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(RXII) to Present at the Association for Research in Vision and Ophthalmology 2016
MARLBOROUGH, Mass., April 18, 2016 — RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics in dermatology and ophthalmology that address significant unmet medical needs, announced today that it will present at the Association for Research in Vision and Ophthalmology (ARVO) 2016 annual meeting. This meeting is the largest gathering of eye and vision researchers in the world drawing 11,000 attendees exploring cutting-edge science. This year’s conference will be held May 1-5, 2016 at the Washington State Convention Center in Seattle, Washington.
On Sunday, May 1, 2016, new data from ongoing research utilizing the Company’s proprietary RNAi platform in the area of therapeutic topical delivery to the eye, will be presented in the 3:15 – 5:00 p.m. PDT poster session: Corneal Wound Repair and Healing. These data may be viewed on Poster 1280 – D0228 entitled, “sd-rxRNA®: Self-Delivering RNAi Compounds Show Potential for Corneal Indications Following Topical Application.”
The poster will be available under the “Investors – Presentations & Posters” section of the Company’s website, www.rxipharma.com approximately 1 hour following the presentation.
About RXi’s Proprietary Self-delivering RNAi (sd-rxRNA®) Platform
Building on the pioneering work of Dr. Craig Mello, Nobel Laureate and RXi’s Scientific Advisory Board Chairman, scientists at RXi developed novel sd-rxRNA compounds where drug-like properties are built into the RNAi compound itself. These proprietary compounds are novel RNAi compounds with enhanced properties for therapeutic use including: efficient spontaneous cellular uptake, stability, reduced potential for immune stimulation, and potent, long-lasting intracellular activity. All cell types tested (primary, neuronal and non-adherent) internalize sd-rxRNA compounds uniformly and efficiently, resulting in potent and long lasting silencing. Efficient cellular uptake is observed both in vitro and in vivo, as well as in tissues including skin, retina, lung, spinal cord and liver.
RXI-109, an sd-rxRNA compound designed to silence connective tissue growth factor (CTGF), which plays a key role in tissue regeneration and repair, is currently being evaluated in clinical trials. A Phase 1/2 clinical study, RXI-109-1501, is underway to evaluate the safety and clinical activity of RXI-109 to prevent the progression of retinal scarring, a harmful component of numerous retinal diseases. In addition, a Phase 2 clinical trial, RXI-109-1402, is currently evaluating RXI-109 as a treatment to reduce the recurrence of hypertrophic scars following scar revision surgery. Over 100 subjects have been treated with RXI-109 by intradermal injection in all trials to date. Multiple intradermal injections were well tolerated at all dose levels. RXI-109 was shown to cause a dose-dependent silencing of CTGF messenger RNA and protein levels in the treated areas of the skin compared to placebo and preliminary results from Phase 2a studies indicate a clinical effect on scar appearance.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a clinical-stage RNAi company developing innovative therapeutics in dermatology and ophthalmology that address significant unmet medical needs. Building on the pioneering work of RXi’s Scientific Advisory Board Chairman and Nobel Laureate Dr. Craig Mello, our discovery and clinical development programs are based on our proprietary RNAi (sd-rxRNA) platform and Samcyprone™, a topical immunomodulator. Our clinical development programs include RXI-109, an sd-rxRNA, for the treatment of dermal and ocular scarring, and Samcyprone™ for the treatment of such disorders as warts, alopecia areata, non-malignant skin tumors and cutaneous metastases of melanoma. RXi’s robust pipeline, coupled with an extensive patent portfolio, provides for multiple product and business development opportunities across a broad spectrum of therapeutic areas. We are committed to being a partner of choice for academia, small companies, and large multinationals. We welcome ideas and proposals for strategic alliances, including in- and out-licensing opportunities, to advance and further develop strategic areas of interest. Additional information may be found on the Company’s website, www.rxipharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about: our ability to successfully develop RXI-109, Samcyprone™ and our other product candidates (collectively “our product candidates”); the future success of our clinical trials with our product candidates; the timing for the commencement and completion of clinical trials; our ability to enter into strategic partnerships and the future success of these strategic partnerships; and our ability to deploy our sd-rxRNA® technology through partnerships, as well as the prospects of these partnerships to provide positive returns. Forward-looking statements about expectations and development plans of RXi’s product candidates and partnerships involve significant risks and uncertainties, including the following: risks that we may not be able to successfully develop and commercialize our product candidates; risks that product development and clinical studies may be delayed, not proceed as planned and/or be subject to significant cost over-runs; risks related to the development and commercialization of products by competitors; risks related to our ability to control the timing and terms of collaborations with third parties; and risks that other companies or organizations may assert patent rights preventing us from developing or commercializing our product candidates. Additional risks are detailed in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q under the caption “Risk Factors.” Readers are urged to review these risk factors and to not act in reliance on any forward-looking statements, as actual results may differ from those contemplated by our forward-looking statements. RXi does not undertake to update forward-looking statements to reflect a change in its views, events or circumstances that occur after the date of this release.
Contact
RXi Pharmaceuticals Corporation
Tamara McGrillen
508-929-3646
tmcgrillen@rxipharma.com
(CNCK) Engages Bonwick Capital Partners as Financial and Corporate Advisor
LOS ANGELES, CA and NEW YORK, NY–(Apr 18, 2016) – Content Checked Holdings, Inc. (OTCQB: CNCK) (the “Company”), a creator of mobile applications for people with dietary restrictions, today announced that the Company has engaged Bonwick Capital Partners LLC (“Bonwick”) as its financial and corporate advisor. Bonwick will assist the Company with its financial, corporate, and mergers and acquisitions strategy, as well as with the Company’s planned application submission for uplisting to NASDAQ later this fiscal year. Bonwick is a FINRA registered broker/dealer and SIPC member firm, providing top tier service to institutional clients across sales and trading, investment banking and corporate advisory.
In order to qualify for and maintain its listing, the Company will be required, among other things, to adhere to the corporate governance standards set forth by NASDAQ, including audit committee, independent directors, and management and officer compensation requirements.
Kris Finstad, the Company’s CEO and President, stated, “We are excited to work with Bonwick Capital in helping us execute our growth and financial strategy and with what has always been an important part of our corporate development plan: an uplisting to NASDAQ.” Mr. Finstad continued, “Bonwick Capital has assembled a specialized team of experienced financial and industry professionals who will play an essential role in our overall strategy of increasing shareholder value. Our planned uplisting to NASDAQ will allow us to tap into much broader capital market resources and further solidify our short- and long-term goals of successfully executing our business strategy.”
For more information on the Company, or to download its apps, please visit: www.contentchecked.com.
About Bonwick Capital Partners
Bonwick Capital Partners, LLC is a full-service broker dealer dedicated to providing top tier service to institutional clients across sales and trading, investment banking and corporate advisory business lines. Bonwick’s clients rely upon the firm’s deep industry knowledge to assist them through the investment process, sourcing deals, conducting due diligence, capital raises and business solutions. Bonwick has a diverse global client base, which spans five continents, and these relationships allow the firm to address a wide range of client needs across different time zones and cultures. Bonwick is headquartered in New York City with offices in Chicago and Los Angeles. For more information, go to www.bonwickcapital.com
About Content Checked Holdings, Inc.
Content Checked Holdings, Inc. (www.contentchecked.com) has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications. ContentChecked and MigraineChecked are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for over 70% of conventional U.S. food products.
Each app gives consumers the ability to scan a product’s bar code and determine if it is safe for consumption based on their allergy settings. The apps will recommend a suitable alternative if a product does contain one or more of a user’s allergens. This enables the applications to meet the needs of millions of people in the U.S. In the U.S. alone, there are more than 15 million people who suffer from food allergies and 38 million people who suffer from migraines and chronic headaches. The food allergy and intolerances market has been valued at approximately US$13 billion in 2015. As a result, the Company has created a pivotal way for food manufacturers and producers to showcase their products to consumers who are actively seeking them at the point of purchase.
The Company has created a robust database of allergens, migraine triggers and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database, updated regularly. All applications serve as easy shopping tools for consumers to decipher often misleading food labels and receive recommendations for healthier alternative products as they shop in real time. The Company’s mission is to offer fast, reliable and efficient mobile apps that help consumers make more informed purchasing decisions and live healthier lives in accordance to their dietary preferences.
For more information on the Company, please visit its social media channels via Facebook (www.facebook.com/contentchecked), (www.facebook.com/migrainechecked) and (www.facebook.com/sugarchecked); Instagram (www.instagram.com/contentchecked), (www.instagram.com/migrainechecked) and (www.instagram.com/sugarchecked); or YouTube (www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ).
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 and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects”, “anticipates”, “intends”, “estimates”, “plans”, “potential”, “possible”, “probable”, “believes”, “seeks”, “may”, “will”, “should”, “could” or the negative of such terms or other similar expressions. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2015, the Company’s Quarterly Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.
Contacts:
Investor Relations
Christine J. Petraglia
Managing Director, Investor Relations
PCG Advisory Group
535 5th Avenue, 24th Floor
New York, NY 10017
646-731-9817
www.pcgadvisory.com
Content Checked Holdings, Inc.
Victoria Nunez
Director of Business Development
8730 Sunset Blvd., Suite 240
West Hollywood, CA 90069
424-205-1777
www.contentchecked.com
(EBIX) Signs Pioneering Contract to Deploy Single Exchange Platform
ATLANTA, GA–(Apr 15, 2016) – Ebix, Inc. (NASDAQ: EBIX), a leading international supplier of On-Demand software and E-commerce services to the insurance, financial and healthcare industries, today announced that it has signed a contract with Placing Platform Limited (PPL), to deploy a single insurance exchange across the entire London insurance marketplace, to facilitate electronic placement of insurance, while capturing and processing risks electronically. The PPL Board signed the contract on behalf of the International Underwriting Association (IUA), the London & International Insurance Brokers’ Association (LIIBA) and the Lloyd’s Market Association (LMA).
In 2013, the London Market Group’s (LMG) Future Process review concluded, amongst other things, that the market needed to improve its accessibility by delivering a central placing platform. This platform would support a flexible negotiation process, facilitate access to the market and offer faster placement for the benefit of the client. The platform would support both traditional face-to-face negotiations and purely electronic placements or a combination of both. The IUA, LIIBA and LMA agreed that such a central placing platform would be best delivered via a market utility. As a result, the PPL was formed with full support from both broker and insurer firms, to coalesce around a single electronic “platform.” PPL was set up as a genuine team effort with all sectors of the market being brought together in a fully representative organization.
A total of 26 subject matter expert practitioners, representing both carriers and brokers, were involved in the selection process, drawing up a detailed description of requirements. Independent consultants were hired to ensure the selection process was objective, transparent and fair. After a thorough evaluation process, PPL selected Ebix’s team and technology for the provision, governance and management of the platform.
Over the last few years, Ebix has worked closely with PPL to enhance the platform to meet the London modernization goals, while completing extensive platform testing. Ebix also disclosed that its contract with PPL is primarily a subscription contract that is expected to generate upwards of $75 million over the next 5 years ($15 million per year) from the electronic placement exchange service, with more than 85% of that number coming from annual subscription fees payable to Ebix. Ebix will bill PPL for its services, which in turn will be funded by all the market constituents, funding commitments for which have already been secured by PPL.
David Ledger, Chairman of PPL commented: “We are delighted that the contract has been signed. Ebix has been really supportive through the process and worked closely with the PPL team to make sure the project stayed on track. We are excited about working with them to take the launch forward, and are confident that the combination of their technology and the market’s insurance expertise will make for a world class solution which will make London an easier place to do business.”
Robin Raina, President & CEO of Ebix said, “It is the first time in the world that a single Exchange platform is being deployed to facilitate electronic placement of insurance across a market comprised of all the constituents. That it is being done by the largest insurance marketplace in the world — London — makes this a particularly significant event in the global insurance market. We are honored and excited to be powering the technology behind this Exchange endeavor and are committed to doing everything within our means to make this world-leading, ground-breaking effort a huge success. I congratulate PPL, LMG and Lloyds for taking the initiative to modernize the London market as a part of LMG’s Target Operating Model (TOM) and assure them of our complete support.”
Some Benefits of the Exchange –
There are considerable advantages derived from the Exchange, not the least of which is the avoidance of considerable costs incurred by carriers integrating with multiple placing systems rather than a single market utility. It is estimated that carriers could avoid over $90 million in such set-up costs and $18 million annually, by supporting one system. Economies of scale and the potential to reduce redundant data-entry and other functions should contribute further financial advantages.
The PPL is also likely to further enhance the London market’s leadership and global reputation. With this exchange, London will be the first and only commercial insurance market globally to implement electronic placing. It will be able to provide real time status updates to clients on the progress of quotes 24 hours a day. Clean, standard, structured contracts will replace scanned versions with manual stamps. Signed line confirmations to carriers could be accelerated by up to 30 days.
Such improvements will make the London market a more efficient place to do business. There is a consensus that London has to continue to modernize to attract more global insurance business and this exchange is designed to lower placement costs and make the market more accessible to international clients.
About Ebix, Inc.
A leading international supplier of On-Demand software and E-commerce services to the insurance, financial and healthcare industries, Ebix, Inc., (NASDAQ: EBIX) provides end-to-end solutions ranging from infrastructure exchanges, carrier systems, agency systems and risk compliance solutions to custom software development for all entities involved in the insurance industry.
With 40+ offices across Brazil, Singapore, Australia, the US, UK, New Zealand, India and Canada, Ebix powers multiple exchanges across the world in the field of life, annuity, health and property & casualty insurance while conducting in excess of $100 billion in insurance premiums on its platforms. Through its various SaaS-based software platforms, Ebix employs hundreds of insurance and technology professionals to provide products, support and consultancy to thousands of customers on six continents. For more information, visit the Company’s website at www.ebix.com
SAFE HARBOR REGARDING FORWARD-LOOKING STATEMENTS
As used herein, the terms “Ebix,” “the Company,” “we,” “our” and “us” refer to Ebix, Inc., a Delaware corporation, and its consolidated subsidiaries as a combined entity, except where it is clear that the terms mean only Ebix, Inc.
The information contained in this Press Release contains forward-looking statements and information within the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. This information includes assumptions made by, and information currently available to management, including statements regarding future economic performance and financial condition, liquidity and capital resources, acceptance of the Company’s products by the market, and management’s plans and objectives. In addition, certain statements included in this and our future filings with the Securities and Exchange Commission (“SEC”), in press releases, and in oral and written statements made by us or with our approval, which are not statements of historical fact, are forward-looking statements. Words such as “may,” “could,” “should,” “would,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “seeks,” “plan,” “project,” “continue,” “predict,” “will,” “should,” and other words or expressions of similar meaning are intended by the Company to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are found at various places throughout this report and in the documents incorporated herein by reference. These statements are based on our current expectations about future events or results and information that is currently available to us, involve assumptions, risks, and uncertainties, and speak only as of the date on which such statements are made.
Our actual results may differ materially from those expressed or implied in these forward-looking statements. Factors that may cause such a difference, include, but are not limited to those discussed in our Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as: the risk of an unfavorable outcome of the pending governmental investigations or shareholder class action lawsuits, reputational harm caused by such investigations and lawsuits, the willingness of independent insurance agencies to outsource their computer and other processing needs to third parties; pricing and other competitive pressures and the Company’s ability to gain or maintain share of sales as a result of actions by competitors and others; changes in estimates in critical accounting judgments; changes in or failure to comply with laws and regulations, including accounting standards, taxation requirements (including tax rate changes, new tax laws and revised tax interpretations) in domestic or foreign jurisdictions; exchange rate fluctuations and other risks associated with investments and operations in foreign countries (particularly in Australia and India wherein we have significant operations); equity markets, including market disruptions and significant interest rate fluctuations, which may impede our access to, or increase the cost of, external financing; and international conflict, including terrorist acts.
Except as expressly required by the federal securities laws, the Company undertakes no obligation to update any such factors, or to publicly announce the results of, or changes to any of the forward-looking statements contained herein to reflect future events, developments, changed circumstances, or for any other reason.
Readers should carefully review the disclosures and the risk factors described in the documents we file from time to time with the SEC, including future reports on Forms 10-Q and 8-K, and any amendments thereto.
You may obtain our SEC filings at our website, www.ebix.com under the “Investor Information” section, or over the Internet at the SEC’s web site, www.sec.gov.
CONTACT:
Darren Joseph
678 -281-2027
Email Contact
David Collins or Chris Eddy
Catalyst Global
212-924-9800
Email Contact
(NAVB) and Macrophage Therapeutics to Provide Business Update
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) announces a conference call on Monday, April 18, 2016 at 4:30 p.m. ET to update the market on recent events. The recent changes to the board provide Navidea with an opportunity to refocus its efforts and to develop a strategic plan that takes maximum advantage of its Manocept™ macrophage targeting technology for immunodiagnostic and immunotherapeutic applications.
Lymphoseek® (technetium Tc 99m tilmanocept) injection represents the first of many potential products that can be developed with this technology. In addition, Lymphoseek, which is currently approved in the U.S. and Europe to guide sentinel lymph node biopsy in breast cancer, melanoma, and oral cavity cancers and in the U.S. for use in solid tumors where lymphatic mapping is a component of surgical management, is being explored for additional immunodiagnostic uses including rheumatoid arthritis as the initial target and ultimately for other autoimmune and inflammatory conditions including cardiovascular disease, infectious diseases and a number of other potential indications. On the immunotherapeutic side there has been significant progress and with the changes at the board level, we are committed to providing the necessary support to enable this effort to achieve its potential.
To achieve our ambitious goals our immediate objective is to right size our expenses to our current revenues so that we attain positive operational cash flow, based on our current revenue stream. Given our projected revenue growth and profitability and a renegotiated distribution agreement following its expiration in less than 2 years, we believe that our ability to refinance our existing senior debt with improved terms is very likely.
In addition we will present an update on the very significant progress that has occurred at Macrophage Therapeutics, the immunotherapeutic-focused subsidiary of Navidea. Over the past six months we have successfully developed new chemical synthetic processes for the synthesis of the first two therapeutic products. These compounds have appropriate purity and have demonstrated high affinity binding to the CD206 (mannose receptor) target. Two different contract manufacturing organizations have successfully produced the materials and there are plans for GMP scale-up as the programs move forward. We have also completed a number of animal studies with our intended anti-inflammatory compound and are in the process of completing dosing in a number of additional animal studies with either our anti-inflammatory compound or our compound designed to destroy via apoptosis disease causing macrophages. We are also in the process of initiating several animal in vivo tumor model studies to investigate the ability to deplete Tumor Associated Macrophages (TAMs) and initiate cancer cell death. As we stated when we created Macrophage Therapeutics, we will be pursuing a partnership model, as we look to explore the many potential uses for this technology in parallel. We have successfully introduced the technology to multiple large pharmaceutical and biotechnology companies and it is our intent to pursue development deals based on their review of the data we are currently generating. We have recently initiated the first collaboration with a large pharmaceutical company that is testing one of our compounds in various anti-inflammatory studies. We will review the current state of affairs at Macrophage Therapeutics on Monday’s call.
Finally we are eager to open the call to Navidea investors and potential investors. We will devote a substantial portion of the call to Q&A as we want to make certain we address the subjects that are important to investors. We plan to discuss the progress of this promising technology during regularly scheduled Macrophage Therapeutics update calls as we appreciate the value of improving communication with investors and prospective investors.
Conference Call Details
Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone also. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins. The webcast replay is expected to be available on our investor website, http://ir.navidea.com, approximately two to four hours after the live event.
| Event: | Navidea and Macrophage Therapeutics Business Update Call | ||||
| Date/Time: | Monday, April 18, 2016 at 4:30 p.m. ET | ||||
| Webcast Link: | http://edge.media-server.com/m/p/e2rzwvkp | ||||
| Dial-in Number – US: | (855) 897-5884 | ||||
| Dial in Number – Int’l: | (720) 634-2940 | ||||
| Participant Passcode: | 93499436 | ||||
| Replay | A webcast replay will be available on the Investor Relations section of our website at http://ir.navidea.com for 30 days. |
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About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results guide therapy decisions and determine patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 600,000 new cases of breast cancer, 160,000 new cases of melanoma and 100,000 new cases of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
• Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
• Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers. In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
About Manocept CD206 Immunotargeting Platform for Therapeutics Development
Manocept™ CD206 Immunotargeting Platform is a proprietary mannose-containing, receptor-directed technology platform designed to engineer novel, synthetic receptor targeted imaging agents and therapeutics for cancer and other diseases. Manocept’s unique structural and molecular properties enable the design of novel immuno-constructs that selectively target and bind to CD206 (mannose receptor) and other C-type Lectins found on activated, disease-associated macrophages and tumor associated macrophages (TAMs). The Manocept CD206 Immunotargeting Platform provides a novel and valuable approach to the design of drug molecules targeting CD206 disease-associated macrophages for therapeutic purposes.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
About Macrophage Therapeutics
Macrophage Therapeutics, Inc., a subsidiary of Navidea Biopharmaceuticals, Inc. (NAVB), is developing therapeutics using the patented Manocept immunotherapy platform licensed from Navidea to target over-active macrophages implicated in cancer, cardiovascular, central nervous system, autoimmune, antiviral, and skin diseases. Manocept specifically targets CD206, or the mannose receptor prevalent on over-active macrophages. The technology enables highly specific targeted delivery of active (either existing or yet to be developed) agents that can modulate the activity of over-active macrophages that have been implicated in many diseases. Targeted delivery should significantly enhance a given compound’s efficacy and safety.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
For Navidea Biopharmaceuticals:
Investors & Media
Sharon Correia, 978-655-2686
Senior Director, Corporate Communications
(PTCT) NICE Recommends Translarna™
-Positive Recommendation Enables Reimbursed Patient Access to First Approved Therapy to Treat Underlying Cause of Devastating Rare Disease-
SOUTH PLAINFIELD, N.J., April 15, 2016 — PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the National Institute for Health and Care Excellence (NICE) has recommended Translarna ∇ (ataluren) for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD) in connection with a Managed Access Agreement (MAA) with NHS England. The provision of patient access is subject to the finalization of the NICE draft guidance, which the agency expects in May of 2016.
“This is an important day for the Duchenne community, which has been working hard to make this ground-breaking drug available to boys with nonsense mutation Duchenne muscular dystrophy,” said Paul Lenihan, Chief Executive of Action Duchenne. “We are delighted by this positive recommendation and NICE’s recognition that Translarna is an important new medicine for patients. This decision is a hugely encouraging sign that both NICE and NHS England have listened to the patient community, bringing hope to each and every parent and patient fighting DMD.”
Primarily affecting males, Duchenne muscular dystrophy (DMD) is a progressive muscle disorder caused by the lack of functional dystrophin protein. Dystrophin is critical to the structural stability of skeletal, diaphragm, and heart muscles. Patients with DMD lose the ability to walk from as early as 10 years of age and experience life-threatening lung and heart complications in their late teens and early twenties.
“We are extremely pleased by the NICE recommendation, which recognizes Translarna as an innovative medicine with the potential to change the course of this devastating disease,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “This is a crucial step for the boys and young men in England with nonsense mutation DMD. We are grateful to the patients, families, advocacy groups and physicians who have supported PTC Therapeutics through this important access process and look forward to working with NHS England to conclude the managed access agreement.”
PTC and NHS England are in the process of finalizing an MAA outlining financial and clinical details surrounding the use of Translarna, including a confidential financial arrangement. The MAA is expected to allow PTC to collect further data on the efficacy of Translarna for the treatment of nmDMD over a five-year period with NICE guidance to be reviewed again at the end of that period.
Translarna was approved by the European Commission in August 2014 to treat nmDMD and is currently available to patients in 23 countries through either expanded access programs or commercial sales.
About Translarna™ (ataluren)
Translarna, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy. Translarna is licensed in the European Economic Area for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Translarna is an investigational new drug in the United States. The development of Translarna has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); Muscular Dystrophy Association; FDA’s Office of Orphan Products Development; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.
Further information about Translarna, including the European Public Assessment Report, Summary of Product Characteristics and Patient Information Leaflet, is available on the European Medicines Association website.
This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system or to PTC at medinfo@ptcbio.com.
About PTC Therapeutics, Inc.
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary small molecule drugs targeting an area of RNA biology we refer to as post-transcriptional control. Post-transcriptional control processes are the regulatory events that occur in cells during and after a messenger RNA is copied from DNA through the transcription process. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has discovered all of its compounds currently under development using its proprietary technologies. PTC plans to continue to develop these compounds both on its own and through selective collaboration arrangements with leading pharmaceutical and biotechnology companies. For more information on the company, please visit our website www.ptcbio.com.
For More Information:
Investors:
Jane Baj
+1 (908) 912-9176
jbaj@ptcbio.com
Media:
Justine O’Malley
+1 (908) 912-9551
jomalley@ptcbio.com
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements, other than those of historical fact, contained in this release are forward-looking statements, including statements about our expectations regarding the potential timing and outcome of final guidance from NICE with respect to Translarna for the treatment of nmDMD; the ability of NHS England and PTC Therapeutics to finalize a MAA in a timely manner, whether on terms acceptable to PTC, or at all; the potential timing, if ever, of the provision of patient access to Translarna for nmDMD in England; the timing and scope of PTC’s commercial and early access program launches; the rate and degree of market acceptance of Translarna; the clinical utility and potential advantages of Translarna; PTC’s estimates regarding the potential market opportunity for Translarna, including the size of eligible patient populations and PTC’s ability to identify such patients; future expectations, plans and prospects for PTC; PTC’s strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management. Other forward-looking statements may be identified by the words “plan,” “guidance,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions.
PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: whether final guidance from NICE recommends Translarna for the treatment of nmDMD; actual reimbursement decisions by NHS England and the acceptability of final terms of the MAA; PTC’s ability to maintain the marketing authorization of Translarna for the treatment of nmDMD in the European Economic Area, or EEA, which is subject to ongoing conditions and is also subject to annual review and renewal by the EMA following its reassessment of the risk benefit balance of the authorization; PTC’s ability to commercialize and commercially manufacture Translarna in general and specifically as a treatment for nmDMD, including its ability to successfully negotiate favorable pricing and reimbursement processes on a timely basis in the countries in which it may obtain regulatory approval; the timing and outcome of future interactions PTC has with the FDA with respect to Translarna for the treatment of nmDMD, including whether PTC is required to perform additional clinical and non-clinical trials at significant cost and whether such trials, if successful, may enable FDA review of a NDA submission; whether the FDA, the EMA or other regulators agree with PTC’s interpretation of the results of ACT DMD and other data with respect to the safety and efficacy of Translarna for the treatment of nmDMD or PTC’s other clinical trials; the outcome of pricing and reimbursement negotiations in those territories in which PTC is authorized to sell Translarna; whether patients and healthcare professionals may be able to access Translarna through alternative means if pricing and reimbursement negotiations in the applicable territory do not have a positive outcome, including whether Translarna may be accessed through a reimbursed importation pathway provided under German law and whether such pathway will minimize any access issues for German patients while maintaining a sustainable price; expectations for regulatory approvals, including PTC’s ability to make or advance regulatory submissions in a timely manner (or at all), the period during which the outcome of regulatory reviews will become available, adverse decisions by regulatory authorities, other delay or deceleration of the regulatory process, and PTC’s ability to meet existing or future regulatory standards with respect to Translarna; the scope of regulatory approvals or authorizations for Translarna (if any), including labeling and other matters that could affect the availability or commercial potential of Translarna; PTC’s ability to fulfill any additional obligations, including with respect to further trials or studies relating to cost-effectiveness, obtaining licenses or satisfying requirements for labor and business practices, in the territories in which it may obtain regulatory approval; the initiation, conduct and availability of data from clinical trials and studies; PTC’s scientific approach and general development progress; the eligible patient base and commercial potential of Translarna and PTC’s other product candidates; and the factors discussed in the “Risk Factors” section of PTC’s most recent Annual Report on Form 10-K as well as any updates to these risk factors filed from time to time in PTC’s other filings with the SEC. You are urged to carefully consider all such factors. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that Translarna will receive full regulatory approval in any territory or maintain its current marketing authorization in the EEA, or prove to be commercially successful in general, or specifically with respect to the treatment of nmDMD.
The forward-looking statements contained herein represent PTC’s views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this release except as required by law.
(GBSN) Strong 1st Quarter Customer Growth Could Indicate Stronger Future Revenue Growth
NEW YORK, NY / April 15, 2016 / Great Basin Scientific, Inc. (NasdaqCM: GBSN) is a molecular diagnostic company that commercializes breakthrough chip-based technologies. The company’s vision is to make molecular testing so simple and cost-effective that every patient will be tested for ever serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease.
What could strong customer growth mean for the company’s stock price?
Get the company background and analyst comments on Great Basin Scientific, Inc. (NASDAQCM: GBSN) please follow this link. There is no cost obligation required to view analyst brief: http://broadstreetalerts.com/future-revenue-growth/.
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(OGES) Reports 2015 Annual Results and Recent Highlights
Cash on Hand Tops $13 Million As the Company Completes Its $40 Million Manufacturing Facility and Begins Shipping Orders
MELBOURNE, FL / April 15, 2016 / Oakridge Global Energy Solutions, Inc. (OTCQB: OGES), a leading US-based technology manufacturer of lithium-ion batteries for military, civilian and medical applications, has today announced financial results for the year ended December 31, 2015 together with recent company highlights.
For the year ended December 31, 2015 the Company remained in pre-revenue phase while completing essential modifications to its new manufacturing facility into which the Company moved in October 2015. The Company booked a net income of $12 million attributed to a one-time other income transaction, compared to a net loss of $9 million in 2014. Total assets increased to $28 million compared to $6 million the year prior. The Company announced it has begun shipping orders in Q1 2016 following the opening of its state-of-the-art $40 million first-of-kind facility.
Full Year & Recent Highlights
– Completion of first-of-kind US-based rechargeable battery facility
– $13 million year-end cash on hand
– Existing pipeline orders of $24 million
– 30% increase in battery life cycle through its proprietary chemistry and technology
– First reported Company revenues in Q1 2016 for its Pro Series battery
– Pays off all outstanding debt ($2 million)
– Strategic Business Alliance Agreement with Sojitz Machinery Corporation of Tokyo, Japan to supply and finance raw materials and expansion of manufacturing equipment
– $30 million in State and local tax credits
– Significant additional new capital equipment on order
Steve Barber, CEO, commented, “In 2015 we significantly advanced our strategy to become a leading global rechargeable battery manufacturer focused on military, civilian and medical applications. We have successfully completed our 2-year restructuring plan and are now beginning to ship our proprietary technology rechargeable batteries to a long list of waiting customers. The April 1, 2016 U.N Agency ban on transporting lithium batteries on passenger planes further positions us to become a major manufacturing player in the rechargeable battery market in the USA.”
“As we transformed our business in 2015 I am particularly pleased with balance sheet liquidity–paying down all of our $2 million debt on one side and a pending stream of customer orders on the other. Our investment in future growth drivers also continues unabated. A recent strategic alliance with Sojitz–which is a world leader in factory automation plants, builder of world-class automated manufacturing facilities for leading global companies, as well as a specialist in the provision of raw materials and manufacturing needs to the lithium battery industry–further affirms that we are on the right track. Oakridge has entered 2016 with a robust pipeline of commercialization opportunities and orders. With our new facility and ongoing manufacturing plant expansion we are positioned for global leadership in the rechargeable battery space. Our top priority is to ship open orders to customers as efficiently and quickly as possible, with second shifts now in place to expedite the manufacturing process. We expect to deliver strong results in 2016, generating significant top-line growth while continuing to invest in our capacity.”
Barber concluded, “With an endless ocean of rechargeable battery applications plus an expansion of our existing product lines for golf carts motorcycle starter batteries, power sports and battery-powered freight trucks–which have a significantly reduced per-mile cost, plus the added benefit of greater leverage in our cost structure–our revenue and earnings power will notably increase. Our confidence is underscored by a growing backlog, which has expanded to $24 million in the last few months, reaching the highest levels since inception. Today, Oakridge is positioned for success with a lean cost structure and growing revenues–in addition, of course, to products and services that continue to make a meaningful impact on lives of customers.”
About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions Inc. leads in the innovation, development, manufacturing and marketing of disruptive energy storage technology for military, civilian and medical uses. The company’s research & development has led to some of the world’s longest-lasting rechargeable power sources currently available, with a battery life up to 3 times greater and a 30 percent longer cycle between charges than its foreign-manufactured counterparts. Located in Palm Bay, Florida, the Company operates the only lithium-ion battery manufacturing facility in the United States. For more information visit: www.oakridgeglobalenergy.com.
Forward-Looking Statements Disclaimer:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainty and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.
Contact:
Oakridge Global Energy Solutions, Inc.
Name: Suzanna Barber
Phone: (321) 610-7959
Email: IR@oakg.net
(TRIL) to Provide Update on CD47 Program at the 2016 AACR
TORONTO, ONTARIO–(April 14, 2016) – Trillium Therapeutics Inc. (NASDAQ:TRIL)(TSX:TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced it will be providing an update on its SIRPaFc immune checkpoint inhibitor program, targeting the CD47 protein, at the 107th Annual Meeting of the American Association for Cancer Research. The meeting will be held April 16-20, 2016 in New Orleans, LA. Details of the poster presentation, entitled “SIRPaFc, a CD47-Blocking Cancer Immunotherapeutic, Triggers Phagocytosis of Lymphoma Cells by Both Classically (M1) and Alternatively (M2) Activated Macrophages“, are listed below:
| Date: | Monday April 18, 2016 |
| Time: | 1:00 pm – 5:00 pm (CT) |
| Session Category: | Immunology |
| Session Title: | Immune Checkpoints 1 |
| Abstract #: | 2345 |
| Presenter: | Dr. Natasja Nielsen Viller |
| Location: | Section 26 |
The company will present data demonstrating that its SIRPaFc fusion protein, which targets the CD47 “do not eat” signal, promotes the phagocytosis of lymphoma cells by diverse types of macrophages. The studies also assess the impact of macrophage polarizing agents on drug activity and delineate the role of different Fc gamma receptors in promoting tumor cell killing by SIRPaFc.
“Macrophages are heterogeneous and certain types, notably M2s, are often implicated in tumor progression,” commented Trillium’s Chief Scientific Officer, Dr. Robert Uger. “Our data indicate that TTI-621, our CD47-blocking decoy receptor, enables all macrophage subsets tested, including M2s, to kill tumor cells. These results suggest that TTI-621 is able to convert otherwise pro-tumor macrophages into efficient anti-tumor effector cells. Rather than ablating M2 macrophages in the tumor microenvironment, these data support using TTI-621 to unleash their tumoricidal function.”
About Trillium Therapeutics:
Trillium Therapeutics Inc. is a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. The Company’s lead program, SIRPaFc, is a fusion protein that consists of the CD47-binding domain of human SIRPa linked to the Fc region of a human immunoglobulin. It is designed to act as a soluble decoy receptor, preventing CD47 from delivering its inhibitory (“do not eat”) signal. Neutralization of the inhibitory CD47 signal enables the activation of macrophage anti-tumor effects by pro-phagocytic (“eat”) signals. A Phase 1 clinical trial (NCT02663518) evaluating SIRPaFc (TTI-621) is ongoing. Trillium also has a proprietary medicinal chemistry platform, using unique fluorine chemistry, which permits the creation of new chemical entities from validated drugs and drug candidates with improved pharmacological properties. Stemming from this platform, the Company’s most advanced preclinical program is an orally-available bromodomain inhibitor, followed by an epidermal growth factor receptor antagonist with increased uptake in the brain. In addition, a number of compounds directed at undisclosed immuno-oncology targets are currently in the discovery phase.
For more information visit: www.trilliumtherapeutics.com
Caution Regarding Forward-Looking Information:
This press release may contain forward-looking statements, which reflect Trillium’s current expectation regarding future results, events or developments, including our belief that TTI-621 is able to convert pro-tumor macrophages into efficient anti-tumor effector cells. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties are described in the company’s ongoing quarterly and annual reporting. Except as required by applicable securities laws, Trillium undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.
Trillium Therapeutics Inc.
James Parsons
Chief Financial Officer
+1 416 595 0627 x232
james@trilliumtherapeutics.com
www.trilliumtherapeutics.com
(ORPN) to Present Final HOPEMD Phase 2 Clinical Study Results of Trehalose
Final Results of 24-Week Open-Label Phase 2 Trial Will be Presented by Professor Zohar Argov, MD, Senior Medical Advisor to BioBlast Pharma
NEW HAVEN, Conn., April 14, 2016 — BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, will present previously announced positive final results from its HOPEMD Phase 2 six-month open-label clinical study in patients with oculopharyngeal muscular dystrophy (OPMD) at the 2016 American Academy of Neurology (AAN) Annual Meeting, being held in Vancouver, Canada April 15-21. OPMD is a rare progressive muscle-wasting disease characterized by swallowing difficulties (dysphagia), leading to the risk of aspiration of food into the lungs, weight loss, and generalized progressive muscle weakness.
American Academy of Neurology 2016 Annual Meeting
April 15-21 in Vancouver, Canada
Title: Intravenous Trehalose for Treatment of Dysphagia and Muscle Function in Oculopharyngeal
Muscular Dystrophy (OPMD): Final Results of 24 Week Open-Label Phase 2 Trial
Session: Integrated Neuroscience Session – Advances in Acquired and Genetic Muscle Diseases
Date: Sunday, April 17, 2016
Time: 5:00pm Pacific Time
Presenter: Prof. Zohar Argov M.D.
Senior Medical Advisor to BioBlast Pharma
Session: S28: Experimental Therapies in Neuromuscular Diseases
Date: Tuesday, April 19, 2016
Time: 7:15am Pacific Time
Presenter: Prof. Zohar Argov M.D.
Senior Medical Advisor to BioBlast Pharma
Twenty-four week results from the HOPEMD Phase 2 open-label study were announced by BioBlast on March 16th, 2016. Trehalose 90mg/mL IV solution was observed to be safe and well-tolerated with no drug-related serious adverse events. Improvements versus baseline were observed in multiple secondary efficacy endpoints related to dysphagia and muscle strength and function.
About Trehalose 90mg/mL IV Solution
Trehalose 90mg/mL IV solution is a chemical chaperone that protects against pathological processes in cells. It has been shown to reduce pathological aggregation of proteins within cells in several diseases associated with abnormal cellular-protein aggregation as well as acting as an autophagy enhancer. Trehalose 90mg/mL IV solution has been documented as demonstrating significant promise in preclinical animal models of OPMD and other PolyA/PolyQ diseases.
In OPMD, trehalose 90mg/mL IV solution is being developed to prevent the aggregation of the pathological protein (PABPN1) in muscle cells, the hallmark of the disease, by stabilizing the protein, reducing the formation of protein aggregations, and promoting their clearance from cells through autophagy, thus preventing muscle cell death.
About Oculopharyngeal Muscular Dystrophy (OPMD)
OPMD is an inherited myopathy characterized by dysphagia (difficulty in swallowing), eyelid drooping (ptosis), the loss of muscle strength, and weakness in multiple muscles of the body. Symptoms generally appear in mid-life and get worse over time. As the dysphagia becomes more severe, patients become malnourished, lose significant weight, and may suffer from repeated incidents of aspiration pneumonia. Aspiration pneumonia and severe emaciation may result in death. The disease is caused by a genetic mutation responsible for the creation of a mutant protein (PABPN1) with an expanded polyalanine domain that aggregates within patient muscle cells. There is currently no approved pharmacologic treatment for OPMD.
About BioBlast Pharma Ltd.
BioBlast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases. The Company has a portfolio of product candidates with the potential to address unmet medical needs for incurable diseases. The BioBlast platforms are based on a deep understanding of disease-causing biological processes, and potentially offer solutions for several diseases that share the same biological pathology. BioBlast was founded in 2012 and is traded on the NASDAQ under the symbol “ORPN”. For more information, please visit the Company’s website, www.bioblast-pharma.com, the content of which is not incorporated herein by reference.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, the Company is using forward looking statements when it discusses, potential uses of its product candidates for various indications, building a diverse portfolio of product candidates with the potential to address unmet medical needs for incurable diseases, or that BioBlast’s platforms potentially offer solutions for several diseases that share the same biological pathology. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or those historic results referred to in this press release would not be interpreted differently in light of additional research and clinical and preclinical trial results. Because such statements deal with future events and are based on BioBlast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of BioBlast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in BioBlast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 29, 2016, and in any subsequent filings with the SEC. Except as otherwise required by law, BioBlast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
INVESTOR CONTACT: Matthew P. Duffy Managing Director LifeSci Advisors, LLC Telephone: 212-915-0685
(GBSN) Announces Q1 Revenues and Customer Acquisition Results
Company sees 59.4% growth in revenue, and 119.8% customer growth year-over-year; will provide customer acquisition targets and 2016-2017 product roadmap on Business Update Call later today
Great Basin Scientific, Inc. (Nasdaq:GBSN), a molecular diagnostics company, today reported preliminary revenue results for the first quarter 2016. For the first quarter 2016, revenue was $731,422, an increase of 59.4% over the first quarter of 2015. The Company also reported that its customer base of revenue generating customers grew to 222 as of March 31, 2016, an increase of 119.8% over first quarter last year. The company will provide guidance for the 2016-2017 customer acquisition targets and menu expansion on a call later today.
“We are extremely pleased with the Company’s execution over the last 12 months, including our ability to significantly grow our customer base, develop and launch new tests, and the accelerating growth in our revenues,” said Ryan Ashton, Co-founder and Chief Executive Officer of Great Basin. “We’re committed to building on this momentum in 2016, by advancing the development of new molecular tests and panels that will differentiate our platform and increase potential revenue per customer. We remain dedicated to executing on the fundamentals that will serve both our target market and our stockholders, and look forward to sharing these plans during our Business Update call this afternoon.”
Great Basin invites all interested parties to join the call by dialing 877-407-0789. The call will also be broadcast live over the internet and can be accessed on the Investor Relations section of the Company’s website at www.gbscience.com.
About Great Basin Scientific
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease.
Forward-Looking Statements
This press release includes forward-looking statement regarding events, trends and business prospects, which may affect our future operating results and financial position, including statements regarding the Company’s anticipated revenues and customer acquisitions, the Company accelerating its ability to develop and launch the tests and panels, that such tests and panels will differentiate the Company’s solution offering and other similar statements. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history or losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.
Media:
ICR
Kate Ottavio Kent, 203-682-8276
Kate.Ottavio-Kent@icrinc.com
or
Investor Relations:
CorProminence
Scott Gordon, 516-222-2560
gbinfo@corprominence.com
or
ICR
David Clair, 646-277-1266
David.Clair@icrinc.com
(DRWI) Successfully Completes First Five Harmony Enhanced MC Trials
DragonWave has successfully completed five customer trials of Enhanced MC, with five additional trials planned over the next three months
OTTAWA, CANADA–(April 14, 2016) – DragonWave Inc. (TSX:DWI)(NASDAQ:DRWI), a global supplier of packet microwave radio systems, today announced that they have successfully completed five customer trials of the newly launched Harmony Enhanced MC dual carrier product. DragonWave has also scheduled five additional trials of Harmony Enhanced MC to be conducted in the next three months.
“Operators are finding that Harmony Enhanced MC can be easily deployed today to expand backhaul capacity on their overburdened networks, while offering them the capacity and functionality to support next-generation network builds,” said Earl Lum, founder and president, EJL Wireless Research. “Harmony Enhanced MC provides a cost-effective solution today with added value capabilities to support backhaul demands for 5G.”
The completed trials successfully demonstrated the full range of Harmony Enhanced MC capabilities, resulting in positive feedback about the radio’s high capacity performance and industry-leading system gain. Discussions continue with the respective operators where Harmony Enhanced MC can be used for high capacity LTE, while readying the backhaul network for future 5G deployments. The trials were conducted both in lab and outdoor deployments, with first trials run in North America and further trials planned in Europe and The Middle East.
“The successful completion of these trials has demonstrated the industry-leading functionality of Harmony Enhanced MC,” said Greg Friesen, vice president, Product Management, DragonWave. “We are excited to see verification of the tested features that address the business case challenges for 4G backhaul networks, while also providing the network scalability to address future 5G deployments.”
Harmony Enhanced MC delivers the next level of capacity by introducing integrated dual carrier and fully integrated XPIC capabilities into a single Outdoor Unit (ODU). With its integrated switch, and the Industry’s first 10GE port on a wireless backhaul radio, Harmony Enhanced MC delivers a true all-outdoor, Ethernet solution with unmatched system gain and spectral efficiency. With integrated 112 MHz channel support, 4096QAM capability, Bandwidth Accelerator+ and MIMO, Harmony Enhanced MC delivers over 4 Gbps in a single radio, with scalability to deliver 8Gbps on a single antenna. The Harmony Enhanced MC also provides the highest systems gain in an all-outdoor microwave system, leveraging the latest RF ASIC technology to increase reach by more than 30% reducing tower costs.
About DragonWave
DragonWave® is a leading provider of high-capacity packet microwave solutions that drive next-generation IP networks. DragonWave’s carrier-grade point-to-point packet microwave systems transmit broadband voice, video and data, enabling service providers, government agencies, enterprises and other organizations to meet their increasing bandwidth requirements rapidly and affordably. The principal application of DragonWave’s portfolio is wireless network backhaul, including a range of products ideally suited to support the emergence of underlying small cell networks. Additional solutions include leased line replacement, last mile fiber extension and enterprise networks. DragonWave’s corporate headquarters is located in Ottawa, Ontario, with sales locations in Europe, Asia, the Middle East and North America. For more information, visit http://www.dragonwaveinc.com.
DragonWave®, Horizon® and Avenue® are registered trademarks of DragonWave Inc.
Forward-Looking Statements
Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements as to DragonWave’s growth opportunities and the potential benefits of, and demand for, DragonWave’s products. These statements are subject to certain assumptions, risks and uncertainties, including our view of the relative position of DragonWave’s products compared to competitive offerings in the industry. Readers are cautioned not to place undue reliance on such statements. DragonWave’s actual results, performance, achievements and developments may differ materially from the results, performance, achievements or developments expressed or implied by such statements. Risk factors that may cause the actual results, performance, achievements or developments of DragonWave to differ materially from the results, performance, achievements or developments expressed or implied by such statements can be found in the public documents filed by DragonWave with U.S. and Canadian securities regulatory authorities. DragonWave assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Media Contact:
Nadine Kittle
Marketing Communications
DragonWave Inc.
nkittle@dragonwaveinc.com
+1-613-599-9991 ext 2262
Media Contact:
Becky Obbema
Interprose
(for DragonWave)
Becky.Obbema@interprosepr.com
+1-408-778-2024
Investor Contact:
Peter Allen
CEO
DragonWave Inc.
pallen@dragonwaveinc.com
+1-613-599-9991
(EXPI) Fundamental Research Corp. Initiates Coverage of eXp World Holdings, Inc.
BELLINGHAM, WA–(April 14, 2016) – Fundamental Research Corp. an independent research firm specializing in the small-cap and microcap sectors, has announced that it has initiated coverage of eXp Realty International Corporation (name change to eXp World Holdings, Inc. presently pending) (OTCQB: EXPI). The report includes a rating and a price target. To the view the report in its entirety visit http://www.otcmarkets.com/financialReportViewer?symbol=EXPI&id=152868.
eXp World Holdings, Inc. is the holding company for a number of entities including eXp Realty, the Agent-Owned Cloud Brokerage and First Cloud Mortgage, Inc. The Company’s real estate brokerage operations now has more than 1,100 real estate professionals who span across 36 states and parts of Canada.
In the report, Fundamental Research Corp. discusses the implementation of eXp’s agent-ownership initiatives, and the fundamentals of its business model stating that the Company’s “ability to attract 1,000+ agents, and over $2 billion in transactions, indicates their attractive value proposition to real estate professionals.”
About Fundamental Research Corp. We do not undertake to advise you as to changes in figures or our views. This is not a solicitation of any order to buy or sell. Fundamental Research Corp. is not a market maker and does not sell to or buy from customers on a principal basis. The above statement is the opinion of Fundamental Research Corp. and is not a guarantee that the target price for the stock will be met or that predicted business results for the company will occur. There may be instances when fundamental, technical and quantitative opinions contained in this report are not in concert. Analysts and members of the Research Department are prohibited from buying or selling securities issued by the companies that Fundamental Research Corp has a research relationship with, except if ownership of such securities was prior to the start of such relationship, then an Analyst or member of the Research Department may sell such securities after obtaining expressed written permission from Compliance. As of the date of this report no Fundamental Research Corp employees had a position in the stock of the company mentioned in this report.
All research issued by Fundamental Research Corp. is based on public information. Fees were paid by EXPI to FRC. The purpose of the fee is to subsidize the high costs of research and monitoring. FRC takes steps to ensure independence including setting fees in advance and utilizing analysts who must abide by CFA Institute Code of Ethics and Standards of Professional Conduct. Additionally, analysts may not trade in any security under coverage. Our full editorial control of all research, timing of release of the reports, and release of liability for negative reports are protected contractually. To further ensure independence, EXPI has agreed to a minimum coverage term including four reports.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 90.5% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, New Mexico and Texas.
The corporate name change to “eXp World Holdings, Inc.” has been approved by our Board and stockholders but is not yet effective, pending the mailing of a definitive information statement to our stockholders in accordance with applicable rules and a 20-day notice period thereafter.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit investors.exprealty.com or www.exprealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
President
eXp Realty World Holdings, Inc.
jason@expworldholdings.com
617-970-8518
Contact:
Sid Rajeev, CFA
Fundamental Research Corp.
www.researchfrc.com
Direct: 604-682-7065
(CYRX) Signs Strategic Partnership Deal With Worthington Industries
IRVINE, Calif., April 13, 2016 — Cryoport, Inc. (NASDAQ: CYRX), the world’s leading cryogenic logistics company, announced today that it has entered into a strategic partnership with Worthington Industries (NYSE: WOR), maker of cryogenic storage vessels and equipment. Through this partnership, Worthington’s CryoScience by Taylor Wharton business will design and manufacture biostorage and logistics equipment for use in Cryoport’s life sciences cryogenic logistics solutions.
Cryoport’s proprietary cold chain logistics solutions protect frozen life sciences commodities from adverse thermal excursions during clinical development through commercial manufacture; thereby, contributing to increased success in transport and storage and efficacy. Through its recently-acquired CryoScience by Taylor Wharton product line, Worthington manufactures cold chain storage and transport vessels and equipment that provide critically reliable transportation of biological commodities.
Jerrell Shelton, CEO of Cryoport, stated, “This strategic arrangement with Worthington’s CryoScience by Taylor Wharton Division is important to Cryoport as Worthington is one of the most important and most competent manufacturers serving our space. With the added competencies Worthington’s CryoScience by Taylor Wharton brings to Cryoport, we can concentrate on further advancing and expanding our cold chain solutions to meet the growing and varied demands for validated cryogenic logistics solutions in the life sciences market. Cryoport’s leading-edge logistics solutions for biopharma, animal health, and reproductive medicine are second to none. In this new age of biology, Cryoport is more than a “nice to have,” it is a strategic consideration. And, with new, innovative, validated solutions enabled by Worthington, we are confident that our partnership will prove to be a great success in the marketplace for both parties.”
As the premier provider of cold chain logistics solutions to the life sciences industry Cryoport is committed to maintaining its leadership and will further enhance its proprietary shippers, information technology and specialized cold chain logistics expertise to continue differentiating its services and providing superior value to clients. This partnership also gives Cryoport the opportunity to expand into other logistics areas such as storage thereby advancing Cryoport’s offerings to clients in the storage and fulfilment areas of logistics.
“Working in tandem with Worthington’s CryoScience by Taylor-Wharton team allows Cryoport to meet the demands of a more diverse clientele through a broader offering which in turn, increases our revenue opportunity as well as provides us the opportunity to rapidly scale to support our clients’ commercialization activities,” said Mark Sawicki, Chief Commercial Officer of Cryoport.
Andrew Pazahanick, Vice President & GM of Worthington’s CryoScience by Taylor-Wharton business added, “This strategic partnership between Cryoport and Worthington will help meet the quality and reliability demands of the growing life sciences industry. Cold chain logistics has become a strategic consideration, as there is an ever-increasing need for cryogenic logistics in the biopharma, animal health, cellular therapy and reproductive medicine markets. We are pleased to align our business with a key cryogenic logistics solution in the life sciences market that provides us immediate access to a distribution platform for our cryogenic products, equipment and services. We believe that Cryoport combines important elements of packaging, information technology and logistics expertise and we are excited to support its efforts to further scale its solutions.”
About Cryoport
Cryoport is the premier provider of cryogenic logistics solutions to the life sciences industry through its purpose-built proprietary packaging, information technology and specialized cold chain logistics expertise. The Company provides leading edge logistics solutions for biologic materials, such as immunotherapies, stem cells, CAR-T cells and reproductive cells for clients worldwide. Cryoport actively supports points-of-care, CRO’s, central laboratories, pharmaceutical companies, contract manufacturers and university researchers. For more information, visit www.cryoport.com.
To download Cryoport’s investor relations app, which offers access to SEC documents, press releases, videos, audiocasts and more, please click to download from your iPhone and iPad or Android mobile device.
About Worthington Industries
Worthington Industries is a leading global diversified metals manufacturing company with 2015 fiscal year sales of $3.4 billion. With the recent acquisition of the CryoScience by Taylor-Wharton product line, Worthington now offers an expanded portfolio of cryogenic storage vessels and related equipment designed for the life sciences markets ranging from 1.5 liter dewars to the largest LABS Series freezer that stores over 94,000 vials. Headquartered in Columbus, Ohio, Worthington employs approximately 10,000 people and operates 82 facilities in 11 countries.
Forward Looking Statements
Statements in this news release which are not purely historical, including statements regarding Cryoport, Inc.’s intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic conditions, trends in the products markets, variations in the company’s cash flow, market acceptance risks, and technical development risks. The company’s business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended March 31, 2015. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Cryoport, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
(UNXL) Expands Business with Tier 1 Customer with XTouch™ and Diamond Guard™ Wins
Announces Two Additional 2-in-1 Convertible Laptop Design Wins with a Leading PC Manufacturer
SANTA CLARA, Calif., April 13, 2016 — UniPixel, Inc. (NASDAQ: UNXL), a provider of advanced touch solutions to the touchscreen and flexible electronics markets, today announced additional design wins that will feature UniPixel’s XTouch and Diamond Guard products in two new 2-in-1 convertible programs from an existing leading PC manufacturing customer. These two wins expand the company’s ongoing business with this customer to four programs.
Both programs will utilize UniPixel’s XTouch high response touchscreen sensors offering with its outstanding finger-touch and capacitive stylus performance, coupled with the company’s Diamond Guard hardcoat technology to reduce the overall cost and weight of the computing devices. One program will include a device with a 12.3-inch screen, and the other program will include a device with a 12.5-inch screen. Volume production for both programs is expected to commence during the fourth quarter of 2016.
Jeff Hawthorne, president and chief executive officer of UniPixel, said, “These are the third and fourth program awards from this customer already in 2016. This customer is new to us in 2016 and we are delighted with their confidence in the performance of our technology and our ability to deliver the best 2-in-1 experience in the industry. We are pleased with the traction we are gaining in the market with our highly differentiated products. Our XTouch copper metal mesh touch sensor offers important advantages to PC manufacturers resulting from lower sheet resistance which allows for superior touch and stylus performance. And our Diamond Guard hardcoat helps PC manufacturers offer the thinner and lighter computing devices desired by their end-user customers.”
About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touch screen and flexible electronics markets. The company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.
Forward-looking Statements
All statements in this news 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 including the statement that UniPixel’s integrated technologies are expected to provide enhanced yields at a lower cost, thereby expanding UniPixel’s competitiveness in the touch screen market. While management has based any forward-looking statements contained herein 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 the Company’s control, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015. UniPixel operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and Current Reports on Form 8-K.
Trademarks in this release are the property of their respective owners
Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com
(GPRO) Appoints Danny Coster Vice President of Design
Coster brings more than 20 years of storied design experience to GoPro
SAN MATEO, Calif., April 13, 2016 — GoPro (NASDAQ: GPRO) today announced that Daniel (Danny) Coster has been named Vice President of Design, effective the end of April. He will report to GoPro CEO and founder Nick Woodman.
Mr. Coster will influence all aspects of design at GoPro in his new role, including hardware and software and services, lending his strategic vision and expertise to maximizing the GoPro user’s experience from end to end.
“Ironically, Danny and I first met in December, 2001, on the beach in Sayulita, Mexico at the very start of the five month surfing trip where I developed and tested the first GoPro prototype,” said Woodman. “His design pedigree speaks for itself, but I will say that we feel energized to have him join GoPro.”
A core member of Apple’s elite industrial design team for more than 20 years, Mr. Coster is credited for his contributions to a wide range of now iconic consumer electronics ranging from the iPhone 4 to the iPad wireless keyboard. He holds more than 500 design patents and several utility patents, and has been recognized by several international design organizations for his work.
“I’m honored to join the GoPro team,” said Coster. “This extraordinary company is close to the hearts of so many people around the world. Its brand and products inspire us to capture and share our lives’ most important moments. I’m excited to shape the future the incredible team at GoPro.”
About GoPro, Inc. (NASDAQ:GPRO) GoPro, Inc. is transforming the way people visually capture and share their lives. What began as an idea to help athletes self-document themselves engaged in their sport, GoPro has become a standard for how people capture themselves engaged in their interests, whatever they may be. From extreme to mainstream, professional to consumer, GoPro enables the world to capture and share its passion in the form of immersive and engaging content.
GOPRO® and HERO® are trademarks or registered trademarks of GoPro, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.
For more information, visit www.gopro.com or connect with GoPro on YouTube, Twitter, Facebook, Pinterest, Instagram, or LinkedIn.
(EMKR) Announces Favorable Ruling from Sumitomo Arbitration
Tribunal Finds in Favor of EMCORE and Awards Legal Fees of over $2.5 million
ALHAMBRA, Calif., April 13, 2016 — EMCORE Corporation (NASDAQ:EMKR), a leading provider of Indium Phosphide (InP) optical chips, components, subsystems and systems for the broadband and specialty fiber optics market, announced today the receipt of a favorable ruling from the International Court of Arbitration tribunal relating to its ongoing dispute with Sumitomo Electric Industries, Ltd. (“SEI”).
As previously disclosed, in September 2014, SEI filed for arbitration against the Company in connection with certain disputes arising out of the Company’s sale of assets to SEI in May 2012. SEI was seeking $47.5 million from EMCORE relating to numerous claims.
On April 12, 2016, a three member arbitration panel rejected SEI’s claims. The panel ruled that EMCORE owes SEI none of the amounts SEI sought in the arbitration and that the Company is entitled to collect the $1.9 million it is holding in escrow. The Company is also entitled to recover over $2.5 million in fees and costs. At December 31, 2015, EMCORE had accrued for $3.4 million of liabilities relating to potential claims, in addition to the $1.9 million it held in escrow for these claims.
About EMCORE
EMCORE Corporation designs and manufactures Indium Phosphide (InP) optical chips, components, subsystems and systems for the broadband and specialty fiber optics market. EMCORE was the pioneer in linear fiber optic transmission technology, and today is a leader in optical components, as well as a provider of complete end-to-end solutions for high-speed communications network infrastructures, enabling systems and service providers to meet growing demand for bandwidth and connectivity. EMCORE’s advanced optical technologies are designed for cable television (CATV) and fiber-to-the-premise (FTTP) networks, telecommunications and data centers, satellite communications, aerospace and defense, wireless networks, and broadcast and professional audio/video systems. With its world-class InP semiconductor wafer fabrication facility, EMCORE has fully vertically-integrated manufacturing capability and also provides contract design, foundry and component packaging services. EMCORE is headquartered in Alhambra, California with InP wafer fabrication operations in Alhambra, and ISO 9001 certified manufacturing in Alhambra and Langfang, China. For further information about EMCORE, visit http://www.emcore.com.
Contact:
EMCORE Corporation
Mark Weinswig
Chief Financial Officer
(626) 293-3400
Media
Joel Counter
Manager, Corporate Marketing Communications
(626) 999-7017
media@emcore.com
Investor
Erica Mannion
Sapphire Investor Relations, LLC
Phone: (617) 542-6180
investor@emcore.com
(RPRX) Announces Significant Data for Proellex Phase 2 Meeting with FDA
THE WOODLANDS, TX / April 13, 2016 / Repros Therapeutics Inc.® (NASDAQ: RPRX) reported that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.
The Company believes Proellex® represents a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. Once both the vaginal and oral studies complete both 18 week courses of treatment the Company plans to request an end of Phase 2 meeting with the FDA to jointly discuss plans for Phase 3.
We have compiled not only a look at this potential new drug but a fundamental and chart analysis for these securities.
There is no obligation to view the full report focusing on the potential for RPRX and a fundamental chart analysis- http://broadstreetalerts.com/repros-therapeutics-rprx/.
About Broad Street Alerts
We make the connection between sophisticated investors and emerging growth small-cap companies. We are an issuer of reports written by chartered financial analysts (CFA’s) and or market experts who provide an assessment of the profiled company and have pledged to provide factual up to date information in their research. They include stocks traded in the NYSE, NASDAQ, and OTC exchanges.
Safe Harbor Statement
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to anticipated revenues, expenses, earnings, operating cash flows, the outlook for markets and the demand for products. Forward-looking statements are no guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statements. Such statements are based upon, among other things, assumptions made by, and information currently available to, management, including management’s own knowledge and assessment of the Company’s industry and competition. The Company refers interested persons to its most recent Annual Report on Form 10-K and its other SEC filings for a description of additional uncertainties and factors, which may affect forward-looking statements. The company assumes no duty to update its forward-looking statements
Compliance Procedure
Content is researched, written and reviewed on a best-effort basis by a 3rd party research provider. However, we are only human and may make mistakes. This report was prepared for informational purposes only. A full disclaimer can be found by viewing the full analyst report. We do not hold any positions and have not been compensated in any form for this press release and research report. For more information and services provided beyond this press release please use contact information provided below. If you notice any errors or omissions, please notify us.
Contact: editor@BroadStreetAlerts.com
(CRMD) to Present Post-Market Clinical Utility Data from Neutrolin Program
Data to be Presented at the 53rd Joint Congress of the European Renal Association – European Dialysis and Transplant Association
BEDMINSTER, NJ / April 12, 2016 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced that Dr. Christoph Wanner, Professor of Medicine and Director of Nephrology at the University of Wurzburg, will deliver an oral presentation titled, “A Novel Taurolidine Containing Catheter Lock Solution (CLS) Without Reported Antimicrobial Resistance, Reduces the Rates of Infection and Thrombosis in Hemodialysis Patients Enrolled in a Post-Approval Surveillance Study” at the 53rd ERA-EDTA Congress to be held May 21-24, 2015, in Vienna, Austria.
Randy Milby, CorMedix CEO, said, “The Neutrolin Usage Monitoring Program data has produced valuable insights from real world use in the EU, where Neutrolin is approved for the reduction of catheter-related blood stream infections and thrombosis. We’ve shared some general data from the program, which has demonstrated positive results consistent with our trials that appear to validate Neutrolin’s clinical utility. We look forward to presenting a more formal analysis to this esteemed gathering of nephrologists.”
Data published in the abstract will be embargoed until the time of the presentation on Monday, May 23, 2016.
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that initiated a Phase 3 clinical study of a novel anti-infective solution, Neutrolin in hemodialysis patients in the United States in December 2015. The Company seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix’s first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. The FDA has granted Fast Track status to Neutrolin Catheter Lock Solution and also has designated Neutrolin as a Qualified Infectious Disease Product for oncology, hemodialysis, and critical care/intensive care patients, where catheter-related blood stream infections and clotting can be life-threatening. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world. For more information visit: www.cormedix.com.
For Investors & Media:
CorMedix
Maureen McEnroe, CFA: Maureen@machealthcare.com; (914) 588-1873
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of studies regarding Neutrolin® conducted by us and others; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix’s product candidates, including marketing of Neutrolin in countries other than Europe; the risks associated with the launch of Neutrolin in new markets; CorMedix’s ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix’s ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources; the outcome of clinical trials of CorMedix’s product candidates and whether they demonstrate these candidates’ safety and effectiveness; CorMedix’s ability to identify and enter into strategic transactions; CorMedix’s dependence on its collaborations and its license relationships; achieving milestones under CorMedix’s collaborations; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; CorMedix’s dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
(HPJ) Starts Shipments of Lithium Polymer Batteries to DJI
SAN FRANCISCO and SHENZHEN, China, April 12, 2016 — Highpower International, Inc. (“Highpower International” or “the Company”) (NASDAQ: HPJ), a developer, manufacturer, and marketer of lithium and nickel-metal hydride (Ni-MH) rechargeable batteries, and a battery management systems and battery recycling provider, today announced that the Company recently began to receive orders, and started shipping lithium polymer batteries to DJI, a globally recognized manufacturer of commercial and recreational unmanned aerial vehicles, or drones.
Highpower International has received DJI’s supplier qualification approval and began to provide lithium polymer batteries for its drones. The Company has provided its batteries for use in DJI’s Phantom 3 and Phantom 4 drone products and Highpower expects to develop its relationship with DJI further continuously.
Mr. George Pan, Chairman and Chief Executive Officer of Highpower International, stated, “We are pleased to have passed DJI’s requirements as a product manufacturer and supplier, which we feel is a strong verification of both our flexibility and capability to cover a wider spectrum of products at a global reach. We have worked with the leaders in innovative and developing technologies, including the expansion of drone technology for recreational use and commercial enterprises. Working with DJI is a significant milestone in Highpower’s lithium battery business development and represents a new and exciting segment. As a world-leading drone brand, DJI is famous for its cutting-edge technology and rigorous requirements for its products and suppliers. Considering Highpower’s comparative lithium battery advantages and DJI’s high-end technologies, we feel that this is a mutually beneficial relationship that could grow over time.”
About DJI
DJI is a leading manufacturer of commercial and recreational unmanned aerial vehicles for aerial photography and videography. Headquartered in Shenzhen, widely considered China’s Silicon Valley, DJI benefits from direct access to the suppliers, raw materials, and young, creative talent pool necessary for sustained success. Drawing on these resources, the company has grown from a single small office in 2006 to a global workforce of over 3,000. Its offices can now be found in the United States, Germany, the Netherlands, Japan, Beijing and Hong Kong. As a privately owned and operated company, DJI focuses on its own vision, supporting creative, commercial, and nonprofit applications of our technology. Today, DJI products are redefining industries. Professionals in filmmaking, agriculture, conservation, search and rescue, energy infrastructure, and more trust DJI to bring new perspectives to their work and help them accomplish feats safer, faster, and with greater efficiency than ever before.
About Highpower International, Inc.
Highpower International was founded in 2001 and produces high-quality Nickel-Metal Hydride (Ni-MH) and lithium-based rechargeable batteries used in a wide range of applications such as electric buses, bikes, energy storage systems, power tools, medical equipment, digital and electronic devices, personal care products, and lighting. Highpower’s target customers are Fortune 500 companies, and top 10 companies in each vertical segment. With advanced manufacturing facilities located in Shenzhen, Huizhou, and Ganzhou of China, Highpower is committed to clean technology, not only in the products it makes, but also in the processes of production. The majority of Highpower International’s products are distributed to worldwide markets mainly in the United States, Europe, China and Southeast Asia.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995 that are not historical facts. These statements can be identified by the use of forward-looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” or “anticipate” or the negative thereof or comparable terminology, and include discussions of the Company’s future performance, operations and products. Such statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from the results expressed or implied by such statements, including, our ability to successfully expand sales of our lithium battery product in the mobile device market and our ability to effectively compete in that market. For a discussion of these and other risks and uncertainties see “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s public filings with the SEC. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.
CONTACT:
Highpower International, Inc.
Sherry Chen
+86-755-8968-6521
ir@highpowertech.com
INVESTOR RELATIONS:
The Equity Group Inc.
In China
Katherine Yao, Senior Associate
+86-10-6587-6435
kyao@equityny.com
In U.S.
Adam Prior, Senior Vice President
(212) 836-9606
aprior@equityny.com
(LBTYB) to Hold General Meeting of Shareholders
Liberty Global plc (“Liberty Global”) (NASDAQ: LBTYA, LBTYB, LBTYK, LILA and LILAK) will be holding a General Meeting of Shareholders on Wednesday, April 20, 2016, beginning at 10:00 a.m. Mountain Time (5:00 p.m. BST) at the Four Seasons Hotel Denver, 1111 14th Street, Denver, Colorado 80202. This meeting has been scheduled in connection with its previously announced proposed acquisition (the “Acquisition”) of all outstanding issued and to be issued shares of Cable & Wireless Communications Plc (“CWC”) (LSE: CWC).
Only shareholders of record of Liberty Global Class A and Class B Ordinary Shares and LiLAC Class A and Class B Ordinary Shares as of 10:00 p.m. BST (5:00 p.m. Eastern time) on March 10, 2016, may vote at the General Meeting of Shareholders. The meeting will be webcast live at www.libertyglobal.com. We intend to archive the webcast under the investor relations section of our website for approximately 30 days.
Further Information
A copy of this announcement will be made available on Liberty Global’s website at www.libertyglobal.com.
This announcement is for information purposes only and is not intended to, and does not, constitute or form part of any offer, invitation, inducement or the solicitation of an offer to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of or exercise rights in respect of any securities, or the solicitation of any vote or approval of an offer to buy securities in any jurisdiction, pursuant to the Acquisition or otherwise, nor shall there be any sale, issuance or transfer of securities of CWC or Liberty Global pursuant to the Acquisition in any jurisdiction in contravention of applicable law.
This announcement does not constitute a prospectus or prospectus-equivalent document.
Investors should note that, in connection with the Acquisition, Liberty Global is required to disclose, which may be on a daily basis, certain information about its share buyback program and capital structure, as well as other information relating to Liberty Global and the Acquisition. This information may be material to investors in connection with the Acquisition. This information will be posted on our website and will be released through the Regulatory News Service in the UK, as required by the Code. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on our website, as well as through the Regulatory News Service, which can be accessed here:
http://www.londonstockexchange.com/exchange/news/market-news/market-news-home.html.
Overseas Jurisdictions
This announcement has been prepared for the purpose of complying with English law, the Code and the Listing Rules of the Financial Conduct Authority and the information disclosed may not be the same as that which would have been disclosed if this announcement had been prepared in accordance with the laws of jurisdictions outside the United Kingdom.
Copies of this announcement and any formal documentation relating to the Acquisition are not being, and must not be, directly or indirectly, mailed or otherwise forwarded, distributed or sent in or into or from any Restricted Jurisdiction and persons receiving such documents (including custodians, nominees and trustees) must not mail or otherwise forward, distribute or send them in or into or from any Restricted Jurisdiction.
Securities to be issued pursuant to the Acquisition have not been and will not be registered under the relevant securities laws of Japan and the relevant clearances have not been, and will not be, obtained from the securities commission of any province of Canada. No prospectus in relation to the securities to be issued pursuant to the Acquisition has been, or will be, lodged with, or registered by, the Australian Securities and Investments Commission. Accordingly, such securities are not being, and may not be, offered, sold, resold, delivered or distributed, directly or indirectly in or into Australia, Canada or Japan or any other jurisdiction if to do so would constitute a violation of relevant laws of, or require registration thereof in, such jurisdiction (except pursuant to an exemption, if available, from any applicable registration requirements or otherwise in compliance with all applicable laws).
Therefore, any persons who are subject to the laws and regulations of any jurisdiction other than the United Kingdom or who are not resident in the United Kingdom should inform themselves about and observe any applicable requirements in their jurisdiction. Any failure to comply with the applicable requirements may constitute a violation of the laws and/or regulations of any such jurisdiction. None of the securities referred to in this announcement have been approved or disapproved by the SEC, any state securities commission in the United States or any other US regulatory authority, nor have such authorities passed upon or determined the adequacy or accuracy of the information contained in this announcement. Any representation to the contrary is a criminal offence in the United States.
Additional Information for Liberty Global Shareholders
This announcement may be deemed to be solicitation material in respect of the approvals sought at the Liberty Global General Meeting, including the issuance of Liberty Global Shares. The Company’s definitive proxy statement filed with the SEC on March 14, 2016, and other relevant materials in connection with the Acquisition (when they become available), and any other documents filed by Liberty Global with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, shareholders may obtain free copies of the documents filed with the SEC at Liberty Global’s website, http://www.libertyglobal.com, or by contacting Liberty Global’s Investor Relations department in writing at Liberty Global, 1550 Wewatta Street, Suite 1000, Denver, Colorado 80202, USA. SHAREHOLDERS OF LIBERTY GLOBAL SHOULD READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE ACQUISITION THAT LIBERTY GLOBAL FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION.
Additional Information for CWC Shareholders
The Liberty Global Shares to be issued under the Acquisition have not been, and are not expected to be, registered under US Securities Act or under the securities laws of any state or other jurisdiction of the United States. It is expected that the Liberty Global Shares will be issued pursuant to the Scheme in reliance upon an exemption from the registration requirements of the US Securities Act set forth in Section 3(a)(10) thereof. CWC Shareholders (whether or not US persons) who are or will be affiliates (within the meaning of Rule 144 under the US Securities Act) of Liberty Global prior to, or after, the Effective Date will be subject to certain US transfer restrictions relating to the Liberty Global Shares received pursuant to the Scheme. Specifically, Liberty Global Shares delivered to such affiliated CWC Shareholders may not be offered, sold, resold, delivered, distributed or otherwise transferred, directly or indirectly, absent registration under the US Securities Act or an exemption therefrom.
About Liberty Global
Liberty Global is the largest international cable company with operations in 14 countries. We connect people to the digital world and enable them to discover and experience its endless possibilities. Our market-leading products are provided through next-generation networks and innovative technology platforms that connected 27 million customers subscribing to 57 million television, broadband internet and telephony services at December 31, 2015. In addition, we served five million mobile subscribers and offered WiFi service across six million access points.
Liberty Global’s businesses are currently attributed to two tracking stock groups: the Liberty Global Group (NASDAQ: LBTYA, LBTYB and LBTYK), which primarily comprises our European operations, and the LiLAC Group (NASDAQ: LILA and LILAK, OTC Link: LILAB), which comprises our operations in Latin America and the Caribbean.
Liberty Global’s consumer brands are Virgin Media, Ziggo, Unitymedia, Telenet, UPC, VTR and Liberty. Our operations also include Liberty Global Business Services and Liberty Global Ventures. For more information, please visit www.libertyglobal.com.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION
THE FOLLOWING ANNOUNCEMENT IS AN ADVERTISEMENT AND NOT A PROSPECTUS OR PROSPECTUS EQUIVALENT DOCUMENT AND INVESTORS SHOULD NOT MAKE ANY INVESTMENT DECISION IN RELATION TO THE LIBERTY GLOBAL GROUP CLASS A ORDINARY SHARES, THE LIBERTY GLOBAL GROUP CLASS C ORDINARY SHARES, THE LILAC GROUP CLASS A ORDINARY SHARES OR THE LILAC GROUP CLASS C ORDINARY SHARES, EXCEPT ON THE BASIS OF THE INFORMATION IN THE SCHEME DOCUMENT, THE PROSPECTUS AND THE PROXY STATEMENT.
Liberty Global
Investor Relations:
Oskar Nooij, +1 303 220 4218
or
Christian Fangmann, +49 221 8462 5151
or
John Rea, +1 303 220 4238
or
Corporate Communications:
Matt Beake, +44 20 8483 6428
or
Aimee Baxter, +1 646 561 3512
(RPRX) Reports Positive Clinical Data for Vaginal Proellex®
- Primary endpoint of induction of amenorrhea met for both vaginal doses compared to placebo, p<0.0011
- Proellex®-treated subjects reported a median 100% reduction in diary reports of menstrual bleeding product usage (PBAC)
- Statistically significant reduction in fibroid size from baseline achieved for the combined active arms compared to increase in fibroid volume in placebo arm, p=0.0437
- Low dose oral data from a comparable study to be reported in Q2 2016
THE WOODLANDS, Texas, April 12, 2016 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported that vaginal administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.
Normal menstrual blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this small Phase 2b study, 13, 15 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and placebo arms, respectively. At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. The blood loss ranged from a low of 94 mL to a high of 654 mL. The most severe menstrual bleeding at baseline was observed in the 12 mg group. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.
When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. Just over half, 52%, of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. All subjects treated with Placebo continued to menstruate throughout the 18 week dosing period. The p-value for this comparison is 0.0011. Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex® and Placebo.
Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart). Subjects tallied sanitary product usage and stain size as guided by the chart. Proellex®-treated subjects reported a median 100% reduction in PBAC scores while Placebo-treated subjects reported a 25.4% reduction, further supporting the treatment affect associated with bleeding (p=0.0033).
Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex®-treated arms by 18% while the Placebo group showed continued increase in size, p= 0.0437.
The drug was generally well tolerated. Women in the drug arms continued to exhibit levels of estradiol consistent with bone preservation.
After the first 18 week treatment period, the women were withdrawn from drug to allow for menses. The women in the study are currently being treated with the second course of treatment for another 18 weeks. The study treatment assignment remains blinded to the subjects, physicians and those managing the study and data. The results of the second course of treatment should be reported within the next 5 months.
The Company believes Proellex® represents a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. Once both the vaginal and oral studies complete both 18 week courses of treatment the Company plans to request an end of Phase 2 meeting with the FDA to jointly discuss plans for Phase 3.
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to ongoing and future clinical studies and the timing and results thereof, the Company’s plans to communicate with the FDA, possible submission of one or more NDAs and the commercial potential of Proellex®, risks relating to the Company’s ability to protect its intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
(CNCK) Partners With All-Natural Leaner Creamer to Promote a Healthier Java Habit
LOS ANGELES, CA–(Apr 12, 2016) – Content Checked Holdings, Inc. (OTCQB: CNCK) (“Content Checked”), a creator of mobile applications for people with dietary restrictions, today announced a partnership with Leaner Creamer, the only all-natural powdered coffee creamer that promotes weight loss and appetite suppression. The partnership will entail a cross-promotional marketing campaign that will further elevate both parties with health conscious audiences promoting sales and overall brand awareness.
“We are thrilled to be working with Leaner Creamer as it aligns directly with our mission — to better the lives of individuals with dietary restrictions,” said Kris Finstad, CEO and founder of Content Checked. “We truly believe that this healthier alternative will aid in better nutrition habits and weight loss for individuals who are seeking a viable alternative to traditional, calorie-rich, dairy-based creamers.”
Content Checked will leverage Leaner Creamer’s extensive social media presence and celebrity endorsements to further its brand and help drive traffic to its website and encourage downloads. Leaner Creamer will align with Content Checked’s platform, backed by nutritionists, to highlight the product’s all-natural, coconut oil-based blend of citrus aurantium extract, hoodia and green tea extract which promote weight loss.
“With a quick scan-in, Content Checked lets consumers find products that fit within their lifestyle, worry free,” said Jonathan Kashani, CEO of Leaner Creamer. “As a product designed specifically for individuals with gluten and lactose intolerances, we are so proud to be working hand-in-hand to empower consumers as they. make healthier choices.”
About Leaner Creamer
Leaner Creamer LLC is a family owned company headquartered in Los Angeles, California. They are innovators in the diet and health industry, dedicated to providing healthy and delicious alternatives to creamers that are high in fat and laden with chemicals. Leaner Creamer LLC maintains an uncompromising commitment to quality and to promoting health.
About Content Checked
Content Checked Holdings, Inc. (www.contentchecked.com) has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications. ContentChecked and MigraineChecked are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for over 70% of conventional U.S. food products.
Each app gives consumers the ability to scan a product’s bar code and determine if it is safe for consumption based on their allergy settings. The apps will recommend a suitable alternative if a product does contain one or more of a user’s allergens. This enables the applications to meet the needs of millions of people in the U.S. In the U.S. alone, there are more than 15 million people who suffer from food allergies and 38 million people who suffer from migraines and chronic headaches. The food allergy and intolerances market has been valued at approximately US$13 billion in 2015. As a result, Content Checked has created a pivotal way for food manufacturers and producers to showcase their products to consumers who are actively seeking them at the point of purchase.
Content Checked has created a robust database of allergens, migraine triggers and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database, updated regularly. All applications serve as easy shopping tools for consumers to decipher often misleading food labels and receive recommendations for healthier alternative products as they shop in real time. Content Checked’s mission is to offer fast, reliable and efficient mobile apps that help consumers make more informed purchasing decisions and live healthier lives in accordance to their dietary preferences.
For more information on the Company, please visit its social media channels via Facebook (www.facebook.com/contentchecked), (www.facebook.com/migrainechecked) and (www.facebook.com/sugarchecked); Instagram (www.instagram.com/contentchecked), (www.instagram.com/migrainechecked) and (www.instagram.com/sugarchecked); or
YouTube (www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ).
Media Contact:
Aly Crea
aly@pmcgroup.com
310-777-7546
(VKTX) Presents Positive Phase 1b Clinical Data on VK2809
Novel Oral Thyroid Receptor Agonist Triggers Substantial and Clinically Meaningful Reductions in LDL Cholesterol, Triglycerides and Key Atherogenic Proteins Presentation Receives “Best Poster” Award from ACC Conference
SAN DIEGO, April 11, 2016 — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today highlighted positive data from a Phase 1b clinical trial of VK2809 in subjects with mild hypercholesterolemia, presented at the 65th Annual Scientific Session & Expo of the American College of Cardiology (ACC). The results demonstrated substantial and clinically meaningful reductions in subjects’ low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic proteins lipoprotein-a and apolipoprotein B following 14 days of treatment. VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in this patient population.
The randomized, double-blind, placebo-controlled Phase 1b study was designed to evaluate the safety, tolerability and pharmacokinetics of VK2809, at a range of doses, in 56 subjects with elevated serum cholesterol (n = 6 per drug-treated cohort). Following 14 days of VK2809 treatment, subjects demonstrated clinically and statistically significant placebo-adjusted reductions in LDL-C ranging from 15.2% at the 5.0 mg dose (p=0.026) to 41.2% at the 20 mg dose (p<0.0001). In addition, subjects experienced placebo-adjusted reductions in triglycerides ranging from 34.8% at 5.0 mg dose (p=0.052) to 78.6% at the 40 mg dose (p=0.0001). Significant reductions in lipoprotein-a and apolipoprotein B were also observed, with declines of 30% or more reported at all doses above 2.5 mg.
Treatment with VK2809 was also shown to be safe and well-tolerated at all doses studied. No serious adverse events were reported and no treatment- or dose-related trends were observed for abnormal vital signs, electrocardiograms, cardiac rhythm or physical examination assessments. Consistent with liver-targeted thyroid receptor activation, mild, asymptomatic elevations in liver enzymes and decreased thyroid hormone levels were observed at higher doses. Metabolically, VK2809 was not eliminated intact through the kidneys, and less than 3% of the administered dose was eliminated through the kidneys as the drug’s active metabolite, VK2809A.
“We believe these results provide compelling preliminary evidence of VK2809’s efficacy in this important indication. The observed statistically significant effects in a trial of this size and duration are quite promising and demonstrate the potential therapeutic benefits of thyroid receptor modulation for lipid dysregulation,” said Brian Lian, Ph.D., chief executive officer of Viking. “These data, combined with VK2809’s novel liver-targeted delivery and mechanism of action, as well as prior in vivo data demonstrating robust reductions in hepatic fat content, provide a strong rationale for applications in settings such as hypercholesterolemia and fatty liver disease. We believe that receipt of a Best Poster award from a conference of this stature reinforces the potential importance of the results. We are focused on further establishing the safety and efficacy profile of VK2809 and continue to prepare for our upcoming Phase 2 clinical trial, which we expect to initiate mid-year.”
Viking is currently planning to initiate a Phase 2 clinical trial of VK2809 in patients with hypercholesterolemia and fatty liver disease. The Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and fatty liver disease.
About VK2809
VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor entering Phase 2 development for the treatment of patients with hypercholesterolemia and fatty liver disease. VK2809 belongs to a family of novel prodrugs which are cleaved in vivo to release potent thyromimetics. Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of low-density lipoprotein (LDL) receptors and increasing mitochondrial fatty acid oxidation. These characteristics suggest a highly differentiated therapeutic profile relative to existing oral options for patients with hypercholesterolemia and fatty liver disease, such as nonalcoholic steatohepatitis (NASH). The potential markets for these indications are significant. In the U.S., approximately 33% of adults, or 71 million people, have elevated LDL cholesterol. Additionally, NASH is rapidly becoming a leading cause of cirrhosis and liver failure and affects an estimated 6 to 15 million Americans.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist entering Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
Forward Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking’s expectations regarding the company’s proposed Phase 2 clinical trial for VK2809, as well as VK2809’s potential to produce therapeutic benefits. Forward-looking statements are subject to risks and uncertainties that 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: risks associated with the success, cost and timing of Viking’s product candidate development activities and clinical trials; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements.
(ASM) announces Q1 2016 production results
NYSE-MKT: ASM
TSX-V: ASM
FSE: GV6
VANCOUVER, April 11, 2016 – Avino Silver & Gold Mines Ltd. (ASM: TSX-V, ASM: NYSE–MKT, GV6: FSE, “Avino” or “the Company”) is pleased to report its first quarter 2016 production results from its Avino property near Durango, Mexico.
Consolidated Production Highlights for First Quarter 2016 (Compared to First Quarter 2015)
- Silver equivalent production increased by 10% to 715,933 oz*
- Silver production increased by 11% to 403,447 oz
- Gold production decreased by 14% to 1,497 oz
- Copper production increased by 55% to 1,350,912 Lbs
| * For comparison purposes, the silver equivalent ratio has been calculated using metal prices of $14.84 oz Ag, $1,180 oz Au and $2.12 Lb Cu. Mill production figures have not been reconciled and are subject to adjustment with concentrate sales. Calculated figures may not add up due to rounding. |
With a steady first quarter behind us, 2016 is shaping up to be a solid year for Avino. Our operations team delivered another quarter of consistent production and development at the San Gonzalo and Avino Mines respectively, putting us in a strong position to achieve our goals for the year. In 2016 our objectives are to continue to focus on efficient operations including improving recovery rates, meeting production targets, controlling costs and transitioning the Avino Mine from the development phase to underground mining. Underground Mining commenced on April 1 on upper level 11.5 using the long-hole sub-level caving method, which is a cost effective method of extraction.
David Wolfin, President, CEO & Director, Avino Silver & Gold Mines Ltd.
Consolidated First Quarter 2016 Production Highlights
Comparative production results from the first quarter 2016 and the first quarter 2015 are presented below:
| Q12016 | Q12015 | % Change | |
| Total Silver Produced (oz) calculated | 403,447 | 363,210 | 11% |
| Total Gold Produced (oz) calculated | 1,497 | 1,750 | -14% |
| Total Copper Produced (Lbs) calculated | 1,350,912 | 872,884 | 55% |
| Total Silver Eq. Produced (oz) calculated* | 715,933 | 652,619 | 10% |
| * For comparison purposes, the silver equivalent ratio has been calculated using metal prices of $14.84 oz Ag, $1,180 oz Au and $2.12 Lb Cu. Mill production figures have not been reconciled and are subject to adjustment with concentrate sales. Calculated figures may not add up due to rounding. |
Avino Mine First Quarter 2016 Production Highlights
Comparative figures for the first quarter 2016 and the first quarter 2015 for the Avino Mine are as follows; production figures for the first quarter 2016 include production from Mill Circuit 2 and Mill Circuit 3:
| Q12016 | Q12015 | QuarterlyChange % | Notes | |
| Tonnes Mined | 99,199 | 36,318 | 173% | 1 |
| Underground Advancement (m) | 1,143 | 980 | 17% | 1 |
| Mill Availability (%) | 97 | 96 | 1% | 2 |
| Total Mill Feed (dry tonnes) | 119,515 | 76,547 | 56% | 2 |
| Feed Grade Silver (g/t) | 68 | 64 | 6% | 4 |
| Feed Grade Gold (g/t) | 0.27 | 0.36 | -26% | 5 |
| Feed Grade Copper (%) | 0.58 | 0.58 | 0% | 3 |
| Recovery Silver (%) | 87% | 89% | -3% | 4 |
| Recovery Gold (%) | 67% | 82% | -18% | 5 |
| Recovery Copper (%) | 89% | 89% | 0% | 3 |
| Copper Concentrate (dry tonnes) | 2,712 | 1,775 | 53% | 3 |
| Copper Concentrate Grade Silver (kg/t) | 2.60 | 2.46 | 5% | 4 |
| Copper Concentrate Grade Gold (g/t) | 7.87 | 12.61 | -38% | 5 |
| Copper Concentrate Grade Copper (%) | 22.6 | 22.3 | 1% | 3 |
| Total Silver Produced (kg) | 7,038 | 4,371 | 61% | 4 |
| Total Gold Produced (g) | 21,353 | 22,391 | -5% | 5 |
| Total Copper Produced (Kg) | 612,764 | 395,934 | 55% | 3 |
| Total Silver Produced (oz) calculated | 226,264 | 140,518 | 61% | 4 |
| Total Gold Produced (oz) calculated | 687 | 720 | -5% | 5 |
| Total Copper Produced (Lbs) calculated | 1,350,912 | 872,884 | 55% | 3 |
| Total Silver Equivalent Produced (oz) calculated* | 474,206 | 319,216 | 48% | 6 |
| * For comparison purposes, the silver equivalent ratio has been calculated using metal prices of $14.84 oz Ag, $1,180 oz Au and $2.12 Lb Cu. Mill production figures have not been reconciled and are subject to adjustment with concentrate sales. Calculated figures may not add up due to rounding. |
.
First Quarter 2016 Highlights
- Tonnes mined and metres advanced increased by 173% and 17% respectively as there were more working faces available in the first quarter of 2016 compared to 2015; also there was an additional jumbo available in 2016.
- Tonnes processed for the quarter increased by 56% over the first quarter of 2015. The additional tonnage was mainly from the use of Mill Circuit 2 to process Avino material in addition to Mill Circuit 3 . Also, the slightly higher mill availability resulted in an increased throughput.
- Concentrate tons and copper produced increased by 53% and 55% respectively due to the higher tonnage processed, as there was no change to the feed grade and recovery for copper, and only a slight change to the concentrate grade.
- Silver production increased by 61% on account of the higher feed grade and higher tonnage processed despite lower recoveries.
- Gold production decreased by 5%, mainly due to lower feed grade and recovery. Mining in the first quarter occurred in an area where the gold grades are typically low.
- All the above resulted in 48% more silver equivalent ounces produced compared to the first quarter of 2015.
San Gonzalo Mine First Quarter 2016 Production Highlights
Comparative figures for the first quarter 2016 and the first quarter 2015 for the San Gonzalo mine are as follows:
| Q12016 | Q12015 | QuarterlyChange % | Notes | |
| Tonnes Mined | 24,402 | 26,712 | -9% | 1 |
| Underground Advancement (m) | 1,183 | 1,181 | 0% | 1 |
| Mill Availability (%) | 95 | 95 | 0% | 1 |
| Total Mill Feed (dry tonnes) | 20,601 | 18,809 | 10% | 2 |
| Feed Grade Silver (g/t) | 318 | 308 | 3% | 5 |
| Feed Grade Gold (g/t) | 1.49 | 1.54 | -4% | 4 |
| Recovery Silver (%) | 84 | 84 | 0% | 5 |
| Recovery Gold (%) | 82 | 75 | 7% | 4 |
| Bulk Concentrate (dry tonnes) | 800 | 607 | 32% | 3 |
| Bulk Concentrate Grade Silver (kg/t) | 6.85 | 8.02 | -15% | 3 |
| Bulk Concentrate Grade Gold (g/t) | 27 | 35.9 | -25% | 3 |
| Total Silver Produced (kg) | 5,511 | 4,871 | 13% | 5 |
| Total Gold Produced (g) | 25,193 | 21,789 | 16% | 4 |
| Total Silver Produced (oz) calculated | 177,183 | 156,606 | 13% | 5 |
| Total Gold Produced (oz) calculated | 810 | 701 | 16% | 4 |
| Total Silver Equivalent Produced (oz) calculated* | 241,727 | 212,346 | 14% | 6 |
| * For comparison purposes, the silver equivalent ratio has been calculated using metal prices of $14.84 oz Ag, $1,180 oz Au and $2.12 Lb Cu. Mill production figures have not been reconciled and are subject to adjustment with concentrate sales. Calculated figures may not add up due to rounding. |
First Quarter 2016 Highlights
- First Quarter tonnage mined was within budget even though it was 9% lower than the same quarter last year. There was no change in underground metres advanced and mill availability.
- Tonnage processed also was within budget but increased by 10% due to the ball mill being relined during the corresponding quarter last year.
- Bulk concentrate tonnage produced increased by 32%. The increase in tonnage was due to the lower silver and gold grades in the concentrate which were 15% and 25% lower, respectively.
- Gold production increased by 16% due to the 7% improvement in recovery as a result of the use of a gravity concentrator.
- Silver production increased by 13% due to higher tonnage processed and higher feed grade; there was no change in the silver recovery.
- All the above resulted in a 14% increase in silver equivalent ounces produced during the quarter.
Quality Assurance/Quality Control
Mill assays are performed at the Avino property’s on-site lab. Check samples are sent to Inspectorate Labs in Reno, Nevada for verification. All concentrate shipments are assayed by one of the following independent third party labs: AHK, LSI, Alex Stewart and SGS.
Qualified Person(s)
Avino’s Mexican projects are under the supervision of Chris Sampson, P.Eng, Avino consultant and Jasman Yee P.Eng, Avino director, who are both qualified persons within the context of National Instrument 43-101. Both have reviewed and approved the technical data in this news release.
About Avino
Avino’s mission is to create shareholder value through profitable organic growth at the historic Avino property near Durango, Mexico, and the Bralorne property in southwestern British Columbia, Canada. We are committed to managing all business activities in an environmentally responsible and cost-effective manner while contributing to the well-being of the communities in which we operate.
ON BEHALF OF THE BOARD
“David Wolfin”
________________________________
David Wolfin
President & CEO
Avino Silver & Gold Mines Ltd.
Safe Harbor Statement – This news release contains “forward-looking information” and “forward-looking statements” (together, the “forward looking statements”) within the meaning of applicable securities laws and the United States Private Securities Litigation Reform Act of 1995, including our belief as to the extent and timing of various studies including the PEA, exploration results, the potential tonnage, grades and content of deposits, and timing, establishment and extent of resource estimates. These forward-looking statements are made as of the date of this news release and the dates of technical reports, as applicable. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated in or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. While we have based these forward-looking statements on our expectations about future events as at the date that such statements were prepared, the statements are not a guarantee that such future events will occur and are subject to risks, uncertainties, assumptions and other factors which could cause events or outcomes to differ materially from those expressed or implied by such forward-looking statements.
Such factors and assumptions include, among others, the effects of general economic conditions, the price of gold, silver and copper, changing foreign exchange rates and actions by government authorities, uncertainties associated with legal proceedings and negotiations and misjudgments in the course of preparing forward-looking information. In addition, there are known and unknown risk factors which could cause our actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Known risk factors include risks associated with project development; the need for additional financing; operational risks associated with mining and mineral processing; fluctuations in metal prices; title matters; uncertainties and risks related to carrying on business in foreign countries; environmental liability claims and insurance; reliance on key personnel; the potential for conflicts of interest among certain of our officers, directors or promoters with certain other projects; the absence of dividends; currency fluctuations; competition; dilution; the volatility of our common share price and volume; tax consequences to U.S. investors; and other risks and uncertainties. Although we have attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. We are under no obligation to update or alter any forward-looking statements except as required under applicable securities laws.
Cautionary Note to United States Investors – The information contained herein and incorporated by reference herein has been prepared in accordance with the requirements of Canadian securities laws, which differ from the requirements of United States securities laws. In particular, the term “resource” does not equate to the term “reserve”. The Securities Exchange Commission’s (the “SEC”) disclosure standards normally do not permit the inclusion of information concerning “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” or other descriptions of the amount of mineralization in mineral deposits that do not constitute “reserves” by SEC standards, unless such information is required to be disclosed by the law of the Company’s jurisdiction of incorporation or of a jurisdiction in which its securities are traded. U.S. investors should also understand that “inferred mineral resources” have a great amount of uncertainty as to their existence and great uncertainty as to their economic and legal feasibility. Disclosure of “contained ounces” is permitted disclosure under Canadian regulations; however, the SEC normally only permits issuers to report mineralization that does not constitute “reserves” by SEC standards as in place tonnage and grade without reference to unit measures.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
(AMRS) Creates Program to Reduce the Cost and Increase Access to Leading Malaria Treatment
EMERYVILLE, Calif., April 11, 2016 — Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced the signing of a stock purchase agreement for a $5-million equity investment from the Bill & Melinda Gates Foundation. The investment is to fund a program to further reduce the cost of one of the world’s leading malaria treatments so that no child has to go without treatment for malaria. The program will focus on the continued production of high-quality and secure supplies of artemisinic acid and amorphadiene to be converted to artemisinin for use in artemisinin combination therapies (“ACTs”). ACTs are recommended by the World Health Organization (“WHO”) as the primary first-line treatment for malaria.
“We are very pleased with the Gates Foundation’s commitment to eradicating Malaria and are happy to be a part of this effort,” said John Melo, Amyris President & CEO. “We believe in a world where no child should go untreated and that no parent should have to make a choice between treating their child or feeding their family. Lower cost and sustainably-produced artemisinin is a key part of the spectrum of solutions that can help eradicate this disease from our planet.”
Continued Melo, “It is only through the work of public-private partnerships that these solutions can occur. With an advanced and proven platform, Amyris’s technology can, among other things, be used to accelerate drug discovery cost effectively while improving the global supply of important pharmaceuticals. And, we believe it is also poised to help leading pharmaceutical companies respond rapidly to pandemic crises, making the world a safer place for all of us.”
Amyris’s founding purpose was to demonstrate that biotechnology can be used to help solve some of the world’s most pressing problems, such as those outlined in the UN’s overall Millennium Development Goals. The company’s first major milestone came in 2005 when Amyris’s scientists developed technology capable of creating microbial strains to produce artemisinic acid.
Leading Science Recognized by the United Nations for Supporting Global Goals
Amyris was recognized in 2015 with a United Nations Global Citizen Award based on its contributions toward several aspects of the UN’s overall Millennium Development Goals, which are aligned toward reversing the global poverty, hunger and disease affecting billions of people. Among these contributions was the development of a synthetic source for the production of artemisinin.
Financial Details
Under the stock purchase agreement, the Gates Foundation agreed to purchase approximately $5 million of Amyris common stock at $1.14 per share, the average of the daily closing price per share of the common stock on NASDAQ for the twenty days prior to signing. Amyris expects the closing to occur on or about April 29, 2016, subject to customary closing conditions. Additional details of the transaction and a description of the securities are included in a related Current Report on Form 8-K, which the company filed today with the Securities and Exchange Commission (SEC) in conjunction with this news release.
About Amyris
Amyris is the integrated renewable products company that is enabling the world’s leading brands to achieve sustainable growth. Amyris applies its innovative bioscience solutions to convert plant sugars into hydrocarbon molecules, specialty ingredients and consumer products. The company is delivering its No Compromise® products in focused markets, including specialty and performance chemicals, fragrance ingredients, and cosmetic emollients. More information about the company is available at www.amyris.com.
Forward-Looking Statements
This release contains forward-looking statements, and any statements other than statements of historical facts could be deemed to be forward-looking statements. These forward-looking statements include, among other things, statements regarding future events (such as the company’s expectation that the closing of the transaction will occur on or about April 29, 2016 subject to closing conditions, ability to accelerate drug discovery cost effectively while improving global supply and for the company’s technology platform to be leveraged by leading pharmaceutical companies to rapidly respond to pandemic crisis) that involve risks and uncertainties. These statements are based on management’s current expectations and actual results and future events may differ materially due to risks and uncertainties, including risks related to satisfaction of closing conditions set forth in the purchase agreement, manufacturing capacity at Amyris’s Brotas facility, delays or failures in development, production and commercialization of products, liquidity and ability to fund capital expenditures, Amyris’s reliance on third parties to achieve its goals, and other risks detailed in the “Risk Factors” section of Amyris’s quarterly report on Form 10-K filed on March 30, 2016. Amyris disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events, or otherwise.
Amyris is a registered trademark of Amyris, Inc. All other trademarks are trademarks of their respective holders.
Peter DeNardo Director, Investor Relations and Corporate Communications Amyris, Inc. +1 (510) 740-7481 investor@amyris.com pr@amyris.com
(MNKD) to Discuss U.S. Commercialization Update for Afrezza®
– Analyst Call Scheduled for April 19, 2016 at 5:00 PM EDT –
VALENCIA, Calif., April 11, 2016 — MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) will host an analyst call for the investment community to learn about the company’s general commercialization strategy in the US for Afrezza® (insulin human) Inhalation Powder. MannKind has recently assumed responsibility for the worldwide development and commercialization of Afrezza from Sanofi and will begin to distribute Afrezza in the third quarter. Until that time, Sanofi will continue to distribute Afrezza from its existing inventory of product.
To participate in the live call by telephone, please dial (888) 224-7957 or (303) 223-4394 and use the participant passcode: 21809665. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at http://www.mannkindcorp.com.
A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (800) 633-8284 or (402) 977-9140 and use the participant passcode: 21809665. A replay will also be available on MannKind’s website for 14 days.
MannKind’s Chief Executive Officer, Matthew J. Pfeffer, and Chief Commercial Officer, Michael E. Castagna, will discuss the strategic commercial approach for Afrezza in the U.S. The discussion will include plans for sales and marketing of Afrezza, including reimbursement and access programs for patients, marketing programs and expansion plans. Timelines for relaunch activities will also be discussed.
MannKind plans to report quarterly earnings on May 9, 2016 and will discuss financial results of the first quarter of 2016 and future financial projections for the remainder of 2016 and beyond at that time.
INDICATION
Prescription Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin used to treat adults with diabetes for the control of high blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for long-acting insulin; Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
- Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza.
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD.
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.
You must test your blood sugar levels while using insulin, such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor’s care.
The most common side effect of insulin, including Afrezza® (insulin human) Inhalation Powder, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.
Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breast-feeding or planning to breast-feed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.
Please see full Prescribing Information for Afrezza, including Boxed WARNING and www.afrezza.com.
About Afrezza®
Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of 4 unit, 8 unit and 12-unit cartridges. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding MannKind’s ability to directly commercialize Afrezza and the commercial potential of Afrezza. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability to generate significant product sales for MannKind, difficulties or delays in obtaining regulatory feedback or completing and analyzing the results of clinical studies, MannKind’s ability to manage its existing cash resources or raise additional cash resources, stock price volatility and other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
Company Contact: Rose Alinaya SVP, Finance 661-775-5300 ralinaya@mannkindcorp.com
(UEPS) Announces $107 Million Equity Investment by IFC, IFC Asset Management
JOHANNESBURG, SOUTH AFRICA–(April 11, 2016) – Net 1 UEPS Technologies, Inc. (“Net1” or the “Company”) (NASDAQ: UEPS) (JSE: NT1) today announced that it has entered into an agreement with International Finance Corporation and certain funds managed by IFC Asset Management Company (collectively, “IFC”) pursuant to which IFC has agreed to subscribe for 9.98 million shares of the Company’s common stock at a subscription price of $10.79 per share, for total proceeds of $107.7 million. The subscription price represents a 20,6% premium over the closing price of the Company’s shares on Nasdaq on April 8, 2016. IFC will have an 18% interest in the Company following the transaction. Net1 will use the proceeds of the IFC investment primarily for the expansion of its business and technological solution in emerging markets across the globe.
IFC is a member of the World Bank Group and is the largest global development institution focused on the private sector in emerging markets. IFC has been investing in disruptive technologies around the world to help expand access to financial services and as of March 2016 had invested approximately $180 million in 26 financial technology companies around the world, servicing over 220 million people. This is on top of billions of dollars already invested in its successful, decades-long program in support of traditional banks and microfinance institutions.
Closing of the investment is expected to occur during the month of April. IFC will have the right to nominate an independent director to the Net1 board.
“IFC’s equity investment in Net1 represents a landmark moment for the Company,” said Serge Belamant, Chairman and CEO of Net1. “We are honored that IFC has selected Net1 for its largest investment ever in the financial technology sector. IFC’s investment recognizes the achievements, disruptive technologies and business model of the Company and its employees. We are completely aligned with IFC through our shared vision of providing financial inclusion to the billions of unbanked and under-banked citizens of the world and we look forward to the opportunities presented by IFC’s expansive global network and expertise,” he concluded.
Atul Mehta, IFC Director of Telecoms, Media and Technology, said: “Net1 has created impressive propriety technology for the delivery of services and demonstrated its effectiveness in South Africa. IFC and IFC AMC’s funds’ investments will help Net1 expand regionally, especially into African countries where there is limited banking infrastructure and availability of financial services for the poorest segments of the population.”
Gavin E.R. Wilson, CEO of IFC Asset Management Company, said: “Our investment in Net1 recognizes the Company’s demonstrated ability to provide efficient payments services to the unbanked and underbanked in South Africa while innovating in commercially viable ways. Our goal is to help Net1 use its technology to broaden its product offering and expand its customer base to other countries.”
About Net1 (www.net1.com)
Net1 is a leading provider of alternative payment systems that leverage its Universal Electronic Payment System (“UEPS”) or utilize its proprietary mobile technologies. The Company operates market-leading payment processors in South Africa and the Republic of Korea. Through Transact24, Net1 offers debit, credit and prepaid processing and issuing services for Visa, MasterCard and ChinaUnionPay in China and other territories across Asia-Pacific, Europe and Africa, and the United States. Through Masterpayment, Net1 provides payment processing and enables working capital financing in Europe.
UEPS permits the Company to facilitate biometrically secure, real-time electronic transaction processing to unbanked and under-banked populations of developing economies around the world in an online or offline environment. Net1’s UEPS/EMV solution is interoperable with global EMV standards that seamlessly enable access to all the UEPS functionality in a traditional EMV environment. In addition to payments, UEPS can be used for banking, healthcare management, payroll, remittances, voting and identification.
Net1’s mobile technologies include its proprietary mobile payments solution – MVC, which offers secure mobile-based payments, as well as mobile banking and prepaid value-added services in developed and emerging countries. The Company intends to deploy its varied mobile solutions through its ZAZOO business unit, which is an aggregation of innovative technology companies and is based in the United Kingdom.
Net1 has a primary listing on the NASDAQ and a secondary listing on the Johannesburg Stock Exchange.
About IFC (www.ifc.org)
IFC, a member of the World Bank Group, is the largest global development institution focused on the private sector in emerging markets. Working with more than 2,000 businesses worldwide, we use our capital, expertise, and influence, to create opportunity where it’s needed most. In FY15, our long-term investments in developing countries rose to nearly $18 billion, helping the private sector play an essential role in the global effort to end extreme poverty and boost shared prosperity.
About IFC Asset Management Company (www.ifcamc.org)
IFC Asset Management Company LLC (AMC), a wholly-owned subsidiary of IFC, invests third party capital, enabling investors to benefit from IFC’s expertise in achieving strong equity returns, as well as positive development impact in the countries in which it invests. AMC has raised $8.7 billion of capital across 11 investment funds. Three AMC managed funds, including the IFC African, Latin American and Caribbean Fund (ALAC Fund), the IFC Financial Institutions Growth Fund (FIG Fund) and the Africa Capitalization Fund, are participating in the Net 1 investment. For more information.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this press release regarding strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. Factors that might cause such differences include, but are not limited to: the possibility that the expected benefits from the IFC investment will not be realized; disruption from the investment making it more difficult to maintain business and operational activities; and other factors, many of which are beyond the Company’s control; and other important factors included in the Company’s reports filed with the Securities and Exchange Commission, particularly in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2015, as such Risk Factors may be updated from time to time in subsequent reports. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Dhruv Chopra
Head of Investor Relations
Phone: +1-917-767-6722
Email: dchopra@net1.com
(CLRB) Receives Positive NASDAQ Listing Determination
MADISON, Wis., April 07, 2016 — Cellectar Biosciences, Inc. (NASDAQ:CLRB) (“Cellectar” or the “company”), an oncology-focused biotechnology company, announced today that on April 6, 2016, the NASDAQ Listing Qualifications Panel (the “panel”) issued a determination granting the company’s request for the continued listing of its common stock on the NASDAQ Capital Market (“NASDAQ”).
The company’s continued listing on NASDAQ is subject to, among other things, the company evidencing compliance with the minimum $2.5 million stockholders’ equity requirement by May 16, 2016. Cellectar must also provide the panel with updated information regarding its ability to maintain compliance for a period of one year.
“We are pleased with the panel’s decision to support Cellectar’s continued listing on NASDAQ,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We are confident in our capability to successfully satisfy the required evidence of compliance.”
The company is taking definitive steps to evidence compliance with the terms of the Panel’s decision; however, there can be no assurance that it will be able to do so.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.
This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTOR AND MEDIA CONTACT: Jules Abraham JQA Partners 917-885-7378 jabraham@jqapartners.com
(CPHR) Proposes Adding Rosemary A. Crane and Dr. Renee P. Tannenbaum To Board
MISSISSAUGA, ON, April 7, 2016 – Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) (“Cipher” or “the Company”) today announced that Rosemary A. (Rose) Crane and Dr. Renee P. Tannenbaum, two pharmaceutical industry leaders, are being proposed for election to Cipher’s Board of Directors at the Company’s Annual and Special Meeting on May 5, 2016.
Ms. Crane has more than 30 years of experience in large global pharmaceutical companies and development-stage companies. She currently serves on the Board of Directors of Teva Pharmaceutical Industries, Ltd. (NASDAQ: TEVA) one of the largest generic pharmaceutical companies in the world. Previously, Ms. Crane served as President and Chief Executive Officer of MELA Sciences, Inc. from 2013 to 2014. Ms. Crane was Head of Commercialization and a partner at Appletree Partners from 2011 to 2013. Previously, she served as President and Chief Executive Officer of Epocrates Inc.; and held several senior executive positions at Johnson & Johnson, including as Group Chairman, OTC & Nutritional Group, Group Chairman, Consumer, Specialty Pharmaceuticals and Nutritionals, and Executive Vice President of Global Marketing for the Pharmaceutical Group. Prior to that, she held various positions at Bristol-Myers Squibb from 1982 to 2002, including as President of U.S. Primary Care and as President of Global Marketing and Consumer Products. Ms. Crane has served as Vice Chairman of the Board of Zealand Pharma A/S since 2015. Ms. Crane received an M.B.A. from Kent State University in 1986 and a B.A. in communications and English from the State University of New York in 1981.
Dr. Tannenbaum has more than 30 years of experience with leading companies in the biopharmaceutical industry. Most recently, she served as Head of Global Customer Excellence at AbbVie, Inc. (NYSE: ABBV) where she was responsible for building commercial capabilities for the organization. Prior to joining AbbVie, Dr. Tannenbaum served as President of Myrtle Potter & Company, LLC, a global life sciences consulting and advisory firm. From 2009 to 2011, she served as Executive Vice President and Chief Commercial Officer at Elan Pharmaceuticals, Inc., where she was responsible for revenue generation for Elan’s marketed products and preparation for the commercialization of the company’s pipeline. Prior to her role at Elan, Dr. Tannenbaum was at Novartis Pharma AG for three years, where she led the Global Commercial Operations organization. Prior to that, she spent nine years at Bristol Myers Squibb and 16 years at Merck and Company in a variety of leadership positions. Dr. Tannenbaum received her Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Sciences, where she retains an Adjunct Faculty position in the Mayes College of Healthcare Business and Policy, her MBA from Temple University, and her Bachelor of Science degree in Pharmacy from the University of Connecticut. She currently serves on the Board of Directors of Zogenix, Inc. (NASDAQ: ZGNX)
“We’re fortunate to attract two highly accomplished pharmaceutical industry leaders as potential independent directors,” said Gerry McDole, Chair of Cipher’s Board of Directors. “As Cipher continues on its path to building the most customer-centric dermatology company in North America, Renee and Rose would bring proven and relevant industry experience to complement and strengthen our existing Board skill-set.”
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (NASDAQ:CPHR; TSX:CPH) is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products with the goal of becoming the most customer-centric dermatology company in North America.
Cipher completed seven transactions in 2015, including the acquisition of Innocutis and its nine branded dermatology products, to build its U.S. commercial presence, expand its Canadian dermatology franchise and broaden its pipeline. Cipher is well-capitalized to drive long-term, sustained earnings growth by leveraging its proven clinical development capabilities and efficient commercial execution. For more information, visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release may be forward-looking and therefore subject to various risks and uncertainties. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company’s Annual Information Form, Form 40-F and other filings with Canadian and U.S. securities regulatory authorities. These factors include, but are not limited to our ability to enter into in-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on three products; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of our products; the product approval process is highly unpredictable; the timing of completion of clinical trials; reliance on third parties to manufacture our products; we may be subject to product liability claims; unexpected product safety or efficacy concerns may arise; generate revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; dependence on key managerial personnel and external collaborators; no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions; limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies; various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which it operates; foreign currency risk; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent law; litigation in the pharmaceutical industry concerning the manufacture and supply of novel versions of existing drugs that are the subject of conflicting patent rights; inability to protect our trademarks from infringement; shareholders may be further diluted; volatility of our share price; a significant shareholder; we do not currently intend to pay dividends; and our operating results may fluctuate significantly; we may be unsuccessful in evaluating material risks involved in complete and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; operations in the U.S.; and inability to meet covenants on our credit facilities.. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian or U.S. securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
(ICPT) FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva™
PDUFA Date is May 29, 2016
Intercept to host investor conference call today at 5:30 p.m. ET
NEW YORK, April 07, 2016 — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA)’s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva™ (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.
“We’re pleased that the Advisory Committee strongly supported the approval of Ocaliva for people living with PBC. Today’s positive recommendation is an encouraging step for the PBC community,” said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept. “We’d like to thank the many patients and physicians who took part in the research discussed in today’s meeting, as their participation and dedication has been – and remains – instrumental in evolving the treatment paradigm for PBC.”
Intercept is seeking accelerated approval of Ocaliva for the treatment of PBC in patients with an inadequate response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the only approved therapy for this disease. While UDCA has a marked impact on clinical outcomes in PBC, a substantial percentage of UDCA-treated patients have a suboptimal response or are intolerant to treatment, leaving them at significantly increased risk of an adverse outcome.
The Advisory Committee’s recommendation is based on data from the clinical development program for Ocaliva in PBC, including the Phase 3 POISE trial, which assessed the safety and efficacy of Ocaliva in 216 PBC patients who had an inadequate therapeutic response to, or were unable to tolerate, UDCA. Intercept’s New Drug Application (NDA) includes data for 432 PBC patients who have received Ocaliva with an amassed total of 675 patient years of exposure and some patients on therapy for over five years. In accordance with the FDA guidelines for accelerated approval, Intercept is currently enrolling COBALT, a global Phase 4 long-term outcomes trial to confirm the clinical benefit of Ocaliva in people living with PBC.
PBC is a rare chronic liver disease, and if patients are left untreated or have an inadequate response to UDCA therapy, the disease typically progresses to hepatic fibrosis, cirrhosis, liver failure and death unless they receive a liver transplant.
The brand name Ocaliva has been provisionally approved by the FDA and European Medicines Agency, but Ocaliva is an investigational medicine that has not been granted marketing authorization or approval from any regulatory authority.
Conference Call Information
Intercept will host a conference call today, Thursday, April 7, 2016, at 5:30 p.m. ET to discuss the outcome of the Gastrointestinal Drugs Advisory Committee meeting. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) five minutes prior to the start time (no passcode required). A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks.
About Primary Biliary Cirrhosis, recently renamed Primary Biliary Cholangitis
PBC is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. Since 1988, PBC has been the second-leading overall cause of liver transplant in women in the United States, behind hepatitis C. In Europe, the disease accounts for approximately half of liver transplants due to cholestatic diseases and 6% of all liver transplants.
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases. The Company’s lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. Intercept’s pipeline of product candidates includes other novel bile acid analogs such as INT-767, which is in clinical development. For more information about Intercept, please visit the Company’s website at: www.interceptpharma.com.
Safe Harbor Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated approval and launch of OCA in PBC and the timelines related thereto, the clinical relevance and utility of the endpoints used in the Phase 3 POISE trial, the anticipated prevalence of PBC, the continued development of OCA and Intercept’s other product candidates, and our strategic directives under the caption “About Intercept.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; our ability to obtain and maintain intellectual property protection for its product candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products, which may be affected by the reimbursement that our products receive from payors; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; our collaborators’ election to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our ability to retain key scientific or management personnel; and other factors discussed under the heading “Risk Factors” contained in our annual report on Form 10-K for the year ended December 31, 2015 filed on February 29, 2016 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.
Contact For more information about Intercept Pharmaceuticals, please contact: Mark Vignola +1-646-747-1000 investors@interceptpharma.com Christopher Frates +1-646-757-2371 media@interceptpharma.com
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