Archive for July, 2015
(OHRP) Positive Results of a Phase II Clinical Study for OHR-102 in Retinal Vein Occlusion
OHR-102 Combination Therapy Enhances Visual Recovery in Macular Edema Secondary to Retinal Vein Occlusion
NEW YORK, July 13, 2015 — Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced positive final results from a Phase II investigator sponsored clinical trial of OHR-102 (0.2% Squalamine lactate ophthalmic solution) in patients with macular edema secondary to branch (BRVO) and central retinal vein occlusion (CRVO). The results demonstrated that, following an initial 10 week combination therapy treatment period, patients who continued to receive a combination of topical OHR-102 BID plus Lucentis® achieved greater visual acuity gains than the control group who received Lucentis alone. At week 38, the mean gain in visual acuity from baseline for patients randomized (at week 10) to treatment with OHR-102 + Lucentis PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis plus PRN alone (control group), a clinically meaningful difference of +4.5 letters. The data were presented by John Wroblewski, MD, a retina specialist at Cumberland Valley Retina Consultants on Saturday, July 11 at the 2015 Annual Meeting of the American Society of Retina Specialists (ASRS) in Vienna, Austria.
“These very promising final results demonstrate a clinically meaningful treatment effect of OHR-102 combination therapy for the treatment of macular edema secondary to retinal vein occlusion,” said John Wroblewski, MD, principal investigator of this Phase II study. “The 38 week data confirm a positive and meaningful effect on both visual acuity and macular edema. Importantly, continued treatment with OHR-102 combination therapy for the full 38 weeks of the study resulted in further improvements in visual gains over those patients that only received combination therapy for the first 10 weeks of the study.”
This investigator-sponsored trial was designed to determine the effect of OHR-102 in eyes with macular edema secondary to retinal vein occlusion. The data presented at ASRS included the final analysis of patients that, following a 10 week initial combination treatment period, were randomized to receive either continued OHR-102 + LucentisPRN therapy or only Lucentis monotherapy PRN through week 38. After the initial combination therapy phase, the mean gain in visual acuity from week 10 to week 38 was +7.4 letters for patients who continued treatment with OHR-102 + Lucentis PRN compared with +3.1 letters in those receiving Lucentis PRN alone. Furthermore, at week 38, 80% of patients in the OHR-102 + Lucentis treated group had a gain in visual acuity, compared with 50% of patients treated with Lucentis alone. Additionally, at week 38, none of the patients in the OHR-102 + Lucentis treated group lost any vision. Patients treated with OHR-102 + Lucentis PRN required a mean of 2.0 Lucentis injections between weeks 10 and 38, compared with a mean of 3.3 Lucentis injections for the monotherapy group over the same time period.
“The positive results of this Phase II study demonstrates the role of OHR-102 combination therapy in RVO and represent an important milestone for the development of OHR-102 in the treatment of this disease,” said Dr. Jason Slakter, Chief Medical Officer of Ohr. “This trial constitutes the second clinical study in a retinal vascular disorder which has shown a positive and clinically meaningful benefit in visual acuity using OHR-102 combination therapy versus an intravitreal anti-VEGF injection alone. The consistency of the efficacy data in this study, combined with the favorable safety profile of OHR-102, we believe warrants further study in a large controlled clinical trial.”
Study Design
The 38 week, investigator sponsored, Phase II clinical trial enrolled 20 treatment naïve patients with macular edema due to retinal vein occlusion. All patients received OHR-102 topically for the first 10 weeks of treatment, with two injections of Lucentis given at week 2 and week 6. The week 10 results were presented at ASRS 2014, and demonstrated that the combination of topical OHR-102 eye drops and intravitreal Lucentis led to a mean gain in visual acuity of 20.3 letters and resolution of the foveal edema in 95% of the patients. In the extension stage of the study (weeks 10 to 38), patients were randomized 1:1 at week 10 to either continue administering OHR-102 eye drops or discontinue drops for the remainder of the study. Retreatment with Lucentis injections were administered monthly as needed (PRN) through week 38 based on OCT criteria.
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. is an ophthalmology research and development company whose lead product, Squalamine, is being studied as an eye drop formulation (OHR-102) in several company-sponsored and investigator sponsored Phase II clinical trials for various back-of-the-eye diseases. These diseases include wet-AMD, retinal vein occlusion, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. Additional information on the company may be found at www.ohrpharmaceutical.com.
Lucentis® is a registered trademark of Genentech, Inc.
CONTACT: Ohr Pharmaceutical Inc. Investor Relations 888-388-2327 ir@ohrpharmaceutical.com LifeSci Advisors, LLC Michael Wood 646-597-6983 mwood@lifesciadvisors.com
(IIN) Signs Supplier Agreement for AudioNova’s Smartsound Listening Devices
IntriCon Corporation (NASDAQ: IIN), a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has signed a two-year manufacturing agreement with AudioNova International B.V. for their smartsound brand of listening devices. AudioNova is one of Europe’s leading hearing aid providers, operating more than 1,300 retail stores in 11 countries.
Through the program, AudioNova will offer technically advanced hearing devices, manufactured by IntriCon. AudioNova’s smartsound brand is based on IntriCon’s Audion™ amplifier, which includes proven value-added features such as wide-dynamic-range compression, patented adaptive feedback cancelling and layered noise reduction, at value hearing health price points.
“We are thrilled to work with AudioNova to deliver high-quality, low-cost hearing devices to the European market,” said Mark S. Gorder, president and chief executive officer of IntriCon. “AudioNova is one of the largest and most well-respected hearing aid retailers in Europe—and this is a great opportunity for both organizations. Furthermore, we believe our value hearing health vision is closely aligned with their focus on removing barriers to hearing device use.”
AudioNova has begun rollout of the smartsound brand in the Netherlands and intends to expand the program to other targeted European countries in the future. IntriCon expects to begin shipping product in the third quarter. Revenue from this program is included in the company’s growth estimate for 2015.
Concluded Gorder, “This is another meaningful milestone in our strategy to drive business in the growing value hearing health market. And we are very pleased to be expanding our European presence, especially with a partner of AudioNova’s stature. As a company, we are well-positioned to serve their needs and we look forward to our partnership.”
About AudioNova International B.V.
Headquartered in Rotterdam, Netherlands, AudioNova International B.V. is one of the largest retail hearing aid companies on the world. The company operates over 1,300 retail stores in 11 European countries. The company is focused on providing their customers with the selection of the best hearing solution for their needs, improving quality of life through better hearing. AudioNova is owned and supported by HAL Investments, an active long term investor who is fully committed to assist and finance AudioNova’s strategy. For more information about AudioNova, visit http://www.audionova.com.
About IntriCon Corporation
Headquartered in Arden Hills, Minn., IntriCon Corporation designs, develops, manufactures and distributes miniature and micro-miniature body-worn devices. The company is focused on three key markets: medical, hearing health, and professional audio communications. IntriCon has facilities in the United States, Asia and Europe. The company’s common stock trades under the symbol “IIN” on the NASDAQ Global Market. For more information about IntriCon, visit www.intricon.com.
Forward-Looking Statements
Statements made in this release and in IntriCon’s other public filings and releases that are not historical facts or that include forward-looking terminology are “forward-looking statements” within the meaning of the Securities Exchange Act of 1934, as amended. These forward-looking statements may be affected by known and unknown risks, uncertainties and other factors that are beyond IntriCon’s control, and may cause IntriCon’s actual results, performance or achievements to differ materially from the results, performance and achievements expressed or implied in the forward-looking statements. These risks, uncertainties and other factors are detailed from time to time in the company’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014. The company disclaims any intent or obligation to publicly update or revise any forward-looking statements, regardless of whether new information becomes available, future developments occur or otherwise.
At IntriCon:
Scott Longval, CFO, 651-604-9526
slongval@intricon.com
or
At PadillaCRT:
Matt Sullivan, 612-455-1700
matt.sullivan@padillacrt.com
(WPPGY) Wins Two Communique Awards
PARSIPPANY, NJ–(Jul 8, 2015) – Ogilvy CommonHealth Worldwide (www.ochww.com), the health behavior change specialists of Ogilvy & Mather (www.ogilvy.com), and a WPP company (NASDAQ: WPPGY) (www.wpp.com), today announced one of the network’s UK-based agencies, Ogilvy HealthPR, achieved double honors at this year’s Communiqué Awards, announced last week in London. Ogilvy HealthPR received an award in the category of Excellence in Digital Communications – Prescription Products/Patient Health and was Highly Commended in the Excellence in Corporate Communications category.
“Our clients continuously challenge us to create innovative and memorable PR campaigns to help them stand out from the crowd,” commented Antonia Betts, Managing Director of Ogilvy HealthPR. “Our success at the Communiqué Awards is yet another recognition of our strategic thinking and careful campaign execution that enables effective healthcare communications across the globe.”
Despite working in a highly regulated industry, Ogilvy HealthPR has been leading the field in the use of social media for healthcare education. Winning the Excellence in Digital Communications Communiqué Award for the fourth time in five years is testament to the agency’s innovative approach to social media and its vital role in integrated multi-stakeholder communications.
Earlier this year, Ogilvy CommonHealth Worldwide published a new report entitled Connecting the Dots: Which Pharma Companies Are Succeeding in the Social Media Space?, which was the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies. To find out more about the report, please visit: http://bit.ly/1P5R5Ws.
About Ogilvy CommonHealth Worldwide
Ogilvy CommonHealth Worldwide is committed to creativity and effectiveness in healthcare communications, everywhere. Our global headquarters are in Parsippany, NJ, with additional hubs in New York, London, Paris and Singapore. We maintain multiple additional offices in markets critical to our clients’ global aspirations. Ogilvy CommonHealth Worldwide provides marketing services including behavioral insights, content strategy and management, digital, interactive and new media services, marketing analytics and research, media planning and buying, medical education, payer marketing and market access, professional advertising and promotion, public affairs and relations, relationship marketing, sales training development, social media and social listening, and wellness and consumer advertising and promotion. The network also offers scientific communications and publications planning services through a wholly owned separate legal entity. The organization houses and maintains individual Ogilvy CommonHealth and Ogilvy Healthworld brand identities within the marketplace.
About WPP
WPP is the world’s largest communications services group with billings of US$76 billion and revenues of US$19 billion. Through its operating companies, the Group provides a comprehensive range of advertising and marketing services including advertising & media investment management; data investment management; public relations & public affairs; branding & identity; healthcare communications; direct, digital, promotion & relationship marketing and specialist communications. The company employs over 189,000 people (including associates and investments) in over 3,000 offices across 111 countries. For more information, visit http://www.wpp.com. WPP was named Holding Company of the Year at the 2015 Cannes Lions International Festival of Creativity for the fifth year running. WPP was also named, for the fourth consecutive year, the World’s Most Effective Holding Company in the 2015 Effie Effectiveness Index, which recognizes the effectiveness of marketing communications.
Contact:
Beth Paulino
Kerianne Slattery
Ogilvy CommonHealth Worldwide
973.352.1000 tel
(QLGC) Approves Grant of Equity-Based Award
ALISO VIEJO, Calif., July 10, 2015 — QLogic Corp (Nasdaq:QLGC), a leading supplier of high performance network infrastructure solutions, today announced that on July 9, 2015, the Compensation Committee of the Board of Directors of QLogic Corporation approved a grant of an equity-based award to one individual in connection with his commencing employment with the company and its subsidiaries and as an inducement material to his accepting such employment. The grant consisted of an award to this newly-hired non-executive employee of 40,000 restricted stock units that will vest over a four-year period, subject to his continued employment with the company. The grant was not individually negotiated and was made in accordance with Nasdaq Listing Rule 5635(c)(4).
Follow QLogic @ twitter.com/qlogic
QLogic – the Ultimate in Performance
QLogic (Nasdaq:QLGC) is a global leader and technology innovator in high performance server and storage networking connectivity products. Leading OEMs and channel partners worldwide rely on QLogic for their server and storage networking solutions. For more information, visit www.qlogic.com.
Disclaimer – Forward-Looking Statements
This press release contains statements relating to future results of the company (including certain beliefs and projections regarding business and market trends) that are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied in the forward-looking statements. The company advises readers that these potential risks and uncertainties include, but are not limited to: potential fluctuations in operating results; gross margins that may vary over time; unfavorable economic conditions; the stock price of the company may be volatile; the company’s dependence on the networking markets served; the company’s ability to compete effectively with other companies; the company’s dependence on a small number of customers; the ability to maintain and gain market or industry acceptance of the company’s products; the company’s dependence on sole source and limited source suppliers; the company’s dependence on relationships with certain third-party subcontractors and contract manufacturers; uncertain benefits from strategic business combinations, acquisitions and divestitures; the ability to attract and retain key personnel; the complexity of the company’s products; declining average unit sales prices of comparable products; sales fluctuations arising from customer transitions to new products; seasonal fluctuations and uneven sales and purchasing patterns with our customers and suppliers; changes in the company’s tax provisions or adverse outcomes resulting from examination of its income tax returns; international economic, currency, regulatory, political and other risks; facilities of the company and its suppliers and customers are located in areas subject to natural disasters; the ability to protect proprietary rights; the ability to satisfactorily resolve any infringement claims; a reduction in sales efforts by current distributors; declines in the market value of the company’s marketable securities; changes in and compliance with regulations; difficulties in transitioning to smaller geometry process technologies; the use of “open source” software in the company’s products; system security risks, data protection breaches and cyber-attacks; and the company’s ability to borrow under its credit agreement is subject to certain covenants.
More detailed information on these and additional factors that could affect the company’s operating and financial results are described in the company’s Forms 10-K, 10-Q and other reports filed, or to be filed, with the Securities and Exchange Commission. The company urges all interested parties to read these reports to gain a better understanding of the business and other risks that the company faces. The forward-looking statements contained in this press release are made only as of the date hereof, and the company does not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
QLogic and the QLogic logo are registered trademarks of QLogic Corporation. Other trademarks and registered trademarks are the property of the companies with which they are associated.
CONTACT: Media Contact: Jess Page QLogic Corporation 949.542.1455 jess.page@qlogic.com Investor Contact: Doug Naylor QLogic Corporation 949.542.1330 doug.naylor@qlogic.com
(TSYS) Receives $11.3 Million Contract to Support State of Maryland
Represents First TCS Contract under Maryland’s Consulting and Technical Services+ (CATS+) IDIQ
ANNAPOLIS, Md., July 10, 2015 — TeleCommunication Systems, Inc. (TCS) (NASDAQ: TSYS), a world leader in secure and highly reliable wireless communication technology, today announced that it has been awarded a contract to provide the State of Maryland Department of Human Resources (DHR) with statewide Technical Operations Support Services (TOSS). The contract base-award term is three years with two 1-year option terms, which if exercised have a total contract value of $11.3 million.
News Facts:
- CATS+ enables State of Maryland agencies to purchase Professional and Technical Services in 17 primary areas, including software engineering, information system security, geographical information systems and IT management consulting.
- TCS and its team members will work with the DHR personnel to collectively develop, enhance, maintain and support the department’s IT needs.
- Representing one category of TCS’ comprehensive TotalCom® portfolio, IT services are administered by highly qualified on-site TCS program managers and staff to provide reliable solutions with expert service.
- TCS’ Government Solutions Group delivers information and communication services to private enterprises and federal, state and local government clients. Services include network and server support, and premium services such as enterprise architectural design and implementation, information assurance, knowledge management, IT governance, and visual information and video teleconferencing. TCS has a 28-year track record as a proven, trusted provider of government communication technology solutions under conditions that demand the highest level of reliability, availability and security.
TCS Government Solutions Group President Michael Bristol said: “The Department of Human Resources is an innovator in advancing the critical assistance and services that Maryland families and individuals need for healthy, stable environments. TCS is dedicated to delivering the technology expertise necessary to achieve their objectives. For the TOSS project, we have teamed with leading IT small businesses BITHGROUP Technologies, Realistic Computing and Serigor. These premier TCS partners have played integral roles in other TCS Maryland-based contracts for the past 14 years, and we are now applying our proven collaboration and experience to ensure success for DHR.”
About TeleCommunication Systems, Inc.
TeleCommunication Systems, Inc. (TCS), headquartered in Annapolis, Maryland, is a world leader in secure and highly reliable wireless communications. Our patented solutions, global presence, operational support and engineering talent enable 9-1-1, commercial location-based services and deployable wireless infrastructure; cybersecurity; defense and aerospace components; and applications for mobile location-based services and messaging. Our principal customers are wireless network operators, defense and public safety government agencies, and Fortune 150 enterprises requiring high reliability and security. Learn more at www.telecomsys.com.
Except for the historical information contained herein, this news release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These statements are subject to risks and uncertainties and are based upon TCS’ current expectations and assumptions that if incorrect would cause actual results to differ materially from those anticipated. Risks include the possibility that future period funding will not be received, and those detailed from time to time in the Company’s SEC reports, including the Annual Report on Form 10-K for the year ended December 31, 2014 and on Form 10-Q for the quarter ended March 31, 2015.
Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information in this press release, whether as a result of new information, future events or circumstances, or otherwise.
Company Contact: | Investor Relations: |
TeleCommunication Systems, Inc. | Liolios Group, Inc. |
Meredith Allen | Scott Liolios |
410-295-1865 | 949-574-3860 |
PR@telecomsys.com | info@liolios.com |
(ICLD) Next Gen Wireless Professional Services Contracts in Excess of $1.5 Million
SHREWSBURY, N.J., July 10, 2015 — InterCloud Systems, Inc. (Nasdaq:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, announced today that it was recently awarded a series of contracts from new and existing clients valued at over $1.5 million to provide engineering, design and implementation of next generation wireless networks. Further details are withheld due to the nature of the project and associated critical infrastructure.
Mark Munro, CEO of InterCloud Systems stated: “InterCloud continues to win new business from our growing pipeline of sales opportunities. Contracts such as these are indicative of our continued growth and the confidence we enjoy from our customers. This opportunity is expected to be completed over the next several months.”
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a single-source provider of end-to-end information technology (IT) and next-generation network solutions including Software Defined Networking (SDN) and Network Function Virtualization (NFV) to the telecommunications service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations InterCloud Systems, Inc. Telephone 561-988-1988 Website www.intercloudsys.com
(MSLI) Announces Filing of Preliminary Base Shelf Prospectus
TORONTO, July 10, 2015 – Merus Labs International Inc. (“Merus” or the “Company“) [TSX: MSL, NASDAQ: MSLI], announced today that it has filed a preliminary short form base shelf prospectus with the securities commissions in all provinces in Canada, other than Quebec, Nova Scotia and Newfoundland, and a corresponding shelf registration statement on Form F-10 with the U.S. Securities and Exchange Commission (the “SEC”) under the U.S./Canada Multijurisdictional Disclosure System.
The base shelf prospectus and corresponding shelf registration statement, when made final or effective, will allow Merus to offer up to $250,000,000 of common shares, warrants, preferred shares, subscription receipts and units, or any combination thereof, from time to time over a 25-month period. The specific terms of any offering of securities will be set forth in a shelf prospectus supplement. The Company filed this base shelf prospectus to maintain financial flexibility but has no immediate intentions to undertake an offering.
The shelf registration statement filed today with the SEC has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction.
A copy of the preliminary short form base shelf prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
About Merus Labs International Inc.
Merus Labs is a specialty pharmaceutical company focused on acquiring established products. The Company leverages its expertise in European and North American markets to optimize the value of underdeveloped pharmaceutical assets.
Cautionary Statement
Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of Section 21E (i) (1) of the United States Securities Exchange Act of 1934. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Merus’ actual results to be materially different from any future results expressed or implied by these statements. Such factors include the following: general economic and business conditions, changes in demand for Merus’ products, changes in competition, the ability of Merus to complete future acquisitions and to integrate these acquisitions into its business, Merus’ ability to complete future debt and/or equity financings required to complete future acquisitions, interest rate fluctuations, currency exchange rate fluctuations, dependence upon and availability of qualified personnel and changes in government regulation. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Merus that Merus’ plans and objectives will be achieved. These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
(SLTD) Congratulates Clients Chosen for Inclusion in the Russell Microcap® Index
SANTA MONICA, Calif., July 9, 2015 — IRTH Communications, a provider of Investor Relations, Financial Marketing, and Strategic Consulting services to high-growth small-cap companies, congratulates three of its clients, IDI Inc., Solar3D Inc., and Vuzix Corporation, on being selected for inclusion in the Russell Microcap® Index. IDI, Inc. (NYSE MKT: IDI) is an information solutions provider. Solar3D, Inc. (NASDAQ: SLTD) provides solar power solutions and is the developer of a proprietary high efficiency solar cell. Vuzix® Corporation (NASDAQ: VUZI) is a leading supplier of Video Eyewear and Smart Glasses products in the consumer, enterprise and entertainment markets.
The Russell Microcap Index measures the performance of the microcap segment of the U.S. equity market, a select group of small-cap U.S. equity shares. It includes approximately 1000 of the smallest companies by market capitalization in the small-cap Russell 2000® Index. The Russell 2000 is reconstituted each year to maintain an accurate representation of the small capitalization universe, with membership in the Index conferred for one year.
IRTH Communications provides investor and media relations, financial communications and strategic consulting services to select companies with exciting new technologies, processes, products and services within their respective industries. Its client industries include intellectual property (IP), technology, alternative energy, energy efficiency, green and sustainable products, clean-tech, telecommunications & mobile engagement, entertainment, healthcare, consumer goods, and food products industries and others. IRTH Communications’ team of seasoned professionals has decades of public market experience focused on small cap companies.
Andrew Haag, Managing Partner of IRTH Communications, commented, “We have worked with client companies as they have gone through the uplisting process to move from the OTC market to a NASDAQ or NYSE listing. We are pleased to see them continue to move forward, broaden their shareholder composition and gain greater visibility, as a result of inclusion in the Russell Index.”
About IRTH Communications
Founded in 2008, IRTH Communications assists entrepreneurs, corporate executives and investors in realizing their visions and achieving their goals by delivering effective Investor Relations, Financial Marketing, and Strategic Consulting services. IRTH supports companies focused on alternative energy, clean and renewable technology, natural and organic products, and socially responsible activities by providing advisory services and direct access to investment funds and other industry professionals. The result provides clients better access to capital and more time to focus on their mission. Over the past 12 months, IRTH Communications has expanded its operations and client base and continues to strategically grow its offerings. To learn more about IRTH Communications visit, www.irthcommunications.com.
(WPRT) Completes HPDI Technology Program with Daimler AG
~Westport HPDI 2.0 Meets Challenging Performance Targets~
VANCOUVER, July 9, 2015 – Westport Innovations Inc. (TSX:WPT / NASDAQ:WPRT), engineering the world’s most advanced natural gas engines and vehicles, announced today that it has completed an engineering program with Daimler AG to develop and assess Westport High Pressure Direct Injection (HPDI) system for a Daimler heavy duty engine. The prototype HPDI engine met all technical targets resulting in a payment of 2.4 million Euro (approximately $2.7 million USD) by Daimler to Westport. For competitive reasons, further terms of the program have not been disclosed.
About Westport™ HPDI 2.0
Westport™ HPDI 2.0 is the only natural gas technology capable of delivering performance and fuel economy equivalent to that of current high performance diesel-fueled engines, but with diesel substitution of over 90%. This combination of high performance and high efficiency is critical for heavy-duty engines in demanding commercial applications. In addition to delivering performance and fuel economy, Westport™ HPDI 2.0 is designed to meet the latest in stringent emission regulations, including Euro VI and EPA 2014.
About Westport
Westport engineers the world’s most advanced natural gas engines and vehicles. More than that, we are fundamentally changing the way the world travels the roads, rails and seas. We work with original equipment manufacturers (OEMs) worldwide from design through to production, creating products to meet the growing demand for vehicle technology that will reduce both emissions and fuel costs. To learn more about our business, visit westport.com, subscribe to our RSS feed, or follow us on Twitter @WestportDotCom.
(CLNE) Refuse Business Continues to Drive Growth
Clean Energy Fuels Corp. (NASDAQ:CLNE) today announced that it has completed 14 station construction projects for refuse customers in the first six months of the year and expects to complete another 22 by the end of 2015, which will enable new or expanding refuse fleets to fuel with clean, less-expensive natural gas. These stations support the country’s largest waste companies such as Waste Management, Republic Services and Progressive Waste Solutions, as well as regional companies like Knight Waste and municipalities like the City of Medicine Hat in Alberta, Canada.
Clean Energy’s refuse business continues to steadily expand, providing a significant portion of the company’s revenues now through three sources. In addition to revenue received from the construction of new stations and expansion of existing stations and the recurring revenues from fuel sales and operating and maintaining stations for long-term refuse customers, more and more companies are now taking advantage of Clean Energy’s Facility Modification Services unit. Clean Energy has been contracted by Waste Management, Republic Services and others to upgrade vehicle maintenance facilities to comply with all local and national code requirements for a number of refuse customers.
“Despite being the first market to fully adopt natural gas years ago, the refuse industry continues to provide Clean Energy with very healthy growth,” said Andrew J. Littlefair, president and CEO of Clean Energy. “The second half of each year typically provides the most robust activity in station construction for our refuse customers as this is when their new trucks arrive and we believe 2015 will be no exception.”
Over 60% of the new refuse trucks sold in the United States today are powered by natural gas with some companies reaching 90%. Clean Energy has relationships with over 125 individual waste companies and municipality waste divisions in North America, and over 9,400 refuse trucks fuel at a Clean Energy built or maintained station daily.
“It has become almost a requirement for refuse companies to convert at least part of their fleets to natural gas in order to stay economically and environmentally competitive,” said Raymond Burke, vice president of Clean Energy for business development (solid waste). “Clean Energy works with each of our customers to assess their individual needs to make the transition or expansion to natural gas seamless so that they can begin to enjoy the benefits of natural gas fueling without a hiccup.”
Watch a short video about Clean Energy’s refuse business at: https://www.youtube.com/watch?v=zTOkYcXlVds
Natural gas fuel costs up to $1.00 less than gasoline or diesel, depending on local market conditions. The use of natural gas fuel not only reduces operating costs for vehicles, but also reduces greenhouse gas emissions up to 30% in light-duty vehicles and 23% in medium- to heavy-duty vehicles. In addition, nearly all natural gas consumed in North America is produced domestically.
About Clean Energy
Clean Energy Fuels Corp. (NASDAQ:CLNE) is the leading provider of natural gas fuel for transportation in North America. We build and operate compressed natural gas (CNG) and liquefied natural gas (LNG) fueling stations; manufacture CNG and LNG equipment and technologies for ourselves and other companies; develop renewable natural gas (RNG) production facilities; and deliver more CNG, LNG and Redeem RNG fuel than any other company in the U.S. For more information, visit www.cleanenergyfuels.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the station construction activity for refuse customers in the second half of 2015, the anticipated revenue associated with construction of new stations and expansion of existing stations and the benefits of natural gas relative to gasoline and diesel. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including without limitation the price of natural gas relative to gasoline and diesel, the cost and operating experience associated with natural gas vehicles, and permitting and other factors affecting construction. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Additionally, the reports and other documents the Company files with the SEC (available at www.sec.gov) contain risk factors, which may cause actual results to differ materially from the forward-looking statements contained in this news release.
Clean Energy Media Contact:
Gary Foster, 949-437-1113
gfoster@cleanenergyfuels.com
or
Clean Energy Investor Contact:
Tony Kritzer, 949-437-1403
tkritzer@cleanenergyfuels.com
(RARE) Positive Interim Bone Treatment Data From Ongoing Pediatric Phase 2 Study
8 of 11 Patients Showed Improvement in Rickets Bone Disease, Including 5 of 5 in Biweekly Dosing Group
NOVATO, Calif., July 9, 2015 — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data from the first 12 patients in the ongoing pediatric Phase 2 study for its recombinant human monoclonal antibody KRN23 against fibroblast growth factor 23 (FGF23) for the treatment of X-linked hypophosphatemia (XLH). An improvement in mean rickets score was observed after 40 weeks of treatment with investigational KRN23 in these patients. Ultragenyx is conducting the Phase 2 study under a collaboration and license agreement with Kyowa Hakko Kirin to develop and commercialize KRN23.
Bone Disease Efficacy
Eleven of the first 12 patients enrolled had been on standard of care oral phosphate/Vitamin D therapy for an average of 6 years (3.3–9.4 years) prior to the baseline assessment. The mean rickets score was 1.4 at baseline using the Thacher Rickets Severity Scoring method as evaluated by a blinded expert reader and decreased to 0.6 after 40 weeks of treatment with KRN23, a 58% reduction. Eight out of 11 patients with rickets at baseline demonstrated an improvement in rickets, of which three patients no longer exhibited radiographic evidence of rickets at week 40. One patient in the biweekly dosing group did not present with radiographic evidence of rickets at baseline and was excluded from the analysis.
Of the 12 patients, 6 received biweekly dosing and 6 received monthly dosing of KRN23. Of the 5 patients with rickets at baseline in the biweekly dosing group, 100% demonstrated improvement in rickets from a mean baseline rickets score of 1.5 to a mean score of 0.3 at week 40, representing an 80% reduction in rickets score. Of the 6 patients in the monthly dosing group, 50% demonstrated improvement in rickets from a mean baseline score of 1.3 to a mean score of 0.8 at week 40, representing a 38% reduction in rickets score. Two patients in the monthly dosing group did not show a change and one patient in the monthly dosing group worsened by 0.5 points.
“These interim data are encouraging as they are the first indication that KRN23 may improve rickets beyond what can be achieved with standard of care,” commented Sunil Agarwal, M.D., Chief Medical Officer of Ultragenyx. “We look forward to discussing these data with the U.S. and European Union regulatory agencies to determine appropriate next steps for the pediatric development program.”
Metabolic Measures
In the biweekly dosing group (n=6), mean serum phosphorus increased by 0.70 mg/dL, from 2.78 mg/dL at baseline to 3.48 mg/dL, which is in the normal range (3.2–6.1 mg/dL). In the monthly dosing group (n=6), mean serum phosphorus at peak increased by 1.06 mg/dL, from 2.42 mg/dL at baseline to 3.48 mg/dL. The monthly dosing patients showed a decrease to the trough level before the next dose, unlike the biweekly regimen which showed stable phosphate levels.
Increases in renal phosphate reabsorption (TmP/GFR) and in serum 1,25 dihydroxy vitamin D levels were observed in all 12 patients.
Safety and Tolerability
No serious adverse events have been reported in the study to date and there have been no discontinuations from the study for any reason. For the 12 patients who had reached 40 weeks at the time of the interim analysis, the most common adverse events considered to be treatment related were injection site reactions. All of the treatment-related adverse events were considered mild in severity.
No significant changes were observed in serum calcium, urinary calcium, or serum intact parathyroid hormone (iPTH) in the 12 patients. None of the patients had serum phosphorus levels above the upper limit of normal in either dosing group. Safety data on renal ultrasounds, echocardiograms, or immune response to KRN23 are not yet available.
All patients in the study continue to receive KRN23. An additional 40-week analysis for 36 patients is planned for the fourth quarter of 2015.
FDA Fast Track Designation
Ultragenyx also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the KRN23 program in XLH. Fast Track Designation is intended to facilitate the development and expedite the review of drugs for serious and life-threatening conditions that have the potential to address an unmet medical need. The designation allows for more frequent interaction with the FDA review team. It also enables eligibility for priority review and the potential for a rolling review of the Biologics License Application, when and if filed.
About X-Linked Hypophosphatemia (XLH)
XLH is a disorder of phosphate metabolism caused by phosphate wasting in the urine leading to severe hypophosphatemia. XLH is the most common heritable form of rickets (the softening and weakening of bones) that is inherited as an X-linked dominant trait affecting both males and females, though some reports indicate that the disease may be more severe in males. XLH is a distinctive bone disease characterized by inadequate mineralization of bone that leads to a spectrum of abnormalities, including rickets, progressive bowing of the leg, osteomalacia, bone pain, waddling gait, short stature, gross motor impairment, muscle weakness, frequent/poorly healing pseudofractures, spinal stenosis, enthesopathy, and osteoarthritis.
Most pediatric patients and some adult patients are managed using oral phosphate replacement and vitamin D (calcitriol) therapy, which requires frequent divided doses and careful medical monitoring. It is partially effective at reducing rickets in pediatric patients, but it does not improve growth and can be challenging to optimize the dose without increasing the risk of depositing phosphate-calcium precipitates in the kidneys (nephrocalcinosis).
Phase 2 Study Design
The randomized, open-label, dose-finding Phase 2 study is evaluating safety and efficacy in approximately 50 pediatric XLH patients ages 5 to 12. The study consists of a 16-week individual dose-titration period followed by a 48-week treatment period, for a total of 64 weeks. Patients are divided into three cohorts of escalating starting dose levels of KRN23 with either monthly or biweekly dosing regimens. Patients can continue to have their dose increased throughout the duration of the study to reach an individually-optimized dose.
The evaluation of rickets in the study is done via radiographs of the wrists and knees. The scoring was done using the Thacher Rickets Severity Score, a pre-specified 10-point scale that measures knee and wrist irregularities. Each radiograph is scored by one central independent reviewer who is blinded to the subject’s adherence, dose, dose regimen, and radiographic sequence.
Safety, changes in serum phosphorus, and other pharmacodynamic parameters were evaluated at the 16-week analysis. The current interim analysis includes the first 12 patients enrolled in the study by the lead investigator Thomas Carpenter, M.D. Additional safety, tolerability, and efficacy data, including radiographic evidence of rickets severity, will be evaluated for all patients at the 40-week and 64-week analyses.
About KRN23 and FGF23
KRN23 is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23). It is being developed by Ultragenyx to treat XLH, a disease characterized by excess activity of FGF23. FGF23 is a hormone that reduces serum levels of phosphorus and vitamin D by regulating phosphate excretion and vitamin D production by the kidney. Phosphate wasting in XLH is caused by excessive levels and activity of FGF23. KRN23 is designed to bind to and thereby inhibit the excessive biological activity of FGF23. By blocking excess FGF23 in patients with XLH, KRN23 is intended to restore normal phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.
Multiple clinical studies of KRN23 in adult patients with XLH have been completed and Ultragenyx intends to continue development of KRN23 in adults with XLH. In addition, a Phase 2 study in pediatric patients with XLH is ongoing.
KRN23 is also being developed for tumor-induced osteomalacia (TIO), a disease characterized by typically benign tumors that produce excess levels of FGF23, which can lead to severe osteomalacia, fractures, bone and muscle pain, and muscle weakness.
About Ultragenyx
Ultragenyx is a clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology, and immunology/allergy. Kyowa Hakko Kirin leverages antibody-related leading-edge technologies to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.
For more information, please visit www.kyowa-kirin.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding timing of release of additional data and analysis of same, discussions with regulatory authorities, and the potential benefits of Fast Track Designation, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings, and other matters that could affect the availability or commercial potential of our drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2015, and its subsequent periodic reports filed with the Securities and Exchange Commission.
CONTACT: Ultragenyx Pharmaceutical Inc. Investors & Media Robert Anstey 844-758-7273
(VNET) Announces Appointment of Financial Advisor and Legal Counsels
BEIJING, July 9, 2015 — 21Vianet Group, Inc. (Nasdaq:VNET) (“21Vianet” or the “Company”), a leading carrier-neutral Internet data center services provider in China, today announced that the special committee of its board of directors (the “Special Committee”) has retained Morgan Stanley Asia Limited as its financial advisor, K&L Gates LLP as its international and U.S. legal counsel and Conyers Dill & Pearman as its Cayman legal counsel in connection with its review and evaluation of a preliminary non-binding proposal dated June 10, 2015 from Mr. Josh Sheng Chen, the Chairman and Chief Executive Officer of the Company, Kingsoft Corporation Limited and Tsinghua Unigroup International Co., Ltd. (the “Proposal”).
In addition, Skadden, Arps, Slate, Meagher & Flom LLP will act as the Company’s legal counsel in connection with the Proposal.
21Vianet’s board of directors cautions the Company’s shareholders and others considering trading in its securities that the Special Committee is continuing its evaluation of the Proposal and no decisions have been made by the Special Committee with respect to 21Vianet’s response to the Proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that the Proposal or any other transaction will be approved or consummated.
About 21Vianet
21Vianet Group, Inc. is a leading carrier-neutral internet data center services provider in China. 21Vianet provides hosting and related services, managed network services, cloud services, content delivery network services, last-mile wired broadband services and business VPN services, improving the reliability, security and speed of its customers’ internet infrastructure. Customers may locate their servers and networking equipment in 21Vianet’s data centers and connect to China’s internet backbone through 21Vianet’s extensive fiber optic network. In addition, 21Vianet’s proprietary smart routing technology enables customers’ data to be delivered across the internet in a faster and more reliable manner. 21Vianet operates in more than 30 cities throughout China, servicing a diversified and loyal base of more than 2,000 customers that span numerous industries ranging from internet companies to government entities and blue-chip enterprises to small- to mid-sized enterprises.
Safe Harbor Statement
This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. 21Vianet may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about 21Vianet’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. All information provided in this press release and in the attachments is as of the date of this press release, and 21Vianet undertakes no duty to update such information, except as required under applicable law.
CONTACT: Investor Relations Contact: 21Vianet Group, Inc. Eric Chu, CFA +1(908)7072062 IR@21Vianet.com Joseph Cheng +861084562121 IR@21Vianet.com ICR, Inc. Calvin Jiang +1(646)405-4922 IR@21Vianet.com
(RMGN) Awarded Multimillion Dollar Contract to Provide Transformational Retail Solution
Represents One of the Largest Project Wins in RMG’s History
DALLAS, TX–(Jul 9, 2015) – RMG Networks Holding Corporation (NASDAQ: RMGN), or RMG Networks™, a leading provider of technology-driven visual communications, today announced the signing of a multimillion agreement to support one of the world’s largest telecommunication companies. Initial purchases under the award total $1.1 million, a majority of which will be recognized as margin for accounting purposes. Significant future orders representing up to an additional $4 million are likely as the solution continues to roll out in 2016 across the customer’s retail footprint. The opportunity represents one of the largest awards in RMG Networks’ history.
RMG Networks will provide multiple stores with interactive and non-interactive video walls, LED displays and interactive Smart Screens that allow customers to learn about product and service options with multi-language support. The project is in direct support of the international telecommunications provider’s recently unveiled new store concept designed to transform its retail experience and drive sales with a contemporary, fully digital environment for its customers.
“Built on a cutting-edge digital strategy, this retail transformation will elevate our customer’s in-store environment,” said Robert Michelson, Chief Executive Officer and President of RMG Networks. “Working in close collaboration, we are deploying a solution that will deliver a modern retail experience for shoppers. Together we are implementing the concept of connecting people’s lives to the company by improving opportunities to engage with staff, products and services.”
RMG Networks was awarded this tender through a rigorous selection process including multiple competitors from around the globe.
For additional information, visit: http://www.rmgnetworks.com/
© 2015 RMG Networks Holding Corporation. RMG Networks and its logo are trademarks and/or service marks of RMG Networks Holding Corporation.
About RMG NETWORKS
RMG NETWORKS (NASDAQ: RMGN) is a worldwide leader in intelligent visual communications that help businesses increase productivity, efficiency and engagement through digital messaging. By combining best-in-class software, hardware, business applications and services, RMG Networks offers a single point of accountability for integrated data visualization and real-time performance management. The company, who values 70% of the Fortune 100 as clients, is headquartered in Dallas, Texas, with additional offices in the United States, United Kingdom, Singapore and the United Arab Emirates. For more information, visit www.rmgnetworks.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, compensation and other benefits derived from the sale of the Airline Media Network business, guidance relating to future financial performance and expected operating results, such as revenue growth, our ability to achieve profitability, our position within the markets that we serve, efforts to grow our business and the impact of litigation.
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, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: the company’s ability to raise additional capital on satisfactory terms, or at all; success in retaining or recruiting, or changes required in, its management and other key personnel; the limited liquidity and trading volume of the company’s securities; the competitive environment in the markets in which the company operates; the risk that the anticipated benefits of acquisitions that the company may complete may not be fully realized; the risk that any projections, including earnings, revenues, margins or any other financial items are not realized; changing legislation and regulatory environments; business development activities, including the company’s ability to contract with, and retain, customers on attractive terms; the general volatility of the market price of the company’s common stock; risks and costs associated with regulation of corporate governance and disclosure standards (including pursuant to Section 404 of the Sarbanes-Oxley Act); and general economic conditions.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Media Contact:
Ashley Knapp
TallGrass Public Relations
Ashley.Knapp@tallgrasspr.com
605-275-4075
Investor Contact:
Hayden IR
Brett Maas/Rob Fink
rmgn@haydenir.com
646-536-7331/646-415-8972
(CRV) To Be Acquired By (LKQ)
CHICAGO, July 09, 2015 — LKQ Corporation (Nasdaq:LKQ) and The Coast Distribution System, Inc. (NYSE MKT:CRV) today announced that they have signed a definitive agreement for LKQ to acquire Coast for $5.50 per share in cash. Coast is a leading distributor of replacement parts, supplies and accessories for recreational vehicles (RVs) primarily to retail parts and supplies stores, service and repair establishments, and new and used RV dealers in North America. Under the terms of the definitive agreement, a subsidiary of LKQ will commence a tender offer to acquire all outstanding shares of Coast’s common stock for $5.50 per share in cash. The tender offer is required to be commenced within 10 business days and to remain open for at least 20 business days after launch. The consummation of the tender offer is subject to satisfaction of customary conditions, including that the holders of at least a majority of Coast’s outstanding shares accept the offer. Any shares not tendered in the offer will be acquired, following consummation of the tender offer, in a second step merger at the same cash price as in the tender offer. The acquisition is currently expected to close in the third quarter of 2015. Coast’s Board of Directors has unanimously recommended that Coast stockholders accept the offer and tender their shares. Total cash consideration payable for Coast’s outstanding shares is approximately $29 million. As of June 30, 2015 Coast had $19.5 million outstanding under its long-term revolving bank line of credit.
“The combination of Coast with our Specialty segment and RV business presents tremendous distribution and logistics synergies with our existing network, and expands our RV business with the addition of unique product offerings and brands,” stated Robert L. Wagman, President and Chief Executive Officer of LKQ Corporation.
Robert W. Baird & Co. Incorporated and Duff & Phelps, LLC are acting as financial advisors to The Coast Distribution System, Inc. in this transaction.
About LKQ Corporation
LKQ Corporation (www.lkqcorp.com) is a leading provider of alternative and specialty parts to repair and accessorize automobiles and other vehicles. LKQ has operations in North America, the United Kingdom, the Netherlands, Belgium, France, Scandinavia, Australia and Taiwan. LKQ offers its customers a broad range of replacement systems, components, equipment and parts to repair and accessorize automobiles, trucks, and recreational and performance vehicles.
About The Coast Distribution System, Inc.
The Coast Distribution System, Inc. (www.coastdistribution.com) is one of North America’s largest wholesale aftermarket suppliers of replacement parts, supplies and accessories for the recreational vehicle (RV) and outdoor recreation markets. Coast supplies more than 14,000 products through 17 distribution centers located in the United States and Canada. Coast’s customers consist of independently-owned RV dealers, supply stores and service centers.
Additional Information
The tender offer described in this news release has not yet commenced. This news release and the description contained herein is neither an offer to purchase nor a solicitation of an offer to sell shares of Coast Distribution System, Inc. At the time the tender offer is commenced, LKQ and its wholly owned subsidiary, KAO Acquisition Sub, Inc., intend to file with the Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and Coast intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. LKQ, KAO Acquisition Sub and Coast intend to mail these documents to the stockholders of Coast. These documents will contain important information about the tender offer and stockholders of Coast are urged to read them carefully when they become available. Stockholders of Coast will be able to obtain a free copy of these documents (when they become available) and other documents filed by Coast, LKQ or KAO Acquisition Sub with the SEC at the website maintained by the SEC at www.sec.gov. In addition, stockholders will be able to obtain a free copy of these documents (when they become available) from the information agent named in the offer to purchase or from LKQ.
Forward Looking Statements
Certain statements in this press release that are not historical facts are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements generally include expectations, beliefs, hopes, intentions or strategies regarding our future, including with respect to the proposed transaction described and statements or assumptions regarding the expected timetable for completing the transaction, financial and operating results, benefits and synergies of the transaction, and other statements that are based on management’s current beliefs and expectations of the company and the combined businesses. Forward looking statements are subject to risks, uncertainties and other factors some of which are not currently known to us. Actual events or results may differ materially from those expressed or implied in the forward looking statements as a result of various factors. Some of such risks, uncertainties and other factors are described in LKQ’s and Coast’s annual reports on Form 10-K for the year ended December 31, 2014 and in subsequently filed quarterly reports on Form 10-Q. We assume no obligation to publicly update any forward looking statement to reflect events or circumstances arising after the date on which it was made, except as required by law.
Contacts: Joseph P. Boutross-LKQ Corporation Director, Investor Relations (312) 621-2793 jpboutross@lkqcorp.com James Musbach, President and CEO – The Coast Distribution System, Inc. (408) 782-6686 jmusbach@coastdist.com
(STXS) First Procedure With Stereotaxis Niobe(R) ES Technology in Japan
ST. LOUIS, July 8, 2015 — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that the first procedure with its Niobe® ES magnetic navigation system has been performed in Japan. Dr. Kohei Yamashiro of Takatsuki General Hospital completed a cardiac ablation on a patient with ventricular tachycardia, noting, in particular, the improved navigation of the ablation catheter and ease of mapping with the Niobe system compared to manual methods for lesion creation.
“We are excited to be the first institution in Japan to offer this unique, innovative approach to treating complex cardiac arrhythmias, which continue to rise in prevalence at a rapid rate with our aging population,” said Dr. Yamashiro. “The Niobe system provides greater visibility and precise control of the ablation catheter, as well as significantly increased safety, which I expect to translate into improved outcomes for my patients.” Dr. Yamashiro has more than 10 procedures scheduled for the Niobe system’s first two weeks of operation.
Takatsuki General Hospital is located near Osaka, Japan and recently underwent a complete renovation to support the latest medical advances and provide higher quality, more integrated patient services. Installation of the Niobe system was completed in the second quarter, as Dr. Yamashiro, its primary operator, received comprehensive training at Stereotaxis sites in the U.S. The hospital held a grand opening lecture on the Niobe system lab July 3, featuring presentations by Dr. Yamashiro and Dr. Hiroshi Nakagawa, a prominent electrophysiologist, who has educated Japanese physicians and government officials on the use of Stereotaxis technologies.
“We have envisioned this day for some time and are very pleased to see it come to fruition,” said William C. Mills, Stereotaxis’ Chief Executive Officer. “Our momentum continues to build in Japan as we set our sights on becoming the region’s first choice in the treatment of complex electrophysiology cases.”
About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received U.S. clearance. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
CONTACT: Press Contact: Martin Stammer Chief Financial Officer 314-678-6155 Investor Contact: Todd Kehrli / Jim Byers MKR Group, Inc. 323-468-2300
(ROVI) Names James E. Meyer Chairman of the Board
Rovi Corporation (NASDAQ:ROVI) a leading provider of advanced entertainment discovery, data analytics, and monetization solutions, today announced that James E. Meyer has been unanimously elected as independent Chairman of the Rovi Board of Directors effective July 7, 2015.
“Rovi has made great strides over the past several years in evolving its strategy and developing cloud-based solutions and other next-generation products to drive and complement its growing IP licensing business,” said James. E. Meyer. “Rovi’s products continue to gain momentum and traction in the market, and we are working on several very significant IP license renewals. I am honored to take on the role of Chairman during this exciting time at the Company, and believe Rovi is well positioned to capture the substantial opportunities ahead in the dynamic market in which we operate. I look forward to working alongside the other members of Rovi’s Board, as well as the management team, to build value for all of the Company’s stakeholders.”
Tom Carson, CEO of Rovi, said “Jim is a demonstrated leader with critical industry, technology and operational insights, as well as years of experience both on Boards and as the CEO of a public company. Jim knows Rovi and the industry we operate in very well, and is the right person to lead Rovi’s Board during our next stage of growth.”
Mr. Meyer has served as Chief Executive Officer of SiriusXM since December 2012. Prior to that role, Mr. Meyer served as President of Operations and Sales of SiriusXM and its predecessors from April 2004 to December 2012. From 1997 to 2002, Mr. Meyer served in various executive capacities at Thomson Multimedia Corporation. Mr. Meyer holds a B.S. in Economics and an MBA from St. Bonaventure University.
Additionally, the Audit and Compensation Committees were brought back into compliance with the Nasdaq Stock Market listing rules, as the Board of Directors unanimously constituted the membership of its committees as follows:
Audit Committee: Alan Earhart (Chair), Steve Lucas and Ruthann Quindlen
Compensation Committee: Glenn Welling (Chair), Steve Lucas and Jim Meyer
Corporate Governance & Nominating Committee: Jim Meyer (Chair), Alan Earhart and Raghu Rau
The Company intends to promptly notify the Nasdaq Stock Market of the above appointments.
About Rovi
Rovi is leading the way to a more personalized entertainment experience. The company’s pioneering guides, data, and recommendations continue to drive program search and navigation on millions of devices on a global basis. With a new generation of cloud-based discovery capabilities and emerging solutions for interactive advertising and audience analytics, Rovi is enabling premier brands worldwide to increase their reach, drive consumer satisfaction and create a better entertainment experience across multiple screens. The company holds over 5,000 issued or pending patents worldwide and is headquartered in Santa Clara, California. Discover more about Rovi at rovicorp.com.
Investors
Rovi Corporation
Peter Ausnit, 818-565-5200
or
Media
Sard Verbinnen & Co.
John Christiansen/Megan Bouchier, 415-618-8750
(OCLS) Receives New U.S. Patent for Microcyn(R) Atopic Dermatitis Technology
PETALUMA, Calif., July 8, 2015 — Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced the receipt of a new U.S. patent for the use of the Microcyn® Technology hypochlorous acid in the treatment and mitigation of atopic dermatitis.
Dr. Bob Northey, Oculus senior vice president for research and development said: “Our intellectual property portfolio is perfectly synced with our new focus on the dermatology market with our direct sales force. The empirical evidence demonstrating Microcyn’s efficacy in the treatment of atopic dermatitis is highly compelling. This new patent provides Oculus market exclusivity for the use of hypochlorous acid with broad ranges of activity in the treatment of atopic dermatitis until the year 2027 when the patent expires.”
The latest-issued patent joins an intellectual property estate (either owned or licensed to Oculus) that now includes 44 issued and allowed patents (nine in the United States and 35 foreign patents) as well 82 pending applications (both U.S. and foreign) directed to chemical compositions, apparatuses, methods of manufacturing and therapeutic uses.
About Atopic Dermatitis
In a 2009 GlobalData study, it was estimated the global atopic dermatitis therapeutics market delivered revenues of $643 million in 2009. It is expected to grow to $810 million at a Compound Annual Growth Rate (CAGR) of 3.4% by 2016. Globally, the United States remains the largest market for atopic dermatitis therapeutics, and generated revenue of $402 million in 2009. It is forecast to grow at a CAGR of 3.8% over the next seven years to reach $582 million by 2016.
Physicians often define atopic dermatitis or eczema, as a long-lasting, or chronic, skin condition that causes intense itching and then a red, raised rash. The current standard of care to mitigate the symptoms of atopic dermatitis are topical steroids. In the United States, data from Wolters Kluwers suggests that physicians write prescriptions for topical steroids for atopic dermatitis approximately 12,500,000 times, each year.
Symptoms of atopic dermatitis are characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor.
Topical corticosteroids (such as hydrocortisone, betamethasone, and fluticasone) are the most common treatment for atopic dermatitis. As eczema tends to be persistent, most people will have to use topical steroids on and off for many years. If used continuously topical steroids may lose their effectiveness after a few weeks. This is known as tachyphylaxis.
About Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.oculusis.com.
Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “provides” and “joins,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s common stock and warrants may be delisted from NASDAQ, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, the Company may not be able to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its annual report on Form 10-K for the year ended March 31, 2015. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Oculus® and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
CONTACT: Media and Investor Contact: Oculus Innovative Sciences, Inc. Dan McFadden VP of Public and Investor Relations (425) 753-2105 dmcfadden@oculusis.com
(GBSN) Announces Commercial Launch of Group B Strep Molecular Test
Company Secures More than 40 Evaluations since Launch
Great Basin Scientific, Inc. (NASDAQ: GBSN, GBSNU), a molecular diagnostics company, announced today its Group B Streptococcus (GBS) test—which received U.S. Food and Drug Administration (FDA) clearance in April—is now available to hospitals and laboratories in the U.S. Two laboratories have already converted their Group B Strep testing to Great Basin’s molecular test, and as of July 7, more than 40 sites are in active evaluation or scheduled to evaluate the sample-to-result test for GBS. Further, the Company announced its customers evaluating the test are forecasting usage of the GBS test at volumes 50 percent greater than their usage of the Company’s C. diff test.
Vista Labs, a stand-alone reference lab and long-time customer of Great Basin, chose to adopt the GBS test shortly after evaluation: “The ease of use with no prep steps to run this assay—compared to our prior non-molecular method—provided a huge incentive for us to adopt this test. Our previous Lim broth culture method for GBS was time consuming and had low-sensitivity. Above all, patient care is a priority for our lab. Getting a definitive diagnostic result our clients can trust, plus hands-on time savings for our employees, combined with the cost savings inherent in their business model makes Great Basin the right choice for our needs,” said Vista Labs Molecular Supervisor Robin Johnson.
“Initial response to our GBS test has exceeded our expectations,” said Great Basin co-founder and Chief Executive Officer, Ryan Ashton. “We believe this speaks to an unmet need in the market that Great Basin addresses by delivering simplified workflow, at appropriate cost, and the sensitivity, specificity and speed of molecular testing that our lab customers demand. Our unique business model, we believe, enables us to launch products efficiently, and we will continue to work diligently to deliver against our product roadmap of tests that assist clinicians in better diagnosing and managing their patients’ infectious disease early and effectively.”
The Centers for Disease Control (CDC) continues to report that a high proportion of early onset GBS disease cases are occurring among infants born to women with negative prenatal GBS culture screens. Great Basin brings innovative technology to molecular diagnostic testing with the relative sensitivity of its assay over traditional culture method being 97.9 percent versus 42.3 percent. Additionally, the Company’s GBS assay has a simple workflow that saves critical time for lab clinicians and Great Basin’s no-cost instrumentation and low per-test costs streamlines entry into molecular testing.
The Company also announced today the GBS test has been released as a CE-IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices, making the test commercially available to more than 32 countries in Europe through the Company’s European distributor network. This is the second CE marked molecular diagnostic assay designation for Great Basin following its test for C. diff.
About Great Basin Scientific
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at www.gbscience.com.
Forward-Looking Statements
This press release includes forward-looking statement regarding events, trends and business prospects, which may affect our future operating results and financial position. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization, including the GBS test mentioned herein; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2014. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.
ICR
Media Contact:
Kate Ottavio Kent, 203-682-8276
Kate.Ottavio-Kent@icrinc.com
or
Investor Relations Contact:
Bob Yedid, 646-277-1250
bob.yedid@icrinc.com
(NTIP) Court Rules in Favor of Network-1 Subsidiary in Mirror Worlds Patent Litigation
Denies Motions to Dismiss by Apple and Microsoft
NEW YORK, July 8, 2015 — Network-1 Technologies, Inc. (NYSE: NTIP) today announced that the United States District Judge Robert Schroeder III of the Eastern District of Texas issued an order denying motions to dismiss the patent infringement suits filed by Mirror Worlds Technologies, Inc., a wholly owned subsidiary of Network-1, against Apple, Inc. and Microsoft, Inc. The cases against Apple and Microsoft were stayed pending Judge Schroeder’s opinion.
In December 2014, Apple brought a motion for summary judgment based on the Kessler Doctrine arguing that Mirror Worlds was precluded from initiating patent litigation against Apple because of an earlier case brought by the previous owner of the Mirror Worlds patent portfolio against Apple. Judge Schroeder denied the motion and granted Mirror Worlds’ motion that there was no preclusion based on the MW1 case holding that the Kessler Doctrine did not apply to the facts of the present Mirror Worlds case.
In early 2015, Apple and Microsoft each brought motions for a judgment on the pleadings that U.S. Patent No. 6,006,227, owned by Mirror Worlds, is invalid for covering subject matter not patentable under Section 101 of the U.S. Patent Act. This argument was based on a recent decision by the United States Supreme Court in Alice vs. CLS Bank, which has led to the invalidation of numerous U.S. patents in the months since the decision. In applying the reasoning of Alice decision, Judge Schroeder found that although the ‘227 Patent is directed to an abstract idea, the abstract idea “is necessarily directed to improving computer technology” and that “the Defendants have not provided any evidence that claimed computer functions (using persistent mainstreams and substreams) were well-understood, routine, conventional activities previously known to the industry at the time of filing” as would be required to be invalid under Alice.
Based on the Court’s Order, the stay of cases against Apple and Microsoft has been lifted and the case against Microsoft and Apple will now proceed toward trial.
“We are obviously very pleased with today’s Order,” commented Corey M. Horowitz, Chairman and CEO of Network-1. “We feel strongly about the merits of our case, and our position on these motions in particular, and are gratified that the Court issued such a well-reasoned opinion.”
ABOUT NETWORK-1 TECHNOLOGIES, INC.
Network-1 Technologies, Inc. is engaged in the development, licensing and protection of its intellectual property and proprietary technologies. Network-1 works with inventors and patent owners to assist in the development and monetization of their patented technologies. Network-1 currently owns twenty-four (24) patents covering various telecommunications and data networking technologies as well as technologies relating to document stream operating systems and the identification of media content. Network-1’s current strategy includes continuing to pursue licensing opportunities for its Remote Power Patent and its efforts to monetize two patent portfolios (the Cox and Mirror Worlds patent portfolios) acquired by Network-1 in 2013. Network-1’s acquisition strategy is to focus on acquiring high quality patents which management believes have the potential to generate significant licensing opportunities as Network-1 has achieved with respect to its Remote Power Patent.
This release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements address future events and conditions concerning Network-1’s business plans. Such statements are subject to a number of risk factors and uncertainties as disclosed in the Network-1’s Annual Report on Form 10-K for the year ended December 31, 2014 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015 filed with the Securities and Exchange Commission, including, among others, the continued validity of Network-1’s Remote Power Patent, the ability of Network-1 to successfully execute its strategy to acquire high quality patents with significant licensing opportunities, Network-1’s ability to achieve revenue and profits from the Mirror Worlds Patent Portfolio and the Cox Patent Portfolio as well as intellectual property it may acquire in the future, the ability of Network-1 to enter into additional license agreements, the ability of Network-1 to continue to receive material royalties from its existing license agreements for its Remote Power Patent, the uncertainty of patent litigation and proceedings at the United States Patent and Trademark Office, the difficulty in Network-1 verifying royalty amounts owed to it by its licensees, Network-1’s ability to enter into strategic relationships with third parties to license or otherwise monetize their intellectual property, the continued viability of the PoE market, future economic conditions and technology changes and legislative, regulatory and competitive developments. Except as otherwise required to be disclosed in periodic reports, Network-1 expressly disclaims any future obligation or undertaking to update or revise any forward-looking statement contained herein.
Corey M. Horowitz, Chairman and CEO |
Network-1 Technologies, Inc. |
(212) 829-5770 |
(MATR) Announces Strong Bookings, Increased Revenue Guidance, Key Hires
CHICAGO, IL–(Jul 7, 2015) – Mattersight Corporation (NASDAQ: MATR), the pioneer in personality-based software applications, today provided an update on its second quarter business activity.
“We are pleased with our continued progress and increasing business momentum,” says Kelly Conway, Mattersight President and CEO. “We had a strong bookings quarter fueled by new logo growth and pilot conversions, and are encouraged with what we see in the second half of the year. Our momentum is helping us attract great new customers and excellent new talent.”
Second Quarter 2015 Financial Highlights
- Bookings: Annual Contract Value (ACV) bookings for the second quarter were $5.8 million, the second-highest bookings quarter in the company’s history. This brings ACV bookings over the last four quarters to a record $19.0 million, a 46% year-over-year increase. The strong bookings were driven by adding several important new logo customers, and by increasing sales momentum from Mattersight’s Predictive Behavioral Routing product.
- Guidance: Based on its current outlook, Mattersight is raising its 2015 guidance as follows:
- Total revenue growth guidance is increased to 33% to 38%, up from 30% to 35%
- Total subscription growth guidance is increased to 38% to 43%, up from 35% to 40%
Key New Hires
- New Chief Financial Officer
Mattersight announces the appointment of Sheau-ming Ross as Vice President and Chief Financial Officer, effective July 6, 2015. Ms. Ross, who brings more than 17 years of finance, operations, corporate development, strategy, venture investing and investment banking experience to her new role, will be responsible for Mattersight’s finance and accounting functions.Before joining Mattersight, Ms. Ross was Chief Financial Officer of EPAY Systems, a high growth SaaS provider in the workforce management space. Prior to EPAY Systems, she served as Chief Financial Officer for Silver Chalice, a next-generation digital sports media company. Previously, Ms. Ross worked for twelve years in various financial leadership positions for the Tribune Company, including Chief Financial Officer for Chicago’s WGN-TV, CLTV, and WGN Radio as well as WGN America, a nationally distributed basic cable and satellite television channel. Ms. Ross also previously worked in the strategy, corporate development and corporate venture capital groups at Tribune Company. Ms. Ross started her career in investment banking Credit Suisse Group; and she holds a Bachelor’s degree in Economics from the University of Chicago and an MBA from Northwestern University’s Kellogg School of Management. - New Senior Vice President of Sales
Mattersight also announces the hiring of Frank Suljic as Senior Vice President of Strategic Sales. Mr. Suljic returns to Mattersight after a previous tenure with the company, during which time he served as Vice President of Sales. Reporting to Executive Vice President of Sales Richard Dresden, in his new role Mr. Suljic will lead the team responsible for accelerating Mattersight’s penetration of the growing total addressable market within subscription clients.Mr. Suljic has 25 years of experience in the Fortune 500 enterprise technology market. His unique blend of business acumen and engineering expertise distinguish him as a trusted business advisor for clients. Mr. Suljic has held senior sales and leadership positions at companies including IBM, Oracle, Siebel Systems, SeeSaw Networks and Visual IQ. Notably, Mr. Suljic served as Co-Founder and EVP Practice Development for Inforte Corporation, where he led sales from inception through $1B IPO. Most recently, he was Vice President of Sales at AudienceScience. Mr. Suljic earned an engineering degree from the University of Wisconsin and an MBA from the University of Chicago’s Booth School of Business.
Mattersight will hold its second quarter earnings call on August 5th, after the close of the market. Further information regarding the conference call will be provided at a later date.
About Mattersight
Mattersight’s mission is to help brands have more effective and effortless conversations with their customers. Using a suite of innovative personality-based software applications, Mattersight can analyze and predict customer behavior based on the language exchanged during service and sales interactions. This insight can then facilitate real-time connections between customers and the agents best capable of handling their needs. Mattersight’s patented stack of SaaS applications has influenced hundreds of millions of shorter, more satisfying customer interactions. Organizations across the Financial Services, Healthcare, and Telco industries rely on Mattersight to drive customer retention, employee engagement, and operating efficiency. An independent research study documents the average return on investment for these organizations is 344%. To learn more about how Mattersight can help your company, please visit www.mattersight.com.
Contact is:
Jason Wesbecher
Chief Marketing Officer
Jason.Wesbecher@Mattersight.com
(MZOR) Reports it Received Purchase Orders for Seven Renaissance Systems In Q2
Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a developer of innovative guidance systems and complementary products, announced today that it received purchase orders for and delivered seven Renaissance systems and one system upgrade in the second quarter ended June 30, 2015. Six of the systems were delivered to U.S. hospitals and one was delivered to Spain. The Company ended the quarter with 93 Renaissance systems installed globally, with 53 in the U.S., the Company’s primary growth market, compared with 72 and 39 systems for the second ended June 30, 2014, respectively.
“Our results in the second quarter demonstrate solid execution by our global sales and marketing team,” said Ori Hadomi, Chief Executive Officer. “The quarter reflects the successful implementation of several key initiatives, such as engaging with the hospital c-suite earlier in the sales cycle to have a better understanding of their process and level of commitment as well as expanding into new metropolitan markets. These continuing efforts together with the market’s increasing awareness and interest in Renaissance give us momentum as we enter the second half of 2015.”
The Company currently intends to report its complete financial results for the second quarter ended June 30, 2015 on July 28, 2015.
About Mazor
Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic-based technology and products aimed at redefining the gold standard of quality care. Mazor Robotics Renaissance® Guidance System enables surgeons to conduct spine and brain procedures in a more accurate and secure manner. For more information, please visit www.MazorRobotics.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the Company’s momentum as we enter the second half of 2015, or regarding the intended release date of the financial results for the quarter ended June 30, 2015, e, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on April 29, 2015 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.
U.S.:
EVC Group
Investors
Michael Polyviou/Doug Sherk
212-850-6020; 415-652-9100
mpolyviou@evcgroup.com; dsherk@evcgroup.com
or
Media
David Schemelia, 646-201-5431
dave@evcgroup.com
(ESPR) Announces Removal of 240 mg Partial Clinical Hold for ETC-1002
ANN ARBOR, MI–(July 07, 2015) – Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.
“We are pleased to receive a positive and rapid response from the FDA following our submission in early June of a complete response to the 240 mg partial clinical hold,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We look forward to continuing our discussions with the FDA at next month’s End-of-Phase 2 meeting as we advance ETC-1002 through the final phase of development.”
Esperion’s Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two preclinical product candidates.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-cholesterol-lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, Esperion’s lead product candidate, is a first-in-class, orally available, once-daily small molecule designed to lower elevated LDL-cholesterol levels and avoid the side effects associated with currently available LDL-cholesterol lowering therapies. ETC-1002 is being developed for patients with primary hyperlipidemia and mixed dyslipidemia. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of, and clinical development plan for, ETC-1002. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the risk that positive results from a clinical study of ETC-1002 may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or the risk that other unanticipated developments could interfere with the development (and commercialization) of ETC-1002, as well as other risks detailed in Esperion’s filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on From 10-Q. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
(IPDN) Exceeds 500,000 New Users Per Month
CHICAGO, July 7, 2015 — Professional Diversity Network, Inc. (“PDN”) (NASDAQ:IPDN), a developer and operator of online networks and technologies that provide access to employment opportunities for diverse professionals in the United States, announced today that it has sustained the rapid registered user growth it previously reported and surpassed 530,000 new registered users per month during June.
HIGHLIGHTS:
- 1,535,226 new registered users in the past 6 months
- 530,251 new registered users in June 2015 alone
- Nearly 2,000% new registered user growth on a month over month basis in June 2015 (over 530K) versus October 2014 (26.5K), last full month before Noble Voice acquisition
- Q2 bookings of $10.3 million, up nearly 800% compared to second quarter 2014
“In June we added over half a million new users, all of whom are job seekers who help us achieve our mission of matching diverse workers with the employers who need them,” said Jim Kirsch, CEO. Kirsch continued, “With the rollout of HireAdvantEDGE, our latest product, which helps employers improve candidate quality while reducing time to hire, it is critical to continue to bring new users into our system and feed our employer partners’ demand. The graph below proves the maxim that a picture is worth a thousand (or in this case over half a million) words, and tells us that we are succeeding.”
Sergio Zlobin, VP of Technology, added, “For a technology company to achieve success it must grow its user base in an efficient and sustainable way. At PDN our users are job seekers, and we have created a formula that allows us to add new users, at a declining marginal cost per user, while we are seeing similar growth in our employer partners. This means that we are growing supply (job seekers) while growing demand (employers), and matching the two in a manner we believe we can sustain and continue to grow. While our growth is always subject to market conditions and the like, we are absolutely prepared from a structural and technology perspective, and I am very confident that we can continue to refine and improve not only our formula for attracting new users but our technology for delivering them to employers.”
“It strikes me that when 2015 began we had enrolled just over 3 million users over the entire 12 year lifetime of our company,” said Mr. Kirsch. He continued, “So far in 2015 we have already registered over 1.5 million new users, with the rate growing every month. There is a very strong and fundamental relationship between registered users and our future potential. In recruitment, our greatest asset is the human capital inventory we can access and the efficiency in which we connect our diverse users and employers. That is why we are thrilled about the 497 employers utilizing our network to place our new registered users in careers across the nation. Our entire executive team believes that our prospects have never been better, and with $10.3 million in new bookings for the second quarter, the numbers we are reporting today back that up.”
About Professional Diversity Network, Inc.
Professional Diversity Network, Inc. (PDN) is an Internet software and services company that develops and operates online professional networking communities dedicated to serving diverse professionals in the United States and employers seeking to hire diverse talent. Our subsidiary, National Association of Professional Women (NAPW), is one of the largest, most recognized networking organizations of professional women in the country, spanning more than 200 industries and professions. Through an online platform and our relationship recruitment affinity groups, we provide our employer clients a means to identify and acquire diverse talent and assist them with their efforts to comply with the Equal Employment Opportunity Office of Federal Contract Compliance Program. Our mission is to utilize the collective strength of our affiliate companies, members, partners and unique proprietary platform to be the standard in business diversity recruiting, networking and professional development for women, minorities, veterans, LGBT and disabled persons globally.
Forward-Looking Statements
This press release contains certain forward-looking statements regarding the future based on our current expectations, forecasts, beliefs, intentions, strategies and assumptions. Forward-looking statements can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. Forward-looking statements involve risks and uncertainties and our actual results may differ materially from those stated or implied in such forward-looking statements. Factors that could contribute to such differences include, but are not limited to: failure to realize synergies and other financial benefits from mergers and acquisitions within expected time frames, including increases in expected costs or difficulties related to integration of merger and acquisition partners; inability to identify and successfully negotiate and complete additional combinations with potential merger or acquisition partners or to successfully integrate such businesses, including our ability to realize the benefits and cost savings from, and limit any unexpected liabilities acquired as a result of, any such business combinations; our limited operating history in a new and unproven market; increasing competition in the market for online professional networks; our ability to comply with increasing governmental regulation and other legal obligations related to privacy; our ability to adapt to changing technologies and social trends and preferences; our ability to attract and retain a sales and marketing team, management and other key personnel and the ability of that team to execute on the Company’s business strategies and plans; our ability to obtain and maintain intellectual property protection for our intellectual property; any future litigation regarding our business, including intellectual property claims; and the risk factors disclosed in our Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2015 and any subsequent filings made by us with the SEC. Forward-looking statements in this release are based on information available to us as of the date hereof and we assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise. The Form 10-K filed with the SEC on March 31, 2015, together with this press release are available on our website, www.prodivnet.com.
CONTACT: RedChip Companies, Inc. Jon Cunningham (800-733-2447), ext. 107 jon@redchip.com
(PBMD) Receives Positive Scientific Advice From EMA on Lead Product IMP321
The EMA Has Now Confirmed in Writing Its Endorsement of the Development Program of IMP321 in Metastatic Breast Cancer
SYDNEY, AUSTRALIA–(Jul 7, 2015) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”), a leading immuno-oncology company, is pleased to announce that it has received positive Scientific Advice from the European Medicines Agency (“EMA” or the “Agency”) on the development path for its lead product, IMP321 in metastatic breast cancer.
The EMA, located in London, is the agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. After dialogue between Prima and the EMA, the Agency has now confirmed in writing its endorsement of the development program of IMP321 in metastatic breast cancer.
Encouragingly, the planned Phase IIb study, to be called AIPAC (Active Immunotherapy PAClitaxel) is considered well designed by the Agency. AIPAC is now expected to initiate in Europe during the 4th quarter of 2015. While the EMA never endorses any statement on the likelihood of future regulatory decisions, the Agency’s communication has suggested that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study.
After a smaller safety run-in phase that will extend into 2016 and will yield valuable safety, pharmacokinetic and pharmacodynamic data, AIPAC will proceed to recruit around 200 patients with HER-2 negative metastatic breast cancer, randomising them 1:1 to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321.The trial will have Progression-Free Survival as its Primary Endpoint, with response rates according to the RECIST criteria and Overall Survival among the secondary endpoints. The study has been powered to show a four-month PFS advantage for the treatment group1. Allowing time for patient recruitment and follow-up, AIPAC’s expected duration is around three years.
Prima’s Chief Scientific and Medical Officer, Professor Frédéric Triebel, stated, “The EMA’s Scientific Advice represents a significant step forward in terms of IMP321 clinical development in Europe. We now have the opportunity to introduce active immunotherapy to metastatic breast cancer patients, a promising novel strategy that we believe has the potential to fulfil an unmet medical need,” Dr. Triebel added, “We wish to thank the EMA’s Scientific Advice Working Party for their input and guidance.”
About Scientific Advice
Scientific Advice is a procedure offered by the EMA to pharmaceutical industry participants for clarification of questions arising during development of medicinal products. Scientific Advice is prospective in nature and it focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorisation Application (MAA). Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes. Nevertheless, the advice provided is taken into consideration during MAA and any deviations from the advice given need to be well justified.
About AIPAC (Active Immunotherapy PAClitaxel)
AIPAC is the acronym for Prima’s planned multicenter, Phase IIb, randomized, double blinded, placebo-controlled clinical trial in HER-2 negative metastatic breast cancer patients receiving IMP321 or placebo as adjunctive to the standard-of-care chemotherapy drug paclitaxel. In a Phase IIa trial, IMP321 was able to increase the response rate (as per the RECIST criteria) at six months in these patients from the 25% expected of paclitaxel2 to 50% for IMP321 plus paclitaxel3. The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival in this patient population (power 80%). Details of the AIPC study will be posted on www.clinicaltrials.gov in due course.
About IMP321 and cancer immunotherapy
IMP321 is a cancer immunotherapy agent currently in mid-stage clinical development with Prima BioMed, where it is the company’s lead compound. Immunotherapy is a process whereby a disease such as cancer is treated either by activating or suppressing components of the immune system to generate a response. LAG-3, or Lymphocyte Activation Gene 3, is able to stimulate and in other cases inhibit an immune response, through involvement in a number of immune pathways. IMP321 is a soluble LAG-3Ig fusion protein which works by binding to MHC class II molecules on APCs such as dendritic cells to activate them. The APCs are important for showing cancer antigens to T cells and activating them to destroy cancer cells. IMP321 is a first-in-class APC activator.
About Prima BioMed
Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.
Prima’s original product, called CVac, is an ex vivo dendritic cell priming therapy that in May 2015 yielded favourable Phase II data in second remission ovarian cancer patients. Prima is currently seeking partners for further development of this therapy. Prima’s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is soluble LAG-3, is a T cell immunostimulatory factor for cancer chemoimmunotherapy which has completed early Phase II trials. A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.
Prima BioMed is listed on the Australian Stock Exchange, on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.
For further information please contact:
1 In HER2-negative metastatic breast cancer PFS can be as low as 6 months – see Miller et. al., N Engl J Med. 2007 Dec 27; 357(26):2666-76.
2 See Gray et. al., J Clin Oncol. 2009 Oct 20; 27(30): 4966-4972.
3 See Brignone et.al., J Transl Med. 2010 Jul 23;8:71.
Prima BioMed Ltd:
Stuart Roberts
Global Head of Investor Relations
+61 (0) 447 247 909
stuart.roberts@primabiomed.com.au
Australia Investor/Media:
Mr Matthew Gregorowski
Citadel-MAGNUS
+61 (0) 422 534 755
mgregorowski@citadelmagnus.com
Europe Investor/Media:
Mr. Axel Muhlhaus
edicto GmbH
+49 (0) 69 905505-52
amuehlhaus@edicto.de
(DEPO) Confirms Receipt of Unsolicited Proposal from Horizon Pharma
Board Previously Reviewed and Rejected Identical Highly Conditional, Unsolicited Proposal
NEWARK, Calif., July 7, 2015 — Depomed, Inc. (NASDAQ: DEPO) (“Depomed” or the “Company”) today confirmed that it has received an unsolicited, highly conditional, non-binding proposal from Horizon Pharma plc (NASDAQ: HZNP) (“Horizon”) to acquire all of the outstanding shares of Depomed in an all-stock transaction valued at $29.25 per share (the “Proposal”).
Depomed noted that Horizon’s Proposal is identical in all material respects to the Horizon proposal received by Depomed on May 27, 2015 and reiterated on June 12, 2015 (the “Prior Proposal”). The Depomed Board, after careful consideration and in consultation with its financial and legal advisors, unanimously determined that it was not in the best interests of Depomed or its shareholders to pursue the Prior Proposal. The Board is confident that continuing to execute on its strategic plan is the best path forward for the Company and its shareholders at this time.
In making its determination with respect to the Prior Proposal, the Depomed Board considered a number of factors, including:
- The Prior Proposal does not reflect the inherent value of Depomed in light of the Company’s standalone prospects:
- Depomed is in a period of significant growth given the highly successful execution of its acquisition and commercialization strategy which has delivered tremendous value to its shareholders, with Depomed’s stock price recently reaching an all-time high of $28.16 on April 27, 2015. The Prior Proposal suggests an acquisition premium of only approximately 3.9% over such price.
- Depomed is expected to benefit from the NUCYNTA® franchise, which significantly increases the Company’s product revenue, cash flow, EBITDA and adjusted earnings per share in 2015 and beyond. This, together with Depomed’s other significant growth opportunities that extend well into the next decade, makes the timing of the Proposal opportunistic as a combination would transfer the future value of Depomed to Horizon at a price the Company believes does not represent the true value of its assets, business and prospects.
- Depomed’s financial and share price performance over the last three years speaks to the soundness of the Company’s strategy and its ability to create value for all Depomed stakeholders. In 2012, Depomed had product sales of approximately $27.5 million. In 2014, Depomed’s product sales were $114.2 million and guidance for 2015 anticipates total product sales of $310-$335 million – and this includes only three quarters of NUCYNTA sales. At the midpoint of Depomed’s 2015 estimate, the Company’s revenues will have grown at a compound annual growth rate of 127%. Depomed’s share price has increased approximately 330% over the same time period, as of the date of Depomed’s response to Horizon on June 25, 2015.
- The Prior Proposal further suggests that Depomed shareholders would own only approximately 27% of the combined company. However, Depomed’s preliminary analysis shows that the Company’s contribution across various metrics such as revenue, EBITDA and unlevered free cash flow would be much greater.
The Depomed Board unanimously believes that the interests of Depomed shareholders would be best served by benefiting from 100% of the upside inherent in Depomed.
The following is the text of the letter that was sent on June 25, 2015, to Horizon’s Chairman, President and Chief Executive Officer, Timothy Walbert with respect to the Prior Proposal:
Dear Tim:
The Board of Directors (“Board“) of Depomed, Inc. (“Depomed” or the “Company“) received your letters dated May 27, 2015 and June 12, 2015 communicating an unsolicited proposal that Horizon Pharma plc (“Horizon“) acquire all of the outstanding shares of Depomed in an all-stock transaction (the “Proposal“).
The Board carefully reviewed the Proposal with the assistance of its financial advisors, Morgan Stanley & Co. LLC and Leerink Partners LLC, and its legal counsel, Baker Botts L.L.P. After deliberate and thorough consideration, it is the unanimous view of the Board that Horizon’s unsolicited proposal does not reflect the inherent value of Depomed in light of the Company’s standalone prospects, including the realization of the expected benefits from our transformational acquisition of the NUCYNTA franchise, and is not in the best interests of the Company and its shareholders.
Depomed’s Ongoing Transformation
Over the last four years, Depomed has transformed into a leading specialty pharmaceutical company focused on pain and neurology. Unlike many of our peers in the industry, Depomed has built a portfolio of differentiated products with substantial, organic growth opportunities and lengthy patent exclusivity. Depomed has demonstrated commercial success, significantly growing prescription demand for our products. Further, Depomed has had unparalleled success in defending and enforcing its intellectual property rights, and in securing market exclusivity for its products that extend well into the next decade.
Since 2012, Depomed has acquired and re-launched Zipsor® (diclofenac potassium), indicated for mild to moderate pain, Lazanda® (fentanyl nasal spray CII), a nasally delivered formulation of fentanyl for the treatment of breakthrough cancer pain, and CAMBIA® (diclofenac potassium for oral solution), the only single agent in its therapeutic class approved in the U.S. for the treatment of acute migraine attacks in adults.
Building on this success, Depomed in April 2015 acquired the U.S. rights to the NUCYNTA® franchise – a transformational transaction for the Company. The NUCYNTA franchise includes NUCYNTA ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, NUCYNTA (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults, and NUCYNTA (tapentadol) oral solution, an approved oral form of tapentadol that has not been commercialized.
Depomed re-launched NUCYNTA ER and NUCYNTA last week with an expanded, highly experienced pharmaceutical sales force and a focused marketing message that highlights the unique, differentiated aspects of the product. The NUCYNTA franchise is a flagship product for Depomed in the multi-billion dollar pain market. The Board is highly confident in the Company’s ability to deliver shareholder value by successfully executing its strategy for the NUCYNTA franchise and its other differentiated products.
Depomed’s financial and share price performance over the last three years speaks to the soundness of our strategy and our ability to create value for all Depomed stakeholders. In 2012, Depomed had product sales of approximately $27.5 million. In 2014, Depomed’s product sales were $114.2 million and guidance for 2015 is for total product sales between $310-$335 million, and this includes only three quarters of NUCYNTA sales. At the midpoint of our 2015 estimate, our product sales will have grown at a compound annual growth rate of 127%. Depomed’s share price has increased approximately 330% over the same time period.
In summary, Depomed’s successful execution of its business plan has created a high-growth, pain-focused therapeutics company that is expected to become one of the top-five largest companies in the U.S. pain market based on revenues. Given our broad pain product portfolio, including the recent NUCYNTA acquisition, we are poised for long-term, sustainable growth and will continue to deliver significant value to our shareholders.
Horizon’s Opportunistic Proposal Undervalues Depomed, and is Not in the Best Interest of Depomed Shareholders
Depomed’s transformation has delivered tremendous value to its shareholders, with Depomed’s stock price recently reaching an all-time high of $28.16 on April 27, 2015. The Board notes that the Proposal suggests an acquisition premium of approximately 3.9% over such price. Together with Depomed’s significant growth opportunities that extend well into the next decade, our Board believes the indicated value of the Proposal of $29.25 substantially undervalues Depomed and its business.
As outlined above, Depomed is expected to benefit from the NUCYNTA franchise, which significantly increases the Company’s product revenue, cash flow, EBITDA and adjusted earnings per share in 2015 and beyond. The timing of the Proposal is opportunistic as the combination would transfer the future value of Depomed to Horizon at a price we believe does not represent the true value of our assets, business and prospects.
The Proposal further suggests that Depomed shareholders would own only 27% of the combined company. However, Depomed’s preliminary analysis shows that our contribution across various metrics such as revenue, EBITDA and unlevered free cash flow would be much greater. In addition, the organic growth rate for Depomed’s current product portfolio appears to far exceed that of Horizon’s current product portfolio in 2016 and beyond.
Conclusion
For the reasons stated above, the Board unanimously rejects the Proposal. Given the highly successful execution of Depomed’s acquisition and commercialization strategy over the past several years, the Company is in a period of significant growth, and is well-positioned for future success. Depomed has a highly experienced management team, talented and dedicated employees, a differentiated portfolio of products, a strong intellectual property position and lengthy market exclusivities for all of its products. The Board strongly believes that an independent Depomed will create significant and sustainable, long-term value for its shareholders through the focused execution of our business plan and strategic vision.
Morgan Stanley & Co. LLC and Leerink Partners LLC are serving as financial advisors to Depomed and Baker Botts LLP is serving as legal counsel.
About Depomed
Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults. Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults. Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise, Nucynta ER and various partner product candidates are formulated with Depomed’s proven, proprietary Acuform® drug delivery technology. Additional information about Depomed may be found at www.depomed.com.
Forward-Looking Statements
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to Depomed’s prospects as a standalone business, Depomed’s business strategy, expectations regarding Depomed’s future financial results, and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K for the year ended December 31, 2014 and its most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company’s plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Investor Contact:
August J. Moretti
Depomed, Inc.
510-744-8000
amoretti@depomed.com
Media Contact:
Joele Frank, Wilkinson Brimmer Katcher
Eric Brielmann
415-869-3950
Andy Brimmer and Averell Withers
212-355-4449
(NVIV) Significant Improvement In Neuro-Spinal Scaffold Implant Patients
InVivo Therapeutics Holdings Corp. (NVIV) today announced a one-month post-implant update for the third study patient and a six-month post-implant update for the second study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.
In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.
The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.
The Neuro-Spinal Scaffold was implanted in both patients by Dr. Dom Coric of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center (CMC) in Charlotte, NC. The study is being led at CMC by Dr. Coric and Dr. William Bockenek, Chief Medical Officer of Carolinas Rehabilitation and Chairman of the Department of Physical Medicine and Rehabilitation at CMC.
Dr. Coric said, “I am very encouraged with the third patient’s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.” Dr. Bockenek further stated, “It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.”
Mark Perrin, InVivo’s CEO, said, “We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10-T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury. To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure. We look forward to continuing to follow these patients and expect to complete enrollment of the remaining two patients in our pilot trial within the coming months.”
About the Neuro-Spinal Scaffold
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding continued enrollment in our pilot trial and the expected benefits, efficacy and future clinical outcomes of the company’s Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to modify its pilot trial protocol or to conduct a future study; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics Holdings Corp.
Investor Relations
Brian Luque, 617-863-5535
bluque@invivotherapeutics.com
(CATB) Receives FDA Fast Track Designation for CAT-1004 in Muscular Dystrophy
Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that CAT-1004 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). CAT-1004 is designed to inhibit activated NF-kB, which has the potential to reduce muscle inflammation and degeneration, and promote muscle regeneration for patients with DMD regardless of the underlying mutation. DMD is a rare disease that involves progressive muscle degeneration that eventually leads to death and for which there are no approved therapies in the United States.
“Fast Track designation for CAT-1004 highlights its potential to treat a serious, life threatening disease with few treatment options for these young patients,” said Jill C. Milne, Ph.D., co-founder and chief executive officer of Catabasis. “By targeting activated NF-kB in pre-clinical studies, CAT-1004 has demonstrated disease-modifying potential for this devastating condition.”
The FDA Fast Track process is designed to expedite the development and review of drugs to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Companies that receive Fast Track designation are allowed to submit New Drug Applications (NDA) on a rolling basis, expediting the FDA review process, and benefiting from more frequent communication with the FDA to discuss all aspects of clinical development. In addition, drugs that receive Fast Track designation are eligible for accelerated approval and priority review if certain criteria are met.
About CAT-1004
CAT-1004 is an oral small molecule that inhibits activated NF-kB, a protein that coordinates cellular response to muscular damage, stress and inflammation and plays an important role in muscle health. In skeletal muscle, activated NF-kB drives muscle degeneration and suppresses muscle regeneration. In animal models of DMD, CAT-1004 inhibited activated NF-kB, reduced muscle inflammation and degeneration and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004 inhibited activated NF-kB and was well-tolerated with no observed safety concerns. The FDA has previously granted CAT-1004 orphan drug designation for the treatment of DMD.
About Catabasis
Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics using its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform. The Company’s SMART linker technology platform is based on the concept of treating diseases by simultaneously modulating multiple targets in one or more related disease pathways. The Company engineers bi-functional product candidates that are conjugates of two molecules, or bioactives, each with known pharmacological activity, joined by one of its proprietary SMART linkers. The SMART linker conjugates are designed for enhanced efficacy and improved safety and tolerability. The Company’s focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of serious lipid disorders. For more information on the Company’s technology and pipeline of drug candidates, please visit www.catabasis.com.
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com
(RADA) Radar Selected by a Leading European Defense Contractor
RADA’s Tactical Multi-Mission Hemispheric Radar Provides Volume Surveillance and Detection of Multiple Threat Types, Including UAVs, Manned Aircraft, Mortars and Rockets
NETANYA, Israel, July 6, 2015 — RADA Electronic Industries of Netanya, Israel (NASDAQ:RADA) announces the purchase by a leading European defense contractor of a Multi-Mission Hemispheric Radar (MHR). This contractor is the second major European defense contractor that purchased RADA’s MHR. The radar, which will be embedded in a test system by the contractor, will be delivered before the end of 2015.
The MHR — an S-Band, software-defined, Pulse-Doppler, active electronically scanned array radar — has sophisticated beam forming capabilities and advanced signal processing, provides multiple missions on each radar platform, and offers unprecedented performance-to-price ratio. It is compact and mobile, delivering ideal organic, tactical surveillance solutions for force and border protection applications such as counter rockets and mortars, counter unmanned aerial systems, ground moving target indicator, and air surveillance. Zvi Alon, RADA’s CEO, remarked, “We are very happy with the selection of our MHR by another major defense contractor in Europe. It is an additional vote of confidence by a world-leading defense contractor for the unique capabilities that the MHR has to offer in this field. We are confident that the radars ordered during the last few weeks indicate the broad industry recognition of their advantages.”
About RADA
RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The Company specializes in the development, production, and sale of Tactical Land Radars for Force and Border Protection, Inertial Navigation Systems for air and land applications, and Avionics Systems and Upgrades.
CONTACT: RADA Dov Sella (CBDO) Tel: +972-9-892-1111 mrkt@rada.com www.rada.com
(PDII) Aetna Publishes Favorable Coverage Policy for ThyGenX™ Thyroid Mutation Panel
PARSIPPANY, N.J., July 6, 2015 — PDI, Inc. (NASDAQ: PDII) subsidiary Interpace Diagnostics announced today that effective June 2015, ThyGenX™,i the company’s genetic mutation panel, has been approved by Aetna for assessing fine needle aspiration (FNA) samples from indeterminate thyroid nodules. Aetna’s coverage decision now means that ThyGenX is considered medically necessary. Aetna covers 46 million lives and its positive coverage decision brings the total number of lives covered for ThyGenX to more than 100 million.
Approximately 15-30% of the 525,000 thyroid FNA’s performed on an annual basis are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX. ThyGenX has been validated in a prospective, clinical study involving over 600 patients and has a specificity rate of 89%.ii
Guidelines from the National Comprehensive Cancer Network (NCCN) indicate that molecular diagnostic approaches may be useful in the evaluation of thyroid FNA samples that are indeterminate to assist in patient management, including identifying patients who are appropriate candidates for surgery and those for whom surveillance is appropriate.
According to Nancy Lurker, PDI’s CEO, “Aetna’s decision results in the first major commercial coverage for ThyGenX and it continues to affirm the value that ThyGenX offers to patients with indeterminate cytology for thyroid FNAs. We are pleased that Aetna’s members now have access to ThyGenX, a test already validated through peer-reviewed publications and that can help reduce unnecessary thyroid surgeries.”
About PDI, Inc.
PDI is a leading healthcare commercialization company providing go-to-market strategy and execution to established and emerging pharmaceutical, biotechnology, diagnostics and healthcare companies in the United States through its Commercial Services business, and developing and commercializing molecular diagnostic tests through its Interpace Diagnostics business. PDI’s Commercial Services is focused on providing outsourced pharmaceutical, biotechnology, medical device and diagnostic sales teams to its corporate customers. PDI’s Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. For more information about us, please visit www.pdi-inc.com.
About ThyGenX™
Interpace Diagnostics’ ThyGenX™ Thyroid Oncogene Panel molecular diagnostic test is used to improve surgical decision-making for patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant indeterminate thyroid nodules by utilizing state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid malignancies. The ThyGenX panel design is based on the miRInform® test, whose high predictive value has been validated in a recent prospective clinical study involving over 600 patients. Interpace Diagnostics acquired the miRInform test from Asuragen in 2014, and has now enhanced it by upgrading to a NGS platform which provides greater genomic insights and increased panel content.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. PDI has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond PDI’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause PDI’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the market’s acceptance of our molecular diagnostic tests; projections of future revenues, growth, gross profit and anticipated internal rate of return on investments; the loss, early termination or significant reduction of any of our existing service contracts; the failure to meet performance goals in PDI’s incentive-based arrangements with customers; the inability to secure additional business; or our inability to develop more predictable, higher margin business through sales of our molecular diagnostic tests, in-licensing or other means. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in PDI’s periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 5, 2015 and in PDI’s Form 10-Q filed with the SEC on May 12, 2015. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, PDI undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Corporate Media:
Corinne de Palma
CD Public Relations
(212) 399-0887
Corinne@CDPublicrelations.net
Trade Media:
Caren Begun
Green Room Communications
(856) 424-2023
caren@greenroompr.com
Investor Relations:
Chris Dailey/Michael Polyviou
EVC Group, Inc.
(646) 445-4800
cdailey@evcgroup.com
i ThyGenX is adapted and rebranded from Asuragen’s miRInform®
ii Labourier, Emmanuel et al. The Journal of Clinical Endocrinology & Metabolism (2015): jc-2015.http://press.endocrine.org/doi/abs/10.1210/jc.2015-1158. Accessed July 1, 2015.
(VSAR) Removal of FDA Partial Clinical Hold, Continuation of VRS-317 Clinical Trial
MENLO PARK, Calif., July 6, 2015 — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company’s Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.
Jay Shepard, Chief Executive Officer, said, “Our team has continued to work diligently with the FDA and we are excited to be moving forward with the Phase 3 clinical trial of VRS-317 in pediatric GHD patients. There is a significant need for these patients to have treatment options that are less burdensome than the daily injections that are the current standard of care. We continue to expect VRS-317 to be the first and longest-acting rhGH product candidate in development to reach the market and, with the removal of the partial clinical hold, we remain on track to achieve this goal.”
The Company reaffirmed its previously stated anticipated milestones for the VELOCITY Phase 3 clinical trial, including interim 6-month mean height velocity data by the end of 2016 and top line data on the 12-month mean height velocity primary endpoint by mid-2017, enabling a potential Biologics License Application submission, followed by a potential FDA approval by late-2018.
About the VELOCITY Trial
The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Trial is a randomized, open-label, Phase 3 registration trial being conducted in the United States, Western Europe and Canada. This study is expected to enroll up to 136 naïve to treatment, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 twice-monthly to daily rhGH at the highest approved dose on the labels of Genotropin® and Norditropin® 34 µg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12-month mean height velocity. After completing the Phase 3 trial, all patients will be offered the opportunity to continue treatment with VRS-317 in the ongoing pediatric Extension Study. Additional information on the VELOCITY trial can be found at www.velocitytrial.com.
About Versartis, Inc.
Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and initiated a global Phase 3 registration trial, VELOCITY, in GHD children in January 2015. In addition, the Company initiated a Phase 2/3 trial in Japan for children with GHD in April 2015. Additional information on the VELOCITY trial can be found at www.velocitytrial.com. Further information on Versartis can be found at www.versartis.com.
Cautionary Note on Forward-Looking-Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of VRS-317. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on VRS-317; VRS-317 being a new chemical entity; the risk that VRS-317 may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that VRS-317 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing VRS-317; if VRS-317 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2014 and in our Quarterly Report on Form 10-Q for the three months ended March 31, 2015, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Corporate & Investors: Joshua Brumm Chief Financial Officer (650) 963-8582 IR@versartis.com Investors: Nick Laudico The Ruth Group (646) 536-7030 nlaudico@theruthgroup.com Media: Debra Bannister Corporate Communications (530) 676-7373 media@versartis.com
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