoma. Secondary endpoints include duration of response, overall survival (OS), PFS for patients with INI1-negative tumors, safety and pharmacokinetics (PK).

The pediatric phase 1 multicenter study will enroll approximately 40 patients in a dose escalation design, followed by dose expansion, with an oral suspension of tazemetostat. The study will enroll subjects with INI1-negative tumors or synovial sarcoma. INI1-negative tumors include MRT, ATRT, RTK, and other INI1-negative tumors as previously described. The primary endpoint of study is safety with the objective of establishing the recommended phase 2 dose in pediatric patients. Secondary endpoints include PK, ORR, duration of response, PFS and OS.

Epizyme will present a clinical update for the phase 1 portion of the ongoing phase 1/2 trial of tazemetostat at ESMO’s European Cancer Conference on September 26, 2015. This update will include safety data from the entire cohort and efficacy data from patients with solid tumors including INI1-negative tumors.

About EZH2 in Cancer

EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include non-Hodgkin lymphomas, INI1-negative cancers such as malignant rhabdoid tumors, epithelioid sarcomas, and a range of other solid tumors including synovial sarcoma.

About the Tazemetostat Clinical Program

In addition to the aforementioned studies in patients with INI1-negative tumors and synovial sarcoma, Epizyme is evaluating tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and solid tumors in a phase 1/2 study. The dose escalation and dose expansion cohorts from the ongoing phase 1 part of the study are fully enrolled.

The phase 2 NHL study is the phase 2 portion of the phase 1/2 study. This trial is a five-arm, multi-center, international study that will assess the safety and activity of tazemetostat in patients with relapsed or refractory non-Hodgkin lymphoma. The study will enroll up to 30 patients in each arm, prospectively stratified for EZH2 mutation status and cell-of-origin, assuming each arm of the study achieves its primary response rate goal in its first stage. The five study arms are enrolling relapsed/refractory patients with:

  • Germinal center DLBCL with mutant EZH2
  • Germinal center DLBCL with wild-type EZH2
  • Follicular lymphoma with mutant EZH2
  • Follicular lymphoma with wild-type EZH2
  • Non-germinal center DLBCL

The Company also plans to initiate additional clinical evaluations of tazemetostat, including a combination with R-CHOP in patients with DLBCL, and a combination with a B-cell signaling agent or other emerging targeted therapies for B-cell lymphomas.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of non-Hodgkin lymphoma patients and patients with INI1-negative tumors or synovial sarcoma. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In many human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about the ongoing phase 1/2 program, including clinical trial information, may be found here: https://clinicaltrials.gov/ct2/show/NCT01897571.

About Epizyme, Inc.

Epizyme, Inc. is a clinical stage biopharmaceutical company creating novel epigenetic therapeutics for cancer patients. Epizyme has built a proprietary product platform that the Company uses to create small molecule inhibitors of a 96-member class of enzymes known as histone methyltransferases, or HMTs. HMTs are part of the system of gene regulation, referred to as epigenetics, that controls gene expression. Genetic alterations can result in changes to the activity of HMTs, making them oncogenic (cancer-causing). By focusing on the genetic drivers of cancers, Epizyme’s targeted science seeks to match the right medicines with the right patients.

For more information, visit www.epizyme.com and connect with us on Twitter at @EpizymeRx.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Epizyme, Inc. and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation of future clinical studies or expansion of ongoing clinical studies, availability and timing of data from ongoing clinical studies, whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials, expectations for regulatory approvals, development progress of the Company’s companion diagnostics, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates or companion diagnostics and other factors discussed in the “Risk Factors” section of our Form 10-Q most recently filed with the SEC, and in our other filings from time to time with the SEC. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward- looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

1 According to a report by Clarion Healthcare commissioned by Epizyme.

Media/Investors:
Epizyme, Inc.
Andrew Singer, 617-500-0712
Executive Vice President and Chief Financial Officer
asinger@epizyme.com

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(GALE) IDSMC Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax

PORTLAND, Ore., Aug. 24, 2015  — Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that the Independent Data Monitoring Committee (IDMC) has recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. The trial is being run under a Special Protocol Assessment (SPA) approved by the U.S. Food and Drug Administration (FDA).

Following its most recent IDMC meeting in June 2015, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.

Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated, “We are pleased to see that cardiac events have not appeared as a safety issue thus far in the study, relative to published reports of cardiac toxicity associated with other HER2 directed therapies. Importantly, the recommendation by the IDMC to reduce the frequency of cardiac assessments, per the protocol, facilitates the ongoing compliance and patient retention on trial.”

Per the PRESENT protocol, the IDMC was established and is made up of a group of physicians including medical oncologists, a cardiologist, and an independent statistician with pertinent expertise to evaluate accumulated data from the trial. The IDMC meets periodically and advises Galena regarding the continuing safety of trial patients, efficacy, as well as the continuing validity, integrity, and the overall conduct of the trial.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. NeuVax has been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26 molecules. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.

NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com (clinicaltrials.gov identifier: NCT01479244). Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in neoadjuvantly treated node positive and negative HER2 IHC 3+ patients not achieving a pathological complete response (pCR) or adjuvantly treated node positive HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

About Galena Biopharma

Galena Biopharma, Inc. (NASDAQ:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care.  Galena’s development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company’s commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena’s clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects.  For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the progress of the commercialization of Abstral® and Zuplenz® and development of Galena’s product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.

CONTACT: Remy Bernarda
         SVP, Investor Relations & Corporate Communications
         (503) 405-8258
         rbernarda@galenabiopharma.com
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(ACTS) Commences Dutch Auction Tender Offer

ZHUHAI, China, Aug. 24, 2015  — Actions Semiconductor Co., Ltd. (Nasdaq: ACTS) (“Actions Semiconductor” or “the Company”), one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics, announced today that it is commencing a self “Dutch auction” tender offer today to purchase for cash up to 48,000,000 of its issued and outstanding ordinary shares, which represents approximately 13.7% of Actions Semiconductor’s currently outstanding ordinary shares, $0.000001 par value per share (the “Shares”) (including Shares represented by American Depositary Shares (the “ADSs”)), at a purchase price not greater than $21/60 per Share (or $2.10 per ADS) nor less than $18/60 per Share (or $1.80 per ADS). Under the terms of the tender offer, the Company will invite holders of Shares and ADSs (together, the “Securities”) to tender their Securities at prices specified by such holders within such range of prices described further in the offer materials. The Company will select the lowest single per Share purchase price or per ADS purchase price, as applicable, that will allow it to buy up to 48,000,000 issued and outstanding Shares (including Shares represented by ADSs) at completion of the tender offer. The tender offer will expire at 5:00 p.m., Eastern Daylight Savings Time, on Tuesday, September 22, 2015, unless extended by the Company.  Tenders of Securities must be made on or prior to the expiration of the tender offer and may be withdrawn at any time on or prior to the expiration of the tender offer.  The tender offer is subject to the terms and conditions described in the offer to purchase and the related materials being distributed to holders of the Securities and filed with the Securities and Exchange Commission (the “SEC”).

Mr. David Lee, Chairman of the Company, noted that, “Over the last year, we successfully realigned our internal reporting structure and employee incentive program, and we continue to seek potential strategic alliance partners along the supply chain to help us expand our sales channels, enhance our technology base and create a larger ecosystem around our platform. We are also exploring the possibility of listing our subsidiaries on one of the exchanges in the Greater China region, which could in turn increase the valuation of our ADSs listed in the US, as well as other strategic initiatives to further increase our shareholder value.”

“Although our ability to increase our revenue over the last few years has been limited, we have established a solid foundation to address the rapidly expanding Bluetooth, IoT and smart hardware markets in the future.  We also continue to anticipate revenue growth in the second half of 2015, notwithstanding that, as everyone is aware, China’s growth rate has slowed. We hope our potential expansion into these high growth markets, along with the tender offer, will serve to increase shareholder value and, in the meanwhile, provide holders of our Securities with sufficient liquidity to exit the market while maintaining a sufficient volume of traded shares for investors who continue to value our Company.”

Neither Actions Semiconductor, its board of directors, dealer managers nor the information agent is making any recommendation to holders of the Securities as to whether to tender or refrain from tendering their Securities or as to the purchase price on any tender. Actions Semiconductor has been advised that none of its directors or executive officers intends to tender any Securities pursuant to the offer. The information agent for the tender offer will be Laurel Hill Advisory Group, LLC and the depositary for the tender offer will be Laurel Hill Advisory Group Company.  Laurel Hill Securities, LLC and Imperial Capital, LLC will act as the dealer managers for this tender offer.

This announcement is for informational purposes only and does not constitute an offer to purchase or a solicitation of an offer to sell Actions Semiconductor’s Securities. The solicitation of offers to buy Actions Semiconductor’s Securities will only be made pursuant to the offer to purchase, issued in connection with the commencement of the tender offer (as may be amended or supplemented), the related letter of transmittal, and other related documents that Actions Semiconductor intends to send to holders of its Securities. The tender offer materials contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials are being distributed by Actions Semiconductor to the holders of its Securities at no expense to them. In addition, all of the materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s website at www.sec.gov and by contacting Laurel Hill Advisory Group, the Information Agent for the Offer, by telephone at (888) 742-1305.

About Actions Semiconductor

Actions Semiconductor is one of China’s leading fabless semiconductor companies that provides comprehensive portable multimedia and mobile internet system-on-a-chip (SoC) solutions for portable consumer electronics. Actions Semiconductor products include SoCs, firmware, software, solution development kits, as well as detailed specifications of other required components. Actions Semiconductor also provides total product and technology solutions that allow customers to quickly introduce new portable consumer electronics to the mass market in a cost effective way. The Company is headquartered in Zhuhai, China, with offices in Shanghai, Shenzhen, Hong Kong and Taipei. For more information, please visit the Actions Semiconductor website at http://www.actions-semi.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

Statements contained in this release that are not historical facts are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements relating to the Company’s Dutch auction tender offer and ability to compete successfully in the Bluetooth,IoT and smart hardware markets. Actions Semiconductor uses words like “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project” and similar expressions to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are estimates reflecting current assumptions, expectations and projections about future events and involve significant risks, both known and unknown, uncertainties and other factors that could cause actual results to differ materially and adversely from those expressed in any forward-looking statement.  The risks and uncertainties referred to above include, but are not limited to, the trading price of the ADSs, the security holders’ interest in participating in such tender offer, the review of this matter by the SEC, the Company’s proposed cash requirements and future prospects and results of operations, and current market and economic conditions, as well as such other factors described in the Company’s filings with the SEC.  In light of these risks, uncertainties, assumptions and factors, the forward-looking events discussed in this press release may not occur. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this press release. Except as required by law, Actions Semiconductor undertakes no obligation and does not intend to update or revise any forward-looking statement to reflect subsequent events or changed assumptions or circumstances.

Investor Contacts:
Elaine Ketchmere, CFA Ally Xie, CA, CPA
Compass Investor Relations Actions Semiconductor
eketchmere@compassir.com investor.relations@actions-semi.com
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Monday, August 24th, 2015 Uncategorized Comments Off on (ACTS) Commences Dutch Auction Tender Offer

(BIOC) Announces Personnel Change

Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, today announced the voluntary resignation of Bill Kachioff, Senior Vice President and Chief Financial Officer, to pursue other business opportunities. The company also announced that Mark G. Foletta has been appointed as the company’s interim Chief Financial Officer, effective immediately.

“Bill has been a valued member of our management team for more than four years and on behalf of Biocept and its board of directors, I thank him for his dedicated service to our company,” said David F. Hale, Chairman of Biocept. “We wish him well in his future endeavors.”

“Mark has more than 20 years of financial experience primarily in the healthcare industry, including serving as the Chief Financial Officer of a rapidly growing, publicly traded biotechnology company,” said Michael Nall, President and Chief Executive Officer of Biocept. “This is an exciting time at Biocept as we expand into new cancer indications and increase our portfolio of biomarkers. I’m delighted that Mark has agreed to join us as we continue to expand the clinical utility and adoption of our liquid biopsy assays in order to improve patient outcomes and reduce healthcare costs.”

Mr. Foletta served as Senior Vice President and Chief Financial Officer of Amylin Pharmaceuticals, Inc. from 2000 through its acquisition by Bristol-Myers Squibb in 2012. At Amylin he was responsible for capital formation, financial management, financial reporting and investor relations. He participated in the successful commercial launch of three novel pharmaceutical products as the company evolved from R&D to commercialization. Prior to Amylin Mr. Foletta held a number of management positions with Intermark, Inc. and Triton Group Ltd., and served as an Audit Manager with Ernst & Young. Mr. Foletta received a BA in Business Economics form the University of California, Santa Barbara, is a certified public accountant (inactive) and is a member of the Corporate Directors Forum. Mr. Foletta serves on the boards of directors of publicly traded healthcare companies AMN Healthcare Services, Inc., Regulus Therapeutics, Inc. and Dexcom, Inc., and privately held ViaCyte, Inc.

About Biocept

Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept’s patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer and melanoma, and plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to validate the use of liquid biopsies for targeted therapies, our ability to expand into new cancer indications and grow our portfolio of biomarker assays, our ability to expand the clinical utility and adoption of our liquid biopsy assays, our liquid biopsy technology providing accurate biomarker information, improvement of patient outcomes and our impact on diagnostic strategies and healthcare costs, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.

 

Investors:
LHA
Jody Cain, 310-691-7100
jcain@lhai.com

Friday, August 21st, 2015 Uncategorized Comments Off on (BIOC) Announces Personnel Change

(MDXG) Patent Infringement Lawsuits Receive Favorable Rulings

MARIETTA, Ga., Aug. 21, 2015  — MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare, announced today the Patent Trial and Appeal Board (“PTAB”) has ruled in favor of the Company’s primary EpiFix® and AmnioFix® patents.

In April 2014, MiMedx filed patent infringement lawsuits in the United States District Court for the Northern District of Georgia against Liventa Bioscience, Inc., Medline Industries, Inc. and Musculoskeletal Transplant Foundation, Inc. for permanent injunctive relief and unspecified damages. In May 2014, the Company also filed a separate action against Transplant Technology, Inc. d/b/a Bone Bank Allograft and Texas Human Biologics Ltd. for patent infringement.

In both suits, MiMedx asserted that these organizations infringed and continue to infringe at least six MiMedx patents. As part of their defense strategy, two of the four defendants submitted certain of the MiMedx patents to the inter partes review process, which means they are asking the PTAB to review the subject matter covered by the MiMedx patents and decide whether it was proper for the patents to have been granted in the first place.

In general, the inter partes review process works as follows: If the PTAB rejects the request for inter partes review, it essentially means that the PTAB found no basis to challenge the patent on obvious or anticipation grounds.  If the PTAB grants inter partes review, it means that the PTAB has found that it is worth reviewing the patent, but by no means is it an indication in and of itself that there is something wrong with the subject patent. ‎

MiMedx received two recent rulings from the PTAB. One PTAB ruling was made in regard the inter partes review request related to the MiMedx primary EpiFix patent and the other recent PTAB decision was for the inter partes review request related to the MiMedx AmnioFix patent. In both rulings, the PTAB found no basis to challenge these patents and fully rejected the request for review on these patents.

Parker H. “Pete” Petit, Chairman and CEO said, “This victory means that the key patents for both of our flagship brands, EpiFix and AmnioFix, have withstood the scrutiny of the request for inter partes review, and they stand unaltered by the PTAB.”  ‎

Bill Taylor, President and COO, added, “It is important to note that inter partes review is granted by the PTAB in 93% of the cases in which it is requested by defendants. Therefore, it is extremely common for inter partes review to be granted. These rulings to not grant these customary reviews are a testimony to the strength we have created to protect the Company’s intellectual property.”

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane.  “Innovations in Regenerative Biomaterials is the framework behind our mission to give physicians products and tissues to help the body heal itself.  Our biomaterial platform technologies are AmnioFix®, EpiFix® and CollaFix™.  AmnioFix® and EpiFix® are our tissue technologies processed from human amniotic membrane derived from donated placentas. Through our donor program, a mother delivering via full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 450,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. CollaFix™, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.  CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to the fact that the PTAB rulings to not grant the customary inter partes reviews are a testimony to the strength MiMedx has created to protect the Company’s intellectual property, and the strength of the patents generally.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that fact that the PTAB rulings to not grant the customary inter partes reviews may not necessarily authenticate the strength MiMedx has created to protect the Company’s intellectual property, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2014 and its most recent Form 10Q.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

Friday, August 21st, 2015 Uncategorized Comments Off on (MDXG) Patent Infringement Lawsuits Receive Favorable Rulings

(ARAY) Awarded Multi-System Order by 21st Century Oncology

SUNNYVALE, Calif., Aug. 21, 2015  — Accuray Incorporated (NASDAQ: ARAY) announced today it has received a multi-system order from 21st Century Oncology for one CyberKnife® M6™ and four TomoHDA™ Systems. These are the latest generation CyberKnife and TomoTherapy Systems, and are used worldwide to provide extremely precise radiation treatments for cancerous and non-cancerous tumors throughout the body. The TomoTherapy Systems will replace conventional linear accelerators in single vault freestanding centers, reinforcing the TomoTherapy’s value as a mainstream radiation therapy device. Accuray booked the order in its first fiscal quarter of 2016.

“This latest transaction by 21st Century is the most recent example of a multiple unit order for Accuray systems,” said Joshua H. Levine, president and chief executive officer of Accuray. “Whether clinicians choose to order both the CyberKnife and TomoTherapy Systems or multiple units of a single system, we believe these orders speak to the high degree of flexibility and precision our systems provide and growing market interest in our customer-driven solutions.”

21st Century is the largest integrated network of cancer treatment centers and affiliated physicians in the world. The 21st Century network offers a high level of coordinated care from cancer diagnosis through surgery, radiation, and systemic treatment as required. As of June 30, 2015, the Company operated 183 treatment centers, including 148 centers located in 17 U.S. states and 35 centers located in six countries in Latin America. 21st Century strives to provide each cancer patient with state-of-the-art treatments that precisely address his or her individual needs. With the new order for the CyberKnife and TomoHDA Systems, 21st Century is supporting this goal, and positively impacting the way cancer treatments are managed at their centers.

About the CyberKnife and TomoTherapy Systems
The Accuray CyberKnife M6 Series and TomoTherapy H Series treatment solutions cover the entire spectrum of radiation therapy needs. The CyberKnife M6 Series enables precise, high-quality, high-dose distributions to be confidently delivered to the patient with extreme accuracy over a minimum number of treatments, reducing side effects and preserving patients’ quality of life. The CyberKnife System is the only robotic full-body radiosurgery system available today. The TomoTherapy H Series efficiently enables physicians to customize treatment plans for the entire range of radiation therapy patients and disease types. Its innovative design enables treatment plans to be delivered with integrated, daily CT image guidance, enhancing accuracy and delivering highly precise, intensity-modulated radiation for optimal sparing of healthy tissue and critical structures.

Further information on Accuray, the CyberKnife and TomoTherapy Systems is available at www.accuray.com.

About Accuray
Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company’s leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments.

Safe Harbor Statement
Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to market success, adoption of our products, clinical benefits of our technologies, patient outcomes and Accuray’s leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed under the heading “Risk Factors” in the company’s report on Form 10-K, filed on August 29, 2014, the company’s reports on Form 10-Q, filed on November 7, 2014, February 6, 2015 and May 7, 2015, and the company’s other filings with the SEC.

Forward-looking statements speak only as of the date the statements are made and are based on information available to Accuray at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.

Friday, August 21st, 2015 Uncategorized Comments Off on (ARAY) Awarded Multi-System Order by 21st Century Oncology

(STNR) to be Acquired by Catterton for $65 Per Share in Cash

NASSAU, The Bahamas and GREENWICH, Conn., Aug. 21, 2015  — Steiner Leisure Limited (NASDAQ:STNR) (“Steiner Leisure” or “the Company”), a worldwide provider and innovator in the fields of beauty, wellness and education, and Catterton, the leading consumer-focused private equity firm, today announced that they have entered into a definitive merger agreement under which an affiliate of Catterton will acquire all of the outstanding shares of Steiner Leisure for $65 per share in cash.

The purchase price represents a premium of approximately 21.5% over Steiner Leisure’s 90 day weighted-average closing share price on August 20, 2015, the last trading day prior to today’s announcement. The total transaction value, including assumed net debt, is approximately $925 million.

Steiner Leisure’s Board of Directors unanimously approved the merger upon the recommendation of a Special Committee comprised entirely of independent directors.

The Special Committee issued the following statement: “We are pleased to reach this agreement, which provides cash value for all Steiner Leisure shareholders. After careful consideration in conjunction with our independent advisors, the Special Committee has unanimously concluded that this transaction is in the best interest of our shareholders. Our Board has been committed to maximizing value for our shareholders, and we believe that this all-cash transaction with Catterton accomplishes that goal.”

Leonard Fluxman, President and Chief Executive Officer of Steiner Leisure, said, “We are proud to partner with Catterton, which has a strong reputation and proven track record of supporting the growth of many of the most successful retail and consumer companies. This transaction will provide Steiner Leisure with greater flexibility to focus on our long-term business initiatives and to improve our role as a global provider and innovator in beauty, wellness and education. Catterton’s partnership is an important endorsement of our brands and the hard work and commitment of our team. We are confident that with Catterton’s support and expertise in beauty, health and wellness, we are opening an exciting new chapter for our employees, customers and all our stakeholders.”

J. Michael Chu, Co-Founder and Managing Partner of Catterton, said, “We are pleased to make this investment in Steiner Leisure, which has an attractive portfolio of distinguished beauty and wellness brands and services. We are excited about the Company’s future and look forward to leveraging our retail and consumer expertise and network to help Steiner Leisure enhance its position as an industry leader. We look forward to working with the Steiner Leisure team and its talented employees to drive growth and innovation for consumers as we capitalize on the many growth opportunities in the industry.”

The transaction is expected to close in the fourth quarter of 2015 or early in 2016, and is subject to the expiration or termination of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, other regulatory approvals and approval of Steiner Leisure shareholders.

The transaction is not subject to a financing condition. The merger agreement provides for a “go-shop” period until October 6, 2015, during which the Special Committee – with the assistance of its financial advisor Jefferies LLC – may actively solicit alternative proposals to acquire Steiner Leisure from third parties. There can be no assurances that this process will result in a superior transaction.

For further information regarding all terms and conditions contained in the definitive merger agreement, please see Steiner Leisure’s Current Report on Form 8-K, which will be filed in connection with this transaction.

Jefferies LLC is serving as financial advisor to Steiner Leisure’s Special Committee, and Dechert LLP is serving as legal advisor to Steiner Leisure’s Special Committee. Kirkland & Ellis LLP is serving as legal advisor to Catterton.

About Steiner Leisure Limited

Steiner Leisure Limited is a worldwide provider and innovator in the fields of beauty, wellness and education, dedicated to maintaining the highest quality standards and continually evolving to include and anticipate new developments within the industry. Steiner Leisure aims to maintain and expand its existing diverse portfolio of services, products and brands, as well as to seek out new opportunities to complement its business.

Steiner services include traditional and alternative massage, body and skin treatment options, fitness, acupuncture, herbal medicine, and medi-spa treatments. Steiner provides its customers with a wide-ranging assortment of premium skin, body and hair care products under the Elemis®, La Thérapie™, Bliss®, Remède®, Laboratoire Remède® and Jou® brands. Its products are distributed through over 200 Steiner-operated day spas, resorts and spas-at-sea under its Elemis®, Mandara®, Chavana®, Bliss® and Remède® brands.

Steiner’s Ideal Image is the nation’s largest cosmetic and aesthetic services provider in the U.S. Those services are provided by highly trained, experienced practitioners through a nationwide network of 127 treatment centers across 31 states, as well as two locations in Canada.

Steiner is also an accredited educator teaching students the skills necessary to be a spa professional, including massage and skincare services. For more information, please see www.steinerleisure.com.

About Catterton

Catterton is a leading consumer-focused private equity firm with more than $4.0 billion currently under management and a twenty-six year track record of success in building high growth companies. Since its founding in 1989, Catterton has leveraged its category insight, strategic and operating skills, and network of industry contacts to establish one of the strongest private equity investment track records in the middle market. Catterton invests in well-positioned and distinctive businesses across all major consumer segments, including Food and Beverage, Retail and Restaurants, Consumer Products and Services, Consumer Health, and Media and Marketing Services. Some of Catterton’s investments include: Restoration Hardware, CorePower Yoga, Pure Barre, StriVectin, Cover FX, Frederic Fekkai, Baccarat, PIRCH, Outback Steakhouse, Plum Organics, Mendocino Farms, Noodles & Company, John Hardy, Build-A-Bear Workshop, Wellness and Nature’s Variety pet food, Odwalla and P.F. Chang’s, to name a few. More information about Catterton can be found at catterton.com.

Forward-Looking Statements

Any statements in this press release about prospective performance and plans for the Company, the expected timing of the completion of the proposed merger and the ability to complete the proposed merger, and other statements containing the words “estimates,” “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, other than historical facts, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Factors or risks that could cause the Company’s actual results to differ materially from the results the Company anticipates include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (ii) the inability to complete the proposed merger due to the failure to obtain shareholder approval for the proposed merger or the failure to satisfy other conditions to completion of the proposed merger, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the receipt of other required regulatory approvals; (iii) the failure to obtain the necessary financing arrangements as set forth in the debt and equity commitment letters delivered pursuant to the merger agreement, or the failure of the proposed merger to close for any other reason; (iv) risks related to disruption of management’s attention from the Company’s ongoing business operations due to the transaction; (v) the outcome of any legal proceedings, regulatory proceedings or enforcement matters that may be instituted against the Company and others relating to the merger agreement; (vi) the risk that the pendency of the proposed merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the pendency of the proposed merger; (vii) the effect of the announcement of the proposed merger on the Company’s relationships with its customers, operating results and business generally; and (viii) the amount of the costs, fees, expenses and charges related to the proposed merger. Consider these factors carefully in evaluating the forward-looking statements. Additional factors that may cause results to differ materially from those described in the forward-looking statements are set forth in the Company’s Annual Report on Form 10–K for the fiscal year ended December 31, 2014, which was filed with the Securities and Exchange Commission (the “SEC”) on March 2, 2015, under the heading “Item 1A. Risk Factors,” and in subsequently filed Forms 10-Q and 8-K. The forward-looking statements represent the Company’s views as of the date on which such statements were made and the Company undertakes no obligation to publicly update such forward-looking statements.

Additional Information and Where to Find It

This filing may be deemed to be solicitation material in respect of the proposed acquisition of the Company by Catterton Partners and its affiliates. In connection with the proposed merger, the Company will file with the SEC and furnish to the Company’s shareholders a proxy statement and other relevant documents. This filing does not constitute a solicitation of any vote or approval. BEFORE MAKING ANY VOTING DECISION, THE COMPANY’S SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER.

Investors will be able to obtain a free copy of the proxy statement, when available, and other relevant documents filed by the Company with the SEC at the SEC’s website at www.sec.gov. In addition, investors may obtain a free copy of the proxy statement, when available, and other relevant documents from the Company’s website at www.steinerleisure.com or by directing a request to: Steiner Leisure Limited, c/o Steiner Management Services, 770 S. Dixie Highway, Coral Gables, Florida 33146, Attn: Investor Relations, (305) 284-1417.

Participants in the Solicitation

The Company and its directors, executive officers and certain other members of management and employees of the Company may be deemed to be “participants” in the solicitation of proxies from the shareholders of the Company in connection with the proposed merger. Information regarding the interests of the persons who may, under the rules of the SEC, be considered participants in the solicitation of the shareholders of the Company in connection with the proposed merger, which may be different than those of the Company’s shareholders generally, will be set forth in the proxy statement and the other relevant documents to be filed with the SEC. Shareholders can find information about the Company and its directors and executive officers and their ownership of the Company’s common stock in the Company’s definitive proxy statement for its most recent annual meeting of shareholders, which was filed with the SEC on April 30, 2015, and in Forms 4 of directors and executive officers filed with the SEC subsequent to that date.

CONTACT: Steiner Leisure Contacts:

         Leonard Fluxman
         President and Chief Executive Officer
         305-284-1415

         Stephen Lazarus
         Chief Operating Officer and Chief Financial Officer
         305-284-1421

         Catterton Contacts:

         Eric Brielmann / Andi Rose / Alyssa Cass
         Joele Frank, Wilkinson Brimmer Katcher
         212-355-4449
Friday, August 21st, 2015 Uncategorized Comments Off on (STNR) to be Acquired by Catterton for $65 Per Share in Cash

(HOTR) Provides Pricing Guidance for Its up to $10 Million Rights Offering

CHARLOTTE, NC–(August 21, 2015) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer” or the “Company”), owner and operator of multiple restaurant brands internationally and domestically, today is providing pricing guidance for its non-transferable rights offering which will allow its shareholders to acquire additional shares of common stock (the “rights offering”). The Company is planning to commence the rights offering in order to raise equity capital in a timely and cost-effective manner, while providing Chanticleer’s shareholders the opportunity to participate.

Chairman and CEO of Chanticleer Holdings, Mike Pruitt, stated, “This rights offering is intended to provide Chanticleer with the capital to fund the closing of our acquisition of Little Big Burger, a gourmet fast-casual restaurant concept with 8 locations in Oregon. With significant brand recognition in the regional market and a loyal customer base, LBB recorded $6 million in net sales in 2014 and their unit economic model with EBITDA margin greater than 25% will be accretive to Chanticleer’s earnings. In addition to our U.S. expansion strategy, our rights offering would provide the capital to execute on increasing our interest in Hooters Australia from 60% to 80% to take greater control of a business which can generate increased returns. Proceeds will also support our purchase of other restaurant properties and assets both in the U.S. and abroad.”

Mr. Pruitt continued, “As stated previously, although we believe that our current share price does not reflect the value of our Company, we believe that these are attractive opportunities and management and the board determined a rights offering to be the fairest and most efficient way to raise the funds to advance the Company while also best preserving our over $26.3 million net operating U.S. federal and state net operating loss carry-forwards. We have already received positive interest from shareholders and selling group members.”

Mr. Pruitt concluded, “We have dramatically evolved and expanded our business and created a scalable growth platform driven by diverse revenue streams from our established and emerging restaurant brands. Over the past year we have doubled the number of our branded restaurants worldwide to 47 through a combination of new store openings and acquisitions. Furthermore, the franchising strategy which we launched with our acquisition of BGR is progressing well and we are executing on our strategy to convert the 80 plus BGR franchise locations that are under development agreement.”

The rights offering will be made through a dividend in the form of non-transferable subscription rights to purchase one share of common stock per each share of common stock owned on the record date at an exercise price based on an 8% up to 12% discount to Market. “Market” shall be defined as the Volume Weighted Average Price of HOTR for Thursday August 27, Friday August 28 and Monday August 31 (subject to final board approval).

The dividend of the subscription rights settles T+3, so in order to be considered a shareholder of record, shareholders must own the stock in their brokerage accounts as of 4:00 PM ET on Tuesday, September 1, 2015, which is three trading days before the record date of Friday, September 4, 2015. The proposed rights offering will also include an over-subscription privilege, which will entitle each rights holder that exercises all of its basic subscription privilege in full the right to purchase additional shares of common stock that remain unsubscribed at the expiration of the rights offering. Both the basic and over subscription privileges are subject to the availability and pro rata allocation of shares among participants. All basic subscription rights and over-subscription privileges may be exercised during the subscription period of Tuesday, September 8, 2015 through 5:00 PM ET Friday, September 18, 2015 on a pro-rata basis. The Company may extend the offering up to an additional 30 days, at its sole discretion, in which case the offering would continue on a subscriptions first-in, first served basis, calculated on a daily basis with the potential for pro-rata allocation of shares among participants subscribing on the last day the offering remains open.

In addition, the Company recommends that current stockholders consider notifying their broker or financial advisor about the upcoming rights offering to ensure they will maximize their ability to participate in the rights offering.

See below expected calendar:

Tuesday, September 1, 2015 Ownership Day, must own HOTR by 4:00 PM ET to be considered a shareholder of record.
Wednesday, September 2, 2015 Shares trade Ex-Right
Friday, September 4, 2015 Record Date
Tuesday, September 8, 2015 Subscription Period Begins
Friday, September 18, 2015 Subscription Period expires at 5:00 PM ET

The Company has entered into an agreement with Source Capital Group, Inc. to act as dealer manager and placement agent for the rights offering. Source Capital Group invites any broker dealers interested in participating in the rights offering to contact Source’s syndicate department at HOTR@sourcegrp.com.

The rights offering is being made pursuant to Chanticleer’s effective shelf registration statement on Form S-3 (Reg. No. 333-203679) on file with the Securities Exchange Commission. The information herein is not complete and is subject to change. This document is not an offer to sell these securities and is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. This document is not an offering, which can only be made by a final prospectus. Investors should consider the Company’s investment objective, risks, charges and expenses carefully before investing. The base prospectus contains this and additional information about the Company and the prospectus supplement will contain this and additional information about the Offering, and should be read carefully before investing. The base prospectus and the prospectus supplement, when it is filed, may be found by clicking on the following link:

http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001106838&owner=exclude&count=40&hidefilings=0

Requests for copies of the base prospectus and the prospectus supplement or questions from shareholders relating to the rights offering may be directed to the information agent for the rights offering, as follows:

Rights Information Agent:
Okapi Partners LLC
437 Madison Avenue, 28th Floor
New York, NY 10022
Phone 212.297.0720 or 877.869.0171
hotr@okapipartners.com

About Source Capital Group, Inc.
The Investment Banking Group at Source Capital offers a wealth of Wall Street experience through our seasoned professionals to the underserved small cap company sector and start-up companies as well. We have successfully funded both public and private companies. We offer equity and debt financing to help further the growth of companies that are often overlooked by the larger investment banking firms. Structured finance vehicles have also been used to achieve the needs of larger companies, while creating specific advantages that enhance their balance sheets. Source Capital began as an independent firm specializing in small to medium-sized investment banking transactions. Since 1992, we have grown into a full-service financial institution, while adhering to the highest standards of quality and integrity.

About Chanticleer Holdings, Inc.
Headquartered in Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including Australia, South Africa, and Europe, and two Hooters restaurants in the United States. The Company also owns and operates American Burger Co., BGR: The Burger Joint, BT’s Burger Joint and owns a majority interest in Just Fresh restaurants in the U.S.

For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts

Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Contact Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone 704.366.5122
ir@chanticleerholdings.com

Investor Relations
John Nesbett/Jennifer Belodeau
Institutional Marketing Services (IMS)
Phone 203.972.9200
jnesbett@institutionalms.com

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(SPIL) Responds to ASE Takeover Announcement

TAICHUNG, Taiwan, Aug. 21, 2015  — Siliconware Precision Industries Co., Ltd.  (“SPIL” or the “Company“) (Taiwan Stock Exchange: 2325.TT, NASDAQ: SPIL) today announced that regarding the announcement of Advanced Semiconductor Engineering, Inc. (“ASE“) today to propose a tender offer for SPIL’s common shares and/or ADSs, the Company was not aware of such matter in advance.

The Company will take all actions in accordance with the applicable laws upon receipt of the public tender offer prospectus, and will provide a formal response, together with recommendation and explanations, to the Company’s shareholders within seven (7) days.

Contact:  Janet Chen, IR Director
Siliconware Precision Industries Co., Ltd.    janet@spil.com.tw
No.45, Jieh Show Rd. +886-3-5795678#3675
Hsinchu Science Park, Hsinchu Byron Chiang, Spokesperson
Taiwan, 30056 byronc@spil.com.tw
www.spil.com.tw +886-3-5795678#3671
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(EFOI) Selects Energy Focus Tubular LED Technology

SOLON, Ohio, Aug. 20, 2015  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, today announced that it has signed an agreement with the Cleveland Clinic Foundation (the “Cleveland Clinic”) to supply its “Buy American” tubular LEDs (“TLEDs”) to replace existing fluorescent lights for all of the Cleveland Clinic’s facilities. The initial phase of this LED retrofit project covers the Cleveland Clinic’s main campus near downtown Cleveland and is expected to require approximately 250,000 TLEDs and take 18 to 24 months to complete.

In addition to its main campus, the Cleveland Clinic also administers more than 75 northern Ohio outpatient locations, 16 full-service family health centers, eight community hospitals, as well as healthcare facilities in Florida, Las Vegas, Canada and Abu Dhabi.

“We are extremely honored and gratified that the Cleveland Clinic—one of the most respected and innovative medical centers in the world—has chosen Energy Focus as its LED lighting partner, after more than a year of extensive, rigorous evaluations of our TLEDs against other major lighting brands,” said James Tu, Executive Chairman and Chief Executive Officer of Energy Focus, Inc. “Lighting consumes approximately a quarter of the energy used in hospitals. By switching to our industry leading TLED lights, the Cleveland Clinic will see energy savings of 50% or more over the current fluorescent lighting, and well over 10% of all its total energy consumption. In additional to energy savings, our TLEDs offer distinctive health benefits over fluorescent lighting as they produce much smoother, more natural and flicker-free light. We are thrilled to be collaborating with the Cleveland Clinic to dramatically enhance its sustainability profile as well as patient and employee wellbeing through one of the largest TLED retrofits ever in the global healthcare industry.”

“In addition to recognizing the industry leading performance, quality and total cost of ownership of our TLEDs, with this sizable and encompassing supply agreement, the Cleveland Clinic, as the largest private employer in northeast Ohio, demonstrates its commitment to both pioneering innovation and to the greater Cleveland region,” said Eric Hilliard, President and Chief Operating Officer of Energy Focus, Inc. “Energy Focus has increased its U.S. workforce by more than 60% since the beginning of 2014, the majority of which are located at our Solon, Ohio headquarters facility. The Cleveland Clinic’s choice of utilizing our “Buy American” TLED lighting will further propel Energy Focus’ momentum for high-tech job creation in the U.S.”

Energy Focus, Inc. is a recognized lighting technology developer and manufacturer with over 82 patents in advanced lighting technology. It has been supplying its military Intellitube® to the U.S. Navy since 2007 with zero failures reported to date, and remains the only military-spec qualified TLED lamp provider. The Company completed its first commercial TLED installation in 2010, and over 99% of its commercial LED systems installed since then are still running today.

Forward Looking Statements:

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Generally, these statements can be identified by the use of words such as “believes,” “estimates,” “anticipates,” “expects,” “seeks,” “projects,” “intends,” “plans,” “may,” “will,” “should,” “could,” “would” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include all matters that are not historical facts. By their nature, forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from Energy Focus’ forward-looking statements. These risks and uncertainties include, but are not limited to: the number of TLEDs and the time expected to complete the project if it is completed at all; the benefits and performance of our lighting products; our strategy with regard to protecting our proprietary technology and any challenges to our proprietary rights; our ability to market and gain customer acceptance of new products; relationships with, dependence upon, and the ability to obtain components from suppliers and our ability to outsource manufacturing; the growth in the markets into which Energy Focus sells; conditions of the lighting industry and the economy in general; our ability to maintain or improve our competitive position; our ability to finance our product development and marketing initiatives based on future operating results; our liquidity and ability to generate cash and cash reserves; our ability to manage growth in the demand for our products and in our sales efforts; relationships with customers and distributors; and trends in the price and performance of LED lighting products. For more information about potential factors that could affect the financial results of Energy Focus, please refer to the Company’s SEC reports, including its Annual Reports on Form 10-K and its quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof. Energy Focus disclaims any intention or obligation to update or revise any forward-looking statements.

About Energy Focus

Energy Focus, Inc. is a leading provider of energy efficient LED lighting products and a developer of energy efficient lighting technology. Our LED Lighting products provide energy savings, aesthetics, safety and maintenance cost benefits over conventional lighting. Our long-standing relationship with the U.S. Government continues to enable us to provide energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets. Customers include national, state and local U.S. government agencies as well as Fortune 500 companies and many other commercial and industrial clients. Company headquarters are located in Solon, Ohio with additional sales offices in Washington, D.C., and New York. For more information, see our web site at www.energyfocusinc.com.

CONTACT: Energy Focus, Inc.
         Marcia J. Miller, Chief Financial Officer
         (440) 715-1300
         ir@energyfocusinc.com

         or

         Darrow Associates, Inc.
         Investor Relations
         Peter Seltzberg, Managing Director
         (516) 510-8768
         pseltzberg@darrowir.com
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(ANY) Launches “Let’s Get Smart on Technology” Targeting SMEs

New Partnership Between Sphere 3D and the U.S. Black Chambers, Inc. Will Offer Application Mobility, Data Management and Data Protection Solutions to Their 245,000 Business Members

SAN JOSE, CA–(Aug 20, 2015) – Sphere 3D Corp (NASDAQ: ANY) a leader in virtualization technology and data management solutions, announces “Let’s Get Smart on Technology,” a new program designed to help small and medium-sized businesses (SMBs) secure and access their company’s data anywhere, any place, anytime whether in the office or in the cloud. The initial launch of the program is specifically tailored to the U.S. Black Chambers, Inc. (USBC) and its 115 Chambers in 28 states with 245,000 business members.

In partnership with the USBC, Sphere 3D will offer an integrated set of technologies and support, which will include executive level interactions with the organization’s local Chamber presidents for delivery of a variety of solutions and services.

“The U.S. Black Chambers understands the importance of secure application mobility and data protection to the SMB; however it has been a service out of reach for many of our members,” said Ron Busby, Sr., president and CEO, U.S. Black Chambers. “This partnership with Sphere 3D is not only a commitment to our members, it is a commitment to the success of small businesses.”

By 2020, 78 percent of small businesses will be fully adapted to the cloud, up from 37 percent in 2014, according to Small Business Success in the Cloud, a recent research report jointly produced from Intuit (INTU) and Emergent Research. Let’s Get Smart On Technology is one tenet of Sphere 3D’s go to market strategy specifically aimed at reaching and protecting the SMB market by offering enterprise grade solutions that meet the needs of smaller organizations.

“To remain competitive today, organizations must have the capability to provide their employees secure access to critical information anywhere, anytime,” said Eric Kelly, Chairman and CEO, Sphere 3D Corp. “We are proud to partner with the U.S. Black Chambers in supporting this exciting new initiative to provide technology to the USBC members.”

Today’s SMBs have smaller budgets than their large corporation counterparts but still require enterprise IT solutions that can help them efficiently manage their day-to-day operations. Like larger enterprises, SMBs need insight into their customers and the business intelligence to successfully adapt to fluid business environments. Unfortunately, getting the right infrastructure to meet these needs can be difficult. Traditional solutions quite often require multi-vendor disciplines as well as IT staff and budgets that most SMBs find cost prohibitive.

Through specialty product bundles and vertically tailored professional services, SMB’s can install all-in-one solutions that are designed to provide immediate availability of advanced IT capabilities. This approach allows businesses to benefit from increased mobility and access to their data so that they can be more productive, while maintaining enterprise grade data management and security at an affordable price.

Whether in Healthcare, Retail, Education, Finance or a multitude of other business verticals, a simplified and functional IT solution can help your business effectively improve the bottom line. Sphere 3D’s offerings provide the greatest level of flexibility for SMB’s looking to modernize their IT infrastructure through hybrid cloud solutions that allow applications and data to reside either in the cloud, on premise or both. To learn more please visit www.sphere3d.com

About Sphere 3D
Sphere 3D Corp. (NASDAQ: ANY) delivers virtualization technology and data management solutions that enable workload-optimized solutions. We achieve this through a combination of virtual applications, virtual desktops, virtual storage and physical hyper-converged platforms. Sphere 3D’s value proposition is simple and direct — we allow organizations to deploy a combination of public, private or hybrid cloud strategies, while backing them up with state of the art storage solutions at an affordable price. Sphere 3D, along with its wholly-owned subsidiaries Overland Storage and Tandberg Data, has a strong portfolio of brands including Glassware 2.0™, SnapCLOUD™, SnapScale®, SnapServer®, V3, RDX®, and NEO®. For more information, visit: www.sphere3d.com

About the U.S. Black Chambers, Inc.
An association of more than 100 self-sustaining Black Chambers and small business associations nationwide, the U.S. Black Chambers provides committed, visionary leadership and advocacy in the realization of economic empowerment. Through the creation of resources and initiatives, we support the Black Chambers of Commerce and business organizations in their work of developing and growing Black enterprises. The USBC serves close to 250,000 small businesses, and its infrastructure allows for mobilization of messaging and support in all 50 states. The USBC is headquartered in Washington, DC and has five regional directors, and 115 Black Chamber Associations. More information can be found at www.usblackchambers.org

Safe Harbor Statement
This press release contains forward-looking statements relating to strategic goals, plans and other matters that involve risks, uncertainties, and assumptions that are difficult to predict. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties including, without limitation, our ability to retain customers of and market share for the purchased assets, our ability to integrate the purchased assets with our existing RDX business, continued market adoption of RDX technologies, unforeseen changes in the course of Sphere 3D’s business or the business of its wholly-owned subsidiaries, including, without limitation, Overland Storage and Tandberg Data; any increase in Sphere 3D’s cash needs or our inability to obtain additional debt or equity financing; market adoption and performance of our products; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in Sphere 3D’s periodic reports contained in our Annual Information Form and other filings with Canadian securities regulators (www.sedar.com) and in prior periodic reports filed with the United States Securities and Exchange Commission (www.sec.gov), and risks detailed in the Form 40-F filed by us with the SEC for the year ended December 31, 2014. Sphere 3D undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

All product and company names herein may be trademarks of their registered owners.

Media Contact:
Sphere 3D:
Tina Brown
Tina.brown@sphere3D.com
1-408.283.4731

Media Contact:
U.S. Black Chambers, Inc.
Rae Robinson Trotman
703-869-5448
rae@irmediallc.com

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(GGN) Continues Monthly Distributions, Declaring Distributions of $0.07 Per Share

The Board of Trustees of the GAMCO Global Gold, Natural Resources & Income Trust (NYSE MKT:GGN) (the “Fund”) approved the continuation of its policy of paying monthly cash distributions. The Board of Trustees declared cash distributions of $0.07 per share for each of October, November, and December 2015.

The distribution for October 2015 will be payable on October 23, 2015 to common shareholders of record on October 16, 2015.

The distribution for November 2015 will be payable on November 20, 2015 to common shareholders of record on November 13, 2015.

The distribution for December 2015 will be payable on December 18, 2015 to common shareholders of record on December 11, 2015.

Each quarter, the Board of Trustees reviews the amount of any potential distribution from the income, realized capital gain, or capital available. The Board of Trustees will continue to monitor the Fund’s distribution level, taking into consideration the Fund’s net asset value and the financial market environment. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund.

The Fund makes annual distributions of its realized net long-term capital gains and monthly cash distributions of all or a portion of its investment company taxable income (which includes ordinary income and net realized short-term capital gains) to common shareholders. A portion of the distribution may be a return of capital. Various factors will affect the level of the Fund’s income, such as its asset mix and use of covered call strategies. To permit the Fund to maintain more stable distributions, the Fund may distribute more than the entire amount of income earned in a particular period. Because the Fund’s current monthly distributions are subject to modification by the Board of Trustees at any time and the Fund’s income will fluctuate, there can be no assurance that the Fund will pay distributions at a particular rate or frequency.

If the Fund does not generate sufficient earnings (dividends and interest income and realized net capital gain) equal to or in excess of the aggregate distributions paid by the Fund in a given year, then the amount distributed in excess of the Fund’s earnings would be deemed a return of capital. Since this would be considered a return of a portion of a shareholder’s original investment, it is generally not taxable and is treated as a reduction in the shareholder’s cost basis. Under federal tax regulations, some or all of the return of capital distributed by the Fund may be taxable as ordinary income in certain circumstances. This may occur when the Fund has a capital loss carry forward, net capital gains are realized in a fiscal year, and distributions are made in excess of investment company taxable income.

Short-term capital gains, qualified dividend income, ordinary income, and return of capital, if any, will be allocated on a pro-rata basis to all distributions to common shareholders for the year. Based on the accounting records of the Fund as of August 17, 2015, each of the distributions paid to common shareholders in 2015 would be deemed 100% return of capital on a book basis and does not represent information for tax reporting purposes. The estimated components of each distribution are updated and provided to shareholders of record in a notice accompanying the distribution and are available on our website (www.gabelli.com). The final determination of the sources of all distributions in 2015 will be made after year end and can vary from the monthly estimates. Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of the current distribution. All shareholders with taxable accounts will receive written notification regarding the components and tax treatment for all 2015 distributions in early 2016 via Form 1099-DIV.

Investors should carefully consider the investment objectives, risks, charges, and expenses of the Fund before investing. More information regarding the Fund’s distribution policy and other information about the Fund is available by calling 800-GABELLI (800-422-3554) or visiting www.gabelli.com.

The GAMCO Global Gold, Natural Resources & Income Trust is a non-diversified, closed-end management investment company with $786 million in total net assets whose primary investment objective is to provide a high level of current income. The Fund invests primarily in equity securities of gold and natural resources companies and intends to earn income primarily through a strategy of writing (selling) primarily covered call options on equity securities in its portfolio. The Fund is managed by Gabelli Funds, LLC, a subsidiary of GAMCO Investors, Inc. (NYSE:GBL).

 

GAMCO Global Gold, Natural Resources & Income Trust
Molly Marion or Laurissa Martire
914-921-5070

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(PPSI) to Consolidate its North American Dry-Type Transformer Factories

Affirms commitment to customers in Canada and US

FORT LEE, N.J., Aug. 20, 2015  — Pioneer Power Solutions, Inc. (Nasdaq: PPSI) (“Pioneer” or the “Company”), a company engaged in the manufacture, sale and service of electrical transmission, distribution and on-site power generation equipment, today announced that it intends to consolidate its dry-type transformer production activities to a new, larger, state-of-the art facility located in Reynosa, Mexico.

The new facility will be near Pioneer’s existing location in Reynosa, which will be vacated by the second quarter of 2016. In addition, production at Pioneer’s facility located in Farnham, Quebec, will be transitioned in stages to Reynosa, by June 2016. This transition is expected to permanently affect approximately 70 jobs at the Farnham location, with no changes expected to Pioneer’s Canada-based staff of sales and engineering personnel dedicated to dry-type transformers.

The plant consolidation is anticipated to significantly reduce Pioneer’s manufacturing cost, make the Company more competitive in its standard and custom product offerings, and assist Pioneer to better serve its North American distribution, OEM and industrial and commercial customers. These changes further Pioneer’s long-term commitment to supporting the distribution transformer needs of its customers in Canada and the U.S.

About Pioneer Power Solutions, Inc.
Pioneer Power Solutions, Inc. manufactures, sells and services a broad range of specialty electrical transmission, distribution and on-site power generation equipment for applications in the utility, industrial, commercial and backup power markets. The Company’s principal products and services include custom-engineered electrical transformers, low and medium voltage switchgear and engine-generator sets and controls, complemented by a national field-service organization to maintain and repair power generation assets. Pioneer is headquartered in Fort Lee, New Jersey and operates from 14 additional locations in the U.S., Canada and Mexico for manufacturing, centralized distribution, engineering, sales, service and administration. To learn more about Pioneer, please visit its website at www.pioneerpowersolutions.com

CONTACT:
Brett Maas, Managing Partner
Hayden IR
(646) 536-7331
brett@haydenir.com

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(UNXL) Delivers First Samples Combining XTouch, Diamond Guard and Hybrid-Metal Plating

SANTA CLARA, Calif., Aug. 20, 2015  — UniPixel, Inc. (NASDAQ: UNXL), a provider of Performance Engineered Films™ to the touchscreen and flexible electronics markets, announced today that it has shipped to a potential new major PC and consumer electronics OEM customer the first touch sensor engineering samples that integrate its XTouch touch sensor technology with its new hybrid-metal plating process and Diamond Guard resin coating. The samples are being delivered for assembly into a touchscreen panel that will be evaluated for use in a new 10 inch tablet product.

The samples are the first to be delivered with this combination of attributes. The hybrid-metal plating further improves the visual appearance of the XTouch sensors, and is expected to further enhance robustness of the sensor under extreme environmental stress conditions. Diamond Guard adds a protective coating to the sensor that makes it easier for the touch panel integrator to handle XTouch without damage during the touch panel assembly process and eliminates need for an extra film layer to be added by the touch panel integrator for robustness. This represents both a material handling improvement and a key element of our overall manufacturing cost reduction program.

Mr. Brett Gaines, vice president of sales and marketing, commented, “We are pleased that yet another major PC and consumer electronics manufacturer, this time based in Japan, will be evaluating our technology for inclusion into a new device. The integration of the Atmel touch screen technology that we recently acquired, into UniPixel’s advanced touch screen technology brings together the best attributes of two compelling touch technologies that promises unmatched total performance and cost efficiencies. Additionally, UniPixel’s ability to shorten the lead-time required to generate a custom design in order to react to this opportunity highlights another aspect of our competitiveness in the marketplace. We continue to expand the number of leading manufacturers that are actively considering UniPixel technology for new product offerings.”

UniPixel’s XTouch sensors support features such as narrow borders, curved touch surfaces and even edgeless touchscreens while achieving improved linearity, reliability and thinner sensor stacks. As an alternative to traditional touch sensors, XTouch provides the ability to turn unique touch-based concepts into functional designs at lower total system costs.

About UniPixel

UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touch screen and flexible electronics markets. The company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.

Forward-looking Statements

All statements in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended including the statement that Uni-Pixel’s integrated technologies are expected to provide enhanced yields at a lower cost, thereby expanding UniPixel’s competitiveness in the touch screen market.  While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014. We operate in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and Current Reports on Form 8-K.

Trademarks in this release are the property of their respective owners

Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com

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(FTEK) Awarded Air Pollution Control Orders Totaling $7.7 Million

Fuel Tech, Inc. (NASDAQ:FTEK), a world leader in advanced engineering solutions for the optimization of combustion systems and emissions control in utility and industrial applications, today announced the receipt of multiple air pollution control (APC) contracts from customers in South America, China and the US. These awards have an aggregate value of approximately $7.7 million.

The order in South America is from a power company in Chile for a turnkey installation of Low NOx Burners (LNBs), Over-Fire Air (OFA) system and mill upgrades on a coal-fired unit. Equipment deliveries are scheduled to commence during the fourth quarter of 2015, with project completion planned for the second quarter of 2016. Fuel Tech’s technologies are a cost-effective way to reduce nitrogen oxide (NOx) emissions and solve combustion problems in coal, gas or oil combustion systems. Fuel Tech’s OFA systems reduce NOx formation by diverting air from the burner zone to the upper furnace for enhanced combustion staging. Low NOx Burners limit the formation of thermal NOx and control how the fuel bound nitrogen is released. The mill upgrades will help improve the existing coal mill load throughput.

In China, an order was received for multiple ULTRA™ systems that will be installed on utility coal-fired units being retrofitted with NOx reduction technology. Fuel Tech’s ULTRA process provides for the safe and cost-effective on-site conversion of urea to ammonia for use as a reagent in the selective catalytic reduction (SCR) of NOx, eliminating the hazards associated with the transport, storage and handling of anhydrous or aqueous ammonia. Equipment deliveries are expected to occur in the third quarter of 2015.

In the US, an order was received for additional ESP equipment for a previously announced project in the Southeast. Delivery is scheduled for the fourth quarter of 2015.

Vincent J. Arnone, President and Chief Executive Officer, commented, “We have consciously expanded our international presence to achieve both growth and regulatory diversification in our air pollution control business. This contract award represents our third LNB project in Chile and demonstrates our global reach and combustion capabilities. With our industry-leading suite of APC products and services, we believe we are well positioned to compete for additional opportunities in the domestic and international markets.”

Mr. Arnone continued, “Our ULTRA technology simplifies on-site ammonia generation for SCR applications of all types. We are pleased to see that our APC product line continues to play a vital role in assisting China in its endeavor to reduce harmful air pollutants.”

About Fuel Tech

Fuel Tech is a leading technology company engaged in the worldwide development, commercialization and application of state-of-the-art proprietary technologies for air pollution control, process optimization, and advanced engineering services. These technologies enable customers to produce both energy and processed materials in a cost-effective and environmentally sustainable manner.

The Company’s nitrogen oxide (NOx) reduction technologies include advanced combustion modification techniques and post-combustion NOx control approaches, including NOxOUT®, HERT™, and Advanced SNCR systems, ASCR™ Advanced Selective Catalytic Reduction systems, and I-NOx™ Integrated NOx Reduction Systems, which utilize various combinations of these systems, along with the ULTRA™ process for safe ammonia generation. These technologies have established Fuel Tech as a leader in NOx reduction, with installations on over 900 units worldwide.

Fuel Tech’s technologies for particulate control include Electrostatic Precipitator (ESP) products and services including complete turnkey capability for ESP retrofits, with experience on units up to 700 MW. Flue gas conditioning (FGC) systems include treatment using sulfur trioxide (SO3) and ammonia (NH3) based conditioning to improve the performance of ESPs by modifying the properties of the fly ash particle. Fuel Tech’s particulate control technologies have been installed on more than 125 units worldwide.

The Company’s FUEL CHEM® technology revolves around the unique application of chemicals to improve the efficiency, reliability, fuel flexibility, boiler heat rate, and environmental status of combustion units by controlling slagging, fouling, corrosion, opacity and improving boiler operations. The Company has experience with this technology, in the form of a customizable FUEL CHEM program, on over 110 units.

Fuel Tech also provides a range of services, including boiler tuning and selective catalytic reduction (SCR) optimization services. In addition, flow corrective devices and physical and computational modeling services are available to optimize flue gas distribution and mixing in both power plant and industrial applications.

Many of Fuel Tech’s products and services rely heavily on the Company’s exceptional Computational Fluid Dynamics modeling capabilities, which are enhanced by internally developed, high-end visualization software. These capabilities, coupled with the Company’s innovative technologies and multi-disciplined team approach, enable Fuel Tech to provide practical solutions to some of our customers’ most challenging problems. For more information, visit Fuel Tech’s web site at www.ftek.com.

This press release may contain statements of a forward-looking nature regarding future events. These statements are only predictions and actual events may differ materially. Please refer to documents that Fuel Tech files from time to time with the Securities and Exchange Commission for a discussion of certain factors that could cause actual results to differ materially from those contained in the forward-looking statements.

 

Fuel Tech, Inc.
David S. Collins, 630-845-4500
Chief Financial Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President

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(ELTK) $1.1 Million In Orders From Three U.S. Customers in Medical Device Sector

PETACH-TIKVA, Israel, August 19, 2015 —

Eltek Ltd. (NASDAQ:ELTKNews), the leading Israeli manufacturer of advanced circuitry solutions, including complex build-ups of rigid and flex-rigid printed circuit boards, announced today that since the beginning of the third quarter, it has received several orders from three U.S. customers in the medical device sector, amounting to US$ 1.1 million in the aggregate. The majority amount of these orders is expected to be delivered to the customers in 2015, and the balance in the first half of 2016.

Mr. Yitzhak Nissan, Chairman of the Board and Chief Executive Officer said: “I am proud that Eltek is repeatedly selected as the supplier of choice for Printed Circuit Boards used in advanced medical devices. These new orders represent the continued market recognition of the high quality, advanced technology and reliability of our products. We are focused on the medical and defense global markets as part of our long-term business plan.”

About Eltek

Eltek is Israel’s leading manufacturer of printed circuit boards, the core circuitry of most electronic devices. It specializes in the complex high-end of PCB manufacturing, i.e., HDI, multilayered and flex-rigid boards. Eltek’s technologically advanced circuitry solutions are used in today’s increasingly sophisticated and compact electronic products. For more information, visit Eltek’s web site at http://www.nisteceltek.com.

Forward Looking Statement:

Certain matters discussed in this news release are forward-looking statements that involve a number of risks and uncertainties including, but not limited to statements regarding expected results in future quarters, risks in product and technology development and rapid technological change, product demand, the impact of competitive products and pricing, market acceptance, the sales cycle, changing economic conditions and other risk factors detailed in the Company’s Annual Report on Form 20-F and other filings with the United States Securities and Exchange Commission.

Investor Contact:
Amnon Shemer,
Chief Financial Officer
amnons@nisteceltek.com
+972-3-9395023

Wednesday, August 19th, 2015 Uncategorized Comments Off on (ELTK) $1.1 Million In Orders From Three U.S. Customers in Medical Device Sector

(APRI) Seeking a Global Partner for Femprox Treatment for Female Sexual Dysfunction

SAN DIEGO, Calif., Aug. 19, 2015  — Apricus Biosciences, Inc. (“Apricus” or the “Company”) (Nasdaq:APRI) (http://www.apricusbio.com) announced today that it re-affirms its intent to seek a global development partner for Femprox®, the Company’s topical alprostadil cream for the treatment of female sexual interest/arousal disorder (“FSIAD”). Femprox is a topically applied formulation of 0.4% alprostadil delivered using Dodecyl 2-(N, N dimethylamino)-propionate (DDAIP), Apricus’ proprietary drug delivery technology. The Company has completed a near 400 subject proof-of-concept clinical trial on Femprox, which achieved statistical significance in both its primary and secondary endpoints.

“Given the recent FDA approval of Sprout Pharmaceuticals, Inc.’s flibanserin for female sexual dysfunction, Apricus now believes that a potential regulatory path exists in the U.S. for Femprox,” said Richard Pascoe, Apricus’ Chief Executive Officer. “We will immediately initiate a disciplined partnering process to identify potential licensees for the global development and commercialization rights for Femprox with the goal of maximizing our return on investment for the potential benefit of shareholders.”

About Femprox®

Femprox® is a 0.4% alprostadil cream intended for the treatment of FSIAD. To date, Apricus Bio has completed nine clinical studies with Femprox, including one, 98-subject Phase II study in the U.S. and a near 400-subject proof-of-concept study in China.  Femprox exerts a local, relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow.  The resultant increase in lubrication and sensory feedback is believed to produce an increase in sexual arousal in women with FSIAD.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (Nasdaq:APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has initiated a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus recently completed enrollment in a Phase 2a trial for RayVa(TM), its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. Apricus’ lead commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros include Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus’ second-generation room temperature Vitaros is under development.

For further information on Apricus, visit http://www.apricusbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the timing and success of any development plan and the regulatory pathway for Femprox® and Apricus’ intent to partner with a third-party to develop Femprox. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus’ control, including, but not limited to: Apricus’ ability to partner with a third-party to develop Femprox on favorable terms, or at all; potential changes in regulatory approval requirements; dependence on any partner for key development activities, and the potential that a partner will have limited resources or otherwise not prioritize Femprox relative to its other development priorities; and the results of any additional clinical trials on Femprox or other drug candidates targeting FSIAD. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC’s website at www.sec.gov or without charge from Apricus.

CONTACT: Matthew Beck
         mbeck@troutgroup.com
         The Trout Group
         (646) 378-2933
Wednesday, August 19th, 2015 Uncategorized Comments Off on (APRI) Seeking a Global Partner for Femprox Treatment for Female Sexual Dysfunction

(OCAT) Secures $10 Million in Debt Financing

Ocata Therapeutics, Inc. (NASDAQ: OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has entered into a secured term loan facility of up to $10 million with Silicon Valley Bank. Ocata received initial funding of $6 million and has a conditional option to receive an additional $4 million upon the successful completion of certain clinical and corporate milestones. Ocata intends to use the proceeds for general corporate purposes including the initiation of the Phase 2 dry age-related macular degeneration (AMD) and pivotal Stargardt’s macular degeneration (SMD) clinical studies and the advancement of its promising pre-clinical programs.

“We are pleased to secure this additional, non-dilutive financing from a leading debt lender, with a history of supporting emerging biotechnology companies,” said Ted Myles, Chief Financial Officer and Chief Operating Officer. “The addition of this debt facility to the proceeds from our recently completed equity offering provides us with additional flexibility as we initiate our dry AMD Phase 2 safety trial, planned for this quarter and our SMD pivotal study, planned for the fourth quarter of this year.”

Katherine Andersen, Managing Director of Silicon Valley Bank commented, “We are pleased to partner with the Ocata Therapeutics team, which is driving important medical advancements to treat vision loss. Our aim is to provide Ocata with the right financing and global services as the company continues to advance its exciting programs.”

About Ocata Therapeutics, Inc.

Ocata Therapeutics, Inc. is a clinical stage biotechnology company focused on the development and commercialization of Regenerative Ophthalmology therapeutics. Ocata’s most advanced products are in clinical trials for the treatment of Stargardt’s macular degeneration, dry age-related macular degeneration, and myopic macular degeneration. Ocata’s intellectual property portfolio includes pluripotent stem cell platforms – hESC and induced pluripotent stem cell (iPSC) – and other cell therapy research programs. For more information, visit www.ocata.com.

About Silicon Valley Bank

For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Forbes named SVB one of America’s best banks (2015) and one of America’s best-managed companies (2014). Learn more at svb.com.

Silicon Valley Bank is the California bank subsidiary and commercial banking operation of SVB Financial Group (NASDAQ: SIVB), and a member of the FDIC. Silicon Valley Bank and SVB Financial Group are members of the Federal Reserve System.

About Age-related Macular Degeneration

Age-related macular degeneration is the leading cause of vision loss in people over the age of 50. Every year in the USA there are 1.8 million patients newly diagnosed with dry AMD which occurs when light-sensitive photoreceptor cells in the macula, located in the center of the retina, slowly break down, causing vision loss as a result. Photoreceptor breakdown is a consequence of loss or damage to the RPE layer. As the disease progresses, patients may have difficulty reading and recognizing faces. There is currently no proven medical therapy for dry AMD and the projected number of people worldwide with age-related macular degeneration in 2020 is 196 million, increasing to 288 million in 2040 underscoring the urgent need for new treatments.

About Stargardt’s Disease

Stargardt’s macular degeneration is a form of juvenile macular degeneration that affects vision in children and young adults between the ages of six and 20, with a prevalence of approximately one in 10,000 people in the United States. It is an orphan disease and loss of vision is an inevitable aspect of SMD, with more than half of the patients experiencing vision loss in the range of 20/200-20/400. Like dry AMD, it occurs as a result of damage to the RPE layer and there are no treatments currently approved to prevent or slow the vision loss associated with SMD.

Forward-Looking Statements

All statements, other than historical facts, contained in this news release, including statements regarding the initiation or expected timing of Ocata’s planned clinical trials, the release of top line and other data from such trials, the ability to finance such trials, the expected release of data regarding Ocata’s preclinical pipeline, and any other statements about Ocata’s future expectations, beliefs, goals, plans, results or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the fact that Ocata has no product revenue and no products approved for marketing; Ocata’s limited operating history; Ocata’s need for and limited sources of future capital; potential failures or delays in obtaining regulatory approval of products; risks inherent in the development and commercialization of potential products; reliance on new and unproven technology in the development of products; the need to protect Ocata’s intellectual property; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support Ocata’s product candidate claims; the risk that physicians and patients may not accept or use Ocata’s products, even if approved; Ocata’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its product candidates; and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Ocata’s periodic reports, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2014. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of Ocata’s management at the time they are made, and Ocata does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that Ocata’s future clinical trials will be successful or that the results of previous clinical studies will lead to commercialization or products or therapies.

 

Investors:
Westwicke Partners
John Woolford, 443-213-0506
john.woolford@westwicke.com
or
Press:
Russo Partners
David Schull, 858-717-2310
david.schull@russopartnersllc.com

Wednesday, August 19th, 2015 Uncategorized Comments Off on (OCAT) Secures $10 Million in Debt Financing

(RCPI) to Present at Annual BioPharm America International

SARASOTA, Fla., Aug. 19, 2015  — Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a clinical stage, drug development company which has focused on the application of its lead compounds to chronic inflammatory conditions, announced that the Company has been invited to present at BioPharm America 2015 in Boston (Sept. 15-17, 2015) at The Boston Marriott Copley Place.

Michael Mullan, MBBS, PhD, Chairman and CEO of Rock Creek Pharmaceuticals, will present clinical data associated with the Company’s ongoing drug development initiatives. as well as an update to the company’s corporate and regulatory strategy.

About BioPharm America 2015

BioPharm America™ is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter into strategic relationships. Equipped with partneringONE®, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®.

Additional links and information:

Follow BioPharm America 2015 on Twitter: @EBDGroup (hashtag: #BPA15).

About Anatabine Citrate:

Rock Creek Pharmaceuticals’ compound is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of the Company’s compound. In addition, the Company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.

About Rock Creek Pharmaceuticals, Inc.:

Rock Creek Pharmaceuticals, Inc. is  clinical stage drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic and acute inflammatory diseases.

For more information, visit: http://www.rockcreekpharmaceuticals.com

Forward Looking Statements:

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, pending litigation matters, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on March 12, 2015. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

CONTACT:

Ted Jenkins
Vice President, Corporate Strategy & Development
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL  34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com

Wednesday, August 19th, 2015 Uncategorized Comments Off on (RCPI) to Present at Annual BioPharm America International

(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