Archive for November, 2015
HOLLISTON, Mass., Nov. 12, 2015 — Harvard Apparatus Regenerative Technology, Inc. (HART) (Nasdaq: HART), a biotechnology company developing bioengineered implants for life-threatening conditions, today announced significant results – including clear evidence of complete esophageal tissue regeneration – from recently conducted animal research on HART’s 2nd Generation (Gen2) bioengineered implant platform. HART will hold a conference call at 5:00 p.m. ET today to discuss these results.
Jim McGorry, HART CEO, commented: “We pursued these animal studies to test the design and technology enhancements we have made to our second generation technology and to prepare us for our upcoming studies with the Mayo Clinic. We are very encouraged by the results of these studies and by the significant advancements we have made across all three indications. In particular, results for the Gen2 implant in the esophagus far exceeded our expectations, particularly given the study’s brief duration. Over a two-week period, all layers of the esophagus, most notably the epithelial and muscle layers, were fully regenerated, and components of esophageal nerves were present. Such nerves are fundamental to the proper contraction of the muscles that move food along the esophagus.”
Mr. McGorry continued, “Based on the strong performance of our Gen2 implants in all three indications, we are well-positioned as we move forward with confirmatory longer-term large-animal studies with Mayo Clinic in December.”
Research and Development Highlights:
- HART’s Gen2 technology reflects design enhancements to improve the body’s response to the implant and to better guide the repair of tissue in the healing process.
- HART’s recent animal studies tested all three of its Gen2 implants – esophagus, trachea, and bronchus – demonstrating resolution of the negative inflammatory response observed with the prior generation of the technology.
- Clinically significant evidence of tissue and nerve regeneration was observed in the esophageal implant, positioning the esophageal implant as the current lead development priority.
- HART is initiating confirmatory and longer-term large-animal studies with Mayo Clinic in December.
- HART remains on track to conduct human compassionate use surgeries and to file an initial IND application with U.S. FDA in 2016.
Research Findings
Saverio La Francesca, M.D., HART’s CMO, added, “We have demonstrated a very significant improvement in the body’s response to the implant in the tracheal position, and we have observed initial engraftment of the implant into the surrounding tissues. Similar positive findings were noted in the main bronchus position.”
He continued, “We are very encouraged by the anatomical and histological data from our esophageal implant study. Based on these data, we believe that our second generation implant possesses all the necessary cues to elicit full regeneration of the esophagus. Importantly, our esophageal implant addresses a very significant need as a potentially life-saving treatment for patients with esophageal cancer. Each year in the U.S. approximately 17,000 new cases of esophageal cancer are diagnosed, and more than 4,000 are addressed by surgery. Our results underscore the value and potential of our platform technology to treat these patients and pave the way for further studies and our regulatory pathway for human clinical trials.”
Teleconference
A conference call to discuss the company’s animal studies described above, its third quarter results, and business outlook is scheduled today at 5:00 PM (Eastern Time). On that call, management may respond to questions from the audience on any of a number of topics related to the business, including clinical and preclinical research, operations, plans and outlook.
Participating in the call will be Jim McGorry, Chief Executive Officer, Saverio La Francesca, M.D., Executive Vice President and Chief Medical Officer and Tom McNaughton, Chief Financial Officer, of HART.
Investors can access the live conference call by dialing the following phone numbers: toll-free 877-407-8293, or international: 201-689-8349, and referencing Harvard Apparatus Regenerative Technology, Inc. An audio webcast will also be available at http://public.viavid.com/index.php?id=117087
If you are unable to listen to the live conference call, a replay will be available within approximately 3 hours from the end of the call through 11:59pm ET on November 19, 2015 and will be accessible by dialing toll-free 877-660-6853, or toll/international 201-612-7415, and referencing conference ID “13624147”. The replay will also be made available at the web link above and on the company’s web site, www.harvardapparatusregen.com.
About HART: (www.hartregen.com)
Harvard Apparatus Regenerative Technology (HART) makes bioengineered implants for life-threatening conditions. Our technology platform is to be used to restore function in the esophagus and the trachea and bronchus airways. Our first generation tracheal implant has been used successfully in five human implant procedures approved under compassionate use exemptions, but none of our products are yet approved for marketing by a government regulatory authority. HART is completing further large-animal studies to refine our technology platform with the goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to initiate clinical trials for one of our three indications in 2016.
Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the regulatory approval of any HART products by the FDA, EMA, MHRA or otherwise, which approvals may not be obtained on a timely basis or at all, success with respect to any collaborations, clinical trials and other development and commercialization efforts of HART products pertaining to the airway or esophagus, which such success may not be achieved or obtained on a timely basis or at all; anticipated future earnings or other financial measures, and the continued availability of a market for HART securities. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the bioreactors, scaffolds and other devices and product candidates we pursue; the success of our clinical trials and devices; our inability to operate effectively as a stand-alone, publicly traded company; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor and Media Contact:
David Collins, Tanya Kamatu
Catalyst Global
212 924 9800
hart@catalyst-ir.com
AUSTIN, TX–(Nov 12, 2015) – Moxian, Inc. (OTCQB: MOXC) (the “Company”), a leader in online-to-offline platform, announces that it has engaged corporate communications firm DreamTeamNetwork (“DTN”). Austin, Texas-based DTN has assisted more than 300 public companies fine tune their corporate communications strategies, which includes investor relations, public relations, and social media relations, as well as branding and marketing, video production and website development.
“We’re pleased to announce this strategic partnership with DreamTeamNetwork to help us deliver stronger communication channels to our shareholders and initiate greater exposure to potential investors who may not yet have Moxian on their radar,” says Moxian Chief Executive Officer James Mengdong Tan. “We have a great story to tell, and look forward to increasing our exposure without skipping a beat with our ongoing operations.”
DTN will leverage its family of unique brands, along with an extensive network of partners, daily and weekly newsletters, social media channels, blog and other outreach tools to further develop Moxian’s brand awareness and communications with shareholders.
“Moxian is an exciting company that we believe is positioned to capture significant market share as it increases exposure and streamlines communications with the broader investment community,” stated Michael McCarthy, Managing Director for DTN. “We look forward to working closely with Moxian’s senior management and staff to help the company achieve its corporate communications initiatives.”
About Moxian
Moxian engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. The company’s products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. Moxian designs its products and services to allow merchant clients to run advertising campaigns and promotions targeting their customers. Moxian’s platform is also designed and built to entice users to return frequently and to encourage new consumer users to subscribe its website.
For more information visit: http://ir.moxian.com/html-en/
About DreamTeamNetwork
DreamTeamNetwork serves private and public companies via numerous in-house brands and trusted partners. Leveraging the unique strengths of each brand and partner, the company provides a powerhouse blend of investor relations, public relations and social media relations services.
For more information visit www.DreamTeamNetwork.com
Forward-Looking Statements:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Extending the Number of Operators in a Major Wireless Multinational Group to Six
ENGLEWOOD, CO–(Nov 10, 2015) – Evolving Systems, Inc. (NASDAQ: EVOL), a leader in activation, enablement and real-time marketing of services for connected mobile devices, today announced that another wireless operator in Africa has selected the Company’s Dynamic SIM Allocation™ (DSA) solution. The operator is part of a major multinational telecom group, making this order Evolving Systems’ sixth within the group and fourth order for DSA this year.
Due to the unique way DSA activates subscribers — by allocating phone numbers and network resources when the wireless device is purchased and used for the first time — operators are able to streamline their SIM logistics and keep costs under control. These benefits, considered critical in fast moving emerging markets like Africa, allow operators to avoid SIM supply chain complexities and costs usually associated with pre-provisioning.
“We’re very pleased to announce our fourth win in Africa this year, and sixth in total, from this leading telecom group,” said Thad Dupper, Chairman and CEO of Evolving Systems. “DSA will help streamline the operator’s SIM supply chain and reduce operational costs. Our solution will also enable this operator to expand its subscriber base and market share by allowing subscribers a choice of number and tariff plans directly through the handset, providing a highly personalized activation experience.”
Click here for more information on our DSA solution.
About Evolving Systems®
Evolving Systems, Inc. (NASDAQ: EVOL) is a provider of software and services to 75 network operators in over 50 countries worldwide. The Company’s portfolio includes market-leading activation products that address subscriber service activation, SIM card activation, mobile broadband activation and connected devices; mobile data enablement solutions to successfully monetize mobile data traffic; number management products that reliably and efficiently manage number resources; and real-time analytical and marketing solutions offering highly personalized interactive campaigns. Founded in 1985, the Company has headquarters in Englewood, Colorado, with offices in the United States, United Kingdom, India, Malaysia and Romania. For more information please visit www.evolving.com or follow us on Twitter http://twitter.com/EvolvingSystems
CAUTIONARY STATEMENT
This news release contains “forward-looking statements” within the meaning of the United States’ Private Securities Litigation Reform Act of 1995, based on current expectations, estimates and projections that are subject to risk. Specifically, statements about the impact and ability of the solution described in this press release to handle future needs of customers are forward-looking statements. Readers should not place undue reliance on these forward-looking statements, and Evolving Systems may not undertake to update these forward-looking statements. Actual results could differ materially because of many factors, such as internal budgeting changes of customers, the impact of competition and the general state of the telecommunications industry. For a more extensive discussion of Evolving Systems’ business, please refer to the Company’s Form 10-K filed with the U.S. SEC, as well as subsequently filed Forms 10-Q, 8-K and press releases and the Company’s websites.
Contacts
Jay Pfeiffer
Pfeiffer High Investor Relations, Inc.
303-393-7044
Email Contact
Sarah Hurp
Marketing Manager
+44 1225 478060
Email Contact
Former Express Energy Services Executive Brings Significant Sales Leadership Experience to Newly Created Role
HOUSTON, Nov. 11, 2015 — American Electric Technologies, Inc. (NASDAQ:AETI), a leading provider of power delivery solutions for the global energy industry, announced today that Mark Haubert has joined the company as Senior Vice President, Sales and Marketing for its flagship M&I Electric business.
Mr. Haubert brings with him more than 25 years of sales, marketing, engineering, operations and executive leadership experience in the energy industry.
In this role, Mr. Haubert will have global responsibility for leading the company’s strategic and tactical sales and marketing initiatives targeting the oil & gas, power generation and distribution, marine and industrial segments.
Mr. Haubert was most recently Senior Vice President of Sales and Marketing for EMS USA, Inc., a privately held firm offering pipeline and facility construction, pipeline integrity maintenance, production measurement and automation services to the midstream, upstream and downstream markets. Prior to EMS, Mr. Haubert was Executive Vice President of Sales, Marketing and Engineering at Express Energy Services where he led significant revenue growth and market penetration with a blue chip customer base. Mr. Haubert has also held a variety of roles at Baker Hughes, Cameron, and Schlumberger.
Mr. Haubert will report directly to AETI’s President and CEO, Charles Dauber and will be located in the AETI office in the Houston Energy Corridor.
“We are excited to bring Mark on board to help the company take our revenues to the next level,” said Charles Dauber, AETI President and CEO. “Mark brings more than 25 years of energy industry sales leadership experience to his new role at M&I and we look forward to working with him to achieve the next phase of our company’s growth objectives.”
Mr. Haubert received a Bachelor of Science degree in Petroleum Engineering from Louisiana State University and an executive Master of Business Administration from Houston Baptist University.
“I am thrilled to join the M&I Electric team and I look forward to leveraging the quality products and services, customer-centric approach, industry-leading delivery and other value drivers to grow our customer base and to delight our clients,” said Mark Haubert.
American Electric Technologies, Inc. (NASDAQ:AETI) is a leading supplier of power delivery solutions for the global energy industry. AETI offers M&I Electric™ power distribution and control products, electrical services, and E&I construction services. South Coast Electric Systems L.L.C., a subsidiary, services Gulf Coast marine and vessel customers.
AETI is headquartered in Houston and has global operations in Beaumont, Texas; Bay St. Louis, Mississippi, and Rio de Janeiro and Macae, Brazil. In addition, AETI has minority interests in two joint ventures, which have facilities located in Xian, China and Singapore. AETI’s SEC filings, news and product/service information are available at www.aeti.com.

Investor Contacts:
American Electric Technologies, Inc.
713-644-8182
investorrelations@aeti.com
European patent covers the use of antibodies in the capture and detection of rare cells from biological fluids used in the company’s liquid biopsy, or blood-based, molecular diagnostic assays
SAN DIEGO, Nov. 11, 2015 — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the diagnosis and treatment of cancer, announces that the European Patent Office has awarded the patent, “DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS,” as announced in the European Bulletin dated November 11, 2015. The patent covers the use of antibodies in the capture of rare cells, such as circulating tumor cells (CTCs), from blood as well as other biological fluids using the company’s patented microchannel capture device.
Biocept’s antibody capture cocktail along with the microchannel are key components of the company’s Cell Enrichment and Extraction (CEE™) platform, providing for the high-efficiency capture, visualization and microscopic analysis of targeted cancer cells obtained from a patient blood sample and used by physicians for medical decision-making.
Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept, said, “The issuance of this patent further expands our international patent portfolio to include the use of antibodies in the capture of cancer cells in combination with our microchannel for which multiple U.S. and international patents have been granted. Our antibody cocktail is a key part of our patented, proprietary method to capture and analyze cells from a wide variety of tumor types. In addition, this patent expands our IP protection for the use of a simple blood sample and other biological sample types in obtaining valuable biomarker information that can be used by physicians to personalize the treatment of patients with cancer.”
“We have been aggressively broadening IP protection for our unique methods of capturing and analyzing cancer cells in blood and other biological fluids,” said Biocept’s President and Chief Executive Officer Michael Nall. “Our expanding patent portfolio better positions Biocept to capitalize on the growing movement toward the use of liquid biopsy, which we believe can reduce healthcare costs and improve outcomes by identifying patients who can qualify for targeted treatments that physicians can utilize to treat their cancer.”
About Biocept
Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept’s patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer and melanoma, and plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term. For additional information, please visit www.biocept.com.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including, without limitation, statements as to the ability of physicians to use our liquid biopsy technology to personalize treatment for individual patients with cancer, our ability to expand the clinical utility and adoption of our liquid biopsy assays, improvement of patient outcomes and our impact on diagnostic strategies and healthcare costs, and our ability to expand into new cancer indications and grow our portfolio of biomarker assays, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
LOVELAND, Colo., Nov. 11, 2015 — Heska Corporation (NASDAQ: HSKA “Heska” or the “Company”), a leading provider of advanced veterinary diagnostic and specialty products, announced today the acquisition of Cuattro Veterinary, LLC (“Cuattro International”) a global leader in digital radiography, PACS, and other imaging technologies for veterinarians.
Kevin Wilson, Heska’s Chief Executive Officer and President, commented that, “We are excited to combine Cuattro International’s global reach with Heska’s success in the United States. This international expansion provides Heska with a strong and established platform for launching Heska’s blood diagnostics platforms and programs to international markets. With established sales throughout Canada, Mexico, Continental Europe, the United Kingdom, Australia, the Middle East, Singapore, Latin America, and elsewhere, Cuattro International’s imaging products continue to delight global veterinary customers. Now, Heska can leverage our domestic success in the imaging and blood diagnostics space on a worldwide stage. International markets represent a significant portion of worldwide veterinary revenues for which Heska intends to compete. Today, Heska begins to aggressively pursue those markets with advanced blood diagnostics and imaging bundles, a proven go-to-market model, and an expert and expanding team.”
Heska agreed to deliver $6.0 million in stock for 100% ownership of Cuattro International, subject to a minimum of 175,000 shares and a maximum of 200,000 shares. Heska will assume approximately $2.1 million in debt as part of the acquisition. Cuattro International generated approximately $6 million in revenue for the twelve months ended September 30, 2015 and was profitable during this period. The acquisition is subject to closing conditions and is targeted to close January 1, 2016. The Company expects the acquisition to be neutral to slightly accretive to earnings per share in 2016.
Management will conduct a conference call on Wednesday, November 11, 2015 at 9 a.m. MST (11 a.m. EST) to discuss recent financial results and this transaction. To participate, dial 888‑438‑5491 (domestic) or 719-325-2455 (international) and reference conference call access number: 239441. The call will also be broadcast live over the Internet at http://www.heska.com. To listen, simply log on to the web address at least ten minutes prior to the start of the call to register, download and install any necessary audio software. Telephone replays of the conference call will be available for playback on Heska’s home page at www.heska.com until November 25, 2015. The telephone replay may be accessed by dialing 888-203-1112 (domestic) or 719-457-0820 (international). The replay access number is 239441.
Forward-Looking Statements
This announcement contains forward-looking statements regarding Heska’s future financial and operating results. These statements are based on current expectations and are subject to a number of risks and uncertainties. Investors should note that there is an inherent risk in using past results, including trends, to predict future outcomes, including using customer trends to predict future success with customers. Factors that could affect the business and financial results of Heska generally include,but are not limited to, the following: uncertainties related to Heska’s ability to sell different product categories through an existing sales channel; uncertainties related to acquisitions, including the potential that the acquired entity’s financial performance will not meet expectations; risks related to relying on third-party distributors; risks related to personnel; competition; and the risks set forth in Heska’s filings and future filings with the Securities and Exchange Commission, including those set forth in Heska’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015.
SILVER SPRING, Md., Nov. 11, 2015 — Discovery Communications (Nasdaq: DISCA, DISCB, DISCK) today announced that President and CEO David Zaslav will present at the 2015 UBS Global Media and Communications Conference at 2:30 p.m. ET on Monday, December 7, 2015, at the New York Hilton Midtown in New York, NY.
A link to a live audio webcast of the presentation will be available in the “Investor Relations” section of Discovery Communications’ website at www.discoverycommunications.com. A replay of the webcast will be available on the company’s website for 180 days following the presentation.
About Discovery Communications
Discovery Communications (Nasdaq: DISCA, DISCB, DISCK) is the world’s #1 pay-TV programmer reaching 3 billion cumulative subscribers in more than 220 countries and territories. For 30 years Discovery has been satisfying curiosity and entertaining viewers with high-quality content through its global brands, led by Discovery Channel, TLC, Animal Planet, Investigation Discovery, Science and Turbo/Velocity, as well as U.S. joint venture network OWN: Oprah Winfrey Network, and through the Discovery Digital Networks portfolio, including TestTube, Seeker and SourceFed. Discovery owns Eurosport, the leading pan-regional sports entertainment destination across Europe and Asia-Pacific. Discovery also is a leading provider of educational products and services to schools, including an award-winning series of K-12 digital textbooks, through Discovery Education. For more information, please visit www.discoverycommunications.com.
– Proposal represents a premium of 50% over the unaffected Angie’s List share price and trailing 90 day average trading price – Proposal contemplates either an all cash offer or a stock-for-stock transaction that combines IAC’s HomeAdvisor business with Angie’s List – IAC expects that a transaction could be consummated expeditiously, with no financing condition
NEW YORK, Nov. 11, 2015 — IAC/InterActiveCorp (Nasdaq: IACI) today announced that it has proposed to acquire all of the outstanding shares of Angie’s List, Inc. (Nasdaq: ANGI) common stock for $8.75 per share. The transaction proposed to the Angie’s List Board of Directors would be structured as an all-cash deal; however, IAC has indicated its willingness to consider a combination of Angie’s List with IAC’s HomeAdvisor business through a tax-free stock-for-stock exchange.
The IAC all-cash proposal represents a premium of greater than 50% over the unaffected price of Angie’s List common stock as of October 12, 2015, the day immediately preceding disclosure of TCS Capital’s letter to the Angie’s List Board of Directors advocating pursuit of a strategic transaction between Angie’s List and HomeAdvisor and over the trailing 90 day average trading price for the stock.
“The combination of the Angie’s List brand, highly trafficked website and its network of paying service professionals with our HomeAdvisor business, the category leader which has seen eight consecutive quarters of accelerating growth in its core U.S. business, would cement our position as the premier home services platform,” said Joey Levin, CEO of IAC/InterActiveCorp. “We are fully committed to this transaction and are confident that both Angie’s List stockholders and our stockholders will recognize the value of our proposal.”
Financial and Strategic Benefits of the Proposal
- The all-cash offer represents a compelling premium of 50% over the Angie’s List unaffected share price, as well as the trailing 90-day average trading price for the stock.
- The combination of Angie’s List with HomeAdvisor would create the premier platform in the home services market with over $700 million of revenue and an unparalleled network of active and high quality service professionals capable of delivering consumers a best-in-class experience.
- The combined company would have more than $35 billion in gross transaction value and over an estimated 15 million unique visitors per month.
- The combination of Angie’s List’s nationally recognized brand and directory monetization model with HomeAdvisor’s performance based on demand monetization (including Instant Booking, Instant Connect and Market Matching products) will provide the best experience to the largest number of consumers and service providers alike.
IAC delivered its proposal to the Angie’s List Board of Directors today. Below is the text of the letter that was sent to the Angie’s List Board of Directors:
November 11, 2015
Board of Directors
Angie’s List, Inc.
1030 E. Washington Street
Indianapolis, IN 46202
Dear Ladies and Gentlemen:
We very much appreciated Scott Durchslag and Thomas Fox taking the time to meet with us on October 23. We were disappointed to hear that the Board is not interested in further engaging with us regarding a strategic transaction involving Angie’s List. We continue to believe a transaction involving our companies has a compelling strategic rationale, and we are confident we are well-positioned to swiftly consummate a transaction that will be in the best interests of Angie’s List stockholders. In an effort to demonstrate our strong commitment to bringing our two companies together, outlined below is an updated proposal for the Board’s consideration.
We propose to acquire 100% of the outstanding capital stock of Angie’s List for a price of $8.75 per share in cash, representing a compelling premium of greater than 50% over the unaffected price of Angie’s List common stock as of October 12, 2015, the day immediately preceding disclosure of TCS Capital’s letter to the Angie’s List Board advocating pursuit of a strategic transaction, and over the trailing 90 day average trading price for the stock. Our price represents a greater than 18x multiple of the midpoint of your forecasted EBITDA range for this year – a very rich multiple for a business currently growing revenue at 7% year over year on a standalone basis.
While we see many benefits of a clear, high-premium, all-cash offer that would deliver immediate liquidity and certain value to your stockholders, we are also prepared to discuss a combination of Angie’s List with our HomeAdvisor business. This could be structured as a tax-free exchange for Angie’s List stockholders and would allow Angie’s List stockholders to participate in the upside resulting from the opportunities available to the combined company.
A combined HomeAdvisor-Angie’s List would have unparalleled consumer reach and an incomparable network of paid service professionals. It would have the ability to deploy technological innovations across an enormous footprint, creating an unmatched ability to deliver the best experience to the largest number of consumers and service providers alike. We are confident that the operating outlook for Angie’s List in a combination scenario would be substantially improved over its standalone prospects.
We believe the work required to finalize a mutually agreeable transaction would be quick, and we can manage it efficiently so as not to disrupt the Angie’s List day-to-day operations. The definitive terms of our proposal could be agreed in the course of a week and completed within a few months, as promptly as the regulatory processes permit. Our proposal is not conditioned on the receipt of financing.
Our strong preference would have been to work with you on a confidential and cooperative basis. However, we have been unable to develop any meaningful dialogue with you for many months now and were disappointed by your unwillingness to continue discussions with us following our meeting. Further, in light of the increase in the Angie’s List share price during the days that followed our October 5 letter to the Board expressing an interest in discussions, and further increases following our October 23 meeting and acquisition proposal, we determined it was advisable to publicly release the text of this letter concurrent with its delivery to the Board to ensure that your stockholders are fully apprised of the significant value afforded by our proposed transaction.
This letter does not represent or create any legally binding or enforceable obligations. No such obligations will be imposed on any party unless and until a definitive agreement is executed.
I assure you that this transaction has the highest priority for IAC. We look forward to working towards a transaction that creates value for all of our stockholders and, as we have indicated previously, we are prepared to meet with you immediately to discuss the same.
Sincerely,
Joey Levin
Chief Executive Officer
About IAC/InterActiveCorp
IAC (NASDAQ: IACI) is a leading media and Internet company. It is organized into four segments: Match Group, which includes dating and education businesses with brands such as Match, OkCupid, Tinder and The Princeton Review; Search & Applications, which includes brands such as About.com, Ask.com, Dictionary.com and Investopedia; Media, which consists of businesses such as Vimeo, Electus, The Daily Beast and CollegeHumor; and eCommerce, which includes HomeAdvisor and ShoeBuy. IAC’s brands and products are among the most recognized in the world reaching users in over 200 countries. IAC is headquartered in New York City and has offices worldwide.
About HomeAdvisor
HomeAdvisor.com is a local home services marketplace providing homeowners the tools and resources for home repair, maintenance, and improvement projects. HomeAdvisor’s marketplace lets homeowners view average project costs coast-to-coast, find local pre-screened home professionals, and instantly book appointments online. Access to all of HomeAdvisor’s resources is free for homeowners, with no membership or fees required. HomeAdvisor is based in Golden, Colo., and is an operating business of IAC (NASDAQ: IACI)
Important Additional Information
This communication does not constitute an offer to buy or solicitation of an offer to sell any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.
Subject to future developments, IAC may file a registration statement and/or tender offer documents with the SEC in connection with a possible transaction with Angie’s List. IAC and Angie’s List stockholders should read those filings, and any other filings made by IAC with the SEC in connection with a possible transaction, as they will contain important information. Those documents, if and when filed, as well as IAC’s other public filings with the SEC, may be obtained without charge at the SEC’s website at www.sec.gov and at IAC’s website at www.iac.com/investor-relations.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
This communication contains “forward‑looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as “anticipates,” “expects,” “intends,” “plans” and “believes,” among others, generally identify forward-looking statements. These forward-looking statements include statements relating to: future financial performance, business prospects and strategy, anticipated trends, prospects in the industries in which our businesses operate and other similar matters. These forward‑looking statements are based on management’s current expectations and assumptions about future events, which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. Actual results could differ materially from those contained in these forward‑looking statements for a variety of reasons, including, among others: changes in senior management at IAC or its businesses, adverse changes in economic conditions, adverse trends in the online advertising industry, our ability to convert visitors to our websites into users, risks relating to acquisitions, technology changes, our ability to expand successfully into international markets and regulatory changes. These statements also include assumptions about our offer to acquire Angie’s List (including its benefits, results, effects and timing) that may not be realized. Risks and uncertainties related to the proposed transaction include, among others: the possibility that a possible transaction will not be pursued or will be pursued on different terms or conditions; adverse effects on the market price of IAC’s common stock and on IAC’s operating results because of a failure to agree to or complete a possible combination; in the event a definitive transaction agreement is executed, the risk that Angie’s List stockholders do not approve the transaction; uncertainties as to the timing of the transaction; the risk that regulatory or other approvals required for the transaction are not obtained, the risk that the other conditions to the closing of the transaction are not satisfied; and, in the event a transaction combining the Angie’s List and HomeAdvisor businesses is consummated, risks related to the costs and difficulties related to the integration of Angie’s List businesses and operations with HomeAdvisor and IAC’s businesses and operations; the inability to obtain, or delays in obtaining, cost savings and synergies from the transaction; unexpected costs, charges or expenses resulting from the transaction; litigation relating to the transaction; and the inability to retain key personnel. Certain of these and other risks and uncertainties are discussed in IAC’s filings with the Securities and Exchange Commission. Other unknown or unpredictable factors that could also adversely affect our business, financial condition and results of operations may arise from time to time. In light of these risks and uncertainties, these forward‑looking statements may not prove to be accurate. Accordingly, you should not place undue reliance on these forward‑looking statements, which only reflect the views of our management as of the date of this press release. We do not undertake to update these forward-looking statements.
Contact Us
IAC Investor Relations
Mark Schneider / Alexandra Caffrey
(212) 314-7400
IAC Corporate Communications
Isabelle Weisman
(212) 314-7361
Moffitt Cancer Center Grants Aptose Exclusive Global Rights to Highly Potent Multi-Targeting Epigenetic Inhibitors
Exclusive Agreement with Laxai Avanti Life Sciences to Design Next Generation Epigenetic Therapeutics
REDWOOD CITY, Calif., TORONTO, TAMPA, Fla. and HYDERABAD, India, Nov. 10, 2015 — Aptose Biosciences Inc. (Nasdaq:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced two collaborations that will provide exclusive access to new epigenetic therapeutics for the Company’s oncology pipeline. These partnerships have been strategically formed to leverage Aptose’s scientific and clinical expertise in cancer and hematologic diseases to develop mechanistically differentiated and high-value epigenetic drug candidates.
Strategic Collaboration with Moffitt Cancer Center
Aptose has entered into a definitive agreement with Moffitt Cancer Center for exclusive global rights to potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers. These small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes. The molecules developed by Moffitt exhibit single-digit nanomolar potency against the BET family members and specific oncogenic kinases which, when inhibited, are synergistic with BET inhibition. Under the agreement, Aptose will gain access to the drug candidates developed by Moffitt and the underlying intellectual property covering the chemical modifications enabling potent bromodomain (BRD) inhibition on the chemical backbone of a kinase inhibitor. Aptose expects lead clinical candidates to emerge from the collaboration by late 2016.
Transcriptional dysregulation in cancer cells may occur through various means, including chromatin remodeling, histone modification and super-enhancer formation. The bromodomain proteins play a critical role in this dysregulation, and hence targeting specific bromodomains represents a validated treatment approach for various cancers. Aptose is committed to developing a pipeline of molecules that inhibit key epigenetic targets with the potential to intervene in oncogenesis and induce remission.
“We’ve built an oncology drug development organization with valuable ties to leading clinical centers and thought leaders,” said William G. Rice, Ph.D., Chairman, President and CEO, “and we are exceptionally pleased to partner with Moffitt on advancing new epigenetic inhibitors, specifically bromodomain inhibitors that simultaneously inhibit specific kinases in key regulatory pathways.”
“Aptose views a multi-targeting approach, which incorporates bromodomain inhibition, as an exciting means to enhance efficacy and diminish therapeutic resistance relative to the current landscape in cancer treatment. This is even more beneficial when inhibition of the pathways is highly synergistic. The researchers at Moffitt have made unprecedented progress in this field,” continued Dr. Rice.
“We view the advancement of epigenetic multi-inhibitors as a highly promising strategy in the treatment of cancer,” said the principal investigators Ernst Schonbrunn, Ph.D. and Nicholas Lawrence, Ph.D., members of the Drug Discovery Program at Moffitt, “and targeting broad-acting epigenetic regulators of transcription like bromodomain proteins is needed to suppress the induction of gene expression that results when cancer cells respond to kinase inhibitors.”
“We are excited to work with an organization as scientifically driven to develop novel therapeutics as Aptose,” said Haskell Adler, Ph.D., MBA, Senior Licensing Manager at Moffitt.
Exclusive Agreement with Laxai Avanti Life Sciences
Aptose today also announced an exclusive drug discovery partnership with Laxai Avanti Life Sciences (LALS) for their expertise in next generation epigenetic-based therapies. Under the agreement, LALS will be responsible for developing multiple clinical candidates, including optimizing candidates derived from Aptose’s relationship with the Moffitt Cancer Center. Aptose will own global rights to all newly discovered candidates characterized and optimized under the collaboration, including all generated intellectual property.
“We have identified LALS as an organization with high-caliber medicinal chemistry and with robust, and highly efficient drug discovery capabilities that complement our capabilities at Aptose,” said Dr. Rice. “These collaborations are designed to build upon insights into the epigenetic field that were informed by the mechanism of APTO-253. As we continue to advance APTO-253 into late-stage clinical development, we are committed to creating and acquiring additional differentiated agents and building a staged oncology pipeline behind APTO-253.”
About APTO-253
Epigenetic suppression of the KLF4 gene has been reported in the scientific literature as a key transforming event in AML and high-risk myelodysplastic syndromes. APTO-253, Aptose’s lead drug candidate, is a first-in-class inducer of the Krüppel-like factor 4 (KLF4) tumor suppressor gene, and the only clinical-stage compound targeted for patients with suppressed KLF4 levels. APTO-253 has demonstrated a favorable safety profile with no evidence of bone marrow suppression. Preclinical studies have shown potent single-agent activity and an opportunity for combination therapy with a variety of anti-cancer therapeutics. The drug candidate is in a Phase 1b clinical study in patients with relapsed or refractory hematologic malignancies.
About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 45 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. With more than 4,600 team members, Moffitt has an economic impact in the state of $1.9 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.
About Laxai Avanti Life Sciences
Laxai Avanti Life Sciences (LALS) was established in 2007 with a vision to innovate and accelerate the drug discovery campaigns of global pharmaceutical companies. The goal of LALS is to provide intelligent solutions to global pharmaceutical and biotechnological companies by providing high quality services with accelerated timelines. LALS provides a one-stop service for pharmaceutical and biotechnology companies around the globe to accelerate drug discovery programs. LALS current client base includes Biopharmaceutical, Agrochemical and Specialty Chemical Companies in Europe and the US.
About Aptose Biosciences
Aptose Biosciences is a clinical-stage biotechnology company committed to discovering and developing personalized therapies addressing unmet medical needs in oncology. Aptose is advancing new therapeutics focused on novel cellular targets on the leading edge of cancer research, coupled with companion diagnostics to identify the optimal patient population for our products. The Company’s small molecule cancer therapeutics pipeline includes products designed to provide enhanced efficacy with existing anti-cancer therapies and regimens without overlapping toxicities. Aptose Biosciences Inc. is listed on NASDAQ under the symbol APTO and on the TSX under the symbol APS.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Canadian and U.S. securities laws. Such statements include, but are not limited to, the ability of the company to develop mechanistically differentiated and high-value epigenetic drug candidates; that the licensed molecules will be potent, multi-targeting, single-agent inhibitors for the treatment of hematologic and solid tumor cancers; that the small molecule agents are highly differentiated inhibitors of the Bromodomain and Extra-Terminal motif (BET) protein family members, which simultaneously target specific kinase enzymes; that lead clinical candidates may emerge from the collaboration by late 2016; that future bromodomain inhibitors will simultaneously inhibit specific kinases in key regulatory pathways; that we will be able to enhance efficacy and diminish therapeutic resistance relative to the current landscape in cancer; that the researchers at Moffitt Cancer Center have made unprecedented progress in this field; that we will continue to advance APTO-253 into late-stage clinical development and statements relating to the Company’s plans, objectives, expectations and intentions and other statements including words such as “continue”, “expect”, “intend”, “will”, “should”, “would”, “may”, and other similar expressions. Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance or achievements described in this press release. Such expressed or implied forward looking statements could include, among others: our ability to obtain the capital required for research and operations; the inherent risks in early stage drug development including demonstrating efficacy; development time/cost and the regulatory approval process; the progress of our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key personnel; changing market conditions; and other risks detailed from time-to-time in our ongoing quarterly filings, annual information forms, annual reports and annual filings with Canadian securities regulators and the United States Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should the assumptions set out in the section entitled “Risk Factors” in our filings with Canadian securities regulators and the United States Securities and Exchange Commission underlying those forward-looking statements prove incorrect, actual results may vary materially from those described herein. These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty therein.
CONTACT: For further information, please contact:
Aptose Biosciences
Avanish Vellanki
SVP, Chief Business Officer
650-718-5021
avellanki@aptose.com
BCC Partners
Karen L. Bergman or Susan Pietropaolo
650-323-1717 or 845-638-6290
kbergman@bccpartners.com or spietropaolo@bccpartners.com
Moffitt Cancer Center
Kim Polacek
Public Relations Account Services Coordinator
Moffitt Cancer Center
Kim.Polacek@Moffitt.org
813-745-7408
National CineMedia, Inc. (NASDAQ: NCMI) (the Company), the managing member and owner of 45.2% of National CineMedia, LLC (NCM LLC), the operator of the largest digital in-theatre network in North America, today announced that the Company will participate at the MKM Partners Entertainment, Leisure & Internet Conference on Thursday, November 19, 2015 at The New York Palace in New York, NY. The Company’s CEO Kurt Hall will present at 08:00 AM EST.
Investors and interested parties may listen to a webcast of the event by visiting the investor relations section of the Company’s website at www.ncm.com.
About National CineMedia, Inc.
National CineMedia (NCM) is America’s Movie Network. As the #1 weekend network in the U.S., NCM helps brands get in front of the movies that shape the national conversation. More than 700 million moviegoers annually attend theatres that are currently under contract to present NCM’s FirstLook pre-show in over 40 leading national and regional theatre circuits including AMC Entertainment Inc. (NYSE:AMC), Cinemark Holdings, Inc. (NYSE:CNK) and Regal Entertainment Group (NYSE: RGC). NCM’s cinema advertising network offers broad reach and unparalleled audience engagement with approximately 20,050 screens in approximately 1,600 theaters in 187 Designated Market Areas® (49 of the top 50). NCM Digital goes beyond the big screen, extending in-theatre campaigns into online and mobile marketing programs to reach entertainment audiences. National CineMedia, Inc. (NASDAQ:NCMI) owns a 45.2% interest in, and is the managing member of, National CineMedia, LLC. For more information, visit www.ncm.com.
National CineMedia, Inc.
Investor Contact:
David Oddo, 800-844-0935
investors@ncm.com
Senior Human Resources Leader Brings More Than 25 Years of Experience from Oracle, Microsoft, Siebel Systems and Electronic Arts
PALO ALTO, Calif., Nov. 9, 2015 — Jive Software, Inc. (Nasdaq: JIVE) today announced that Gabrielle Toledano has been appointed to its board of directors. Ms. Toledano joins the Jive board with a distinguished 25-year career in technology industry human relations, including her current role as executive vice president and chief talent officer at Electronic Arts.
“Gabrielle brings a wealth of experience managing human resources and cultural innovation at some of the biggest companies in the industry, and she will be an incredible addition to the board,” said Elisa Steele, chief executive officer at Jive Software. “She will help us push the boundaries of what’s possible across all aspects of our business.”
At Electronic Arts, Ms. Toledano is responsible for the company’s organization and leadership capability development, global staffing and resourcing, benefits and compensation, rewards and recognition, facilities, and corporate social responsibility. Previously, she served as chief human resources officer for Siebel Systems and has held strategic human resources positions with Microsoft and Oracle.
“People are at the center of every organization, and in today’s competitive talent landscape it’s imperative for companies to foster meaningful relationships with their employees, customers and partners,” said Gabrielle Toledano. “Jive lives and breathes this belief every day — delivering solutions that directly impact how millions of people around the world connect, communicate and collaborate. I’m honored to join Jive’s team and support its mission to help people work better together.”
Ms. Toledano will replace Jonathan Heiliger, who is resigning to focus full time on his role as partner at Vertex Ventures. “As we welcome Gabrielle, I want to also recognize the dedication and impact that Jonathan has made as a member of Jive’s board,” added Steele. “We’re thankful for his contributions to Jive’s business over the years.”
About Jive Software
Jive (Nasdaq: JIVE) is the leading provider of modern communication and collaboration solutions for business. Recognized as a leader by the industry’s top analyst firms in multiple categories, Jive enables employees, partners and customers to work better together. More information can be found at www.jivesoftware.com or the Jive News Blog.
Contract continues Orion’s dominance in cold storage and food distribution, with fixtures to be installed in 29 facilities at a total project value between $12-15 million
One of the premier supermarket chains and top ten global retailers has awarded its national LED lighting contract for distribution centers to Orion Energy Systems, Inc. (NASDAQ: OESX), a leading designer and manufacturer of high-performance, energy-efficient retrofit lighting platforms.
The contract continues Orion’s long history of successful partnerships with over fifty of the best-known cold storage, food distribution and warehousing facilities. In this market, Orion has completed nearly $60 million in installations at over 650 sites.
Orion is now the specified supplier of all interior LED lighting for the company. The total value of upgrading 29 distribution and cold storage centers from fluorescent to LED technology is expected to be $12-15 million over the next three years, with projects ranging from $150,000 to over $1 million depending on the size of the facility.
“Because we understand the unique requirements and incredible margin pressure these clients face, we’ve become the go to company in the cold storage and food distribution industry,” said John Scribante, Chief Executive Officer of Orion Energy Systems. “Orion creates unique LED lighting retrofit products specifically designed to not only reduce their utility bill, but also install and ship faster, perform better, and provide long-lasting, no-maintenance and green solutions for their facilities and communities.”
The global retailer had previously selected Orion for its initial lighting retrofit from metal halide to a combination of Orion Compact Modular High Bay four lamp T8 fluorescent fixtures and ENCF Freezer Enclosed fixtures with dual switch motion sensors. For this new contract, Orion beat out eight other companies, including all of the largest lighting manufacturers in the US. Orion stood out as the clear winner in the final competitive demonstration because it set a new standard for shipment and installation, and used fewer LED fixtures to deliver more light for less energy.
In the typical 12-fixture aisle, Orion was able to reduce the amount of fixtures by 50 percent while improving light levels due to superior LED optics. The fixtures with dimming smart motion controls were also delivered and installed within two weeks vs. a more than 12-week ship time for the runner-up.
Under the contract, Orion products will be installed for a variety of interior lighting applications, including the Orion ISON™ Open LED High Bay, Apollo® LED High Bay (ALHB), Apollo® LED Strip Retrofit (OLSR), Apollo® LED Troffer Retrofit (LDR) and Harris Exit Signs. For freezer applications, the newest generation of LED technology provides additional functionality and controls that were not available before with fluorescent fixtures, including the ability to completely power off the LED fixtures without affecting lifetime performance or output. Over the life of these new Orion LED fixtures, the retailer expects to save over $94,000 for the average facility.
About Orion Energy Systems
Orion is leading the transformation of commercial and industrial buildings with state-of-the-art energy efficient lighting systems and retrofit lighting solutions. Orion manufactures and markets a cutting edge portfolio of products encompassing LED Solid-State Lighting and high intensity fluorescent lighting. Many of Orion’s 100+ granted patents and pending patent applications relate to lighting systems that provide exceptional optical and thermal performance, which drive financial, environmental, and work-space benefits for a wide variety of customers in the retrofit markets.
Investor Relations Contact:
Orion Energy Systems, Inc.
Bill Hull
Chief Financial Officer
(920) 482-0520
or
Media Relations Contact:
Orion Energy Systems, Inc.
Erica St. Angel
SVP Marketing
(920) 892-5653
A single treatment with PRX302 (topsalysin) demonstrated a statistically significant improvement in BPH symptoms over a 12 month period
SAN DIEGO and VANCOUVER, British Columbia, Nov. 10, 2015 — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing PRX302 (topsalysin) for the treatment of urological diseases, today announced final results from its Phase 3 “PLUS-1” study of PRX302 as a treatment for lower urinary tract symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). PRX302 demonstrated a statistically significant improvement in International Prostate Symptom Score (IPSS) total score from baseline over 12 months compared to the vehicle-only control group (7.60 vs. 6.58 point overall improvement; p = 0.043), the primary endpoint of the study. PRX302 continues to demonstrate a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects.
“A 7.60 point improvement in IPSS total score over 12 months indicates that patients are experiencing a significant relief of their BPH symptoms and improvement in their quality of life following a single treatment with PRX302,” said Dr. Allison Hulme, chief operating officer and head of research and development at Sophiris Bio. “Oral medications such as alpha blockers and 5-alpha reductase inhibitors typically demonstrate a 3-6 point improvement in IPSS total score. We believe that a statistically significant improvement in IPSS, if replicated in a second Phase 3 trial, may be sufficient for registration with the FDA.”
Efficacy Analysis
The primary efficacy endpoint of the IPSS total score change from baseline over 52 weeks was analyzed, per guidance from the FDA, using the repeated measures linear mixed model applied to the modified intent-to-treat population of every patient randomized and dosed with study drug. The 7.60-point overall improvement for the PRX302 group was statistically significantly superior to the 6.58 point improvement in the vehicle-only group (p = 0.043).
In a secondary efficacy analysis of IPSS total score using an ANCOVA model and LOCF (Last Observation Carried Forward) to impute missing post-baseline data, the improvement in IPSS for PRX302 was well sustained over the 52 weeks following the single administration. The maximal effect of 8.31 points improvement in IPSS vs vehicle 6.89 points (p = 0.012) was achieved at Week 18 with 8.04 points of improvement for PRX302 still remaining at Week 52 vs 6.64 points for patients treated with vehicle only (p = 0.022) representing an end-of-study preservation of 97% of the peak benefit.
“The combination of the efficacy and safety profile makes PRX302 a particularly compelling potential option for men suffering from BPH and may help men avoid more invasive, surgical procedures,” said Randall Woods, President and CEO of Sophiris. “PRX302 is the only single-administration investigational treatment for BPH that has demonstrated a statistically significant improvement in symptoms of BPH, is well-tolerated, and has a favorable safety profile. The results of the study demonstrate clear biological activity of PRX302 and increase our confidence in the mechanism of action.”
Secondary efficacy endpoints included analysis of Qmax (maximum urine flow) change from baseline over 52 weeks by the repeated measures linear mixed model, which showed overall improvement of 1.77 mL/sec for PRX302, representing a statistical trend that narrowly missed statistical significance (p = 0.055) compared to the vehicle group.
An additional efficacy endpoint was the patient self-assessment of disease specific Quality of Life. On the 0 to 6 point Quality of Life (QOL) from the IPSS questionnaire, the PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to vehicle for every post-baseline visit beginning at Week 18 (reaching p = 0.004).
Safety Analysis
PRX302 treatment was generally well-tolerated, and no patient was withdrawn from the study or had their study drug injection altered because of an adverse event (AE). The safety profile was consistent with that reported in the TRIUMPH Phase 2 trial published in the Journal of Urology in April 2013. Adverse events occurring in >5% of patients treated with PRX302 regardless of assessed relatedness to study treatment are set forth in the table below. These adverse events are not unexpected manifestations of the intraprostatic cellular destruction and resultant inflammation integral to the PRX302 mechanism of action. The median duration for each of these adverse events was typically less than one day. In general, these adverse events were mild or moderate, transient, began within the first few days after treatment (primarily on the same day as the study drug injection) and were resolved without consequences.
Adverse Events Occurring in >5% of Patients Treated with PRX302 (Safety Population)
Reported Any Time over the Entire 52 Weeks of Study and Regardless of Assessed Relatedness to Study Treatment:
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Adverse Event(1) |
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Vehicle (N=240)n (%) |
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PRX302 (N=239)n (%) |
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Dysuria (e.g., burning, pain, or discomfort on urination) |
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20 (8.3) |
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48 (20.1) |
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Haematuria (microscopic or visible red blood cells in urine) |
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36 (15.0) |
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45 (18.8) |
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Pollakiuria (frequent urination) |
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14 (5.8) |
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23 (9.6) |
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Pyrexia (fever) |
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10 (4.2) |
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21 (8.8) |
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Perineal Pain |
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13 (5.4) |
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21 (8.8) |
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1(MedDRA Dictionary Preferred Terms)
The incidence of serious AEs (SAEs) was similar in both treatment groups. There were two SAEs assessed by the Investigator as at least possibly related to treatment for PRX302 and one such SAE for vehicle. The PRX302-related SAEs were moderate events of “acute non-infectious prostatitis” and “fever following prostate procedure” not unexpected manifestations of the intraprostatic cellular destruction and resultant inflammation integral to the PRX302 mechanism of action. The vehicle-related SAE was a mild event of “urinary tract infection.”
PLUS-1 Study Background
The Phase 3 “PLUS-1” study is an international, multicenter, randomized, double-blind, and vehicle-controlled trial to assess the efficacy and safety of a single intraprostatic administration of PRX302 (0.6 mg/g prostate) for the treatment of BPH. Patients were randomized in a 1:1 ratio to either PRX302 or vehicle-only injection, and then monitored for 1 year. A total of 479 patients with moderate to severe BPH were enrolled and dosed by September 2014. The 52-week completion rate was 91.9%, with a similar number of premature withdrawals from study for the PRX302 group (8.8%) vs. the vehicle group (7.5%). On average, the injection itself was completed in less than 4 minutes.
Treatment groups were well balanced at baseline, including average IPSS total score (21.2 points both groups), Qmax (maximum urine flow) (9.5 mL/sec both groups), total prostate volume (49.8 mL for PRX302 vs. 48.1 mL vehicle), prior BPH treatment (55.2% PRX302 vs. 55.1% vehicle), and quality of life (4.5 points both groups, “mostly dissatisfied” to “unhappy” with current urinary condition).
About PRX302
PRX302 (topsalysin) is a modified recombinant protein that has been engineered to be selectively activated by an enzyme in the prostate, leading to localized cell death and tissue disruption without damaging neighboring tissue and nerves. PRX302 binds to the GPI-anchored receptors on the cell surface of prostate cells. Once activated by PSA, PRX302 combines with other activated PRX302 molecules, forming stable transmembrane pores that induce cell death. The prostate specific activation of PRX302 by enzymatically active PSA thus limits exposure of non-prostate tissues to the drug’s activity, contributing to the safety of the therapy.
About BPH Market Opportunity
Our market research suggests that as many as 36 million men in the United States are affected by BPH with approximately 5 million of these men suffering from bothersome symptoms. While 3 million men are prescribed pharmaceuticals for BPH in the US each year, these treatments lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. With current pharmaceutical treatments, symptoms will usually return if medication is discontinued. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH. However, any type of prostate surgery can cause side effects, such as semen flowing backward into the bladder (retrograde ejaculation), loss of bladder control (incontinence) and impotence (erectile dysfunction). There is a demand for better balance between efficacy, safety and quality of life.
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing PRX302, a clinical-stage, targeted therapy for the treatment of urological diseases. PRX302 is in Phase 3 clinical development for the treatment of the symptoms of BPH and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. PRX302 is also currently in a Phase 2a proof of concept study for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophiris.com.
Certain statements included in this press release may be considered forward-looking, including the quotes of Sophiris’ President and CEO and our COO and head of research and development and any expectations relating to future development of PRX302 for the treatment of symptoms of BPH, including a second Phase 3 clinical trial necessary to pursue registration of PRX302, the results of the Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer l or Sophiris’ capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risks associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective and risks relating to raising sufficient capital to fund development and commercialization of drug products. All forward-looking statements are based on Sophiris’ current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact: |
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Peter Slover |
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Chief Financial Officer |
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(858) 777-1760 |
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Corporate Communications and Investor Relations: |
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Jason Spark |
Michael Moore |
Canale Communications |
NATIONAL Equicom |
Corporate Communications and IR |
Investor Relations |
(619) 849-6005 |
858-886-7813 |
jason@canalecomm.com |
mmoore@national.ca |
November 9, 2015
In September, Elephant Talk Communications Corp. set the stage for sustainable international growth when it was selected by EUTV Brazil, a pioneering telecom provider, to provide its proprietary ET Software DNA® 2.0 mobile service platform throughout Brazil. Through this partnership, ETAK will deliver its core virtualized software service platform to the telecom provider, enabling Surf Telecom®, EUTV Brazil’s tier one authorized mobile brand, to provide superior services to end users and mobile virtual network operators (MVNOs).
“We are very proud to have been selected by Surf Telecom after they thoroughly assessed the capabilities of our virtualized ET Software DNA 2.0 platform,” Martin Zuurbier, co-president of mobile platform business with ETAK, stated in a news release. “Elephant Talk welcomes the partnership… as we enter the vibrant Brazilian mobility market, a market ranked fifth worldwide in 2014 based on the number of subscribers, according to the International Telecommunications Union.”
ETAK’s ET Software DNA 2.0 intelligent mobile service platform empowers mobile network operators (MNOs) and MVNOs with fully-functional tier one, on premise or cloud-based mobile communications core network infrastructure functionality at a fraction of the cost of in-house solutions. By utilizing a software-as-a-service model, the company is able to offer its customers dramatically improved system reliability and overall return on investment. Additionally, thanks to its real-time simultaneous processing capabilities, ETAK’s platform delivers some of the highest key performance indicators in the industry, improving the ability of its customers to adapt to market changes faster while delivering a better overall service experience to mobile subscribers.
Through its innovative suite of mobile network software and services, ETAK enables telecom carriers and MNOs around the globe to offer a range of products, delivery platforms, support services, superior industry expertise and high quality customer service without a substantial upfront investment. Following its partnership with Surf Telecom, the company’s reach covers the entire globe, with a customer base and network of partners on every continent. ETAK already counts several of the world’s leading MNOs and technology firms – including Fair Isaac Corporation (NYSE: FICO), Hewlett-Packard (NYSE: HPQ), T-Mobile (NASDAQ: TMUS) and Vodafone (NASDAQ: VOD) – amongst its customers and partners.
Moving forward, ETAK is in a strong position to build on its presence on the international stage, particularly in the rapidly expanding markets of Latin America. Look for the company to leverage its recent partnership with Surf Telecom in order to continue promoting strong financial growth in the months to come.
For more information, visit www.elephanttalk.com
Leader in Global Product Safety Testing Confirms Award-Winning Wireless Charging Technology Meets Power Delivery and Transmission Expectations
SAN JOSE, CA–(November 09, 2015) – Energous Corporation (“Energous®” or “the Company”) (NASDAQ: WATT), the developer of WattUp™, a revolutionary wire-free charging technology for mobile and IoT devices that provides “over-the-air” power at a distance, today announced the results of an industry-first, independent performance evaluation completed by Underwriters Laboratories, Inc. (UL). The UL testing, which was conducted at their labs, evaluated the performance of the award-winning WattUp technology and validated receive power at various distances, simultaneous multiple device receive capability as well as mobility.
“We are pleased to have the leading independent testing facility confirm that WattUp exceeded performance expectations for delivering power within various charging ranges,” said Stephen R. Rizzone, CEO of Energous. “As the leader in the emerging Uncoupled Power market, we have set the bar and validated the performance of Energous’ award-winning WattUp wireless charging solution. These results independently document the rapid progress of our product development efforts that are expected to enable us to release products to the consumer through our licensing partnerships in late 2016, early 2017.”
TARGETED PERFORMANCE
- 4W delivered within 0-5 feet
- 2W delivered within 5-10 feet
- 1W delivered within 10-15 feet
UL TESTING RESULTS
The UL testing conducted in their lab measured the amount of actual power delivered to a device at varying distances from a single WattUp transmitter. The test noted below measures actual power received by a device.
DISTANCE:
Distance |
Power Received at the Receiver |
0-5 feet |
5.55W |
5-10 feet |
3.74W |
10-15 feet |
1.06W |
RECEPTION OF POWER SIMULTANEOUSLY BY MULTIPLE DEVICES:
UL tested a single transmitter sending power simultaneously to multiple receivers at a distance of five feet yielding the following results:
Device |
Power |
Receiver 1 |
5.44W |
Receiver 2 |
6.66W |
MOBILITY:
UL testing facilities did not have a robotic arm capable of simulating motion. To validate mobility, a single WattUp transmitter located, acquired and transmitted power sequentially in near-real-time to four WattUp receivers spread 30 degrees apart, equidistant at 8.5 feet. Actual power delivered in sequence is as follows:
Device |
Power |
Receiver 1 |
2.36W |
Receiver 2 |
2.02W |
Receiver 3 |
2.08W |
Receiver 4 |
2.04W |
UL (www.UL.com) is a global independent safety science company with more than a century of expertise in testing and innovating safety solutions. For more information on the results and to view the full downloadable report, please see www.energous.com/report.
About Energous Corporation
Energous Corporation (NASDAQ: WATT) is developing WattUp, an award-winning wire-free charging technology that will transform the way people and industries charge and power their electronic devices at home, in the office, in the car and beyond. WattUp is a revolutionary, patent-pending solution that delivers intelligent, scalable power via the same radio bands as a Wi-Fi router. WattUp differs from current wireless charging systems in that it will deliver meaningful, usable power, at a distance, to multiple devices, resulting in a wire-free experience that saves users from having to remember to plug in their devices or place them on a mat. For more information, please visit Energous.com, or follow Energous on Twitter and Facebook.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements in this release that are not based on historical fact are “forward looking statements”. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Receives $1.4 Million Order for Advanced Signal Generator Products
SAN RAMON, Calif., Nov. 09, 2015 — Giga-tronics Incorporated announced today that it has received a $1.4 million order from a major prime contractor for its new Advanced Signal Generator. The Company anticipates fulfilling the order in the current fiscal year, under the expectation the Company gains an ISO9001 certification of its Supplier Quality Management System which the order requires.
John Regazzi, President and CEO of Giga-tronics, said, “Having received a multiple unit order from a second top tier defense prime contractor is a further proof point from the electronic warfare community of the unique performance and cost effectiveness of our new Advanced Signal Generator product, and validates our focus and commitment to this market space as a strategic company direction. We are working on our ISO9001 certification and plan to have it in place when the initial units under this order are ready to ship.”
Giga-tronics is a publicly held company, traded on the NASDAQ Capital Market under the symbol “GIGA”. Giga-tronics produces instruments, subsystems and sophisticated microwave components that have broad applications in defense electronics, aeronautics and wireless telecommunications.
This press release contains forward-looking statements concerning operating results, future orders, and sales of new products, long term growth, shipments, quality control certification and customer acceptance of new products. Actual results may differ significantly due to risks and uncertainties, such as: delays in customer orders for the new Advanced Signal Generation System and our ability to manufacture it, receipt or timing of future orders, cancellations or deferrals of existing or future orders, our need for additional financing, probable delisting from trading on the NASDAQ Capital Market and moving to the OTCQB marketplace; the volatility in the market price of our common stock; the ability to regain AS9100C or substantially equivalent certification; and general market conditions. For further discussion, see Giga-tronics’ most recent annual report on Form 10-K for the fiscal year ended March 28, 2015 Part I, under the heading “Risk Factors” and Part II, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

Contact: Steven D. Lance
Vice President of Finance/Chief Financial Officer
slance@gigatronics.com
(925) 302-1056
Littelfuse, Inc. (NASDAQ:LFUS) today announced it has entered into a definitive agreement to acquire the circuit protection business of TE Connectivity Ltd. (NYSE:TEL) for $350 million in cash. This business has a leading position in polymer-based resettable circuit protection devices with a strong global presence in the automotive, battery, industrial, communications and mobile computing markets. The business is headquartered in Menlo Park, California with manufacturing facilities in Shanghai and Kunshan, China and Tsukuba, Japan.
“This business is an excellent strategic fit with Littelfuse,” said Gordon Hunter, CEO of Littelfuse. “It will expand our global circuit protection product portfolio as well as our presence in the automotive electronics and battery end markets. This business has a long history of technology innovation and new product development, and its synergies with our existing circuit protection business will drive deeper engagement with our customers and channel partners. The business will also significantly increase our presence in Japan and serve as a platform for future growth.”
Transaction Highlights
The TE circuit protection business had estimated revenue of $190 million in fiscal 2015 with an EBITDA margin of approximately 20%. The company expects the transaction to be immediately accretive to earnings excluding acquisition and integration related costs. The company expects cost synergies of at least $10 million annually starting in 2017.
The transaction, which was approved by the Littelfuse Board of Directors, is subject to customary closing conditions and regulatory approvals. The acquisition is expected to close in the first quarter of 2016 and will be financed through a combination of cash on hand and bank debt. Wachtell, Lipton, Rosen and Katz is acting as legal advisor to Littelfuse.
Conference Call and Webcast Information
Littelfuse will hold a conference call for investors on Monday, November 9, at 9:00 a.m. CST to discuss this announcement. The call will be broadcast live over the Internet and be accessed through the company’s website: www.littelfuse.com, including presentation materials. Listeners should go to the website at least 15 minutes prior to the call to download and install any necessary audio software. An audio replay of the call will be available on the company’s website beginning November 9.
About Littelfuse
Founded in 1927, Littelfuse is the world leader in protection with growing global platforms in power controls and sensing. The company serves global customers in the electronics, automotive and industrial markets with technologies including fuses, semiconductors, polymers, ceramics, relays and sensors. Littelfuse has over 8,000 employees in more than 35 locations throughout the Americas, Europe and Asia.
For more information, please visit the Littelfuse website: littelfuse.com.
Safe Harbor Statement
The statements in this press release that are not historical facts are intended to constitute “forward-looking statements” entitled to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties, including, but not limited to, risks relating to product demand and market acceptance, economic conditions, the impact of competitive products and pricing, product quality problems or product recalls, capacity and supply difficulties or constraints, coal mining exposures reserves, failure of an indemnification for environmental liability, exchange rate fluctuations, commodity price fluctuations, the effect of the company’s accounting policies, labor disputes, restructuring costs in excess of expectations, pension plan asset returns less than assumed, integration of the acquired business or other acquisitions, the ability to consummate the proposed transaction on the anticipated timeline or at all, the ability to realize the anticipated benefits of the proposed transaction, and other risks which may be detailed in the company’s other Securities and Exchange Commission filings. Should one or more of these risks or uncertainties materialize or should the underlying assumptions prove incorrect, actual results and outcomes may differ materially from those indicated or implied in the forward-looking statements. This press release should be read in conjunction with information provided in the financial statements appearing in the company’s Annual Report on Form 10-K for the year ended December 27, 2014. For a further discussion of the risk factors of the company, please see Item 1A. “Risk Factors” to the company’s Annual Report on Form 10-K for the year ended December 27, 2014.
Use of Non-GAAP Financial Measures
The information provided in this press release includes the non-GAAP financial measure EBITDA margin. This non-GAAP financial measure should not be considered in isolation or a substitute for the comparable GAAP measure. Management uses this non-GAAP measure to compare operating results to other industry participants. A reconciliation of EBITDA margin to the most directly comparable GAAP measure is not accessible without unreasonable effort due to the nature of the acquisition, particularly the acquisition of certain, but not all, assets of the seller.
LFUS-A
Littelfuse, Inc.
Phil Franklin, 773-628-0810
Executive Vice President and CFO
Sterling Construction Company, Inc. (NasdaqGS:STRL) (“Sterling” or “the Company”) today announced that Ronald A. Ballschmiede has been named Executive Vice President & Chief Financial Officer effective November 9, 2015 and that Kevan Blair will resume his role as Senior Vice President, Corporate Finance.
Mr. Ballschmiede brings nearly 40 years of accounting and financial management experience to Sterling, most recently with Chicago Bridge & Iron (NYSE: CBI) (“CB&I”), where he served as Executive Vice President and Chief Financial Officer from June 2006 to March 2015. Based in The Haag, Netherland, with its administrative office in The Woodlands, Texas, CB&I is a leading engineering, procurement and construction contractor with approximately $13 billion in sales and 54,000 employees.
Prior to joining CB&I, Ron was a Partner with Deloitte & Touche LLP, joining the firm in 2002. Previously, he had been with Arthur Andersen since 1977, becoming a Partner in 1989. While with Andersen, Ballschmiede was the Lead Client Service Partner for CB&I from 1989 to 2002. In addition, he led the manufacturing and industrial products audit practice and served a number of major manufacturing and construction companies. He holds a B.S. in Accounting from Northern Illinois University and is a Certified Public Accountant.
“We feel very fortunate to have Ron join our organization,” stated Paul J. Varello, Sterling’s Chief Executive Officer. “We are confident that Ron’s experience in managing a highly sophisticated global finance operation will translate into the adoption and implementation of best practices for Sterling. CB&I is a very large, world class construction company with an outstanding track record of executing complex construction projects, particularly for energy infrastructure markets. The Board and I want to thank Kevan Blair for stepping in as Interim CFO on short notice in July. Kevan’s efforts over the last several months have been critical to supporting the turnaround that is now underway at Sterling. We are pleased that we will continue to benefit from his hard work and expertise as he returns to the role of our Senior Vice President, Corporate Finance.”
Sterling is a leading heavy civil construction company that specializes in the building and reconstruction of transportation and water infrastructure projects in Texas, Utah, Nevada, Arizona, California, Hawaii, and other states where there are profitable construction opportunities. Its transportation infrastructure projects include highways, roads, bridges and light rail. Its water infrastructure projects include water, wastewater and storm drainage systems.
This press release includes certain statements that fall within the definition of “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Any such statements are subject to risks and uncertainties, including overall economic and market conditions, federal, state and local government funding, competitors’ and customers’ actions, and weather conditions, which could cause actual results to differ materially from those anticipated, including those risks identified in the Company’s filings with the Securities and Exchange Commission. Accordingly, such statements should be considered in light of these risks. Any prediction by the Company is only a statement of management’s belief at the time the prediction is made. There can be no assurance that any prediction once made will continue thereafter to reflect management’s belief, and the Company does not undertake to update publicly its predictions or to make voluntary additional disclosures of nonpublic information, whether as a result of new information, future events or otherwise.
Sterling Construction Company, Inc.
Jennifer Maxwell, 281-951-3560
Director of Investor Relations
or
Investor Relations Counsel:
The Equity Group, Inc.
Fred Buonocore, 212-836-9607
or
Linda Latman, 212-836-9609
First Chronic Dosing Trial of Oral Omecamtiv Mecarbil Showed Statistically Significant Improvements in Several Pre-Specified Measures of Cardiac Function and Volumes
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Nov. 8, 2015 — Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ: CYTK) today announced the presentation of data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, in a Late-Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando, Fla. The trial met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.1,2
The expansion phase of COSMIC-HF was designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or a dose titration group where 25 mg twice daily dosing could be increased to 50 mg twice daily depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment with the 25 mg dose. Data from the expansion phase showed that dose titration controlled patient exposure to omecamtiv mecarbil. Approximately 60 percent of patients in the dose titration group escalated dosing to 50 mg twice daily.
Following 20 weeks of treatment, statistically significant improvements were observed in pre-specified secondary endpoint measures of cardiac function in the dose titration group, compared to placebo. Systolic ejection time increased by 25.0 msec (p<0.001), stroke volume increased by 3.63 mL (p=0.022) and heart rate decreased by 2.97 beats per min (p=0.007). Left ventricular end-systolic and end-diastolic dimensions decreased by 1.79 mm (p=0.003) and 1.29 mm (p=0.013), respectively, and were associated with statistically significant reductions in left ventricular end-systolic and end-diastolic volumes. N-terminal pro-brain natriuretic peptide (NT-proBNP) decreased by 970 pg/mL (p=0.007). Additionally, in the 25 mg twice daily group, there were statistically significant increases in systolic ejection time and stroke volume and a decrease in NT-proBNP. All changes are from baseline compared to placebo. The pharmacodynamic effects of omecamtiv mecarbil were generally dose dependent and larger in patients that received oral dosing with 50 mg twice daily.
Adverse events (AEs), including serious AEs, in patients on omecamtiv mecarbil were comparable to placebo. The incidence of adjudicated deaths (2.7 percent died on placebo, 1.4 percent died on omecamtiv mecarbil), myocardial infarction (1.34 percent on placebo, 0.34 percent on omecamtiv mecarbil) and unstable angina (0 percent on placebo, 0.34 percent on omecamtiv mecarbil) was similar. Other cardiac AEs were generally balanced between placebo and active treatment groups. In the omecamtiv mecarbil groups, compared to placebo, cardiac troponin increased by 0.001 ng/mL and 0.006 ng/mL (median change from baseline at week 20) in the 25 mg twice daily group and dose titration group, respectively. Events of increased troponin (n=278 across all treatment groups) were independently adjudicated and none were determined to be myocardial ischemia or infarction.
“Heart failure remains a large and growing problem for the global health care community. The results from COSMIC-HF suggest chronic dosing of omecamtiv mecarbil may have a favorable and meaningful impact on cardiac function and remodeling,” said John Teerlink, M.D., professor of Clinical Medicine at the University of California San Francisco and director of Heart Failure at the San Francisco Veterans Affairs Medical Center. “The magnitude of cardiac effects observed in this trial are impressive and could potentially translate into improvements in clinical outcomes.”
“The improvements observed in cardiac function with omecamtiv mecarbil in the COSMIC-HF trial are promising,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Omecamtiv mecarbil is a unique investigational therapy for heart failure patients, and we continue to review the data with Cytokinetics and leading heart failure experts to better understand the potential role of this novel medicine.”
“Data from COSMIC-HF highlight the potential of cardiac myosin activation for the treatment of heart failure patients,” said Robert I. Blum, president and CEO at Cytokinetics. “It’s particularly gratifying to see the consistency of effect with chronic omecamtiv mecarbil therapy across important echocardiographic measures of cardiac function.”
Heart failure is a common condition that affects more than 23 million people worldwide,3,4 about half of whom have reduced left ventricular function.5 It is the leading cause of hospitalization and readmission in people age 65 and older.6,7 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.8 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.9,10
COSMIC-HF Trial Design
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) is a double-blind, randomized, placebo-controlled, multicenter, Phase 2 trial designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. The trial consisted of two parts, a dose escalation phase and a larger and longer expansion phase. The dose escalation phase, which completed in 2013, assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil and was used to select one formulation for further evaluation in the expansion phase. In the dose escalation phase, 96 patients were randomized 1:1:1:1 to placebo or one of three omecamtiv mecarbil oral modified-release formulations in two cohorts (25 mg twice daily or 50 mg twice daily). Each patient cohort was followed for 35 days.
The expansion phase evaluated 448 chronic heart failure patients with reduced ejection fraction who were dosed with the selected oral formulation of omecamtiv mecarbil for 20 weeks and followed for a total of 24 weeks. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or 25 mg with dose escalation to 50 mg twice daily depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment. The primary endpoints for the expansion phase were to assess the maximum and pre-dose plasma concentration of omecamtiv mecarbil. The secondary endpoints were to assess changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) at week 20, as well as the safety and tolerability of omecamtiv mecarbil including incidence of adverse events from baseline to week 24.
COSMIC-HF was not designed to assess the impact of omecamtiv mecarbil on cardiovascular outcomes in heart failure patients.
COSMIC-HF was conducted by Amgen in collaboration with Cytokinetics.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes.1,2,11
Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Additionally, Les Laboratoires Servier obtained an exclusive option to commercialize omecamtiv mecarbil in Europe.
About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.12 Amgen’s research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today’s important unmet patient needs, such as high cholesterol and heart failure.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics’ specified development and commercialization participation rights. For additional information about Cytokinetics, visit www.cytokinetics.com.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Nov. 8, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
Cytokinetics Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the significance and utility of COSMIC-HF clinical trial results and the potential progression of omecamtiv mecarbil to Phase 3 development; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Amgen’s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)
CONTACT: Cytokinetics, South San Francisco
Diane Weiser, 415-290-7757 (investors and media)
References
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- Shen YT, Malik FI, Zhao X, et al. Improvement of Cardiac Function by a Cardiac Myosin Activator in Conscious Dogs With Systolic Heart Failure. Circ Heart Fail. 2010;3(4):522-527.
- Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011;8:30-41.
- McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J. 1998;19 (Suppl P):P9–P16.
- Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327.
- Centers for Disease Control and Prevention. National Health Statistics Report: 2006 National Hospital Discharge Survey. http://www.cdc.gov/nchs/data/nhsr/nhsr005.pdf. Accessed November 2015.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. NEJM. 2009;360:1418-1428.
- Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in First Hospitalization for Heart Failure and Subsequent Survival Between 1986 and 2003. Circulation. 2009;119:515-523.
- Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics—2015 Update: A Report From the American Heart Association. Circulation. 2015;131:e1-e294.
- Rogers VL, Weston SA, Redfield MM, et al. Trends in Heart Failure Incidence and Survival in a Community-Based Population. JAMA. 2004;292:344-350.
- Malik FI, Morgan BP. Cardiac myosin activation part 1: From concept to clinic. J Mol Cell Cardiol. 2011;51:454-461.
- World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed November 2015.
– Company to Provide Updated Conference Call Scheduling Later This Week –
NEW YORK, Nov. 9, 2015 — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that it will be rescheduling its 2015 third quarter financial results conference call originally scheduled for November 10, 2015 at 11 a.m. ET to a future date to be determined later this week.
About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.
About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.
Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com
Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net
– Goal is to Utilize ATLASTM to Discover Biologically Relevant Neoantigens for Vaccine Development –
– Company to Discuss Collaboration and Oncology Strategy on Third Quarter 2015 Earnings Call at 9am ET Today –
Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced a collaboration with Memorial Sloan Kettering Cancer Center to screen the T cell responses of melanoma and non-small cell lung cancer patients treated with checkpoint inhibitors (CPI) against the complete repertoire of patient-specific putative cancer neoantigens.
The goals of the collaboration are to identify signatures of T cell response in cancer patients associated with response or non-response to CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS will be used in conjunction with Memorial Sloan Kettering’s patient-specific cancer neoantigen sequences and blood samples from the same cancer patients. This new collaborative work will be led by investigators Timothy A. Chan, M.D., Ph.D., Vice Chair, Department of Radiation Oncology, and Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center.
“ATLAS is unique in that it makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of all the mutations that may yield novel targets and reveals clinically relevant T cell antigens that associate with protective immunity,” said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. “We believe that ATLAS is a powerful platform that enables the identification of T cell responses that must be present to see an effective response to therapy. This can ultimately lead to the discovery of T cell antigens that may drive cancer vaccine development.”
About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.
About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.
Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising product candidates in oncology; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.
For media:
Spectrum Science Communications
Megan Lustig, 202-955-6222
mlustig@spectrumscience.com
or
For investors:
Genocea Biosciences
Jonathan Poole, 617-876-8191
jonathan.poole@genocea.com
CSG Systems International, Inc. (NASDAQ: CSGS), a global provider of interactive transaction-driven solutions and services, announced today that the company’s Chief Executive Officer, Peter Kalan, President and Chief Operating Officer, Bret Griess and Senior Vice President of Investor Relations and Strategic Communications, Liz Bauer, will participate in the 2015 RBC Capital Markets’ Technology, Internet, Media & Telecommunications Conference.
The conference will be held November 10 – 11, 2015 in New York City, New York. CSG International’s fireside chat is scheduled for Wednesday, November 11th at 4:30 p.m. ET and can be accessed via the following URL: http://www.veracast.com/webcasts/rbc/technology2015/52215339518.cfm.
About CSG International
CSG Systems International, Inc. (NASDAQ:CSGS) is a market-leading business support solutions and services company serving the majority of the top 100 global communications service providers, including leaders in fixed, mobile and next-generation networks such as AT&T, Charter Communications, Comcast, DISH Network, Orange, T-Mobile, Telefonica, Time Warner Cable, Vodafone, Vivo and Verizon. With over 30 years of experience and expertise in voice, video, data and content services, CSG International offers a broad portfolio of licensed and Software-as-a-Service (SaaS)-based products and solutions that help clients compete more effectively, improve business operations and deliver a more impactful customer experience across a variety of touch points. For more information, please visit www.csgi.com.
CSG International
Liz Bauer, +1 303-804-4065
Investor Relations
Liz.bauer@csgi.com
EDGEWOOD, NY–(Nov 5, 2015) – CPI Aerostructures, Inc. (“CPI Aero®“) (NYSE MKT: CVU) today announced that it has won Penton’s Aviation Week Program Excellence Award in the Sub-System Production Category. As the Aerospace & Defense industry’s preeminent honor for strong program performers with innovative ideas, technologies and process improvements, the awards were announced at a gala dinner on November 4, during Aviation Week’s Aerospace & Defense Programs Conference in Litchfield Park, AZ.
CPI Aero was recognized for the Phenom 300 engine inlet program it performs for Embraer, the manufacturer of the Phenom 300 executive jet. According to a report by the General Aviation Manufacturers Association (GAMA), the Phenom 300 was the most delivered business jet in the world for the past two years. Embraer, S.A., headquartered in São José dos Campos, Brazil, is the world’s largest manufacturer of aircraft up to 130 seats.
“Aviation Week provides the industry’s most extensive intelligence and analysis available about programs, so it is a great honor to celebrate the best of the best programs — programs that are delivering results but also finding entirely new ways to be more innovative, more efficient, and better at delivering value to customers, the companies involved, and to the people who make it happen,” said Carole Rickard Hedden, Aviation Week’s editorial director for Executive Intelligence and the Program Excellence initiative.
Douglas McCrosson, President and CEO of CPI Aero commented, “The Aviation Week Program Excellence Award is one of our industry’s most prestigious awards and we are honored to have been recognized by our customers and peers. I want to congratulate Nazz Palmerini, Director of Program Management, Derick Martin, Program Manager, and the talented men and women that work on the Embraer program for this amazing accomplishment. This award recognizes the years of investment CPI Aero has made in creating world class manufacturing, program management and supply chain management capabilities, and it is especially gratifying to be considered the best of the best in this regard. This award would not have been possible without Embraer’s commitment to its supply chain partners, so I’d like to thank Embraer for fostering a culture of cooperation and teamwork that put CPI Aero in the best position to succeed on this assembly program.”
About Penton’s Aviation Week Network
Penton’s Aviation Week Network is the largest multimedia information and services provider for the global aviation, aerospace and defense industries that has a database of 1.2 million professionals around the world. Industry professionals rely on Aviation Week for analysis, marketing and intelligence. Customers include the world’s leading manufacturers, suppliers, airlines, business aviation operators, militaries, governments and other organizations that serve this global market. The product portfolio includes Aviation Week & Space Technology, Air Transport World, AviationWeek.com, Aviation Week Intelligence Network, and SpeedNews, among others.
About CPI Aero
CPI Aero is a U.S. manufacturer of structural assemblies for fixed wing aircraft, helicopters and airborne Intelligence Surveillance and Reconnaissance (ISR) pod systems in both the commercial aerospace and national security markets. Within the global aerostructure supply chain, CPI Aero is either a Tier 1 supplier to aircraft original equipment manufacturers or a Tier 2 subcontractor to major Tier 1 manufacturers. CPI also is a prime contractor to the U.S. Department of Defense, primarily the Air Force. In conjunction with its assembly operations, CPI Aero provides engineering, program management, supply chain management, and MRO services. Among the key national security programs that CPI Aero supplies are the E-2D Advanced Hawkeye surveillance aircraft, the UH-60 BLACK HAWK® helicopter, the F-16 Falcon fighter, the T-38C Talon trainer, the MH-53/CH-53 variant helicopters, the MH-60S mine countermeasure helicopter, the AH-1Z ZULU attack helicopter, the DB-110 reconnaissance pod, the ALMDS mine detecting pod, and the A-10 Thunderbolt attack jet. In the commercial aviation market CPI Aero manufactures products for the Gulfstream G650 ultra-large cabin business jet, the HondaJet advanced light jet, the Embraer Phenom 300 business jet, the new Cessna Citation X+, and the S-92® helicopter. CPI Aero is included in the Russell Microcap® Index.
The above statements include forward looking statements that involve risks and uncertainties, which are described from time to time in CPI Aero’s SEC reports, including CPI Aero’s Form 10-K for the year ended December 31, 2014 and Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015.
CPI Aero® is a registered trademark of CPI Aerostructures, Inc.
— Based on Positive Safety Data and Preliminary Signs of Efficacy, Study Expected to Advance to Phase 2 Portion in Early 2016 —
SOUTH SAN FRANCISCO, Calif., Nov. 5, 2015 — OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced initial data from a Phase 1b/2 study of the company’s lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient™ (pazopanib) in patients with advanced recurrent ovarian cancer. The data are from the ongoing “PAZOFOS” study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.
“The initial results we’ve seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016,” said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. “We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer.”
Dr. Rustin reported that 12 patients have been enrolled in the phase 1b portion of the study. Nine of the patients were evaluated for objective response using RECIST criteria, showing two partial responses, five stable diseases and two progressive diseases. Eight of the ten patients with evaluable data demonstrated decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria. Dr. Rustin also noted that four patients were still on treatment, and that the efficacy data are currently preliminary and unverified. Safety data showed that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). The most commonly reported AEs were hypertension, fatigue, and pain. The Development Safety Update Report #1 submitted to the regulatory body stated that no definitive conclusions can be made regarding the benefit of treatment in the small subset of patients treated so far.
“The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors,” said William D. Schwieterman, MD, OXiGENE’s President and CEO. “We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin® in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016.”
PAZOFOS is a randomized, controlled clinical study consisting of a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone. The study is designed to enroll up to 128 patients at up to ten sites in the United Kingdom. The primary endpoint for the phase 2 portion is progression-free survival; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.
PAZOFOS is sponsored by The Christie NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by OXiGENE and GlaxoSmithKline/Novartis, respectively.
About CA4P
CA4P (also known as fosbretabulin) is a vascular disrupting agent and is OXiGENE’s lead investigational drug. CA4P exerts its anti-tumor effects by targeting an established tumor’s immature endothelial cells within the tumor’s blood vessels, compromising the tumor vasculature and leading to widespread ischemia and necrosis of the cells within the central core of the tumor. OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which prevent the growth of new tumor blood vessels. Following an extensive clinical review, OXiGENE recently announced its plans to focus on initiation of two late-stage clinical programs for CA4P in 2016. These planned programs combine CA4P with standard-of-care in platinum-resistant ovarian cancer and in glioblastoma multiforme. In addition to PAZOFOS, CA4P is also being evaluated in an ongoing study in neuroendocrine tumors.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company’s investigational drugs include CA4P, which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE’s reports to the Securities and Exchange Commission, including OXiGENE’s reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.
CONTACT: Investor and Media Contact:
ir@oxigene.com
650-635-7000
WALTHAM, Mass., Nov. 5, 2015 — Eyegate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced interim data on the effects of iontophoretic delivery of their EGP-437 ophthalmic solution on Macular Edema patients.
“Overall, the interim data from this pilot trial suggests that iontophoresis can non-invasively deliver EGP-437 to the back of the eye. The non-invasive delivery of EGP-437 has demonstrated a positive response in some patients with macular edema. We believe that this data is encouraging, and warrants an extension to the trial to continue to work on the ideal dose and dosing regimen for the iontophoretic delivery of EGP-437,” said Dr. Jeffrey Heier, M.D., Director of Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston and the principal investigator of the trial.
The ongoing Phase 1b / 2a clinical trial is a multi-center, open-label trial. To date, the trial has enrolled 19 patients with macular edema associated with Retinal Vein Occlusion, Diabetic Retinopathy or Post-Surgical (cystoid) Macular Edema. The primary objective of this trial was to evaluate the safety and efficacy of iontophoretic EGP-437 in patients suffering from Macular Edema. Three treatments at 14.0 mA-min (3.5mA) were administered on day 0, day 4 and day 9. Primary outcome of the trial measured reduction in mean central subfield thickness on day 4, day, 9 and day 14. Ozurdex® was administered as control to patients that did not respond to the investigational therapy at day 14 and were re-evaluated at day 28.
A positive response was observed in some of the patients, with pseudophakic eyes (an eye implanted with an intraocular lens) responding better than phakic eyes (an eye with a natural lens). Additionally, the investigational therapy showed no serious treatment emergent adverse effects including no increase in ocular pressure even at three times the iontophoretic dose that was used for the Company’s Phase 3 non-infectious anterior uveitis trial.
“The interim results of the trial are highly promising and suggest the ability of the EyeGate® II Delivery System to deliver drug to the posterior segment of the eye, which could present important new opportunities for our iontophoretic technology and drug formulations in additional disease indications. We look forward to additional data from the extension of this trial, which we expect in mid-2016,” said Stephen From, President and Chief Executive Officer of EyeGate.
The extension stage of the trial will recruit an additional 15 patients with a modified dosing regimen, 3 consecutive days at the same iontophoretic dosage. It was observed that the edema returns when drug has cleared from the tissues. Thus the new dosing regimen may help to overcome this issue by providing a cumulative effect. The extension of the trial will also evaluate the efficacy of iontophoretic EGP-437 in phakic versus pseudophakic eyes to collect additional data on the differences in the responses of both types of eyes. This data may be interesting from a physiological standpoint and will be helpful in designing further clinical trials. The extension of the trial is expected to begin by the end of 2015.
About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. EGP-437, the Company’s first and only product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate® II Delivery System. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EGP-437, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on March 31, 2015, or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
CONTACT: Lee Roth / Joseph Green
The Ruth Group for Eyegate Pharmaceuticals
646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
MISSION VIEJO, Calif., Nov. 04, 2015 — The Ensign Group, Inc. (NASDAQ:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that its board of directors approved a new stock repurchase program, which allows Ensign to repurchase up to $15 million of its common stock over the next 12 months.
“This program reflects our strong commitment to enhancing shareholder value and our confidence in the Company’s short- and long-term operating and financial performance,” said Christopher Christensen, Ensign’s President and Chief Executive Officer. Mr. Christensen reaffirmed that the Company expects to continue paying quarterly dividends and growing and diversifying its business, noting, “We are pleased that Ensign is in a position to simultaneously return value to shareholders through our quarterly dividends and share repurchases. Management and the Board of Directors believe that repurchasing Company common stock is an important piece of our multipronged capital allocation strategy.”
Mr. Christensen noted that the Company’s strong balance sheet, robust cash flow and existing credit facility provide the flexibility to opportunistically repurchase Ensign shares while continuing to acquire well-performing and struggling long-term care skilled nursing operations, assisted living operations, urgent care centers and start-up or early-stage hospice and home health agencies.
Under the stock repurchase program, the Company is authorized to repurchase its issued and outstanding common shares from time to time in open-market and privately negotiated transactions and block trades in accordance with federal securities laws, including Rule 10b-18 promulgated under the Securities Exchange Act of 1934 as amended. The Company has no obligation to repurchase any dollar amount or number of shares under this repurchase program authorization, and the program may be suspended, discontinued or modified at any time, in the discretion of the board of directors and in accordance with legal and regulatory requirements.
The number of shares repurchased by the company will depend entirely upon the levels of cash available, the attractiveness of alternate investment and business opportunities either at hand or on the horizon, and management’s determination of value relative to market price, as well as other legal, regulatory and contractual requirements.
Safe Harbor Statement
This press release may include forward-looking statements, including, but not limited to, statements as to our plans, objectives, expectations and business strategy. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words. These forward-looking statements include, but are not limited to, statements regarding growth prospects, future operating and financial performance. They are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to materially and adversely differ from those expressed in any forward-looking statement. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Ensign with the Securities and Exchange Commission. Ensign undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
About Ensign(TM)
The Ensign Group, Inc.’s independent operating subsidiaries provide a broad spectrum of skilled nursing and assisted living services, physical, occupational and speech therapies, home health and hospice services, urgent care services and other rehabilitative and healthcare services at 182 facilities, thirteen hospice agencies, fifteen home health agencies, three home care businesses and seventeen urgent care clinics in California, Arizona, Texas, Washington, Utah, Idaho, Colorado, Nevada, Iowa, Nebraska, Oregon, Wisconsin, Kansas and South Carolina. More information about Ensign is available at http://www.ensigngroup.net.
CONTACT: The Ensign Group, Inc., (949) 487-9500, ir@ensigngroup.net
Largest Order to Date from an Existing Customer
AUSTIN, TX–(Nov 4, 2015) – Ideal Power Inc. (NASDAQ: IPWR), a developer of innovative power conversion technologies, announced today that it has received an order for 14.5 MW of its power conversion products for use in Battery Energy Storage Systems predominately for California and Hawaii. The order comes from an existing customer and includes a mixture of the Company’s 30kW Battery Converter, Grid-Resilient 30kW Multi-Port Power Conversion System, and the newly released Grid-Resilient 125kW Power Conversion System. The products are expected to be delivered throughout 2016 with initial deliveries expected to begin in January.
“This represents the largest order in Ideal Power’s history and positions us to enter 2016 with a robust backlog and enhanced visibility,” said Dan Brdar, CEO of Ideal Power. “This commitment validates that our channel partners are closing business, further establishing our market leadership in providing power conversion systems for behind-the-meter energy storage solutions.”
About Ideal Power Inc.
Ideal Power Inc. (NASDAQ: IPWR) has developed a novel, patented power conversion technology called Power Packet Switching Architecture™ (PPSA). PPSA improves the size, cost, efficiency, flexibility and reliability of electronic power converters. PPSA can scale across several large and growing markets, including commercial grid storage, combined solar and storage, microgrids, and electrified vehicle charging. Ideal Power also has a capital-efficient business model that can enable it to address these markets simultaneously. Ideal Power has won multiple grants for its PPSA technology, including a $2.5 million grant from the Department of Energy’s Advanced Research Projects Agency – Energy (ARPA-E) program, and market-leading customers are incorporating PPSA as a key component of their systems. For more information, visit www.IdealPower.com.
Safe Harbor Statement
All statements in this release that are not based on historical fact are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, whether the patents for our technology provide adequate protection and whether we can be successful in maintaining, enforcing and defending our patents, whether a demand for energy storage products will grow, whether demand for our products, which we believe are disruptive, will develop and whether we can compete successfully with other manufacturers and suppliers of energy conversion products, both now and in the future, as new products are developed and marketed. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. The order described in this release is subject to commercial terms that enable the customer to delay or reschedule delivery of product, thereby impacting the timing of our recognition of associated revenue. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.
SOUTH SAN FRANCISCO, Calif., Nov. 4, 2015 — Veracyte, Inc. (NASDAQ: VCYT) announced that company and external researchers will present four abstracts at the PFF Summit 2015: From Bench to Bedside that reveal current diagnostic challenges associated with interstitial lung disease (ILD), as well as the potential for improvement using new genomic-based testing approaches. The biennial international Summit is being held November 12-14 at the JW Marriott Hotel in Washington, DC.
Each year in the United States and Europe, up to 200,000 patients are suspected of having an ILD, including idiopathic pulmonary fibrosis (IPF), which is among the most common and most deadly, and is notoriously difficult to diagnose.
“The recent availability of therapies that slow progression of IPF makes improved, timely diagnosis of this disease even more imperative,” said Bonnie Anderson, president and chief executive officer of Veracyte. “We are proud that the new research findings that we and others are sharing at this year’s Summit help to elucidate the specific challenges associated with ILD and IPF diagnosis, as well as promising, potential solutions.”
All four abstracts are part of a poster session taking place Thursday, November 12 from 5:00-8:00 p.m. EST in the Penn Avenue Terrace of the JW Marriott Hotel. During this session, researchers will share updated findings from a study evaluating the ability of a Veracyte molecular classifier to help distinguish IPF from other ILDs among patient samples obtained through bronchoscopy. This ability may potentially enable improved IPF diagnosis without the need for invasive surgery.
Abstract Title: |
Diagnosis of idiopathic pulmonary fibrosis: Classifying the usual interstitial pneumonia pattern in transbronchial biopsies using machine learning |
Presenter: |
Jing Huang, Ph.D., Veracyte |
Three additional presentations will quantify the significant challenges that physicians and patients face in confirming an ILD diagnosis. These presentations include results from a national physician survey exploring the potential clinical utility of Veracyte’s in-development molecular classifier to reduce the need for invasive diagnostic procedures, as well as assessing the degree to which non-specialist pulmonologists differ from ILD specialists in their use of invasive diagnostic procedures. Additionally, data from a national survey exploring the diagnostic experiences of 600 ILD and IPF patients will be presented. The latter survey was commissioned by the Pulmonary Fibrosis Foundation (PFF) with sponsorship from Veracyte.
Abstract Title: |
The clinical utility of a molecular diagnostic in differentiating idiopathic pulmonary fibrosis from other interstitial lung diseases |
Presenter: |
Xiaoping Wu, M.D., Weill Cornell Medical College |
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Abstract Title: |
Current diagnostic approaches in ILD: ILD versus non-specialty clinics |
Presenter: |
Elizabeth Belloli, M.D., University of Michigan |
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Abstract Title: |
Interstitial lung disease patient diagnostic journey (INTENSITY) survey |
Presenters: |
David J. Lederer, M.D., Pulmonary Fibrosis Foundation |
All abstracts and results are embargoed until 5:00 p.m. EST, Thursday, November 12.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for approximately 150 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.
BELLEVUE, Wash. and AUSTIN, Texas, Nov. 4, 2015 — Expedia, Inc., (NASDAQ: EXPE) and HomeAway, Inc., (NASDAQ: AWAY) announced today that they have entered into a definitive agreement under which Expedia has agreed to acquire HomeAway, including all of its brands, for an equity value of approximately $3.9 billion in cash and Expedia common stock, representing a per share price for HomeAway shares of $38.31, based on Expedia’s closing price on November 3, 2015. Under the terms of the transaction, Expedia will offer to acquire each outstanding share of common stock of HomeAway in exchange for $10.15 in cash and 0.2065 of a share of Expedia common stock.
The Boards of Directors of both companies unanimously approved the transaction, which remains subject to customary closing conditions, including regulatory approvals and the tender of a majority of the outstanding shares of HomeAway common stock. The companies expect the transaction to close in the first quarter of 2016.
“We have long had our eyes on the fast growing ~$100 billion alternative accommodations space and have been building on our partnership with HomeAway, a global leader in vacation rentals, for two years. Bringing HomeAway into the Expedia, Inc. family and adding its leading brands to our portfolio of the most trusted brands in travel is a logical next step,” said Dara Khosrowshahi, Chief Executive Officer, Expedia, Inc. “We have tremendous respect for the HomeAway team and the business they have built. With our expertise in powering global transactional platforms and our industry-leading technology capabilities, we look forward to partnering with them to accelerate their shift from a classified marketplace to an online, transactional model to create even better experiences for HomeAway’s global traveler audience and the owners and managers of its 1.2 million properties around the world.”
“We could not be more excited about joining the Expedia family of leading travel brands and what this move means for our very bright future,” said Brian Sharples, Chief Executive Officer of HomeAway, Inc., noting that the company has been moving toward a fully online bookable marketplace and closer to the type of transactional business model with which Expedia has tremendous experience. “We’re eager to benefit from Expedia’s distribution, technology and expertise, which will allow us to provide an even better product and service experience for our owners, property managers and travelers. In this way, I believe our combination with Expedia will turbocharge our growth and industry leadership for many years to come.”
Conference Call to Discuss Transaction
Expedia, Inc., and HomeAway, Inc., will host a conference call to discuss the transaction on Wednesday, November 4, 2015 at 1:45 p.m. Pacific Time / 3:45 p.m. Central Time. Callers in the U.S. and Canada may dial 877-741-4244 and use passcode 4111332. All other international callers may dial 719-325-4784 and use passcode 4111332. A live webcast of the conference call will be available to the public at http://ir.expediainc.com and http://investors.homeaway.com. A replay of the call is expected to be available for at least three months.
About Expedia, Inc.
Expedia, Inc. (NASDAQ: EXPE) is one of the world’s leading travel companies, with an extensive brand portfolio that includes leading online travel brands, such as:
- Expedia.com®, a leading full service online travel agency with localized sites in 32 countries
- Hotels.com®, the hotel specialist that offers Hotels.com® Rewards and Secret Prices through its mobile booking apps and localized websites in more than 65 countries
- Hotwire®, a leading discount travel site that offers Hot Rate® Hotels, Hot Rate® Cars and Hot Rate® Airfares, as well as vacation packages
- Orbitz Worldwide, a global travel portfolio including Orbitz, ebookers, HotelClub and CheapTickets, brands and business-to-business offerings, including Orbitz Partner Network and Orbitz for Business
- Travelocity®, a pioneer in online travel and a leading online travel agency in the US and Canada
- Egencia®, a leading corporate travel management company
- Venere.com™, an online hotel reservation specialist in Europe
- trivago®, a leading online hotel search with sites in 52 countries worldwide
- Wotif Group, a leading portfolio of travel brands operating in the Australia/New Zealand region, including Wotif.com®, Wotif.co.nz, lastminute.com.au®, lastminute.com.nz and travel.com.au®
- Expedia Local Expert®, a provider of online and in-market concierge services, activities, experiences and ground transportation in hundreds of destinations worldwide
- Classic Vacations®, a top luxury travel specialist
- Expedia® CruiseShipCenters®, a provider of exceptional value and expert advice for travelers booking cruises and vacations through its network of 200 retail travel agency franchises across North America
- CarRentals.com™, the premier car rental booking company on the web
The company delivers consumers value in leisure and business travel, drives incremental demand and direct bookings to travel suppliers and provides advertisers the opportunity to reach a highly valuable audience of in-market consumers through Expedia® Media Solutions. Expedia also powers bookings for thousands of affiliates, including some of the world’s leading airlines, top consumer brands and high traffic websites through Expedia® Affiliate Network. For corporate and industry news and views, visit us at www.expediainc.com or follow us on Twitter @expediainc.
Trademarks and logos are the property of their respective owners. © 2015 Expedia, Inc. All rights reserved. CST: 2029030-50
About Homeaway, Inc.
HomeAway, Inc. based in Austin, Texas, is the world leader in vacation rentals, with sites representing over one million paid listings of vacation rental homes in 190 countries. Through HomeAway, owners and property managers offer an extensive selection of vacation homes that provide travelers with memorable experiences and benefits, including more room to relax and added privacy, for less than the cost of traditional hotel accommodations. The company also makes it easy for vacation rental owners and property managers to advertise their properties and manage bookings online. The HomeAway portfolio includes the leading vacation rental websites HomeAway.com, VRBO.com and VacationRentals.com in the United States; HomeAway.co.uk and OwnersDirect.co.uk in the United Kingdom; HomeAway.de in Germany; Abritel.fr and Homelidays.com in France; HomeAway.es and Toprural.es in Spain; AlugueTemporada.com.br in Brazil; HomeAway.com.au and Stayz.com.au in Australia; Bookabach.co.nz in New Zealand, and Asia Pacific short-term rental site, travelmob.com.
HomeAway also operates BedandBreakfast.com, the most comprehensive global site for finding bed-and-breakfast properties, providing travelers with another source for unique lodging alternatives to chain hotels. For more information about HomeAway, please visit www.HomeAway.com.
Additional Information and Where to Find It
The exchange offer referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for any offer materials that Expedia, Inc. (“Expedia”) and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (“SEC”). At the time the exchange offer is commenced, Expedia and its acquisition subsidiary will file a tender offer statement on Schedule TO, Expedia will file a registration statement on Form S-4, and HomeAway will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the exchange offer. THE EXCHANGE OFFER MATERIALS (INCLUDING AN OFFER TO EXCHANGE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER EXCHANGE OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION. HOMEAWAY STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF HOMEAWAY SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING EXCHANGING THEIR SECURITIES. The Offer to Exchange, the related Letter of Transmittal and certain other exchange offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of HomeAway stock at no expense to them. The exchange offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Expedia’s Investor Relations department at (425) 679-3759.
In addition to the Offer to Exchange, the related Letter of Transmittal and certain other exchange offer documents, as well as the Solicitation/Recommendation Statement, Expedia and HomeAway file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Expedia and HomeAway at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Expedia and HomeAway’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.
Forward-Looking Statements
This press release includes 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. These forward-looking statements generally can be identified by phrases such as “will,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. Similarly, statements herein that describe the proposed transaction, including its financial and operational impact, and other statements of management’s beliefs, intentions or goals also are forward-looking statements. It is uncertain whether any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on the results of operations and financial condition of the combined companies or the price of Expedia or HomeAway stock. These forward-looking statements involve certain risks and uncertainties, many of which are beyond the parties’ control, that could cause actual results to differ materially from those indicated in such forward-looking statements, including but not limited to the ability of the parties to consummate the proposed transaction on a timely basis or at all and the satisfaction of the conditions precedent to consummation of the proposed transaction, including majority of HomeAway’s shares being validly tendered into the exchange offer, the ability to secure regulatory approvals on the terms expected, at all or in a timely manner; the ability of Expedia to successfully integrate HomeAway’s operations; the ability of Expedia to implement its plans, forecasts and other expectations with respect to HomeAway’s business after the completion of the transaction and realize expected synergies; business disruption following the merger; the proposed transaction may not be completed on the timeframe expected or at all; and the other risks and important factors contained and identified in Expedia’s and HomeAway’s filings with the Securities and Exchange Commission (the “SEC”), such as their respective Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, any of which could cause actual results to differ materially from the forward-looking statements, the Tender Offer Statement on Schedule TO (including the offer to purchase, the letter of transmittal and other documents relating to the tender offer) to be filed by Expedia and its acquisition subsidiary, the registration statement on Form S-4 to be filed by Expedia, and the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by HomeAway. As a result of these and other risks, the proposed transaction may not be completed on the timeframe expected or at all. The forward-looking statements included in this press release are made only as of the date hereof. Neither Expedia nor HomeAway undertakes any obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by law.
NEW YORK, Nov. 4, 2015 — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that the Company will host its 2015 third quarter financial results conference call on Tuesday, November 10, 2015 at 11:00 a.m. EST.
All interested participants should dial in approximately 5 to 10 minutes prior to the 11:00 a.m. EST conference call and ask for the Elephant Talk third quarter conference call.
About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK), is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.
About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.
Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com
Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net