Archive for September, 2016
$VCYT Major #Medicare Coverage Milestone for #Percepta – #LungCancer
Conference Call and Webcast Today at 11:00 a.m. Eastern
SOUTH SAN FRANCISCO, Calif., Sept. 8, 2016 — Veracyte, Inc. (NASDAQ: VCYT) today announced that Noridian Healthcare Solutions, the nation’s largest Medicare Administrative Contractor (MAC), has issued a draft local coverage determination (LCD) for the Percepta Bronchial Genomic Classifier. When finalized, this LCD will enable coverage for over 30 million – or more than half – of the Medicare beneficiaries in the United States. The Percepta classifier is the first genomic test for use in lung cancer diagnosis to achieve this important Medicare coverage milestone. The test is supported by multiple published studies demonstrating its ability to make lung cancer screening and diagnosis more accurate and safe by reducing unnecessary surgeries on suspicious lung nodules found on computed tomography (CT) scans.
The draft local coverage determination posted online by Noridian establishes the Percepta coverage policy for Medicare beneficiaries in the MAC’s 14-state jurisdiction and provides coverage for the more than 17 million Medicare Advantage members nationwide. Noridian’s jurisdiction includes California, where Veracyte performs and bills for the molecular test. The LCD specifies coverage for the use of Percepta in patients with an inconclusive bronchoscopy to identify those who may be followed with CT surveillance in lieu of further invasive biopsies or surgery. Under CMS rules, the draft LCD is open to a 45-day public comment period. The company anticipates the final LCD will be issued and go into effect on or about January 1, 2017.
“This is a tremendous achievement for the company,” said Bonnie Anderson, president and chief executive officer of Veracyte. “The strength of the evidence supporting Percepta met a high bar for coverage established by the Medicare MolDx Program and serves as a solid foundation for commercial expansion in 2017. We expect that the other MACs that participate in the Palmetto GBA-administered MolDx Program and typically follow its policies will also issue local coverage determinations for Percepta in the future.”
Lung cancer kills nearly 160,000 Americans each year – more than the next three leading cancers combined. In 2015, more than eight million Americans became eligible through Medicare and private insurers for annual lung cancer screening with low-dose CT in an effort to find cancers earlier, when they are more treatable. Veracyte estimates that over 50 percent of these individuals are covered by Medicare.
“Lung cancer screening has the potential to save lives,” said Avrum Spira, M.D., M.Sc., professor of medicine at Boston University School of Medicine and co-inventor of the genomic test. “One of the biggest challenges in lung cancer screening, however, has been the risk of finding lung nodules that are not clearly benign or cancerous. While bronchoscopy is often the initial diagnostic tool used in this setting, it is frequently inconclusive. This often leads to costly and potentially risky surgeries on nodules that ultimately prove to be benign.”
The Percepta test is run following an inconclusive result from bronchoscopy – a minimally invasive procedure that is commonly used to evaluate suspicious lung nodules and lesions found on CT. Clinical validation data from two prospective, multicenter studies were published in July 2015 in The New England Journal of Medicine and demonstrate that the Percepta test identified patients at low risk of cancer with a high degree of accuracy (negative predictive value of 91 percent). The test also increased the accuracy of bronchoscopy (97 percent combined sensitivity for cancer versus 75 percent using bronchoscopy alone). Published clinical utility data suggest that use of the Percepta test could reduce unnecessary surgeries and other invasive procedures by 50 percent. Veracyte estimates the U.S. market opportunity for Percepta to be $425 million to $525 million today and expects the market to increase in size as lung cancer screening expands.
About Percepta
The Percepta Bronchial Genomic Classifier is designed to improve the accuracy and safety of lung cancer screening and diagnosis. The 23-gene classifier identifies patients with lung nodules who are at low risk of cancer following an inconclusive bronchoscopy result, making it possible to monitor these patients with CT scans in lieu of invasive diagnostic procedures. The classifier uses proprietary genomic technology to detect molecular changes that occur in the epithelial cells lining the lung’s respiratory tract in current or former smokers with lung cancer. These changes can be detected in cells obtained from standard brushings taken during bronchoscopy from the mainstem bronchus and indicate the presence of malignancy or disease processes from distant sites in the lung. Thus, the test is designed to determine a lung nodule’s or lesion’s likelihood of cancer, without the need to sample the nodule or lesion directly. The Percepta classifier is performed at Veracyte’s CLIA-certified laboratory in South San Francisco, California. For more information, view the Percepta video.
Conference Call today at 11:00 a.m. Eastern
Ms. Anderson and members of Veracyte’s management team will conduct a live conference call and webcast today at 11:00 a.m. Eastern to discuss the draft Medicare coverage for the Percepta classifier, the clinical and market landscape for the test and the company’s commercialization plans.
The live webcast and subsequent replay may be accessed by visiting Veracyte’s website at http://investor.veracyte.com. Alternatively, please call (855) 541-0980 (U.S.) or (970) 315-0440 (international) to listen to the live conference call. The conference ID number is 70727748. The webcast replay will be available on the company’s website approximately two hours following completion of the call.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for 180 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta® Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. In the fourth quarter of 2016, Veracyte plans to launch its second pulmonology product, the Envisia™ classifier, to improve diagnosis of interstitial lung diseases including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2016 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; the size of the market opportunity for our Percepta Bronchial Genomic Classifier; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; the amount the use of the Percepta Bronchial Genomic Classifier is able to reduce invasive procedures and reduce healthcare costs; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
$EVI Announces #Acquisition of #WesternStateDesign
EnviroStar, Inc. (“EVI”) (NYSE MKT: EVI) today announced that it has executed a definitive asset purchase agreement to acquire substantially all of the assets of Western State Design LLC (“Western State Design”), one of the nation’s largest distributors of commercial, industrial, and coin-operated laundry products and a provider of installation and routine maintenance services. Closing of the transaction is subject to certain closing conditions, including a financing condition, and the closing of the private placement described below. The parties intend to close the transaction promptly after all the closing conditions are satisfied, which is expected to occur within the next 30 to 45 days. The transaction is expected to be accretive to EVI’s earnings in its current fiscal year ending June 30, 2017.
Pursuant to the asset purchase agreement, the purchase price is $28.0 million, of which $18.0 million will be paid in cash at the closing and $10.0 million will be paid in shares of EVI’s common stock. The cash portion of the purchase price will be funded in part by the private sale of 1,290,323 shares of EVI’s common stock to Symmetric Capital II LLC, a company controlled by EVI’s Chairman and Chief Executive Officer, at $4.65 per share, which was the closing price of EVI’s common stock on the NYSE MKT on September 6, 2016. The balance of the cash portion of the purchase price is expected to be funded by a credit facility that EVI intends to enter into with a commercial bank prior to the closing. The total number of shares of common stock to be issued to Western State Design will be 2,044,990. The maximum number of shares of EVI’s common stock to be issued at the closing of the asset purchase agreement will not exceed 19.9% of the total number of shares of EVI’s common stock outstanding at the time of closing. The Company will obtain stockholder approval prior to the issuance of the shares in excess of such amount prior to their issuance.
Founded in 1974 and based in Hayward, California, Western State Design distributes a comprehensive line of commercial and industrial laundry equipment and related parts for new laundry facilities and to the replacement laundry market. Western State Design distributes certain commercial laundry brands on an exclusive basis within the states of California, Oregon, Washington, Alaska, and parts of Nevada, Arizona and Idaho. Western State Design serves over 6,000 customers in the healthcare, hospitality, cruise line, correctional, government, and commercial and coin-operated laundry industries. Under the joint direction of Dennis Mack and Tom Marks, Western State Design has increased its revenues, profitability, and market share, resulting in recognition as one of the leading distributors and service providers in the industry. For the twelve months ended December 31, 2015, Western State Design generated approximately $60.2 million in revenue.
Consistent with EVI’s buy and build strategy and its operating philosophy, Western State Design will operate as a wholly owned subsidiary of EVI under its current name, from its present locations, led by its existing management team and employees, and with the added benefit of EVI’s support and resources to assist Western State Design in the execution of its growth plans. Additionally, following the closing, Dennis Mack will be named a director and executive officer of EVI and Tom Marks will become an executive officer of EVI.
Dennis Mack, President of Western State Design, and Tom Marks, Executive Vice President of Western State Design, jointly said: “On behalf of the entire team at Western State Design, we are very pleased to be joining the EVI family of commercial laundry businesses. EVI’s goal of becoming the industry’s largest and most versatile commercial laundry products distributor and service provider is promising, and we are aligned with EVI’s business plans and long-term growth strategy. We are also excited about the new opportunities our employees will have to continue their mission of providing superior products, exceptional service, and competitive pricing to our valued customers for many years into the future.”
Henry M. Nahmad, EVI’s Chairman and Chief Executive Officer, commented: “We are thrilled to welcome Dennis Mack, Tom Marks, and all of the employees of Western State Design to the EVI family. We recognize that Western State Design’s success is based on a thriving entrepreneurial culture, strong customer relationships, dedicated employees, and a commitment to exceptional service. For those reasons and others, we believe that the addition of Western State Design to the EVI family will benefit EVI and its customers, employees, and stockholders.”
This press release contains only a brief description of the proposed transactions. EVI will file a Current Report on Form 8-K with the Securities and Exchange Commission (the “SEC”) describing in more detail the terms of the acquisition and the private placement.
Additional Information and Where to Find it
In connection with the issuance of the shares of EVI’s common stock under the asset purchase agreement which requires stockholder approval, EVI intends to either (i) file a proxy statement in accordance with Regulation 14A under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or (ii) file an information statement in accordance with Regulation 14C under the Exchange Act, and in each case, other relevant materials with the SEC. The definitive proxy statement or definitive information statement, as the case may be, will also be mailed to EVI’s stockholders, who are urged to read the definitive proxy statement or definitive information statement, as the case may be, and all other relevant documents filed with the SEC, when they become available, because they will contain important information. EVI’s stockholders will be able to obtain these documents (when available) free of charge at the SEC’s web site, http://www.sec.gov. In addition, they may obtain free copies of these documents by contacting EVI’s Secretary at 290 N.E. 68th Street, Miami, Florida 33138, telephone: (305) 754-4551.
If EVI solicits proxies from its stockholders in connection with the issuance of shares of EVI’s common stock under the asset purchase agreement which requires stockholder approval, EVI and certain of its directors and executive officers may be deemed to be participants in such solicitation. A list of the names and other information regarding the directors and executive officers of EVI is available in EVI’s Definitive Proxy Statement for its 2015 Annual Meeting of Stockholders filed with the SEC on October 14, 2015, which can be obtained free of charge from the sources indicated above. Additional information regarding the interests of such potential participants will be included in any definitive proxy statement relating to the stock issuances that require stockholder approval when it becomes available.
Forward Looking Statements
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results, trends, performance or achievements of EnviroStar, or industry trends and results, to differ from the future results, trends, performance or achievements expressed or implied by such forward-looking statements. These risks and uncertainties include, among others, those relating to the proposed acquisition and private placement described in this press release, including that the potential benefits of the proposed acquisition may not be realized to the extent anticipated or at all, integration risks, risks related to the business, operations and prospects of Western State Design, and the risk that the conditions, including financing condition, to closing the proposed private placement and acquisition may not be satisfied and that the proposed private placement and acquisition may not otherwise be consummated when expected, in accordance with the contemplated terms, or at all, and the risks related to EnviroStar’s operations, results, financial condition and growth strategy. Reference is also made to other economic, competitive, governmental, technological and other risks and factors discussed in EnviroStar’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended June 30, 2015 filed with the SEC on September 23, 2015. Many of these risks and factors are beyond EnviroStar’s control. In addition, past performance and perceived trends may not be indicative of future results. EnviroStar cautions that the foregoing factors are not exclusive. Any forward-looking statements relating to the proposed acquisition discussed above are based on EVI’s current expectations, assumptions, estimates and projections and involve significant risks and uncertainties, including the many variables that may impact or are related to consummation of the transaction. EVI assumes no obligation for updating any such forward-looking statements to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking statements.
EnviroStar, Inc.
Henry M. Nahmad, 305-754-4551
or
Venerando J. Indelicato, 813-814-0722
$LPTN & #ApolloEndosurgery Sign #Merger Agreement Creates #Obesity Powerhouse
Merger to create NASDAQ-listed medical device company focused on developing and commercializing minimally-invasive interventional treatments for Obesity
AUSTIN, Texas and SAN DIEGO, Sept. 8, 2016 — Lpath, Inc. (Nasdaq: LPTN) and Apollo Endosurgery, Inc. today announced that they have entered into a definitive merger agreement under which the security holders of Apollo would become the majority owners of Lpath. Under terms of the agreement, Lpath will issue new shares of its common stock or rights to acquire its common stock to Apollo security holders. The Apollo security holders are expected to own approximately 95.8 percent of the combined company and the Lpath security holders are expected to own approximately 4.2 percent of the combined company, subject to adjustments as described in the merger agreement.
Concurrent with the closing of the merger, Apollo’s major investors have committed to invest approximately $29 million of new equity in the combined company, which will form part of the Apollo 95.8 percent ownership. The major investors include affiliates of PTV Healthcare Capital, H.I.G. BioHealth Partners, Remeditex Ventures, Novo A/S, and CPMG Inc. As of June 30, 2016 Apollo’s cash was approximately $11.6 million and long term debt was approximately $50 million. Apollo’s consolidated revenue for the calendar year ended December 31, 2015 was approximately $68 million.
The boards of directors of both Lpath and Apollo have unanimously approved the transaction, which is subject to customary closing conditions, including approval by the stockholders of each of Lpath and Apollo. The merger agreement contains certain termination rights for both Lpath and Apollo.
The transaction is expected to close during the fourth quarter of 2016. Upon closing of the transaction Lpath will be renamed Apollo Endosurgery, Inc. and the combined company intends to apply for listing on The NASDAQ Global Market under a new trading symbol.
Todd Newton, chief executive officer of Apollo, said, “Executing this transaction with Lpath is an expedient way to introduce our company to the public market. With the additional equity support we will receive from Apollo’s major investors as part of this transaction, we will have the resources to meet our near-term business needs.”
Gary Atkinson, Lpath’s chief executive officer added, “Following an extensive and thorough review of strategic alternatives, we have chosen to merge with Apollo because we believe the transaction provides Lpath stockholders with an attractive opportunity for value appreciation.”
Piper Jaffray & Co. is the exclusive financial advisor for Apollo in this transaction and Cooley LLP is Apollo’s legal counsel. Lpath’s exclusive financial advisor in the transaction is Torreya Partners LLC and Lpath’s legal counsel is Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP.
Management and Organization
The directors and executive officers of Lpath will resign from their positions with Lpath upon the closing of the proposed merger, and the combined company will be under the leadership of Apollo’s Newton and its current executive management team. Following the closing of the proposed merger, the Board of Directors of the combined company is expected to consist of nine members all of whom will be designated by Apollo, including representatives of each of Apollo’s five major investors. Chairman of the Board of the combined company will be Richard J. Meelia, former Chairman and Chief Executive Officer of Covidien Ltd. The corporate headquarters will be located in Austin, TX.
Conference Call & Webcast
Management of both Apollo and Lpath will host a joint conference call to discuss the transaction on Monday, September, 12 at 4:30 p.m. EST. Interested participants and investors may access the conference call by dialing 1-855-239-3117 for domestic callers or 1-412-542-4126 for international callers or 1-855-669-9657 for Canada callers and ask to join the Lpath conference call. The conference call will be webcast live under the investor relations section of the Lpath website at www.Lpath.com and will be archived there for 60 days following the call.
About Apollo
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 500 million people globally, as well as other gastrointestinal disorders. Our device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 80 countries today. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
About Lpath
San Diego-based Lpath, Inc. (NASDAQ: LPTN) discovers and develops therapeutic antibodies that bind and inhibit bioactive lipids that contribute to disease. The company concluded mid-stage clinical development of drug candidates iSONEP™ (sphingomab) in wet age-related macular degeneration and ASONEP™ (anti-S1P antibody for systemic delivery) in renal cell carcinoma in 2015. Lpath demonstrated the safety of Lpathomab™ (antibody against lysophosphatidic acid) in a Phase 1 study and academic, government-funded research continues in traumatic brain injury. Last year the company initiated a corporate reorganization and evaluation of strategic alternatives. For more information, visit www.Lpath.com.
Safe Harbor Statements
Additional Information about the Proposed Merger and Where to Find It
In connection with the proposed merger, Lpath and Apollo intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S‑4 that will contain a prospectus and a proxy statement. Investors and security holders of Lpath and Apollo are urged to read these materials when they become available because they will contain important information about Lpath, Apollo and the proposed merger. The proxy statement, prospectus and other relevant materials (when they become available), and any other documents filed by Lpath with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Lpath by directing a written request to: Lpath, Inc., 4025 Sorrento Valley Blvd. San Diego, CA 92121, Attention: CEO. Investors and security holders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Lpath and its directors and executive officers and Apollo and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Lpath in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the joint proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Lpath is also included in Lpath Annual Report on Form 10-K for the year ended December 31, 2015 and the proxy statement for Lpath’s 2016 Annual Meeting of Stockholders. These documents are available free of charge at the SEC web site (www.sec.gov) and from the CEO at Lpath at the address described above.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the structure, timing and completion of our proposed merger with Apollo; our continued listing on NASDAQ prior to and after the proposed merger; our expectations regarding the capitalization, resources and ownership structure of the combined organization; our expectations regarding the sufficiency of the combined organization’s resources to fund the combined company; the timing and nature of the planned equity investment in connection with the proposed merger; the nature, strategy and focus of the combined organization; the safety, efficacy and commercial potential of any products; the executive officer and board structure of the combined organization; and the expectations regarding voting by Lpath and Apollo stockholders. Lpath and/or Apollo may not actually achieve the proposed merger, or any plans or product development goals in a timely manner, if at all, or otherwise carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Lpath’s and Apollo’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with stockholder approval of and the ability to consummate the proposed merger through the process being conducted by Lpath and Apollo, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for combined company operations and to conduct or continue planned product development programs, the ability to successfully develop any of Apollo’s products, the ability to successfully sell products and increase market share, and the risks associated with the process of developing, obtain regulatory approval for and commercializing surgical products that are safe and effective for use in human surgical procedures. Risks and uncertainties facing Lpath are described more fully in Lpath’s periodic reports filed with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Lpath undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
$TIVO #Acquisition by $ROVI Complete
Combined Company Furthers Legacy of Ground-Breaking Entertainment Technology and Compelling Consumer Experiences
Rovi Corporation (NASDAQ: ROVI) today announced that it has completed its acquisition of TiVo Inc. The company is adopting the iconic TiVo brand, marking the emergence of a new global leader in innovative products and licensable inventions that power consumer entertainment experiences and transform the value of audience relationships. The new TiVo is the convergence of two industry visionaries in media entertainment with complementary products and services, and innovative patented technologies that will usher in a new era of the consumer entertainment experience.
The combined company will immediately begin the process of integrating technological and product capabilities, harnessing the power of the unified product and innovation portfolios to enable traditional, over-the-top (OTT) and emerging providers to create new and compelling consumer experiences.
“Today’s consumers face a fragmented media landscape when it comes to devices and platforms, and content owners and service providers want to understand their audiences better and help their customers navigate an ever-increasing set of content choices,” said Tom Carson, president and CEO, TiVo. “The new TiVo is uniquely positioned to provide ground-breaking offerings that address the rapidly changing media landscape. Our broader product portfolio, more innovative patented technologies, increased resources and a stronger financial profile position us strongly for success and to continue providing the ultimate entertainment experiences to consumers across the globe.”
TiVo’s history of innovation in DVR functionality across set-top boxes, tablets and mobile devices naturally complements Rovi’s signature capabilities in guides, personalization, advertising, analytics and cloud services. TiVo will bring together the next generation of technologies, products and critical scale necessary to address today’s insatiable demand for media and entertainment and to achieve the company’s strategic business goals and deliver sustainable stockholder value.
The new TiVo will have significant financial and operational scale. The company provides guidance solutions to more than 25 million households, serving more than 500 pay-TV operators, and has technologies that span more than 70 countries. The company expects to realize at least $100 million in annual cost synergies, with 65 percent of these synergies recognized in the first 12 months. The company intends to provide fiscal 2016 estimates during its next regularly scheduled earnings conference call.
The closing value of the transaction, based on the volume-weighted average of Rovi’s common stock price on the NASDAQ Stock Market, as reported by Bloomberg L.P., for the fifteen consecutive trading days ended on and including September 1, 2016 (the trading day three business days prior to September 7, 2016, the closing date of the mergers), which was $20.6344 per share, and the corresponding exchange ratio for TiVo common stock of 0.3853x, all as provided for in the merger agreement, was $1.1 billion, comprised of approximately $270 million in cash and 39.7 million new TiVo shares. Shares of new TiVo will be traded on the NASDAQ under the ticker symbol “TIVO”. Additionally, consistent with Rovi’s prior announcement, former TiVo Inc. board members Daniel Moloney and Jeffrey T. Hinson joined the new TiVo board of directors as of the completion of the acquisition.
About TiVo
TiVo (NASDAQ: TIVO) is the global leader in entertainment technology and audience insights. From the interactive program guide to the DVR, TiVo delivers innovative products and licensable technologies that revolutionize how people find content across a changing media landscape. TiVo enables the world’s leading media and entertainment providers to deliver the ultimate entertainment experience. Explore the next generation of entertainment at tivo.com, forward.tivo.com or follow us on Twitter @tivo or @tivoforbusiness.
Forward-looking Statement
Certain statements made herein, including, for example, regarding the integration efforts of TiVo Inc. and Rovi Corporation, the industry landscape and the combined company’s position therein, the enhanced product strength, global reach and customer base of the combined companies, the expected synergies to be realized from the combination, and any other statements about the combined company management’s future expectations, beliefs, goals, plans or prospects, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on the combined company’s current expectations, estimates and projections about its business and industry, management’s beliefs and certain assumptions made by the combined company, all of which are subject to change. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “anticipate,” “will,” “may,” “would” and similar statements of a future or forward-looking nature may be used to identify forward-looking statements. All forward-looking statements address matters that involve risks and uncertainties, many of which are beyond our control, and are not guarantees of future results. Accordingly, there are or will be important factors that could cause actual results to differ materially from those indicated in such statements and, therefore, you should not place undue reliance on any such statements and caution must be exercised in relying on forward-looking statements. We believe that these factors include, but are not limited to, the following: 1) failure to realize the anticipated benefits of the proposed transactions, including as a result of delay in integrating or failure to successfully integrate the businesses of TiVo Inc. and Rovi Corporation and/or insufficient customer demand for the combined company’s technologies and integrated offerings; 2) the expected amount and timing of cost savings and operating synergies; 3) unexpected costs, charges or expenses resulting from the transactions; 4) uncertainty as to the long-term value of the combined company’s common stock; 5) unpredictability and severity of natural disasters; 6) adequacy of the combined company’s risk management and loss limitation methods; 7) the resolution of intellectual property claims; 8) seasonal trends that impact consumer electronics sales; 9) the combined company’s ability to implement its business strategy; 10) adequacy of the combined company’s and its subsidiaries’ loss reserves; 11) retention of key personnel by the combined company; 12) intense competition from a number of sources; 13) potential loss of business from one or more major licensees; 14) general economic and market conditions; 15) the integration of businesses that the combined company may acquire or new business ventures that the combined company may start; 16) evolving legal, regulatory and tax regimes; 17) litigation related to the transactions; and 18) other developments in the DVR and advanced television solutions market, as well as management’s response to any of the aforementioned factors.
The foregoing review of important factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included herein and elsewhere, including the Risk Factors included in our most recent reports on Form 10-K and Form 10-Q and other documents of TiVo Corporation, Rovi Corporation and TiVo Inc. on file with the Securities and Exchange Commission (“SEC”). Our SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statements made or incorporated by reference herein are qualified in their entirety by these cautionary statements, and there can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us or our business or operations. Except to the extent required by applicable law, we undertake no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160908005518/en/
Press:
Finn Partners
Ricca Silverio
tivo@finnpartners.com
+1-949-439-7869
or
Investors:
TiVo Inc.
Peter Ausnit
VP, Investor Relations
peter.ausnit@tivo.com
+1-818-565-5200
$OPCO Licenses Polymer Bonded #Patent
FAIRPORT HARBOR, OH–(Sep 8, 2016) – OurPet’s Company (OTCQX: OPCO), a leading proprietary pet supply company, today reported that it has licensed its Patent No. US 8,973,529 B1 to another licensee, a major stainless steel pet bowl manufacturer based in India. The patent was issued March 10, 2015 and OurPet’s announced its licensing on June 9, 2016. Under the terms of the non-exclusive agreement, the new licensee will pay a royalty to OurPet’s for each stainless steel bowl sold in the United States that has polymer materials applied to any portion of the bottom. OurPet’s now has licensed the ‘529 patent to three pet bowl manufacturer/marketers and is currently negotiating with several others.
About OurPet’s Company
The OurPet’s Company (OTCQX: OPCO) designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets® and Pet Zone® brands domestically and internationally. OurPets® and Pet Zone® products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. Since its founding in 1995, the OurPet’s Company has been building an extensive intellectual property portfolio with more than 170 patents in either issued or pending status all devoted to solving problems related to the human/pet bond. OurPet’s was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, the OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.
CONTACT:
OurPet’s Company
Dr. Steven Tsengas
CEO
(440) 354-6500 (Ext. 111)
INVESTOR RELATIONS:
DreamTeamNetwork
Michael McCarthy
(512) 758-8877
$SGMS Positions Itself to Accelerate Growth in Its #Interactive Business
Company to Consider New Growth Opportunities Including Joint Ventures, Acquisitions, IPO, and Other Partnerships
LAS VEGAS, Sept. 7, 2016 — Scientific Games Corporation (NASDAQ: SGMS) (“Scientific Games” or “the Company”), a leading developer of technology-based products and services and associated content for worldwide gaming, lottery and interactive markets, today announced it has designated the Company’s wholly owned interactive social gaming subsidiaries, including Dragonplay Ltd. and Phantom EFX, LLC, as unrestricted subsidiaries under its debt agreements, with the goal of maximizing growth for the company. The Company will consider a range of options to solidify its leadership in this fast growing segment, including potential new joint ventures, acquisitions, IPO, and other growth options.
“Our industry leading investment in innovation is paying off. Following our company’s third consecutive quarter of revenue growth, we see this as a perfect time to accelerate momentum and explore additional opportunities to deliver greater value from this strong and rapidly growing segment of our business,” said Kevin Sheehan, CEO and President of Scientific Games.
The Company’s social gaming business has generated sequential double-digit growth in each of the most recent three quarters and a 68-percent increase in revenue year-over-year for the most recent quarter (second quarter ended June 30, 2016).
Following unrestricted designation, the social gaming entities will remain wholly owned by Scientific Games and continue under the leadership of Barry Cottle, Chief Executive – Interactive and Jordan Levin, President – Interactive.
About Scientific Games
Scientific Games Corporation (NASDAQ: SGMS) is a leading developer of technology-based products and services and associated content for worldwide gaming, lottery, and interactive markets. The Company’s portfolio includes gaming machines, game content and systems; table games products and shufflers; instant and draw-based lottery games; server-based lottery and gaming systems; sports betting technology; loyalty and rewards programs; and interactive content and services. For more information, please visit www.scientificgames.com.
COMPANY CONTACTS:
Investor Relations:
Bill Pfund +1 702-532-7663
Vice President, Investor Relations
bill.pfund@scientificgames.com
Media Relations:
Susan Cartwright +1 702-532-7981
Vice President, Corporate Communications
susan.cartwright@scientificgames.com
© 2016 Scientific Games Corporation. All Rights Reserved. All ® notices signify marks registered in the United States.
Forward-Looking Statements
In this press release, Scientific Games makes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements describe future expectations, plans, results or strategies and can often be identified by the use of terminology such as “may,” “will,” “estimate,” “intend,” “plan,” “continue,” “believe,” “expect,” “anticipate,” “explore,” “target,” “should,” “could,” “potential,” “opportunity,” “goal,” or similar terminology. These statements are based upon management’s current expectations, assumptions and estimates and are not guarantees of timing, future results or performance. Actual results may differ materially from those contemplated in these statements due to a variety of risks and uncertainties and other factors, including, among other things: competition; U.S. and international economic and industry conditions, including declines in or slow growth of gross gaming revenues or lottery retail sales, reductions in or constraints on capital spending by gaming or lottery operators and bankruptcies of, or credit risk relating to, customers; limited growth from new gaming jurisdictions, declines in the replacement cycle of existing gaming machines and slow addition of casinos in existing jurisdictions; ownership changes and consolidation in the gaming industry, including by casino operators; opposition to legalized gaming or the expansion thereof; inability to adapt to, and offer products that keep pace with, evolving technology; inability to develop successful gaming concepts and content; laws and government regulations, including those relating to gaming licenses and environmental laws; inability to identify and capitalize on trends and changes in the gaming, lottery and interactive industries; dependence upon key providers in our social gaming business; inability to retain or renew, or unfavorable revisions of, existing contracts, and the inability to enter into new contracts; level of our indebtedness, higher interest rates, availability or adequacy of cash flows and liquidity to satisfy indebtedness, other obligations or future cash needs; inability to reduce or refinance our indebtedness; restrictions and covenants in our debt agreements, including those that could result in acceleration of the maturity of our indebtedness; protection of our intellectual property, inability to license third party intellectual property, and the intellectual property rights of others; security and integrity of our software and systems and reliance on or failures in our information technology systems; natural events that disrupt our operations or those of our customers, suppliers or regulators; inability to benefit from, and risks associated with, strategic equity investments and relationships, including (i) the inability of our joint venture to realize the anticipated benefits under its private management agreement with the Illinois lottery or from the disentanglement services performed in connection with the termination thereof, (ii) the inability of our joint venture to meet the net income targets or other requirements under its agreement to provide marketing and sales services to the New Jersey Lottery or otherwise to realize the anticipated benefits under such agreement and (iii) failure to realize the anticipated benefits related to the award to our consortium of an instant lottery game concession in Greece; failure to achieve the intended benefits of the Bally acquisition or the WMS acquisition, other recent acquisitions, or future acquisitions, including due to the inability to successfully integrate such acquisitions or realize synergies in the anticipated amounts or within the contemplated time frames or cost expectations, or at all; disruption of our current plans and operations in connection with our recent acquisitions (including in connection with the integration of Bally and WMS), including departure of key personnel or inability to recruit additional qualified personnel or maintain relationships with customers, suppliers or other third parties; incurrence of employee termination or restructuring costs, and impairment or asset write-down charges; changes in estimates or judgments related to our impairment analysis of goodwill or other intangible assets; implementation of complex revenue recognition standards; fluctuations in our results due to seasonality and other factors; dependence on suppliers and manufacturers; risks relating to foreign operations, including fluctuations in foreign currency exchange rates (including those fluctuations related to the affirmative vote in the U.K. to withdraw from the EU), restrictions on the payment of dividends from earnings, restrictions on the import of products and financial instability, including the potential impact to our business resulting from the affirmative vote in the U.K. to withdraw from the EU and the potential impact to our instant lottery game concession or VLT lease arrangements resulting from the recent economic and political conditions in Greece; dependence on our key employees; litigation and other liabilities relating to our business, including litigation and liabilities relating to our contracts and licenses, our products and systems, our employees (including labor disputes), intellectual property and our strategic relationships; influence of certain stockholders; and stock price volatility.
Additional information regarding risks, uncertainties and other factors that could cause actual results to differ materially from those contemplated in forward-looking statements is included from time to time in our filings with the SEC, including the Company’s current reports on Form 8-K, quarterly reports on Form 10-Q and its latest annual report on Form 10-K filed with the SEC on February 29, 2016 (including under the headings “Forward Looking Statements” and “Risk Factors”). Forward-looking statements speak only as of the date they are made and, except for Scientific Games’ ongoing obligations under the U.S. federal securities laws, Scientific Games undertakes no obligation to publicly update any forward-looking statements whether as a result of new information, future events or otherwise.
$EVOK Positive Non-Clinical Pre- #NDA Meeting with #FDA for #Gimoti
SOLANA BEACH, Calif., Sept. 07, 2016 — Evoke Pharma, Inc. (Nasdaq:EVOK) (the “Company”), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has completed a pre‑New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company’s planned 505(b)(2) NDA for Gimoti.
Prior to the pre-NDA meeting, Evoke submitted an information package describing the proposed content and format of the regulatory, CMC, and non-clinical sections of the Gimoti NDA. The subsequent face-to-face pre-NDA meeting afforded Evoke the opportunity to gain further understanding of the FDA’s expectations regarding these key sections of the NDA.
Based on the FDA’s response to the information package and the pre-NDA meeting discussion, Evoke believes it now has the information needed to complete these sections of the NDA in a manner that will be acceptable for the FDA’s review of the complete package.
“We are pleased to have begun discussions with the Agency regarding our proposed NDA submission for Gimoti utilizing the 505(b)(2) pathway. We had a very productive meeting and this portion of our data package was well-received,” Dave Gonyer, R.Ph., President and CEO, stated. “Additionally, it was agreed that Evoke will request to meet with the FDA again in the near future to discuss the clinical data that will comprise the remaining sections of the NDA.”
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.
Safe Harbor Statement
Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “or expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: potential NDA submission and regulatory pathway for Gimoti, including Evoke’s belief that the sections of the NDA regarding the regulatory, CMC and non-clinical information will be acceptable to the FDA; the timing, if any, of an additional pre-NDA meeting with the FDA to discuss the clinical sections of the NDA; and the potential for regulatory approval and commercialization of Gimoti. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke’s business, including, without limitation: additional analyses of data from the Phase 3 trial may produce negative or inconclusive results and may not serve as the basis for an NDA submission or regulatory approval; the final FDA minutes may be inconsistent with Evoke’s understanding of the FDA’s position on the matters addressed at the meeting, or may be inconsistent with previously announced topline results; the inherent risks of clinical development of Gimoti; Evoke is entirely dependent on the success of Gimoti, and Evoke cannot be certain that it will be able to conduct additional trials of Gimoti or obtain regulatory approval for or successfully commercialize Gimoti; Evoke will require substantial additional funding to continue to develop and commercialize Gimoti, and may be unable to raise capital when needed, including to fund ongoing operations; Evoke may not be able to successfully commercialize Gimoti, if approved, as a result of risks associated with market acceptance, coverage and reimbursement and competing products; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Contact: The Ruth Group David Burke O: 646-536-7009 C: 917-618-2651 dburke@theruthgroup.com
$AIRG to Present at 5th Annual #Liolios #GatewayConference on September 7, 2016
SAN DIEGO, Sept. 07, 2016 — Airgain, Inc. (Nasdaq:AIRG), a leading provider of embedded antenna technologies used to enable high performance wireless networking, has been invited to present at the 2016 Gateway Conference being held on September 7-8, 2016 at the Four Seasons Hotel San Francisco.
Airgain management is scheduled to present on Wednesday, September 7 at 2:30 p.m. Pacific time, with one-on-one meetings held throughout the day.
The presentation will be webcast live and available for replay in the Investor Relations section of Airgain’s website and on the Gateway Conference website.
To receive additional information, request an invitation or to schedule a one-on-one meeting, please e-mail gateway@liolios.com.
About the Gateway Conference
The 5th Annual Gateway Conference is an invite-only conference presented by Liolios, which brings together the most compelling companies with the nation’s top institutional investors and analysts. This year’s event features more than 80 companies from a number of growth industries, including technology, business and financial services, consumer, digital media, clean technology, and life sciences. The format has been designed to give attendees direct access to senior management via company presentations, Q&A sessions, and one-on-one meetings. For more information, visit www.gateway-conference.com or www.liolios.com.
About Airgain, Inc.
Airgain is a leading provider of embedded antenna technologies used to enable high performance wireless networking across a broad range of home, enterprise, and industrial devices. Our innovative antenna systems open up exciting new possibilities in wireless services requiring high speed throughput, broad coverage footprint, and carrier grade quality. Our antennas are found in devices deployed in carrier, enterprise, and residential wireless networks and systems, including set top boxes, access points, routers, gateways, media adapters, digital televisions and Internet of things (IOT) devices. Airgain partners with and supplies the largest blue chip brands in the world, including original equipment and design manufacturers, chipset makers and global operators. Airgain is headquartered in San Diego, California, and maintains design and test centers in San Diego, Cambridge, UK, Taipei, Taiwan, and Suzhou, China.
Airgain and the Airgain logo are registered trademarks of Airgain, Inc.
Airgain Contact Matt Glover or Najim Mostamand Liolios Group, Inc. +1 949 574 3860 AIRG@Liolios.com
$GWPH to Present at the #MorganStanley Global #Healthcare Conference
LONDON, Sept. 07, 2016 — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced that Justin Gover, GW’s Chief Executive Officer, is scheduled to present at the Morgan Stanley Global Healthcare Conference to be held at the Grand Hyatt Hotel in New York City on Wednesday, 14 September 2016 at 9:55 a.m. EDT.
A live audio webcast of the presentations will be available through GW’s corporate website in the investor relations section from the investor’s calendar of events page at www.gwpharm.com. A replay will be available soon after the live presentations.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.
Enquiries:
GW Pharmaceuticals plc | (Today) +44 20 3727 1000 |
Stephen Schultz, VP Investor Relations (U.S.) | 917 280 2424 / 401 500 6570 |
FTI Consulting (Media Enquiries) | |
Ben Atwell / Simon Conway | + 44 20 3727 1000 |
FleishmanHillard (U.S. Media) | |
Paddi Hurley / Adam Silverstein | 212 453 2382 / 917 697 9313 |
$RPRX Phase 2 Results, Positive Outcomes for #Oral #Proellex in #Endometriosis
Subjects with moderate to severe endometriosis experienced relief of menstrual pain and a reduction in the use of pain medication with the use of Proellex®
- Proellex® subjects’ menstrual pain by BBSS decreased significantly when compared to those treated with placebo
- Total pain medication use decreased 56% and non-prescription pain medication use decreased 74% in subjects treated with Proellex®
THE WOODLANDS, Texas, Sept. 07, 2016 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today provided the results of the first course of treatment from Repros’ ongoing study of Proellex® for the treatment of premenopausal women with confirmed symptomatic endometriosis.
The study was a Phase 2, double-blind study of oral Proellex® (telapristone acetate) in a population of women with moderate to severe confirmed endometriosis defined as a baseline BBSS Score (Biberoglu and Behrman Symptom Score) of 7 or greater. Subjects were randomized to 6 or 12 mg of Proellex® or placebo in a 1:1:1 fashion. A course of treatment lasted 18 weeks and was followed by an Off Drug Interval. Subjects kept daily diaries recording assessments of pain, menstrual bleeding and analgesic use.
The study randomized 60 subjects, 13 in Argentina and 47 in the US. The subjects’ mean age was 30 years. As anticipated, 70% of subjects treated with Proellex® became amenorrheic. The induction of amenorrhea was associated with a substantial reduction in reported pain and subsequent reduction in analgesic use. Responses were similar across the two doses of Proellex® and are reported here pooled.
Subjects assessed menstrual and non-menstrual pain daily during baseline and treatment. The median percentage change from baseline in the patient BBSS assessment of menstrual pain showed that subjects improved with an 85.4% reduction in baseline score (p < 0.0001). In addition, despite evidence of a placebo response, subjects treated with Proellex® had a statistically significant greater reduction in menstrual pain compared to the 37.5% change from baseline achieved with placebo (p = 0.0008). Although non-menstrual pelvic pain was also reduced with treatment, a difference between treatment groups could not be detected.
Encouragingly, the improvement in menstrual pain translated to a reduction in the use of analgesics. During this first course of treatment, subjects treated with Proellex® experienced a 56% reduction in total pill count while placebo-treated subjects’ pill use declined by 30% (p = 0.0521). The reduction in non-prescription use was most striking: Proellex®-treated subjects had a 74% reduction while placebo-treated subjects only experienced a reduction of 11% (p = 0.0423).
Treatment with Proellex® was generally well tolerated.
Given these results, the Company is preparing to interact with the FDA to discuss plans for late stage development of Proellex® and Phase 3 studies to treat women who struggle with painful menses.
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.
Forward-Looking Statements
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 the timing and nature of the results of clinical studies and the impact of such results. 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 risks that additional phases of clinical studies may not be successfully undertaken or completed, that the FDA may not ultimately approve the product candidate, the risk that any marketing approvals, if granted, may have significant limitations on use, that even if an NDA is approved, the Company may not be able to successfully commercialize the product candidate, risks relating to the Company’s ability to protect its 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
$CGNT Enters Into #DefinitiveAgreement For $25 Million Equity Investment
Proceeds to Provide Resources to Execute Urology Focused Business Development Strategy Proposed Equity Investment at 29% Premium to Market All Current Outstanding Debt to be Converted into Common Shares
MINNEAPOLIS, Sept. 7, 2016 — Cogentix Medical, Inc. (NASDAQ: CGNT), a medical device company that develops, manufactures and markets innovative proprietary products for the urology market, today announced that it has entered into a securities purchase agreement with Accelmed Growth Partners, L.P. Under the terms of the securities purchase agreement, Accelmed would purchase $25 million of Cogentix Medical common stock from the Company at $1.55 per share, a 29% premium over the closing price of the stock on September 6, 2016 and a premium of 36% over the average closing price over the last 30 days. The securities purchase agreement is subject to various closing conditions, including approval by the shareholders of Cogentix Medical. Accelmed is a premier capital resource for the medical device industry and is based in New York, NY and Hertzeliya, Israel. Cogentix would apply the proceeds to working capital as well as the implementation of a business development strategy to acquire growth technologies addressing the urology market.
As a condition to Accelmed closing the equity investment, the Company will convert into common shares all the outstanding debt and accrued interest owed to Lewis C. Pell, one of the Company’s Class I directors. Cogentix currently owes a total of $29.5 million ($28.5 million of principal and $1.0 million of accrued interest) to Mr. Pell. The Company and Mr. Pell have entered into a definitive agreement under which the debt owed by Cogentix to Mr. Pell will be converted into Cogentix common stock at a price per share of $1.67 immediately prior to closing the Accelmed securities purchase agreement. The agreement also provides that, simultaneously with the conversion of such debt, all outstanding warrants to purchase Cogentix common stock that are held by Mr. Pell will be cancelled. The agreement with Mr. Pell is subject to approval of the shareholders of Cogentix Medical.
“The proposed transaction with Accelmed has the ability to transform Cogentix Medical,” said Darin Hammers, President and CEO of Cogentix Medical. “While our team has been successfully executing our sales strategy and building our business in the urology market, we have been resource constrained in terms of providing our sales organization with additional products to bring to our growing customer base. Accelmed is one of the world’s leading private equity firms focused on the medical device industry, and as Israel’s largest med-tech investor, has a proven track record of integrating Israeli technologies into established US med-tech companies. Accelmed believes the Cogentix platform provides an excellent foundation from which to build a broad based leader providing innovative, cost effective and clinically proven solutions to the growing urology marketplace. Overall, the proposed transactions significantly increase our cash resources, eliminate all of our outstanding debt and dramatically improve our capital structure, all at valuations that are 29% higher than what the market is currently awarding our company.”
Upon closing of the proposed transactions, there would be approximately 60.3 million shares of common stock outstanding of which Mr. Pell would own approximately 33% and Accelmed would own approximately 27%. The current debt and accrued interest outstanding of $29.5 million would be eliminated and Cogentix would have approximately $28 million of cash and marketable securities.
In addition, the terms of the proposed transaction call for Accelmed to have the right to nominate two members to the Cogentix Medical Board of Directors, which currently has six members. One of these directors would be Uri Geiger, who will become Chair of the Cogentix board. Mr. Geiger cofounded Accelmed in 2009 and is currently a managing partner of Accelmed. Mr. Geiger has extensive entrepreneurial, management and investment expertise having created and developed many successful medical device companies.
The Board of Directors of Cogentix Medical established a Special Committee of the Board, comprised solely of independent directors, to review these transactions and provide a recommendation to the full Board. The Special Committee engaged Duff & Phelps, LLC to serve as its independent financial advisor and to provide an opinion in connection with the proposed transactions. The Special Committee retained Duff & Phelps based on Duff & Phelps’ qualifications, reputation, and experience in providing fairness opinions, and its experience in valuing companies in the medical device industry. Duff & Phelps has rendered its opinion that the financial terms of the proposed transactions taken as a whole are fair to the unaffiliated public stockholders of the Company. The Special Committee recommended to the full Board that it approve the transactions, and the Cogentix Medical Board of Directors has unanimously approved the transactions.
“We have admired the revenue growth of Cogentix Medical under the leadership of Darin and his team, and believe that with the appropriate resources and a well-planned business development strategy, Cogentix could expand into being one of the leaders in the urology marketplace,” said Mr. Geiger. “As a reflection of our confidence in the management team as well as the potential for the company, we have agreed to make this investment at a premium to the current market price and look forward to working with the board and management to execute on a shared vision for Cogentix.”
Additional Information About the Transaction and Where to Find It
The proposed transactions will be submitted to the shareholders of Cogentix Medical for their approval. The shareholders will be asked to approve the securities purchase agreement and the issuance of shares to Accelmed and Mr. Pell. In connection with that approval, Cogentix will file with the Securities and Exchange Commission (the “SEC”) a proxy statement containing information about the proposed transactions. Shareholders are urged to read the proxy statement when it becomes available, because it will contain important information. Shareholders will be able to obtain a free copy of the proxy statement, as well as other filings containing information about Cogentix, without charge at the SEC’s website (www.sec.gov) or by calling 1-800-SEC-0330. Copies of the proxy statement and other filings with the SEC can also be obtained, without charge, by directing a request to Brett Reynolds, Senior Vice President and Chief Financial Officer, Cogentix Medical, Inc., 5420 Feltl Road, Minnetonka, MN 55343, 952-426-6152.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities to be issued as a result of the proposed transactions. The securities to be issued in connection with the proposed transactions have not been registered under the Securities Act of 1933, as amended, or state securities laws, and may not be offered or sold absent registration with the SEC or an applicable exemption from such registration requirements.
Participants in the Solicitation
Cogentix and some or all of its directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies from Cogentix shareholders in respect of the proposed transactions. Information regarding the directors and executive officers of Cogentix is contained in the proxy statement for our 2016 annual meeting of shareholders, which was filed with the SEC on April 25, 2016. Additional information regarding the interests of such potential participants will also be included in the proxy statement when it becomes available.
About Cogentix Medical
Cogentix Medical, Inc., headquartered in Minnetonka, Minnesota, with additional operations in New York, Massachusetts, The Netherlands and the United Kingdom, is a global medical device company. We design, develop, manufacture and market products for flexible endoscopy with our unique product lines featuring a streamlined visualization system and proprietary sterile disposable microbial barrier, known as EndoSheath technology, providing users with efficient and cost effective endoscope turnover while enhancing patient safety. We also commercialize the Urgent® PC Neuromodulation System, an FDA-cleared device that delivers percutaneous tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder (OAB). OAB is a chronic condition that affects approximately 42 million U.S. adults. The symptoms include urinary urgency, frequency and urge incontinence. We also offer Macroplastique®, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. For more information on Cogentix Medical and our products, please visit us at www.cogentixmedical.com. ‘CGNT-G’
For Further Information:
Cogentix Medical, Inc.
Brett Reynolds, SVP and CFO
952-426-6152
EVC Group
Doug Sherk/Brian Moore (Investors)
415-652-9100/310-579-6199
Cautionary Statements Related to Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Forward-looking statements in this press release include, but are not limited to, statements about the benefits of the proposed transactions; expected levels of continuing debt; expected revenue growth rates; the anticipated timing of cash flow breakeven from operations and cash flow positive from operations; and our plans, objectives, expectations and intentions with respect to future operations, products and services. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the effects of industry, economic or political conditions outside of our control; the failure to appropriately apply the proceeds from the proposed transactions or to realize the benefits of the reduction in our debt, or delay in realization thereof; operating costs and business disruption following completion of the transaction; transaction and related costs; actual or contingent liabilities; the adequacy of our capital resources; and the risks identified under the heading “Risk Factors” in the annual report on Form 10-K, for the fiscal year ended March 31, 2015, filed with the SEC on June 25, 2015, our transition report on Form 10-K for the transition period from April 1, 2015 through December 31, 2015, as well as our subsequent quarterly reports on Form 10-Q and other information filed by us with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this presentation. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this presentation speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
$OMEX #FavorableRuling in the Matter of the #SSCentralAmerica
TAMPA, Fla., Sept. 06, 2016 — Ira Owen Kane, the court-appointed Receiver for the salvor of the SS Central America, Recovery Limited Partnership (RLP), announced today that on August 31, 2016, Chief Judge Rebecca Beach Smith of the United States District Court, Eastern District of Virginia, granted RLP a salvage award of 100% of the fair market value of the items recovered from the 2014 excavation conducted by Odyssey Marine Exploration. Further, Chief Judge Smith awarded title to RLP of all items recovered in order to satisfy the award, the disposition of which will occur under the auspices of the Receiver, subject to approval by Judge Patrick Sheeran of the Court of Common Pleas, Franklin County, Ohio.
In her ruling, Judge Beach stated, “Together, the professionals at RLP and Odyssey spent an impressive amount of time, money, and energy in the 2014 salvage efforts. . . The labor expended has been thorough and commendable at every stage, from the initial planning of the operations through post-salvage storage and conservation.”
“The judge reviewed an immense amount of data and information provided by RLP and Odyssey to reach her decision. We are pleased that the extensive archaeological work, care and conservation of the artifacts and noted professionalism of our deep-ocean marine operations team all contributed to her ruling in favor of RLP,” said Mark Gordon, Odyssey Chief Executive Officer and President. “Having the opportunity to work for RLP on this historic project, where we were not only able to recover valuable assets from the site but were also able to uncover extensive information about the formation of the site was an honor for our company.”
In addition to the judge noting that Odyssey brought experienced personnel and sophisticated equipment to the operation, deep-ocean salvage consultant Michael Anderson, who was also an expert witness in the RMS Titanic Inc. case, testified that RLP could not have selected a better company for the Central America operations than Odyssey Marine Exploration.
In her ruling, Judge Smith also commented, “Recovering treasure located over a mile below the surface of the Atlantic Ocean, and covered with 150 years of accumulated sediment, unquestionably requires great skill… Odyssey brought experienced personnel and sophisticated equipment to the salvage efforts… Operating the ROV to excavate portions of the wreck site and collect gold and cultural heritage items in an archaeologically-sensitive manner required great skill and dedication by the crew… Each item was individually evaluated to determine the necessary procedure to document and preserve the artifact while on board the ship, a task requiring substantial knowledge and outlay of time by the archaeologists and conservator…the Fourth Circuit has previously recognized in this case that saving property from the bottom of the ocean can be considered ‘the ultimate rescue from the ultimate peril.’”
In 2014, RLP contracted with Odyssey Marine Exploration to conduct the archaeological excavation and recover the remaining valuable cargo from the SS Central America shipwreck, which is located approximately 160 miles off the coast of South Carolina in 2,200 meters of water. Under the direction of a project archaeologist, the Odyssey team deployed a remotely operated vehicle, or ROV, to recover and document over 15,500 gold and silver coins, 45 gold bars and hundreds of other artifacts from the SS Central America shipwreck site.
Prior to any recovery work, a photomosaic of the site was created by digitally stitching together over 12,500 high-resolution images of the site. The 2014 SS Central American expedition was conducted over 129 days and included 83 ROV dives recording over 2,000 hours of dive time. The longest dive lasted over 125 hours. A 161,000-square-meter, high-resolution video survey of the shipwreck and surrounding seabed was also completed. During recovery operations, the Odyssey Explorer carried 17 ship crew members and a technical crew of up to 18 individuals and two highly experienced members of the Receiver’s oversight team. Operational reports and inventories of items recovered from the SS Central America are available at www.shipwreck.net/ssca.php.
About Odyssey Marine Exploration
Odyssey Marine Exploration, Inc. (Nasdaq:OMEX) is engaged in deep-ocean exploration using innovative methods and state of-the-art technology. The company has numerous projects in various stages of development around the world from both our own portfolio as well as through third-party contracts. Odyssey provides efficient survey, ROV and recovery solutions to the commercial offshore sector through its Clio Offshore deep-ocean contracting division, which was recently named to Marine Technology Reporter’s Top 100 companies list. For additional details, please visit www.odysseymarine.com or www.cliooffshore.com.
MEDIA CONTACT: Liz Shows Odyssey Marine Exploration, Inc. (813) 876-1776 x 2335 lshows@odysseymarine.com
$ZYNE Launches Phase 2 #ClinicalTrial of #ZYN002 #CBD Gel in #Osteoarthritis
DEVON, Pa., Sept. 06, 2016 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments, today announced that it has initiated a Phase 2 clinical trial, STOP (Synthetic Transdermal Cannabidiol for the Treatment of Knee Pain due to Osteoarthritis (OA)), of ZYN002 cannabidiol (CBD) gel. ZYN002 CBD gel is the first and only patent-protected, synthetic CBD that is formulated as a permeation-enhanced gel for transdermal delivery.
“In the US, there are approximately 31 million people who suffer from osteoarthritis, many of whom are not receiving adequate relief from current therapies,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “In preclinical models, cannabidiol has demonstrated the ability to significantly reduce pain and inflammation associated with OA. ZYN002 may offer an effective treatment alternative to NSAIDs and narcotic opioids with an improved safety profile.”
The STOP clinical trial is a Phase 2 multi-center, double-blind, placebo-controlled, multi-dose clinical trial designed to evaluate the efficacy and safety of ZYN002 in patients with knee pain due to OA. Up to 300 patients will be enrolled in the clinical trial and will be followed for two weeks during a baseline phase, which includes a one-week washout period. After completion of the baseline phase, patients will be randomized 1:1:1 to receive either 250 mg of ZYN002 4.2% CBD gel every 12 hours, 125 mg of ZYN002 4.2% CBD gel every 12 hours or placebo gel every 12 hours for 12 weeks. The primary endpoint of the study is the change from baseline in the weekly mean of the 24-hour average worst pain score. The Company expects to report topline results in the first half of 2017.
About ZYN002 CBD Gel
Zynerba’s ZYN002 CBD gel is the first and only synthetic CBD that is formulated as a patent-protected permeation-enhanced gel. Phase 2 clinical studies are ongoing in adults with refractory epilepsy and in knee pain associated with osteoarthritis. Phase 2 clinical studies in patients with Fragile X Syndrome (FXS) are expected to begin in the second half of 2016. ZYN002 is a clear, permeation-enhanced gel that is designed to provide consistent, controlled drug delivery transdermally with convenient twice-daily dosing. Transdermal therapeutics are absorbed through the skin directly into the systemic circulation, avoiding first-pass liver metabolism and potentially enabling lower dosage levels of active pharmaceutical ingredients and rapid and reliable absorption with high bioavailability. In addition, transdermal delivery avoids the gastrointestinal tract and potential stomach acid degradation of CBD into THC (associated with psychoactive effects), as demonstrated in a Zynerba in vitro study.
About Osteoarthritis
Osteoarthritis is a degenerative joint disease that leads to wear and tear of the joints and affects the cartilage, joint lining, ligaments and bone. It is the most common form of joint disease and tends to occur most often in the hand joints, spine, hip, knees and great toes. It is characterized by the breakdown of the joint cartilage, bony changes in the joints and deterioration of the tendons and ligaments leading to pain and inflammation of the joint lining. Approximately 31 million patients in the US suffer from osteoarthritis.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage specialty pharmaceutical company focused on developing and commercializing proprietary next-generation synthetic cannabinoid therapeutics formulated for transdermal delivery. Zynerba is developing therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of two cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid, and tetrahydrocannabinol (THC). Transdermal delivery has the potential to reduce adverse effects associated with oral dosing. ZYN002, the Company’s CBD gel, is the first and only synthetic CBD formulated as a patent protected permeation-enhanced gel. In June 2016, the company initiated the Phase 2 STAR 1 clinical study of ZYN002 CBD gel in refractory epilepsy patients with focal seizures. In August 2016, the STOP trial in patients with knee pain due to OA was initiated. A Phase 2 study in Fragile X syndrome (FXS) is expected to initiate in the second half of 2016. Zynerba is also developing ZYN001, which utilizes a synthetically manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001 is planned to begin in the second half of 2016. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10K, quarterly reports on Form 10Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Investor Contact Kimberly Minarovich Argot Partners 212.600.1902 kimberly@argotpartners.com Media Contact Eliza Schleifstein Argot Partners 973.361.1546 eliza@argotpartners.com
$GVP Awarded Two International Projects to Modernize #Nuclear #Simulators
GSE Systems, Inc. (“GSE” or “the Company”) (NYSE MKT: GVP), the world leader in real-time high-fidelity simulation systems and training solutions to the power and process industries, today announced that it has been awarded contracts to provide mission-critical updates to multi-unit nuclear site simulator platforms for customers in the UK and Japan. The technical engineering and software solutions to be delivered by GSE provide nuclear power plant operators with modern simulation technology to train operators and provide assistance with complex engineering problems that require solutions. These two projects add over $6 million to the Company’s backlog and include options that could grow backlog significantly further.
In the UK, the Company’s customer is committed to providing world-class, accredited training programs to its operators and engineers. The scope of GSE’s work includes deployment of a high-value, state-of-the-art nuclear plant simulation system to replace legacy simulation models and computer hardware delivered in the early 1990s. The project also includes modeling a second unit of the plant so that site-wide event training can be conducted, and providing greater access to a high-fidelity training environment to more operators and engineers at the plant.
In Japan, GSE will provide a key nuclear plant operator with a modern simulator so that the customer may deliver more comprehensive training to operators and engineers in the post-Fukushima environment. The scope of work includes replacing all existing models of the customer’s existing simulator. With this major upgrade, in addition to providing new simulation capabilities to operators and engineers, the customer will benefit from GSE’s long-term maintenance of the systems, allowing for swift future technology upgrades required to meet evolving post-Fukushima industry regulations.
Both projects utilize GSE’s JADE™ simulation software, the leading high-fidelity nuclear power plant simulation software used for plant design and operator training. JADE provides the global nuclear power industry with a state-of-art software platform that simplifies creating and maintaining accurate models of plant configuration as they exist today and as the plants evolve through capital improvements over the years.
Kyle J. Loudermilk, Chief Executive Officer and President of GSE, said, “We are thrilled and honored to serve our customers on these critical projects in the UK and Japan. These awards demonstrate the value we are able to provide to our customers in key markets across the globe and illustrate the growing importance of nuclear power as the world develops economically viable sources of carbon-free electricity.
“Nuclear power is an increasingly important part of the UK’s energy mix to satisfy the country’s demand for electricity while meeting environmental commitments. The UK is looking to build new reactors in the near and long term, including EPR, ABWR and SMR reactors. GSE technology is ideal to simulate these systems as the UK develops a robust workforce development program to staff and safely operate its nuclear power assets.
“Japan, in turn, was heavily reliant on nuclear power prior to the Fukushima nuclear plant event in 2011. The country is now restarting its reactor fleet to generate carbon-free, economically efficient electricity and to do so requires updated simulation capabilities like those offered by GSE to reflect post-Fukushima design and operating requirements. GSE’s talented staff, proprietary software and technology platform, nuclear simulation know-how, creativity, and commitment to customer satisfaction underpin our ability to deliver excellent solutions in the UK, Japan and across the globe.”
ABOUT GSE SYSTEMS, INC.
GSE Systems, Inc. is a world leader in real-time high-fidelity simulation, providing a wide range of simulation, training and engineering solutions to the power and process industries. Its comprehensive and modular solutions help customers achieve performance excellence in design, training and operations. GSE’s products and services are tailored to meet specific client requirements such as scope, budget and timeline. The Company has over four decades of experience, more than 1,100 installations, and hundreds of customers in over 50 countries spanning the globe. GSE Systems is headquartered in Sykesville (Baltimore), Maryland, with offices in St. Marys, Georgia; Huntsville, Alabama; Chennai, India; Nyköping, Sweden; Stockton-on-Tees, UK; and Beijing, China. Information about GSE Systems is available at www.gses.com.
FORWARD LOOKING STATEMENTS
We make statements in this press release that are considered 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. These statements reflect our current expectations concerning future events and results. We use words such as “expect,” “intend,” “believe,” “may,” “will,” “should,” “could,” “anticipate,” and similar expressions to identify forward-looking statements, but their absence does not mean a statement is not forward-looking. These statements are not guarantees of our future performance and are subject to risks, uncertainties, and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties, and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Company
GSE Systems, Inc.
Chris Sorrells, 410-970-7802
Chief Operating Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
dsullivan@equityny.com
or
Kalle Ahl, CFA, 212-836-9614
Senior Associate
kahl@equityny.com
$JMU #Partnership w/ #ShanghaiChunmin to do Supply Chain Finance Service Platform
BEIJING, Sept. 06, 2016 — Wowo Limited (the “Company”) (NASDAQ:JMU), a leading B2B online e-commerce platform that provides integrated services to suppliers and customers in the foodservice industry in China, today announced that the Company entered into a strategic cooperation agreement with Shanghai Chunmin Internet Financial Information Service Co., Ltd. (“Chunmin”) on September 3rd, 2016.
With China’s large catering and foodservice B2B market and JM Wowo’s fast-growing B2B business, JM Wowo and Chunmin reached a strategic cooperation agreement to jointly build a supply chain finance company to provide JM Wowo’s B2B customers related services, including order factoring, credit granting service on the platform, financing and leasing as well as other aspects of supply chain finance services.
Additionally, JM Wowo and Chunmin will further discuss the cooperation in detail and begin planning the framework of the supply chain finance company’s construction. In particularly, they will blueprint the business model of the supply chain finance company to efficiently support transactions on JM Wowo’s online marketplace.
Chunmin has deep resources and professionally experienced in the supply chain finance arena and is optimistic about JM Wowo’s favorable trend in B2B restaurant and hotel business development. Chunmin shares the same outlook with JM Wowo’s management team about China’s supply chain finance market and has strong confidence in setting up and operating the supply chain finance company together with JM Wowo in the future.
Safe Harbor Statement
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 “aim”, “anticipate”, “believe”, “estimate”, “expect”, “going forward”, “intend”, “ought to”, “plan”, “project”, “potential”, “seek”, “may”, “might”, “can”, “could”, “will”, “would”, “shall”, “should”, “is likely to” and the negative form of these words and other similar expressions. Among other things, statements that are not historical facts, including statements about JM Wowo’s beliefs and expectations, the business outlook and quotations from management in this announcement, as well as JM Wowo’s strategic and operational plans, are or contain 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 general economic and business conditions in China may deteriorate. The growth of Internet and mobile user population in China might not be as strong as expected. JM Wowo’s plan to enhance customer experience, upgrade infrastructure and increase service offerings might not be well received. JM Wowo might not be able to implement all of its strategic plans as expected. Competition in China may intensify further. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and JM Wowo does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
About JM Wowo Limited
Wowo Limited currently operates China’s leading B2B online e-commerce platform that provides integrated services to suppliers and customers in the foodservice industry. With the help of Internet and cloud technologies, the Company has the vision to reshape the procurement and distribution pattern and build a fair business ecosystem in the catering industry in China. The Company is further promoting the use of its platform for small- and medium-sized restaurants and restaurant chains in China.
Through cooperation with national and local industry associations and reputable restaurant groups across China, the Company has formed a leading industrial alliance and has great resource leverage in China’s catering industry. The Company works closely with suppliers and customers in the catering industry, providing one-stop procurement services, as well as other value-added services.
Contact: Zhao Lichao IR Director Wowo Limited zhaolichao@ccjmu.com Tel: 86-183 2119 5582
$BUR First Large-Scale $ADM #CLARISOY Facility to be Commissioned in #Q4
VANCOUVER, British Columbia, Sept. 06, 2016 — Burcon NutraScience Corporation (TSX:BU) (NASDAQ:BUR) (“Burcon”) announced today that, Archer Daniels Midland Company (NYSE:ADM), Burcon’s license and production partner for CLARISOY soy protein, has confirmed plans to achieve full commercial production of CLARISOY this year. ADM plans to begin commissioning the first large-scale CLARISOY production facility at its North American headquarters in Decatur, Illinois, during the fourth quarter of 2016.
“This is a truly significant milestone in the commercialization of CLARISOY,” said Johann Tergesen, Burcon’s president and chief operating officer, adding, “ADM is committing considerable resources to commercializing CLARISOY and is the ideal partner for such innovative proteins. ADM’s line of CLARISOY soy proteins is truly on-trend to meet the demand by consumers for great-tasting, nutritionally enhanced products targeted to the ever growing number of health and wellness-minded consumers.”
About ADM
For more than a century, the people of Archer Daniels Midland Company (NYSE:ADM) have transformed crops into products that serve the vital needs of a growing world. Today, we’re one of the world’s largest agricultural processors and food ingredient providers, with more than 32,300 employees serving customers in more than 160 countries. With a global value chain that includes 428 crop procurement locations, 280 ingredient manufacturing facilities, 39 innovation centers and the world’s premier crop transportation network, we connect the harvest to the home, making products for food, animal feed, industrial and energy uses.
About Burcon NutraScience Corporation
Burcon NutraScience is a leader in developing functionally and nutritionally valuable plant- based proteins. The company has developed a portfolio of composition, application, and process patents originating from a core protein extraction and purification technology.
Burcon’s CLARISOY™ soy protein offers clarity and high-quality protein nutrition for low pH beverage systems and excellent solubility and exceptionally clean flavor at any pH; Peazazz® is a uniquely soluble and clean-tasting pea protein; and Puratein®, Supertein® and Nutratein® are canola protein isolates with unique functional and nutritional attributes. For more information about the company, visit www.burcon.ca.
The TSX has not reviewed and does not accept responsibility for the adequacy of the content of the information contained herein. This press release contains forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation. Forward-looking statements or forward-looking information involve risks, uncertainties and other factors that could cause actual results, performances, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. Forward- looking statements or forward-looking information can be identified by words such as “anticipate,” “intend,” “plan,” “goal,” “project,” “estimate,” “expect,” “believe”, “future,” “likely,” “may,” “should,” “could”, “will” and similar references to future periods. All statements other than statements of historical fact included in this release are forward-looking statements, including, without limitation, intentions and plans contained in this press release. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements or information. Important factors that could cause actual results to differ materially from Burcon’s plans and expectations include the actual results of business negotiations, marketing activities, adverse general economic, market or business conditions, regulatory changes and other risks and factors detailed herein and from time to time in the filings made by Burcon with securities regulators and stock exchanges, including in the section entitled “Risk Factors” in Burcon’s annual information form dated June 27, 2016 filed with the Canadian securities administrators on www.sedar.com and contained in Burcon’s 20-F filed with the U.S. Securities and Exchange Commission on www.sec.gov. Any forward-looking statement or information only speaks as of the date on which it was made and, except as may be required by applicable securities laws, Burcon disclaims any intent or obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Although Burcon believes that the assumptions inherent in the forward-looking statements are reasonable, forward-looking statements are not guarantees of future performance, and accordingly, investors should not rely on such statements.
CLARISOY™ is a trademark of Archer Daniels Midland Company.
Media & Industry Contact: Michael Kirwan Director, Corporate Development Burcon NutraScience Corporation Tel (604) 733-0896, Toll-free (888) 408-7960 mkirwan@burcon.ca www.burcon.ca
$CLCD Primary, Key Secondary Endpoints Met, Phase 3 #Lasmiditan in #Migraine
- 100 mg and 200 mg doses of lasmiditan efficacious on headache pain freedom and most bothersome symptom free at the two-hour time point (p < 0.001)
- Lasmiditan was well tolerated with no significant difference in cardiovascular adverse events in patients dosed with lasmiditan vs. placebo
- SAMURAI conducted under Special Protocol Assessment agreement with FDA
- Conference call being held Tuesday, September 6, 2016 at 9:00 a.m. EDT
CAMBRIDGE, Mass., Sept. 06, 2016 — CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura, announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
Efficacy
The primary endpoint of SAMURAI was the efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo based on freedom from migraine headache pain two hours after dosing. The key secondary endpoint was the efficacy of lasmiditan based on freedom from the most bothersome associated symptom (MBS) of migraine (nausea, phonophobia or photophobia) two hours after dosing. Data from the study were collected using electronic diaries during the treated attack. Beginning pre-dose, patients indicated their degree of headache pain on a 4-point scale: 0, no pain; 1, mild pain; 2, moderate pain; or 3, severe pain. Patients also indicated the presence or absence of nausea, phonophobia or photophobia, and at the pre-dose time point identified the associated symptom present that was “most bothersome.” At each time point assessment, patients were asked to indicate the degree of headache pain and the presence or absence of each associated symptom. The MBS endpoint was patient-centric and measured treatment effect of study drug on associated symptoms. Both the primary and key secondary endpoints of SAMURAI conform to the FDA’s Draft Guidance for Industry, Migraine: Developing Drugs for Acute Treatment, issued in October 2014.
PRIMARY ENDPOINT | Lasmiditan 100mg |
Lasmiditan 200mg |
Placebo | ||||||
% of patients migraine headache pain free at two hours | 28.2 | % | 32.2 | % | 15.3 | % | |||
Odds Ratio (95% confidence interval) | 2.2 (1.6 – 3.0) | 2.6 (2.0 – 3.6) | |||||||
p-value | p < 0.001 | p < 0.001 |
KEY SECONDARY ENDPOINT | Lasmiditan 100mg |
Lasmiditan 200mg |
Placebo | ||||||
% of patients MBS free at two hours | 40.9 | % | 40.7 | % | 29.5 | % | |||
Odds Ratio (95% confidence interval) | 1.7 (1.3 – 2.2) | 1.6 (1.3 – 2.1) | |||||||
p-value | p < 0.001 | p < 0.001 |
Adverse Events
Lasmiditan was well tolerated, with the majority of treatment emergent adverse events (TEAE) being nervous system related, and 91% of TEAE in lasmiditan treated patients being described as mild or moderate in nature. Importantly, there was not a significant increase in cardiovascular adverse events in patients who dosed with lasmiditan versus placebo. There were no serious adverse events in SAMURAI that were considered to be related to treatment. The following table sets forth the percentage of patients who experienced the specified adverse event within the safety population for each dose.
TEAE | Lasmiditan 100mg (n=630) |
Lasmiditan 200mg (n=609) |
Placebo (n=617) |
Dizziness | 75 (11.9%) | 94 (15.4%) | 19 (3.1%) |
Paresthesia | 36 (5.7%) | 46 (7.6%) | 13 (2.1%) |
Somnolence | 33 (5.2%) | 32 (5.3%) | 14 (2.3%) |
Nausea | 16 (2.5%) | 29 (4.8%) | 9 (1.5%) |
Fatigue | 24 (3.8%) | 18 (3.0%) | 1 (0.2%) |
Lethargy | 12 (1.9%) | 14 (2.3%) | 1 (0.2%) |
Vertigo | 6 (1.0%) | 2 (0.3%) | 0 |
Demographics
2,231 patients were randomized at approximately 80 U.S. sites to participate in SAMURAI to treat a single migraine. Patients randomized had a mean age of 41.6 years, 83% were females, and 74% were Caucasian, with a mean migraine history of over 19 years. Patients randomized experienced an average of over five migraines per month and suffered severe disability from migraine, with an average MIDAS (Migraine Disability Assessment) score of 31. Over 25% of patients randomized used prophylactic medication to reduce the frequency of migraine. 82% of patients randomized had multiple cardiovascular risk factors (CVRF) or cardiovascular conditions. The most prevalent CVRF were obesity, family history of coronary artery disease (CAD), smoking, hypertension, post-menopausal women, men over 40 years of age, hyperlipidemia and type 2 diabetes. The most prevalent cardiovascular conditions were arrhythmias, mitral valve disease, angina, atrial fibrillation, congestive heart failure, prior myocardial infarction, Raynaud’s disease, deep vein thrombosis, ischemic stroke, and cerebral infarction.
Analysis
In accordance with the SPA agreement for SAMURAI, the protocol pre-specified the analysis population as the modified intent to treat population (mITT). The mITT was defined in the protocol as all randomized patients who used at least one dose of study drug to treat a qualifying migraine attack and had any post-dose assessments. Patients were evaluated by the study medication to which they were randomized and a qualifying migraine attack was defined as a migraine treated with study drug within four hours of onset. Similar to other migraine clinical trials, approximately 30% of patients randomized in SAMURAI were not included in the mITT due to either a failure to dose a qualifying migraine during the trial, failure to use the electronic diaries for any time point assessment, or post-randomization ineligibility (clinical lab values). In the trial, 1,239 patients took at least one dose of lasmiditan versus 617 who took at least one dose of placebo. The mITT consisted of 1,021 patients who took lasmiditan and 524 who took placebo. Analysis was conducted using a one-sided test from a logistic regression model with treatment group and background use of medication to reduce the frequency of migraines as covariates.
Detailed results from SAMURAI will be presented at a symposium during the 5th European Headache and Migraine Trust International Congress (EHMTIC 2016) taking place in Glasgow, Scotland on September 17, 2016.
Richard B. Lipton, MD, Edwin S. Lowe Professor and Vice Chair of Neurology, Professor of Epidemiology and Population Health at Albert Einstein College of Medicine and the Director, Montefiore Headache Center commented, “The SAMURAI study was successful from the twin perspectives of efficacy and tolerability. The treatment effects, even in patients with high levels of headache related disability, are impressive. The inclusion of patients with cardiovascular conditions and risk factors makes the safety profile compelling. Lasmiditan has the potential to become an important treatment option, particularly for migraine patients at high risk for cardiovascular disease. In these patients, available acute migraine treatments such as triptans and ergot alkaloids may be contraindicated or have precautions and warnings because of their vasoconstrictive effects.”
“We have shown in SAMURAI that lasmiditan was effective in the acute treatment of migraine and well tolerated,” said Thomas P. Mathers, President and Chief Executive Officer of CoLucid. “The study demographics represented the largest group of patients diagnosed and treated for migraine in the United States: primarily woman over the age of 40. Most patients, regardless of gender, had either CVRF or cardiovascular conditions. Currently, the use of prescription drug treatments in general, and triptans specifically, is less in these patients as compared to migraine patients with no CVRF. Given the convincing nature of the data, we are eager to complete the ongoing SPARTAN pivotal clinical trial, which uses the same endpoints and same statistical powering.”
Conference Call Details
CoLucid will be hosting a conference call to discuss the top-line data from SAMURAI on Tuesday, September 6, 2016 @ 9 a.m. Eastern Daylight Time:
- US Investors: +1 888-256-1030
- International: +1 913-312-0380
- Passcode: 7859323
- Webcast: http://public.viavid.com/index.php?id=121032
A replay of the conference call will be available through September 20, 2016:
- US Investors: +1 877-870-5176
- International: +1 858-384-5517
- Replay PIN: 7859323
About Lasmiditan
Lasmiditan has been designed for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Lasmiditan has been given the generic stem name “ditan,” which distinguishes it from other drug classes, including triptans, the current standard of care for migraine.
CoLucid is currently enrolling patients in a second pivotal Phase 3 clinical trial of lasmiditan oral tablets, SPARTAN. The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the United States, United Kingdom and Germany. CoLucid expects that migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”). CoLucid has obtained an SPA agreement from the FDA for SPARTAN. Top-line results from SPARTAN are expected in 2H/2017.
CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who have completed CoLucid’s first Phase 3 pivotal trial, SAMURAI, as well as the Company’s second Phase 3 pivotal trial, SPARTAN, are eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 patients, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application (“NDA”) for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.
About Migraine
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
About CoLucid Pharmaceuticals, Inc.
CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.
Forward-Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to CoLucid’s expectations for lasmiditan’s efficacy, anticipated marked demand, anticipated physician prescribing patterns, clinical trial enrollment goals and the timing of future clinical trials. Actual enrollment results, market demand, use of cash and other developments may occur that differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that enrollment goals will not be met, trials may not be commenced or successful or may take longer to complete than anticipated, regulatory approval may not be obtained, physicians may not prescribe lasmiditan, and projected cash needs and expected financial results may be different. More information about the risks and uncertainties faced by CoLucid are contained in its periodic reports filed with the Securities and Exchange Commission. CoLucid disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Thomas Mathers Chief Executive Officer CoLucid Pharmaceuticals, Inc. (857) 285-6494 Hans Vitzthum Managing Director LifeSci Advisors, LLC. (212) 915-2568
$SSYS Expands w/ #3DPrint #InjectionMolding Division using #Stratasys Machines
Stratasys Ltd. (Nasdaq:SSYS), the 3D printing and additive manufacturing solutions company, today announced that Promolding – a Dutch specialist in global design, engineering and manufacturing of high-tech plastic parts and components – has expanded its operations with the introduction of a 3D PRinted Injection Molding division (PRIM). Utilizing Stratasys PolyJet 3D printing solutions to produce molds, the company has reduced injection mold lead times for its customers by 93%.
Stratasys’ Objet500 Connex color, multi-material 3D Printer has been a key driver in the launch of PRIM, enabling Promolding to reduce injection mold lead times for its customers by 93% (Photo: Business Wire).
With a reputation for creating high-tech plastic parts using high performance polymer-based solutions, Promolding provides advanced designs and products to a diverse customer base, including household names such as Heineken and Airbus. Having initially utilized Stratasys PolyJet 3D printing to solve a number of complex applications within product development, the company has extended the use of its Objet500 Connex 3D Printer to enhance the injection molding process – opening the door to a new business opportunity.
“We became increasingly aware of the need for a 3D printer that would help us optimize our product development process,” says Jeroen Gross, Product Development Manager, Promolding. “We looked at several different options, but fell in love with Stratasys’ Objet Connex 3D Printer and its ability to not only improve our prototyping, but also become a key driver for our PRIM business. Traditionally, injection mold development required at least a six-week lead time, but by designing and 3D printing the molds in-house, we can produce molds in just three days.
“PRIM is available to our customers as an additional service in parallel to prototyping and traditional injection molding,” he adds. “In the future, we believe PRIM will be seen as a commonplace process of its own. We have come a long way and we’ll continue to explore further applications in which PolyJet 3D printing can enhance our offering.”
With increased flexibility and significant time efficiencies a key part of the PRIM division’s value proposition, Promolding is able to rapidly design and develop very complex parts and products for its customers. When recently designing a fibre optic sensor house for Fugro, a world leader in integrated geotechnical, survey, subsea and geoscience services, the company quickly produced a series of complex molds using its Objet500 Connex 3D Printer in order to meet the customer’s tight deadline. Each mold enabled the production of over 50 samples of the intricate sensor housing in a number of final product materials, including PP, TPE and PBT.
“Particularly with the development of bigger and more complex products, it is crucial as a business that we are as efficient as possible throughout the product development process, without compromising on quality,” explains Gross. “Having our 3D printer has enabled us to achieve this and given us an incredible level of flexibility. We can use the technology in the early development phases to speed up the design process and develop, review and adapt prototypes earlier, but also extend the efficiencies into production through our PRIM process. It really has been a game-changer and we’ve seen the benefits passed onto our customers.”
“Additive manufacturing has the power to transform business models and Promolding is a prime example,” concludes Andy Middleton. “We are seeing more and more customers realize the full potential of our PolyJet 3D printing technology, going beyond the immediate efficiencies within product design and pioneering the disruption of traditional manufacturing processes. In the case of injection molding, 3D printed injection molds are redefining the price-performance benchmark for low volume production, giving manufacturers the flexibility to produce products in the final injected material faster than ever before.”
For more than 25 years, Stratasys Ltd. (NASDAQ:SSYS) has been a defining force and dominant player in 3D printing and additive manufacturing – shaping the way things are made. Headquartered in Minneapolis, Minnesota and Rehovot, Israel, the company empowers customers across a broad range of vertical markets by enabling new paradigms for design and manufacturing. The company’s solutions provide customers with unmatched design freedom and manufacturing flexibility – reducing time-to-market and lowering development costs, while improving designs and communications. Stratasys subsidiaries include MakerBot and Solidscape, and the Stratasys ecosystem includes 3D printers for prototyping and production; a wide range of 3D printing materials; parts on-demand via Stratasys Direct Manufacturing; strategic consulting and professional services; and the Thingiverse and GrabCAD communities with over 2 million 3D printable files for free designs. With more than 2,700 employees and 800 granted or pending additive manufacturing patents, Stratasys has received more than 30 technology and leadership awards. Visit us online at: www.stratasys.com or http://blog.stratasys.com/, and follow us on LinkedIn.
Stratasys and Connex is a registered trademark of Stratasys Ltd. and/or its subsidiaries or affiliates.
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$AMED Closes #ProfessionalProfiles #Acquisition
BATON ROUGE, La., Sept. 02, 2016 — Amedisys, Inc. (NASDAQ:AMED), one of America’s leading home health and hospice companies, as of September 1, 2016, has closed on the previously announced acquisition of Professional Profiles, Inc., for $4.4 million.
“This transaction solidifies our footprint in Massachusetts, building on our March acquisition of Associated Home Care, the leading personal care company in Greater Boston,” stated Amedisys President and Chief Executive Officer Paul Kusserow. “It also takes us yet another key step closer to achieving our long-term strategy in adding personal care to complement our home health and hospice businesses in Massachusetts.”
Professional Profiles, Inc., with corporate headquarters in Danvers, Massachusetts, cares for more than 1,000 clients per year. The Company has 384 employees, offices in Brookline, Melrose and Lowell and covers all of Eastern Massachusetts.
About Amedisys:
Amedisys, Inc. is a leading healthcare at home Company delivering personalized home health and hospice care. Amedisys is focused on delivering the care that is best for our patients, whether that is home-based recovery and rehabilitation after an operation or injury, care focused on empowering them to manage a chronic disease, or hospice care at the end of life. More than 2,200 hospitals and 61,900 physicians nationwide have chosen Amedisys as a partner in post-acute care. Founded in 1982, headquartered in Baton Rouge, LA with an executive office in Nashville, TN, Amedisys is a publicly held company. With more than 13,000 employees, in 411 care centers in 34 states, Amedisys is dedicated to delivering the highest quality of care to the doorsteps of 360,000 patients in need every year. For more information about the Company, please visit: www.amedisys.com.
We use our company website as a channel of distribution for important company information. Important information, including press releases, analyst presentations and financial information regarding the Company is routinely posted on and accessible on the “Investor Relations” subpage of our website, which is accessible by clicking on the tab labeled “Investors” on our website home page. We will also use our website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the Securities and Exchange Commission (“SEC”) disclosing the same information. In addition, we make available on the Investor Relations subpage of our website (under the link “SEC filings”) free of charge our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, ownership reports on Forms 3, 4 and 5 and any amendments to those reports as soon as practicable after we electronically file such reports with the SEC. Further, copies of our Certificate of Incorporation and Bylaws, our Code of Ethical Business Conduct and the charters for the Audit, Compensation, Nominating and Corporate Governance, Quality of Care and Compliance and Ethics Committees of our Board are also available on the Investor Relations subpage of our website (under the link “Corporate Governance”).
Forward-Looking Statements:
When included in this press release, words like “believes,” “belief,” “expects,” “plans,” “anticipates,” “intends,” “projects,” “estimates,” “may,” “might,” “would,” “should” and similar expressions are intended to identify forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a variety of risks and uncertainties that could cause actual results to differ materially from those described therein. These risks and uncertainties include, but are not limited to the following: changes in Medicare and other medical payment levels, our ability to open care centers, acquire additional care centers and integrate and operate these care centers effectively, changes in or our failure to comply with existing Federal and State laws or regulations or the inability to comply with new government regulations on a timely basis, competition in the home health industry, changes in the case mix of patients and payment methodologies, changes in estimates and judgments associated with critical accounting policies, our ability to maintain or establish new patient referral sources, our ability to attract and retain qualified personnel, changes in payments and covered services due to the economic downturn and deficit spending by federal and state governments, future cost containment initiatives undertaken by third-party payors, our access to financing due to the volatility and disruption of the capital and credit markets, our ability to meet debt service requirements and comply with covenants in debt agreements, business disruptions due to natural disasters or acts of terrorism, our ability to integrate and manage our information systems, our ability to comply with requirements stipulated in our corporate integrity agreement and changes in law or developments with respect to any litigation relating to the Company, including various other matters, many of which are beyond our control.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on any forward-looking statement as a prediction of future events. We expressly disclaim any obligation or undertaking and we do not intend to release publicly any updates or changes in our expectations concerning the forward-looking statements or any changes in events, conditions or circumstances upon which any forward-looking statement may be based, except as required by law.
Media Contact: Kendra Kimmons Marketing & Communications 225-299-3720 kendra.kimmons@amedisys.com
$CPAAU Class A Common Stock, Warrants Commence Trading September 6
NEW YORK, Sept. 2, 2016 — Conyers Park Acquisition Corp. (the “Company”) (NASDAQ: CPAA) today announced that the holders of the Company’s units may elect to separately trade the Class A common stock and warrants underlying the units commencing on September 6, 2016. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. Those units not separated will continue to trade on the NASDAQ Capital Market under the symbol “CPAAU” and the Class A common stock and the warrants are expected to trade under the symbols “CPAA” and “CPAAW”, respectively.
The units were initially offered by the Company in an underwritten offering. Deutsche Bank Securities Inc. and Goldman, Sachs & Co. acted as joint book-runners and Cantor Fitzgerald & Co. acted as co-manager for the offering.
A registration statement relating to the units and the underlying securities was declared effective by the Securities and Exchange Commission on July 14, 2016.
This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A copy of the final prospectus relating to the offering may be obtained for free by visiting the U.S. Securities and Exchange Commission website at http://www.sec.gov. Alternatively, a copy of the prospectus related to this offering may be obtained from Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, by telephone at 1- 800-503-4611 or by email at prospectus.CPDG@db.com; Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone toll-free at 1-866-471-2526 or by email at prospects-ny@ny.email.gs.com; or Cantor Fitzgerald & Co., Attn: Prospectus Group, 499 Park Avenue, New York, NY 10022, by telephone at 1-212-915-1067 or by email at prospectus@cantor.com.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus for the offering filed with the Securities and Exchange Commission (“SEC”). Copies are available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Contact:
Julia Wilfert
Brunswick Group
212-333-3810
jwilfert@brunswickgroup.com
$MEMP Announces Changes in Leadership Roles
HOUSTON, Sept. 02, 2016 — The Board of Directors (the Board) of Memorial Production Partners GP LLC (MEMP GP), the general partner of Memorial Production Partners LP (NASDAQ:MEMP), announced today that John A. Weinzierl has submitted his resignation as Chief Executive Officer of MEMP GP effective immediately. Mr. Weinzierl will remain actively involved with MEMP by continuing to serve as a director on the Board, a position he has held since the partnership’s initial public offering in 2011.
The Board has elected William J. Scarff, the current President of MEMP GP, to the additional role of Chief Executive Officer, and Jonathan M. Clarkson, currently serving as an independent director on the Board, will transition to the role of non-executive Chairman of the Board. Mr. Scarff has over 30 years of oil and gas industry experience, including starting and leading successful private energy companies, and has made significant contributions to MEMP since he became President in January 2014. Mr. Scarff is also a member of the Board. Mr. Clarkson has an oil and gas career spanning over 40 years and has held numerous financial management positions with both public and private oil and gas exploration and production companies, including as Chief Financial Officer of Ocean Energy Corp., leadership positions, including Chairman, President and CEO of Houston Region of Texas Capital Bank, and roles on several other public and private company management teams and boards.
“On behalf of the Board, we would like to thank John for his years of service as CEO. John was the driving force behind MEMP’s formation and its IPO and led MEMP’s growth from producing under 50 MMcfe/d in one state in MEMP’s first quarter as a public company to over 230 MMcfe/d in five states in the second quarter of 2016,” said Jonathan M. Clarkson. “I am pleased that we are able to make a seamless CEO transition and have confidence that Bill will effectively and successfully lead the Company.”
“John has made a tremendous imprint on this organization, and I am honored by the Board’s confidence in me to take on this new role,” said William J. Scarff. “Both John Weinzierl and Jon Clarkson have been instrumental in MEMP’s success since the IPO and we are fortunate to have their involvement on an ongoing basis. I look forward to working with the Board, the management team and our employees, as we continue to strive for value creation for our stakeholders.”
“Given Bill’s position as President of MEMP GP and Jon’s role as a member of the Board since MEMP’s IPO in 2011, and the wealth of experience they each bring from their respective very successful oil and gas careers, the other members of the Board and I are assured that MEMP will be effectively managed and will thrive,” said John A. Weinzierl. “I look forward to supporting MEMP with strategic input in my ongoing role as a member of the Board and will be available for whatever Bill and the management team see as helpful and appropriate.”
About Memorial Production Partners LP
Memorial Production Partners LP is a publicly traded partnership engaged in the acquisition, production and development of oil and natural gas properties in the United States. MEMP’s properties consist of mature, legacy oil and natural gas fields. MEMP is headquartered in Houston, Texas. For more information, visit www.memorialpp.com.
Forward-Looking Statements
This press release includes “forward-looking statements.” All statements, other than statements of historical facts, included in this press release that address activities, events or developments that MEMP expects, believes or anticipates will or may occur in the future are forward-looking statements. Terminology such as “will,” “would,” “should,” “could,” “expect,” “anticipate,” “plan,” “project,” “intend,” “estimate,” “believe,” “target,” “continue,” “potential,” the negative of such terms or other comparable terminology are intended to identify forward-looking statements. These statements include, but are not limited to, statements about MEMP’s future capital expenditures (including the amount and nature thereof), expectations regarding cash flows, distributions and distribution rates, and expectations of plans, goals, strategies (including measures to implement strategies), objectives and anticipated financial and operating results of MEMP, including as to production, lease operating expenses, hedging activities, commodity price realizations, capital expenditure levels and other guidance. These statements are based on certain assumptions made by MEMP based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances, but such assumptions may prove to be inaccurate. Such statements are also subject to a number of risks and uncertainties, many of which are beyond the control of MEMP, which may cause MEMP’s actual results to differ materially from those implied or expressed by the forward-looking statements. These include risks and uncertainties relating to, among other things, the uncertainty inherent in the development and production of oil, natural gas and natural gas liquids and in estimating reserves; drilling activities; volatility in the prices for, oil, natural gas and natural gas liquids, including a further or extended decline in commodity prices; potential difficulties in the marketing of oil, natural gas and natural gas liquids; competition in the oil and natural gas industry; potential failure or shortages of, or increased costs for, drilling and production equipment and supply materials for production; risks related to acquisitions, including MEMP’s ability to integrate acquired properties; risks related to MEMP’s ability to generate sufficient cash flow to pay distributions, to make payments on its debt obligations and to execute its business plan; MEMP’s ability to access funds on acceptable terms, if at all, because of the terms and conditions governing MEMP’s indebtedness or otherwise; and the risk that MEMP’s hedging strategy may be ineffective or may reduce its income. Please read MEMP’s filings with the Securities and Exchange Commission (“SEC”), including “Risk Factors” in MEMP’s Annual Report on Form 10-K, and if applicable, MEMP’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, which are available on MEMP’s Investor Relations website at http://investor.memorialpp.com/sec.cfm or on the SEC’s website at http://www.sec.gov, for a discussion of risks and uncertainties that could cause actual results to differ from those in such forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements in this press release are qualified in their entirety by these cautionary statements. Except as required by law, MEMP undertakes no obligation and does not intend to update or revise any forward-looking statements, whether as a result of new information, future results or otherwise.
Contacts Memorial Production Partners LP Bobby Stillwell – Chief Financial Officer (713) 588-8347 ir@memorialpp.com Memorial Production Partners LP Martyn Willsher – Treasurer (713) 588-8346 ir@memorialpp.com
$CPRX Announces #FDA #OrphanDrug Designation of #Firdapse
CORAL GABLES, Fla., Sept. 02, 2016 — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for Firdapse® (amifampridine phosphate) for the treatment of myasthenia gravis.
Myasthenia Gravis caused by antibodies to the muscle-specific kinase (MuSK-MG) is a rare disease that is estimated to inflict 5-8% of all myasthenia gravis patients (equating to an estimate of approximately 4,500 patients in the United States). MuSK antibodies identify a clinically distinguishable, more severe form of MG. The disease is characterized by a predominance in females, prominent bulbar involvement, more severe clinical condition and resistance to treatment. Although many patients with MuSK-MG are presently treated with anticholinesterase inhibitors or immunosuppressants, such patients do not generally respond adequately to these treatments.
“We are pleased that the FDA has granted Orphan Drug designation to Firdapse for myasthenia gravis, as it provides Catalyst with a number of benefits through development and commercialization,” stated Patrick J. McEnany, Chief Executive Officer of Catalyst. He continued, “We are currently supporting an investigator-sponsored, randomized, double-blind, placebo controlled study evaluating Firdapse for the treatment of patients with MuSK-MG, and we anticipate the investigator reporting top-line results from this study in early 2017. If this trial is successful, and subject to the availability of funding, we hope to initiate a registration quality trial in the U.S. evaluating Firdapse for the treatment of patients with MuSK-MG.”
About Orphan Drug Designation
Orphan Drug designation is granted by the FDA’s Office of Orphan Products Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan Drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include an accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for Orphan Drug grants; and waiver of Prescription Drug User Fee Act (PDUFA) and certain other administrative fees.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette’s Disorder. Firdapse for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette’s Disorder. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril (vigabatrin).
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, what study design for a second trial evaluation of Firdapse for the treatment of LEMS will be acceptable to the FDA, the timing of such trial, and whether it will be successful, whether Catalyst’s assumptions in its updated business plan will be accurate and the impact of unanticipated events or delays in projected activities on Catalyst’s cash requirements and on Catalyst’s ability to get to an accepted NDA submission for Firdapse without the need for additional funding, what clinical trials and studies will be required before Catalyst can resubmit an NDA for Firdapse for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether the investigator-sponsored study evaluating Firdapse for the treatment of MuSK-MG will be successful, whether any NDA for Firdapse resubmitted to the FDA will ever be accepted for filing, the timing of any such NDA filing or acceptance, whether, if an NDA for Firdapse is accepted for filing, such NDA will be given a priority review by the FDA, whether Firdapse will ever be approved for commercialization, whether Catalyst will be the first company to receive approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether CPP-115 will be determined to be safe for humans, what additional testing will be required before CPP-115 is “Phase 2 ready”, whether CPP-115 will be determined to be effective for the treatment of infantile spasms, post-traumatic stress disorder, Tourette’s Disorder or any other indications, whether Catalyst can successfully design and complete a bioequivalence study of its version of vigabatrin compared to Sabril that is acceptable to the FDA, whether any such bioequivalence study the design of which is acceptable to the FDA will be successful, whether any ANDA that Catalyst submits for a generic version of Sabril will be accepted for filing, whether any ANDA for Sabril accepted for filing by the FDA will be approved (and the timing of any such approval), whether any of Catalyst’s product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2015 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Investor Contact Brian Korb The Trout Group LLC (646) 378-2923 bkorb@troutgroup.com Media Contacts David Schull Matt Middleman, M.D. Russo Partners (212) 845-4271 (212) 845-4272 david.schull@russopartnersllc.com matt.middleman@russopartnersllc.com Company Contact Patrick J. McEnany Catalyst Pharmaceuticals Chief Executive Officer (305) 420-3200 pmcenany@catalystpharma.com
$SIEB and #KennedyCabot Acquisition Announce #DefinitiveAgreement
Siebert Financial Corp. (NASDAQ:SIEB) and Kennedy Cabot Acquisition, LLC are pleased to announce they have entered into a definitive agreement under which Kennedy Cabot Acquisition will acquire approximately 90% of the outstanding common stock of Siebert Financial Corp. from the Estate of Muriel F. Siebert. Siebert Financial is the owner of Muriel Siebert & Co., Inc., the broker-dealer founded in 1967 by the late Muriel F. “Mickie” Siebert, the first woman to own a seat on the New York Stock Exchange and the first woman to head a NYSE member firm.
Jane Macon, the Chairwoman of Siebert Financial said, “We look forward to a smooth transition and are pleased that the enduring vision and legacy established by Mickie Siebert nearly fifty years ago will continue into the future.”
Gloria E. Gebbia, the owner and managing member of Kennedy Cabot Acquisition said, “The team being assembled at Kennedy Cabot Acquisition has many years of experience in the brokerage industry including successfully acquiring and growing broker-dealers and bring a strong and experienced management team to Siebert Financial Corp.”
Under the terms of the agreement, Kennedy Cabot Acquisition will make a tender offer for the outstanding common stock of Siebert Financial not owned by the Estate. Holders of Siebert Financial shares may accept the tender offer and sell their shares or not tender their shares and remain shareholders of Siebert Financial. The closing of the sale and the tender offer is expected to occur in the fourth quarter of 2016, conditioned upon approval by the Financial Industry Regulatory Authority (FINRA).
Prior to closing, Siebert Financial anticipates paying a dividend to all Siebert Financial shareholders in the amount of approximately $0.20 per share.
Siebert Financial’s principal activity is providing online and traditional discount brokerage and related services to retail investors through the broker-dealer, and serves as a registered investment advisor through its Siebert Investment Advisors business unit.
Siebert Financial considers the sale to Kennedy Cabot Acquisition to be the strongest strategic alternative to continue the company and maximize shareholder value in the wake of the 2013 passing of Muriel F. “Mickie” Siebert, Siebert Financial’s founder and former Chairwoman, President and Chief Executive Officer.
Kennedy Cabot Acquisition plans to continue to build upon the strong existing foundation at Siebert Financial to further strengthen the customer experience. The acquisition agreement does not provide for the merger of Siebert Financial with or into Kennedy Cabot Acquisition.
Mrs. Gebbia added, “Speaking for myself and the other principals of Kennedy Cabot Acquisition, we are all very excited about the acquisition and embrace the opportunity not only to expand the business but also to build a world-class financial firm dedicated to serving client financial needs.”
Mrs. Gebbia and her family are the majority owners of StockCross Financial Services, Inc. The Gebbia family has been successfully involved with financial services companies since the early 1970’s and during such time they built a broker-dealer into a national brand, which they sold to Toronto Dominion Bank in 1997. Mrs. Gebbia is also the President of the Associates for Breast and Prostate Cancer Studies which raises funds for the John Wayne Cancer Institute. Through Mrs. Gebbia’s leadership since 1998 over $14 million has been raised for cancer research studies.
About Siebert Financial Corp.
Siebert Financial is a holding company that conducts its retail discount brokerage business through its wholly-owned subsidiary, Muriel Siebert & Co., Inc. The firm became a member of the NYSE in 1967, when Ms. Siebert became the first woman to own a seat on the Exchange. In addition, in 2014 the Company began business as a registered investment advisor through a wholly-owned subsidiary, Siebert Investment Advisors, Inc. Siebert Financial is based in New York City with additional retail branches in Boca Raton, FL and Beverly Hills, CA. www.siebertnet.com
About Kennedy Cabot Acquisition
Kennedy Cabot Acquisition is a Nevada limited liability company. The principals of Kennedy Cabot Acquisition have substantial experience in the brokerage industry and are/were affiliates of StockCross Financial Services, Inc. StockCross is a broker-dealer member of FINRA with offices across the United States.
Cautionary note regarding forward-looking statements
This communication contains “forward-looking statements” (as defined in the Securities Litigation Reform Act of 1995) regarding, among other things, future events. Words such as “anticipate,” “expect,” “intend,” “believe,” and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. Forward-looking statements relating to the proposed transactions include, but are not limited to: statements about the benefits of the proposed transactions; Siebert Financial’s and Kennedy Cabot Acquisition’s plans, objectives, expectations and intentions; the expected timing of completion of the proposed transactions; and other statements relating to the transactions that are not historical facts. Forward-looking statements are based on information currently available to Siebert Financial and Kennedy Cabot Acquisition, as the case may be, and involve estimates, expectations and projections. Investors are cautioned that all such forward-looking statements are subject to risks and uncertainties, and important factors could cause actual events or results to differ materially from those indicated by such forward-looking statements. With respect to the proposed transactions between Siebert Financial and Kennedy Cabot Acquisition, these risks and factors could include, but are not limited to: securing regulatory approval; the risk that a condition to closing may be delayed or may not be satisfied; the diversion of management time on transaction-related issues; changes in the general economic environment, or social or political conditions, that could affect the business of Siebert Financial and the Broker-Dealer; and the potential impact of the announcement or consummation of the proposed transactions on relationships with customers, competitors, management and other employees.
Additional information concerning other risk factors is also contained in Siebert Financial’s most recently filed Annual Reports on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other SEC filings.
Notice to Investors
This communication is provided for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any securities of Siebert Financial. The tender offer for the outstanding common stock of Siebert Financial not owned by the Estate has not yet commenced. Any offers to purchase or solicitation of offers to sell will be made only pursuant to the tender offer statement (including the offer to purchase, the letter of transmittal and other documents relating to the tender offer) which will be filed on Schedule TO by Kennedy Cabot Acquisition with the SEC, and soon thereafter Siebert Financial will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Siebert Financial’s shareholders are advised to read these documents and any other documents relating to the tender offer that will be filed with the SEC carefully and in their entirety because they contain important information. Siebert Financial’s shareholders may obtain copies of these documents for free at the SEC’s website at www.sec.gov or by contacting Siebert Financial’s investor relations department at Siebert Financial Corp., 885 Third Avenue, New York, New York 10022, Attention: Investor Relations.
SIEBERT FINANCIAL CORP.
Media:
Rubenstein
Marcia Horowitz, 212-843-8014
mhorowitz@rubenstein.com
or
LHK Communications LLC / New York
Laura Hynes-Keller, +1 646-797-6992
laurahk@lhkcommunications.com
or
KENNEDY CABOT ACQUISITION, LLC
Media:
Gusrae Kaplan Nusbaum PLLC / New York
Martin H. Kaplan, 212-514-8369
kcacquisition@gmail.com
$AKAO Completes Enrollment Phase 3 #EPIC #ClinicalTrial of #Plazomicin
Top-Line Data in Phase 3 EPIC and CARE Studies Expected Early in First Quarter of 2017; Planning NDA Submission for Second Half of 2017
SOUTH SAN FRANCISCO, Calif., Sept. 01, 2016 — Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has completed patient enrollment ahead of schedule in its Phase 3 EPIC registration clinical trial of plazomicin. Additionally, the Company has closed enrollment in the Phase 3 CARE trial of plazomicin and expects to report top-line results from both the EPIC and CARE clinical trials early in the first quarter of 2017. Achaogen is developing plazomicin to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
“We are extremely grateful to the patients, investigators and clinical trial sites that participated in the EPIC trial. Their extraordinary teamwork enabled us to quickly enroll the EPIC trial in less than eight months, significantly faster than our original projections. We look forward to announcing top-line data early in the first quarter next year,” said Kenneth Hillan, M.B., Ch.B., Achaogen’s Chief Executive Officer. “With the rapid completion of the EPIC trial, we closed enrollment in the CARE trial several months earlier than anticipated and we are one step closer to our goal of submitting the plazomicin NDA in the second half of 2017 and, if approved, making plazomicin available as an important option for treating patients with CRE infections.”
About the Phase 3 EPIC Clinical Trial
EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections. EPIC is evaluating the efficacy and safety of plazomicin compared to meropenem and 609 patients were randomized to receive either plazomicin or meropenem intravenously. The primary objective of the EPIC trial is to demonstrate the non-inferiority, with a 15% non-inferiority margin as agreed by FDA, of plazomicin compared to meropenem based on the difference in composite microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat (mMITT) population at both the Day 5 and test-of-cure visits. The Company expects the EPIC trial to serve as a single registration trial and support a New Drug Application (NDA) submission in the second half of 2017.
About the Phase 3 CARE Clinical Trial
CARE (Combating Antibiotic Resistant Enterobacteriaceae) is a resistant pathogen-specific trial that describes the efficacy and safety of plazomicin in patients with infections due to CRE. Due to the rapid completion of enrollment of the EPIC trial, the Company closed enrollment in the CARE trial several months earlier than anticipated with a total of 69 patients enrolled. CARE contains a randomized, open-label cohort (Cohort 1; 39 patients) that compares the efficacy and safety of plazomicin with colistin in the treatment of patients with bloodstream infections (BSI) or hospital-acquired pneumonia (HABP, VABP) due to CRE. An additional single-arm cohort (Cohort 2; 30 patients) enrolled patients with BSI, HABP, VABP, cUTI or AP due to CRE, and who were not eligible for enrollment in Cohort 1, to be treated with plazomicin-based therapy. The Company plans to submit the Phase 3 CARE trial results as supportive data with the plazomicin NDA, which is based on the Phase 3 EPIC trial, and to submit the results to peer-reviewed journals and for presentation at medical meetings. The CARE trial is primarily a descriptive study (no formal hypothesis testing will be performed); the Company believes the trial will provide important and meaningful data regarding the efficacy, safety, microbiology, and dosing, to better inform physician use of plazomicin in the potential treatment of patients with CRE infections.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding (i) whether the Phase 3 EPIC trial will serve as a single registration clinical trial supporting an NDA for plazomicin, (ii) the timing for completion of Achaogen’s Phase 3 trials and submission of an NDA to the FDA, (iii) the potential for plazomicin to treat serious bacterial infections due to MDR Enterobacteriaceae and patients with CRE infections; (iv) whether the Phase 3 EPIC trial will create a substantial opportunity for plazomicin to address the unmet medical need arising from MDR infections; (v) the Company’s plans to submit the Phase 3 CARE trial results as supportive data with the plazomicin NDA based on the Phase 3 EPIC trial and to submit the Phase 3 CARE trial results to peer-reviewed journals and for presentation at medical meetings; and (vi) whether the Phase 3 CARE trial will provide important and meaningful data regarding the safety, microbiology, and dosing, to better inform physician use of plazomicin in the potential treatment of patients with CRE infections. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; specific risks related to the ongoing Phase 3 EPIC trial and Phase 3 CARE trial, including the lack of a prior clinical trial in patients with CRE infections; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen’s ability to raise additional capital to support the development of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen’s reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen’s reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen’s dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen’s programs, including the risk that BARDA could terminate Achaogen’s contract for the funding of the plazomicin development program; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen’s patents or proprietary rights; and the risk that Achaogen’s proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Achaogen’s business in general, see Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
$VRA Announces Licensing Agreements in Stationery and Publishing
Company targeting additional partnerships in key areas of home, fashion, and beauty
FORT WAYNE, Ind., Sept. 01, 2016 — Vera Bradley, Inc. (Nasdaq:VRA) (“Vera Bradley” or the “Company”) today announced it has entered into two licensing agreements for stationery and publishing.
Rob Wallstrom, Chief Executive Officer of Vera Bradley, noted, “One of our main objectives this year was to explore appropriate licensing opportunities to strengthen our brand, expand our reach to even more distribution points and customers, and establish a solid foundation for international growth. Entering into these two arrangements is a great start.”
“We have been working diligently over the last few months to identify the right licensing partners in our focus businesses of home, fashion, and beauty,” commented Sue Fuller, Chief Merchandising Officer for Vera Bradley. “We are very fortunate that there is enormous interest in Vera Bradley in each of these areas and that we are able to be selective and develop relationships with the expert partners that are the best fits for our Company. We expect to announce additional licensing agreements in the future.”
Fuller added, “Our distinctive patterns naturally lend themselves to a myriad of products in home, fashion, and beauty.”
The Company has entered into an arrangement with Lifeguard Press for signature stationery and home and office organizational products. The Company will transition from an internally-managed program and will introduce the expanded line of products in fall 2017. The Company has also entered into a licensing agreement with Fox Chapel Publishing for coloring activity and design books and gift sets featuring Vera Bradley’s iconic patterns, which will be available for holiday 2016.
These products will be sold in appropriate distribution channels including Vera Bradley stores, verabradley.com, and specialty and chain stores throughout the country.
Vera Bradley will work with the licensing partners in the development and final approval of all product designs. Management does not expect licensing partnerships to have a material impact on the company’s financial performance for the fiscal years ending January 28, 2017 and February 3, 2018.
About Vera Bradley, Inc.
Vera Bradley is a leading designer of women’s handbags, luggage and travel items, fashion and home accessories and unique gifts. Founded in 1982 by friends Barbara Bradley Baekgaard and Patricia R. Miller, the brand’s innovative designs, iconic patterns and brilliant colors continue to inspire and connect women unlike any other brand in the global marketplace. The Company’s commitment to bringing more beauty into women’s lives includes its dedication to breast cancer research through the Vera Bradley Foundation for Breast Cancer. For more information about Vera Bradley (Nasdaq:VRA), visit www.verabradley.com.
About Lifeguard Press
Lifeguard Press is a leading, premier manufacturer of licensed-branded and private-label merchandise, working with world-class lifestyle brands to design, produce, and distribute products including accessories, drinkware, gifts, home décor, outdoor entertaining, tech, travel, and stationery. Licensed partners include Vera Bradley, Kate Spade New York, and Lilly Pulitzer. For more information, please visit www.lifeguardpress.com.
About Fox Chapel Publishing
Fox Chapel Publishing inspires and informs readers who enjoy a wide variety of hobbies, crafts, and lifestyle interests. The company specializes in illustrated nonfiction with a focus on artisan and high-quality craft books. Fox Chapel publishes more than 1,200 book titles and three quarterly magazines, including DO Magazine, the #1 coloring magazine in its class. The publisher’s imprints include Design Originals, IMM Lifestyle Books, and Creative Homeowner. For more information, please visit www.foxchapelpublishing.com.
Vera Bradley Safe Harbor Statement
Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect the Company’s current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected, including: possible adverse changes in general economic conditions and their impact on consumer confidence and spending; possible inability to predict and respond in a timely manner to changes in consumer demand; possible loss of key management or design associates or inability to attract and retain the talent required for our business; possible inability to maintain and enhance our brand; possible inability to successfully implement our growth strategies or manage our growing business; possible inability to successfully open new stores as planned; adverse changes in the cost of raw materials and labor used to manufacture our products; and possible adverse effects resulting from a significant disruption in our single distribution facility. More information on potential factors that could affect the Company’s financial results is included from time to time in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s public reports filed with the SEC, including the Company’s Form 10-K for the fiscal year ended January 30, 2016. We undertake no obligation to publicly update or revise any forward-looking statement. Financial schedules are attached to this release.
CONTACTS: Investors: Julia Bentley, VP of Investor Relations and Communications jbentley@verabradley.com (260) 207-5116 Media: 877-708-VERA (8372)
$JAGX Additional #Topline #Results from #Neonorm Calf #Study
Jaguar Animal Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses, announced additional topline results today from its study conducted in conjunction with researchers from Cornell University College of Veterinary Medicine (“Cornell”) to evaluate the efficacy of the prophylactic use of a second-generation, powder formulation of Neonorm™ Calf, administered in liquid, on naturally occurring diarrhea and dehydration in preweaned dairy calves.
Neonorm™ Calf, one of Jaguar’s lead non-prescription products, has been formulated and clinically tested to help proactively retain fluid in dairy calves and reduce the severity of diarrhea—aiding the animals in avoiding debilitating, dangerous levels of dehydration associated with scours. The powder form of the product allows for ease of administration for entire herd management.
This double-blind, randomized study involved 40 newborn Holstein bull calves and compared the prophylactic use of Neonorm™ against a placebo. Treatment administration was performed twice daily for 14 days starting on the first feeding after colostrum administration. The calves were kept for an additional 10 days after the final treatment administration for clinical observation and sample collection. Calves were housed in individual pens and feeding was restricted to saleable whole milk. Data regarding fecal dry matter were used to measure water loss due to secretory diarrhea.
The study results show that calves under prophylactic administration of Neonorm™ had significantly lower water content in fecal samples at multiple measurement points, lower incidence of diarrhea, and had fewer fluid therapy interventions.
Fecal scoring, which was conducted daily during the study period, indicated a significantly lower incidence of diarrhea among Neonorm™-treated calves on most treatment days than among calves in the placebo group. The study also assessed the incidence of diarrhea from days 1 to 25 of life. Calves in the Neonorm™-treated group experienced a highly significant reduction in the incidence of diarrhea during this period compared to those in the placebo group.
Dehydration was assessed twice daily for all calves in the study. Results showed that severe dehydration requiring the administration of intravenous (“IV”) fluid therapy was reduced by approximately 50% in the Neonorm™-treated calves. Moreover, overall rescue therapy, requiring either oral or IV fluid administration, for both severe and moderate dehydration, was significantly reduced in the Neonorm™-treated animals.
The study results complement the results of a prior study, also conducted by Jaguar in association with Cornell, that evaluated the effect of Neonorm™ on diarrhea severity and consistency in newborn Holstein bull calves experiencing diarrhea induced by enterotoxigenic Escherichia coli (E. coli). The results of this earlier study were published in the official journal of the American Dairy Science Association, Journal of Dairy Science, in 2015, and the Cornell team hopes to publish the full results of the recently-completed study as well.
“The results appear to support the potential prophylactic benefits of an easy-to-administer powder formulation of Neonorm™ on reducing the incidence and severity of diarrhea and associated fluid loss, herd-wide, in calves,” commented Dr. Andre Gustavo Teixeira of Cornell, the principal investigator of the recently completed study.
Lisa Conte, Jaguar’s president and CEO, stated, “We are quite pleased by the additional findings from this study. The positive prophylactic effect of the powder formulation of Neonorm™ in calves supports and underscores the prophylaxis data generated by the recently completed piglet studies of the powder formulation of Neonorm™ conducted in China by Chinese investigators. As the most common disease in newborn pigs1, diarrhea has a significant impact on the global swine market as well as food security.”
As Jaguar announced this past July, the Company has entered into negotiations for a potential exclusive distribution relationship for Neonorm™ for dairy cattle and pigs in the Chinese marketplace with the China-based business entity that was involved in conducting the piglet studies.
About Neonorm™
Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Jaguar intends to develop species-specific formulations of Neonorm™ in six additional target species.
About Jaguar Animal Health, Inc.
Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, foals, and high value horses. Canalevia™ is Jaguar’s lead prescription drug product candidate, intended for the treatment of various forms of diarrhea in dogs. SB-300 is Jaguar’s prescription drug product candidate for the treatment of gastrointestinal ulcers in horses. Canalevia™ and SB-300 contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are the Company’s lead non-prescription products. Neonorm™ is a standardized botanical extract derived from the Croton lechleri tree. Canalevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm™ in six additional target species, formulations of SB-300 in horses, and Canalevia™ for cats and dogs.
For more information, please visit www.jaguaranimalhealth.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the potential prophylactic benefits of a powder formulation of Neonorm™ on reducing the incidence and severity of diarrhea and associated fluid loss, herd-wide, in calves, a potential exclusive distribution relationship for dairy cattle and pigs in the Chinese marketplace between Jaguar and the China-based business entity involved in conducting the piglet studies, the Company’s intention to develop formulations of SB-300 in horses and species-specific formulations of Neonorm™ in additional target species, and the Company’s plan to develop formulations of Canalevia™ for cats and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1Diarrhoea or Scour. Retrieved July 24, 2016, from http://www.thepigsite.com/pighealth/article/276/diarrhoea-or-scour/.
Jaguar-JAGX
KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
$VBIV to Present at the #Vaccine Congress
CAMBRIDGE, MASSACHUSETTS–(Sept. 1, 2016) – VBI Vaccines Inc. (NASDAQ:VBIV)(TSX:VBV) (“VBI”) is scheduled to present at the 10th Vaccine Congress on Monday, September 5, 2016 at 12:45 PM CEST (6:45 AM ET). The event is being held at the NH Grand Hotel Krasnapolsky in Amsterdam, the Netherlands.
During the presentation, eVLP Delivery of an Optimized Form of CMV gB Antigen for Prophylactic Vaccination against Congenital CMV, Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, will summarize recent developments in the company’s cytomegalovirus (“CMV”) vaccine program, including new data that demonstrates the desirable properties of VBI’s eVLP Platform.
VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are an innovative new class of vaccines that closely mimic the target virus to elicit a potent immune response. Because of their structural similarity to viruses found in nature, vaccination with a target protein expressed in an eVLP may be capable of imparting greater immunity than vaccination with the same recombinant target protein alone(1).
New data from a preclinical study, conducted over a twelve-month time period, demonstrates that prior exposure to eVLPs does not impact the kinetics or potency of subsequent eVLP vaccinations.
“This new data shows that there is a potent immune response to the target CMV antigen being presented by the eVLP, but very little immune response to the eVLP itself,” said Dr. Diaz-Mitoma. “This is important because a strong immune reaction to the eVLP might lead to rapid clearance by the immune system, potentially impacting the effectiveness of subsequent vaccinations. We are encouraged by this data, which supports the use of multiple dose regimens of eVLP vaccines.”
VBI’s lead eVLP is a preventative CMV vaccine candidate. VBI is conducting a Phase I clinical study to assess the safety and tolerability of its CMV vaccine candidate in 125 healthy CMV-negative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection. The study is expected to last 20 months with preliminary results anticipated in the first half of 2017.
CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and mental retardation(2). CMV affects more live births than Down syndrome or fetal alcohol syndrome(3), making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement(4).
(1) Kirchmeier M, Fluckiger AC, Soare C, et al. Enveloped virus-like particle expression of human cytomegalovirus glycoprotein B antigen induces antibodies with potent and broad neutralizing activity. Clin Vaccine Immunol. 2014;21(2):174-80.
(2) http://www.cdc.gov/cmv/clinical/congenital-cmv.html
(3) Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital cytomegalovirus disease epidemic. BMC Public Health 5:70
(4) Stratton KR et al, Committee to Study Priorities for Vaccine Development, Inst. of Med.; Washington, DC
To download a copy of Dr. Diaz-Mitoma’s presentation, visit: http://www.vbivaccines.com/wire/tenth-vaccine-congress/.
Event Details
- Event: 10th Vaccine Congress
- Date: Monday, September 5, 2016
- Time: 12:45 PM CEST (6:45 AM ET)
- Location: The NH Grand Hotel Krasnapolsky in Amsterdam, the Netherlands
- Event Website: http://www.vaccinecongress.com/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vacis approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology allows for the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.
- Website Home: http://www.vbivaccines.com/
- News and Insights: http://www.vbivaccines.com/wire/
- Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “potentially”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements. Such forward-looking statements included, but are not limited to: the capability of an eVLP to impact immunity, the impact of an eVLP on vaccination effectiveness and design parameters and measurement levels of the Phase I study.
Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; competitive conditions; and changes in applicable laws, rules and regulations.
VBI cautions the reader that forward-looking statements and information involve known and unknown risks, uncertainties and other factors that may cause actual results and developments to differ materially from those expressed or implied by such forward-looking statements or information contained in this news release and VBI has made assumptions and estimates based on or related to many of these factors.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
VBI Contact
Perri Maduri
Communications Executive
(617) 830-3031 x124
ir@vbivaccines.com
VBI Investor Contact
Nell Beattie
Director, Corporate Development and Investor Relations
(617) 830-3031 x128
nbeattie@vbivaccines.com
$ATEC Completes Sale of International Business to $GMED
Substantially reduced debt and improved balance sheet strengthens Alphatec’s financial position and enables future growth strategies
CARLSBAD, Calif., Sept. 01, 2016 — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced the completion of the previously announced sale of its international operations and distribution channel to Globus Medical (NYSE:GMED), a leading musculoskeletal implant manufacturer.
With the closing of the transaction, the Company is now focused solely on the U.S. market, which Alphatec believes constitutes nearly 65% of the world’s spinal fusion market.
Over the past several years, the Company has focused its R&D programs and invested in the development of a leading, robust suite of products that are available to surgeons in the U.S. today—including Arsenal™ Degenerative, Arsenal Deformity and Battalion™ Universal Interbody. In addition, the Company has recently obtained U.S. clearance for its new XYcor® Expandable Spinal Spacer System, which the Company plans to launch later this year. The Company also made significant progress through its initiative to outsource its manufacturing operations—reducing capital investment in equipment, partnering with valued suppliers to provide flexible capacity, while achieving unit level cost reductions and margin improvements. As a result, Alphatec believes it is now better positioned to compete more effectively in the marketplace, accelerate growth and continue to improve profitability.
“Today marks the beginning of a new chapter for Alphatec,” said Jim Corbett, President and Chief Executive Officer of Alphatec Spine. “I am excited about the long-term prospects for the company as we pursue the U.S. spinal market with the resources we need to support continued investment in the commercialization of our robust product line. We have the right products, an exceptional team and a newly streamlined balance sheet to support our growth across the country, and we look forward to executing on our vision.”
Terms of the Transaction
Globus acquired Alphatec’s international operations and distribution channel for a purchase price of $80 million in cash. Globus will also provide Alphatec a five-year senior secured credit facility of up to $30 million. In addition, Alphatec has entered into a supply agreement through which Alphatec will supply its products to Globus for up to five years.
New Capital Structure
With the closing of this transaction, Alphatec believes that it can now establish a new capital structure that appropriately reflects the capital needs of its U.S.-focused business and positions the company for achieving future profitability. As part of the closing, Alphatec implemented the following related to this new capital structure:
- Drew down $25M of the $30M credit facility from Globus upon closing;
- Paid off the existing Deerfield credit facility balance and retired the credit facility;
- Reduced the MidCap Financial term loan to a $5M balance; and
- Reduced the MidCap Financial revolver commitment to $22.5M.
With this, Alphatec expects to have paid down approximately $66 million of existing debt and debt-related expenses.
Concurrent with this transaction, Deerfield Management Company, L.P. has utilized its cashless exercise provision under its warrant agreements, converting its warrants to purchase up to 11.45 million shares of common stock to approximately 3.2 million shares on a pre-reverse split basis. This will constitute approximately 269 thousand shares on a post-reverse split basis. As a reminder, on August 25, 2016 the Company completed a one-for-twelve reverse stock split.
“As a result of this transaction, we are able to improve Alphatec’s forward-looking balance sheet by reducing our overall debt while providing the liquidity and reserves needed to invest in commercializing our robust product portfolio,” said Mike O’Neill, Alphatec’s Chief Financial Officer. “The new term loan from Globus, in conjunction with a planned revolving line of credit from MidCap Financial, provides the company with credit facilities of up to $57.5 million, which will offer sufficient liquidity and appropriate financing to successfully support Alphatec’s transition to a U.S. market based company. Upon closing, we estimate our total debt drawn will be approximately $45 million. I would like to thank Deerfield who has been an excellent partner and we appreciate the support that they have provided to the company through the years. I am also pleased that MidCap will remain as a lender and provide funding for the company going forward. I want to thank them for their continued commitment and support to Alphatec.”
The Company expects that its stronger financial foundation coupled with its strong product portfolio will support future investments in its capital instrument base each year. These investments will be used to drive the commercial expansion of its new product lines, which are expected to contribute substantially to its planned growth profile. In addition, the Company has already made substantial headway towards its goal of reducing its operating expenses by $20 million. The Company expects this to continue for the remainder of 2016 and into 2017, translating to positive cash flow and profitability in the back half of 2017.
About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops, manufactures and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. and internationally via a direct sales force and independent distributors.
Additional information can be found at www.alphatecspine.com.
About Globus Medical
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.
Forward Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions you that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the Company’s ability to compete in the U.S. marketplace, accelerate growth and continue to improve profitability, continued investment in the commercialization of the U.S. product lines and in its capital instrument base, expected capital re-structuring and expected reductions in operating expenses and the timing and likelihood of cash flow and profitability. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: the Company’s ability to execute on its business plan and effectively compete in the U.S. marketplace; the Company not realizing the full economic benefit from the transaction, including as a result of indemnification claims under the definitive purchase agreement and the retention by the Company of certain liabilities associated with the international business; the Company’s ability to meet its obligations under the supply agreement and its credit facilities; the uncertainty of success in developing new products or commercializing products currently in the Company’s pipeline, including the products discussed in this press release; the Company’s ability to successfully reduce and control its costs, improve its margins and improve its profitability; claims related to the Company’s intellectual property; product liability exposure; and other risks detailed in the Company’s public periodic filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement.
CONTACT: Investor/Media Contact: Christine Zedelmayer Investor Relations Alphatec Spine, Inc. (760) 494-6610 czedelmayer@alphatecspine.com
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