Archive for December, 2014
(OGXI) to Regain Rights to Custirsen from Teva
BOTHELL Wash. and VANCOUVER, British Columbia, Dec. 30, 2014 — OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced that it has executed an initial agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers. This transfer of rights would occur in connection with the termination of the collaboration agreement between OncoGenex and Teva executed in 2009.
The initial agreement reached by OncoGenex and Teva provides that, following execution of the final agreement to terminate the collaboration between the parties, OncoGenex will receive a $27 million payment from Teva, subject to certain adjustments. In addition, OncoGenex will take over responsibility for all custirsen related expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs, which are currently being managed by Teva. OncoGenex expects that the $27 million payment from Teva will allow for the completion and final results from the AFFINITY trial, as well as continuation of the ENSPIRIT trial through the second interim futility analysis expected in the first half of 2015.
“Teva’s strategic focus has shifted away from oncology research and development. However, OncoGenex remains committed to the continued investigation of custirsen, particularly in patients who have advancing disease despite previous treatments,” said Scott Cormack, President and CEO of OncoGenex. “This agreement provides OncoGenex with greater control of custirsen’s development, including the modification of the ENSPIRIT statistical analysis plan to involve a more rigorous second interim futility analysis to be completed in the second quarter of 2015 that, if passed, would enable the trial to continue with a smaller enrollment requirement, increased confidence in success and shorter time to regulatory submission.”
The Company expects that the $27 million payment from Teva and the Company’s current resources should enable the completion of the AFFINITY trial through data readout in late 2015/early 2016, allow for the continuation of the ENSPIRIT trial through the second interim futility analysis that is expected in the first half of 2015 and the achievement of key apatorsen clinical milestones, such as the completion of patient enrollment in the Borealis-2™ trial and final data from the Spruce™ and Rainier™ clinical trials.
The Company anticipates a final agreement will be executed in January 2015. Additional terms of the initial agreement with Teva can be found in the Company’s Form 8-K filed today and available at http://ir.oncogenex.com.
About Custirsen
Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration. By inhibiting clusterin, custirsen is designed to alter tumor dynamics, slowing tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was administered to 294 patients with various types of cancer. The majority of adverse events were mild. The most common serious adverse events (SAEs) associated with custirsen were febrile neutropenia, fever, pleural effusion, and dyspnea, with each SAE event observed in approximately 2 to 4 percent of patients. In the Phase 3 SYNERGY trial, custirsen was administered to approximately 500 men with metastatic castrate-resistant prostate cancer (CRPC). Adverse events observed were similar to custirsen’s known adverse event profile. The most common SAEs observed in 2 percent of patients treated with custirsen, beyond those observed in the control arm, included febrile neutropenia, pneumonia, and fever. Although the SYNERGY study did not meet its primary endpoint of significantly improved overall survival (OS) in combination with first-line docetaxel, exploratory analyses showed improved OS for some men who received custirsen and who had poor prognostic scores across several risk factors, including performance status ≤ 80.
Two important custirsen milestones were reached during the second half of 2014. The AFFINITY trial successfully completed enrollment of 635 men with metastatic CRPC and the ENSPIRIT trial completed its first interim futility analysis, which included rigorous criteria in order to continue the trial. Based on this analysis, the independent data monitoring committee determined that continued enrollment in the ENSPIRIT trial was warranted.
About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company’s Twitter account https://twitter.com/OncoGenex_IR.
OncoGenex’ Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning the expected execution of a final agreement with Teva with respect to the termination of the collaboration agreement, the expected transfer of rights to custirsen and receipt of the expected upfront termination payment contemplated by the initial agreement, our ability to control development plans and achieve long term benefit for stockholders, our anticipated product development activities, such as expected clinical trial completion and design and statements regarding potential results from interim analysis and regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that a final agreement is not completed on the expected terms, if at all, the risk that our financial resources are not sufficient to fund our planned operations during the expected term, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Borealis-2™, Spruce™ and Rainier™ are registered trademarks of OncoGenex Pharmaceuticals, Inc.
(TRUE) December site traffic jumps 50 percent as car-buying process evolves
Mobile users now account for nearly half of all unique visitors to TrueCar.com
SANTA MONICA, Calif., Dec. 30, 2014 — TrueCar, Inc., the negotiation-free car buying and selling platform, saw a year-over-year spike in unique visitor volume in December as more consumers accessed the site via mobile devices. In fact, mobile users led the way with over 90 percent growth.
Unique visitors to TrueCar.com totaled 3.7 million in December versus 2.4 million a year ago. This increase coincides with reinvigorated consumer confidence that helped push TrueCar.com’s unique visitor count to a one-day record high of nearly 200,000 on Dec. 27.
“The future of car buying is mobile,” said Scott Painter, TrueCar CEO and founder. “At TrueCar we are seeing a radical adoption of this technology among modern buyers.”
The jump in visitors to TrueCar’s site via smartphone, tablet and desktop computers comes as December auto sales, aided by holiday and year-end promotions, are on pace to hit nearly 1.5 million units, the best in a decade. TrueCar expects automakers to close out 2014 with a combined 16.5 million units, a sales level not seen since 2007.
Downloads of TrueCar’s smartphone app surpassed 1.3 million downloads at the end of November. The mobile app’s Price Check feature, introduced earlier this year for iOS devices, was made available for Android phones in November, enabling users to get real time pricing while on TrueCar Certified Dealer lots simply by scanning VIN stickers.
Looking ahead to 2015, TrueCar is focused on further enhancing the mobile experience for customers and improving the sales process for TrueCar Certified Dealers.
“There’s a tipping point when consumers understand they can use their mobile devices to buy a car, and TrueCar hit that in December,” said Neeraj Gunsagar, the company’s chief revenue officer. “When it comes to big ticket purchases, people in general have felt more secure in front of their desktop. Today mobile is undergoing a similar evolution, but at a much faster pace.”
About TrueCar
TrueCar, Inc. (NASDAQ: TRUE) is the negotiation-free car buying and selling platform. TrueCar enables a negotiation-free car buying experience by giving buyers transparent insight into what others actually paid (price confidence), upfront pricing information (price discovery), and access to a network of trusted TrueCar Certified Dealers who provide guaranteed savings certificates and seamlessly complete the car purchase. The reality is that buying a car is painful and buyers fear they are going to overpay or be surprised with hidden fees. TrueCar’s transparent upfront pricing information makes the car buying process simple so there are no surprises and buyers never overpay. TrueCar’s mission is to make car buying simple, fair and fun. Its national network of more than 9,000 TrueCar Certified Dealers, including both new car franchise dealers and non-franchise dealers, is committed to providing negotiation-free savings off MSRP and upfront pricing information for all car-buyers, including members of some of the country’s largest membership and service organizations such as AARP, American Express, AAA, and USAA. Note: Not all program features are available in all states. Go to www.truecar.com for program details. TrueCar is headquartered in Santa Monica, Calif., with offices in Santa Barbara, Calif., San Francisco, Calif., and Austin, Texas.
(WILC) to Acquire Interest in Mendelson Infrastructures and Industries
YAVNE, Israel, December 30, 2014 —
G. Willi-Food International Ltd. (NASDAQ: WILC) (the “Company” or “Willi-Food“), a global company that specializes in the development, marketing and international distribution of kosher foods, announced today that it is negotiating with Netz Group Ltd. (“Netz“) (TASE: NETZ) with respect to a proposed acquisition by the Company of Netz’s holdings in Mendelson Infrastructures & Industries Ltd. (TASE: MNIN), a company which trades and markets products in the field of water and sewage distribution, and products for fire protection, automation, and sanitation for many industrial sectors.
There is no certainty whether these negotiations will result in a binding agreement, or whether the conditions precedent set forth in any such binding agreement will be satisfied.
About G. Willi-Food International Ltd.
G. Willi-Food International Ltd. (http://www.willi-food.com) is an Israeli-based company specializing in high-quality, great-tasting kosher food products. Willi-Food is engaged directly and through its subsidiaries in the design, import, marketing and distribution of over 600 food products worldwide. As one of Israel’s leading food importers, Willi-Food markets and sells its food products to over 1,500 customers in Israel and around the world including large retail and private supermarket chains, wholesalers and institutional consumers. The Company’s operating divisions include Willi-Food in Israel and Gold Frost, a wholly owned subsidiary who designs, develops and distributes branded kosher, dairy-food products.
FORWARD LOOKING STATEMENT
This press release contains forward-looking statements within the meaning of safe harbor provisions of the Private Securities Litigation Reform Act of 1995 relating to future events or our future performance, such as statements regarding trends, demand for our products and expected sales, operating results, and earnings. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied in those forward-looking statements. These risks and other factors include but are not limited to: monetary risks including changes in marketable securities or changes in currency exchange rates- especially the NIS/U.S. Dollar exchange rate, payment default by any of our major clients, the loss of one of more of our key personnel, changes in laws and regulations, including those relating to the food distribution industry, and inability to meet and maintain regulatory qualifications and approvals for our products, termination of arrangements with our suppliers, in particular Arla Foods, loss of one or more of our principal clients, increase or decrease in global purchase prices of food products, increasing levels of competition in Israel and other markets in which we do business, changes in economic conditions in Israel, including in particular economic conditions in the Company’s core markets, our inability to accurately predict consumption of our products and changes in consumer preferences, our inability to protect our intellectual property rights, our inability to successfully integrate our recent acquisitions, insurance coverage not sufficient enough to cover losses of product liability claims and risks associated with product liability claims. We cannot guarantee future results, levels of activity, performance or achievements. The matters discussed in this press release also involve risks and uncertainties summarized under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F for the year ended December 31, 2013, filed with the Securities and Exchange Commission on April 30, 2014. These factors are updated from time to time through the filing of reports and registration statements with the Securities and Exchange Commission. We do not assume any obligation to update the forward-looking information contained in this press release.
Company Contact:
G. Willi Food International Ltd.
Itai Loewenstein, CFO
+972-8-932-1000
itai@willi-food.co.il
(HNH) Proposal To Acquire JPS Industries For $10.00 Per Share In Cash
WHITE PLAINS, N.Y., Dec. 30, 2014 — Handy & Harman Ltd. (NASDAQ: HNH) (“HNH” or the “Company”), a diversified global industrial company, today announced that it has sent a letter to JPS Industries, Inc. (“JPS”) (Pink Sheets: JPST) stating its willingness to enter into a definitive merger agreement with JPS to acquire all of the outstanding shares of common stock of JPS not already owned by HNH or HNH’s parent, Steel Partners Holdings L.P. (“SPH”), for $10.00 per share in cash. HNH’s all-cash proposal, which is not subject to any due diligence and not expected to be subject to any financing contingency, represents a premium of approximately 44.5% over JPS’ closing price of $6.92 on December 29, 2014. SPH currently owns approximately 39% of JPS’ outstanding shares.
In a letter addressed to the two members of a Special Committee of JPS’ Board of Directors, Alan B. Howe and Robert J. Capozzi, and to JPS CEO Mikel Williams, HNH stated that while its strong preference would have been for a private, consensual process, HNH had little choice but to make its proposal public given the lack of any meaningful progress since first submitting an offer to acquire JPS in early June. HNH further noted in the letter that JPS has not traded at or above the proposed $10.00 per share price since July of 1998 and that JPS shareholders have otherwise enjoyed very little opportunity for liquidity in recent years. Accordingly, HNH stated that JPS’ unaffiliated shareholders should not be denied their right and opportunity to determine for themselves whether they would sell their shares at the proposed $10.00 per share price.
The full text of the letter follows:
December 30, 2014
Alan B. Howe
Robert J. Capozzi
Special Committee of the Board
and
Mikel Williams, Chief Executive Officer
c/o JPS Industries, Inc.
55 Beattie Place
Greenville, SC 29601
Dear Gentlemen:
Handy & Harman Ltd. (“H&H”, “we”, “us” or “our”) has repeatedly expressed to you our desire to enter into a negotiated transaction with JPS Industries, Inc. (“JPS” or “the Company”) that we believe would create meaningful value and immediate liquidity for the Company’s shareholders. Our parent, Steel Partners Holdings L.P. (“SPH”), has been a significant shareholder of JPS for almost 14 years and currently owns approximately 39% of the Company’s outstanding shares. As you know, on numerous occasions over the past several years, SPH has attempted to work with you and the other members of the Board and senior management in an effort to maximize value for shareholders through a sale of the Company to SPH or the highest bidder. SPH has made compelling proposals to acquire the Company at a significant premium to the then current market price of the Company’s shares in a transaction that we do not expect to be subject to any financing contingency. Despite SPH’s exhaustive efforts to convince you of the clear benefits to all constituents of a sale of the Company, the Board refused to negotiate with SPH.
While it was H&H’s strong preference to communicate privately with the Special Committee regarding a value enhancing transaction, no progress has been made since our offer to acquire the Company on June 2, 2014, when we first expressed interest in acquiring the Company. JPS’ unaffiliated shareholders should not be denied their right and opportunity to determine for themselves whether they would sell their shares.
Accordingly, H&H hereby publicly sets forth its willingness to enter into a definitive merger agreement with JPS to acquire all of the outstanding shares of common stock of the Company not already owned by us or SPH for $10.00 per share in cash (the “Proposal”), on the terms set forth on the attached term sheet. Notably, our Proposal is not subject to due diligence and is not expected to be subject to any financing contingency. Based upon discussions with our lenders, we anticipate obtaining all financing commitments prior to execution of a definitive merger agreement. If the Board of Directors (the “Board”) would waive the shareholder rights plan, we are prepared to commence a tender offer to all shareholders so that they can have an opportunity to choose to have immediate liquidity for their shares.
Our Proposal affords shareholders an attractive and certain means of monetizing their investment, as opposed to the uncertainty offered by the status quo. Our Proposal represents a premium of approximately 44.5% premium over JPS’ closing price of $6.92 on December 29, 2014, and a 98% premium to the 52 week low price this year of $5.05 on February 6, 2014. Notably, JPS has not traded at our Proposal price of $10.00 per share since July of 1998, more than 16 years ago, nor have JPS shareholders received any dividends while enduring such a prolonged period of dismal stock performance. We note that there have only been approximately 108,000 shares that have traded in the last 12 months (some of this has been double counted) and shareholders have had very little opportunity for liquidity.
We are highly confident that Houlihan Lokey, the Company’s investment banker, will be in a position to provide a fairness opinion which allows the pension trustees or independent fiduciary to the plan to support a transaction with us or a higher bidder without any issue.
In order to achieve immediate and maximum value for all shareholders, H&H has for many months now been urging you, the Special Committee, to pursue a sale of JPS to us or the highest bidder. The Special Committee has refused to do so. As the largest shareholder of JPS, with approximately 39% of the Company’s outstanding shares held by SPH, we are uniquely positioned to negotiate, finance and consummate such a value-maximizing transaction. In order to ensure that shareholders receive the highest price available in any transaction, we would be willing to negotiate a definitive agreement that includes a “go shop” period in order to allow the Company’s financial advisor, Houlihan Lokey, to shop for a higher bidder. We have also repeatedly made it clear that if a subsequent offer emerges from another party to acquire the entire Company at a price greater than what we are willing to pay that we would be supportive of such a transaction. We have attempted to alleviate any concern that our interests are somehow not aligned with those of all unaffiliated shareholders in pursuing a transaction of JPS.
Unfortunately, our acquisition overtures have been rebuffed and our efforts have been frustrated at every turn by the Special Committee. While we have been working towards catalyzing a value-maximizing liquidity event for all shareholders, it appears that you have been more intent on protecting your own interests and positions than maximizing value for the benefit of JPS’ unaffiliated shareholders.
The Special Committee’s handling of this process has been too slow, too costly, and appears to be too reliant on input from Lloyd Miller, a 15% shareholder who has recently nominated each of you, as well as CEO Mikel Williams and former JPS CEO Michael Fulbright, who if elected will not be an independent director, for election at the Company’s 2015 Annual Meeting of Shareholders (the “2015 Annual Meeting”). That you have agreed to be nominated by Mr. Miller as part of a group that is seeking control of JPS at the 2015 Annual Meeting calls into serious doubt your true intentions with respect to the future of JPS and your ability to negotiate in good faith with potential acquirers. Not to mention that you have aligned yourselves with Mr. Fulbright, who the current Board, including yourselves, elected to remove and pay a multi-million dollar severance package to after years of underperformance and mismanagement under his leadership. We are willing to pay a premium to shareholders to acquire JPS. Your group appears to be seeking complete control of JPS without paying shareholders a dime. The status quo may be the better alternative for you, but it is clearly not what is best for most of the Company’s unaffiliated shareholders.
SPH has a fundamental disagreement with you and management regarding the manner in which JPS is operated. SPH has been urging the Company to pursue a lean-focused operational plan based on driving new product creation while reducing corporate overhead costs and allocating capital more efficiently. On the other hand, each of you appear intent on continuing to operate the Company as a standalone public company, incurring significant public company costs, bloated overhead costs, redundancy in senior management positions, with an inefficient capital structure and for your continued personal benefit.
On August 18, 2014, we indicated that we were prepared to increase our offer price to a range of $8.00 and $10.00 per share in cash and that the definitive agreement would not be subject to any financing contingency. In fact, our offers to date have only been subject to limited conditions, including confirmatory due diligence, waiver of any anti-takeover provisions and certain customary conditions for a transaction of the size and type we have proposed.
Instead of commencing good-faith negotiations with us, you hid behind an unreasonable demand that we agree to a $12.50 per share cash bid as a starting point for any negotiations. We have repeatedly stressed to you that the Special Committee’s demand that we offer not less than $12.50 per share to continue to negotiate is unacceptable.
Nevertheless, on October 31, 2014, we informed the Company that H&H was prepared to confirm its offer to acquire JPS at the high-end of our offer range, $10.00 per share in cash. In response, you required us to sign a confidentiality and standstill agreement that contained onerous and overreaching provisions that we believe were intended to entrench your positions on the Board in the event that a deal was not ultimately reached. In light of your uncooperative approach to our acquisition overtures to date, you knew that we could not sign away our rights to protect our interests and ability to seek Board representation. With a November 22, 2014 nomination deadline looming for the 2015 Annual Meeting, SPH nominated a slate of four director nominees on November 20, 2014 to preserve its rights to (i) elect a slate of directors who are committed to a sale of the Company to H&H or the highest bidder in the event that the Special Committee continues to inexcusably spurn our acquisition proposals, and (ii) seek representation on the Board in the event that a majority of the Board fails to re-nominate Jack Howard and John Quicke.
We are now at an impasse where SPH, on the one hand, is seeking to catalyze a value-maximizing transaction for shareholders, whether through us or a higher third party offer, and where you, on the other hand, have usurped the corporate machinery and are using shareholder capital to protect your positions as Board members and put up roadblocks to prevent shareholders from being allowed to vote on a transaction that will result in them receiving full and fair value for their investment. It is unacceptable for you to continue to use the Special Committee under the guise of protecting shareholder interests as a vehicle to run up unnecessary fees and expenses in order to protect your own interests while seeking control of the Board together with Mr. Miller. In fact, we reserve the right to reduce our offer price to the extent the Special Committee continues to waste significant corporate assets on legal fees and other expenses.
We also have serious concerns that the Investment Committee of the Company’s pension fund, which consists of Mikel Williams and another employee, intends to vote the 1.9 million shares of JPS held by the pension fund to further the efforts of Messrs. Miller, Williams, Capozzi, and Howe to take effective control of JPS without paying for it. We note that Mr. Capozzi has been on the Board since October 1997. The shares held by the pension fund should not be permitted to be voted at the 2015 Annual Meeting without specific authority from an independent trustee or the beneficiaries, and we reserve our rights to take whatever action we believe is required to ensure that management does not use the pension fund as a vehicle for entrenching themselves and taking control of the Company.
We strongly urge you to reconsider your uncooperative approach, and instead immediately engage seriously with us to explore our Proposal and negotiate a transaction. The problematic status quo, consisting of management’s high corporate overhead cost structure and waste of corporate assets, including the frivolous lawsuit filed against Messrs. Howard and Quicke, is untenable and value destructive. The shareholders of JPS have waited long enough, they deserve better.
Our intentions are directly aligned with the best interests of all JPS shareholders and our actions have been consistent with what we believe should be the fiduciary duties of all directors – to get the highest cash price for JPS. We will continue to take any and all actions that we believe are required to ensure that JPS shareholders have the opportunity to realize immediate and value-maximizing liquidity for their investment, ensure that the Board is fairly evaluating our Proposal and any third party acquisition proposals in a manner consistent with the best interests of all shareholders, and to allow the shareholders to vote on their own fate. As always, we stand ready to meet with you as soon as possible.
Sincerely,
/s/ Warren G. Lichtenstein
Outline of Proposed Terms of Agreement
between Handy & Harman and JPS Industries
This term sheet (“Term Sheet“) summarizes the principal terms of the proposed transaction (the “Proposed Transaction“) between Handy & Harman Ltd. (“HNH“) and JPS Industries, Inc. (the “Company“, and together with HNH, the “Parties“). This Term Sheet is for discussion purposes only. There is no obligation on the part of any Party until the Parties sign a definitive agreement in form and substance reasonably satisfactory to the Parties (the “Agreement“).
Proposed Purchase Price | HNH proposes to acquire the outstanding shares of common stock of the Company (the “Shares“) not already owned by HNH, Steel Partners Holdings L.P. or their affiliates at a price of $10.00 per Share (the “Purchase Price“). |
No Financing Condition | The Proposed Transaction is not expected to be conditioned upon HNH obtaining any third-party financing. |
No Due Diligence | The Proposed Transaction shall not be conditioned upon HNH engaging in any due diligence review with respect to the Company. |
Survival of Representations and Warranties | The customary representations and warranties in the Agreement to be agreed upon by the Parties shall not survive the closing of the Proposed Transaction. |
Go-Shop | The Parties agree that the Agreement shall include a customary 30-day go-shop period (the “Go-Shop“). |
Break-Up Fee | Following the termination of the Go-Shop period the Parties agree that the Company shall pay a 3% break-up fee if it terminates the Agreement. |
Investment Bank Fees | The terms of any investment banking fees shall be mutually agreed upon by the Parties. |
Other Terms | The Agreement will contain other customary terms and provision to be agreed upon by the Parties. |
About Handy & Harman Ltd.
Handy & Harman Ltd. is a diversified manufacturer of engineered niche industrial products with leading market positions in many of the markets it serves. Through its wholly-owned operating subsidiaries, HNH focuses on high margin products and innovative technology and serves customers across a wide range of end markets. HNH’s diverse product offerings are marketed throughout the United States and internationally.
HNH’s companies are organized into five businesses: Joining Materials, Tubing, Building Materials, Arlon, and Kasco.
The Company sells its products and services through direct sales forces, distributors, and manufacturer’s representatives. HNH serves a diverse customer base, including the construction, electronics, telecommunications, transportation, utility, medical, semiconductor, aerospace, aviation, military electronics and food industries.
The Company’s business strategy is to enhance the growth and profitability of the HNH business units and to build upon their strengths through internal growth and strategic acquisitions. Management expects HNH to continue to focus on high margin products and innovative technology. Management has evaluated and will continue to evaluate, from time to time, potential strategic and opportunistic acquisition opportunities, as well as the potential sale of certain businesses and assets.
The Company is based in White Plains, N.Y., and its common stock is listed on the NASDAQ Capital Market under the symbol HNH. Website: www.handyharman.com
Forward-looking Statements
This press release may contain forward-looking statements, including, but not limited to, statements regarding HNH’s offer to acquire JPS. Forward-looking statements may be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company’s most recent annual or quarterly report filed with the Securities and Exchange Commission (“SEC”) as detailed from time to time in the Company’s filings with the SEC, which factors are incorporated herein by reference, as well as and risks and uncertainties relating to the proposed merger, including the negotiation and completion of a formal transaction agreement and regulatory approval processes. Readers are cautioned not to place undue reliance on any of these forward-looking statements. HNH undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
James F. McCabe, Jr., Senior Vice President and Chief Financial Officer
212-520-2376
jmccabe@steelpartners.com
(AQXP) Initiates Patient Dosing Phase 2 of AQX-1125 in Atopic Dermatitis
VANCOUVER, British Columbia, Dec. 30, 2014 — Aquinox Pharmaceuticals, Inc. (“Aquinox”) (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that it has initiated dosing in a Phase 2 clinical trial of AQX-1125 for the treatment of atopic dermatitis (AD).
The KINSHIP clinical trial is being conducted at clinical research centers in Canada as a randomized, double-blind, multicenter, placebo-controlled Phase 2 trial evaluating the efficacy and safety of AQX-1125 in approximately 50 adult patients with mild to moderate AD. The KINSHIP trial’s primary endpoint is change from baseline in Total Lesion Symptom Score (TLSS) after 12 weeks of treatment. The TLSS is a comprehensive assessment of AD symptoms where AQX-1125 may have a beneficial effect. Secondary endpoints include safety, pharmacokinetics and additional parameters for assessing AD.
“We believe AQX-1125’s ease of administration as a once daily, oral, anti-inflammatory medicine, and its ability to reduce immune cell migration to inflamed surfaces, could provide a clinically meaningful benefit to AD patients,” said Dr. Stephen Shrewsbury, Senior Vice President of Clinical Development and Chief Medical Officer of Aquinox. “The KINSHIP trial has been designed to first evaluate AQX-1125’s safety and efficacy in mild to moderate AD patients. Our eventual interest is AQX-1125’s potential as an effective, oral therapy for moderate to severe AD patients.”
The prevalence of AD ranges from 1%-20% worldwide. An estimated 17.8 million Americans are affected by AD, which is considered underdiagnosed by physicians. Approximately two-thirds of Americans with AD suffer from the moderate to severe form of the disease, where existing therapies are often ineffective or unsuitable for long-term treatment.
About AQX-1125
AQX-1125, Aquinox’s lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration. AQX-1125 has demonstrated preliminary safety and favorable drug properties in multiple preclinical studies and clinical trials. Aquinox is currently exploring AQX-1125 as a once-daily oral treatment in several Phase 2 trials.
About Aquinox Pharmaceuticals
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Aquinox has successfully completed multiple preclinical studies and clinical trials with AQX-1125 and is advancing through Phase 2 development. The company has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
Cautionary Note on Forward-looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to: the success and timing of our Phase 2 clinical trials and potential market opportunities for AQX-1125. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for AQX-1125 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of AQX-1125 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of AQX-1125 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Aquinox is contained in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 filed with the Securities and Exchange Commission. Aquinox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR CONTACT:
Brendan Payne,
Aquinox Pharmaceuticals, Inc.
Senior Manager, Investor Relations
604-629-9223
bpayne@aqxpharma.com
MEDIA & PUBLIC RELATIONS CONTACT:
Bianca Nery
MacDougall Biomedical Communications
650-339-7533
aquinox@macbiocom.com
(NDRM) Topline Results of Phase IIa Study of ND0612H and ND0612L in Parkinson’s
REHOVOT, Israel, Dec. 30, 2014 — NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that continuous, subcutaneous delivery of the company’s proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson’s disease patients, may provide an effective therapy alternative to current treatments requiring surgery.
“Maintaining consistent levodopa concentrations has been the most significant hurdle in Parkinson’s disease therapy,” said Sheila Oren, MD, NeuroDerm’s Vice President of Clinical and Regulatory Affairs. “The results from this study demonstrate that ND0612H can reach high LD plasma levels that, to date, could only be reached and maintained by products that require surgical intervention. ND0612H is designed to be delivered continuously, thus we believe it should offer a simple and effective treatment option that will minimize the need for surgical intervention in advanced Parkinson’s patients.”
Due to the short half-life of oral levodopa, patients are required to take multiple LD/CD doses daily. This results in sharp fluctuations in levodopa levels which are associated with erratic “off” and “on” periods experienced by many patients. Continuous LD administration can overcome this limitation, but steady LD delivery can currently only be achieved after undergoing an invasive surgical procedure whereby a tube is permanently implanted into the duodenum, the upper part of the small intestine.
The primary endpoints of the IIa study were to assess the safety, tolerability and pharmacokinetics (PK) of six dose regimens of ND0612H and ND0612L, which provide continuous, subcutaneously-delivered liquid LD/CD formulations through a belt-worn pump, in Parkinson’s disease patients. Sixteen (16) advanced PD patients, with motor fluctuations, chronically treated with standard of care oral LD/CD, were enrolled in the study and were treated with ND0612L (n=9) or ND0612H (n=7) for eight hours per day, for three consecutive days, with high and low doses of CD, and with adjunct oral entacapone. The pharmacokinetics of LD/CD were assessed and compared to baseline pharmacokinetics of orally administered, immediate release LD/CD tablets. A top-line, intent-to-treat analysis showed that levodopa plasma levels were proportionate to dose and, with ND0612H, achieved maximum daytime concentrations of 1,333ng/ml and 1,436ng/ml (with different CD concentrations in the formulation), and 1,807ng/ml with adjunct dosing of oral entacapone. ND0612L achieved maximum daytime concentrations of 528ng/ml and 477ng/ml (with different CD concentrations in the formulation), and 596ng/ml with adjunct dosing of oral entacapone. Fluctuations in LD plasma levels were markedly reduced when comparing oral LD/CD dosing to ND0612H and ND0612L. Per-protocol analysis, that omitted three data sets from two patients because of concomitant use of oral LD, yielded similar LD plasma values.
Treatment with ND0612L and ND0612H did not raise safety and tolerability concerns, causing only minimal and transient local reactions at the infusion site and no particular systemic adverse events, which corroborates the results obtained in previous studies. All patients completed the study.
“These results add to the growing body of clinical data confirming our thesis that continuous, subcutaneous delivery of LD/CD leads to more consistent therapy, which we expect to have a dramatic effect on patient outcomes and quality of life, replacing in most cases the need for surgical intervention,” said Oded S. Lieberman, PhD, CEO of NeuroDerm. “Based on these positive PK results, we will proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015.”
About Levodopa
Oral administration of LD/CD is regarded as the “gold standard” treatment for patients suffering from Parkinson’s disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually all patients diagnosed with Parkinson’s disease will require levodopa at some point over the course of their treatment for the disease, and 70% to 80% of patients receive the drug at any given point in time. However, levodopa is limited by its short half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma. In addition, levodopa suffers from low absorption when administered orally, with only about 30% of the levodopa entering the blood stream.
ND0612H, ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson’s disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night. ND0612H is intended to provide an alternative to surgical treatments associated with serious side effects that are currently offered to patients with severe Parkinson’s disease.
About Parkinson’s Disease
Parkinson’s disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient’s motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient’s quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as “off” time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the “off” time, some patients experience involuntary movements, or dyskinesia. The “off” time and dyskinesia affect the majority of Parkinson’s disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson’s disease patients, however, a convenient route of continuous administration has not been introduced to date.
About NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson’s disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson’s disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson’s disease patients, respectively, and ND0680 for a subset of severe Parkinson’s disease patients whose symptoms have advanced to a highly advanced stage, requiring even higher doses of LD/CD. In addition NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson’s disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under “Risk Factors” in our prospectus, dated November 13, 2014 and filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
CONTACT: NeuroDerm Contact: Oded S. Lieberman, PhD, MBA, CEO oded@neuroderm.com Tel.: +972-8-946 2729 Cell: +1-617-517 6077 U.S. Investor Contact: David Carey Lazar Partners Ltd. dcarey@lazarpartners.com +212-867-1762 U.S. Media Contact: Hollister Hovey Lazar Partners Ltd. hhovey@lazarpartners.com +212-867-1762
(RPRX) Court Rules Inventors Correctly Named on Androxal(R) Patents
Repros Therapeutics Inc.(R) Confirmed as Sole Owner
THE WOODLANDS, Texas, Dec. 29, 2014 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced a federal judge in Texas has issued a definitive ruling finding correct inventorship for two Repros Therapeutics Androxal® patents, thus confirming that Repros Therapeutics is the sole and rightful owner of the patents, U.S. Patent No. 7,759,360 (the “‘360 patent”) and U.S. Patent No. 7,737,185 (the “‘185 patent”).
Calling Dr. Harry Fisch’s claims of co-inventorship “strained to the point of absurdity,” Judge Vanessa Gilmore of the U.S. District Court for the Southern District of Texas found that Dr. Fisch “contributed nothing to the actual invention” of the ‘360 patent. She also found “an absence of material facts to support a finding of co-inventorship” of the ‘185 patent.
Dr. Fisch, a New York urologist and fertility specialist, has made numerous statements, including to the news media, that he was a co-inventor and had contributed to the conception of the patents.
Repros filed suit against Dr. Fisch in August 2013 seeking a declaratory judgment of ownership and inventorship of the ‘360 and ‘185 patents regarding the treatment of hypogonadism in men. In the lawsuit, the Company asserted that Repros’ President and CEO, Joseph S. Podolski, was correctly named as the sole inventor of the ‘360 patent, and that he and Repros Vice President of Research and Development, Ronald Wiehle, were correctly named as co-inventors of the ‘185 patent.
In October 2013, Dr. Fisch filed counterclaims against Repros as well as against Mr. Podolski and Dr. Wiehle, seeking correction of inventorship of these patents.
On the basis of equitable estoppel and an absence of material facts to support a finding of co-inventorship in the case of each of the patents, the court granted both of Repros’ motions for summary judgment and denied Dr. Fisch’s motion for summary judgment.
The decision confirms Repros’ rights to the Androxal® patents.
About Repros Therapeutics Inc. ®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to planned clinical studies and the timing and nature of the results thereof, the impact of the studies on the Androxal® label and the commercial potential of Androxal® and the timing of the Company’s expected filing of an NDA for Androxal®. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including the ability to have success in the clinical development of the Company’s technologies, the reliability of interim results to predict final study outcomes, the ability to protect the Company’s intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
(SRNE) Appoints Robert Rosen and Henry Ji to its Board of Directors
Conkwest, Inc. (the Natural Killer Cell Company of the West), an immuno-oncology company developing Neukoplast™ (NK-92™), a proprietary Natural Killer (NK) cell-line based therapy, announces the appointments of Robert Rosen and Henry Ji, Ph.D. to the Company’s Board of Directors. Mr. Rosen is President of Heron Therapeutics (NASDAQ:HRTX) and Dr. Ji is co-founder, President and CEO of Sorrento Therapeutics, Inc. (NASDAQ:SRNE).
“Robert Rosen and Henry Ji bring valuable skills and experience to Conkwest, and we welcome them to our Board of Directors,” said Patrick Soon-Shiong, M.D., Co-Chairman of the Conkwest Board of Directors. “Neukoplast is the only known cell line that can be commercialized as a direct, scalable, off-the-shelf cancer-killing product. We look forward to developing this proprietary asset, including the next-generation CAR-TNK products.”
“We are thrilled to add to our Board of Directors these two industry executives with strong records of commercial success,” said Barry J. Simon, M.D., President and CEO of Conkwest.
“Robert’s commercial oncology experience spans specialty pharma, global biotechnology and Big Pharma. Importantly, he has led campaigns to commercialize billion dollar products in addition to experience with cell-based oncology therapeutics. He brings broad-based expertise in strategic planning, research, portfolio management, business development and partnership management, as well as three decades of connections in the oncology community.”
“Henry has extensive experience with developing oncology therapeutics, as well as with entrepreneurial, fast-moving companies. His background including both clinical research and executive management responsibilities will be invaluable to Conkwest as we advance our business plan. Henry also brings to our Board a deep commitment to success given the business and financial ties between Conkwest and Sorrento Therapeutics.”
Mr. Rosen has worked in the healthcare industry for the past 30 years, including more than 20 years with oncology therapeutics. Since 2012 he has been with Heron Therapeutics, a pharmaceutical company developing treatments for cancer and pain, where he currently serves as President. He is a Director of Heron Therapeutics as well as a Director of La Jolla Pharmaceutical Co. (NASDAQ:LJPC), a biopharmaceutical company focused on life-threatening diseases. Prior to Heron Therapeutics he was Senior Vice President of Global Commercial Operations at Dendreon Corporation, an oncology biotechnology company.
Earlier in his career Mr. Rosen was Global Head of Oncology at Bayer HealthCare Pharmaceuticals with responsibility for the Americas, Europe, Japan and Asia Pacific. At Bayer he led the launch of Nexavar® (sorafanib) for the treatment of renal cell carcinoma and hepatocellular carcinoma. He also led premarket activities for Stivarga® (regorafenib) for gastrointestinal stromal tumors and colon cancer, and Alpharadin® (radium 2234 dichloride), now known as Xofigo, for prostate cancer.
Prior to Bayer he was Vice President of the Oncology Business Unit at Sanofi-Synthelabo, where he was responsible for developing the U.S. oncology business and the launch of Eloxatin® (oxaliplatin) for colon cancer.
Mr. Rosen received a BS in pharmacy from Northeastern University.
Dr. Ji co-founded and has served as a Director of Sorrento Therapeutics since 2006 and as President and CEO since 2012. Previously he served as the company’s Chief Scientific Officer and as Interim CEO.
Earlier in his career Dr. Ji served as a Vice President of CombiMatrix with responsibility for strategic technology alliances, and was Director of Business Development and Vice President of the biotechnology company Stratagene (later acquired by Agilent Technologies). He co-founded Stratagene Genomics, a wholly-owned subsidiary of Stratagene Corporation, and served as President and CEO.
Dr. Ji received a BS in biochemistry from Fudan University in Shanghai and a Ph.D. in animal physiology from the University of Minnesota.
About Conkwest
Conkwest is an innovative immuno-oncology company that is developing and commercializing a portfolio of highly potent and selective cellular therapies for the treatment of cancers and serious viral infections. Conkwest’s products are based on its proprietary cancer-killing cell line Neukoplast™ (also known as NK-92), the only known cell line that can be commercialized as a direct, scalable, off-the-shelf cancer-killing product. Neukoplast™ recognizes, binds to and directly kills cells expressing stress ligands such as LFA-3, Heparin Sulfate, ICAM-1 and other stress-induced proteins commonly found on cancers and virally infected cells. It has demonstrated broad anti-cancer activity both in vitro and in human clinical trials while sparing patients from the serious adverse reactions often seen with T-CAR based therapies. Cancer patients have been treated in Phase I clinical trials at Rush University, Frankfurt AM Main, Princess Margaret Hospital and University of Pittsburgh Cancer Institute, and preparations for the first U.S. Phase II trial in Merkel cell carcinoma are underway. Conkwest’s universal antibody-targeted CD16-Neukoplast™, a reengineered product that expresses both the high-affinity version of FcgammaR3 (CD16) and ER-IL2 to efficiently target therapeutic monoclonal antibodies such as Rituxan, Herceptin and Erbitux is advancing through the preclinical stage of development. Conkwest also commercializes Neukopanel™, an NK-92 based bioassay panel for the screening and qualification of therapeutic monoclonal antibody products, with revenue-bearing licenses to many large pharma and biotechnology companies.
Forward-Looking Statements
This release may contain forward-looking statements, which express the current beliefs and expectations of Conkwest’s management. Such statements involve a number of known and unknown risks and uncertainties that could cause the company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Any statements contained herein that do not describe historical facts, including but not limited to, statements regarding Mr. Rosen’s expected contributions to Conkwest’s Board of Directors are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. These forward-looking statements are made only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
LHA
Bruce Voss, 310-691-7100
bvoss@lhai.com
(ATHX) Finishes Enrollment of Phase 2 Study of MultiStem(R) in Ischemic Stroke
Top-Line Data Readout Expected Around the End of the First Quarter, 2015
CLEVELAND, Dec. 29, 2014 — Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys’ MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.
“With enrollment now finished, we look forward to the initial 90-day results from this study,” commented Dr. Gil Van Bokkelen, Chief Executive Officer at Athersys. “An ischemic stroke can be a devastating event for a patient, and effective treatments for stroke are limited, resulting in substantial opportunities for new therapies. Based upon MultiStem’s preclinical efficacy profile, its novel mechanisms of action, and a favorable safety profile demonstrated in preclinical and clinical settings, we believe that MultiStem could provide meaningful benefit to these patients. The results from this study are expected to provide significant insight into the potential for MultiStem therapy for the treatment of ischemic stroke.”
Ischemic stroke is caused by a blockage of blood flow to the brain. A leading cause of death and disability globally, each year more than 15 million people are estimated to suffer a stroke, including more than two million people in the United States, Japan and European Union, combined. According to the American Heart Association, ischemic strokes comprise more than 85% of all strokes. Current standard of care for ischemic stroke involves the administration of a thrombolytic (clot dissolving) agent within three to four hours after a stroke has occurred, a narrow window that results in only a small percentage of patients receiving such treatment.
In this Phase 2 trial, stroke victims were administered MultiStem cells or placebo intravenously one to two days after the stroke had occurred. If this study shows that MultiStem treatment is both safe and effective following such administration, as was demonstrated in non-clinical studies, the treatment window could be expanded significantly, from hours to days, providing an important new therapeutic option for stroke patients. Based on preclinical studies, Athersys believes that MultiStem treatment has the potential to substantially improve neurological and functional recovery following stroke by attenuating the inflammatory activity that follows the stroke, accelerating the return to immune system homeostasis, supporting protection of at-risk neurons, and by supporting conditions for neuronal recovery and growth, thereby enhancing repair and patient recovery. The MultiStem treatment’s potential multidimensional impact distinguishes the cell therapy from other pharmaceutical therapies focused on a single mechanism of benefit.
The randomized, double-blind, placebo-controlled Phase 2 clinical trial is being conducted by Athersys at sites in the United States and United Kingdom, and has enrolled subjects who received either MultiStem treatment or placebo one to two days following the stroke. The primary endpoints for the study include safety over the first seven days following treatment and global stroke recovery at day 90, which assesses global disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index). Additionally, there are multiple secondary and exploratory endpoints evaluating multiple elements of recovery and dysfunction, including biomarkers associated with the condition and recovery, and safety variables over the study period.
About MultiStem
MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas. It represents a unique “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency.
About Athersys
Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft-versus-host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.
The Athersys, Inc. logo is available at: http://www.globenewswire.com/newsroom/prs/?pkgid=4548
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “suggest,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction, stroke and other disease indications, including lysosomal storage disorders, and the prevention of graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; changes in external market factors; changes in our industry’s overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones under our collaboration agreements; our collaborators’ ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships and advance our programs; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: William (B.J.) Lehmann, J.D. President and Chief Operating Officer Tel: (216) 431-9900 bjlehmann@athersys.com Investor Relations: Lisa M. Wilson In-Site Communications Tel: (917) 543-9932 lwilson@insitecony.com
(NEWT) Expects Dividend for First Quarter 2015 of $0.38 per Share
Newtek Business Services Corp. Expects to Pay Annual Cash Dividend of Approximately $1.80 per Share for 2015
NEW YORK, Dec. 29, 2014 — Newtek Business Services Corp., (NASDAQ: NEWT), a business development company (“BDC”), today announced that it currently expects to pay an annual cash dividend(1) of approximately $1.80 per share for 2015, payable quarterly from anticipated taxable earnings, and is based on 10,206,323 shares of the Company’s Common Stock outstanding as of December 22, 2014. The Company currently expects its dividend payable for the first quarter of 2015 will be $0.38 per share, which is expected to be declared on April 6, 2015 and payable on April 13, 2015 to shareholders of record on March 30, 2015.
In accordance with the Company’s conversion to a BDC on November 12, 2014, Newtek’s board of directors expects to maintain a dividend policy with the objective of making quarterly distributions in an amount that approximates at least 90% of the Company’s taxable income. The timing and actual amount of such distribution, if any, remains subject to the sole discretion of our board of directors.
The dividend estimation herein is merely intended to give investors guidance and is not to be solely relied upon for investment purposes. Because the guidance is based on the Company’s current estimate of its 2015 quarterly taxable income and is unaudited at this time, there is no assurance that such results will be achieved or that the forecasted 2015 full year distribution, if made, will consist solely of taxable income.
(1) The dividend will be paid in cash or shares of the Company’s Common Stock through participation in the Company’s dividend reinvestment program at the election of the shareholders.
About Newtek Business Services Corp.
Newtek Business Services Corp., The Small Business Authority®, is the Authority for the small- and medium-sized business (SMB) market providing a wide range of business services and financial products under the Newtek® brand. Since 1999, Newtek has provided state-of-the-art, cost-efficient products and services and efficient business strategies to over 100,000 business accounts across all 50 States to help them grow their sales, control their expenses and reduce their risk.
Newtek’s products and services include: The Newtek Advantage™, Electronic Payment Processing, The Secure Gateway, Managed Technology Solutions (Cloud Computing), eCommerce, Business Lending, Insurance Services, Web Services, Data Backup, Storage and Retrieval, Accounts Receivable Financing and Payroll.
The Small Business Authority® is a registered trade mark of Newtek Business Services Corp., and neither are a part of or endorsed by the U.S. Small Business Administration.
Note Regarding Forward Looking Statements
Statements in this press release including statements regarding Newtek’s beliefs, expectations, intentions or strategies for the future, may be “forward-looking statements.” All forward-looking statements involve a number of risks and uncertainties that could cause actual results to differ materially from the plans, intentions and expectations reflected in or suggested by the forward-looking statements. Such risks and uncertainties include, among others, intensified competition, operating problems and their impact on revenues and profit margins, anticipated future business strategies and financial performance, anticipated future number of customers, business prospects, legislative developments and similar matters. Risk factors, cautionary statements and other conditions, which could cause Newtek’s actual results to differ from management’s current expectations, are contained in Newtek’s filings with the Securities and Exchange Commission and available through http://www.sec.gov.
For more information, please visit the following websites:
www.thesba.com
Contacts:
Newtek Business Services Corp.
Barry Sloane
Chairman and CEO
212-356-9500
bsloane@thesba.com
Newtek Business Services Corp.
http://www.thesba.com
Investor Relations
Contact: Jayne Cavuoto
Telephone: (212) 273-8179 / jcavuoto@thesba.com
Contact: Brett Maas
Telephone: (646) 536-7331 / brett@haydenir.com
Public Relations
Contact: Simrita Singh
Telephone: (212) 356-9566 / ssingh@thesba.com
(RVLT) Enters Into Strategic Distribution Partnership with Fastenal
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a global provider of advanced LED lighting solutions, announced today that it has entered into a strategic distribution partnership with the Fastenal Company. Fastenal is one of the largest MRO (Maintenance, Repair and Operations) suppliers. Under the terms, through its U.S. stores and distribution centers, Fastenal will stock and make available a variety of Revolution Lighting Technologies’ LED products.
“We are very excited about the opportunity to work with Fastenal and confident our pure play LED product offering, along with our exclusive sales network, will be a valued asset in securing LED lighting retrofit projects with Fastenal’s extensive customer base,” said Vincent Alonzi, VP of Network Sales, Revolution Lighting Technologies.
“We are looking forward to having Revolution Lighting support our customers with their superior energy efficient LED products,” said Jamey Koehler, Director of Lighting, Fastenal.
“The Fastenal partnership is well aligned with Revolution Lighting’s strategic growth plan. This relationship provides Fastenal with access to our expansive LED product line, in addition to a world-class service and support infrastructure. Revolution Lighting gains a market leading partner that will facilitate our entry into the large MRO marketplace. We believe as this relationship continues to develop, it has the potential to contribute positively to our financial performance.” said Robert V. LaPenta, Chairman and Chief Executive Officer, Revolution Lighting Technologies.
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. is a leader in the design, manufacture, marketing, and sale of light emitting diode (LED) lighting solutions focusing on the industrial, commercial and government markets in the United States, Canada, and internationally. Through advanced technology and aggressive new product development, Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive advanced product platform. The company goes to market through its Seesmart brand, which designs, engineers and manufactures an extensive line of high-quality interior and exterior LED lamps and fixtures; Lighting Integration Technologies Inc., which sells and installs Seesmart products; Lumificient, which supplies LED illumination for the signage industry; Relume Technologies, a leading manufacturer of outdoor LED products; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting Technologies markets and distributes its product through a network of independent sales representatives and distributors, as well as through energy savings companies, national accounts and its wholly owned subsidiary, Value Lighting, a leading supplier of lighting solutions to the multifamily residential housing sector and new construction marketplace across the U.S. Revolution Lighting Technologies trades on the NASDAQ under the ticker RVLT. For additional information, please visit: www.rvlti.com.
About Fastenal Company
Fastenal sells different types of industrial and construction supplies in the following product categories: threaded fasteners and miscellaneous supplies; tools; metal cutting tool blades and abrasives; fluid transfer components and accessories for hydraulic and pneumatic power; material handling; storage and packaging products; janitorial, chemical and paint products; electrical supplies; welding supplies; safety supplies; metals, alloys and materials; and office supplies.
Fastenal operates approximately 2,700 stores located primarily in North America with additional locations in Asia, Europe, Central and South America, and Africa. The Company operates 14 distribution centers; eleven in the United States – Minnesota, Indiana, Ohio, Pennsylvania, Texas, Georgia, Washington, California, Utah, North Carolina, Kansas, and three outside the United States – Ontario, Canada; Alberta, Canada; and Nuevo Leon, Mexico. Additional information regarding Fastenal is available on the Fastenal Company website at www.fastenal.com.
ICR
Anton Nicholas / Cory Ziskind, 203-682-8200
Anton.Nicholas@icrinc.com / Cory.Ziskind@icrinc.com
(CLM) Announce Completion of Reverse Stock Splits
NEW YORK, NY–(Dec 29, 2014) – Cornerstone Progressive Return Fund (NYSE MKT: CFP), Cornerstone Strategic Value Fund, Inc. (NYSE MKT: CLM) and Cornerstone Total Return Fund, Inc. (NYSE MKT: CRF), (individually the “Fund” and collectively, the “Funds”), each a closed-end management investment company, announced that the previously disclosed one-for-four reverse stock split (“Reverse Split”) for each Fund was executed today prior to the opening of trading on the NYSE MKT exchange. Trading of the Funds’ shares on a split-adjusted basis will begin today under new CUSIP numbers of 21924B302 for CLM, 21924U300 for CRF and 21925C200 for CFP.
The Reverse Splits resulted in every four outstanding shares being converted into one share, thereby reducing the number of outstanding shares by a factor of four. For CFP, the number of outstanding shares of beneficial interest was reduced from 66,260,614 to approximately 16,565,153. For CLM, the number of outstanding shares of common stock was reduced from 32,779,170 to approximately 8,194,792. For CRF, the number of outstanding shares of common stock was reduced from 17,908,591 to approximately 4,477,147.
Stockholders/shareholders will be paid cash for any fractional shares that may result from the Reverse Split, except for stockholders/shareholders participating in each Fund’s Dividend Reinvestment Plan, who will receive fractional shares. Once the Reverse Splits are complete, each stockholder/shareholder account will reflect fewer shares with a higher net asset value and market price per share. It is anticipated that each Fund’s trading price may initially increase by a factor of four, making it potentially available to a wider range of investors. Each stockholder/shareholder will hold the same percentage of its Fund’s outstanding shares immediately following the Reverse Split as held immediately prior to the split, subject to rounding adjustments for the intended sale of fractional shares resulting from each transaction.
The Funds will not issue new post-split share certificates. Current holders of certificates representing pre-split shares of the Funds will receive additional information regarding the reverse stock split from the Funds’ transfer agent, American Stock Transfer & Trust Co., LLC. Any holders of certificates representing pre-split shares of the Funds’ common shares, upon submitting their pre-split certificate shares, will receive non-certificated post-split shares of the Funds’ common share, meaning a shareholder’s/stockholder’s holdings of post-split shares will be reflected only in the Funds’ record books and no new share certificates will be issued. Please note that holders of certificates will not be able to trade their shares until they surrender their pre-split share certificates. However, all Fund distributions will continue to be made without interruption.
Although the Reverse Split will not result in a taxable transaction for stockholders/shareholders of the Funds, the exchange of fractional shares for cash may cause some stockholders/shareholders to realize gains or losses for those fractional shares, which could create a taxable event for those stockholders/shareholders.
Cornerstone Progressive Return Fund, Cornerstone Strategic Value Fund, Inc. and Cornerstone Total Return Fund, Inc. are traded on the NYSE MKT exchange under the trading symbols “CFP,” “CLM,” and “CRF”, respectively. Each Fund’s investment adviser is Cornerstone Advisors, Inc. For more information regarding each Fund please visit www.cornerstoneprogressivereturnfund.com, www.cornerstonestrategicvaluefund.com and www.cornerstonetotalreturnfund.com.
Past performance is no guarantee of future performance. An investment in a Fund is subject to certain risks, including market risk. In general, shares of closed-end funds often trade at a discount from their net asset value and at the time of sale may be trading on the exchange at a price that is more or less than the original purchase price or the net asset value. An investor should carefully consider a Fund’s investment objective, risks, charges and expenses. Please read a Fund’s disclosure documents before investing.
In addition to historical information, this release contains forward-looking statements, which may concern, among other things, domestic and foreign markets, industry and economic trends and developments and government regulation and their potential impact on the Fund’s investment portfolio. These statements are subject to risks and uncertainties, including the factors set forth in the Fund’s disclosure documents, filed with the SEC, and actual trends, developments and regulations, in the future and their impact on the Fund could be materially different from those projected, anticipated or implied. The Fund has no obligation to update or revise forward-looking statements.
(VIMC) Reports on Profitability for 2014 and Project Implementation Progress
BEIJING, Dec. 23, 2014 — Vimicro International Corporation (NASDAQ: VIMC) (“Vimicro” or the “Company”), a leading video surveillance technology and solution provider in China, is issuing this update to keep its shareholders apprised of the current status and timing of its previously announced projects. The Company also expects 2014 to be a profitable year primarily driven by on-track project deliveries and its competitiveness in China’s video surveillance market.
Vimicro Electronics Corporation (“Vimicro Tianjin”) was contracted by China Unicom to provide SVAC-compliant video surveillance system, products and installation services to the Police Traffic Control Detachment of Ziyang City, Sichuan Province (“Ziyang Project”) in September 2013, for approximately USD 9 million. Ziyang Project was already fully completed and received the satisfactory inspection and acceptance by the customer.
Shanxi Zhongtianxin Science and Technology Co., Ltd. (“Zhongtianxin), a joint venture in which Vimicro holds 51% interest, entered into a contract with the government of Baoding City, Hebei Province to provide SVAC-compliant system, products and installation services for approximately RMB 250 million (“Baoding Project”) in December 2013. Baoding Project will be completed by December 31, 2014.
Zhongtianxin was contracted to provide SVAC-compliant video surveillance system, products and installation to the Traffic Police Detachment of Taiyuan (“Taiyuan Traffic Control”) for RMB 76 million in June 2014. Taiyuan Traffic Control project is on track according to the project planning. The project is expected to be completed in 2015.
Zhongtianxin won the competitive bid to provide SVAC-compliant video surveillance system, products and installation services for Taiyuan’s Phase II Public Security Video Surveillance Information System (“Taiyuan Phase II”) with the estimated contract value of RMB 220 million, following the successful implementation of Phase I project in Taiyuan in 2013. Taiyuan Phase II project is currently being implemented in accordance with the project plan and is expected to be completed in the first quarter of 2015.
Zhongtianxin is also on track in implementing newly obtained projects in Chenzhou City, Hunan Province and Xiaodianqu District of Taiyuan City, Shanxi Province, for approximately RMB 179 million and RMB 58.6 million, respectively. Both of these contracts are expected to be completed in 2015.
“We are very pleased to announce profitability for the year of 2014, while reporting satisfactory implementation progress on some of our completed and on-going projects at the end of a successful year for Vimicro,” commented by Peter Li, CFO of Vimicro. “For the nine month period ended September 30, 2014, the company reported revenue growth at 58% compared with the same period of last year, while our video surveillance business posted a 108% growth on a year-on-year basis in the same period. In addition to Vimicro’s financial achievement, Vimicro is ranked fourth in the Top 100 Security and Surveillance Manufacturers released by China Public Security Magazine recently, after Hikvision, Dahua, and Huawei.”
John Deng, Chairman and CEO of Vimicro, further commented, “The year of 2014 will mark a milestone year for the company by turning profitable after several consecutive years of net loss. We owe our current success in 2014 to our strong focus in our new video surveillance business by transformation and divesture of non-core businesses over the past few years. We will continue to deliver solid solutions and project implementation to our customers’ satisfaction, based on our proprietary video surveillance technology and product suites. We believe our customer satisfaction, together with our leading edge on SVAC video surveillance national standard, will ensure our continued and greater success in China’s robust video surveillance industry in 2015 and beyond, to realize long-term value for our shareholders.”
About Vimicro International Corporation
Vimicro International Corporation (NASDAQ: VIMC) is a leading video surveillance technology and solution provider that designs, develops and markets a full range of video surveillance products and solutions to governments, private enterprises, and consumers in China. Vimicro co-developed SVAC (Surveillance Video and Audio Coding), the national video surveillance technological standard, which demonstrates its unique strengths in proprietary multimedia IC technology, making it a leader in China’s fast-growing security and surveillance market. Vimicro is headquartered in Beijing, China and has subsidiaries and offices throughout China and in Silicon Valley. Vimicro’s ADSs each represent four ordinary shares and are traded on the NASDAQ Global Market exchange under the ticker symbol “VIMC.”
Forward-Looking Statements
This announcement contains forward-looking statements. These statements 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,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Among other things, the quotations from management in this announcement, as well as Vimicro’s expectations and forecasts, contain forward-looking statements. Vimicro may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission on forms 20-F and 6-K, etc., 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. Statements that are not historical facts, including statements about Vimicro’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company’s ability to develop and sell new mobile multimedia products; the expected growth of the mobile multimedia market; the Company’s ability to increase sales of notebook camera multimedia processors; the Company’s ability to retain existing customers and acquire new customers and respond to competitive market conditions; the Company’s ability to respond in a timely manner to the evolving multimedia market and changing consumer preferences and industry standards and to stay abreast of technological changes; the Company’s ability to secure sufficient foundry capacity in a timely manner; the company’s ability to effectively protect its intellectual property and the risk that it may infringe on the intellectual property of others; and cyclicality of the semiconductor industry. Further information regarding these and other risks is included in Vimicro’s annual report on Form 20-F filed with the Securities and Exchange Commission. Vimicro does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of the date hereof, and Vimicro undertakes no duty to update such information, except as required under applicable law.
Contact:
Vimicro International Corporation
Investor Relations
Phone: +8610-5884-8898
E-mail: ir@vimicro.com
(APDN) SeeThruEquity Initiates Research Coverage Price Target of $5.40
New York, NY – December 23, 2014 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has initiated coverage on Applied DNA Sciences, Inc. (NASDAQ: APDN) with a 12-month price target of $5.40.
The report is available here: APDN Initiation Report. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will also be available on these platforms. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.
“APDN offers biosecurity solutions across a broad spectrum of supply chain security, brand protection and property and business security applications. At the core of all of its biosecurity solutions is APDN’s SigNature DNA, which is based on full, double-stranded plant DNA. SigNature DNA can be incorporated into labeling, packaging and even into products themselves, giving manufacturers a wide range of options. The company recently received a Popular Science Best of What’s New 2014 Award in the Security category for SmokeCloak DNA, and its products and solutions are gaining visibility within many industries looking to enhance product security,” stated Ajay Tandon, CEO of SeeThruEquity. “APDN has also taken some significant recent steps to increase visibility in the company and strengthen the balance sheet. These include a 1-for-60 reverse stock split, an uplisting to the NASDAQ and a $9.1mn public offering. APDN is actively looking to expand the end market potential for its products, and has announced a string of contract wins over the past few quarters. We see the opportunity for significant growth in the upcoming quarters for APDN. We are initiating coverage with a 12-month price target of $5.40 per share.”
Additional investment highlights are as follows:
Unique solutions for growing, global counterfeiting crisis
According to the International AntiCounterfeiting Coalition, the projected value of global trade in counterfeit and pirated goods could approach $1.8 trillion in 2015. According to research from Davis Wright Tremaine LLP, the market for counterfeit goods and pirated property represents approximately 5-7% of global trade. This translates to between $500 billion and $600 billion annually. APDN uses the DNA of everyday plants to mark objects in a unique manner that it believes cannot be replicated, and then identify these objects by detecting the absence or presence of the DNA. APDN offers a variety of marking and biosecurity solutions, and looks to seamlessly customize the insertion of its markers into a manufacturer’s production process.
Wide variety of end market applications for APDN’s technology
APDN has been very measured in expanding into its current markets of microelectronics, textiles and security marking solutions. APDN plans to continue to focus its efforts on target vertical markets that are characterized by a high level of vulnerability to counterfeiting, product diversion, piracy, fraud, identity theft, and unauthorized intrusion into physical locations and databases. Future target markets of note include homeland security, law enforcement, identification cards and secure documents, pharmaceuticals, consumer products, fine wine and art and collectibles. APDN’s DNA technology can be embedded into a range of host carriers such as ink, varnish, thread, laminates and metal coatings. It can also be incorporated into liquids, plastic, fiber, metals and other composite materials, making the end market potential practically limitless.
NASDAQ uplisting and private placement highlight recent events
On October 29, 2014, APDN announced a 1-for-60 reverse split of its common stock. This was done in part to prepare the company for an uplisting to NASDAQ, which was then announced on November 17, 2014. The common stock and warrants of APDN both trade on the NASDAQ under the symbols APDN and APDNW, respectively. On November 17th, APDN also announced the pricing of an underwritten public offering. The offering closed on November 20, 2014 and the gross proceeds to APDN were approximately $9.1 million before deducting the underwriting discount and other offering expenses. APDN intends to use the net proceeds from the offering to fund working capital, repurchase warrants, and for business development and research and development purposes. The uplisting and capital raise should give APDN increased visibility to a broad new range of investors.
Please review important disclosures on our website at www.seethruequity.com.
About Applied DNA Sciences Inc.
APDN is a provider of botanical-DNA based security and authentication solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature(R) DNA describes the uncopyable marker that is at the heart of all of our security and authentication solutions. SigNature DNA is at the core of a family of products such as DNAnet(R), our anti-theft product, SigNature(R)T, targeted toward textiles, and digitalDNA(R), providing powerful track and trace. All provide a forensic chain of evidence and can be used to prosecute perpetrators.
For more information, please visit the company’s website at www.adnas.com.
About SeeThruEquity
SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. We do not conduct any investment banking or commission based business. We are approved to contribute our research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks and distribute our research to our database of opt-in investors. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.
For more information visit www.seethruequity.com.
Contact:
Ajay Tandon
SeeThruEquity
info@seethruequity.com
(SPCB) Names Shai Vardi as VP of Secure Financial Solutions
HERZLIYA, Israel, December 23, 2014 —
SuperCom (NASDAQ: SPCB), a leading provider of Digital Security Solutions for e-Government, Public Safety, HealthCare, and Mobile Payment solutions announced today that it has named Mr. Shai Vardi as its new VP of Secure Financial Solutions.
Mr. Shai Vardi brings over 20 years of experience as an executive in the technology industry, including managing large scale divisions with over a thousand employees and hundreds of million dollar projects. He is an expert in Financial Technology, Cyber Security and Home land security.
Mr. Vardi previously served for 10 years as an Executive Vice President & CIO at Israel Discount bank (DSCT:IT), where he lead the bank’s technology and planning divisions and global IT operations. Prior to that, he served for 7 years as Commander / Colonel in the Israel National Police as the head of information technology.
“We are very pleased to welcome Shai to the SuperCom family. Given his strong background in information technology, secure banking and financial services along with his deep understanding of customer needs in the finance and banking sectors globally, we expect he will be a very valuable asset. We look forward to him helping us better serve the fast growing global e-banking and payments sectors as we move ahead with our strategy to become a key mobile payment Solution provider.” commented Mr. Arie Trabelsi, President of SuperCom.
“I am very proud to join SuperCom. I see in SuperCom a great opportunity as a fast growing company and believe that its solutions for secure mobile payments can quickly make it a true market leader in the space. This advanced secure mobile payments suite that ranges from mobile wallet to mobile POS , allowing customers to securely make payments using any mobile device and merchants to turn any mobile device or any existing POS into as a secure mobile payment POS,” commented Mr. Shai Vardi.
About SuperCom
Since 1988, SuperCom has been a leading global provider of traditional and digital identity solutions, providing advanced safety, identification and security solutions to governments and organizations, both private and public, throughout the world. Through its proprietary e-Government platforms and innovative solutions for traditional and biometrics enrollment, personalization, issuance and border control services, SuperCom has inspired governments and national agencies to design and issue secured Multi-ID documents and robust digital identity solutions to its citizens and visitors. SuperCom offers a unique all-in-one field-proven RFID & mobile technology and product suite, accompanied by advanced complementary services for various industries including healthcare and homecare, security and safety, community public safety, law enforcement, electronic monitoring, livestock monitoring, and building and access automation.
SuperCom’s website: http://www.supercom.com
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. Statements preceded or followed by or that otherwise include the words “believes”, “expects”, “anticipates”, “intends”, “projects”, “estimates”, “plans”, and similar expressions or future or conditional verbs such as “will”, “should”, “would”, “may” and “could” are generally forward-looking in nature and not historical facts. Forward-looking statements in this release also include statements about business and economic trends. Investors should also consider the areas of risk described under the heading “Forward Looking Statements” and those factors captioned as “Risk Factors” in the Company’s periodic reports under the Securities Exchange Act of 1934, as amended, or in connection with any forward-looking statements that may be made by the Company. These statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements arising from the annual audit by management and the Company’s independent auditors. The Company undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
Investor Relations Contacts:
Matthew Selinger
MZ Group Tel:
Tel: +1-949-298-4319
mselinger@mzgroup.us
Company Contact:
Ordan Trabelsi, President, North America
1 212 675 4606
ordan@supercom.com
(KNDI) China’s Science and Technology Minister Back Micro Public EV Model
JINHUA, China, Dec. 23, 2014 — Kandi Technologies Group, Inc. (the “Company” or “Kandi”) (Nasdaq:KNDI), today announced that a seminar on China’s innovative electric vehicle business model for the public transportation was hosted in Hangzhou on December 19. The top Chinese government officials, and other environmental and transportation experts including China’s Science and Technology Minister Wan Gang attended the event. The delegation group visited the headquarter of Kandi Electric Vehicles Group Co., Ltd. (the “JV Company”)*, and the Micro Public EV Time-Sharing Program (“Car-Share Program”)’s smart vertical garage, one of the on-street parking/charging stations, as well as the multimedia dispatching center.
Mr. Hu Xiaoming, Chairman & CEO of Kandi provided a detailed introduction on the new electric vehicle business model, the Car-Share Program to the delegation group. At present, there were 9,850 Kandi Brand electric vehicles (“EVs”) in total delivered in Hangzhou. Zhang Genming, Mayor of Xihu District Government addressed that Xihu District as the first to launch the Car-Share Program in the nation has achieved a noticeable progress in alleviating traffic congestions and would continue the effort to promote and support the program. Furthermore, Zhang Hongming, Mayor of Hangzhou, the researcher from Development Research Center of the State Council, Zhang Yongwei, the Secretary of ChinaEV100, as well as the senior officials and department leaders from Ministry of Science and Technology, National Development and Reform Commission, Ministry of Finance, Ministry of Industry and Information Technology, Ministry of Transport and other experts also recognized and acknowledged the success of the Car-Share business model.
Most importantly, Wan Gang, the Vice Chair of the National Committee of the Chinese People’s Political Consultative Conference (CPPCC) & Minister of China’s Science and Technology Ministry reinforced the value and importance of Kandi’s Car-Share business model and said in his final remarks: “The Car-Share Program is highly recognized. In order to increase the popularity of the electric vehicle, the market shall be ready with the strong infrastructure and government supporting policies. There are enormous potential demands in the Car-Share Program in China. The market growth today is driven by the business innovation, in my opinion, the Car-Share Program will most likely transform the market demand into the reality.”
Kandi’ s Car-Share business model has earned the recognition, affirmation, and endorsement from all the government officials at the seminar. With the government’s guidance suggested, Kandi’s Car-Share business model as innovative public transportation role model in China will have a great impact on development of EV industry and urban public transportation in China.
* The JV Company is a 50/50 joint venture between Kandi and Geely Automobile.
About Kandi Technologies Group, Inc.
Kandi Technologies Group, Inc. (Nasdaq:KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicle products. Kandi has established itself as the one of the world’s largest manufacturers of pure electric vehicle (“EV”) products, Go-Kart vehicles, three-wheel motorcycles and utility vehicles (UTVs), among others. More information can be viewed at its corporate website is http://www.kandivehicle.com. Kandi routinely posts important information on its website.
Safe Harbor Statement
This press release contains certain statements that may include “forward-looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on the SEC’s website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CONTACT: Kandi Technologies Group, Inc. Ms. Kewa Luo Phone: 1-212-551-3610 Email: IR@kandigroup.com
(CAR) Applauds Volkswagen and Hyundai for Canadian Car of the Year Awards
TORONTO, Dec. 23, 2014 — Avis Budget Group’s Canadian operations today congratulated Volkswagen Group Canada Inc. and Hyundai Auto Canada Corp. for winning recognition for manufacturing some of Canada’s best new vehicles. The car manufacturers were recently honored by the Automobile Journalists Association of Canada (AJAC) with the Canadian Car of the Year “Best New” Awards. The Association named the 2015 Volkswagen Golf as the “Best New Small Car over $21,000,” the 2015 Hyundai Sonata as the “Best New Family Car over $30,000” and the 2015 Hyundai Genesis as the “Best New Luxury Car over $50,000.”
Avis Budget Group is proud to feature all three award-winning vehicles in its 2015 model-year fleet, available for rent at select Avis Car Rental and Budget Car Rental locations across Canada.
The winners were selected by a group of Canada’s best-known automotive journalists who conducted a five-day test-drive of brand-new or significantly-changed vehicle models. The vehicles were driven on public roads under the same conditions to ensure fair and objective comparisons.
“Test Fest, as the test-drive event is commonly known, is one of the most rigorous vehicle evaluation programs in Canada,” said Roman Zelyk, director of fleet operations, Canada, Avis Budget Group. “We applaud Volkswagen and Hyundai on their wins.”
Avis Car Rental serves customers at nearly 200 Canadian locations, at airports large and small as well as metropolitan and local market facilities in all ten provinces. Budget Car Rental, with approximately 300 locations across Canada, at all major airports and in all major cities, is conveniently located to serve customers in all ten provinces.
About Avis Budget Group
Avis Budget Group, Inc. (Nasdaq:CAR) is a leading global provider of vehicle rental services, both through its Avis and Budget brands, which have more than 10,000 rental locations in approximately 175 countries around the world, and through its Zipcar brand, which is the world’s leading car sharing network, with more than 900,000 members. Avis Budget Group operates most of its car rental offices in North America, Europe and Australia directly, and operates primarily through licensees in other parts of the world. Avis Budget Group has approximately 29,000 employees and is headquartered in Parsippany, N.J. More information is available at www.avisbudgetgroup.com.
CONTACT: Alice Pereira (973) 496-3916 PR@avisbudget.com
(VRML) Announces Equity Financing of up to $18.9 Million; Suspends ATM Program
AUSTIN, Texas, Dec. 23, 2014 — Vermillion, Inc. (Nasdaq: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today that investors including Oracle Investment Management, Jack W. Schuler, Birchview Fund LLC and several Vermillion directors have agreed to purchase approximately $10.5 million of unregistered shares of Vermillion’s common stock and warrants to purchase unregistered shares of Vermillion common stock in a private placement.
Under the terms of the private placement, Vermillion has agreed to sell an aggregate of 6,944,445 shares of its common stock at the price of $1.44 per share, the closing price quoted on NASDAQ on December 18, 2014. In addition, the investors will receive warrants to purchase up to an aggregate of 4,166,659 shares of Vermillion common stock at an exercise price of $2.00 per share. The warrants become exercisable six months after the closing of the private placement and have a term of three years from the date of issuance. If and when the warrants are exercised, the company will realize an additional $8.3 million in proceeds, bringing the total investment to approximately $18.9 million, before transaction costs.
In connection with the transaction, Vermillion agreed to use commercially reasonable efforts to file as soon as reasonably practicable but no later than 60 days after the closing a registration statement with the Securities and Exchange Commission to register the resale of both the shares and the shares underlying the warrants issued at the closing.
The private placement is expected to close on or about December 23, 2014, subject to customary closing conditions. The proceeds will be used for working capital and general corporate purposes.
“We are pleased with the success of this capital raise. It will provide the funds necessary to propel our commercial transition,” said James LaFrance, Chairman, President and Chief Executive Officer of Vermillion. “With this additional round of financing, we are also suspending our at-the-market offering.”
“I am very excited about the year we have in front of us. This investment represents a commitment from our current investors in our ‘new’ team and five year strategy. It is a recognition of our skills and expertise to become a leader in proprietary diagnostic and bio-analytical solutions for the gynecological disease. Our goal is to improve the quality of life one patient at a time, and there are significant unmet clinical needs in gynecologic disease, starting with ovarian cancer,” said Valerie Palmieri, incoming President and Chief Executive Officer of Vermillion.
The funds will enable Vermillion to expedite its Ova2 launch, as well as build our Adnexal mass registry, which is the foundation for portfolio and market expansion.
About Adnexal Masses
- 500,000 – 1 million women experience ovarian masses and 150,000 – 300,000 women have suspicious ovarian tumors removed annually in the US.
- Ovarian cancer is rarely diagnosed in early stages and has the highest mortality rate of all gynecological cancers.
- Over 65,000 OVA1 tests have been ordered to date.
- Vermillion has launched ASPiRA Labs, a CLIA certified national clinical lab, to serve as a cutting-edge biomarker diagnostics center for gynecological cancers.
About OVA1
- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and trigger the involvement of a specialist (gynecologic oncologist) for higher risk patients
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical “risk score” that stratifies patients into “higher risk” and “lower risk” when combined with clinical assessment
- In two pivotal clinical trials, (Ueland FR, DeSimone CP, Seamon et al. Obstetrics & Gynecology 2011;117:1289-1297; Bristow RE, Smith A, Zhang Z et al. Gynecologic Oncology 2013;128:252-259) OVA1 plus clinical impression detected 96% of all malignancies vs. 75% for clinical impression alone. It subsequently reduced the number of malignancies missed from 25% to 4%, a reduction of 83%.
- For early-stage cancers specifically, 31% were missed by clinical impression alone. This was reduced to 5% when OVA1 was added to clinical impression, a reduction of 85%.
- Vermillion is currently developing a next-generation test, OVA2, which has an expected release in the second half of 2015.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities. The securities offered and sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration under the Securities Act and applicable state securities laws.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company’s lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995 that involve significant risks and uncertainties, including statements regarding the closing of the private placement, the exercise of the warrants and the expected use of proceeds. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ from those projected in such forward-looking statements include but are not limited to: (1) Vermillion’s ability to increase the volume of OVA1 sales; (2) Vermillion’s ability to market its test through sales channels other than Quest Diagnostics; (3) failures by third-party payers to reimburse OVA1 or changes or variances in reimbursement rates; (4) Vermillion’s ability to secure additional capital on acceptable terms to execute its business plan; (5) Vermillion’s ability to commercialize OVA1 outside the United States; (6) Vermillion’s ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; (7) Vermillion’s ability to compete successfully; (8) Vermillion’s ability to obtain any regulatory approval for Vermillion’s future diagnostic products; (9) Vermillion’s suppliers’ ability to comply with FDA requirements for production, marketing and post market monitoring of its products; (10) Vermillion’s ability to maintain sufficient or acceptable supplies of immunoassay kits from its suppliers; (11) Vermillion’s ability to continue to develop, protect and promote its proprietary technologies; and (12) other factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2013 and Vermillion’s Form 10-Q for the quarter ended September 30, 2014 filed with the Securities and Exchange Commission (the “SEC”). Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com
(CRRS) Resource Services Confirms Compliance with Wells Fargo
Corporate Resource Services, Inc. (NASDAQ: CRRS), (the “Company” or, “CRS”), a diversified technology, staffing, recruiting, and consulting services firm, continues to make progress in its refinancing process with investment bank, Carl Marks Advisors. The Company and Carl Marks are currently in discussions with potential new lenders and have received letters which achieved the December 19th, 2014 milestone in its amendment with Wells Fargo Bank, National Association.
“We are pleased to be moving forward in our financing process and are working closely with our current and prospective lenders,” said John P. Messina, Chief Executive Officer of Corporate Resource Services.
About Corporate Resource Services, Inc.
Corporate Resource Services, Inc. provides cloud-based enterprise applications and hosting services to PEO and staffing companies, as well as diversified staffing, recruiting, and consulting services. The Company offers trained employees in the areas of Insurance, Information Technology, Accounting, Legal, Engineering, Science, Healthcare, Life Sciences, Creative Services, Hospitality, Retail, General Business and Light Industrial work. The company’s blended staffing solutions are tailored to our customers’ needs and can include customized employee pre-training and testing, on-site facilities management, vendor management, risk assessment and management, market analyses and productivity/occupational engineering studies.
The Company operates approximately 250 staffing and on-site facilities throughout the United States and the United Kingdom and it offers its services to a wide variety of clients in many industries, ranging from sole proprietorships to Fortune 1000 companies. To learn more, visit http://www.crsco.com.
Makovsky
John McInerney, 212-508-9628
jmcinerney@makovsky.com
(IRMD) Resumes Domestic Distribution of Infusion Pumps
WINTER SPRINGS, Fla., Dec. 22, 2014 — IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems for use during magnetic resonance imaging (MRI) procedures, announced today that it has resumed domestic distribution of its MRI compatible MRidium 3860 IV infusion pump systems.
This follows a September 2, 2014 announcement that the Company received a warning letter from the FDA requesting that it cease commercial distribution of its MRI IV infusion pumps and submit a 510(k). Upon receipt of the warning letter, the Company immediately ceased domestic shipments and began preparing a 510(k) submission. The Company submitted the 510(k) on November 24, 2014 and it was formally accepted for review by the FDA on December 12, 2014. During the FDA’s review of the submission, the Company has resumed sales and domestic distribution of its MRidium 3860 IV infusion pump systems. The separately sold DERS (Dose Error Reduction System) option (P/N 1145) will not be made available again until the pending 510(k) is cleared by the FDA. The FDA is aware of the Company’s resumption of sales and domestic distribution of the 3860 MRI IV infusion pump systems and the Company’s continued withholding of the DERS option. The Company stated it will continue to work with the FDA as it conducts its review of the 510(k) submission.
Chris Scott, the Company’s CFO, stated, “Given the timing of this step we expect a marginal increase in revenue and earnings for the fourth quarter 2014 compared to our guidance and expect to issue 2015 revenue and earnings guidance on January 12th.”
Forward-Looking Statements
This press release includes forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding expectations about future events affecting the Company and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond the Company’s control and could cause the Company’s actual results to differ materially and adversely from those expressed in its forward-looking statements as a result of various factors, including but not limited to: risks related to the Company’s ability to receive clearance of its 510(k) submission, additional actions by or requests from the FDA (including a request to once again cease product distribution) and unanticipated costs or delays associated with resolution of these matters; as well as other factors discussed in the “Risk Factors” section of the Company’s most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. There can be no guarantee that the Company’s efforts will be successful and that it will be able to resume commercial distribution of its IV infusion pumps. Although the Company believes that the expectations reflected in its forward-looking statements are reasonable, it does not know whether its expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. The Company does not undertake any obligation to update, amend or clarify these forward-looking statements or the “Risk Factors” contained in the Company’s most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
About IRADIMED CORPORATION
IRADIMED CORPORATION is the leading provider of non-magnetic IV infusion pump systems that are safe for use during MRI procedures. Electromechanical medical devices and pumps contain magnetic and electronic parts which generate radio frequency noise, create interference and are dangerous to operate in the presence of the powerful magnet which drives an MRI. The company’s MRidium (3850/3860+) IV pump systems have been designed with non-ferrous parts, ceramic ultrasonic motors, non-magnetic mobile stands and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. The company’s pump solution provides a seamless approach to providing IV fluids before, during and after an MRI scan, which is important to critically-ill patients who cannot be removed from their vital medications, and children and infants must generally be sedated in order to remain immobile during an MRI scan. For more information please visit www.iradimed.com. MRidium is a trademark of IRADIMED CORPORATION.
CONTACT: Media Contact: Chris Scott Chief Financial Officer IRADIMED CORPORATION (407) 677-8022 InvestorRelations@iradimed.com
(XNET) Announces An Up to US$20 million Share Repurchase Program
SHENZHEN, China, Dec. 22, 2014 — Xunlei Limited (“Xunlei” or the “Company”) (Nasdaq: XNET), China’s leading provider of acceleration products and services, today announced that its board of directors has approved an up to US$20 million share repurchase program to repurchase Xunlei’s issued and outstanding shares.
“Our management team and Board of Directors have a strong conviction in our core business and long-term prospects. We believe repurchasing our shares is a prudent use of our cash and are pleased that our financial position also allows us to start building Xunlei’s track record of returning value to shareholders,” Mr. Sean Zou, Chairman and Chief Executive Officer of Xunlei, commented.
Xunlei’s share repurchases may be made in accordance with applicable laws and regulations through open market transactions, privately negotiated transactions or other legally permissible means as determined by Xunlei’s management, including through Rule 10b5-1 share repurchase plans. Xunlei expects to implement this share repurchase program over the next 12 months. The timing and extent of any purchases will depend upon market conditions, the trading price of its ADSs and other factors. Xunlei’s Board of Directors will review the share repurchase program periodically, and may authorize adjustment of its terms and size accordingly.
The share repurchase program will be funded using Xunlei’s existing cash balance. As of 30 September, 2014, Xunlei had cash, cash equivalents and short-term investments of approximately US$433 million.
About Xunlei
Xunlei Limited (“Xunlei”) is one of the top 10 largest Chinese Internet companies, with an average of approximately 309 million monthly unique visitors as at September of 2014, according to iResearch. Xunlei is the No. 1 acceleration product provider in China as measured by market share. Xunlei operates a powerful Internet platform in China based on cloud computing to provide users with quick and easy access to digital media content through its core products and services, Xunlei Accelerator and the cloud acceleration subscription services. Xunlei is increasingly extending into mobile devices in part through potentially pre-installed acceleration products in mobile phones and to living rooms through TV coverage. Benefitting from the large user base accumulated by Xunlei Accelerator, Xunlei has further developed various value-added services, including Xunlei Kankan, online game and pay per view, to meet a fuller spectrum of its users’ digital media content access and consumption needs.
Safe Harbor Statement
This press release contains statements of a forward-looking nature. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward- looking statements by terminology such as “will,” “expects,” “believes,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the management’s quotations regarding the share repurchase program contain forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company and the industry. Forward-looking statements involve inherent risks and uncertainties, including but not limited to: the Company’s ability to continue to innovate and provide attractive products and services to retain and grow its user base; the Company’s ability to keep up with technological developments and users’ changing demands in the Internet industry; the Company’s ability to convert its users into subscribers of its premium services; and the Company’s ability to deal with existing and potential copyright infringement claims and other related claims; and the Company’s ability to compete effectively. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results. Further information regarding risks and uncertainties faced by the Company is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of the press release, and the Company undertakes no obligation to update any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.
IR Contact:
Mr. Yuanyuan Chen (English and Chinese)
Investor Relations Director
Mobile +86 139-2337-7882 or +852 6954-7509 in Shenzhen
chenyuanyuan@xunlei.com
PR Contact:
Fleishman-Hillard
Email: hkg.xnet@fleishman.com
(CFRX) FDA Approval to Initiate Clinical Trials of CF-301 for MRSA
YONKERS, NY–(Dec 22, 2014) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) completed the review of its submission and has removed the full clinical hold on ContraFect’s investigational new drug (IND) application for CF-301. This action allows for the initiation of clinical trials, which ContraFect expects to commence in Q1 2015.
Julia P. Gregory, ContraFect’s chief executive officer commented, “CF-301 will be the first recombinant bacteriophage lysin allowed by FDA to advance to human clinical trials, marking a very important step for patients with serious infection. We believe it has great potential to address the global crisis of drug-resistance. CF-301, with its novel mechanism of action and full activity against drug-resistant bacteria and biofilms, is sorely needed to treat these life-threatening infections. We look forward to commencing the Phase 1 trial.”
About CF-301:
CF-301, which was licensed from The Rockefeller University and developed at ContraFect, is a bacteriophage lysin with potent activity against Staph aureus infections. Staph infections occur in both hospital and community settings, and in the United States there are approximately 120,000 cases annually of Staph bacteremia (a bloodstream infection), which causes approximately 30,000 deaths annually. Of further concern, drug-resistant strains of Staph are now evolving and developing additional resistance against standard-of-care antibiotics, which may ultimately result in increased number of cases and mortality from Staph bacteremia. A recent study commissioned by U.K. Prime Minister David Cameron found that without action drug-resistant infections that already kill hundreds of thousands a year globally could exceed 10 million by 2050.
CF-301 is a bacteriophage lysin that has the potential to be a first-in-class treatment for Staph bacteremia. CF-301 has specific and rapid bactericidal activity against Staph. Combinations of CF-301 with vancomycin or daptomycin increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 targets a conserved region of the cell wall that is vital to bacteria, thus making resistance less likely to develop. When used in combination with standard-of-care antibiotics, the result is a novel combination therapy that has the potential to combat the high unmet clinical need of Staph aureus infections.
About ContraFect:
ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions under Section 21E of the Securities Exchange Act of 1034. Forward-looking statements can be identified by words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “projects,” “should,” “will,” “would” or similar references. Forward-looking statements included in this release include statements made regarding the potential that lysins in general or ContraFect’s product candidates specifically will develop into commercially available drugs that are efficacious in combating Staph aureus or other diseases. Forward-looking statements are based on ContraFect’s current beliefs, expectations and assumptions; however, forward-looking statements are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control. Actual results may differ from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ include, among others, the cost, timing and success of clinical trials for ContraFect’s product candidates, whether such clinical trials demonstrate these candidates’ safety and effectiveness, the ability of ContraFect to obtain regulatory approvals required to conduct clinical trials and to commercialize its product candidates, ContraFect’s ability to obtain additional financing to support its research and development in a timely basis and on commercially reasonable terms, ContraFect’s dependence on clinical investigators and personnel, clinical research organizations and consultants and other factors described in the “Risk Factors” and elsewhere in ContraFect’s 10-Qs, 10-Ks and other periodic reports filed with the U.S. Securities and Exchange Commission. Any forward-looking statement contained in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time.
Contact:
Barry Kappel, Ph.D., MBA
SVP Business Development
Tel: 914-207-2300
E-Mail: Email Contact
or visit: www.contrafect.com
(CNET) Online Holdings Signs Strategic Partnership Agreement With MediaFun
BEIJING, Dec. 22, 2014 — ChinaNet Online Holdings, Inc. (Nasdaq:CNET) (“ChinaNet” or the “Company”), a leading B2B (business to business) Internet technology company providing online-to-offline (O2O) sales channel expansion services for small and medium-sized enterprises (SMEs) and entrepreneurial management and networking services for entrepreneurs in the People’s Republic of China, announced today that the Company has signed a long-term strategic partnership agreement with MediaFun Creative Co. (MediaFun), a total solution service platform for cloud print services company based in Taiwan.
MediaFun’s creative printing services platform allows non-professional users to complete the professional design process in a few minutes, and independently modify and print work by customers. The Company’s main products include school graduation memento books, photobooks and personalized photo gifts such as photo albums, cards and other merchandise.
MediaFun’s growth is being fueled by the substantial graduate market in Taiwan, which accounts for approximately 5% of the total population every year. Cloud printing is also being supported by the Taiwan government in an effort to update the traditional print industry. MediaFun sees this partnership opportunity as the beginning of a long-term growth strategy into the expanding China market. MediaFun currently has approximately 250 customers in Taiwan.
Under the terms of the agreement, ChinaNet will leverage its experience and advantages in the SME industry in China to help MediaFun expand its B2b2c market sales marketing to multiple of cities through mobile and internet. MediaFun will in turn share its cloud printing technology to help individuals utilize their print services throughout the China market. The two companies intend to share in profits and commissions under a joint venture agreement.
On December 22, 2014, a signing ceremony was held for the two companies at the Taiwan Trade Center of Beijing.
“We are excited to undertake this new strategic partnership with MediaFun, who is revolutionizing the field of print services,” said George Chu, ChinaNet Online’s Chief Operating Officer. “This cooperative agreement continues our ongoing efforts to expand our marketing and related value-added services for our clients. We in turn look forward to utilizing our deep experience in franchising and the China market to help MediaFun expand its business opportunities. This is a milestone for our company to help an overseas SME to efficiently expand its sales channel in China through ChinaNet services and technology.”
About MediaFun Creative Co.
MediaFun Creative Co.,headquartered in Taiwan, is the first total solution service platform for cloud print services. Founded in 2006, focusing on the integration of prepress workflow, the cloud cultural and creative printing services platform it developed allows non-professional users to complete the professional design process in a few minutes, and independently modify and print work by customers. This service platform is widely used in all types of schools yearbook and personalized market in Taiwan. The main products are the school’s graduation memento book, photo book series, personalized photo gifts, such as photo albums, cards, and personalized merchandise. Taiwan’s Ministry of Economic Affairs approved the MediaFun as R & D subsidies unit; the company awarded several technical R & D subsidies, and selected the display manufacturers of Taiwan famous brand exhibition in 2014.
About ChinaNet Online Holdings, Inc.
The Company, a parent company of ChinaNet Online Media Group Ltd., incorporated in the BVI (“ChinaNet”), is a leading digital B2B (business to business) Internet technology company focusing on providing O2O sales channel expansion service for small and medium-sized enterprises (SMEs) and entrepreneurial management and networking service for entrepreneurs in China. The Company, through certain contractual arrangements with operating companies in the PRC, provides Internet advertising and other services for Chinese SMEs via its portal websites, 28.com, Liansuo.com and Chuangye.com, TV commercials and program production via China-Net TV, and in-house LCD advertising on banking kiosks targeting Chinese banking patrons. Website: http://www.chinanet-online.com.
Safe Harbor
This release contains certain “forward-looking statements” relating to the business of ChinaNet Online Holdings, Inc., which can be identified by the use of forward-looking terminology such as “believes,” “expects,” “anticipates,” “estimates” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including business uncertainties relating to government regulation of our industry, market demand, reliance on key personnel, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission. These forward-looking statements are based on ChinaNet’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting ChinaNet will be those anticipated by ChinaNet. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the Company) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. ChinaNet undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
CONTACT: MZ North America Ted Haberfield, President Direct: +1-760-755-2716 Email: thaberfield@mzgroup.us Web: www.mzgroup.us
(SKYS) Announces Entry Into China Solar Market
HONG KONG, Dec. 22, 2014 — Sky Solar Holdings, Ltd. (Nasdaq:SKYS) (“Sky Solar” or the “Company”), a global renewable energy developer and independent power producer today announced its intention to enter the Chinese solar market. Sky Solar believes that the country is a high-priority growth opportunity due to its large size and rapidly growing renewable energy sector, as well as the Company’s own extensive knowledge of the market.
The Company intends to own fully operational solar assets, as well as build and transfer assets to external third parties which are mainly state-owned conglomerates and public companies. The Company has always planned to target selective provinces with large imbalances between power supply and demand, as well as the most attractive financial strength, based on the ability to make timely payments of feed-in-tariffs.
The Company’s board of directors approved the establishment of legal and operational entities to enter the China market, and authorized the Company’s management team to evaluate acquisition targets to build the operating assets in China. Among the targets under evaluation include solar park and EPC assets owned by private entities controlled by the Company’s Chairman, Mr. Weili Su, which own 165 MW of projects in operation and under construction and 4.9 GW of projects in various stages of development.
Pursuant to the Company’s Corporate Governance Guidelines, a majority of the Company’s directors, including all of the Company’s independent directors, must approve any acquisition of businesses, solar parks or other assets from related parties or independent third parties. All approvals are based on a myriad of factors including but not limited to IRR, technical specifications of the solar project (including sun irradiation hours, components and performance guarantees) and technical, financial and legal due diligence. The Company believes that these strong internal controls ensure that any related-party transaction will occur at a fair market price. In addition, under the Company’s Corporate Governance Guidelines, two-thirds of all shareholders must also approve certain purchases from related parties that are individually or in the aggregate over the last twelve months equivalent to 20% or more of the Company’s market capitalization.
The Company is also establishing a new business platform, to be named “Sky-Link”, for integrating supply-chain and industry data and analysis, and standardizing solar project quality control and monitoring. The Company will use these capabilities internally as well as offer the services to third parties for a fee. The Company is evaluating a potential acquisition of Changzhou Sky Solar New Energy Technology Co., Ltd. (“Changzhou Sky Solar New Energy Technology”) at fair market value by Sky-Link, in order to quickly enter the solar project quality control and monitoring business. Changzhou Sky Solar New Energy Technology is a well-established vendor of services including (i) PV materials, products and plants testing, (ii) project acceptance inspections, and (iii) solar project supervision. Changzhou Sky Solar New Energy Technology is a related entity controlled by the Company’s Chairman Mr. Su, and accordingly the acquisition would be need to be approved under the Company’s strict Corporate Governance Guidelines.
To quickly establish Sky Solar’s China operations, the Board has approved the transfer of a number of experienced senior leaders from the private entities controlled by Chairman Su to Sky Solar Holdings, Ltd. The Company expects the addition of these experts to provide the market and operating knowledge necessary for the Company to succeed in this initiative. Notable management changes include the appointment of the Company’s current Chief Investment Officer, Mr. Zhi Hao, as the new Managing Director of Sky Solar China. Mr. Yu Hu, a new addition to the Company, will be appointed as Executive Vice President of the Company and President of Sky-Link.
The Company is currently pursuing a number of financing alternatives to implement the proposed transactions associated with this strategic initiative.
About Sky Solar Holdings, Ltd.
Sky Solar Holdings is a global independent power producer (“IPP”) that develops, owns and operates solar parks and generates revenue primarily by selling electricity. Since its inception, Sky Solar has focused on the downstream solar market and has developed projects in Asia, South America, Europe, North America and Africa. The Company’s broad geographic reach and established presence across key solar markets are significant differentiators that provide global opportunities and mitigate country-specific risks. Sky Solar aims to establish operations in select geographies with highly attractive solar radiation, regulatory environments, power pricing, land availability, financial access and overall power market trends. As a result of its focus on the downstream PV segment, Sky Solar is technology agnostic and is able to customize its solar parks based on local environmental and regulatory requirements. As of September 30, 2014, the Company has developed 200 solar parks with an aggregate capacity of 181.7 MW and owns and operates 54.5 MW of solar parks.
Safe-Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends, “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in Sky Solar’s filings with the U.S. Securities and Exchange Commission, including its final prospectus filed pursuant to Rule 424(b)(4). Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: For Additional Information: Company: Matthew Yeh IR@skysolarholding.com Investor Relations: ICR, LLC Gary Dvorchak, CFA Senior Vice President China: +86 (10) 6583-7500 US: +1 (310) 954-1123 gary.dvorchak@icrinc.com
(CFD) and CTF Propose Plan to Convert to ETF Structure
Funds to seek shareholder approval for structure change that seeks a closer alignment between market price and net asset value
Nuveen Investments, a leading global provider of investment services to institutions as well as individual investors, today announced that Nuveen Commodities Asset Management (“NCAM”), the manager for the Nuveen Diversified Commodity Fund (NYSE MKT: CFD) and the Nuveen Long/Short Commodity Total Return Fund (NYSE MKT: CTF), has approved a plan to convert the Funds into open-end exchange-traded funds (“ETFs”). The purpose of the conversion plan is to seek a closer alignment between the funds’ share price and net asset value (“NAV”). The conversion of the funds to ETFs will be subject to shareholder and regulatory approvals. The funds are not currently, and after the conversion will not be, mutual funds or any other type of investment company within the meaning of the Investment Company Act of 1940.
The funds are currently structured as actively managed closed-end commodity pools. After the conversion, the funds will remain actively managed commodity pools, but they will adopt an open-end ETF structure. Under the ETF structure, investors will continue to be able to buy and sell shares of the funds on the exchange (as part of the conversion plan, the funds intend to apply to list their shares on the NYSE Arca) throughout the day at market price. In addition, the funds will adopt the creation/redemption process commonly employed by ETFs for the purpose of promoting the trading of the funds’ shares at prices equal to or near their NAV, although there can be no assurance that this process will be successful.
The conversion plan is subject to certain conditions, including shareholder and regulatory approvals. A proposal to convert the funds to ETFs will be submitted to a vote at each fund’s next annual meeting of shareholders, expected to be held on or before March 31, 2015. Prior to its annual meeting, each fund plans to file relevant materials, including a proxy statement relating to the conversion plan, with the Securities and Exchange Commission (“SEC”). Promptly after filing its definitive proxy statement, each fund will mail the proxy statement and a proxy card to each shareholder entitled to vote at the annual meeting. Shareholders are urged to thoroughly read the proxy statements (including any supplements thereto) and any other relevant documents that the funds file with the SEC when they become available, as they will contain important information. Shareholders will be able to obtain, free of charge, copies of the proxy statements and any other documents filed by the funds with the SEC in connection with the annual meetings at the SEC’s website at www.sec.gov, by calling NCAM at 877-827-5920 or by writing the funds at 333 W. Wacker Drive, Chicago, Illinois, 60606.
The conversion plan is also contingent on approval of the funds’ listing on the NYSE Arca by the exchange and the SEC, as well as other customary regulatory approvals. Assuming shareholder and regulatory approvals are obtained, NCAM anticipates that the conversion will be completed within approximately 8 to 10 months. As progress is made, updates will be provided periodically with respect to the conversion plan and time frame. There can be no assurance that such approvals will be obtained, or if obtained, that the conversions will be completed in the anticipated time frame or will achieve their stated purpose.
Gresham Investment Management, which has actively managed commodity futures investments since 1987 and which currently has over $13 billion in institutional commodity assets under management, will continue to serve as the funds’ commodity subadviser. CFD invests long in a diversified portfolio of approximately 30 exchange-traded commodity futures and options contracts in energy, agriculture, livestock, and metals. CTF invests in a long/short strategy which changes positions based on commodity price momentum, holding long, short, or flat positions in approximately 20 exchange-traded commodity futures and options contracts in energy, agriculture, livestock, and metals.
Until the conversion occurs, the funds expect to continue to pay regular monthly distributions and that the open-market share repurchase programs will remain active. As market conditions and portfolio performance may change, the funds’ distribution policies, distribution amounts, and/or frequency could change.
Investors planning to purchase shares of the funds prior to year end should refer to the tax section of their respective Information Statements, review the detailed Tax Q&A located on the Funds’ website, and consult their tax advisors. Investors who buy shares at a discount to NAV and hold them through year end may be subject to an acceleration of capital gain recognition. Important information regarding the funds’ investment strategies and risks is set forth in their respective Information Statements available on the funds’ website.
Investments in shares of the funds are subject to investment risk, including the possible loss of the entire amount invested. The funds invest primarily in commodity futures contracts and options on commodity futures contracts, which have a high degree of price variability and are subject to rapid and substantial price changes. The funds could incur significant losses on their commodity investments. The funds are not mutual funds, closed-end funds, or any other type of “investment company” within the meaning of the Investment Company Act of 1940, as amended, and are not subject to regulation thereunder. For more information about the funds, including a more complete description of risks, please see the funds’ website.
This is not a solicitation to buy or sell the funds’ shares, nor is it a solicitation of any proxy. The funds do not presently offer any new shares for sale; existing shares trade on the NYSE MKT.
Nuveen Investments provides high-quality investment services designed to help secure the long-term goals of institutional and individual investors as well as the consultants and financial advisors who serve them. Nuveen Investments markets a wide range of specialized investment solutions which provide investors access to capabilities of its high-quality boutique investment affiliates—Nuveen Asset Management, LLC, Symphony Asset Management LLC, NWQ Investment Management Company, LLC, Santa Barbara Asset Management, LLC, Tradewinds Global Investors, LLC, Winslow Capital Management, LLC and Gresham Investment Management LLC, all of which are registered investment advisers and independent investment subsidiaries of Nuveen Investments, Inc. Nuveen Commodities Asset Management, LLC (“NCAM”) NCAM is the manager of the Funds. NCAM is registered as a commodity pool operator (“CPO”) with the Commodity Futures Trading Commission (“CFTC”). Nuveen Investments operates as a separate subsidiary within TIAA-CREF, which is a leading provider of retirement and financial services in the academic, research, medical and cultural fields. In total, Nuveen Investments managed approximately $229 billion as of September 30, 2014. For more information, please visit the Nuveen Investments website at www.nuveen.com.
Forward-Looking Statements
This press release includes forward-looking statements, including statements concerning the purposes and timing of the conversion plan, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or the negative of these terms or other comparable terminology. These forward-looking statements are based on current expectations, estimates and projections and are subject to a number of risks, uncertainties and other factors, both known and unknown, that could cause the actual results, performance, prospects or opportunities of the funds to differ materially from those expressed in, or implied by, these forward-looking statements.
You should not place undue reliance on any forward-looking statements. Except as expressly required by the federal securities laws or otherwise, the funds undertake no obligation to publicly update or revise any forward-looking statements or the risks, uncertainties or other factors described in this press release, as a result of new information, future events or changed circumstances or for any other reason after the date of this press release.
4953-INV-O12/15
Nuveen Investments
Media Contact:
Kristyna Munoz
(312) 917-8343
KRISTYNA.MUNOZ@NUVEEN.COM
(FLML) econd Clinical Trial With Micropump(R) Sodium Oxybate
Results Confirm Elimination of the “Middle-of-the-Night Dose” Achieved in Previous Study Meeting With FDA Will Be Requested in the First Quarter of 2015
LYON, FRANCE–(Dec 19, 2014) – Flamel Technologies (NASDAQ: FLML) today announced that its second clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, confirming the results of a previous, first-in-man, study. The current dosing regimen for the standard of care, Xyrem® (sodium oxybate), in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later. The elimination of the second dose for narcolepsy patients would not only provide more convenience, but may improve the benefit sodium oxybate provides as there will be no disruption to nighttime sleep. The potential for additional benefits, including improved safety, will be studied.
The trial was designed as a 2-arm study with 12 patients in each arm evaluating two different formulations of Micropump® sodium oxybate at a nightly dose of 4.5g, 6g and 7.5g. Each subject consumed a standard meal two hours prior to dosing. Subjects were instructed to maintain a consistent meal time and dosing schedule throughout the study. One subject dropped out of the study prior to the completion of the 7.5g dosing portion for reasons unrelated to drug. The data for both formulations at the 4.5g and 6g doses were consistent with the data seen in the previous study which showed:
- Onset of action similar to Xyrem
- Cmax lower than Xyrem
- Mean blood concentration (ug/ml) at hours 7 and 8 similar to Xyrem
The data at the 7.5g dose for both formulations were consistent with expectations given the data generated at the lower doses. While both formulations were successful, Flamel has chosen to move forward with the optimal formulation.
To date, Micropump® sodium oxybate has been tested in 40 healthy subjects across three doses among three different formulations with no safety or tolerability issues.
Flamel plans to meet with the U.S. Food and Drug Administration (FDA) before the middle of 2015. Based on current expectations, the Company plans to begin registration studies prior to the end of 2015.
Flamel’s Micropump technology is protected by intellectual property through at least 2025 in the United States. Micropump is a proven drug delivery platform for the oral delivery of small molecules.
Narcolepsy is a sleep disorder involving irregular patterns in Rapid Eye Movement (REM) sleep and significant disruptions of the normal sleep/wake cycle. People with narcolepsy experience excessive daytime sleepiness, sleep attacks, cataplexy, sleep paralysis, hallucinations and disrupted nighttime sleep.
Xyrem® is sold in the United States by Jazz Pharmaceuticals plc, in Canada by Valeant Canada Limited (via license from Jazz) and in twenty-two EU countries and Mexico by UCB Pharma Limited (via license from Jazz).
About Flamel Technologies – Flamel Technologies SA’s (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company markets Bloxiverz® (neostigmine methylsulfate) and Vazculep™ (phenylephrine hydrochloride) in the US and licenses the Micropump-based microparticles technology to Recipharm AB for application to the manufacturing under FDA-audited GMP guidelines of Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes chemical and biological drugs formulated with its Micropump® (and its applications to the development of liquid formulations LiquiTime® and of abuse-deterrent formulations Trigger Lock™) and Medusa™ proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
Safe Harbor: This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the launch of Bloxiverz® and Vazculep™ will not be as successful as anticipated; our ability to bring other R&D projects of the former Éclat Pharmaceuticals to market may be unsuccessful; clinical trial results may not be positive or our partners may decide not to move forward; products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; products in development may not achieve market acceptance; competitive products and pricing may hinder our commercial opportunities; we may not be successful in identifying and pursuing opportunities to develop our own product portfolio using Flamel’s technology; and the risks associated with our reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel’s Annual Report on Form 20-F for the year ended December 31, 2013 that has been filed with the Securities and Exchange Commission (SEC). All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.
(PARN) Management Adopts 10b5-1 Trading Plans
OVERLAND PARK, Kan., Dec. 19, 2014 — Parnell Pharmaceuticals Holdings Ltd (Nasdaq:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, reported today that Robert Joseph, President and Chief Executive Offer, and Brad McCarthy, Chief Financial Officer, have each adopted a prearranged trading plan effective December 15, 2014 in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934 and Parnell policy. The 10b5-1 plans call for the personal purchase of shares of company stock by Mr. Joseph and Mr. McCarthy in market transactions which commenced on December 17, 2014.
“I believe strongly in Parnell’s prospects for continued growth and success, as the company continues to advance our diversified animal health product pipeline and expand our commercial activities in the U.S. and worldwide,” said Mr. Joseph. “This is not a Parnell-sponsored stock repurchase, it is personal purchases of PARN stock by Brad and I based on our confidence in Parnell. We have adopted the 10b5-1 plans to ensure the highest level of integrity in our trading.”
Rule 10b5-1 permits officers and directors of public companies to adopt written plans for buying or selling securities in a non-discretionary, prescheduled manner when they are not in possession of material nonpublic information in order to gradually diversify their investment portfolio, to minimize the market effect of stock purchases or sales and to avoid concerns about initiating stock transactions while in possession of material nonpublic information.
About Parnell
Parnell (Nasdaq:PARN) is a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions. Parnell currently markets five products for companion animals and production animals in 14 countries and augments its pharmaceutical products with proprietary software platforms – iKAM and mySYNCH. These innovative technology solutions are designed to enhance the quality of life or performance of animals, while driving customers’ operational efficiency and profitability. Parnell believes its value-added solutions help establish them as a business partner with customers rather than only as a commodity provider, differentiating them from competitors.
For more information on Parnell and its products, please visit www.parnell.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of the U.S. Private Securities Reform Act of 1995. Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “develops,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify forward-looking statements. Forward-looking statements represent management’s present judgment regarding future events and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding Parnell’s research and development activities, its ability to conduct clinical trials of product candidates and the results of such trials, as well as risks and uncertainties relating to litigation, government regulation, economic conditions, markets, products, competition, intellectual property, services and prices, key employees, future capital needs, dependence on third parties, and other factors, including those described in Parnell’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on September 15, 2014, along with our other reports filed with the SEC. In light of these assumptions, risks, and uncertainties, the results and events discussed in the forward-looking statements contained in this press release might not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Parnell is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise.
CONTACT: Parnell Pharmaceuticals Holdings Brad McCarthy, 913-274-2100 brad.mccarthy@parnell.com BCC Partners Karen Bergman, 650-575-1509 kbergman@bccpartners.com Susan Pietropaolo, 845-638-6290 spietropaolo@bccpartners.com
(ADXS) Completes $17 Million Financing
PRINCETON, N.J., Dec. 19, 2014 — Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that it has executed definitive securities purchase agreements with two institutional investors for gross proceeds of approximately $16.7 million in a registered direct offering of approximately 3.9 million shares at a price of $4.25 per share.
Adage Capital Management, L.P. (Adage) was the lead investor in this financing, with certain funds and accounts managed by T. Rowe Price Associates, Inc. also participating in the transaction. Proceeds from this financing will be used primarily to fund the continued clinical development of Advaxis’s cancer immunotherapy pipeline.
Adage was founded in 2001 by Robert Atchinson and Phillip Gross. Adage is a Boston based institutional money manager.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’s ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.
Advaxis’s second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. (“Merck”), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis’s Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.
Advaxis is also developing Lm-LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-cHER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.
For more information please visit www.advaxis.com.
Forward-Looking Statements
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2013, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
CONTACTS: |
Company: |
Advaxis, Inc. |
Greg Mayes, Executive Vice President and COO |
mayes@advaxis.com |
609.452.9813 ext. 102 |
Media Contact: |
Tiberend Strategic Advisors, Inc. |
Amy S. Wheeler |
awheeler@tiberend.com |
646.362.5750 |
(VHC) & (MSFT) Settle Pending Patent Disputes
ZEPHYR COVE, Nev. and REDMOND, Wash., Dec. 19, 2014 — VirnetX Holding Corporation (NYSE MKT: VHC) and Microsoft Corporation announced today that on December 17, 2014, VirnetX, Inc. and Microsoft Corporation have signed an Amended Settlement and License Agreement. This agreement amends and restates certain terms of the original Settlement and License Agreement, dated May 14, 2010, between VirnetX, Inc. and Microsoft Corporation. As a result of the agreement, the parties have settled their pending patent disputes.
Under the terms of the amended agreement, Microsoft has agreed to pay $23 million to VirnetX to settle the patent dispute and expand Microsoft’s license. The parties have also agreed to dismiss the patent infringement case brought by VirnetX, Inc. before the U.S. District Court for the Eastern District of Texas and jointly move to terminate the pending inter partes review proceedings between Microsoft and VirnetX, Inc. as to Microsoft. All other aspects of the agreement were not disclosed.
“We are pleased to have come to an agreement with Microsoft Corporation and put all our legal disputes behind us,” said Kendall Larsen, Chief Executive Officer and Chairman of VirnetX, Inc. “This agreement allows us to focus our resources towards the release of our Gabriel Secure Communication Platform™ and Gabriel Collaboration Suite™ products in the first-half of 2015 and our ongoing licensing and strategic partnership efforts.”
“Microsoft Corporation is pleased to have come to an agreement with VirnetX and that the settlement includes an expanded license to VirnetX’s entire patent portfolio,” said a Microsoft spokesperson.
About Microsoft
Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services, devices and solutions that help people and businesses realize their full potential.
About VirnetX
VirnetX Holding Corporation is an Internet security software and technology company with patented technology for secure communications including 4G LTE security. The Company’s software and technology solutions, including its secure domain name registry and GABRIEL Connection Technology™, are designed to facilitate secure communications and to create a secure environment for real-time communication applications such as instant messaging, VoIP, smartphones, eReaders and video conferencing. The Company’s patent portfolio includes over 107 U.S. and international patents with over 100 pending applications. For more information, please visit www.virnetx.com.
Forward Looking Statements
Statements in this press release that are not statements of historical or current fact, including statements regarding the strength of Virnetx’s intellectual property, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on expectations, estimates and projections about the markets in which the Company operates, management’s beliefs, and certain assumptions made by management and involve known and unknown risks, uncertainties and other unknown factors that could cause the actual results of the Company to be materially different from the historical results or from any future results expressed or implied by such forward-looking statements, including but not limited to (1) the outcome of any legal proceedings that have been or may be initiated by the Company or that may be initiated against the Company;, including pending and future inter partes review proceedings in the Patent and Trademark Office (2) the ability to capitalize on the Company’s patent portfolio and generate licensing fees and revenues; (3) the ability of the Company to be successful in entering into licensing relationships with its targeted customers on commercially acceptable terms; (4) potential challenges to the validity of the Company’s patents underlying its licensing opportunities; (5) the ability of the Company to achieve widespread customer adoption of the Company’s GABRIEL Communication Technology™ and its secure domain name registry; (6) the level of adoption of the 3GPP Series 33 security specifications; (7) whether or not the Company’s patents or patent applications may be determined to be or become essential to any standards or specifications in the 3GPP LTE, SAE project or otherwise; (8) the extent to which specifications relating to any of the Company’s patents or patent applications may be adopted as a final standard, if at all; and (9) the possibility that Company may be adversely affected by other economic, business, and/or competitive factors. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” or “plans” to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s reports and registration statements filed with the Securities and Exchange Commission, including those under the heading “Risk Factors” in Company’s Quarterly Report on Form 10-Q filed with the SEC on November 10, 2014. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict. Except as required by law, the Company is under no duty to update any of the forward-looking statements after the date of this press release to conform to actual results.
Contact:
Greg Wood
VirnetX Holding Corporation
775.548.1785
greg_wood@virnetx.com
David Cuddy
Microsoft Corporation
425.421.2502
dcuddy@microsoft.com
VirnetX and GABRIEL Connection Technology are trademarks of VirnetX Holding Corporation. Other company and product names may be trademarks of their respective owners
(TRXC) Pre-Clinical Robotic Surgical Procedures Complete; FDA Timeline Affirmed
SurgiBot system FDA 510(k) filing on track for mid-2015 submission
TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the successful completion of four general surgery and urology procedures using its SurgiBot system patient-side robotic surgery system. Management also stated that the preparation of its FDA 510(k) filing is proceeding as planned, and affirmed prior guidance of its intention to submit the filing in mid-2015.
Using the SurgiBot system in the porcine model, Dr. Juan-Carlos Verdeja, a general surgeon and Chief of General Surgery at Baptist Health Medical Group in Miami, performed two cholecystectomy (gallbladder removal) procedures, and Dr. Michael N. Ferrandino, a urologist and Director of Minimally Invasive Urologic Surgery at the Duke Division of Urology, performed two nephrectomy (kidney removal) procedures.
“The SurgiBot system has the ability to offer multiple instruments and a camera through a single small incision. It is designed to limit surgical trauma while enabling the surgeon with advanced vision, dexterity and control,” said Dr. Verdeja. “I was impressed with the system’s capabilities, providing ergonomic benefits as well as excellent visualization in 3DHD. Being able to perform the procedure from within the sterile field, and with tactile feedback, increases the control a surgeon has when performing surgery.”
Dr. Ferrandino commented, “I can envision the SurgiBot being utilized in a wide variety of surgical procedures. This system provides an elegant and effective combination of the best of single-port, laparoscopic and robotic approaches in surgery.”
“These pre-clinical procedures support our expectation for commercial success with the SurgiBot,” said Todd M. Pope, president and CEO of TransEnterix. “We are pleased with our progress and our FDA 510(k) filing remains on track for a mid-2015 submission.”
About SurgiBot
The SurgiBot system, currently in development, is a minimally invasive, patient-side robotic surgery system. The system utilizes flexible instruments through articulating channels controlled directly by the surgeon, with robotic assistance, at the patient’s bedside. The flexible nature of the system allows for multiple instruments to be introduced and deployed through a single incision. The SurgiBot system has not been cleared by the FDA for use the in United States.
About TransEnterix
TransEnterix is a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery. The company is focused on the development and commercialization of the SurgiBot system, a minimally invasive surgical robotic system that allows the surgeon to be patient-side within the sterile field. For more information, visit the company’s website at www.transenterix.com.
Forward Looking Statements
This press release includes statements relating to the SurgiBot system, our flexible energy device and our current regulatory and commercialization plans for these products. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations, including whether we will successfully submit our SurgiBot system regulatory filings in mid-2015, whether we will be able to successfully commercialize the SurgiBot system and whether the SurgiBot system will be able to be utilized in a wide variety of procedures. Factors that could cause our results to differ materially from those described include, but are not limited to, whether the SurgiBot system’s 510(k) application(s) will be cleared by the U.S. FDA. For a discussion of the most significant risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2013 filed on March 5, 2014 as amended, and other filings we make with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
Investor Contact:
Westwicke Partners
Mark Klausner, 443-213-0501
transenterix@westwicke.com
or
Media Contact:
TransEnterix, Inc.
Mohan Nathan, 919-917-6559
mnathan@transenterix.com
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