Archive for November, 2015

(KANG) Receipt of Competing Non-Binding “Going Private” Proposal

BEIJING, Nov. 30, 2015  — iKang Healthcare Group, Inc. (“iKang” or the “Company”) (Nasdaq:KANG), China’s largest private preventive healthcare services provider, today announced that its board of directors (the “Board”) received on November 29, 2015 a preliminary non-binding proposal letter, dated November 27, 2015, from Jiangsu Sanyou Group Co., Ltd. (“Jiangsu Sanyou”), Cathay Capital Private Equity SAS (“Cathay”), Shenzhen Ping An Decheng Investment Co., Ltd. (“Ping An”), Taiping Guofa (Suzhou) Capital Management Co., Ltd. (“Taiping”), Sequoia China Investment Management LLP (“Sequoia”) and Huatai Ruilian Fund Management Co., Ltd. (“Huatai Ruilian,” and together with Jiangsu Sanyou, Cathay, Ping An, Taiping and Sequoia, the “Jiangsu Sanyou Buyer Group”), proposing a going-private transaction in which the Jiangsu Sanyou Buyer Group would acquire all of the outstanding Class A common shares (“Class A Shares”), Class C common shares (“Class C Shares,” and together with Class A Shares, the “Shares”) and American depositary shares (“ADSs,” each representing ½ of a Class A Share) of the Company in an all-cash transaction for US$22.00 per ADS or US$44.00 per Share (the “Jiangsu Sanyou Buyer Group Proposal”).

The Jiangsu Sanyou Buyer Group proposal letter states, among other matters, that its proposed acquisition price represents a premium of 36.9% to the closing trading price of the Company’s ADSs on August 28, 2015, the last trading day before the Company publicly announced receipt of the preliminary non-binding going private proposal letter, dated August 31, 2015, from Mr. Ligang Zhang (“Mr. Zhang”), founder, chairman and chief executive officer of iKang, and certain of his affiliated entities, and FV Investment Holdings (the “Founder Buyer Group Proposal”).  The Jiangsu Sanyou Buyer Group proposal letter further states that the Jiangsu Sanyou Buyer Group intends to finance its proposed transaction with equity capital from the members of the Jiangsu Sanyou Buyer Group.

A copy of the Jiangsu Sanyou Buyer Group proposal letter is attached as Annex A to this press release.

The special committee of independent directors, which was formed to consider the Founder Buyer Group Proposal, will carefully consider and evaluate, with the assistance of the special committee’s independent financial and legal advisors, the Jiangsu Sanyou Buyer Group Proposal, the Founder Buyer Group Proposal and the Company’s strategic alternatives.

The Board cautions the Company’s shareholders and others considering trading in its securities that no decisions have been made with respect to the Company’s response to the Jiangsu Sanyou Buyer Group Proposal or the Founder Buyer Group Proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that the Jiangsu Sanyou Buyer Group Proposal, the Founder Buyer Group Proposal or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to these or any other transactions, except as required under applicable law.

About iKang Healthcare Group, Inc.

iKang Healthcare Group, Inc. is the largest provider in China’s fast growing private preventive healthcare services market, accounting for approximately 13.6% of market share in terms of revenue in calendar year 2014.

Through iKang’s integrated service platform and established nationwide network of medical centers and third-party service provider facilities, the Company provides comprehensive and high quality preventive healthcare solutions, including a wide range of medical examinations services and value-added services including disease screening and other services. iKang’s customers are primarily corporate customers who contract the Company to provide medical examination services to their employees and clients, and pay for these services at pre-negotiated prices. iKang also directly markets its services to individual customers. In the fiscal year ended March 31, 2015, the Company served a total of 3.6 million customer visits under both corporate and individual programs.

As of November 30, 2015, iKang’s nationwide network consisted of 80(1) self-owned medical centers covering 22 of the most affluent cities in China, namely Beijing, Shanghai, Guangzhou, Shenzhen, Chongqing, Tianjin, Nanjing, Suzhou, Hangzhou, Chengdu, Fuzhou, Changchun, Jiangyin, Changzhou, Wuhan, Changsha, Yantai, Yinchuan, Weihai, Weifang and Shenyang, as well as Hong Kong. The Company has also supplemented its self-owned medical center network by contracting with approximately 400 third-party service provider facilities in over 150 cities, which include selected independent medical examination centers and hospitals across all of China’s provinces, creating a nationwide network that allows iKang to serve its customers in markets where it does not have self-owned medical centers.

(1) Among the 80 self-owned medical centers, two medical centers are currently operated primarily by the minority shareholders of these medical centers or their parent company.

Forward-looking Statements

This press release contains forward-looking statements. These statements, including management quotes and business outlook, are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “estimate,” “project,” “predict,” “believe,” “expect,” “anticipate,” “intend,” “potential,” “plan,” “goal” and similar statements. iKang may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These forward-looking statements include, but are not limited to, whether any definitive offer will be made, or if made, whether it will be approved and consummated, and such other risks outlined in iKang’s filings with the Securities and Exchange Commission. iKang undertakes no duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

Annex A

November 27, 2015

The Board of Directors
iKang Healthcare Group, Inc. B-6F, Shimao Tower
92A Jianguo Road
Chaoyang District, Beijing 100022 People’s Republic of China

Dear Sirs:

We, Jiangsu Sanyou Group Co., Ltd. (“Jiangsu Sanyou”), Cathay Capital Private Equity SAS (“Cathay”), Shenzhen Ping An Decheng Investment Co., Ltd. (“Ping An”), Taiping Guofa (Suzhou) Capital Management Co., Ltd. (“Taiping”), Sequoia China Investment Management LLP (“Sequoia”) and Huatai Ruilian Fund Management Co., Ltd. (“Huatai Ruilian”), are pleased to submit our preliminary non-binding proposal (“Proposal”) to acquire all of the outstanding Class A common shares (“Class A Shares”), Class C common Shares (“Class C Shares”, together with Class A Shares, the “Shares”) and American depositary shares (“ADSs”, each representing 1/2 Class A Share) of iKang Healthcare Group, Inc. (the “Company” or “iKang”) in an all-cash transaction for US$22 per ADS or US$44 per Share.

We believe that our Proposal of $22 per ADS and US$44 per Share in cash, as the case may be, provides a very attractive opportunity to the Company’s shareholders and is indisputably more favorable to the Company’s unaffiliated shareholders than the preliminary non-binding proposal from Mr. Ligang Zhang (“Mr. Zhang”), the founder, chairman and chief executive officer of the Company and certain of his affiliated entities, and FV Investment Holdings (together with Mr. Zhang and his affiliated entities, the “Insider Group”), dated August 31, 2015, to acquire all outstanding Class A Shares and ADSs not already owned by the Insider Group for US$17.8 in cash per ADS (the “Insider Proposal”).

Our offer price provides compelling value for iKang’s shareholders as compared with the Insider Proposal as it represents a highly attractive premium of approximately 36.9% to the unaffected closing price on August 28, 2015, the last trading day before iKang publicly announced receipt of the Insider Proposal, and a premium of approximately 23.6% to the Insider Proposal.

We have agreed to work with each other exclusively in pursuing the acquisition of 100% of the share capital of iKang for cash consideration of US$22 per ADS and US$44 per Share as contemplated by our Proposal (the “Transaction”). We will form an acquisition company for the purpose of implementing this Transaction.

We do not anticipate any substantive issues with respect to regulatory approvals, nor do we believe that any regulatory approval will impede or delay our ability to quickly and efficiently consummate the Transaction. We intend to finance the Transaction with equity from the members of our consortium.

We have engaged O’Melveny & Myers LLP as our international legal counsel and Tian Yuan Law Firm as our PRC legal counsel. We believe that we will be in a position to complete customary legal, financial and accounting due diligence for the Transaction in a timely manner and in parallel with discussions on the definitive agreements providing for the Transaction and related transactions (collectively, “Definitive Agreements”).

As we have previously stated, our Proposal does, and the Transaction will, provide superior value to the Company’s shareholders as compared with the Insider Group’s proposal. We recognize that the Company’s Board of Directors has formed a special committee to evaluate the Insider Proposal and we are positioned to negotiate and complete the acquisition in a timely manner. While we are fully prepared to pursue the Transaction upon the terms and subject to the conditions set forth herein, we are open-minded and flexible with respect to the potential structure of the Transaction to expedite the process of delivering value to the Company’s shareholders, including working with other parties, such as Mr. Zhang, through forming a buyer group with them to implement a “going-private” transaction.

As an A share company listed in China, Jiangsu Sanyou may be under certain legal obligations to disclose this letter and we understand that in turn, the Company may then wish to make a public announcement with respect to the receipt of our Proposal. However, we are sure you will agree with us that it is in all of our interests to ensure that we otherwise proceed in a strictly confidential manner, unless otherwise required by law, until we have executed Definitive Agreements or terminated our discussions.

This letter constitutes only a preliminary indication of our interest, and does not constitute any binding commitment with respect to the Transaction. A binding commitment will result only from the execution of Definitive Agreements, and then will be on terms and conditions provided in such documentation. This letter is governed by, and construed in accordance with the laws of People’s Republic of China.

About Jiangsu Sanyou. On August 2015, Meinian Onehealth Healthcare (Group) Co., Ltd (“Meinian”) became an A share listed company through the backdoor listing of Jiangsu Sanyou. Meinian is one of the largest preventive healthcare service providers in China, with more than 100 self-owned medical examination centers in more than 50 core cities in China. In 2014, Meinian provided its services to almost six million customers. Leveraging its high quality and professional medical examination services, Meinian also provides high quality healthcare management services, including preventive healthcare and wellness maintenance, to its corporate and individual customers.

About Cathay. Cathay, founded in 2006 by Mingpo Cai and Edouard Moinet, is an leading international private equity firm in the field of cross-border investment, committed to supporting the international expansion of small and medium enterprises from China, Europe and the United States. Cathay is in charge of six funds including the Cathay Capital I, the Cathay Capital II, the Sino-French Fund for small and medium enterprises, the Sino French (Midcap) Fund, the Sino French Innovation (venture capital) as well as the Cathay Capital North American Sino Fund. With more than EUR 1.5 billion in assets under management, it has invested in 44 companies across three continents. Cathay focuses on industries including consumer goods, health care, modern service industry, environment, agriculture and food security, as well as advanced technology, with teams based in Shanghai, Beijing, Paris, Munich, New York and the Silicon Valley.

About Ping An. Ping An is indirectly controlled by Ping An Insurance (Group) Company of China, Ltd (“Ping An Group”). Since established in 1988, Ping An Group has developed into a personal financial services group with three core businesses of insurance, banking and investment, enjoying parallel growth of its core and internet finance businesses. Ping An Group’s shares are jointly listed on the Hong Kong Stock Exchange (stock code: 2318) and on the Shanghai Stock Exchange (stock code: 601318).

About Taiping. Formed by Taiping Asset Management Co., Ltd. (“Taiping Asset Management”), Taiping is the asset management arm of China Taiping Insurance Holding Co., Ltd. (“CTIH”). As of Dec 31, 2014, Taiping Asset Management’s asset under management reaches RMB 330 billion (equivalent to USD 51.7 billion). CTIH, a subsidiary of China Taiping Insurance Group Co., Ltd., was listed on the Hong Kong Stock Exchange (HK 00966) on June 29, 2000. The overall business of CTIH ranges from life insurance and property insurance in mainland China and property insurance in Hong Kong, to various global underwriting of reinsurance, reinsurance brokerage, asset management, pension insurance etc. CTIH has consistently been listed in “China Fortune 500” since 2009.

About Sequoia. Sequoia is an international private equity and investment firm. Since its inception in September 2005, Sequoia China funds has initiated and managed numerous U.S dollar and RMB funds, and has become one of China’s most successful venture capital and private equity funds.

About Huatai Ruilian. Huatai Ruilian is a well-known private equity firm in China. Until October 2015, Huatai Ruilian has managed three private equity funds with more than USD$ 1.7 billion in assets under management.

We are confident that our Proposal is highly attractive to iKang and its shareholders. We encourage the Board of Directors of iKang and its special committee to take into consideration our flexibility in the proposed structure and willingness to work with Mr. Zhang as an alternative to deliver superior and immediate value to iKang’s shareholders. Jiangsu Sanyou’s senior management team, led by Mr. Rong YU, and O’Melveny & Myers LLP, our legal counsel, are available at your convenience to discuss any aspect of our Proposal.

[signatures are below]

  JIANGSU SANYOU GROUP CO., LTD.
By: /s/RONG YU
Name: Rong Yu
Title:  Authorized Signatory
  CATHAY CAPITAL PRIVATE EQUITY SAS
By: /s/LANCHUN DUAN
Name: Lanchun Duan
Title:  Authorized Signatory
  SHENZHEN PING AN DECHENG INVESTMENT CO., LTD.
By: /s/JIAHUA SHEN
Name: Jiahua Shen
Title:  Authorized Signatory
  TAIPING GUOFA (SUZHOU) CAPITAL MANAGEMENT CO., LTD.
By: /s/ZHONGHUA WANG
Name: Zhonghua Wang
Title:  Authorized Signatory
  SEQUOIA CHINA INVESTMENT MANAGEMENT LLP
By: /s/KUI ZHOU
Name: Kui Zhou
Title:  Authorized Signatory
  HUATAI RUILIAN FUND MANAGEMENT CO., LTD.
By: /s/ZHIJIE CHEN
Name: Zhijie Chen
Title:  Authorized Signatory

 

IR Contact:

iKang Healthcare Group, Inc.
Christy Xie
Director of Investor Relations
Tel: +86 10 5320 8599
Email: ir@ikang.com
Website: www.ikanggroup.com

FleishmanHillard
Ruby Yim
Email: ikang.ir@fleishman.com
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(AVXL) ANAVEX 3-71 Potent Cognitive Enhancer in Alzheimer’s: Independent Research

Data Strengthens Pipeline Including Sigma-1 and Muscarinic Compound ANAVEX 2-73

NEW YORK, Nov. 30, 2015  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease (AD), other central nervous system (CNS) diseases, pain and various types of cancer, announced today the publication of further data for ANAVEX 3-71 (formerly AF710B) in the peer-reviewed scientific journal Neurodegenerative Diseases.  The ANAVEX 3-71 data provides evidence for a positive, more upstream effect on reducing synaptic loss, amyloid and tau pathologies, and neuroinflammation, which is potentially beneficial for the treatment of Alzheimer’s and other neurological diseases.  ANAVEX 3-71 is part of the Company’s pipeline including ANAVEX 2-73 targeting sigma-1 and muscarinic receptors.

“Our preclinical findings for ANAVEX 3-71 demonstrate its significant potential to enhance neuroprotection and cognition via concomitant activation of sigma-1 receptor and M1 muscarinic acetylcholine receptor (M1R), which could be a therapeutic advantage in treating Alzheimer’s and other related protein-aggregation diseases,” said study author Abraham Fisher, PhD.  “Specifically, the study results reveal that ANAVEX 3-71 effects a strong reversal of synaptic loss in hippocampal neurons.  At very low doses, it mitigates cognitive deficits and normalizes major pathological hallmarks in Alzheimer’s disease models indicating that ANAVEX 3-71 exerts a comprehensive disease-modifying effect.  This data adds to the strong foundation of preclinical evidence to support the potential use of ANAVEX 3-71 in Alzheimer’s disease and a wide array of other central nervous system diseases.”

“In addition to ANAVEX 2-73, which is currently the subject of an ongoing PART B longitudinal extension of the Phase 2a study, it appears that ANAVEX 3-71 could be a highly effective treatment for Alzheimer’s when compared with competing drugs, including donepezil (Aricept®), the current standard of care,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.  “Based on the growing body of positive preclinical data, we look forward to continuing to advance ANAVEX 3-71 towards a potential first human clinical trial.”

The results of the preclinical study demonstrate that ANAVEX 3-71:

  • Protects post-synaptic dendritic spines and reverses synaptic loss in hippocampal neurons, which are important for learning and memory and their loss may cause cognitive decline in AD.  Results show that ANAVEX 3-71 efficiently rescues mushroom spines via potential activation of sigma-1 receptor/M1R.
  • Mitigates cognitive impairments and lessens Alzheimer’s-like pathology in the 3xTg-AD animal model.  Notably ANAVEX 3-71 showed exceptional efficacy in restoring cognitive decline associated with AD and with lessening BACE1, GSK3beta activity, p25CDK5, neuroinflammation, soluble and insoluble Abeta40, Abeta42, accumulation of amyloid plaques and tau pathologies.
  • Reverses the cognitive decline induced by the M1R antagonist, trihexyphenidyl via activation of both sigma-1 receptor and M1R.

The paper, “AF710B, a Novel M1/ Sigma-1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s disease,” was published in Neurodegenerative Diseases.  It was co-authored by A. Fisher, the inventor of ANAVEX 3-71, and I. Bezprozvanny, L. Wu, D. A. Ryskamp, N. Bar-Ner, N. Natan, R. Brandeis, H. Elkon, V. Nahum, E. Gershonov, F. M. LaFerla and R. Medeiros from the Israel Institute for Biological Research (Ness-Ziona, Israel), the University of Texas Southwestern Medical Center (Dallas, TX), St. Petersburg State Polytechnical University (St. Petersburg, Russia) and the University of California (Irvine, CA), respectively.

Dr. Abraham Fisher is a member of the Anavex Scientific Advisory Board.

About ANAVEX 3-71

ANAVEX 3-71, previously AF710B, is a promising preclinical drug candidate with a novel mechanism of action shown to enhance neuroprotection and cognition in Alzheimer’s disease.  It is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications.  ANAVEX 3-71 is highly effective in very small doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on neuroinflammation and mitochondrial dysfunctions.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

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

For Further Information

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

Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com 
www.anavex.com
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(ORMP) $50 Million Licensing, Investment Agreements for Oral Insulin Capsule in China

Receiving up to $38,000,000 + royalties for licensing deal and $12,000,000 for equity investment at $10.39 per share

JERUSALEM, Nov. 30, 2015  — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today it has signed definitive licensing and investment agreements valued at up to $50,000,000 with Hefei Tianhui Incubator of Technologies Co., Ltd. (“HTIT”) for exclusive rights to market Oramed’s oral insulin capsule, ORMD-0801, in China, Hong Kong and Macau. The agreements were signed at the Israel Knesset (Parliament).

The license agreement payments include a $3 million payment due upon execution of the agreement, $8 million in near-term payments subject to Oramed entering into certain agreements and the balance payable upon achievement of certain milestones. In addition, if all conditions are met, HTIT will pay a 10% royalty on net sales of the related commercialized products.

In addition to the contemplated payments under the license agreement, pursuant to the investment agreement, Oramed will issue to HTIT 1,155,469 restricted shares of Oramed’s common stock at a price per share of approximately $10.39 and $12 million in total, subject to customary closing conditions.

“China recently became the country with the largest number of diabetics in the world. Having signed these definitive license and investment agreements, our oral insulin capsule could help serve the growing population of people in China living with diabetes,” stated Oramed’s CEO Nadav Kidron.  “In addition to the $50 million in milestone payments and investments, we believe the royalties on net sales throughout China will have a very significant impact on Oramed’s future revenues and earnings, upon market approval of ORMD-0801 in China.”

About Hefei

HTIT, which is partially owned by Sinopharm Group Company Limited, has state of the art insulin production facilities in Hefei, China. HTIT has a business focus which includes industrial investment and incubation services; high-tech product R&D; technology transfer and related consulting services.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801).  Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration.  In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).

For more information, please visit www.oramed.com, the content of which is not part of this press release.

Forward-looking statements:  This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss the closing of the issuance of the shares to HTIT, expected future milestone and royalty payments under the license agreement, our product’s potential to help serve the growing population of people in China living with diabetes, the significant impact that the expected royalties on net sales throughout China will have on our future revenues and earnings, upon market approval of ORMD-0801 in China, and our expected initiation of separate Phase IIb clinical trials in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration, and revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the satisfaction of closing conditions in the investment agreement prior to the issuance of shares to HTIT; meeting certain conditions and future milestones pursuant to the license agreement; risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.

Company Contact
Oramed Pharmaceuticals
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: 1-718-831-2512 ext. 2
Email: ariella@oramed.com

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(HART) Regains Compliance With Nasdaq Minimum Bid Price Listing Rule

HOLLISTON, Mass., Nov. 30, 2015  — Harvard Apparatus Regenerative Technology, Inc. (HART) (Nasdaq: HART), a biotechnology company developing bioengineered organ implants for life-threatening conditions, today announced it has received written notification from The NASDAQ Stock Market that it has regained compliance with the minimum bid price requirements. The letter noted that as a result of the closing bid price of HART’s common stock having exceeded $1.00 per share for more than ten consecutive business days, the company has regained compliance and the matter is now closed.

HART’s CEO, Jim McGorry, commented, “Maintaining our NASDAQ listing is fundamental to our corporate strategy. We are gratified by the investment community’s response to our recent progress, including the positive animal research results on HART’s second generation (Gen2) bioengineered esophageal, tracheal and bronchial implants.”

Mr. McGorry continued, “Going forward, our development plan is focused on getting our technology back into humans on a compassionate use basis and filing our first clinical trial application with the FDA during 2016. We are confident that we will meet these goals given the results of our recent studies using our Gen2 technology across all three applications, our strong scientific team and our collaborations with translational partners. We have initiated confirmatory large-animal studies of our Gen2 implants with Mayo Clinic. The study design has been completed, prerequisite tests are underway, and we expect the animal surgeries to occur in December.”

About HART (www.hartregen.com)
Harvard Apparatus Regenerative Technology (HART) makes bioengineered organ implants for life-threatening conditions. Our technology platform is to be used to restore function in the esophagus and the airways (trachea and bronchus). HART is completing further large-animal studies to refine our technology platform with the goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in 2016, seeking to initiate clinical trials for one of our three product candidates. Our first-generation trachea technology was used in five adult human trachea transplants approved under compassionate use exemptions, but none of our products are yet approved for marketing by a government regulatory authority.

Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any HART products by the FDA, EMA, MHRA or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of HART products, including those pertaining to the airway or esophagus, which such success may not be achieved or obtained on a timely basis or at all . These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the our implant products, bioreactors, scaffolds and other devices and product candidates we pursue; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor and Media Contact:
David Collins, Tanya Kamatu
Catalyst Global
212 924 9800
hart@catalyst-ir.com

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(OGES) Announces Q3 Results

MELBOURNE, FL–(Nov 30, 2015) – Oakridge Global Energy Solutions, Inc. (OTCQB: OGES) is pleased to announce its third-quarter results for the three months ended September 30, 2015, during which the company made significant advances on its new manufacturing facility.

Total company assets for the third quarter of 2015 exceed USD$76.0 million, while liabilities are reported at slightly more than $2.75 million. Over the course of the next 18 months Oakridge plans to continue to strengthen its balance sheet, and ramp-up and install more than 2.6 gigawatt-hours of production capacity of U.S. manufacturing of electrodes, cells and batteries in its facilities located in the Brevard County, Florida area, known as the Space Coast.

“During the process of restructuring this business we had the opportunity to purchase a major supply of equipment and have continued to develop I/P in the battery space,” says Oakridge executive chairman and CEO, Steve Barber. “We are very pleased with the third-quarter results and expect the fourth-quarter results to be even better. Our business plan is simple; we develop, manufacture and sell products. I know it’s a bit old fashioned, but we are in the business of manufacturing.”

The third quarter 2015 earnings report may be viewed at http://www.otcmarkets.com/financialReportViewer?symbol=OGES&id=147767

Notably, in the third quarter, Barber has, through the majority ownership of Oakridge by Precept Fund Management SPC (“Precept”), funded the creation of a major full-scale manufacturing facility for Oakridge in Brevard County, Florida, in Melbourne and Palm Bay, which greatly contributes to the company’s current strengthened position in the broader battery industry.

“Our third-quarter results reflect the significant investment that Precept has made into this exciting business,” says Barber. “From development of products to purchase of manufacturing equipment, this business is now fully operational and poised for growth.”

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc. is an integrated energy storage solutions company that uses state-of-the-art technology in the design, development and manufacture of high-quality cells, batteries, and energy storage systems. The company’s innovative ‘Made in the USA’ product line includes multiple lithium-ion chemistries, technologies and form factors that are optimized to address multiple high-demand target markets.

Operating out of a new 68,000 sq. ft. facility for corporate offices and manufacturing, Oakridge Global Energy Solutions currently has a market cap of just over $140,000,000 USD and plans to ramp up and install more than 2.6 Gigawatt-hours of production capacity over the next 16 months. Additional information can be accessed on the company’s website www.oakg.net.

Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Company Contact:
Oakridge Global Energy Solutions, Inc.
Info@oakg.net
www.oakg.net
3520 Dixie Highway
Palm Bay, 32905, Florida
USA
Ph: (321) 610-7959

Investor Inquiries:
Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
Editor@DreamTeamNetwork.com

Monday, November 30th, 2015 Uncategorized Comments Off on (OGES) Announces Q3 Results

(CNCK)’s Examiner.com Debut Provides Healthy, Tasty Holiday Eating Tips

LOS ANGELES, CA–(Nov 30, 2015) – ContentChecked Holdings, Inc. (OTCQB: CNCK), the developer of a family of health apps for people with dietary restrictions and/or food preferences, is also growing its reputation as a knowledgeable and sought-after source of nutritional information. Company nutritionist Tara Zamani earlier last week was featured in an article entitled, “Quick Tips for a Healthier Thanksgiving,” which was published on Examiner.com, one of several recent media publications to highlight the company’s expertise.

Zamani shares several ways you can “indulge without the bulge with tips that will lessen the effects of the gut-busting Thanksgiving binge.”

Contributing to the Examiner.com article she writes, “Avoid using canned and packaged foods when possible. As much as canned and pre-packaged foods seem like a wonderful solution when you’re in a crunch these foods are highly processed and usually contain high amounts of sodium and preservatives that can lead to dehydration and increased food cravings … Reduce or eliminate caffeine. When preparing to indulge in that delicious meal, cut back on your caffeine intake a day or two prior. The ups and downs of caffeine which include dehydration and blood sugar swings will stabilize, reducing cravings associated with dehydration and blood sugar swings. You’ll naturally eat less and won’t even notice! … Experiment with spices. Coriander, cinnamon, nutmeg, cloves, saffron and cardamom all naturally add flavor to your foods, increase serotonin (love hormone) and reduce cravings. Sprinkling these spices over your foods will naturally suppress cravings without having to give up the foods you love.”

Zamani also provides three unique recipes that are perfect for Thanksgiving or any time consumers are looking for a healthy options — which is complementary to the core mission of ContentChecked and its entire team of professionals.

Read the full article and get the recipes at the following link: http://www.examiner.com/article/quick-tips-for-a-healthier-thanksgiving

From Examiner.com, a highly trafficked site which has approximately 4.3 million unique visitors per month, the article links back to ContentChecked’s website, potentially exposing the company to a broad audience of consumers.

“We’re honored to once again provide consumers with suggestions to help them lead healthy, balanced lives,” says Kris Finstad, CEO of ContentChecked. “Our corporate goal is to introduce to consumers technology that improves lives, contributes to greater healthy, and overall makes the world a better place. Each time we, as a company, are featured in a publication, we live out that mission.”

About ContentChecked Holdings, Inc.

ContentChecked has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications to the market. ContentChecked and MigraineChecked applications are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for most U.S. food products. SugarChecked gives consumers the ability to scan the barcodes of grocery store products and determine what kind of sugars are contained within. This enables the applications to meet the needs of millions of people in the United States. As a result, ContentChecked has created a pivotal way for food producers to, at the point of purchase, be able to showcase their products to consumers who are actively seeking them.

Designed for use by those who suffer from food allergies, dietary intolerances, migraines and chronic headaches, ContentChecked and MigraineChecked applications have reached wide adoption levels. In the U.S. alone there are 15 million people who suffer from food allergies and 38 million from migraine and chronic headaches. The food allergy market currently has an estimated value of $6 billion USD. Both applications give the ability to scan a product’s bar code and determine if it is safe for consumption, and if not the apps will recommend a suitable alternative per the user’s specific dietary profile.

SugarChecked identifies four main types of sugars that consumers can avoid, including added sugars, artificial sweeteners, natural low-calorie sweeteners and sugar alcohols. This application is an easy shopping tool for consumers to decipher often-misleading food labels, and receive recommendations for healthier alternative products as they shop in real time.

ContentChecked has created a robust database of allergens, migraine triggers, and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database that is updated regularly. ContentChecked’s applications are highly scalable and can expand into new geographic areas and product categories with limited modifications and investment.

For more information on ContentChecked, please visit its social media channels via Facebook (http://www.facebook.com/contentchecked), Instagram (http://www.instagram.com/contentchecked), or YouTube (http://www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ). You may also visit the social media channels of MigraineChecked on Facebook (http://www.facebook.com/migrainechecked) or Instagram (http://www.instagram.com/migrainechecked/).

Forward-Looking Statements:

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of the Company’s mobile applications, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including, the Company’s Annual Report on Form 10-K filed with the SEC on July 13, 2015. The Company does not undertake to update these forward-looking statements.

Contact:

Investor Relations
Mike Bowdoin
Bowdoin Group
407-590-6995
Mike@BowdoinGrp.com

Monday, November 30th, 2015 Uncategorized Comments Off on (CNCK)’s Examiner.com Debut Provides Healthy, Tasty Holiday Eating Tips

(ZGNX) ZX008 for Dravet Syndrome to be Presented at 69th Annual ASE

Three Poster Presentations will Highlight Efficacy, Cardiovascular Safety and Mechanism of Action of Low-Dose Fenfluramine in the Treatment of Dravet Syndrome

Zogenix will also Host a Scientific Exhibit Room: “History of the Use of Low-dose Fenfluramine in Pediatric Epilepsy”

SAN DIEGO, Nov. 25, 2015  — Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced the presentation of clinical and scientific posters, and the hosting of a scientific exhibit room at the 69th Annual American Epilepsy Society Meeting, which will take place in Philadelphia, PA, from December 4 – 8, 2015.

One poster will report efficacy data from a new cohort of 7 patients treated with ZX008 (low-dose fenfluramine) for Dravet syndrome. A second poster will focus on the evaluation of cardiovascular safety related to the treatment of the same 7 patients. A third poster reports on investigations into the mechanism of action for fenfluramine as a treatment for Dravet syndrome using a gene knockout zebrafish model.

In addition, on Monday, December 7, 2015, from 8:00 AM – 11:00 AM, Zogenix will host the “History of the Use of Low-dose Fenfluramine in Pediatric Epilepsy: An Intriguing Past, Present, and Future” in a Scientific Exhibit room highlighting all of the posters and publications focused on low-dose fenfluramine as a potential treatment for Dravet syndrome generated to date.

Zogenix expects to initiate Phase 3 clinical studies for ZX008 in 2015. ZX008 is designated as an orphan drug in both the U.S. and Europe for the treatment of Dravet syndrome.

Zogenix at the 69th Annual American Epilepsy Society Meeting

Title: Low-dose Fenfluramine Significantly Reduces Seizure Frequency in Dravet Syndrome: A Prospective Study of a New Cohort of Belgian Patients
Date: Poster Session 2, December 6, 2015
Poster Session #: 2.262

Title: Cardiovascular Side Effects of Low-dose Fenfluramine Treatment in Dravet Syndrome: A Prospective Echocardiographic Pilot Study
Date: Poster Session 2, December 6, 2015
Poster Session #: 2.266

Title: Exploring the Mechanism-of-action of Fenfluramine, an Anti-Epileptic Drug in the Treatment of Dravet Syndrome, Using an scn1Lab Mutant Zebrafish Model
Date: Poster Session 3, December 7, 2015
Poster Session #: 3.039

Fenfluramine Scientific Exhibit
Date: December 7, 2015
Time: 8:00 AM – 11:00 AM
Room: 202A

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing CNS therapies that address specific clinical needs for people living with orphan and other CNS disorders who need innovative treatment alternatives to improve their daily functioning.

For more information, visit www.zogenix.com.

CONTACT: Investors: Andrew McDonald
         Founding Partner, LifeSci Advisors LLC
         646-597-6987 | Andrew@lifesciadvisors.com
Wednesday, November 25th, 2015 Uncategorized Comments Off on (ZGNX) ZX008 for Dravet Syndrome to be Presented at 69th Annual ASE

(CRHM) Secures US$33M Credit Facility From Scotiabank; Replaces Existing Debt

Refinancing Is Immediately Accretive to Both Cash Flow and EPS

VANCOUVER, BRITISH COLUMBIA–(Nov. 25, 2015) – CRH Medical Corporation (TSX:CRH)(NYSE MKT:CRHM) (“CRH” or the “Company”), a North American medical company that provides physicians with innovative products and services for the treatment of gastrointestinal diseases, has entered into an agreement with The Bank of Nova Scotia (“Scotiabank”) for a US$33M Senior Secured Revolving Credit Facility (the “Facility”).

The Facility will replace existing debt and will be used to assist in the financing of potential future acquisitions. The Facility has initially been used to repay in full CRH’s senior secured credit facility with Knight Therapeutics Inc. (“Knight”) in the amount of US$22M, and to repay an unsecured subordinated loan to the Bloom Burton Healthcare Structured Lending Fund II in the amount of US$2M. The interest rate on the loans repaid was 10% and 12%, respectively. The Company’s outstanding indebtedness to Crown Capital Partners (“Crown”) in the amount of CAD$22.5M will remain in place. CRH plans to use the Facility as a revolving facility, keeping cash balances low to further reduce interest expense. The approximate financing expense savings for 2016 is expected to be US$2.5M.

The interest for the Facility is calculated using a set formula with a base rate plus 2.5% – 3.0%, depending on the Company’s total debt to EBITDA ratio. Under the Facility, using the current base rate, CRH has an expected total interest cost of approximately 3.5% per annum. The Facility matures on April 30, 2018 and is self-amortizing with fixed quarterly repayments of approximately 5% of the outstanding balance each quarter.

“For many years, CRH has focused on both growth and strong financial discipline, which is why we are proud to announce that our underlying business fundamentals and financial strength have enabled us to partner with Scotiabank, one of North America’s premier financial institutions. We have now secured a low cost of capital that will further augment our cash flow and which is also accretive to earnings per share,” stated Richard Bear, Chief Financial Officer.

Key benefits of the Scotiabank revolving credit facility

  • Significantly lowers CRH’s cost of capital
  • Accretive to cash flow
  • Accretive to earnings per share (EPS)
  • Establishes a new, low cost source of financing for potential future CRH acquisitions

CEO of CRH, Edward Wright added “Almost exactly one year ago, we announced a transformative acquisition that was financed by Knight, Crown and Bloom Burton & Co. Their capital enabled CRH to execute on a bold vision that has proven to be successful for all CRH stakeholders. We are thankful to them for their early support and having enabled CRH to become a much bigger, more profitable company. Our financial performance has enabled us to secure financing from Scotiabank, and we now have both the platform and low cost of capital to grow CRH’s business even further.”

About CRH Medical Corporation:

CRH Medical Corporation is a North American company that provides physicians with innovative products and services for the treatment of gastrointestinal diseases. The Company’s product distribution strategy focuses on physician education, patient outcomes, and patient awareness. The Company’s first product, the CRH O’Regan System, is a single use, disposable, hemorrhoid banding technology that is safe and highly effective in treating hemorrhoid grades I – IV. CRH distributes the CRH O’Regan System, treatment protocols, operational and marketing expertise as a complete, turnkey package directly to physicians, allowing CRH to create meaningful relationships with the physicians it serves. CRH also operates a full service anesthesia services division serving the gastroenterology community, which provides anesthesia services for patients undergoing endoscopies and colonoscopies. Performing these procedures under anesthesia makes these procedures more comfortable for patients and allows gastroenterologists to perform more procedures than in the absence of anesthesia. CRH expects to leverage the capabilities it acquired through these gastroenterology anesthesia companies to consolidate the highly fragmented gastroenterology anesthesia provider business. The Company’s goal is to establish CRH as the premier provider of innovative products and essential services to gastroenterologists throughout the United States.

Cautionary Note Regarding Forward-looking statements: 

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “plan,” “intend” or “project” or the negative of these words or other variations on these words or comparable terminology. Readers are cautioned regarding statements discussing profitability; growth strategies; anticipated trends in our industry; our future financing plans; and our anticipated needs for working capital. Forward looking statements in this press release include statements regarding potential additional acquisitions and the use of the Facility to finance such acquisitions, the Company’s plan to use the Facility as a revolving credit facility and to keep cash balances low, the amount of anticipated interest savings in 2016, the Company’s expectation of increasing revenue and operating EBITDA, continued growth of our business and leveraging our capabilities, and the anticipated benefits of the Facility. Actual events or results may differ materially from those discussed in forward-looking statements. There can be no assurance that the forward-looking statements currently contained in this press release will in fact occur. The Company bases its forward-looking statements on information currently available to it. The Company disclaims any intent or obligations to update or revise publicly any forward-looking statements whether as a result of new information, estimates or options, future events or results or otherwise, unless required to do so by law.

Forward-looking information reflects current expectations of management regarding future events and operating performance as of the date of this document. Such information involves significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to differ materially from the results discussed in forward-looking information, including, without limitation: our ability to identify suitable acquisition candidates and to complete such acquisitions, our need for additional financing and our estimates regarding our capital requirements, future revenues and profitability; risks related to the Company’s credit facilities; risks related to adverse movements in foreign currency exchange rates; and the other risks described in the Company’s Annual Information Form, Management’s Discussion and Analysis of Financial Condition and Results of Operations; its Registration Statement on Form 40-F and other documents filed with, or furnished to, Canadian securities regulators and the Securities and Exchange Commission.

David Matousek
Director of Investor Relations
CRH Medical Corporation
800.660.2153 x1030
dmatousek@crhmedcorp.com

Wednesday, November 25th, 2015 Uncategorized Comments Off on (CRHM) Secures US$33M Credit Facility From Scotiabank; Replaces Existing Debt

(ACAS) Strategic Review of Alternatives, Expands Existing Stock Buyback

BETHESDA, Md., Nov. 25, 2015  — American Capital, Ltd. (Nasdaq: ACAS) (“American Capital” or the “Company”) announced today that its Board of Directors has instructed the Company to undertake a full strategic review of all alternatives with Goldman Sachs & Co. and Credit Suisse Securities (USA) LLC as its financial advisors to assist in this review.  The strategic review will consider all alternatives for maximizing shareholder value, including a sale of the Company or its various business lines in whole or in part.  The strategic review will be run by an independent committee of the Board consisting of Neil Hahl, Kristen Manos, Kenneth Peterson and David Richards and will be chaired by Mr. Hahl.

“The Strategic Review Committee looks forward to a full independent review with the sole goal of maximizing value for shareholders,” said Mr. Hahl. The Company’s previously announced plan to spin off to its shareholders a new business development company will be evaluated as part of the review.

“We have generated a 16% annualized growth rate in both our book value and price per share over the five years ended September 30, 2015,” said Malon Wilkus, Chair and Chief Executive Officer of the Company.  “Nonetheless, we continue to trade at a meaningful discount to our book value, even as we progress with our plans for the spin off, which is intended to unlock shareholder value.  Therefore, I am fully supportive of this strategic review, which will allow us to realize the optimal value for our shareholders.”

The Company also announced that its Board of Directors has revised and expanded its current stock buyback program, which began in the third quarter of 2015, by increasing it to a range of $600 million to $1 billion from the prior range of $300 million to $600 million.  Under the program, purchases will only be made at per share prices below 85% of the Company’s net asset value per share as of September 30, 2015.   The Company expects to enter into a Rule10b5-1 trading plan to undertake accretive share repurchases on a non-discretionary basis up to the $1 billion limit. The Company expects to complete the upsized program by June 30, 2016.

“We consider our stock to be a terrific bargain,” added Mr. Wilkus.  “Having already purchased shares representing 34% of our shares outstanding when the program started, we intend to purchase additional significant amounts as long as we continue to trade at a significant discount to our book value.  During the course of our strategic review we will continue to be prudent managing our balance sheet and cost structure.”

Since American Capital began stock buybacks in August 2011 through September 30, 2015, American Capital made open market purchases of 117.8 million shares, for an aggregate of $1.4 billion, of American Capital common stock at an average price of $12.05 per share.

American Capital expects to disclose publicly the initial results of its strategic review no later than January 31, 2016.

ABOUT AMERICAN CAPITAL

American Capital, Ltd. (Nasdaq: ACAS) is a publicly traded private equity firm and global asset manager. American Capital, both directly and through its asset management business, originates, underwrites and manages investments in middle market private equity, leveraged finance, real estate, energy & infrastructure and structured products. American Capital manages $23 billion of assets, including assets on its balance sheet and fee earning assets under management by affiliated managers, with $80 billion of total assets under management (including levered assets). Through a wholly-owned affiliate, American Capital manages publicly traded American Capital Agency Corp. (Nasdaq: AGNC), American Capital Mortgage Investment Corp. (Nasdaq: MTGE) and American Capital Senior Floating, Ltd. (Nasdaq: ACSF) with approximately $10 billion of total net book value. From its eight offices in the U.S., Europe and Asia, American Capital and its wholly-owned affiliate, European Capital, will consider investment opportunities from $10 million to $600 million. For further information, please refer to www.AmericanCapital.com.

ADDITIONAL INFORMATION

This press release contains forward-looking information and statements.  Forward-looking statements give our current expectations and projections relating to the Company’s financial condition, results of operations, plans, objectives, future performance and business.  You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts.  These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “confident,” “may,” “should,” “can have,” “likely,” “future” and other words and terms of similar meaning in connection with any discussion of the timing or nature of transaction closings, future operating or financial performance or other events.  Forward looking statements are not guarantees of performance or results, and involve known and unknown risks, uncertainties (some of which are beyond the Company’s control), assumptions and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements.  Should one or more of these risks or uncertainties materialize, the Company’s actual results may vary in material respects from those projected in any forward-looking statements. Certain factors that could cause actual results to differ materially from those contained in the forward-looking statements are included in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and the Company’s subsequent periodic filings.  Copies are available on the SEC’s website at www.sec.gov.  Any forward-looking statement made by the Company in this press release speaks only as of the date on which it is made.  The Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.  Performance data quoted above represents past performance of American Capital.  Past performance does not guarantee future results and the investment return and principal value of an investment in American Capital will likely fluctuate.

Contact:
Media (301) 968-9400
Investor Relations (301) 951-5917

Wednesday, November 25th, 2015 Uncategorized Comments Off on (ACAS) Strategic Review of Alternatives, Expands Existing Stock Buyback

(NVIV) Announces Jay Blackington as New VP, HHR

InVivo Therapeutics Holdings Corp. (NVIV) today announced the appointment of Jay Blackington as Vice President, Head of Human Resources. Mr. Blackington most recently was Senior Vice President, Global Human Resources at the Avid Corporation, a leading global provider of digital media content-creation products and solutions for audio, film, video, and broadcast professionals.

Before Avid, Mr. Blackington served for nine years as Vice President, Global Human Resources at EMC2, an industry-leading global cloud computing and big data IT provider with 50,000 employees. While at EMC2, he held several leadership positions and most recently provided the HR leadership in establishing eight new global delivery Centers of Excellence located in India, China, Russia, Israel, Egypt, Ireland and the USA. Prior to that, Mr. Blackington held human resources leadership positions, located both in the USA and in Asia Pacific, at industry-leading global enterprises including State Street, Monsanto, First Data, and Honeywell.

“Jay comes to InVivo with over three decades of global human resources experience across a number of industries. His wealth of knowledge and ability to effectively attract, develop and maximize human capital will make him a valuable asset as we progress into the pivotal probable benefit study, commercialization, and beyond,” said Mark Perrin, InVivo’s Chief Executive Officer and Chairman.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

 

Investor Relations
InVivo Therapeutics Holdings Corp.
Brian Luque, 617-863-5535
bluque@invivotherapeutics.com

Wednesday, November 25th, 2015 Uncategorized Comments Off on (NVIV) Announces Jay Blackington as New VP, HHR

(MOKO) & Blue Nation Review Transaction

SYDNEY, AUSTRALIA–(Nov 25, 2015) – MOKO Social Media Limited (NASDAQ: MOKO) (ASX: MKB) announces that its political commentary platform, Blue Nation Review, will be sold to True Blue Media, LLC, a newly-formed company currently wholly owned by David Brock, founder of Media Matters, a U.S. progressive-based research and information center.

Media Matters was founded in 2004 by David Brock, who also founded the Super PACs “Correct the Record” and “American Bridge”. Hillary Clinton advised Media Matters in its early stages out of a belief that progressives should follow conservatives in forming think tanks and advocacy groups to support their political goals. According to the New York Times, Media Matters “helped lay the groundwork” for Hillary Clinton’s 2016 presidential campaign.

All Blue Nation Review employees and assets will transfer over to True Blue Media under the strategic editorial vision of BNR Editor-at-Large Jimmy Williams. The terms of the transaction grant MOKO a 20% equity stake in the True Blue Media, with David Brock holding the 80% equity balance.

MOKO Social Media Chairman, Greg McCann, said, “We are very happy with this transaction as the new company will be better able to grow BNR’s influence and our retained equity holding will provide MOKO with a valuable upside opportunity.”

The sale is the result of a strategic decision by MOKO to focus on MOKO’s core student division, as announced in the Chairman’s Annual Review on September 30, 2015.

About MOKO SOCIAL MEDIA Limited

MOKO Social Media is at the forefront of the next generation in social media, providing innovative products and content to enable communities to engage and interact. MOKO provides tailored content for high value, niche user groups including students, political supporters and active lifestyle participants: communities that share common interests and need to engage regularly and efficiently. Within its student space, MOKO is a mobile leading U.S. college intramural and recreational sports platform. Agreements with the largest college and high school sports data providers in the U.S. grant MOKO exclusive access to provide its award-winning app REC*IT, and BigTeams powered by REC*IT, to over 1,100 U.S. colleges, representing approximately 50% of the U.S. college population, and to over 4,400 U.S. high schools respectively.

MOKO aims to capture its target audiences by becoming their destination of choice for information and interaction. It does this by creating highly relevant and exclusive content, and by providing the platforms that enable the communities to consume and share the content seamlessly across devices. This integrated approach gives MOKO unique and exclusive exposure to markets that are highly desired by advertisers and that can be leveraged for growth and revenue through advertising, sponsorship, social network distribution and other monetization of the platforms.

Note
This announcement is for informational purposes only and is neither an offer to sell nor an offer to buy any securities, or a recommendation as to whether investors should buy or sell.

Special Note on Forward-Looking Statements
This press release contains information that may constitute forward-looking statements and uses forward-looking terminology such as “anticipate,” “propose,” “expect,” and “will,” negatives of such terms or other similar statements. You should not place undue reliance on any forward-looking statement due to its inherent risk and uncertainties, both general and specific. Although we believe the assumptions on which the forward-looking statements are based are reasonable and within the bounds of our knowledge of our business and operations as of the date hereof, any or all of those assumptions could prove to be inaccurate. Risk factors that could contribute to such differences include our ability to prepare required documents in connection with the proposed offering, the timing of regulatory review, performance of our shares on the Nasdaq Global Market, and the performance of the United States and global capital markets and companies in our sector, as well as factors relating to the performance of our business, including intense competition we face; failure to innovate and provide products and services that are useful to users; our ongoing need for capital for investment in new and existing business strategies and new products, services and technologies, including through acquisitions; our dependence on advertising revenues; the potential for declines in our revenue growth rate and downward pressure on our operating margin in the future; increased regulatory scrutiny that may negatively impact our business; legal proceedings that may result in adverse outcomes; failure to maintain and enhance our brand; uncertainty as to our ability to protect and enforce our intellectual property rights; and uncertainty as to our ability to attract and retain qualified executives and personnel. The forward-looking information provided herein represents the Company’s estimates as of the date of the press release, and subsequent events and developments may cause the Company’s estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company’s estimates of its future intentions as of any date subsequent to the date of this press release. Our plans may differ materially from information contained in the forward-looking statements as a result of these risk factors or others, as well as changes in plans from our board of directors and management.

U.S. Contact:
Jed Latkin
917-957-4987
jed.latkin@mokosocialmedia.com

Wednesday, November 25th, 2015 Uncategorized Comments Off on (MOKO) & Blue Nation Review Transaction

(CPSI) to Acquire Healthland for $250 Million

Computer Programs and Systems, Inc. (NASDAQ:CPSI), a leading provider of healthcare information solutions to rural and community hospitals, today announced that it has entered into a definitive agreement to acquire Healthland Holding Inc. and its affiliates, Healthland Inc., American HealthTech, Inc. and Rycan Technologies, Inc. The acquisition will strengthen CPSI’s position in providing healthcare information solutions in the markets it serves and will provide new growth markets for the combined company. CPSI also announced the expansion of its senior management team to lead the Company going forward.

Healthland provides electronic health records (EHR) and clinical information management solutions to over 350 hospital customers. American HealthTech is a provider of clinical and financial solutions in the post-acute care space, serving over 3,300 skilled nursing facilities. Rycan offers SaaS-based revenue cycle management workflow and automation software to over 290 hospital customers.

Transaction Highlights:

  • Strengthens CPSI’s position in providing healthcare information systems to community healthcare organizations with approximately 1,200 combined hospital customers;
  • Introduces CPSI to the post-acute care market;
  • Expands the products and capabilities of TruBridge with the addition of Rycan and its suite of revenue cycle management software products; and
  • Immediately accretive to adjusted earnings per diluted share.

The combined company is projected to have annual revenues of approximately $300 million in 2015 and more than 1,900 employees. The transaction is expected to be more than 35% accretive to CPSI’s adjusted earnings per diluted share in 2016 and more than 50% accretive in 2017. Adjusted earnings, a non-GAAP financial measure, include a cash tax benefit from the acquisition and exclude share-based compensation expense, one-time transaction costs, and acquisition-related amortization and deferred revenue adjustments.

“We are excited to welcome Healthland into CPSI’s family of healthcare IT companies,” said Boyd Douglas, president and chief executive officer of CPSI. “Healthland’s history tracks a very similar course to that of CPSI, as we both have over 30 years of experience in the healthcare IT space, and we share a strong commitment to the improvement of community healthcare. The combination of these two long-standing companies creates in CPSI a broad product portfolio across the continuum of care. Together, we will service a client base of approximately 1,200 acute care facilities and more than 3,300 post-acute care facilities, including Healthland’s American HealthTech subsidiary. As the healthcare industry transitions to value-based reimbursement, our combined solutions will connect communities, patients and providers to facilitate more effective population health management, better patient engagement, and the advancement of quality and care coordination. In addition to an expanded client and solution base, the acquisition will also create synergies in our healthcare services offerings to address the acute and post-acute care markets’ demand for improved financial and operational performance. There is no doubt that the addition of Healthland, along with American HealthTech and Rycan, will not only improve CPSI’s offerings in the healthcare IT market, but will provide our combined company with greater opportunities for growth and significantly deepen our knowledge, resources and experience base. We are confident this combination will allow us to continue to be a leading innovator with greater benefits for our customers and the communities they serve, both now and in the years to come.”

Chris Bauleke, chief executive officer of Healthland, stated, “With the ongoing transformation in community healthcare, this combination will enable us to deliver solutions faster for our clients and better scale our development investment and customer support across the many communities we serve. Delivering meaningful solutions for our customers as they prepare for the transition into value-based payment models will continue to be a priority.”

Bauleke added, “Healthland’s acquisitions of American HealthTech, a provider of EHR solutions for post-acute care facilities, in 2013, and Rycan, a revenue cycle solutions company, in April 2015, provide immediate benefits to the markets and solutions that the combined company can leverage.”

Following the acquisition, support for Healthland’s core platforms, Classic and Centriq, will remain in place. Current implementations will continue, and CPSI plans to support and invest in the Centriq platform for at least the next seven years. The Healthland Classic platform will continue to be supported for a minimum of two years, as outlined by Healthland management at their recent Connect 15 User Conference.

Transaction Summary

The contemplated total aggregate consideration to be paid by CPSI is $250 million, payable approximately 65% in cash and 35% in CPSI common stock, subject to certain adjustments at and after closing, as provided for in the merger agreement. The completion of the transaction is subject to review under The Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the satisfaction of other customary closing conditions, and is targeted to close in 2015.

To finance the transaction, CPSI will use cash available on its balance sheet, $150 million of funded debt from a new senior secured credit facility and shares of its common stock. CPSI and Regions Bank have executed a committed financing letter for the new senior secured credit facility that CPSI intends to enter into at the time of closing the transaction.

CPSI’s financial advisor in this transaction was Allen & Company LLC and Maynard, Cooper & Gale, P.C. and Paul, Weiss, Rifkind, Wharton & Garrison LLP served as legal counsel to CPSI. Shearman & Sterling LLP served as legal counsel to Healthland.

CPSI’s Management Team

CPSI also announced a series of changes that expand its management team, effective immediately. David Dye, in addition to continuing to serve as chairman of the board, has assumed the new role of chief growth officer of CPSI and will be focused on driving growth in all segments of CPSI’s business. Chris Fowler, president of TruBridge, will assume the additional role of chief operating officer of CPSI and will be responsible for managing the integration of Healthland and CPSI. Matt Chambless, currently Director of Financial Reporting, is assuming the role of chief financial officer of CPSI.

“Having David Dye focus his experience, industry knowledge and leadership on growth is an exciting opportunity for our company, particularly as we add the Healthland companies to our business,” added Douglas. “Chris Fowler is a proven leader in our company and the right person to lead our operations and the integration of Healthland and CPSI, and Matt Chambless has earned the confidence of our management team and our Board.”

“I am excited about my role as chief growth officer and the opportunity to work with our team to expand our customer base and offer additional products and services in the markets we serve,” noted Dye, who like Boyd Douglas has been with CPSI for over 25 years.

CPSI also announced that Chris Bauleke has agreed to stay on as president of Healthland. Douglas added, “Having Chris as part of our team will be very valuable as we work to integrate these two businesses and position the combined company for future growth. Chris is an experienced executive and has been instrumental in positioning Healthland to compete in a dynamic and growing market. We believe that we have the right team to lead our company into the future and take advantage of the additional opportunities to serve our current customers and expand our service offering. With the addition of the Healthland companies, we also believe it is the right time to expand our senior leadership team and promote some of our younger managers.”

Conference Call

CPSI will discuss the transaction in more detail during a conference call Wednesday, November 25, 2015, at 10:30 a.m. ET. The Company will also provide a slide presentation in connection with the conference call and webcast. A 30-day online replay will be available approximately one hour following the conclusion of the live webcast. To listen to the live webcast or access the replay, visit the Company’s website, www.cpsi.com.

About Healthland

Healthland is a leading provider of integrated technology solutions to rural community and critical access hospitals. Software and services from Healthland, including electronic health records (EHRs), help customers share patient information across care settings to coordinate treatment, improve patient outcomes, and drive patient satisfaction. Healthland is the parent of Mississippi-based American HealthTech, one of the nation’s largest providers of financial and clinical technology solutions in post-acute care. Healthland is headquartered in Minneapolis, Minn., with offices in its founding rural community of Glenwood, Minn. More information is available at www.healthland.com.

About CPSI

CPSI is a leading provider of healthcare solutions for community hospitals. Founded in 1979, CPSI is the parent of two companies – Evident, LLC and TruBridge, LLC. Evident provides comprehensive EHR solutions for community hospitals. TruBridge focuses exclusively on providing business, consulting, and managed IT services to community healthcare organizations, regardless of their IT vendor. For more information, visit www.cpsi.com, www.evident.com, or www.trubridge.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements relating to the anticipated acquisition of Healthland Holding Inc. and certain of its affiliates (“Healthland”) and the timing and benefits thereof, the expected combined operations of CPSI and Healthland and CPSI’s financing plans for the Healthland acquisition. As such, they are subject to the occurrence of many events outside CPSI’s control and are subject to various risk factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statement. Risks include, without limitation, risks related to CPSI’s ability to complete the acquisition on the proposed terms and schedule (including risks relating to regulatory approvals for the transaction); whether CPSI or Healthland will be able to satisfy their respective closing conditions related to the acquisition; whether CPSI will obtain financing for the transaction on the expected timeline and terms; risks associated with business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not occur; unexpected costs, liabilities, charges or expenses resulting from the merger; risks related to future opportunities and plans for the combined company, including uncertainty of the expected financial performance and results of the combined company following completion of the proposed acquisition; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the impact of the issuance of CPSI’s common stock as consideration for the proposed transaction on CPSI’s current holders of common stock, including dilution of their ownership and voting interests; CPSI’s significantly increased level of indebtedness as a result of the proposed transaction, which could limit CPSI’s operating flexibility and opportunities; the inability to retain key personnel; and the possibility that if the combined company does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of CPSI’s common stock could decline. Numerous other risks, uncertainties and other factors may cause actual results to differ materially from those expressed in any forward-looking statements. Such factors include: overall business and economic conditions affecting the healthcare industry; government regulation of the healthcare and health insurance industries; government regulation of CPSI’s products and customers, including changes in healthcare policy affecting Medicare and Medicaid reimbursement rates and qualifying technological standards; potential effects of the federal healthcare reform legislation enacted in 2010, and implementing regulations, on the businesses of CPSI’s hospital customers; funding uncertainties associated with and potential expenditures required by the American Recovery and Reinvestment Act of 2009 in connection with the adoption of EHR; saturation of CPSI’s target market and hospital consolidations; changes in customer purchasing priorities, capital expenditures and demand for information technology systems; competition with companies that have greater financial, technical and marketing resources than CPSI has; failure to develop new technology and products in response to market demands; fluctuations in quarterly financial performance due to, among other factors, timing of customer installations; failure of CPSI’s products to function properly resulting in claims for medical losses; changes in accounting principles generally accepted in the United States; breaches of security and viruses in CPSI’s systems resulting in customer claims against CPSI and harm to CPSI’s reputation; potential intellectual property claims against CPSI; general economic conditions, including changes in financial and credit markets that may affect the availability and cost of credit to CPSI or CPSI’s customers; interruptions in CPSI’s power supply and/or telecommunications capabilities and other risk factors described from time to time in CPSI’s public releases and reports filed with the Securities and Exchange Commission, including but not limited to, CPSI’s most recent Annual Report on Form 10-K. We also caution investors that the forward-looking information described herein represents CPSI’s outlook only as of this date, and CPSI undertakes no obligation to update or revise any forward-looking statements to reflect events or development after the date of this press release.

 

Computer Programs and Systems, Inc.
Boyd Douglas, 251-639-8100
President and Chief Executive Officer

Wednesday, November 25th, 2015 Uncategorized Comments Off on (CPSI) to Acquire Healthland for $250 Million

(AEZS) Affirms Fundamental Strength of Business

QUEBEC CITY, Nov. 25, 2015  – Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”), affirms that its business and prospects remain fundamentally strong and highlights the following developments:

  • Zoptrex™ (zoptarelin doxorubicin) recently received DSMB recommendation to continue the ZoptEC Phase 3 clinical program to completion following review of the final interim efficacy and safety data
  • Zoptrex™ met Phase 2 Primary Endpoint in men with heavily pretreated castration- and Taxane-resistant prostate cancer
  • First patient enrolled in the confirmatory Phase 3 clinical trial of Macrilen™
  • Promotion of Saizen® and EstroGel® by the Company’s sales force continues to show promise
  • Dilution from Series B Share Purchase Warrants has been substantially eliminated

Commenting about the fundamentals of the Company’s business, Chairman, President and Chief Executive Officer David A Dodd stated, “Yesterday’s announcement regarding corporate developments, which was required by IIROC on behalf of the Toronto Stock Exchange, caused some to question the fundamentals of our business. I want to reiterate that we believe the fundamentals remain strong. We have two products in Phase 3. One of the products, Zoptrex™, is in the late stage of Phase 3. We instituted a confirmatory Phase 3 clinical trial of Macrilen™ after a panel of US and EU endocrinology experts advised us to continue to seek approval for the compound because of their confidence in its efficacy and because there currently is no FDA-approved diagnostic test for adult growth hormone deficiency. That Phase 3 study recently enrolled its first patient, keeping us on track to conclude it by the end of 2016.”

Mr. Dodd also commented on the Company’s business development efforts, saying “We continue discussions with others about adding to our portfolio of promoted products and about the commercial rights to and development of Zoptrex™ in markets outside the United States. Of course, our business is subject to the risks inherent in the development of biopharmaceuticals.  But we are successfully moving forward with activities intended to create long-term value for our shareholders. We are confident in our activities and believe we are achieving the necessary progress to build significant value for our shareholders, employees and the medical providers and patients who will benefit from our developing portfolio.”

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health.  For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995.  Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. The following statements in the press release are forward-looking statements:

  • The statement that the confirmatory Phase 3 clinical trial of Macrilen™ is on track for completion by the end of 2016
  • The statements regarding the success of the activities we are undertaking in an effort to create long-term value for our shareholders

Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward looking statements.  Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions.  Investors should consult the Company’s quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements.  We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

Wednesday, November 25th, 2015 Uncategorized Comments Off on (AEZS) Affirms Fundamental Strength of Business

(CBMG) to Present at the Piper Jaffray 27th Annual

SHANGHAI, China and CUPERTINO, Calif., Nov. 24, 2015  — Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced that management will present at the Piper Jaffray 27th Annual Healthcare Investor Conference to be held in New York City on December 1-2, 2015, and will be available for one-on-one meetings throughout the conference.

Investor Presentation: Friday, December 1, 11:30-11:50 EST
Location: The New York Palace Hotel, NY
Presenter: Yihong Yao, PhD, Chief Scientific Officer

To arrange one-on-one meetings with Company management, please contact vivian.chen@grayling.com. Following the conference, an archived presentation will be available on the Company website here: http://www.cellbiomedgroup.com/investor-relations/presentations/.

About Cellular Biomedicine Group

Cellular Biomedicine Group, Inc. develops proprietary cell therapies for the treatment of certain degenerative and cancerous diseases.  Our developmental stem cell and Immuno-Oncology projects are the result of research and development by scientists and doctors from China and the United States. Our GMP facilities in China, consisting of nine independent cell production lines, are designed, certified and managed according to U.S. standards.  To learn more about CBMG, please visit: www.cellbiomedgroup.com

Forward-Looking Statements

Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Grayling
+1 347 481-3711
vivian.chen@grayling.com
Tuesday, November 24th, 2015 Uncategorized Comments Off on (CBMG) to Present at the Piper Jaffray 27th Annual

(NVGN) Taps Leading CRO for Cantrixil Phase 1 Clinical

SYDNEY, Nov. 24, 2015  —

  • Novogen engages Novotech as CRO for upcoming Phase 1 clinical study
  • Cantrixil Phase 1 clinical trial to be conducted in patients with refractory/recurrent peritoneal malignancies with malignant ascites, including ovarian cancer

US-Australian drug discovery company, Novogen Limited (ASX:NRT: NASDAQ: NVGN), announced today that it has engaged Novotech as the Contract Research Organisation (CRO) to conduct its Phase 1 clinical study for the drug candidate, Cantrixil, which will commence in 2016.

This first-in-human study will investigate the safety and feasibility of Cantrixil administered via the intraperitoneal route for patients with refractory /recurrent peritoneal malignancies with malignant ascites.

According to Novogen’s Clinical and Regulatory Affairs Manager, Kimberley Lilischkis, PhD, the Cantrixil Phase 1 study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site.

“However, patients with other cancer types will  also be eligible to enrol in this first study since early preclinical data suggests the drug candidate may benefit patients with a range of cancer types,” Dr Lilischkis said.

“Patients with malignant ascites have been chosen because ethically this patient group stands to receive the most benefit and face the least risk from the insertion of a peritoneal port or catheter, which can be used for drug administration but also for the on-going drainage of malignant ascites.”

Dr Lilischkis said Novogen was continuing to progress Cantrixil through the necessary preclinical regulatory requirements and safety evaluations and was on track to complete the ‘in-life’ phase of the toxicity studies by the end of 2015. The Company expected to receive the final report in early 2016 once a comprehensive pathology review was completed.

Acting CEO, Iain Ross said the appointment of Novotech was a key milestone in progressing Novogen’s first oncology drug candidate, Cantrixil, to the clinic. “Novogen is confident that Novotech will add significant value to the clinical trial program bringing their standard of excellence to the development of this promising drug candidate,” Mr Ross said.

Novotech is a prominent Australian-based CRO with extensive background in oncology drug development and a broad range of clinical trial outsourcing services. Novotech has well-established working relationships with the Australian sites and KOLs working with Novogen on this study. This CRO has world-class electronic data and trial management systems that will support the data management, monitoring and safety reporting activities for this study. Novotech is the only Australian-based CRO that has a Quality Assurance system with ISO9001:2008 accreditation and has a superb track record in managing early phase oncology studies.

“We’re delighted to be working with Novogen on this important study. The development of Cantrixil has the potential to add an important new tool in the fight against cancer, and we are looking forward to leveraging our previous experience in all phases of oncology drug development to the management of this program,” CEO of Novotech, Alek Safarian, said.

About the Cantrixil drug candidate

The candidate Cantrixil drug product is cyclodextrin-based containing the active ingredient, TRXE-002-1. The Company anticipates that if approved the drug product would be used as an intra-cavity chemotherapy to be injected directly into the peritoneal cavity. The aim of intraperitoneal administration is to achieve high localized drug levels within the peritoneal cavity and attenuate the spread of resident tumor initiator cells. The target indication sought for Cantrixil is early-stage cancers of the abdominal cavity (eg. ovarian, uterine, colorectal and gastric carcinomas) with Cantrixil being used as an adjuvant first-line therapy. On completion of the requisite safety studies, Cantrixil will enter the clinic in late-stage patients with abdominal cancers including ovarian cancer. The active pharmaceutical ingredient, TRXE-002, has pan anti-cancer activity resulting in caspase-dependent apoptosis via c-Jun activation and pERK downregulation. The actual drug target remains unidentified.

About Novogen Limited

Novogen is a public, Australian-US drug development company whose shares trade on both The Australian Securities Exchange (NRT) and NASDAQ (NVGN). The Novogen Group includes US-based, CanTx Inc., a joint venture company with Yale University. Novogen has two drug technology platforms [the superbenzopyrans (SBPs) and anti-tropomyosins (ATMs)] yielding drug candidates that are first-in-class with potential application across a range of degenerative diseases. Given the encouraging data from in vitro and in vivo preclinical proof-of-concept studies in the field of oncology, the Company’s immediate focus is to undertake the respective toxicology programs. The target indication for Cantrixil is ovarian cancer, and Diffuse Intrinsic Pontine Glioma (DIPG) for Trilexium. While the initial target pediatric indication for Anisina has been identified as neuroblastoma, Novogen is yet to identify the adult indication and is intending to open an all-comers Phase 1 trial initially based on its preclinical studies. For more information, please visit www.novogen.com

Forward Looking Statement

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. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,” “may,” “target,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Cantrixil, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, Cantrixil, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Cantrixil, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Cantrixil, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

Tuesday, November 24th, 2015 Uncategorized Comments Off on (NVGN) Taps Leading CRO for Cantrixil Phase 1 Clinical

(AUPH) Phase 2b Study in Lupus to Continue as Planned

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH-TSX:AUP) (“Aurinia” or the “Company”) has announced today that the independent Data and Safety Monitoring Board (“DSMB”) for the Company’s Phase 2b lupus nephritis study, known as AURA-LV, has completed its third pre-planned safety review of patients enrolled in the study and recommended continuation of the trial without any modifications. The AURA-LV DSMB has been established according to the FDA Guidance for Clinical Trial Sponsors and is guided by its charter. Aurinia remains blinded to the actual safety and efficacy results.

The DSMB reviewed all the safety data from more than 200 patients that had been enrolled and randomized at the time the data was requested. This included adverse events, laboratory results and compliance with the study protocol.

“We are encouraged by the recommendations of the DSMB,” said Stephen W. Zaruby, President and CEO of Aurinia. “The safety profile of voclosporin has been well characterized in the clinic with over 2,000 patients having received voclosporin in other clinical trials to date, outside of lupus nephritis. It is important that having assessed the data emerging from this study, the DSMB’s view on the safety profile remains unchanged.”

Aurinia anticipates completion of patient enrollment in the AURA-LV study around the end of 2015. Additionally, the Company continues to recruit patients into its AURION study and expects to review data early in 2016.

About Aurinia

Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. It is currently enrolling patients in its Phase 2b clinical trial to evaluate the efficacy of its drug, voclosporin, as a treatment for LN. LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition.

Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with extensive clinical data in over 2,000 patients in other indications. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983). This modification results in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency vs. cyclosporine, an altered metabolic profile, and potential for flat dosing.

About AURA-LV:

The AURA–LV study or “Aurinia Urine Protein Reduction in Active Lupus Nephritis Study” is an adequate and well controlled clinical trial that is being conducted in 20 countries worldwide and is expected to enroll approximately 258 patients which will compare the efficacy of voclosporin against placebo in achieving remission in patients with active lupus nephritis. The AURA-LV study is designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure and to fulfill specific regulatory requests. It will compare two dosage groups of voclosporin (23.7mg and 39.5mg) administered with mycophenolate mofetil (MMF) vs. MMF alone. All patients will also receive oral corticosteroids as background therapy. There will be a primary analysis to determine complete remission at week 24 and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE.

About AURION:

The AURION study or “Aurinia Early Urinary Protein Reduction Predicts Response Study” is an open label, exploratory study being conducted in multiple sites in Malaysia to assess the short term predictors of response using voclosporin in combination with mycophenolate mofetil in patients with active lupus nephritis. This study will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks.

We seek Safe Harbor.

 

Aurinia Pharmaceuticals Inc.
Mr. Michael Martin, 250-708-4272
Chief Operating Officer
Fax: 250-744-2498
mmartin@auriniapharma.com
or
Mr. Stephen W. Zaruby, 250-708-4293
Chief Executive Officer
Fax: 250-744-2498
szaruby@auriniapharma.com
or
Renmark Financial Communications Inc.
Barry Mire
bmire@renmarkfinancial.com
or
Laura Welsh
lwelsh@renmarkfinancial.com
Tel: 416-644-2020 or 514-939-3989

Tuesday, November 24th, 2015 Uncategorized Comments Off on (AUPH) Phase 2b Study in Lupus to Continue as Planned

(CDZI) Announces Agreements to Extend Maturities of Existing Debt

Agreements Extend Maturity of Existing Convertible Debt to March 2020 and Grants Right to Extend First Mortgage to June 2017

LOS ANGELES, Nov. 24, 2015  — Cadiz Inc. (NASDAQ:CDZI) (“Cadiz”, “the Company”) is pleased to announce today that it has entered into an agreement with its senior lenders, including MSD Credit Opportunity Master Fund, L.P., (“Senior Lenders”), which grants the Company the right to extend the maturity date of the $40 million first tranche of its mortgage debt (“First Mortgage”) from March 2016 to June 2017.  Additionally, the Company has also entered into agreements with a majority of its convertible note holders to exchange a minimum of $40 million in outstanding convertible notes presently due in March 2018 for substantially similar convertible notes due in March 2020 (“Convertible Notes” or “Notes”).  These agreements allow the Company enhanced flexibility to progress implementation of the Cadiz Valley Water Conservation, Recovery and Storage Project (the “Water Project”) at its primary landholding in the eastern Mojave Desert.

Under the agreement with the Senior Lenders, if the Company elects to extend the First Mortgage, it must make a $9 million payment to the lenders prior to March 5, 2016, which will also reduce the Company’s outstanding mortgage balance.  The Company may fund this $9 million payment with the proceeds of a possible future equity offering or, alternatively, the Company may replace or extinguish the mortgage debt prior to the March 2016 due date in connection with a potential expansion of the Cadiz Valley agricultural operations. Negotiations with third parties related to such an agricultural expansion are ongoing.

Further, in addition to the agreement with the Senior Lenders, the Company also entered into agreements with a majority of its Convertible Note holders, pursuant to which those holders will exchange their Convertible Notes for new convertible notes with substantially similar terms but with a maturity date in March 2020.  In exchange for this maturity extension, the conversion rate on the new convertible notes will be reduced from $8.05 to $6.75 per share.  Interest will continue to accrue at 7% with no payment due until maturity.

The implementation of the Cadiz Water Project, a public-private partnership that will make available a new water supply for 400,000 people in California, continues to be the Company’s primary objective.  The Water Project has been reviewed and approved under California’s stringent environmental laws and upheld against six separate challenges in California Superior Court.  In October 2015, the US Bureau of Land Management’s (“BLM”) California office issued guidance that may require the Water Project to seek a new permit to construct its water conveyance pipeline within an active railroad right-of-way – a route that will avoid environmental impacts and provide numerous benefits to the host railroad.

The use of an active railroad right-of-way continues to be the safest, most sustainable and preferred pipeline route for the Water Project and, with these agreements successfully completed, the Company will continue to seek the reconsideration, overturning or invalidation of this decision over the next few months.  If these efforts do not result in the issuance of new guidance by the BLM, then the Company will aggressively pursue all administrative and legal remedies available to firmly establish the railroad’s right to grant access to the Company for a water conveyance pipeline that will also further numerous railroad purposes.

The Company paid its Senior Lenders an amendment fee of $2.25 million in additional debt for the right to extend the maturity date of the First Mortgage to June 2017, which is concurrent with the existing due date of the remaining $12 million second tranche of its mortgage debt.  Should the Company opt to extend the First Mortgage maturity date, then it will incur an additional fee of $2.25 million payable in either additional term debt or shares of common stock at the Lenders’ option.   Interest will continue to accrue on the First Mortgage at 8%.

About Cadiz
Founded in 1983, Cadiz Inc. is a publicly-held renewable resources company that owns 70 square miles of property with significant water resources in Southern California. The Company operates an organic agricultural development in the Cadiz Valley of eastern San Bernardino County, California and is partnering with public water agencies to implement the Cadiz Water Project, which over two phases will create a new water supply for approximately 100,000 Southern California families and make available up to 1 million acre-feet of new groundwater storage capacity.  The Company abides by a wide-ranging “Green Compact” focused on environmental conservation and sustainable practices to manage its land, water and agricultural resources. For more information about Cadiz, visit http://www.cadizinc.com/.

FORWARD LOOKING STATEMENT: This release contains forward-looking statements that are subject to significant risks and uncertainties, including statements related to the future operating and financial performance of the Company and the financing activities of the Company.  Although the Company believes that the expectations reflected in our forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct.  Factors that could cause actual results or events to differ materially from those reflected in the Company’s forward-looking statements include the Company’s ability to maximize value for Cadiz land and water resources, the Company’s ability to obtain new financing as needed, the receipt of additional permits for the water project and other factors and considerations detailed in the Company’s Securities and Exchange Commission filings.

CONTACT:
Courtney Degener
213.271.1603
cdegener@cadizinc.com
Tuesday, November 24th, 2015 Uncategorized Comments Off on (CDZI) Announces Agreements to Extend Maturities of Existing Debt

(ADRO) Receives EU Orphan Drug Designation for CRS-207 in Mesothelioma

BERKELEY, Calif., Nov. 23, 2015  — Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to CRS-207 for the treatment of malignant pleural mesothelioma (MPM).

“The receipt of Orphan Drug Designation in the European Union (EU) for CRS-207 for the treatment of MPM marks a significant regulatory milestone for Aduro, as we expand our operations in Europe and advance our therapies closer to the commercial marketplace,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We look forward to working with the EMA to expeditiously advance CRS-207 through development with the goal of bringing this potential therapy to patients throughout Europe suffering from mesothelioma.”

To receive Orphan Drug Designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan Drug Designation provides incentives designed to facilitate development, including protocol assistance and scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.

Aduro is conducting a Phase 1b study of CRS-207 in combination with standard of care chemotherapy in patients with unresectable malignant pleural mesothelioma. The company plans to advance directly to a Phase 3 clinical trial with CRS-207 in combination with standard-of-care chemotherapy in patients with unresectable MPM in the first half of 2016. In addition to the newly granted Orphan Drug Designation from the EMA, CRS-207 received Orphan Status for the treatment of mesothelioma from the U.S. Food and Drug Administration in March 2015.

About CRS-207

CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induces a potent innate and T cell-mediated adaptive immune response. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

About Aduro

Aduro Biotech, Inc. is a clinical-stage immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro’s cyclic dinucleotide (CDN) platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for CRS-207, the potential benefits of Orphan Drug Designation, and the potential for eventual regulatory approval, commercialization and launch of our product candidates. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading “Risk Factors” contained in the most recent Form 10-Q which is on file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

Contact:
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264

Media Contact:
Angela Bitting
925 202 6211
press@aduro.com
Monday, November 23rd, 2015 Uncategorized Comments Off on (ADRO) Receives EU Orphan Drug Designation for CRS-207 in Mesothelioma

(BNSO) Reports Sale of a Residential Unit

HONG KONG, Nov. 23, 2015  — Bonso Electronics International, Inc. (NASDAQ:BNSO) today announced that it has entered into an agreement to sell a residential unit owned by the Company in Shenzhen to a third party.

In October 2015, the Company entered into an agreement with a third party to sell a residential unit located in Shenzhen, People’s Republic of China, for approximately $832,000.  The property was acquired by the company in year 2000, and was leased out to tenants for residential use.  The resulting gain before tax is expected to be approximately $744,000 (or $0.14 per share).

The final sale is subject to the buyer obtaining financing from a bank, and the final payment and transfer of the property are expected to be completed by January 31, 2016.  The gain from this transaction is expected to be reflected in the financial results of the fiscal year ended March 31, 2016.

About Bonso Electronics

Bonso Electronics designs, develops, manufactures, assembles and markets a comprehensive line of electronic scales, weighing instruments, health care products and pet electronics products. Bonso products are manufactured in the People’s Republic of China for customers primarily located in North America and Europe. Company services include product design and prototyping, production tooling, procurement of components, total quality management, and just-in-time delivery. Bonso also independently designs and develops electronic products for private label markets. Bonso is also beginning the process to redevelop the land upon which its Shenzhen factory was previously located. For further information, visit the company’s web site at http://www.bonso.com.

This news release includes forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward looking statements may be identified by such words or phrases as “should,” “intends,” “is subject to,” “expects,” “will,” “continue,” “anticipate,” “estimated,” “projected,” “may,” “I or we believe,” “future prospects,”  “our strategy” or similar expressions. Forward-looking statements made in this press release, which relate to the positive impact resulting from the sale of certain land use rights involve known and unknown risks and uncertainties that may cause the actual results to differ materially from those expected and stated in this announcement. We undertake no obligation to update “forward-looking” statements.

For more information please contact:

Albert So
Chief Financial Officer and Secretary
Tel: 852 2605 5822
Fax: 852 2691 1724
Monday, November 23rd, 2015 Uncategorized Comments Off on (BNSO) Reports Sale of a Residential Unit

(SMMT) Novel Antibiotic Ridinilazole Achieves Statistical Superiority Over Vancomycin

  • Sustained Clinical Response Rates of 66.7% with Ridinilazole vs. 42.4% with Vancomycin
  • Ridinilazole to Advance into Phase 3 Clinical Development
  • Conference Call Scheduled for 1:00pm GMT / 8:00am EST

OXFORD, United Kingdom, Nov. 23, 2015  — Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces the success of CoDIFy, a Phase 2 proof of concept clinical trial that evaluated the novel, oral antibiotic, ridinilazole (SMT19969) against the current standard of care, vancomycin, for the treatment of CDI.

The Phase 2 trial exceeded its primary endpoint with ridinilazole achieving statistical superiority over vancomycin in sustained clinical response (‘SCR’) using the pre-specified 90% confidence interval, with SCR rates of 66.7% for ridinilazole compared to 42.4% for vancomycin. SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of treatment. The statistical superiority in SCR with ridinilazole in this trial was driven by a large numerical reduction in recurrent disease compared with vancomycin.

“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic with the potential to both treat the initial infection and substantially reduce recurrent disease,” commented Glyn Edwards, Chief Executive Officer of Summit. “There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest. Based on the positive top-line results from the CoDIFy trial, we will now evaluate the optimal path to advance ridinilazole into Phase 3 clinical trials. In addition, Summit sincerely thanks the Wellcome Trust for their support in the development of ridinilazole that has helped to achieve this clinical proof of concept milestone.”

“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Professor Mark Wilcox, Consultant Microbiologist & Head of Microbiology at the Leeds Teaching Hospitals NHS Trust, Professor of Medical Microbiology at the University of Leeds, and Public Health England’s Lead on C. difficile in England. “These clinical data suggest that ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge. I, and many other healthcare practitioners, look forward to the continued clinical development of this compound.”

Design and Top-Line Results from CoDIFy Clinical Trial

CoDIFy was a double blind, randomized, active controlled, multicenter, Phase 2 clinical trial that evaluated the efficacy of ridinilazole against vancomycin in a total of 100 patients. Half of the patients received ridinilazole for ten days (200 mg, twice a day), and the remaining half received vancomycin for ten days (125 mg, four times a day). The trial was conducted in the United States and Canada. The primary endpoint was non-inferiority of ridinilazole compared to vancomycin in SCR. The trial met its primary endpoint with ridinilazole achieving an SCR rate of 66.7% compared to 42.4% for vancomycin (non-inferiority margin of 15%, p=0.0004). This also represents statistical superiority of ridinilazole over vancomycin using the pre-specified 90% confidence interval. The primary analysis was conducted on the modified intent-to-treat (‘mITT’) population that comprised subjects with CDI confirmed by the presence of free toxin. Ridinilazole was generally well tolerated and the overall adverse event profiles of ridinilazole and vancomycin were comparable. More detailed findings from the trial will be reported at relevant conferences and in peer-reviewed journals.

The development of ridinilazole was financially supported through to completion of this Phase 2 clinical trial by Seeding Drug Discovery and Translational Awards from the Wellcome Trust. Ridinilazole has received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration.

Conference Call Details

Summit will host a conference call and webcast to discuss the results of the Phase 2 clinical trial today, 23 November 2015, at 1:00pm GMT / 8:00am EST. To participate in the conference call please dial +44 (0)20 3427 1910 (UK and international participants) or +1 646 254 3364 (US local number) and use the conference confirmation code 8280846. Investors may also access a live audio webcast of the call via the investors section of Summit’s website www.summitplc.com. A replay of the webcast will be available shortly after the conference call finishes.

About C. difficile Infection

C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with between 450,000 and 700,000 cases of CDI in the US annually. It is caused by an infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, severe diarrhoea and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the US.

About Ridinilazole (SMT19969)

Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy.

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@Summitplc).

For more information, please contact:

Summit
Glyn Edwards / Richard Pye (UK office) Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office) +1 617 225 4455
Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson Tel: +44 (0)20 77148 7900
N+1 Singer 
(Broker)
Aubrey Powell / Jen Boorer Tel: +44 (0)20 7496 3000
Peckwater PR
(Financial public relations, UK) Tel: +44 (0)7879 458 364
Tarquin Edwards tarquin.edwards@peckwaterpr.co.uk
MacDougall Biomedical Communications
(US media contact) Tel: +1 781 235 3060
Chris Erdman cerdman@macbiocom.com

Forward-looking Statements

Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.

Monday, November 23rd, 2015 Uncategorized Comments Off on (SMMT) Novel Antibiotic Ridinilazole Achieves Statistical Superiority Over Vancomycin

(MOC) U. S. Postal Services Reaffirmation to Award $250M Contract

HERNDON, Va., Nov. 23, 2015  — Command Security Corporation (NYSE MKT:MOC) announced today the notification by the U. S. Postal Service (the “USPS”) of its decision to confirm the award of the USPS contract under Solicitation No. 2B-14-A-0078 (the “USPS Contract”) valued at approximately $250 million over a ten year term of service.  The USPS and Command Security Corporation (the “Company”) will begin to develop the transition process for the Company to formally assume the responsibilities under the USPS Contract.

The Company initially received notification on December 31, 2014 of the award of the USPS Contract, which provides for security services at 50 USPS locations in 18 states, Puerto Rico and the District of Columbia, valued at approximately $20 million per year, as well as the operation of the two USPS National Law Enforcement Communication Centers (NLECC) at Dulles International Airport, Virginia and in Ft. Worth, Texas, valued at approximately $5 million per year. The award includes a four year base contract and three two-year options.

On January 29, 2015, the Company announced that the USPS had issued a stay of the transition of the USPS Contract awarded to the Company pending the resolution of a dispute over the award of such contract. On January 27, 2015, the Company was notified by the USPS that ABM Security Services (“ABM”) had lodged a protest with the USPS seeking to overturn the contract that was awarded to the Company.

In a decision dated June 15, 2015, the USPS Supplier Disagreement Resolution Officer found that the USPS Contract awarded to the Company represented the best value for the USPS. Accordingly, the Supplier Disagreement Resolution Officer denied the disagreement filed by ABM, and lifted the stay on the performance of the USPS Contract with the Company.

On June 17, 2015, the Company was notified by the United States Department of Justice that ABM had expressed intent to file a protest with the Court of Federal Claims challenging the award of the USPS Contract to the Company, and seeking an injunction to stop the transition of the USPS Contract to the Company. On June 23, 2015, ABM filed a protest with the Court of Federal Claims challenging the award of the USPS Contract to the Company, and the USPS expressed an intent to stay the transition of the USPS Contract awarded the Company pending resolution of the Court of Federal Claims protest filed by ABM. The Court of Federal Claims dismissed the protest filed by ABM on July 7, 2015 to allow for the USPS to take corrective action.

“We have waited a long time for this affirmation and hope there will be no further delays or roadblocks imposed to disrupt this important work.  Again, we are extremely gratified and energized to learn of the U. S. Postal Service decision which recognizes the best value proposition our team will provide,” said Craig P. Coy, Chief Executive Officer.

About Command Security Corporation

Command Security Corporation and its Aviation Safeguards subsidiary provides uniformed security officers, aviation security services and support security services to commercial, financial, industrial, aviation and governmental customers throughout the United States. We safeguard against theft, fraud, fire, intrusion, vandalism and the many other threats that our customers are facing today.  By partnering with each customer, we design programs customized to meet their specific security needs and address their particular concerns. We bring years of expertise, including sophisticated systems for hiring, training, supervision and oversight, backed by cutting-edge technology, to every situation that our customers face involving security. Our mission is to enable our customers to operate their businesses without disruption or loss, and to create safe environments for their employees. For more information concerning our company, please refer to our website at www.commandsecurity.com.

Forward-Looking Statements

This announcement by Command Security Corporation (referred to herein as the “Company”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and within the meaning of the Private Securities Litigation Reform Act of 1995 about the Company that are based on management’s assumptions, expectations and projections about the Company.  Such forward-looking statements by their nature involve a degree of risk and uncertainty.  The Company cautions that actual results of the Company could differ materially from those projected in the forward-looking statements as a result of various factors, including but not limited to the factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2015, filed with the Securities and Exchange Commission, and such other risks disclosed from time to time in the Company’s periodic and other reports filed with the Securities and Exchange Commission.  You should consider the areas of risk described above in connection with any forward-looking statements that may be made by the Company.  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.  You are advised, however, to consult any additional disclosures the Company makes in proxy statements, quarterly reports on Form 10-Q, annual reports on Form 10-K and current reports on Form 8-K filed with the Securities and Exchange Commission, which are publicly available at the Securities and Exchange Commission’s website at www.sec.gov/edgar.shtml.

COMPANY CONTACT:
N. Paul Brost
Command Security Corporation
703-464-4735
Monday, November 23rd, 2015 Uncategorized Comments Off on (MOC) U. S. Postal Services Reaffirmation to Award $250M Contract

(CNCK) Nutritionist Lends Expertise in ValuePenguin Publication

LOS ANGELES, CA–(Nov 23, 2015) – ContentChecked Holdings, Inc. (OTCQB: CNCK) prides itself on a roster of employees well-familiar and highly experienced in their respective roles to the company. Among the company’s staff of degreed nutritionists is Tara Zamani, who offered a bit of industry insight in a recent ValuePenguin article on employment as a dietician/nutritionist.

“Los Angeles is full of food gurus, raw foodies, vegans, vegetarians and nutrition-savvy individuals. I love working in L.A. as a nutritionist because many of my clients already have a good understanding of nutrition and are very open-minded when it comes to holistic health. L.A. is a hub for holistic nutrition, alternative medicine and many people here prefer to use natural remedies for healing, rather than traditional methods,” Zamani says in the article. “Nutritionists are in demand, which makes it a great city for a new nutritionist to start a career. L.A. also offers many healthy restaurants, farmers’ markets, co-ops, health food stores and wellness centers, and guiding clients to choose healthier eating places is easy.”

The article (http://www.valuepenguin.com/getting-job-as-dietitian) links back to ContentChecked’s website, potentially exposing the company to ValuePenguin’s audience of approximately 350,000 monthly viewers.

Complementary to ContentChecked’s efforts to raise awareness of its family of health apps, the company is pleased to contribute its expertise where needed and help Americans better manage their food allergies, migraines and overall health.

“Each ContentChecked employee is highly valued for their strong contributions and hard work that firmly roots our company in the marketplace,” says Kris Finstad, CEO of ContentChecked, the developer of MigraineChecked, SugarChecked and ContentChecked, a family of health apps for people with dietary restrictions and/or food preferences. “It’s always a pleasure to see the expertise of one of our team members being sought after and published in a well-recognized and read publication like ValuePenguin.”

About ContentChecked Holdings, Inc.
ContentChecked has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications to the market. ContentChecked and MigraineChecked applications are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for most U.S. food products. SugarChecked gives consumers the ability to scan the barcodes of grocery store products and determine what kind of sugars are contained within. This enables the applications to meet the needs of millions of people in the United States. As a result, ContentChecked has created a pivotal way for food producers to, at the point of purchase, be able to showcase their products to consumers who are actively seeking them.

Designed for use by those who suffer from food allergies, dietary intolerances, migraines and chronic headaches, ContentChecked and MigraineChecked applications have reached wide adoption levels. In the U.S. alone there are 15 million people who suffer from food allergies and 38 million from migraine and chronic headaches. The food allergy market currently has an estimated value of $6 billion USD. Both applications give the ability to scan a product’s bar code and determine if it is safe for consumption, and if not the apps will recommend a suitable alternative per the user’s specific dietary profile.

SugarChecked identifies four main types of sugars that consumers can avoid, including added sugars, artificial sweeteners, natural low-calorie sweeteners and sugar alcohols. This application is an easy shopping tool for consumers to decipher often-misleading food labels, and receive recommendations for healthier alternative products as they shop in real time.

ContentChecked has created a robust database of allergens, migraine triggers, and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database that is updated regularly. ContentChecked’s applications are highly scalable and can expand into new geographic areas and product categories with limited modifications and investment.

For more information on ContentChecked, please visit its social media channels via Facebook (http://www.facebook.com/contentchecked) Instagram (http://www.instagram.com/contentchecked), or YouTube (http://www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ). You may also visit the social media channels of MigraineChecked on Facebook (http://www.facebook.com/migrainechecked) or Instagram (http://www.instagram.com/migrainechecked/).

Forward-Looking Statements:
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of the Company’s mobile applications, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including, the Company’s Annual Report on Form 10-K filed with the SEC on July 13, 2015. The Company does not undertake to update these forward-looking statements.

Contact:
Investor Relations
Mike Bowdoin
Bowdoin Group
407-590-6995
Mike@BowdoinGrp.com

Monday, November 23rd, 2015 Uncategorized Comments Off on (CNCK) Nutritionist Lends Expertise in ValuePenguin Publication

(MOXC) MissionIR Exclusive Audio Interview With Moxian Creative & Marketing VP Edmund Ooi

ATLANTA, GA–(Nov 23, 2015) – MissionIR today announces the online availability of its interview with Mr. Edmund Ooi, Vice President and Director of Creative & Marketing for Moxian, Inc. (OTCQB: MOXC). The full audio interview is available at http://MOXC.MissionIR.com/interview.html.

Moxian is a social multi-media company building an application platform and merchant rewards system that enable small- and medium-sized businesses to better engage their customers and enhancing their marketing initiatives.

After providing a brief overview of the company, Mr. Ooi describes his own experience creating national marketing projects in Singapore, China, the Middle East and Los Angeles, which he currently applies in helping Moxian create product improvements and applications to a larger audience.

He then offers considerable information on other key members of the company’s management team and how their previous endeavors in international markets contribute to Moxian’s growth. Together, this roster of executives has positioned the company to achieve several milestones in 2015, including rapid market acceptance and strategic personnel additions.

“I think we have seen a great leap in our skillset and our ability to [offer] much stronger and more robust software,” Mr. Ooi says.

Moving forward, Mr. Ooi explains Moxian’s near and longer-term outlook, which includes expanding its merchant base; increasing advertising, transaction and sponsorships revenues; uplisting the company’s common stock; and increasing shareholder value.

Mr. Ooi concludes the interview with a recap of recent company news, including an $8.9 million private placement to facilitate Moxian’s continued corporate growth.

About Moxian, Inc.
Moxian, Inc. engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. The company’s products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. Moxian designs its products and services to allow merchant clients to run advertising campaigns and promotions targeting their customers. Moxian’s platform is also designed and built to entice users to return frequently and to encourage new consumer users to subscribe its website.

For additional information, please visit the Company’s corporate website: www.Moxian.com/indexen.html

This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.

Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com

Monday, November 23rd, 2015 Uncategorized Comments Off on (MOXC) MissionIR Exclusive Audio Interview With Moxian Creative & Marketing VP Edmund Ooi

(AFOP) Announces Increase to the Size of Stock Repurchase Program

SUNNYVALE, Calif., Nov. 20, 2015  — Alliance Fiber Optic Products, Inc. (Nasdaq:AFOP) today announced that its board of directors has approved an increase to the size of the current stock repurchase program, which was announced previously on August 24, 2015 with the amount of twenty five million dollars. The revised stock repurchase program will continue purchasing up to thirty five million dollars of its outstanding shares of Common Stock. The duration of the repurchase program is open-ended.

Under the program, AFOP could purchase shares of Common Stock from time to time through open market and privately negotiated transactions at prices depending on prevailing market conditions and other factors. The program does not obligate AFOP to repurchase any particular amount of common stock during any period and the program may be modified or suspended at any time at the Company’s discretion. The repurchase will be funded by cash on hand.

About AFOP

Founded in 1995, Alliance Fiber Optic Products, Inc. designs, manufactures and markets a broad range of high performance fiber optic components and integrated modules. AFOP’s products are used by leading and emerging communications equipment manufacturers to deliver optical networking systems to the long-haul, enterprise, metropolitan and last mile access segments of the communications network. AFOP offers a broad product line of passive optical components including interconnect systems, couplers and splitters, thin film CWDM and DWDM components and modules, optical attenuators, and micro-optics devices. AFOP is headquartered in Sunnyvale, California, with manufacturing and product development capabilities in the United States, Taiwan and China. AFOP’s website is located at http://www.afop.com.

CONTACT: Keting Lin, IR Associate
         Alliance Fiber Optic Products, Inc.
         408-736-6900 x188
         Email: klin@afop.com
Friday, November 20th, 2015 Uncategorized Comments Off on (AFOP) Announces Increase to the Size of Stock Repurchase Program

(HABT) Postpones Proposed Follow-On Offering of Common Stock

IRVINE, Calif., Nov. 20, 2015  — The Habit Restaurants, Inc. (Nasdaq:HABT) (“The Habit” or the “Company”) today announced that, in light of current capital market conditions, its previously announced secondary offering of shares of common stock to be sold by certain of the Company’s stockholders has been postponed. The Company’s registration statement on Form S-1, as filed with the Securities and Exchange Commission (“SEC”) and pursuant to which the Company would receive no proceeds, has not been withdrawn and the Company and certain of the Company’s stockholders expect to continue to evaluate the potential for and timing of such secondary offering by certain of the Company’s stockholders.

Piper Jaffray & Co., Robert W. Baird & Co. Incorporated and Wells Fargo Securities, LLC are acting as lead book-runners for the offering. Raymond James & Associates, Inc. is also acting as a book-runner for the offering and Stifel and Stephens Inc. are acting as co-managers for the offering.

A registration statement relating to this offering was filed with the SEC, but has not yet become effective. The securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor may there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

About The Habit Restaurants, Inc.

The Habit Burger Grill is a fast casual restaurant concept that specializes in preparing fresh, made-to-order char-grilled burgers and sandwiches featuring USDA choice tri-tip steak, grilled chicken and sushi-grade albacore tuna cooked over an open flame. The first Habit opened in Santa Barbara, California in 1969. The Habit has since grown to over 125 restaurants in 12 markets throughout California, Arizona, Utah, New Jersey, Florida and Nevada.

CONTACT: Investors:
         (949) 943-8692
         HabitIR@habitburger.com

         Media:
         (949) 943-8691
         Media@habitburger.com
Friday, November 20th, 2015 Uncategorized Comments Off on (HABT) Postpones Proposed Follow-On Offering of Common Stock

(MRNS) Ganaxolone to be Featured at American Epilepsy Society Annual Meeting

Scientific Exhibit to Showcase Posters on Ganaxolone on Sunday, December 6th

RADNOR, Pa., Nov. 19, 2015  — Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced today that two abstracts featuring Marinus’s CNS-selective GABAA modulator, ganaxolone have been selected for poster presentation at the 69th Annual Meeting of the American Epilepsy Society, which will be held December 4-8, 2015, at the Pennsylvania Convention Center in Philadelphia, PA.

The posters, which will be presented on Sunday, December 6th, in Hall A of the Convention Center, include:

Title: Additional responder analysis on a phase 2 study of ganaxolone in patients with partial onset seizures
Poster Session #: 2.260
Presenting Author: Albena Patroneva, M.D.

Title: Clinical development of an intravenous formulation of ganaxolone for acute care patients supported by non-clinical toxicity studies conducted in rats and rabbits
Poster Session #: 2.238
Presenting Author: Julia Tsai, Ph.D.

Also on Sunday, December 6th, from 2:00 – 5:00 pm in Room 201A, Marinus will be hosting a scientific exhibit, featuring several scientific posters on ganaxolone, including new preclinical data for the recently developed intravenous (IV) formulation.

About Marinus Pharmaceuticals, Inc.

Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders.  Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.  Ganaxolone IV is planned to enter clinical trials in 2016 and is being developed to treat status epilepticus. Ganaxolone IV is complemented by its oral dose forms, providing the potential for IV-to-oral continuation therapy for patients transitioning from acute care to outpatient settings.  Ganaxolone capsule is being evaluated in a Phase 3 multi-national clinical trial as adjunctive treatment of focal onset seizures in adults.  Ganaxolone capsule and liquid are being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders – PCDH19 epilepsy and Fragile X Syndrome. For more information visit www.marinuspharma.com.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.  Examples of forward looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical studies, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters, including the development of formulations of ganaxolone, that could affect the availability or commercial potential of our drug candidates.  Marinus undertakes no obligation to update or revise any forward-looking statements.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.

CONTACTS:

Company:        
Lisa M. Caperelli
Senior Director, Investor Relations & Corporate Communications
Marinus Pharmaceuticals, Inc.
484-801-4674
lcaperelli@marinuspharma.com

Media Contact:
Tiberend Strategic Advisors, Inc.
Amy S. Wheeler
646-362-5750
awheeler@tiberend.com
Friday, November 20th, 2015 Uncategorized Comments Off on (MRNS) Ganaxolone to be Featured at American Epilepsy Society Annual Meeting

(FRAN) Resignation of CFO, Appointment of Interim CFO

francesca’s® Announces Preliminary Fiscal Third Quarter Results
Expects Net Sales of Approximately $103.4 million, Comparable Sales Increase of 4%,
and Diluted Earnings Per Share of $0.15 to $0.16

HOUSTON, Nov. 20, 2015  — Francesca’s Holdings Corporation (the “Company”) (Nasdaq:FRAN) today announced that its Chief Financial Officer, Mark Vendetti, has resigned from the Company effective December 4th, 2015 to accept a CFO position at another publicly traded company. Cindy Thomassee, francesca’s® current VP of Accounting, has been appointed to the role of Interim CFO and will report directly to CEO Michael W. Barnes while the Company conducts a search for a CFO.

Michael W. Barnes, Chairman, President, and CEO stated, “I would like to thank Mark for all of his efforts as our Chief Financial Officer over the last two and a half years. I am grateful for Mark’s time at francesca’s® and I wish him continued success in his new role. We appreciate Cindy stepping into the role of Interim CFO as we conduct a search for a permanent replacement.”

In addition, francesca’s® announced preliminary sales results and updated earnings per share guidance for the third quarter ending October 31, 2015. Net sales increased 19% to $103.4 million as compared to the third quarter last year with comparable sales up 4% for the period. The Company now expects diluted earnings per share to be in the range of $0.15 to $0.16 per diluted share compared to the Company’s previous guidance of $0.12 to $0.15 per diluted share. francesca’s® will report its third quarter results and provide its outlook for the fourth quarter on December 9, 2015, at 8:30 a.m. ET.

Michael W. Barnes, Chairman, President, and CEO stated, “We are pleased with our better than expected sales and comps in the third quarter, driven by a terrific product assortment across categories. During the quarter, we saw strong and broad consumer response to our assortments which is driving improved conversion and higher units per transaction; leading to increased average transaction values and the overall comparable sales increase. I look forward to discussing the details of our third quarter results, as well as fourth quarter and full fiscal year 2015 guidance during our third quarter conference call next month.”

Forward-Looking Statements

Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements reflect our current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected. These risks and uncertainties include, but are not limited to, the following: the risk that we cannot anticipate, identify and respond quickly to changing fashion trends and customer preferences; our ability to attract a sufficient number of customers to our boutiques or sell sufficient quantities of our merchandise through our direct-to-consumer business; our ability to successfully open and operate new boutiques each year; our ability to efficiently source and distribute additional merchandise quantities necessary to support our growth; and our ability to attract and integrate a new Chief Financial Officer. For additional information regarding these and other risks and uncertainties that could cause actual results to differ materially from those contained in our forward-looking statements, please refer to “Risk Factors” in our Annual Report on Form 10-K for the year ended January 31, 2015 filed with the Securities and Exchange Commission on March 27, 2015 and any risk factors contained in subsequent quarterly and annual reports we file with the SEC. We undertake no obligation to publicly update or revise any forward-looking statement.

Preliminary Results

The Company’s announced preliminary results for its fiscal third quarter ended October 31, 2015 are preliminary and may change. The Company and its auditors have not completed their normal quarterly closing and review procedures for the quarter ended October 31, 2015, and there can be no assurance that final results for the quarter will not differ from the preliminary results, including as a result of quarter-end closing procedures or review adjustments. In addition, these preliminary results should not be viewed as a substitute for full interim financial statements prepared in accordance with GAAP that have been reviewed by the Company’s auditors.

About Francesca’s Holdings Corporation

francesca’s® is a growing specialty retailer with retail locations designed and merchandised to feel like unique, upscale boutiques providing customers a fun and differentiated shopping experience. The merchandise assortment is a diverse and balanced mix of apparel, jewelry, accessories and gifts. Today francesca’s® operates 620 boutiques in 47 states and the District of Columbia and also serves its customers through francescas.com. For additional information on francesca’s®, please visit www.francescas.com.

CONTACT: ICR, Inc.
         Jean Fontana
         646-277-1214

         Company
         Kate Venturina
         832-494-2233
         Kate.Venturina@francescas.com
         IR@francescas.com
Friday, November 20th, 2015 Uncategorized Comments Off on (FRAN) Resignation of CFO, Appointment of Interim CFO

(CLDX) Long-term Survival Benefit Demonstrated in Phase 2 ReACT Study of RINTEGA(R)

— At 2 years, 25% RINTEGA survival rate versus 0% for control —
— Hazard ratio of 0.53 (p=0.0137) indicates a significant overall survival advantage for recurrent GBM patients —
— Clinical benefit continues to be observed across multiple endpoints, including PFS, OS, ORR and steroid requirement with all OS subgroup analyses favoring RINTEGA treatment —

HAMPTON, N.J., Nov. 20, 2015  — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented mature survival data from the Company’s randomized, double-blind Phase 2 study of RINTEGA® (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma (GBM) at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO). The data were presented in a podium presentation by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School; and President of the Society for Neuro-Oncology, as well as the lead investigator of the ReACT study. RINTEGA is an investigational EGFRvIII specific therapeutic vaccine and was granted Breakthrough Therapy Designation in February 2014. Patients with recurrent glioblastoma that express the EGFRvIII mutation typically have a worse prognosis than the overall glioblastoma population, including poor long-term survival (median time from recurrence to death for EGFRvIII-positive patients is 8.7 months1). As previously reported, the primary endpoint of the study, progression-free survival at six months (PFS6) has been met.

  • Mature overall survival (OS) data continue to show a marked benefit [hazard ratio = 0.53 (0.32, 0.88); p=0.0137] with a long-term survival benefit clearly seen in the RINTEGA arm. In May, the Company reported a hazard ratio of 0.57 (0.33, 0.98) (p=0.0386) for OS in the study.
  • Nine of 10 patients (one patient lost to follow up) on the RINTEGA arm remain alive since the Company last presented data in May compared to only two out of five patients on the control arm.
  • At two years, the survival rate for RINTEGA patients is 25% versus 0% for control patients in the intent to treat (ITT) population, with five patients extending beyond two years.
  • Five patients in the RINTEGA arm continue survival follow-up without progression per central review, compared to only one patient on the control arm.
  • A clear advantage continues to be demonstrated across multiple, clinically important endpoints including overall survival (OS), long-term progression-free survival (PFS), objective response rate (ORR) and need for steroids.
  • 33% of patients on the RINTEGA arm who were receiving steroids at baseline were able to stop steroids for six months or longer compared to none on the control arm.

“The results of the ReACT study change the way we think about glioblastoma—offering patients and their families new hope in the face of one of the most difficult to treat cancers and upending the notion that the brain, masked behind the blood brain barrier, is beyond the reach of the promise of immunotherapy,” said David A. Reardon, M.D. “The long-term survival benefit observed in this study is unprecedented as it is exceedingly rare for patients with highly aggressive, EGFRvIII-positive glioblastoma—even in the newly diagnosed setting—to live beyond two years. Most striking perhaps is that not only are patients living considerably longer, they are also living better, with minimal side effects and a reduced need for steroids. The ReACT data also build considerable anticipation for the ACT IV study in newly-diagnosed glioblastoma as these patients typically present with much stronger immune systems and stand to derive an even greater benefit.”

“Patients with glioblastoma—especially those who are EGFRvIII-positive—face a staggering diagnosis, and in the face of this news, making the decision to participate in a clinical trial—especially a randomized study—is never an easy decision,” said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex. “To this end, we are extremely gratified on behalf of our ReACT patients, their families and physicians that RINTEGA continues to tell a very consistent, impressive story across multiple, clinically relevant endpoints including, most importantly, long-term survival. These results replicate what we have seen in earlier RINTEGA studies conducted in newly-diagnosed patients, supporting our belief that RINTEGA will be an important treatment option for all patients with EGFRvIII-positive glioblastoma.”

Presentation Details

ReACT is a randomized, controlled Phase 2 exploratory study designed to determine if adding RINTEGA to standard of care bevacizumab (BV; Avastin®) improves outcomes for patients with EGFRvIII-positive, recurrent glioblastoma across multiple measures. Patients [n=73, intent to treat (ITT)] were bevacizumab-naïve at study entry. Tumor responses were evaluated in accordance with RANO criteria by an independent expert review committee blinded to treatment group assignment. Data for this long-term update included study results through September 1, 2015.

  • PFS6: As previously reported, the primary endpoint of PFS6 was met. 10 out of 36 (28%) patients were alive at six months without progression on the RINTEGA arm compared to 6 out of 37 (16%) on the control arm (p=0.1163). Given the exploratory nature and size of the trial, the ReACT study required a PFS6 1-sided p-value of 0.2 (powered at 80%) for positivity.
  • SURVIVAL: RINTEGA+BV demonstrated a statistically significant, clinically meaningful overall survival benefit compared to BV alone. Consistent with previous studies of RINTEGA and the published data observed for immune-mediated therapeutics, this survival benefit includes a “tail” on the RINTEGA survival curve with multiple patients exceeding what is customary survival for EGFRvIII-positive glioblastoma. Nine patients on the RINTEGA arm continue to be followed for survival, including five without disease progression per central review. Two patients on the control arm continue to be followed for survival, including one without disease progression per central review. At two years, the survival rate for RINTEGA patients in the ITT population is 25% versus 0% for control patients.
Overall Survival (OS), Intent to Treat (ITT) Population
     
Hazard Ratio (HR) HR = 0.53 (0.32, 0.88); p=0.0137
     
Median (95% CI) OS 12 months OS 18 months OS 24 months
RINTEGA + BV 11.3 (9.9, 16.2) 44% 32% 25%
Control + BV 9.3 (7.1, 11.4) 32% 13% 0%
  • OBJECTIVE RESPONSE RATE (ORR): Nine out of 30 evaluable ITT patients (30%) on the RINTEGA arm experienced a confirmed objective response versus six out of 34 evaluable patients (18%) on the control arm. Five patients on the RINTEGA arm experienced durable responses greater than six months, and three of these patients experienced durable responses greater than 18 months (range of 18.6+ to 22.2 months). In contrast, only two patients on the control arm experienced a durable response greater than six months, and none experienced a response greater than 7.4 months.
  • STEROID USE: Further emphasizing the level of disease control, 50% of the 18 patients on the RINTEGA arm who were on steroids at the start of treatment were able to stop steroids for at least two months during treatment versus only 26% of the 19 patients on the control arm who were on steroids at the start of treatment. 33% of patients on the RINTEGA arm were able to stop steroids for more than six months, and, of these, three were able to stop for more than one year versus none on the control arm for either time point.
  • IMMUNE RESPONSE: Prolonged survival was associated with high anti-EGFRvIII humoral responses that were predominantly of the cell killing IgG1 isotype, and recent in vivo experiments have shown those immune responses had tumor killing function through antibody dependent cellular cytotoxicity (ADCC) of EGFRvIII-expressing tumor cells. This biologic effector function is rarely proven for immune therapies. Importantly, rapid generation of anti-EGFRvIII humoral response correlated with longer survival; however, even those with slower development of immune responses benefitted. No patient in the control arm had detectable EGFRvIII specific antibody response. This effect is consistent with RINTEGA’s proposed mechanism of action as a targeted immunotherapeutic vaccine.
  • OTHER: Multiple subgroup and adjusted analyses have concluded that the consistent survival benefit observed in the study was not influenced by potential imbalances in patient demographics.
  • SAFETY: RINTEGA was very well tolerated without unexpected additive toxicity to bevacizumab.

RINTEGA® is a registered trademark of Celldex Therapeutics. Avastin® is a registered trademark of Genentech, Inc.
1Data provided the Radiation Therapy Oncology Group (RTOG).

About RINTEGA®

RINTEGA® is an investigational therapeutic vaccine that targets the tumor specific oncogene EGFRvIII, a functional and permanently activated variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long-term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues.

Three Phase 2 trials of RINTEGA—ACTIVATE, ACT II, and ACT III—have been conducted in newly diagnosed EGFRvIII-positive GBM and have shown consistent improvements in both overall survival and progression-free survival compared to matched historical controls. The most common adverse events for RINTEGA include injection site reactions, fatigue, rash, nausea and pruritus. RINTEGA is currently being studied in two clinical trials in EGFRvIII-positive GBM—an international Phase 3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT in recurrent GBM. In February 2014, the U.S. Food and Drug Administration (FDA) granted RINTEGA Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma. The first interim analysis for ACT IV occurred in June 2015, and the study’s Data Safety and Monitoring Board recommended continuation of the study as planned. The Company anticipates that ACT IV will reach the required 75% of events (deaths) to perform the second interim analysis in late 2015 and that the analysis will occur in early 2016.

About Celldex Therapeutics, Inc.

Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.

Forward Looking Statement

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company’s strategic focus and the future development and commercialization (by Celldex and others) of RINTEGA® (“rindopepimut”; “rindo”; CDX-110), glembatumumab vedotin (“glemba”; CDX-011), varlilumab (“varli”; CDX-1127), CDX-1401, CDX-301 and other products and our goals for 2015. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of RINTEGA, glembatumumab vedotin and other drug candidates; our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and derive benefit from the Breakthrough Therapy Designation for RINTEGA, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Company Contact
         Sarah Cavanaugh, Vice President of Investor Relations & Corp Communications
         Celldex Therapeutics, Inc.
         (781) 433-3161
         scavanaugh@celldex.com

         Media Inquiries
         Dan Budwick, Pure Communications, Inc.
         (973) 271-6085
         dan@purecommunicationsinc.com
Friday, November 20th, 2015 Uncategorized Comments Off on (CLDX) Long-term Survival Benefit Demonstrated in Phase 2 ReACT Study of RINTEGA(R)

(NVCR) New Phase 3 Data Illustrates Optune Plus 2nd Line Chemo Superiority

Glioblastoma patients who received Optune in combination with bevacizumab at first recurrence lived significantly longer than patients who received bevacizumab alone

Novocure (NASDAQ: NVCR) announced today new Phase 3 data showing that glioblastoma patients who received TTFields in combination with chemotherapy at first recurrence lived significantly longer than patients who received chemotherapy alone. The data will be presented at the 20th Annual Society for Neuro-Oncology Meeting in San Antonio.

The post-hoc analysis of the EF-14 Phase 3 clinical trial shows that patients treated with TTFields in combination with physician’s best choice second line chemotherapy reduced their risk of death by 31 percent compared to patients treated with physician’s best choice second line chemotherapy alone (HR= 0.695, p= 0.0489). Patients treated with TTFields in combination with bevacizumab (Avastin®), reduced their risk of death by 39 percent compared to patients treated with bevacizumab alone (HR=0.606, p= 0.0428).

“Our analysis shows that GBM patients continue benefiting from TTFields therapy even after their disease has recurred,” says Santosh Kesari, a trial investigator and Chair of Translational Neuro-Oncology and Neurotherapeutics at John Wayne Cancer Institute and Director of Neuro-Oncology at the Pacific Brain Tumor Center at Providence Saint John’s Health Center in Santa Monica, California. “This survival benefit is maintained across multiple lines of second line therapy, including bevacizumab, and points to the need for physicians to incorporate Optune into the standard-of-care for glioblastoma.”

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.

In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.

In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.

Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.

About Novocure

Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on October 27, 2015 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

 

Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

Friday, November 20th, 2015 Uncategorized Comments Off on (NVCR) New Phase 3 Data Illustrates Optune Plus 2nd Line Chemo Superiority

(SKBI) Announces Receipt of Nasdaq Notification Letter

XI’AN, CHINA–(Nov 19, 2015) – Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI), a China-based manufacturer and distributor of veterinary medicine, vaccines, micro-organisms and feed additives, announced that on November 17, 2015, it received a letter from NASDAQ Stock Market indicating that that Skystar failed to comply with Nasdaq’s filing requirement set forth in Listing Rule 5250(c)(1) (the “Rule”) because it failed to file its Form 10-Q for the fiscal quarter ended September 30, 2015 (the “Quarterly Report”).

The Company previously disclosed a notification from Nasdaq informing the Company that is was subject to delisting because it failed to comply with Nasdaq’s filing requirements set forth in Listing Rule 5250(c)(1) because it failed to file its Form 10-K for the fiscal year ended December 31, 2014, and Forms 10-Q for the periods ended March 31, and June 30, 2015. The failure to file the Quarterly Report constitutes an additional basis for delisting. The Company also previously disclosed that Nasdaq had notified the Company of two additional, and separate, bases for delisting under Listing Rule 5250(b)(1) (failure to disclose material non-public information) and Listing Rule 5101 (public interest concerns).

The Company has a hearing scheduled for December 3, 2015 for the hearing panel to review the delisting determination.

About Skystar Bio-Pharmaceutical Company

Skystar is a China-based developer, manufacturer and distributor of veterinary healthcare and medical care products. Skystar has four product lines: veterinary medicines, probiotics, vaccines and feed additives formulated and packaged in house across several modern manufacturing and distributions facilities. Skystar’s distribution network includes almost 3,000 distribution agents of which 360 are franchised stores with exclusivity agreements covering 29 provinces throughout China. For additional information, please visit http://www.skystarbio-pharmaceutical.com.

Safe Harbor Statements

When used in this release, the words “intends,” “believes,” “anticipated” and “expects” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include, without limitation, the Company’s ability to complete its IgG kit effort as well as other related efforts at the Huxian facilities, the Company’s ability to timely, effectively and accurately assess the efficacy and commercial potential of any technologies that may results from such R&D efforts, the Company’s ability to timely and effectively commercialize any such technologies. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact:
Skystar Bio-Pharmaceutical Company
Scott Cramer
Director – Corporate Development & U.S. Representative
(407) 645-4433

Thursday, November 19th, 2015 Uncategorized Comments Off on (SKBI) Announces Receipt of Nasdaq Notification Letter