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(GPL) Ends Option Agreement For Coricancha Mine But Continues Evaluation
Great Panther Silver ends option agreement for Coricancha Mine but continues evaluation
Canada NewsWire
VANCOUVER, May 11, 2016
TSX: GPR
NYSE MKT: GPL
VANCOUVER, May 11, 2016 – GREAT PANTHER SILVER LIMITED (TSX: GPR; NYSE MKT: GPL) (“Great Panther”; the “Company”) announces that it has given notice to Nyrstar that the Company is ending the option agreement for a 100% interest in the Coricancha Mine in Peru. However, Great Panther is continuing with its evaluation of the project and may still enter into negotiations for the purchase of the mine.
“We have completed a significant amount of evaluation work at the Coricancha Mine over the past year”, stated Robert Archer, president & CEO. “Based upon the information generated to date, Great Panther’s management has determined that the most prudent course of action is not to make the second option payment due on May 18th. While this will have the effect of terminating the Company’s right to exclusivity on the Coricancha property, there is more data to be analyzed over the next few months that may result in further negotiations with Nyrstar towards an outright purchase. Consequently, we will continue with our evaluation until we have sufficient information to make a definitive decision in this regard.”
Great Panther is also continuing to seek and evaluate other projects, acquisitions and growth opportunities in the Americas.
ABOUT GREAT PANTHER
Great Panther Silver Limited is a primary silver mining and exploration company listed on the Toronto Stock Exchange trading under the symbol GPR, and on the NYSE MKT trading under the symbol GPL. Great Panther’s current activities are focused on the mining of precious metals from its two wholly-owned mining operations in Mexico: the Guanajuato Mine Complex, which includes the San Ignacio Mine, and the Topia Mine in Durango.
Robert Archer
President & CEO
CAUTIONARY STATEMENT ON FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws (together, “forward-looking statements”). Such forward-looking statements include but are not limited to statements regarding: intentions to further evaluate the Coricancha property for potential acquisition, the evaluation of other projects for acquisition and growth, plans for production at the Company’s Guanajuato Mine Complex and Topia Mine in Mexico, exploring its other properties in Mexico, the overall economic potential of its properties, the availability of adequate financing, and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements expressed or implied by such forward-looking statements to be materially different. Such factors include, among others, risks and uncertainties relating to potential political risks involving the Company’s operations in a foreign jurisdiction, uncertainty of production and cost estimates and the potential for unexpected costs and expenses, uncertainty in mineral resource estimation, physical risks inherent in mining operations, currency fluctuations, fluctuations in the price of silver, gold and base metals, completion of economic evaluations, changes in project parameters as plans continue to be refined, permitting risks, the inability or failure to obtain adequate financing on a timely basis, and other risks and uncertainties, including those described in the Company’s Annual Information Form for the year ended December 31, 2015 and Material Change Reports filed with the Canadian Securities Administrators available at www.sedar.com and reports on Form 40-F and Form 6-K filed with the Securities and Exchange Commission and available at www.sec.gov. There is no assurance that such forward looking statements will prove accurate; results may vary materially from such forward looking statements; and there is no assurance that the Company will be able to identify and acquire additional projects or that any projects acquired will be successfully developed. Readers are cautioned not to place undue reliance on forward looking statements. The Company has no intention to update forward looking statements except as required by law.
(GALT) Phase 2 Trial with GR-MD-02 in Advanced Fibrosis
Top line results of the NASH-FX trial to be reported in September 2016
NORCROSS, Ga., May 11, 2016 — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the completion of enrollment in its Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis (stage 3) (the NASH-FX trial). The Company expects to report the top line results of this trial by the end of September 2016, as previously planned.
“We are pleased that enrollment in our NASH-FX trial was completed right on schedule,” said Peter G. Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “This is one of two Phase 2 trials we are conducting in subjects with NASH, and is designed to assess the efficacy of our lead compound GR-MD-02 in patients with NASH with advanced fibrosis (stage 3). Since the diagnosis of NASH and the monitoring of the disease are hampered by the need for liver biopsy, in addition to providing proof-of-concept on the efficacy of GR-MD-02, this study explores the utility of three non-invasive measures of fibrosis which may be useful in the design and execution of later stage clinical studies and perhaps have relevance in commercial clinical settings.”
The NASH-FX trial has enrolled a total of 30 liver biopsy-confirmed NASH patients with advanced fibrosis (stage 3) – 15 patients to receive 8 mg/kg of GR-MD-02 and 15 patients to receive placebo every other week for 16 weeks, for a total of nine doses. The effect of GR-MD-02 on liver fibrosis will be assessed by three independent non-invasive tests following the treatment period. The primary endpoint will be an assessment of fibrosis using multi-parametric magnetic resonance imaging (LiverMultiScan®), which is a validated and proprietary MRI protocol developed by Perspectum Diagnostics. Secondary endpoints will evaluate liver stiffness, which correlates to the degree of liver fibrosis, as assessed by magnetic resonance-elastography and by FibroScan®. More information on the NASH-FX trial may be found in a post on Dr. Traber’s blog, CEO Perspectives and at www.clinicaltrials.gov.
This single-site study is being conducted by Stephen A. Harrison, M.D., FACP, FAASLD, Colonel, Medical Corps U.S.A., Director, Medical Education, Associate Dean, San Antonio Uniformed Services Health Education Consortium, Professor of Medicine, Uniformed Services University of the Health Sciences and Consultant to The Army Surgeon General for Gastroenterological Diseases, San Antonio Military Medical Center. Dr. Harrison is also the co-lead investigator for Galectin’s Phase 2 NASH-CX trial, which is studying two different doses of GR-MD-02 against placebo in 156 patients with NASH with cirrhosis (the NASH-CX trial).
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scaring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis
Non-alcoholic steatohepatitis (NASH), also known as fatty liver disease, has become a common disease of the liver with the rise in obesity rates. NASH is estimated to affect up to 28 million people in the U.S. Fatty liver disease is characterized by the presence of fat in the liver along with inflammation and damage in people who consume little or no alcohol. Over time, patients with fatty liver disease can develop fibrosis, or scarring of the liver, and it is estimated that as many as 1-2 million individuals in the U.S. have cirrhosis, a severe liver disease for which liver transplant is the only treatment available. Approximately 6,300 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of NASH or liver fibrosis. A recent analyst estimate indicated that by 2025 the worldwide market for NASH treatments could approach $35 billion.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for GR-MD-02 will lead to the first therapy for the treatment of fatty liver disease with advanced fibrosis and/or cirrhosis and/or moderate to severe psoriasis. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. The Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Contacts:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
LHA
Kim Golodetz
(212) 838-3777
kgolodetz@lhai.com
(DTRM) to Present at Needham Emerging Technology Conference
SAN MATEO, CA–(May 11, 2016) – Determine (NASDAQ: DTRM) a leading global provider of SaaS Source to Pay and Enterprise Contract Lifecycle Management (ECLM) solutions, offered through the Determine Cloud Platform, which includes; strategic sourcing, supplier management, contract management, and procure-to-pay applications, was invited to present at Needham’s Emerging Technology Conference (NETC) being held on May 18 – 19, 2016 in New York.
Patrick Stakenas, President & CEO of Determine, is scheduled to discuss the changing landscape of the Source-to-Pay market, as Determine charts its course into its new fiscal year. In his presentation at 3:00 PM (ET) on May 18th, 2016, Mr. Stakenas will review the Determine Cloud Platform as well as the company’s financial and technology progress. In addition, he will also cover the overall market opportunity and a view on the market consolidation with respect to the company’s strategic sourcing, supplier management, contract management and procure-to-pay applications. He will be available for 1-on-1 meetings throughout the day.
About the Needham Emerging Technology Conference:
Open to clients of Needham & Company, LLC only. For further information, please contact your Needham salesperson. Management’s presentation will be webcast live and available for replay here for 90 days following the live presentation. Needham’s Emerging Technology Conference (NETC) will highlight companies in the Consumer, Internet & Digital Media and Software & Services verticals that we believe are most likely to win in today’s rapidly changing competitive environment, as well as those most likely to redefine the investment landscape. The 2-day high-impact conference features public and private company presentations, Q&A sessions, and 1-on-1 meetings for qualified investors. This conference is open to clients of Needham & Company, LLC only. For further information, please contact your Needham salesperson or visit www.needhamco.com.
Supporting Resources
Determine blog
Determine on LinkedIn
Determine on Twitter
Determine guides & misc. resources
About Determine, Inc.
Determine (NASDAQ: DTRM) is a leading global provider of SaaS Source to Pay and Enterprise Contract Lifecycle Management (ECLM) solutions. Our Gartner recognized visionary technologies allow our customers to effectively manage the full scope of Source to Pay and ECLM using our Determine Cloud Platform. Our Source to Pay software suite includes strategic sourcing, supplier management, contract management, and procure-to-pay applications.
The Determine Cloud Platform gives procurement, finance, and legal professionals the ability to deliver profound insights through analysis of their supplier relationships and contractual requirements. Our customers leverage the Determine Cloud Platform to discover previously unseen supplier and spend data; make more informed and smarter business decisions; drive new revenue; control costs; improve workflow efficiencies; and mitigate risk.
Our customers benefit from the Determine Cloud Platform’s robust suite of integrated applications. Whether they start with a full-suite implementation or choose to implement just one application and build over time, each additional application allows for the automatic sharing of data already in place on the Determine Cloud Platform.
For more information, please visit www.determine.com.
Media Relations:
Determine, Inc.
Rose Lee
pr@determine.com
+1.650.532.1590
(CCXI) to Host R&D Day on May 18, 2016
MOUNTAIN VIEW, Calif., May 11, 2016 — ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, today announced that the Company will host an R&D Day on Wednesday, May 18, 2016 at 12:00 p.m. Eastern Time in New York, NY. The Company will be joined by several leading physicians.
The live audio webcast and accompanying slide presentation can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will remain available on the Company’s website for two weeks following the live event.
About ChemoCentryx
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing reduction and elimination of high-dose steroids, part of standard of care for AAV patients, without compromising efficacy or safety in clinical trials to date. CCX168 is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and Immunoglobulin A nephropathy, or IgA nephropathy (IgAN). CCX872, a CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. CCX140, a distinct CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with diabetic nephropathy. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development, Vercirnon (also known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the treatment of inflammatory bowel disease, and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
CCXI-G
Contacts: Susan M. Kanaya Senior Vice President, Finance and Chief Financial Officer investor@chemocentryx.com Media: Denise Powell denise@redhousecomms.com 510.703.9491 Investors: Steve Klass, Burns McClellan 212.213.0006 sklass@burnsmc.com
(GAIA) to Sell Branded Products Business to Focus on Lifestyle Streaming Media
Management to Host Conference Call Today at 5 p.m. ET
BOULDER, CO–(May 10, 2016) – GAIAM, Inc. (NASDAQ: GAIA), a lifestyle company, has entered into definitive agreements to sell its branded consumer product business. These transactions follow the sale of the Company’s travel business on May 4, 2016. The combined gross proceeds of these transactions total approximately $180 million.
Sequential Brands Group, Inc. (NASDAQ: SQBG) and its operating partner Fit For Life LLC have agreed to acquire GAIAM’s branded consumer products business for $167 million in cash, subject to standard closing and post-closing adjustments. GAIAM expects its current net operating loss carryforwards will offset the majority of the gain realized from the sale. The transaction is expected to close this June.
As announced last week, Lindblad Expeditions Holdings, Inc. (NASDAQ: LIND) acquired GAIAM’s 51.4% interest in Natural Habitat, Inc. for $12.85 million in cash (total implied enterprise value of $25 million). GAIAM originally acquired its interest for $0.6 million in 2002.
Both sales of the branded consumer products business have been approved by GAIAM’s board of directors. Upon and subject to the closing of the transactions for $167 million, the Company expects to use a portion of the proceeds to conduct a tender offer for up to $90 million and up to 12 million shares of its Class A common stock and vested stock options at a fixed price of $7.75 per share (less any applicable option exercise price). The remaining proceeds will be used to fund the continuing growth and development of the Company’s subscription-based streaming media business known as Gaia, as well as general corporate purposes. As part of the transition, the Company will change its corporate name from Gaiam, Inc. to Gaia, Inc. and will continue to trade on NASDAQ under the current ticker “GAIA”.
“We take great pride in the powerful brand heritage and authenticity we have cultivated over the years in the Gaiam and SPRI brands, and in our innovative yoga, fitness and wellness products,” said Lynn Powers, CEO of GAIAM. “We are confident that Sequential is the right company to carry our work forward and continue growing these dynamic brands by providing increased resources and market expertise. I’m also happy to report that key members of management and the majority of our sales, marketing and operations teams will be joining Fit For Life to continue the growth and success we’ve experienced in the past.”
The Company will provide pro forma information related to the sale of the Natural Habitat business and the results for the first quarter in the Company’s Form 10-Q filed later today. GAIAM plans to promptly file an Information Statement with additional information regarding the sale of the branded business followed by the filing of the formal tender offer.
GAIAM chairman, Jirka Rysavy, stated: “The divesture of these businesses represents a change in our plans to spin-off Gaia as a separately traded publicly company. However, their sale also reflects the fact that we have been pursuing parallel strategic alternatives for our businesses. Given a number of precipitating factors, the board of directors determined and unanimously agreed that in terms of maximizing shareholder value and providing Gaia the greatest opportunity for success, the divesture of these two businesses presents the best strategic alternative for GAIAM and our shareholders. While we have received most of the necessary approvals, we delayed our planned spin-off to see these transactions through. Should the sale of the branded products business not close as expected, we will proceed with the spin-off.
“We see these transactions truly unlocking shareholder value, further demonstrated with the planned tender offer that has been set above the current market price. I do not plan to personally participate in the tender offer for any of my 24% beneficial ownership interest.”
Advising GAIAM in the transactions are Stifel as exclusive financial advisor and Brownstein Hyatt Farber Schreck LLP as legal advisor.
Important Additional Information
This press release does not constitute an offer to buy or the solicitation of an offer to sell securities, and shall not constitute an offer, solicitation, or sale in any jurisdiction in which such offer, solicitation, or sale is unlawful. This announcement about the tender offer contains important information which should be read carefully before any decision is made with respect to the tender offer. If any GAIAM shareholder is in any doubt as to the contents of this announcement or the action the shareholder should take, GAIAM recommends that its shareholders seek their own financial and legal advice, including as to any tax consequences, immediately from their financial and legal advisors. Any individual or company whose shares are held on his, her, or its behalf by a broker, dealer, bank, custodian, trust company, or other nominee or intermediary must contact such entity to participate in the tender offer. Neither GAIAM nor any of the Depositary or the Information Agent for the tender offer makes any recommendation as to whether GAIAM’s shareholders should tender their shares pursuant to the tender offer.
GAIAM intends to file with the Securities and Exchange Commission (the “SEC”) a tender offer statement on Schedule TO, accompanied by an Offer to Purchase (the “Offer to Purchase”) and other documents relating to the tender offer. GAIAM SHAREHOLDERS ARE ADVISED TO READ CAREFULLY THE TENDER OFFER STATEMENT, THE OFFER TO PURCHASE, AND THE OTHER DOCUMENTS THAT GAIAM WILL FILE WITH THE SEC, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER AND PROCEDURES TO PARTICIPATE IN THE TENDER OFFER. Copies of these documents will be available for free by visiting EDGAR on the SEC website at www.sec.gov. In addition, copies of the Schedule TO and the documents filed with it may be obtained free of charge on GAIAM’s website at http://corporate.gaiam.com.
Conference Call
GAIAM management will host a conference call today in place of its first quarter financial results to discuss these transactions, followed by a question and answer period.
Date: Tuesday, May 10, 2016
Time: 5:00 p.m. Eastern time (3:00 p.m. Mountain time)
Toll-free dial-in number: 1-855-327-6837
International dial-in number: 1-631-891-4304
Conference ID: 10001177
Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Liolios at 1-949-574-3860.
About Gaia
Gaia (formerly GAIAM TV) is a global digital video streaming service and online community that provides curated conscious media content to its subscribers in over 100 countries. Over 90% of its 7,000 titles are available for streaming exclusively on Gaia through almost any device connected to the Internet and 80% of the views are generated by content produced or owned by Gaia. For more information about Gaia, visit www.gaia.com.
About GAIAM
GAIAM, Inc. (NASDAQ: GAIA) is a lifestyle company for yoga, fitness and wellness products and content. With a wide distribution network that consists of approximately 38,000 retail doors, 19,000 store within stores, 5,000 category management locations, and e-commerce, GAIAM is dedicated to making yoga, fitness and wellness accessible to all. GAIAM dominates the health and wellness category and owns the largest library of conscious media. For more information about GAIAM, visit www.gaiam.com or call 1.800.869.3603.
Important Cautions Regarding Forward-Looking Statements
This press release includes forward-looking statements relating to matters that are not historical facts. Forward-looking statements may be identified by the use of words such as “expect,” “believe,” “will,” or comparable terminology or by discussions of strategy. While GAIAM believes its assumptions and expectations underlying forward-looking statements are reasonable, there can be no assurance that actual results will not be materially different. Risks and uncertainties that could cause materially different results include, among others, GAIAM’s ability to successfully close the sale of its branded consumer product business, the level of participation in GAIAM’s proposed tender offer, the results from operations of GAIAM’s other businesses, and other risks and uncertainties included in GAIAM’s filings with the Securities and Exchange Commission. GAIAM assumes no duty to update any forward-looking statements.
Contacts
Steve Thomas
Chief Financial Officer
(303) 222-3782
Email Contact
Cody Slach
Liolios Investor Relations
(949) 574-3860
Email Contact
(DERM) Positive Topline Phase 2b Clinical Trial Results for DRM01
– Safety and Efficacy Data Confirm Results from Previous Phase 2a Trial
– DRM01 Phase 3 Clinical Program Planning Underway
– Management to Host Webcast and Conference Call Today at 5:30 a.m. PT / 8:30 a.m. ET
MENLO PARK, Calif., May 10, 2016 — Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced topline results from its Phase 2b dose-ranging study for DRM01 in patients with facial acne vulgaris. DRM01 is a novel, small molecule designed to inhibit sebum production following topical application. The clinical study evaluated the safety and efficacy of DRM01 and demonstrated statistically significant improvements in all primary endpoints compared to vehicle at the highest dose and in most primary endpoints at the two lower doses. DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.
Based on these results, Dermira plans to initiate a Phase 3 program to evaluate the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients. The initiation of this program is targeted for the first half of 2017, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
“We are incredibly pleased that the data from this trial reaffirm the safety, efficacy and tolerability profile observed with DRM01 in our earlier Phase 2a proof-of-concept study,” said Tom Wiggans, chairman and chief executive officer of Dermira. “Each of the doses we evaluated demonstrated results that we believe could support their advancement into a Phase 3 program. We are encouraged by the potential of this molecule to target the underlying cause of acne following topical application. Our goal is to provide a transformative treatment option for the millions of people coping with acne and its impact on their quality of life.”
In the Phase 2b study, the primary endpoints were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline on the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured at the end of a 12-week treatment period.
DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints at the highest dose of DRM01 (7.5% twice daily), which also demonstrated the highest efficacy in all primary endpoints compared to the two lower doses. The number of inflammatory lesions in patients treated with this highest dose of DRM01 was reduced by an average of 15.0 compared to 10.7 in patients in the combined vehicle group (p=0.001), or an average percentage reduction of 55.6% compared to 40.0% (p<0.001). The number of non-inflammatory lesions in patients treated with this same dose of DRM01 was reduced by an average of 17.5 compared to 9.3 in patients in the combined vehicle group (p<0.001), or an average percentage reduction of 47.8% compared to 28.7% (p<0.001). At the end of the 12-week treatment period, 25.9% of patients treated with this highest dose of DRM01 achieved a successful improvement in the IGA score (minimum two-grade improvement) compared to 9.8% of patients in the combined vehicle group (p=0.004).
Overall, a dose response was observed for all three primary endpoints. At the 4.0% once daily dose, DRM01 demonstrated statistically significant improvements in all three primary endpoints compared to the combined vehicle group. At the 7.5% once daily dose, DRM01 demonstrated statistically significant improvements in the inflammatory and non-inflammatory lesion count endpoints compared to the combined vehicle group, and approached statistical significance in the IGA improvement endpoint (p=0.06). Based on the results, Dermira believes each of the three doses evaluated in the Phase 2b study could be a viable dose for a Phase 3 program. Further data analysis and an end-of-Phase 2 meeting with the FDA are expected to determine the dose and design for the Phase 3 program.
Consistent with the Phase 2a study, DRM01 was well-tolerated. Adverse events were primarily mild or moderate in severity. The most frequently reported adverse events across all three DRM01 treatment groups were common cold (nasopharyngitis; 5.4%), upper respiratory tract infection (2.5%) and application site itching (pruritus; 2.5%). No treatment-related serious adverse events were reported.
“DRM01 is an investigational, topical agent that represents a novel approach to acne treatment by targeting sebum production, a key contributing factor in the development of acne,” said Linda Stein Gold, M.D., director of Dermatology Clinical Research and division head of Dermatology at Henry Ford Hospital (Detroit, Michigan) and one of the investigators for the DRM01 Phase 2b trial. “Based on these results, DRM01 could represent a potentially meaningful new treatment for the dermatology community that offers patients a safe, well-tolerated and effective alternative to current options.”
The data will be submitted for presentation at an upcoming medical conference and for consideration in a peer-reviewed journal.
About DRM01 Phase 2b Trial
The DRM01 Phase 2b trial was a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in adult patients 18 and older with moderate-to-severe facial acne vulgaris. A total of 420 patients were enrolled in the study at 34 sites in the United States and Canada. Inclusion criteria required a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an IGA score of three or greater on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease. Patients were randomized into five separate arms and instructed to apply DRM01 at concentrations of 4.0% once daily (n=106), 7.5% once daily (n=110) or 7.5% twice daily (n=101), or to apply vehicle once or twice daily (n=53 and n=50, respectively), in all cases for 12 weeks. Consistent with the previous Phase 2a trial and in accordance with the published FDA draft guidance for the development of acne drugs, the primary endpoints were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point IGA score. Each endpoint was measured at the end of the 12-week treatment period.
About Acne
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting approximately 50 million Americans. Acne is caused by the accumulation of dead skin cells, oil and bacteria in pores. It is characterized by clogging of the pores and associated local skin lesions. Acne lesions are believed to result from an interaction of multiple pathogenic, or contributing, factors, including excessive sebum production. Acne is not just about blemishes on the skin; it can also affect a person’s quality of life, resulting in social, psychological and emotional impairments.
About DRM01
DRM01 is a novel, small molecule designed to inhibit sebum production following topical application in development for the treatment of acne. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect of acne that is not addressed by available topical therapies. DRM01 is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids.
Conference Call and Webcast
Dermira management will host a webcast and conference call regarding this announcement at 5:30 a.m. PT / 8:30 a.m. ET today. The live call may be accessed by dialing 877-359-9508 for domestic callers and 224-357-2393 for international callers and using the conference code: 6936436. A live webcast and archive of the call will be available from the investor relations sections of the company website at www.dermira.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 6936436.
About Dermira
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio includes three late-stage product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3 development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and DRM01, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
In addition to our filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, we use our website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about our company, our product candidates, our planned financial and other announcements, our attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website and our LinkedIn page in addition to following our SEC filings, press releases, public conference calls and webcasts.
Forward-Looking Statements
The information in this press release contains forward-looking statements and information 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, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to the timing and initiation of a Phase 3 program for DRM01; the prospective end-of-Phase 2 meeting with the FDA; the dose and design for the Phase 3 program; the potential of DRM01 to target the underlying cause of acne following topical application; and the potential and delivery of DRM01 as a transformative, safe and effective alternative treatment for patients with acne. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to our anticipated end-of-Phase 2 meeting with the FDA for DRM01; the design, implementation and outcome of our planned DRM01 Phase 3 program; our dependence on third-party clinical research organizations, manufacturers and suppliers; our ability to obtain regulatory approval for our product candidate; and our ability to continue to stay in compliance with applicable laws and regulations. For a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements, you should refer to the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings we make with the SEC from time to time. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Contacts: Media: Erica Jefferson Senior Director, Head of Corporate Communications 650-421-7216 erica.jefferson@dermira.com Investors: Andrew Guggenhime Chief Operating Officer and Chief Financial Officer 650-421-7200 investors@dermira.com Robert H. Uhl Westwicke Partners Managing Director 858-356-5932 robert.uhl@westwicke.com
(MKTO) and Vibes Unveil Strategic Partnership
Marketers Can Seamlessly Integrate Text Messaging, Mobile Wallet Marketing and Mobile Wallet Advertising into Marketo Campaigns
Marketo, Inc. (Nasdaq: MKTO), the leading provider of engagement marketing software and solutions, and Vibes, a mobile marketing leader, today announced a jointly built integration to enable marketers to add key mobile channels into their automated campaigns. This strategic partnership enables marketers to seamlessly integrate text messaging (SMS/MMS), mobile wallet marketing (Apple Wallet for iPhone, Android Pay for Android phones) and mobile wallet advertising into existing campaigns and greatly increase the opportunity to reach consumers on their preferred devices.
“Marketo clients are hungry to amplify their mobile marketing in order to build stronger relationships with their customers,” said Mike Stocker, Senior Director, Product Solutions & Innovation, Marketo. “By integrating Marketo’s best-in-class marketing automation platform with Vibes’ best-in-class mobile marketing, we’ve created a solution that empowers marketers to reach consumers on their device of choice with both speed and personalization.”
Vibes is already part of Marketo’s LaunchPoint® ecosystem, the most complete network of best-of-breed marketing solutions. This partnership builds upon Marketo’s commitment to helping marketers drive engagement everywhere, at scale, from a single platform.
With this integration, marketers can complement existing marketing channels with marketing and service-based mobile communications. For instance, marketers can now:
- Incorporate text messaging (SMS/MMS) into Marketo-driven marketing campaigns.
- Add mobile wallet content to their email marketing campaigns to enable customers to instantly save offers and loyalty cards to Apple Wallet or Android Pay.
- Utilize mobile wallet as the post-click destination for digital advertising campaigns in Marketo, powered by Vibes’ WalletAds solution.
With the power of marketing automation technology from both partners, marketers can also now offer consumers the ability to determine how they would like to receive personalized messages. If a consumer prefers receiving sale notifications via text, marketers can send these messages via mobile, instead of relying on email.
“General Growth Properties (GGP) (NYSE: GGP) has been able to transform the shopping experience at our 120 world-class malls to delight consumers at every step of their shopping journey,” said Donna Pahel, vice president of digital marketing at GGP. “Today’s consumers expect brands to cater to their needs in a real-time, relevant way across screens. Marketo and Vibes’ automated end-to-end solution will help GGP meet our shoppers’ expectations and execute personalized marketing campaigns at scale across both web and mobile channels.”
Forrester Research, Inc. estimates there are over 30 billion mobile moments each day in the United States. Marketers need automated solutions that deliver both speed and personalization to capitalize on these mobile moments and meet consumer demands in real time.
“In many ways, communication on mobile devices is all about speed, convenience and ease of use, so it’s only natural that mobile is coming to marketing automation,” said Jack Philbin, co-founder and CEO of Vibes. “The most effective marketing is tailored to meet the needs of the end recipient, and more and more frequently we’re seeing that consumers prefer mobile. Combining the power of mobile with the automation technology of Marketo will unlock a solution that benefits both consumers and marketers alike.”
Vibes will be on-site at Marketo’s Marketing Nation® Summit in Las Vegas on May 9–12, 2016. Expected to attract more than 6,000 marketers from around the globe, the conference will feature thought-leadership, educational sessions, workshops and trainings that empower marketers of every level to succeed in today’s digital era.
General Growth Properties, Inc.
General Growth Properties, Inc. is an S&P 500 company focused exclusively on owning, managing, leasing and redeveloping high-quality retail properties throughout the United States. GGP is headquartered in Chicago, Illinois, and publicly traded on the NYSE under the symbol GGP. www.ggp.com
About Marketo
Marketo (NASDAQ: MKTO) provides the leading engagement marketing software and solutions designed to help marketers develop long-term relationships with their customers – from acquisition to advocacy. Marketo is built for marketers, by marketers and is setting the innovation agenda for marketing technology. Marketo puts Marketing First. Headquartered in San Mateo, CA, with offices around the world, Marketo serves as a strategic partner to large enterprise and fast-growing small companies across a wide variety of industries. To learn more about Marketo’s Engagement Marketing Platform, LaunchPoint® partner ecosystem, and the vast community that is the Marketo Marketing Nation®, visit www.marketo.com.
About Vibes
Vibes is a mobile marketing technology leader that helps some of the world’s biggest brands unlock new revenue by arming them with the technology and guidance they need to succeed in mobile marketing. Vibes’ Catapult Mobile Relationship Management (MRM) platform enables marketers to manage all mobile communications including text messaging, push notifications, Apple Wallet (formerly called Passbook), Android Pay (formerly called Google Wallet) and mobile web campaigns — all from a single interface. Vibes has delivered more than 8 billion mobile experiences since 1998 on behalf of customers such as Chipotle, Sears, Home Depot, Verizon, Allstate, The Gap, Pep Boys, Men’s Wearhouse, and Gannett. Vibes is a Tier 1 aggregator with direct connections to all U.S. wireless carriers. To learn more about Vibes, visit www.vibes.com or connect on Twitter.com/Vibes.
Method Communications
Max Nelson, 310-689-7229
max@methodcommunications.com
(RXII) Provides Strategic Update
MARLBOROUGH, Mass., May 10, 2016 — RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics in dermatology and ophthalmology that address significant unmet medical needs, today announced that it is in the process of exploring strategic options including a range of potential M&A and business development opportunities designed to enhance shareholder value. As part of this effort, RXi has engaged Griffin Securities, Inc. (“Griffin”) for one of these transactions.
“Following our recent reverse stock split and the full conversion of our preferred stock at the end of 2015, we have successfully reset the Company’s capital structure and are now better positioned to execute on one or more strategic transactions that would significantly advance our Company,” stated Dr. Geert Cauwenbergh, President and Chief Executive Officer of RXi. “In furtherance of this goal, we have engaged Griffin Securities and are in active discussions regarding a potential merger transaction that, if successful, would be expected to bring substantial synergies to the combined business and significantly advance our clinical pipeline.” He added that: “We are pleased to be working with the highly experienced team at Griffin, and to tap into their expertise in working on this type of project. Although there can be no assurance that the exploration of any alternatives will result in RXi entering into or consummating a transaction, we are committed to enhancing our growth through this type of transactions, and are actively engaged in activities to arrive at this goal.”
There can be no assurance that the exploration of strategic alternatives will result in a transaction. The Company does not intend to provide updates unless or until it determines that disclosure is appropriate or necessary.
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.
About Griffin Securities
Griffin Securities, Inc. is a full service investment banking firm based in New York City focused on identifying world changing ideas and people in the areas of Technology, Healthcare, Energy, Industry and Synthetic Biology. Griffin offers a range of services including raising capital, merger and acquisitions, partnerships and collaborations and financial advisory services complemented by institutional sales and trading and proprietary research. Griffin has established itself as a trusted and respected ally deeply knowledgeable about strategies, development, and operations that deliver sustained growth and shareholder value.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
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 execute on the Company’s strategic goals, including pursuit of the merger transaction referred to in this press release; any benefits of such transaction, if successfully consummated; 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. Forward-looking statements are provided only as of the date of this release and 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
(CCXI) Licenses ChemoCentryx’s Oral 5aR Inhibitor CCX168
– Vifor Pharma to market drug in selected territories outside the US, ChemoCentryx responsible for worldwide development of CCX168 –
– ChemoCentryx to receive USD 85 million comprising USD 60 million in cash and USD 25 million equity investment; Deal also includes regulatory and commercial milestone payments and royalties on net sales to ChemoCentryx in the Vifor Pharma territories –
– Agreement additionally includes exclusive option to negotiate worldwide license for development and commercialization of CCR2 inhibitor CCX140 –
– ChemoCentryx to Host Conference Call Today at 8:30 a.m. Eastern Time –
MOUNTAIN VIEW, Calif., May 10, 2016 — Vifor Pharma, a company of Galenica Group, and ChemoCentryx, Inc. (Nasdaq:CCXI), a biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, announced today that Vifor Pharma has licensed rights to commercialize CCX168, a Complement 5a Receptor (C5aR) inhibitor ready for Phase 3 development for orphan and rare renal diseases, in Europe, Canada, Mexico, Central and South America and South Korea.
CCX168 is being developed by ChemoCentryx for the treatment of conditions including but not limited to anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) and has obtained orphan drug status in the US and Europe. This disease affects approximately 40,000 people in the US, with around 4,000 new cases identified each year, and more than 75,000 people in Europe, with at least 7,500 new cases each year. It is currently treated with courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose corticosteroid administration.
A Phase 3 study of CCX168 in the treatment of AAV is expected to begin later this year. CCX168 is also in development for other orphan and rare renal diseases, including atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy.
“The collaboration with ChemoCentryx underlines our increasing attraction as the partner of choice for innovative pharmaceuticals,” said Søren Tulstrup, CEO of Vifor Pharma. “CCX168 has the potential to address major unmet medical needs of patients in a number of different orphan indications, including AAV. In this field of rare diseases, current treatment options are often limited as well as associated with serious and often fatal side effects. We look forward to working with ChemoCentryx to bring this potentially important new treatment option to patients in Europe and other major markets as quickly as possible.”
“This unique kidney health alliance between Vifor Pharma and ChemoCentryx is an ideal partnership,” said Thomas J. Schall, Ph.D., President and CEO of ChemoCentryx. “Vifor Pharma, together with its nephrology partner company Vifor Fresenius Medical Care Renal Pharma, is a world leader in delivering quality care for patients with kidney disease. Their renal medicines specialization, including access to a vast patient database and nephrology-focused commercial expertise, will be a valuable resource as we develop and commercialize CCX168. We believe that this partnership further validates our approach to blocking chemoattractant receptors such as C5aR and CCR2 in the inflammatory processes in several important diseases.”
Under the terms of the agreement, ChemoCentryx will receive an upfront payment of USD 60 million in cash and a USD 25 million equity investment to purchase ChemoCentryx common stock at a price of USD 7.50 per share. ChemoCentryx will be eligible to receive additional payments on the achievement of certain regulatory and sales-based milestones, as well as tiered double-digit royalties on net sales of CCX168 in the licensed territories. The agreement is the first step of a potentially larger kidney health alliance as it also provides Vifor Pharma with an exclusive option to negotiate a worldwide license agreement for CCX140, ChemoCentryx’s orally-administered inhibitor of the chemokine receptor known as CCR2.
CCX168 is an orally-administered complement inhibitor which specifically targets the receptor for the complement fragment C5a receptor (C5aR). This receptor is known to activate destructive cells in certain autoimmune diseases including AAV. CCX168 is the lead drug candidate in ChemoCentryx’s orphan and rare disease program. In January 2016, ChemoCentryx reported positive top-line data from the Phase II CLEAR trial with CCX168 in 63 evaluable patients with AAV. The objective of the trial was to eliminate chronic high dose steroids, which are associated with significant safety issues including death, from the standard of care (SOC) regimen in AAV and replace them with CCX168. ChemoCentryx plans to initiate a Phase 3 clinical trial with CCX168 for the treatment of AAV by the end of 2016. CCX168 is being developed for other autoimmune disorders including atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy.
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing reduction and elimination of high-dose steroids, part of standard of care for AAV patients, without compromising efficacy or safety in clinical studies to date. CCX168 is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN). CCX872, a CCR2 inhibitor, successfully completed Phase I development and is in development for the treatment of non-resectable pancreatic cancer. CCX140, a distinct CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvement in albuminuria in patients with diabetic nephropathy. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development, vercirnon (also known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the treatment of inflammatory bowel disease, and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.
Vifor Fresenius Medical Care Renal Pharma, a common company of Galenica and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.
Conference Call and Webcast
The Company will host a conference call and webcast today, May 10, 2016 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 5511529. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.
ChemoCentryx Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include statements regarding whether CCX168 will be shown to be effective in Phase 3 clinical trials in the treatment of AAV and other orphan and rare diseases, whether eligible milestone payments or royalties on net sales of CCX168 will be attained and whether ChemoCentryx will enter into a worldwide license agreement for CCX140 with Vifor Pharma. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Annual Report on Form 10-K filed with the SEC March 14, 2016 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
For further information, please contact: Vifor Pharma - Media Relations: Beatrix Benz, Head of Global Communications Tel.: +41 58 851 80 16 E-mail: media@viforpharma.com ChemCentryx Contacts: Susan M. Kanaya Senior Vice President, Finance and Chief Financial Officer E-mail: investor@chemocentryx.com Media: Denise Powell Tel.: +1 510.703.9491 E-mail: denise@redhousecomms.com Investors: Steven Klass Burns McClellan Tel.: +1 212.213.0006 E-mail: sklass@burnsmc.com
(MKGI) Announces Engagement of DreamTeamNetwork Corporate Communications Service Suite
AUSTIN, TX–(May 10, 2016) – Monaker Group, Inc. (the “Company”) (OTCQB: MKGI), a technology-driven travel company, announces that it has engaged corporate communications firm DreamTeamNetwork (“DTN”). Austin, Texas-based DTN has assisted more than 300 public companies fine tune their corporate communications strategies, which includes investor relations, public relations, and social media relations, as well as branding and marketing, video production and website development.
“As we continue to advance our business model and dig our heels into key niches of the travel industry, communication with our shareholders has never been more important,” says Monaker Chairman and Chief Executive Officer Bill Kerby. “By partnering with DTN we have the opportunity to focus on both short and long-term corporate initiatives while strengthening our corporate message.”
Per the agreement, DTN will leverage its family of unique brands, along with an extensive network of partners, daily and weekly newsletters, social media channels, blog and other outreach tools, to further develop Monaker’s brand awareness and communication with shareholders.
“Monaker is rapidly gaining traction in the alternative lodging industry. With a visionary management team and unique booking engine, Monaker has potential for incredible growth in an increasingly lucrative market,” stated Michael McCarthy, Managing Director for DTN. “As a trusted partner, DTN looks forward to assisting the company with its transparency and communication with existing shareholders and the broader investment community.”
About Monaker Group, Inc.
Monaker Group is a technology-driven travel company with multiple divisions and brands, leveraging more than 60 years of operation in leisure travel. Monaker’s flagship is NextTrip.com, the industry’s first real time booking engine featuring alternative lodging (vacation home rentals, resort residences and unused timeshares) as well as a vast array of airlines, hotels, cruises, rental cars, tours and concierge services all combined in one platform to give customers the power of choice when booking their vacations. With key partnerships and established travel brands used as cornerstones, the Company’s mission is to continue to expand offerings to become the “one stop” vacation center. Headquartered in South Florida with offices in California, the Company employs a dedicated team of travel and technology professionals. For more information, visit the company’s website at www.monakergroup.com
About DreamTeamNetwork
DreamTeamNetwork serves private and public companies via numerous in-house brands and trusted partners. Leveraging the unique strengths of each brand and partner, the company provides a powerhouse blend of investor relations, public relations and social media relations services. For more information, visit www.DreamTeamNetwork.com
Forward-Looking Statements:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
DreamTeamNetwork
Austin, Texas
www.DreamTeamNetwork.com
512.758.8877 Office
Email Contact
Monaker Group
Attention: Richard Marshall
Director of Corporate development
Tel: 954-888-9779
Email: Email Contact
(ATRA) to Present Clinical Data on EBV-CTL at 2016 American Transplant Congress
SOUTH SAN FRANCISCO, Calif., May 09, 2016 — Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, today announced that an oral presentation, entitled “Banked EBV-Specific T-Cells for Treatment of Rituximab Refractory EBV+ B-Cell Lymphoma in Solid Organ Transplantation Recipients,” will be delivered by the Company’s collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) during the 2016 American Transplant Congress (ATC), taking place in Boston, MA, June 11-15, 2016. The presentation summarizes clinical experience with the Company’s allogeneic Epstein-Barr virus cytotoxic T-Lymphocyte (EBV-CTL) product candidate for the treatment of patients with rituximab refractory EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) after solid organ transplant (SOT).
To obtain the full text of the abstract, please visit the 2016 ATC website link here. Additional details of the presentation are as follows:
Date & Time: Monday, June 13th, 2016; 5:06 pm Eastern Time
Session Title: Concurrent Session: Late Breaking
Location: Room 210, John B. Hynes Convention Center, Boston, MA
Presenter: Dr. Susan Prockop
About EBV-CTL
T-cells are a critical component of the body’s immune system and can be harnessed to counteract viral infections and some cancers. By focusing the T-cells on specific proteins involved in cancers and infections, the power of the immune system can be employed to combat these diseases. Atara’s EBV-CTL utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to EBV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an “off-the-shelf”, allogeneic, cellular therapeutic option for patients. In the context of EBV-PTLD, Atara’s EBV-CTL finds the cancer cells expressing EBV and kills them. Phase 2 clinical results from trials conducted at MSK have been reported in multiple peer-reviewed forums.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on immunotherapy and oncology. Atara Bio’s programs include T cell product candidates and molecularly targeted product candidates. The T cell product candidates include EBV-CTL, CMV-CTL and WT1-CTL and harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The molecularly targeted product candidates include STM 434. These product candidates target activin and myostatin, members of the TGF-beta family of proteins, and have demonstrated the potential to have therapeutic benefit in a number of clinical indications.
INVESTOR & MEDIA CONTACT: Investors: Steve Klass 212-213-0006 x331 sklass@burnsmc.com Media: Justin Jackson 212-213-0006 x327 jjackson@burnsmc.com
(FWP) Announces Board of Directors Expansion
COPENHAGEN, Denmark, May 09, 2016 — Forward Pharma A/S (NASDAQ:FWP) (the “Company”) today announced that Dr. Karen Smith and Dr. Duncan Moore have been appointed to its Board of Directors as non-executive directors, expanding the Board to seven members. Dr. Moore will also serve as a member of the Audit Committee. The elections took place on May 6, 2016 at the Company’s Annual General Meeting in Copenhagen.
“I am very pleased that Forward Pharma has been able to continue to attract accomplished biotech industry executives to our management team and Board of Directors,” said Florian Schönharting, Chairman of the Board. “We welcome Karen and Duncan to our Board and look forward to benefitting from their wealth of knowledge and experience as the Company approaches important upcoming clinical and intellectual property milestones.”
The Company also announced that Mr. J. Kevin Buchi had left the Board in connection with the Annual Meeting and expressed its sincere appreciation and gratitude for Mr. Buchi’s contributions as a Board and Audit Committee member for the past three years.
Dr. Smith is currently Global Head of Research and Development and Chief Medical Officer at Jazz Pharmaceuticals plc. From January 2011 to March 2015, she was Senior Vice President, Global Medical Affairs and Global Therapeutic Area Head (Dermatology) for Allergan, Inc., a multi-specialty healthcare company. From October 2007 to December 2010, Dr. Smith served initially as Vice President, External Medical Relations, then Vice President, Global Development at AstraZeneca LP, a global innovation-driven biopharmaceutical company. From 2002 to 2007, Dr. Smith held a variety of management and medical roles with Bristol-Myers Squibb Company, a global biopharmaceutical company, in Australia, Canada, and the United States, most recently as Head of US Clinical Operations. In 2001, Dr. Smith was Chief Executive Officer of Boron Molecular, a specialist chemicals manufacturing company. Dr. Smith holds a B.A.Sc. and a B.Sc. from the Curtin University of Technology, a M.D. from the University of Warwick, a Ph.D. in oncology molecular genetics from the University of Western Australia, a M.B.A. from the University of New England (Australia) and a LL.M. in medical law from the University of Salford.
Dr. Moore is a partner at East West Capital Partners since May 2008. Previously, Dr Moore was a top ranked pharmaceutical analyst at Morgan Stanley from 1991 to 2008 and was a Managing Director from 1997 to 2008 leading the firm’s global healthcare equity research team. Whilst at the University of Cambridge he co-founded a medical diagnostics company called Ultra Clone with two colleagues which led to the beginnings of a 20 year career in healthcare capital markets analysis. In 1986 he was involved in setting up the Bank Invest biotechnology funds and was on the scientific advisory board. Duncan was educated in Edinburgh and went to the University of Leeds where he studied Biochemistry and Microbiology. He has an M.Phil and Ph.D. from the University of Cambridge where he was also a post doctoral research fellow. Currently he is an active investor in biomedical companies as Chairman of Lamellar Biomedical, Oncology Ventures and StepJockey. In addition he has board positions at Cycle Pharma and Braidlock.
About Forward Pharma:
Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose.
Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark, and our American Depositary Shares are publicly traded on NASDAQ Stock Market (FWP). For more information about the Company’s products and developments, please visit our web site at http://www.forward-pharma.com.
Forward Pharma A/S Media Contact:
Sharon Klahre, Director, Investor Relations
Forward Pharma USA, LLC
7 Skyline Drive
Hawthorne, NY 10532
SK@forward-pharma.com
+1 914-752-3542
The Ruth Group
Lee Roth
lroth@theruthgroup.com
+1 646-536-7014
Forward Looking Statements:
Certain statements in this press release may constitute “forward-looking statements” of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as “believe,” “expect,” “anticipate,” “hope,” “would” and “potential.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company’s ability to obtain, maintain and defend issued patents with protective claims; the issuance and term of patents; the Company’s ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company’s ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property rights of third parties; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187. These and other factors are identified and described in detail in certain of our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2015.
(MHGC) to be Acquired by SBE
NEW YORK, May 09, 2016 — Morgans Hotel Group Co. (NASDAQ:MHGC), (“Morgans”) today announced it has entered into a definitive agreement under which Morgans will be acquired by leading global lifestyle hospitality company SBE. Under terms of the agreement, SBE will acquire all of the outstanding shares of Morgans common stock for $2.25 per share in cash, which, together with the exchange of Morgans Series A preferred securities, the assumption of debt and transfer of capitalized leases, represents a total enterprise value of approximately $794 million. The per share price represents a 69 percent premium over Morgans’ unaffected closing price on May 5, 2016, and a 54 percent premium to Morgans’ volume weighted average price for the 30 days up to and including May 5, 2016.
As part of the transaction, affiliates of The Yucaipa Companies will exchange $75 million in Series A preferred securities, accrued preferred dividends, and warrants for $75 million in preferred shares and an interest in the common equity in the acquirer and, following the closing, the leasehold interests in three restaurants in Las Vegas currently held by Morgans.
At closing, SBE will acquire Morgans’ portfolio of thirteen owned, operated or licensed hotel properties in London, Los Angeles, New York, Miami, San Francisco, Las Vegas and Istanbul, including its Hudson New York and Delano South Beach properties. SBE is currently working with the lenders to assume the mortgages of the Hudson and Delano properties, approximately $422 million, and expects this to occur at closing.
Howard M. Lorber, Morgans Chairman, said, “Morgans’ Board of Directors carefully considered all of the alternatives available to us and we are pleased to have arrived at a transaction that we believe is in the best interests of our shareholders, while providing a great home for our attractive assets under a renowned hospitality company in SBE.”
The transaction, which was approved by the Board of Directors, is expected to close in the third or fourth quarter, and is subject to regulatory approvals, the assumption or refinancing of Morgans’ mortgage loan agreements, and customary closing conditions, including approval of the transaction by Morgans shareholders. Morgans shareholders representing approximately 29 percent of the Company’s outstanding shares of common stock have signed voting agreements in support of this transaction, including OTK Associates, Pine River Capital Management and Vector Group Ltd. Affiliates of The Yucaipa Companies have also signed a voting agreement in respect of their Series A preferred securities and warrants.
SBE has obtained commitments to finance the transaction through a combination of proceeds from the sale of new preferred equity in the newly-formed company to a third-party investor, liquidity from the refinancing of its existing term loans and a new revolver.
In light of today’s announcement, the Company’s first quarter earnings call, previously scheduled for today at 5:00 PM Eastern Time (U.S.) has been cancelled.
Morgan Stanley & Co. LLC served as financial advisor and Fried, Frank, Harris, Shriver & Jacobson LLP served as legal advisors to Morgans Hotel Group.
About Morgans Hotel Group
Morgans Hotel Group Co. (NASDAQ:MHGC) is widely credited as the creator of the first “boutique” hotel and a continuing leader of the hotel industry’s boutique sector. Morgans Hotel Group operates Delano in South Beach, Mondrian in Los Angeles, South Beach and London, Hudson in New York, Morgans and Royalton in New York, Clift in San Francisco, Shore Club in South Beach and Sanderson and St Martins Lane in London. Morgans Hotel Group has ownership interests or owns several of these hotels. Morgans Hotel Group also licenses its brand through Delano in Las Vegas and 10 Karaköy in Istanbul, Turkey. Morgans Hotel Group has other hotels in various stages of development to be operated under management or franchise agreements, including a Mondrian property in Doha, Qatar and a Delano in Dubai. For more information please visit www.morganshotelgroup.com.
Important Information About the Transaction and Where to Find It
In connection with the proposed transaction, Morgans will file with the Securities and Exchange Commission (“SEC”) a proxy statement. Morgans may also file other documents with the SEC regarding the proposed transaction. MORGANS STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Morgans stockholders may obtain free copies of the proxy statement (when available) and other documents filed with the SEC by Morgans through the web site maintained by the SEC at www.sec.gov or by contacting the investor relations department of Morgans at (212) 277-4188.
Participants in the Solicitation
Morgans and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of Morgans is contained in Morgans’ Form 10-K for the year ended December 31, 2015 and its proxy statement filed on April 15, 2016, which are filed with the SEC. Information regarding the identity of the potential participants, and their direct or indirect interests in the transaction, by security holdings or otherwise, will be set forth in the proxy statement and other materials to be filed with SEC in connection with the transaction.
Legal Notice Regarding Forward-Looking Statements
This press release, and the documents to which Morgans refers in this communication, contain not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent Morgans’ expectations or beliefs concerning future events, including the timing of the transaction and other information relating to the transaction. Forward-looking statements include information concerning possible or assumed future results of operations of Morgans, the expected completion and timing of the transaction and other information relating to the transaction. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “forecasts,” “should,” “estimates,” “contemplate,” “future,” “goal,” “potential,” “predict,” “project,” “projection,” “may,” “will,” “could,” “should,” “would,” “assuming” and similar expressions are intended to identify forward-looking statements. You should read statements that contain these words carefully. They discuss Morgans’ future expectations or state other forward-looking information and may involve known and unknown risks over which Morgans has no control. Those risks include, (i) the risk that the transaction may not be completed in a timely manner or at all, including by reason of the unavailability of financing, which may adversely affect Morgans’ business and the price of the common stock of Morgans, (ii) the failure to satisfy any of the conditions to the consummation of the transaction, including the adoption of the acquisition agreement by the stockholders of Morgans, the assumption or refinancing of Morgans’ mortgage loan agreements and the receipt of governmental and regulatory approvals, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the acquisition agreement, (iv) the effect of the announcement or pendency of the transaction on Morgans’ business relationships, operating results and business generally, (v) risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the transaction, (vi) risks related to diverting management’s attention from Morgans’ ongoing business operations and (vii) the outcome of any legal proceedings that may be instituted against us related to the acquisition agreement or the transaction. Forward-looking statements speak only as of the date of this communication or the date of any document incorporated by reference in this document. Except as required by applicable law or regulation, Morgans does not undertake to update these forward-looking statements to reflect future events or circumstances.
Contacts: Investors Richard Szymanski Morgans Hotel Group Co. 212.277.4188 Media Stephanie Pillersdorf/Pamela Greene/Patrick Scanlan Sard Verbinnen & Co 212.687.8080
(MIFI) Bring Novatel Wireless Solutions to Business Subscribers Across Africa
Novatel Wireless Expands Footprint Across 17 Countries in Africa with Multinational Telecommunications Leader
SAN DIEGO and JOHANNESBURG, South Africa, May 09, 2016 — Novatel Wireless, Inc. (Nasdaq:MIFI), a leading global provider of solutions for the Internet of Things (IoT), including software-as-a-service (SaaS), and Mobile Telephone Network Group (MTN), Africa’s largest telecommunications network operator with 229 million subscribers across Africa and the Middle East, today announced a partnership agreement to offer Ctrack telematics solutions and services to MTN’s IoT customer base.
The solution enables MTN’s business subscribers to seamlessly integrate fleet management and vehicle tracking solutions using MTN’s Pan African IoT SIM cards, enabling businesses to benefit from a single rate for IoT activity across the company’s footprint in Africa. In addition, this allows companies with transcontinental operations to easily monitor and track vehicles across borders.
“Given the similarities in the footprints of Ctrack and MTN, as well as the benefits which fleet management and vehicle tracking solutions provide to our business customers, this partnership is a natural fit,” said Debbie Minnaar, Acting Executive for MTN’s Group Enterprise Business Unit. “Over and above this, the launch of fleet management services marks the beginning of MTN’s journey towards building an IoT ecosystem, whereby services such as fleet management can be leveraged to enable and enhance other offerings related to smart cities, smart health and smart agriculture.”
“Wireless operators are an integral component of the Internet of Things,” said Cobus Grove, General Manager Ctrack Global for Novatel Wireless. “Through this partnership, we dramatically expand our footprint throughout Africa while enabling MTN to offer businesses operating any size of fleet the ability to easily deploy secure and reliable telematics applications.”
The Ctrack fleet management and vehicle tracking platform for MTN is a combination of hardware, software and firmware that dramatically accelerates the time to market of M2M and IoT projects and enables MTN to layer their added-value components on a reliable ready-to-use infrastructure. Ctrack’s extensive network of distributors will provide the in-field support for each country.
About the MTN Group
Launched in 1994, the MTN Group is a leading emerging market operator, connecting subscribers in 22 countries in Africa, Asia and the Middle East. The MTN Group is listed on the JSE Securities Exchange in South Africa under the share code: “MTN.” As of 31 March 2016, MTN recorded 229 million subscribers across its operations in Afghanistan, Benin, Botswana, Cameroon, Cote d’Ivoire, Cyprus, Ghana, Guinea Bissau, Guinea Republic, Iran, Liberia, Nigeria, Republic of Congo (Congo-Brazzaville), Rwanda, South Africa, Sudan, South Sudan, Swaziland, Syria, Uganda, Yemen and Zambia. Visit us at, www.mtnbusiness.com and www.mtn.com
About MTN Business
MTN Business is the enterprise business unit within MTN Group. The unit has presence in 24 markets across Africa and the Middle East. MTN Business offers fully converged mobile and internet-based ICT solutions, aimed at enabling and inspiring the growth of our clients. Our offerings include Unified Communications and ICT solutions in Cloud, Internet of Things, Security and Managed Networks. Solutions are geared toward addressing the needs of clients in the public and corporate sectors, as well as small and medium enterprises. Visit us at www.mtnbusiness.com.
About Novatel Wireless, Inc.
Novatel Wireless, Inc. (Nasdaq:MIFI) is a leading global provider of solutions for the Internet of Things (IoT), including software-as-a-service (SaaS) solutions for the fleet telematics market. Our innovative products and solutions provide anywhere, anytime communications and analytics for consumers and businesses of all sizes, with approximately 164,000 subscribed fleet vehicles for Ctrack among the Company’s 534,000 global subscribers. Novatel Wireless, Inc. is headquartered in San Diego, California. www.novatelwireless.com. @MIFI (Twitter); https://www.linkedin.com/company/novatel-wireless (LinkedIn)
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, statements related to the ability of Novatel Wireless to expand its addressable markets and drive growth in service revenue and broaden its customer base as a result of the acquisition of DigiCore, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Novatel Wireless and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Novatel Wireless undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. These forward-looking statements also involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Novatel Wireless in general, see the risk disclosures in the Annual Report on Form 10-K of Novatel Wireless for the year ended December 31, 2015, and in other filings made with the SEC by Novatel Wireless (available at www.sec.gov).
Editorial Contacts: For Novatel Wireless Anette Gaven agaven@nvtl.com 619.993.3058
(VBIV) & SciVac Announce Completion of Merger Transaction
- SciVac Therapeutics changes its name to VBI Vaccines
- Combined company to begin trading on The NASDAQ Capital Market under the symbol “VBIV”
- Combined company is a biotechnology company with a licensed hepatitis B vaccine and a pipeline of novel technologies that seek to expand vaccine protection in large underserved markets
CAMBRIDGE, Mass., May 09, 2016 — VBI Vaccines Inc., a Delaware corporation (“VBI”), and SciVac Therapeutics Inc., a British Columbia corporation (“SciVac”), are pleased to announce the completion of their previously announced merger transaction, whereby SciVac acquired VBI. VBI survives the merger as a wholly owned subsidiary of SciVac.
Upon completion of the merger, SciVac changed its name to VBI Vaccines Inc. and will commence trading on The NASDAQ Capital Market under the symbol “VBIV” at market open on March 9, 2016.
The merger creates a commercial stage company with an approved hepatitis B vaccine, a pipeline of preventative and therapeutic vaccine candidates, and two novel technology platforms.
Jeff Baxter, President and Chief Executive Officer of VBI, Dr. David Anderson, Chief Scientific Officer of VBI, and Jim Martin, SciVac’s Chief Financial Officer, will continue in those same officer roles with the combined company. Dr. Curtis Lockshin, SciVac’s former Chief Executive Officer, will assume the role of Chief Technology Officer of the combined company. Dr. Steven Gillis, Chairman of the Board of VBI, will serve as Chairman of the Board of the combined company, and will be joined on the board by Adam Logal and Steven Rubin, both of OPKO Health, Inc. (NYSE:OPK), the combined company’s largest shareholder.
“We are thrilled and excited to announce the completion of this merger, which we believe dramatically propels the future development of the assets within each legacy company,” said Mr. Baxter. “SciVac brings Sci-B-Vac, a licensed and marketed third-generation hepatitis B vaccine, which complements a highly innovative infectious disease pipeline of product candidates, the lead program of which targets cytomegalovirus. We feel incredibly fortunate to be able to contribute to the growth of Sci-B-Vac, a pioneering product that is approved in smaller markets, but we believe is capable of being scaled and developed in late-stage clinical trials in order to seek additional approvals in Europe, the United States, Japan, and other large markets.”
Following the merger, the combined company believes it will be well-positioned to advance its infectious disease and immuno-oncology vaccine candidates, as well as its proprietary technology platforms. Current development programs include:
Infectious Disease
- Sci-B-Vac is a commercial stage hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus and is free of any next-generation adjuvant. Sci-B-Vac offers rapid onset of protection, high levels of anti-HBV antibodies, and can be administered at lower doses than competing HBV vaccines. Sci-B-Vac is approved in Israel and in 14 other countries and has demonstrated a favorable safety and efficacy profile in over 300,000 patients.
- VBI is developing a vaccine to prevent cytomegalovirus (“CMV”) infection. CMV is a leading cause of serious birth defects in newborns when a mother is infected during pregnancy. Based on preclinical data, VBI has completed GMP manufacturing of its lead candidate for use in Phase I trials; VBI expects to evaluate safety, tolerability, and also immunological proof of concept in humans during Phase I trials.
- VBI is developing a vaccine to prevent respiratory syncytial virus (“RSV”) infection. RSV is a respiratory virus that infects the lungs and airways. VBI has been awarded grant funding by the National Research Council-Industrial Research Assistance Program (“NRC-IRAP”) to develop a vaccine candidate that expresses the pre-fusion RSV-F protein.
Immuno-Oncology
- VBI is developing a therapeutic vaccine candidate for glioblastoma multiforme (“GBM”). GBM is among the most common and aggressive malignant primary brain tumors in humans. With its novel approach, VBI intends to create a GBM immunotherapy that will stimulate the patient’s own immune system to identify and kill GBM cancer cells, with the goal of creating a commercially-viable therapy that is more effective and tolerable than current treatments.
- VBI is developing additional undisclosed therapeutic vaccine candidates that utilize the eVLP Platform to deliver foreign viral antigens that are highly associated with multiple solid tumors.
Technology Platforms
- VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines. eVLPs are an innovative new class of synthetic vaccines that are designed to closely mimic the structure of viruses. The eVLP Platform has given rise to VBI’s CMV, RSV, and GBM vaccine candidates.
- The LPV Platform is a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is currently leading broad research collaborations with GlaxoSmithKline Biologics SA and Sanofi Pasteur to evaluate the LPV Platform.
In meetings held on January 29, 2016 and May 5, 2016, respectively, shareholders collectively holding approximately 55% of the issued and outstanding SciVac common shares and stockholders collectively holding approximately 75% of the issued and outstanding VBI common stock voted in favor of the merger.
Advisors
Greenberg Traurig, P.A. served as legal counsel to SciVac, and Mitchell Silberberg & Knupp LLP served as VBI’s legal counsel. Blake, Cassels & Graydon LLP served as Canadian counsel to SciVac, and Borden Ladner Gervais LLP served as Canadian counsel to VBI. Pearl Cohen Zedek Latzer Baratz served as SciVac’s Israeli legal counsel, and Yehuda Raveh & Co. served as VBI’s Israeli legal counsel.
Additional Information
VBI Vaccines Inc., a British Columbia corporation (formerly, SciVac Therapeutics Inc.), has relocated its headquarters to VBI’s headquarters in Cambridge, Massachusetts, USA. It is currently planned that VBI’s legacy research & development facilities will remain in Ottawa, Ontario, Canada, and research & development and manufacturing for Sci-B-Vac™ will remain in Rehovot, Israel. Additionally, it is currently planned that the company will maintain the SciVac trade name in Israel and will continue to sell Sci-B-Vac™ under that name. The SciVac facility in Rehovot also offers contract development and manufacturing services to the life sciences and biotechnology markets.
Additional combined company information can be found:
Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: the anticipated benefits of the merger; and statements regarding the operation of each of VBI and SciVac’s historical businesses, including the expected development and/or commercialization of each of VBI and SciVac’s products.
Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties’ respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations.
Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company’s products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company’s reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
VBI Contact Perri Maduri, Communications Executive Phone: (617) 830-3031 x124 Email: ir@vbivaccines.com VBI Investor Contact Nell Beattie Director, Corporate Development and Investor Relations Phone: (617) 830-3031 x128 Email: nbeattie@vbivaccines.com
(APOL) Shareholders Approve Merger Agreement to be Acquired by Consortium
Apollo Education Group, Inc. (NASDAQ: APOL) today announced that its shareholders have approved the merger agreement for the proposed acquisition by a consortium of investors, including The Vistria Group, LLC, funds affiliated with Apollo Global Management, LLC (NYSE: APO) and the Najafi Companies.
More than 63 percent of the Class A shares voted at Apollo Education Group’s Special Meeting of Shareholders today voted in favor of the transaction, representing approximately 54 percent of all outstanding Class A shares. One hundred percent of Class B shares voted in favor of the proposals. At completion of the merger, Apollo Education Group shareholders will receive $10.00 per share in cash.
“We appreciate the support from our shareholders in approving this transaction,” said Greg Cappelli, Chief Executive Officer of Apollo Education Group. “This has been a robust process in which our Board of Directors reviewed many strategic alternatives and found this transaction to be in the best interest of all stakeholders. We believe this new ownership structure will allow Apollo Education Group to continue to transform University of Phoenix, further expand our global operations, drive operational efficiency and serve as the leading provider of high quality education for working adults.”
Tony Miller, Partner at The Vistria Group who will become Chairman of the Apollo Education Group upon transaction close, said, “We are committed to making University of Phoenix the most trusted provider of career-relevant higher education for working adults in the country. We have a vision for how to dramatically improve student outcomes, while addressing the concerns from critics of the for-profit education industry. It remains our belief that success is rooted in graduating students with the knowledge and skills that employers need, in an affordable way that ensures a compelling return on their educational investment.”
The transaction is subject to financial, operational and customary closing conditions. It is also subject to foreign and domestic regulatory conditions and approvals, including by the U.S. Department of Education, the Higher Learning Commission, and state regulatory and programmatic accreditation bodies. The acquisition is expected to be completed by year-end 2016.
About Apollo Education Group, Inc.
Apollo Education Group, Inc. is one of the world’s largest private education providers, serving students since 1973. Through its subsidiaries, Apollo Education Group offers undergraduate, graduate, professional development, and other non-degree educational programs and services, online and on-campus principally to working learners. Its educational programs and services are offered throughout the United States and in Europe, Australia, Latin America, Africa and Asia, as well as online throughout the world. For more information about Apollo Education Group, Inc. and its subsidiaries, call (800) 990-APOL or visit the Company’s website at www.apollo.edu.
About The Vistria Group
The Vistria Group is a Chicago, Ill.-based private investment firm focused on investing in middle market companies in the healthcare, education and financial services sectors. Vistria’s team is comprised of highly experienced operating partners and private equity executives with proven track records of working with management teams in building innovative market leading companies.
About Apollo Global Management
Apollo Global Management, LLC is a leading global alternative investment manager with offices in New York, Los Angeles, Houston, Chicago, Bethesda, Toronto, London, Frankfurt, Madrid, Luxembourg, Mumbai, Delhi, Singapore, Hong Kong and Shanghai. Apollo Global Management had assets under management of approximately $173 billion as of March 31, 2016 in private equity, credit and real estate funds invested across a core group of nine industries where Apollo Global Management has considerable knowledge and resources. Affiliates of Apollo Global Management have significant experience managing investments in the education sector with current and former private equity fund investments in leading companies, including McGraw Hill Education, Connections Academy and Sylvan Learning Centers. The portfolio companies owned by funds managed by affiliates of Apollo Global Management are managed and operate independently from one another. For more information about Apollo, please visit www.agm.com.
About Najafi Companies
Najafi Companies is an international private investment firm based in Phoenix, Ariz., targeting education, media, consumer products, internet services and direct marketing sectors. The firm makes highly selective investments in companies with strong management teams across a variety of industries, often in areas undergoing rapid transformation. Najafi Companies funds its investments with internally generated capital, not through a fund. The firm is able to move quickly and decisively when investing and make investments that create maximum value for the long term.
Forward-Looking Statements Safe Harbor
Statements about Apollo Education Group and its business in this release which are not statements of historical fact, including statements regarding Apollo Education Group’s future strategy and plans and commentary regarding future results of operations and prospects, are forward-looking statements and are subject to the Safe Harbor provisions created by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current information and expectations and involve a number of risks and uncertainties. Actual plans implemented and actual results achieved may differ materially from those set forth in or implied by such statements due to various factors, including, without limitation: (i) the timing of the completion of the merger; (ii) the failure of Parent to obtain the necessary equity financing set forth in the equity commitment letters received in connection with the merger agreement or the failure of that financing to be sufficient to complete the merger and the transactions contemplated thereby; (iii) the inability to complete the merger due to the failure to satisfy conditions to completion of the merger, including receipt of required regulatory approvals; (iv) the risk that regulatory agencies impose restrictions, limitations, costs, divestitures or other conditions in connection with providing regulatory approval of the merger; (v) the outcome of pending or potential litigation or governmental investigations; (vi) disruptions resulting from the proposed merger making it more difficult for Apollo Education Group to maintain relationships with its students, customers, employees, suppliers and strategic partners; (vii) competitive responses to the proposed merger; (viii) unexpected costs, liabilities, charges or expenses resulting from the merger; (ix) the inability to obtain, renew or modify permits in a timely manner, or comply with government regulations; (x) the inability to retain key personnel of Apollo Education Group or its subsidiaries; (xi) the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement, including a termination of the merger agreement under circumstances that could require Apollo Education Group to pay a termination fee; (xii) unexpected expenses or other challenges in integrating acquired businesses, student, consumer or regulatory impact arising from consummation of such acquisitions, and unexpected changes or developments in the acquired businesses; (xiii) diversion of management’s attention from ongoing business concerns; (xiv) limitations placed on Apollo Education Group’s ability to operate its business by the merger agreement; (xv) the impact of increased competition from traditional public universities and proprietary educational institutions; (xvi) the impact of the initiatives to transform the University of Phoenix into a more-focused, higher-retaining and less-complex institution, including the near-term impact on enrollment; (xvii) the impact of Apollo Education Group’s ongoing restructuring and cost-reduction initiatives; (xviii) impacts from actions taken by our regulators that could affect the University of Phoenix’s eligibility to participate in or the manner in which it participates in U.S. Federal and state student financial aid programs, including the recent requirement that all substantial changes be approved by the U.S. Department of Education in advance; (xix) further delay in the University of Phoenix’s pending recertification by the U.S. Department of Education for participation in Title IV student financial aid programs, or any limitations or qualifications imposed in connection with any recertification; (xx) the impact of any reduction in financial aid available to students, including active and retired military personnel, due to the U.S. government deficit reduction proposals, debt ceiling limitations, budget sequestration or otherwise; (xxi) changes in regulation of the U.S. education industry and eligibility of proprietary schools to participate in U.S. Federal student financial aid programs; (xxii) changes in the University of Phoenix’s enrollment or student mix; (xxiii) the impact on student enrollments of the announcement of the proposed merger and general economic conditions; (xxiv) the impact of third party claims that Apollo Education Group’s products and services infringe their intellectual property rights; and (xxv) fluctuations in non-U.S. currencies that could impact reported operating results of foreign subsidiaries. For a discussion of the various factors that may cause actual plans implemented and actual results achieved to differ materially from those set forth in the forward-looking statements, please refer to the risk factors and other disclosures contained in Apollo Education Group’s Form 10-K for fiscal year 2015, filed with the Securities and Exchange Commission (the “SEC”) on October 22, 2015, Form 10-Q for the quarterly period ended February 29, 2016, filed with the SEC on April 7, 2016, Form 10-Q for the quarterly period ended November 30, 2015, filed with the SEC on January 11, 2016, and other filings with the SEC which are available at www.apollo.edu. The cautionary statements referred to above also should be considered in connection with any subsequent written or oral forward-looking statements that may be issued by Apollo Education Group or persons acting on Apollo Education Group’s behalf. Apollo Education Group undertakes no obligation to publicly update or revise any forward-looking statements for any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, Apollo Education Group cannot guarantee future results, events, levels of activity, performance, or achievements.
For Apollo Education Group, Inc.:
Investors
Apollo Education Group, Inc.
Beth Coronelli, +1 312-660-2059
beth.coronelli@apollo.edu
or
Media
Brunswick Group
Tripp Kyle / Tom Maginnis, +1 212-333-3810
apollo@brunswickgroup.com
or
For Apollo Global Management:
Investors
Apollo Global Management, LLC
Gary M. Stein, +1 212-822-0467
Head of Corporate Communications
gstein@apollolp.com
or
Apollo Global Management, LLC
Noah Gunn, +1 212-822-0540
Investor Relations Manager
ngunn@apollolp.com
or
Media
Rubenstein Associates, Inc.
Charles Zehren, +1 212-843-8590
czehren@rubenstein.com
or
For The Vistria Group:
SKDKnickerbocker
Amy Brundage, +1 202-464-6900
abrundage@skdknick.com
or
For The Najafi Companies:
Lavidge Company
Anne Robertson, +1 480-998-2600
(SPPI) Apaziquone Presentation at 2016 Annual AUA, May 6-10
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today presentations of clinical data for apaziquone to be presented at an oral presentation and a moderated poster session at the American Urological Association Education and Research Inc., being held in San Diego, California, from May 6-10, 2016.
For more information about the AUA Meeting and for a complete list of abstracts, please refer to the conference web site at http://www.aua2016.org/abstracts/
| Friday, May 6, 2016 1:00 PM-3:00 PM PT (Moderated Poster Session) | ||||||||||||
| Abstract # | Type | Title | First Author | Location | ||||||||
| MP13-07 | Poster | Improved Efficacy of Adjuvant, Single Dose Intravesical Apaziquone by Timing post-Resection in Two Doubleblind, Randomized, Placebo-Controlled Phase 3 Studies in Non-Muscle Invasive Bladder Cancer | Fred Witjes | Room 28 ABC | ||||||||
| Saturday, May 7, 2016, 8:00 AM-10:00 AM PT (Podium Presentation) | ||||||||||||
| Abstract # | Type | Title | First Author | Location | ||||||||
| PD11-07 | Podium | Integrated Results of Two Multicenter, Randomized, Placebo Controlled, Double Blind, Phase 3 Trials (SPI-611/612) of Single-Dose Intravesical Apaziquone Immediately Following Resection in Patients with Non-Muscle Invasive Bladder Cancer | Lawrence Karsh | Room 23 AB | ||||||||
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and expects an FDA decision on another drug in the second half of 2016. Additionally, Spectrum’s pipeline includes three drugs in advanced stages of clinical development that have the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Spectrum Pharmaceuticals
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
(AVXS) Reports Data from Ongoing Phase 1 Trial of AVXS-101 in Spinal Muscular Atrophy Type 1
— Jerry Mendell, MD, Presented Data as of April 1, 2016 at the American Society of Gene & Cell Therapy 19th Annual Meeting —
— Company to Host Webcast Today at 4:30 p.m. Eastern Daylight Time —
CHICAGO, May 06, 2016 — AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases, today presented an interim analysis of data as of April 1, 2016 from the ongoing Phase 1 trial of AVXS-101 for the treatment of spinal muscular atrophy (SMA) Type 1. Jerry Mendell, MD, director of the Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital, presented the data at the 19th Annual Meeting of the American Society of Gene & Cell Therapy in Washington, D.C.
The data reported at the meeting show that AVXS-101 continues to demonstrate a favorable safety profile in patients studied, with no new treatment-related safety or tolerability concerns identified; all patients in both the low-dose and proposed therapeutic-dose cohorts remain without an “event,” defined as death or until a patient requires at least 16 hours per day of ventilation support for breathing for 14 consecutive days in the absence of an acute reversible illness, or perioperatively; and the mean motor function score continues to increase, with two patients having achieved motor function in a range considered to be normal.
Dr. Mendell said, “Given the rapid and devastating disease course of SMA Type 1, it is very encouraging to see that all patients in both dosing cohorts have remained event free, and all patients have demonstrated sustained improvements above baseline in motor function since receiving AVXS-101. Additionally, new data presented today appear to indicate that AVXS-101 may have a positive impact on both the pulmonary and nutritional support of patients in the trial suffering from SMA Type 1, which may be impacting the overall survival benefit.”
The ongoing Phase 1 study is designed to evaluate safety and preliminary indications of efficacy of AVXS-101 in patients suffering from SMA Type 1. Data as of April 1, 2016 has shown:
- AVXS-101 appears to have a favorable safety profile and to be generally well tolerated in patients studied. There has been a total of 74 adverse events (AEs) reported, 22 of which were determined to be serious adverse events (SAEs). Two of the 22 were deemed treatment-related and, as previously reported, those SAEs were clinically asymptomatic liver enzyme elevations. Of the 52 non-serious AEs, 3 were treatment-related elevations in liver enzymes experienced by two patients. All elevated liver enzyme AEs and SAEs were resolved with prednisolone treatment. Other non-treatment-related AEs were expected and were associated with SMA.
- No patients in either dosing cohort have experienced an “event.” The median event-free age of all 15 patients was 14.9 months, and the median event-free age of patients in Cohort 1 was 25.7 months and in Cohort 2 was 11.7 months. The natural history of the disease indicates that 25 percent of untreated SMA Type 1 patients survive event-free at 13.6 months of age and that 8 percent survive event-free at 20 months of age1.
- Mean increases of 8.7 points and 19.2 points in CHOP-INTEND scores were observed in Cohort 1 and Cohort 2, respectively. Nine out of 12 patients (75 percent) and 7 out of 12 patients (58 percent) in Cohort 2 have achieved CHOP-INTEND scores of at least 40 points or 50 points, respectively. Two patients achieved the maximum score of 64. A score of 60 is considered normal. The Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) is a test developed to measure motor skills of patients with SMA Type 1.
- The natural history of SMA Type 1 indicates that bulbar weakness leads to impaired swallowing, malnutrition and growth failure. The median age to growth failure is 7 months of age2. The median age to nutritional support is 8 months of age (IQR 6-13 months)1. AVXS reported today that 7 of 7 (100%) of AVXS-101 patients that did not require feeding support before treatment continued without feeding support as of April 1, 2016 in the ongoing Phase 1 trial. Five patients had gastric feeding tube placement prior to gene therapy. One patient in Cohort 2 who had gastric feeding tube placement prior to gene transfer is also feeding orally.
- The natural history of SMA Type 1 indicates that bulbar muscle weakness, skeletal muscle weakness in the neck and intercostal muscle weakness lead to respiratory impairment, poor clearance of airway secretions, risk of aspiration and recurrent infections leading to death or permanent ventilation. The median age to permanent ventilation or death is 10.5 months (IQR 8.1-13.6 months), and by 13.6 months only 25 percent of SMA Type 1 patients are alive and free of permanent ventilation1. In the ongoing trial, 8 of 10 (80%) of AVXS-101 patients that did not use biphasic/bi-level ventilation (BiPAP) support before gene transfer continue without any ventilation support as of April 1, 2016 (the 2 exceptions being after severe illness/hospitalizations to assist recovery).
“We are encouraged by these interim results as we work diligently to bring AVXS -101 to patients who suffer from SMA Type 1, a devastating disease for which there are currently no FDA-approved therapies,” said Suku Nagendran, MD, Senior Vice President and Chief Medical Officer, AveXis. “We look forward to reviewing the ongoing data from this study over the coming year as we continue the development of AVXS-101.”
Webcast at 4:30 p.m. EDT
AveXis will host a live audio webcast of a conference call to discuss the interim Phase 1 trial data today at 4:30 p.m. EDT. Analysts and investors can participate in the conference call by dialing (877) 508-0547 for domestic callers and (615) 247-5963 for international callers, using the conference ID 95576133. The webcast can be accessed live on the Events and Presentations page in the Investors and Media section of the AveXis website, www.AveXis.com. The webcast will be archived on the company’s website for 30 days and will be available for telephonic replay for 14 days following the call by dialing (855) 859-2056 (Domestic) or (404) 537-3406 (International), conference ID 95576133.
Phase 1 Trial Design
The Phase 1 open-label, dose-escalation study is designed to evaluate safety and preliminary indications of efficacy of AVXS-101 in patients suffering from SMA Type 1. The primary outcome in the study is safety and tolerability. The secondary outcome measure is efficacy as defined by the time from birth to an “event,” with an event defined as death or until a patient requires at least 16 hours per day of required ventilation support for breathing for 14 consecutive days in the absence of an acute reversible illness or perioperatively. Exploratory outcome measures include motor function testing, measured by the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), a test developed to measure motor skills of patients with SMA Type 1, and other motor milestone development surveys and tests.
The clinical protocol requires that each patient receive a one-time dosage of AVXS-101, by intravenous injection over a one-hour period. The patient remains at the clinical trial site for 48 hours after dosing for monitoring prior to discharge, and weekly follow-up evaluations are conducted for one month after dosing. After the first month, additional evaluations are conducted monthly for 23 months.
The trial has fully-enrolled with a total of 15 patients who met enrollment criteria of diagnosis of SMA Type 1 before six months of age, with two copies of the SMN2 backup gene, as determined by genetic testing. The trial includes two dosing cohorts:
- Cohort 1 (low dose) includes three patients dosed at (6.7 X1013 vg/kg), aged 5.9 to 7.2 months at time of dosing;
- Cohort 2 (proposed therapeutic dose) includes 12 patients dosed at (2.0 X1014 vg/kg), aged 0.9 to 7.9 months at time of dosing.
About SMA
SMA is a severe neuromuscular disease characterized by the loss of motor neurons leading to progressive muscle weakness and paralysis. SMA is caused by a genetic defect in the SMN1 gene that codes SMN, a protein necessary for survival of motor neurons. The incidence of SMA is approximately one in 10,000 live births.
The most severe form of SMA is Type 1, a lethal genetic disorder characterized by motor neuron loss and associated muscle deterioration, which results in mortality or the need for permanent ventilation support before the age of two for greater than 90 percent of patients. SMA Type 1 is the leading genetic cause of infant mortality.
About AVXS-101
AVXS-101 is a proprietary gene therapy candidate of a one-time, intravenous treatment for SMA Type 1 and is the only clinical-stage gene therapy in development for SMA. AVXS-101 is designed to address the monogenetic root cause of SMA and prevent further muscle degeneration by addressing the defective and/or loss of the primary SMN gene. AVXS-101 also targets motor neurons providing rapid onset of effect, and crosses the blood brain barrier allowing an intravenous (IV) dosing route and effective targeting of both central and systemic features.
About AveXis, Inc.
AveXis is a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. The company’s initial proprietary gene therapy candidate, AVXS-101, is in an ongoing Phase 1 clinical trial for the treatment of SMA Type 1. For additional information, please visit www.avexis.com.
1. Finkel, R. et al. Observational study of spinal muscular atrophy type I and implications for clinical trials. Neurology 83,810–817 (2014).
2. Sproule, D. et al. Age at Disease Onset Predicts Likelihood and Rapidity of Growth Failure Among Infants and Young Children with Spinal Muscular Atrophy Types 1 and 2. J Child Neurol 27, 845-851 (2012).
Forward-Looking Statements:
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, AveXis’ research, development and regulatory plans for AVXS-101, including the expected timing for reporting results from the ongoing Phase 1 clinical trial and the potential for AVXS-101 to positively impact the pulmonary and nutritional support of patients suffering from SMA Type 1. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the scope, progress, expansion, and costs of developing and commercializing AveXis’ product candidates; regulatory developments in the United States and foreign countries, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of AveXis’ Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 18, 2016. In addition to the risks described above and in the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect AveXis’ results. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. AveXis cautions investors not to rely too heavily on the forward-looking statements AveXis makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). AveXis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Media Inquiries: Lauren Barbiero W2O Group 646-564-2156 lbarbiero@w2ogroup.com Investor Inquiries: Jim Goff AveXis, Inc. 650-862-4134 jgoff@avexis.com
(GSV) Completes Strategic Investment in Battle Mountain Gold
VANCOUVER, BRITISH COLUMBIA–(May 6, 2016) – Gold Standard Ventures Corp. (TSX VENTURE:GSV)(NYSE MKT:GSV) (“Gold Standard” or the “Company”) of Suite 610 – 815 West Hastings Street, Vancouver, B.C. V6C 1B4 announces that further to its news release of April 20, 2016, it has acquired ownership of 10,481,435 common shares of Battle Mountain Gold Inc. (“Battle Mountain“) representing 19.9% of Battle Mountain’s issued and outstanding common shares at a price of $0.35 per share for a total subscription price of $3,668,502.25. Gold Standard has also acquired ownership of share purchase warrants entitling the Company to purchase of up to an additional 5,240,717 common shares of Battle Mountain for a period of two years at a price of $0.37 per share, provided that the Company is prohibited from exercising the warrants pending shareholder approval from Battle Mountain for the creation of Gold Standard as a control person. Assuming exercise of the warrants, Gold Standard will own a total of 15,722,152 common shares or approximately 27.15% of Battle Mountain’s issued and outstanding common shares on a post-conversion beneficial ownership basis.
The common shares and warrants were acquired by Gold Standard as principal for investment purposes pursuant to a private placement offering by Battle Mountain (the “Private Placement“) in reliance upon the “minimum investment amount” exemption from the prospectus requirements of applicable securities legislation in National Instrument 45-106 Prospectus Exemptions.
Gold Standard did not own or control any shares of Battle Mountain, either alone or together with any joint actors prior to closing of the Private Placement and, other than the potential exercise of warrants, Gold Standard has no present intention to acquire further securities of Battle Mountain although Gold Standard may in the future and in accordance with applicable securities laws, increase or decrease its investment in Battle Mountain by acquiring or disposing of other securities of Battle Mountain, through the market, privately or otherwise, depending on market conditions or any other relevant factors.
Gold Standard has agreed to vote its shares of Battle Mountain in accordance with the recommendations of Battle Mountain’s board of directors for a period of 18 months and give Battle Mountain prior notice of any sales of shares exceeding 2% of Battle Mountain’s then issued and outstanding shares in any 15 day period for so long as Gold Standard owns not less than 9.9% of Battle Mountain’s issued and outstanding shares.
A report respecting this acquisition will be electronically filed with the applicable securities commission in each jurisdiction where Battle Mountain is reporting and will be available for viewing through the Internet at the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
ABOUT GOLD STANDARD VENTURES – Gold Standard is an advanced stage gold exploration company focused on district scale discoveries on its Railroad-Pinion Gold Project, located within the prolific Carlin Trend. The 2014 Pinion and Dark Star gold deposit acquisitions offer Gold Standard a potential near-term development option and further consolidates the Company’s premier land package on the Carlin Trend. The Pinion deposit now has an NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 31.61 million tonnes grading 0.62 grams per tonne (g/t) gold (Au), totaling 630,300 ounces of gold and an Inferred Resource of 61.08 million tonnes grading 0.55 g/t Au, totaling 1,081,300 ounces of gold, using a cut-off grade of 0.14 g/t Au (announced March 15, 2016). The Dark Star deposit, 2.1 km to the east of Pinion, has a NI43-101 compliant resource estimate consisting of an Inferred Resource of 23.11 million tonnes grading 0.51 g/t Au, totaling 375,000 ounces of gold, using a cut-off grade of 0.14 g/t Au (announced March 3, 2015). The 2014 and 2015 definition and expansion of these two shallow, oxide deposits demonstrates their growth potential.
The scientific and technical content and interpretations contained in this news release have been reviewed, verified and approved by Steven R. Koehler, Gold Standard’s Manager of Projects, BSc. Geology and CPG-10216, a Qualified Person as defined by NI 43-101, Standards of Disclosure for Mineral Projects.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) nor the NYSE MKT accepts responsibility for the adequacy or accuracy of this news release.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. All statements, other than statements of historical fact, included herein including, without limitation, statements about our proposed financing are forward looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Risk factors affecting the Company include, among others: the results from our exploration programs, global financial conditions and volatility of capital markets, uncertainty regarding the availability of additional capital, fluctuations in commodity prices; title matters; and the additional risks identified in our filings with Canadian securities regulators on SEDAR in Canada (available at www.sedar.com) and with the SEC on EDGAR (available at www.sec.gov/edgar.shtml). These forward-looking statements are made as of the date hereof and, except as required under applicable securities legislation, the Company does not assume any obligation to update or revise them to reflect new events or circumstances.
CAUTIONARY NOTE FOR U.S. INVESTORS REGARDING RESERVE AND RESOURCE ESTIMATES
All resource estimates reported by the Company were calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission for descriptions of mineral properties in SEC Industry Guide 7 under Regulation S-K of the U. S. Securities Act of 1933. In particular, under U. S. standards, mineral resources may not be classified as a “reserve” unless the determination has been made that mineralization could be economically and legally produced or extracted at the time the reserve determination is made. Accordingly, information in this press release containing descriptions of the Company’s mineral properties may not be comparable to similar information made public by US public reporting companies.
On behalf of the Board of Directors of Gold Standard,
Jonathan Awde, President and Director
Gold Standard Ventures Corp.
Jonathan Awde
President
604-669-5702
info@goldstandardv.com
www.goldstandardv.com
(EXPI) Real Estate Brokerage Division Appoints CEO and President
BELLINGHAM, WA –(May 06, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI) announced today that it has appointed Jason Gesing Chief Executive Officer of its real estate brokerage division and Vikki Bartholomae as division President.
Bartholomae has over 15 years of real estate industry experience, including more than 6 years as a Team Leader in the Keller Williams organization, during which time she achieved net agent gain of 192% and gains in both agent production (47%) and profit (56%) in the market centers she managed in Southern California and Texas. Bartholomae also has extensive experience in the coaching and training of real estate professionals, which includes the development of mentor programs for new agents. Bartholomae joined eXp Realty in Houston, Texas, where she now resides, in July 2015.
“Becoming part of eXp Realty, was a defining moment for me both personally and professionally,” said Bartholomae. “It is so exciting to be part of the future of the industry I love. eXp’s business model is completely disruptive in real estate by eliminating bricks and mortar and giving the agents true ownership in the company. My role as President gives me the opportunity to serve my agent ownership partners and bring about revolutionary change to our industry at the same time.”
Gesing, who joined eXp Realty in 2010, became EXPI president in October of 2013. Since that time, the Company’s brokerage division has increased its family of real estate professionals from approximately 300 to more than 1,200 and the Company’s revenues have increased from $10.7 million (2013) to $22.87 (2015).
“The eXp Realty business model offers unique and empowering professional development and wealth-building opportunities to real estate professionals because of the Company’s innovative use of technology,” said Gesing. “However, as beneficial and lucrative as the model is, people are joining us because we’ve been able to create an environment and a community that entrepreneurial agents want to be a part of. It’s a community of professionals who work very closely together, who support one another, and whose voices are and will continue to be heard, both as agents and brokers of the company, and as its shareholders.”
“I am very excited about Jason and Vikki working together to steward the real estate division of eXp World Holdings,” said EXPI Founder and CEO, Glenn Sanford. “Jason and I have been working closely together over the last three years and he has really articulated the value proposition in a way that resonates with those who are making meaningful differences in the industry. I have also been very impressed with the way Vikki has selflessly engaged with the Company from the moment she joined, serving to improve and grow the organization even when her role with the company was not well defined. Vikki possesses and has demonstrated great strength and tremendous talent and it quickly became clear that she needed to play a much larger role in the leadership of the company. I believe, based on my observations over the last six months in particular, that Jason and Vikki working together to lead the real estate division will result in even greater differentiation of the agent ownership model relative to the rest of the industry. I fully expect that the culture of the company will continue to strengthen and that the growth of the company will continue to accelerate.”
Vikki Bartholomae can be reached at vikki.bartholomae@exprealty.com or at 714-273-6041.
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 World Holdings, Inc.
jason@expworldholdings.com
617-970-8518
(FCEL) & (XOM) Pursue Novel Technology in Carbon Capture
- Advancing a novel application of carbonate fuel cells for power plant carbon dioxide capture
- Substantial cost savings relative to commercial technology through unique process that generates power while capturing carbon
Exxon Mobil Corporation (NYSE:XOM) and FuelCell Energy, Inc. (Nasdaq:FCEL) today announced an agreement to pursue novel technology in power plant carbon dioxide capture through a new application of carbonate fuel cells, which could substantially reduce costs and lead to a more economical pathway toward large-scale application globally.
“Advancing economic and sustainable technologies to capture carbon dioxide from large emitters such as power plants is an important part of ExxonMobil’s suite of research into lower-emissions solutions to mitigate the risk of climate change,” said Vijay Swarup, vice president for research and development at ExxonMobil Research & Engineering Company. “Our scientists saw the potential for this exciting technology for use at natural gas power plants to enhance the viability of carbon capture and sequestration while at the same time generating additional electricity. We sought the industry leaders in carbonate fuel-cell technology to test its application in pilot stages to help confirm what our researchers saw in the lab over the last two years.”
Chip Bottone, president and chief executive officer of FuelCell Energy, Inc., said his company is pleased to bring its global leadership in the development of carbonate fuel cells to this project.
“Carbon capture with carbonate fuel cells is a potential game-changer for affordably and efficiently concentrating carbon dioxide for large-scale gas and coal-fired power plants,” Bottone said. “Ultra-clean and efficient power generation is a key attribute of fuel cells and the carbon capture configuration has the added benefit of eliminating approximately 70 percent of the smog-producing nitrogen oxide generated by the combustion process of these large-scale power plants.”
Two years of comprehensive laboratory tests have demonstrated that the unique integration of two existing technologies – carbonate fuel cells and natural gas-fired power generation – captures carbon dioxide more efficiently than existing scrubber conventional capture technology. The potential breakthrough comes from an increase in electrical output using the fuel cells, which generate power, compared to a nearly equivalent decrease in electricity using conventional technology.
The resulting net benefit has the potential to substantially reduce costs associated with carbon capture for natural gas-fired power generation, compared to the expected costs associated with conventional separation technology. A key component of the research will be to validate initial projected savings of up to one-third.
The scope of the agreement between ExxonMobil and FuelCell Energy will initially focus for about one to two years on how to further increase efficiency in separating and concentrating carbon dioxide from the exhaust of natural gas-fueled power turbines. Depending on reaching several milestones, the second phase will more comprehensively test the technology for another one to two years in a small-scale pilot project prior to integration at a larger-scale pilot facility.
ExxonMobil is a leader in carbon capture and sequestration and has extensive experience in all of the component technologies of carbon capture and storage, including participation in several carbon dioxide injection projects over the last three decades. In 2015, ExxonMobil captured 6.9 million metric tons of carbon dioxide for sequestration – the equivalent of eliminating the annual greenhouse gas emissions of more than 1 million passenger vehicles.
“We are continually researching technologies that have an ability to reduce carbon dioxide emissions,” Swarup said. “Most solutions that can make an impact of the scale that is required are not found overnight. Our research with FuelCell Energy will be conducted methodically to ensure that all paths toward viability are explored.”
Using fuel cells to capture carbon dioxide from power plants results in reduced emissions and increased power generation. In the carbon capture context, power plant exhaust is directed to the fuel cell, replacing air that is normally used in combination with natural gas during the fuel cell power generation process. As the fuel cell generates power, the carbon dioxide becomes more concentrated, allowing it to be more easily and affordably captured from the cell’s exhaust and stored.
NOTE TO EDITORS:
Vijay Swarup and Chip Bottone will be available to answer questions from media on a conference call today at 10:30 a.m. CDT. Dial-in details are as follows:
| Company Name: | Exxon Mobil Corporation | ||
| Date/Time: | May 5, 2016, 10:30 AM CDT | ||
| Participant Number: | USA: (877) 311-5896 | ||
| Participant Number: | International: (281) 241-6149 | ||
| Conference ID Number: | 7316844 | ||
About ExxonMobil
ExxonMobil, the largest publicly traded international oil and gas company, uses technology and innovation to help meet the world’s growing energy needs. ExxonMobil holds an industry-leading inventory of resources, is among the largest refiners and marketers of petroleum products and its chemical company is one of the largest in the world. For more information, visit www.exxonmobil.com or follow us on Twitter www.twitter.com/exxonmobil.
Cautionary Statement: Statements of future events or conditions in this release are forward-looking statements. Actual future results, including project plans and timing and the impact of new technologies, could vary depending on the outcome of further research and testing; the development and competitiveness of alternative technologies; the ability to scale pilot projects on a cost-effective basis; political and regulatory developments; and other factors discussed in this release and under the heading “Factors Affecting Future Results” on the Investors page of ExxonMobil’s website at exxonmobil.com.
About FuelCell Energy, Inc.
Direct FuelCell® power plants are generating ultra-clean, efficient and reliable power at more than 50 locations worldwide. With more than 300 megawatts of power generation capacity installed or in backlog, FuelCell Energy is a global leader in providing ultra-clean baseload distributed generation to utilities, industrial operations, universities, municipal water treatment facilities, government installations and other customers around the world. The company’s power plants have generated over four billion kilowatt hours of ultra-clean power using a variety of fuels including renewable biogas from wastewater treatment and food processing, as well as clean natural gas. For additional information, please visit www.fuelcellenergy.com, follow us on Twitter and view our videos on YouTube.
ExxonMobil
Media Relations, 972-444-1107
or
FuelCell Energy
Investor Relations, 203-830-7494
(SPHS)To Present Topsalysin Phase 3 Data from Positive PLUS-1 Study
SAN DIEGO and VANCOUVER, British Columbia, May 5, 2016 — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, today announced that positive data from its Phase 3 study of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia will be presented as a late breaking poster on May 7, 2016 from 4:00 p.m. to 5:30 p.m. pacific time in the Science and Technology Hall at the 111th American Urological Association Annual Meeting.
Abstract No. 16-8385 (LB-S&T-04): “Prospective, Randomized, Double Blind, Vehicle Controlled, Multinational, Phase 3 Clinical Trial of the Pore Forming Protein PRX302 for Targeted Treatment of Symptomatic Benign Prostatic Hyperplasia (The PLUS-1 Trial)”
Presenting Author: Dr. Claus Roehrborn, UT Southwestern Medical Center
Poster Session: Late-Breaking Science & Technology Poster
Time: May 7, 2016 from 4:00 p.m. to 5:30 p.m. pacific time
The abstract related to the poster can be accessed through the American Urological Association website at http://www.aua2016.org/abstracts/.
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing topsalysin, a clinical-stage, targeted therapy for the treatment of urological diseases. Topsalysin is in Phase 3 clinical development for the treatment of the symptoms of benign prostatic hyperplasia (BPH) and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Topsalysin is also currently in a Phase 2a proof of concept study for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophirisbio.com.
| Company Contact: | |
| Peter Slover | |
| Chief Financial Officer | |
| (858) 777-1760 | |
| Corporate Communications and Investor Relations: | |
| Jason Spark | Michael Moore |
| Canale Communications | NATIONAL Equicom |
| Corporate Communications and IR | Investor Relations |
| (619) 849-6005 | (858) 886-7813 |
| jason@canalecomm.com | mmoore@national.ca |
(CRME) and Allergan Announce XYDALBA™ Licensing Agreement
VANCOUVER, May 5, 2016 – Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that its affiliate has signed an exclusive license agreement with an affiliate of Allergan plc that will result in the Cardiome Group (“Cardiome”) commercializing XYDALBA™ (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada. Cardiome will provide Allergan with a staggered upfront payment totalling US$13 million and will provide Allergan additional milestone payments and royalties based upon commercial achievements and sales of XYDALBA™. Additional terms of the agreement were not disclosed.
XYDALBA™ was approved by the European Medicines Agency (EMA) in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialized under the trade name DALVANCE® in the U.S. and XYDALBA™ in certain countries outside the U.S.
“Our license of XYDALBA™ is a transformational moment for Cardiome,” said William Hunter, M.D., President and CEO of Cardiome. “Over the past three years we have restructured and redirected Cardiome to become a differentiated specialty pharmaceutical company focused on commercializing proprietary growth pharmaceuticals in Europe and Canada. XYDALBA™ will fit perfectly within our current commercial footprint alongside BRINAVESS, AGGRASTAT and ESMOCARD. Licensing a product of this profile is a strong signal of our progress and we look forward to working with Allergan to bring this compelling medicine to patients in need across our territories.”
XYDALBA™ is approved for sale in the following territories licensed by Cardiome: the U.K., Germany, France, Denmark, Iceland, Finland, Malta, Norway, Sweden, Belgium, Netherlands, Luxemburg, and Ireland. XYDALBA™ is not yet approved in other countries for which Cardiome has licensed rights in including Canada and Switzerland. Cardiome expects to initiate commercial sales of XYDALBA™ in its territories as early as 2016.
Conference Call
Cardiome will hold a teleconference and webcast on Friday, May 6, 2016 at 8:00 am Eastern (5:00 am Pacific). To access the conference call, please dial 416-764-8609 or 1-888-390-0605 and use conference ID 47992527. The webcast can be accessed through Cardiome’s website at www.cardiome.com or through the following link:
http://event.on24.com/r.htm?e=1186804&s=1&k=D38CF3F76EA1C201FE12E6E82186C18E
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through June 6, 2016. Please dial 416-764-8677 or 888-390-0541 and enter code 992527# to access the replay.
About XYDALBA
XYDALBA™ is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. XYDALBA™ is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes, and a single dose regimen of 1500 mg also administered over 30 minutes. XYDALBA™ demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
About ABSSSI
There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 percent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the U.S. are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner AOP Orphan Pharma in select European markets. Cardiome has also licensed TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension, for Europe, the Middle East and for Canadian markets.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2016 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
(AAWW) Announces Agreement with Amazon To Provide Air Transport Service
Service to Include 20 B767-300 Aircraft with a Lease Term of 10 Years
Amazon Granted Rights to Acquire AAWW Equity
PURCHASE, N.Y., May 05, 2016 — Atlas Air Worldwide Holdings, Inc. (Nasdaq:AAWW) announced today that it will provide air cargo services to support Amazon’s (Nasdaq:AMZN) package deliveries to its customers. The new agreements are expected to be meaningfully accretive to Atlas Air Worldwide’s earnings and cash flows over time.
“We are excited to begin a strategic long-term relationship with Amazon to support the continuing expansion of its e-commerce business and to enhance its customer delivery capabilities,” said President and Chief Executive Officer William J. Flynn. “We appreciate Amazon’s confidence in our capabilities, global scale and operating excellence.”
The long-term commercial agreements will include the operation of 20 B767-300 converted freighters for Amazon on a CMI (crew, maintenance and insurance) basis by Atlas Air Worldwide’s airline subsidiary, Atlas Air, Inc., as well as dry leasing by its Titan Aviation leasing unit. The dry leases will have a term of 10 years, while the CMI operations will be for seven years (with extension provisions for a total term of 10 years). Operations under the agreements are expected to begin in the second half of 2016 and ramp up to full service through 2018.
“We are excited to welcome a great provider, Atlas Air, to support package delivery to the rapidly growing number of Prime members who love ultra-fast delivery, great prices and vast selection from Amazon,” said Dave Clark, Amazon’s senior vice president of worldwide operations.
As part of the inherent value creation and to align interests and strengthen the long-term relationship, Atlas Air Worldwide granted Amazon warrants to acquire up to 20 percent (after the issuance) of AAWW’s common shares at a price of $37.50 per share over a period of five years, with vesting tied in part to the commencement of operations of the 20 B767-300 freighter aircraft and other conditions.
The agreements also provide for future growth of the relationship as Amazon may increase its business with Atlas. Atlas Air Worldwide granted Amazon warrants to acquire up to an additional 10 percent (after the issuance) of AAWW’s common shares at the same exercise price, over a period of seven years, with vesting tied to payments made by Amazon in connection with that business.
Morgan Stanley & Co. LLC is serving as financial advisor and Cravath, Swaine & Moore LLP is serving as legal advisor, both to Atlas Air Worldwide, in connection with the transaction.
About Atlas Air Worldwide:
Atlas Air Worldwide is a leading global provider of outsourced aircraft and aviation operating services. It is the parent company of Atlas Air, Inc. (Atlas), Southern Air Holdings, Inc. (Southern Air) and Titan Aviation Holdings, Inc. (Titan), and is the majority shareholder of Polar Air Cargo Worldwide, Inc. (Polar). Atlas Air Worldwide’s companies operate the world’s largest fleet of Boeing 747 freighter aircraft and provide customers the broadest array of 747, 777, 767, 757 and 737 aircraft for domestic, regional and international applications.
Atlas, Southern Air, Titan and Polar offer a range of outsourced aircraft and aviation operating services that include ACMI service – in which customers receive an aircraft, crew, maintenance and insurance on a long-term basis; CMI service – in which customers receive crew, maintenance and insurance but not an aircraft; express network and airport-to-airport cargo service; cargo and passenger charters; and dry leasing of aircraft and engines.
Atlas Air Worldwide’s press releases, SEC filings and other information may be accessed through the Company’s home page, www.atlasair.com.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect Atlas Air Worldwide’s current views with respect to certain current and future events and financial performance. Such forward-looking statements are and will be, as the case may be, subject to many risks, uncertainties and factors relating to the operations and business environments of Atlas Air Worldwide and its subsidiaries (collectively, the “companies”) that may cause the actual results of the companies to be materially different from any future results, express or implied, in such forward-looking statements.
Factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to, the following: our ability to effectively operate the network service contemplated by our agreement with Amazon, including the cost and timing of securing any aircraft necessary to fulfill our agreement; our ability to obtain any shareholder approvals that may be required with respect to the equity arrangements expressed in our agreement with Amazon; the ability of the companies to operate pursuant to the terms of their financing facilities; the ability of the companies to obtain and maintain normal terms with vendors and service providers; the companies’ ability to maintain contracts that are critical to their operations; the ability of the companies to fund and execute their business plan; the ability of the companies to attract, motivate and/or retain key executives and associates; the ability of the companies to attract and retain customers; the continued availability of our wide-body aircraft; demand for cargo services in the markets in which the companies operate; economic conditions; the effects of any hostilities or act of war (in the Middle East or elsewhere) or any terrorist attack; labor costs and relations; financing costs; the cost and availability of war risk insurance; our ability to maintain adequate internal controls over financial reporting; aviation fuel costs; security-related costs; competitive pressures on pricing (especially from lower-cost competitors); volatility in the international currency markets; weather conditions; government legislation and regulation; consumer perceptions of the companies’ products and services; anticipated and future litigation; and other risks and uncertainties set forth from time to time in Atlas Air Worldwide’s reports to the United States Securities and Exchange Commission.
For additional information, we refer you to the risk factors set forth under the heading “Risk Factors” in the most recent Annual Report on Form 10-K and subsequent reports on Form 10-Q filed by Atlas Air Worldwide with the Securities and Exchange Commission. Other factors and assumptions not identified above may also affect the forward-looking statements, and these other factors and assumptions may also cause actual results to differ materially from those discussed.
Atlas Air Worldwide assumes no obligation to update such statements contained in this release to reflect actual results, changes in assumptions or changes in other factors affecting such estimates other than as required by law.
Contacts: Dan Loh (Investors) – (914) 701-8200 Bonnie Rodney (Media) – (914) 701-8580
(MOXC) Adopts Oracle Database Solutions for Payment and Transaction Platform
BEIJING, CHINA–(May 5, 2016) – Moxian, Inc. (OTCQB: MOXC) is leveraging Oracle Exadata Database Machine, Oracle Database, Oracle Database Appliance and Oracle ZFS Storage solutions as the foundation for its latest payment and transaction platform, and also big data analytics system. Through Moxian’s big data analytics system, Moxian has a clear-cut picture of its targeted customers, their demands and payment data. Furthermore, the end-user data generated from the platform helps Moxian’s merchant clients achieve precision marketing.
Founded in 2013 in Shenzhen, China, Moxian is a leading offline-to-online (O2O) integrated platform operator. Moxian offers social media platform solutions especially suitable for SMB, integrated entertainment, commerce, shopping and customer loyalty rewards providers. With the fast growth of end-users, the demand for a more stable, powerful and scalable IT system to support the heavy traffic has become more important. Moxian is leveraging Oracle solutions as the foundation for its payment and transaction platform, eliminating the performance bottleneck of massive data management.
“Moxian is committed to providing high quality services to end-users and the company’s merchant clients,” said James Tan, CEO of Moxian. “Oracle’s solutions meet Moxian’s needs with their rich features and best-in-class performance, scalability, stability and reliability. As Moxian continues to expand in domestic and overseas markets, we look forward to furthering our successful relationship with Oracle.”
Moxian not only focuses on the domestic market, but also the global market with Moxian’s data centers in China and Singapore. Moxian is using Oracle Exadata Database Machine in a private cloud environment in its data center in China for more flexible database computing and to maximize database performance on the cloud platform. The implementation also allows Moxian to further save storage space and cost. Moxian’s data center in Singapore leverages the Oracle Database Appliance to improve database performance and reduce overall investment cost with Flash, RAC Heartbeat, memory planning, ASM replication and intelligent data technologies.
The results of high-speed processing tests on Oracle Exadata Database Machine has further demonstrated Oracle’s significant performance advantages. Balanced software and hardware configuration of Oracle Exadata Database Machine has removed a performance bottleneck in terms of virtual currency tracking in Moxian applications with up to 5,000 SQLs processing per second. In addition, Moxian can quickly perform ultra-large table query of billions of records within one minute among massive amounts of data in over 10,000 stores, and the system just went live in the first half of the deployment phase.
Oracle Exadata Database Machine achieves higher application performance and scalability than traditional architecture by dynamically allocating CPU, memory and I/O resources. Its latest information platform provides best-in-class security to ensure business continuity based on isolated security deployment where multiple applications can run independently. Oracle Exadata Database Machine is an integrated software and hardware platform with a consolidated IT architecture, which is able to enhance the cost performance and further optimize ROI.
Apart from product and technology support, Oracle’s professional teams and partners also provided on-site support service to maximize the performance of Oracle’s suite of solutions. Being on-site enabled the new Moxian system to successfully migrate and go live. Ensuring the new system’s operational efficiency, Oracle’s implementation team provided Moxian with comprehensive project planning and training, enabling Moxian to rapidly learn the required systems knowledge, skills and tools.
“Oracle is excited to partner with Moxian to build up its latest payment and transaction platform based on a solid IT architecture,” said Calvin Dang, General Manager, South Region, Oracle China. “The database and infrastructure layer is an important foundation of the IT architecture as it provides powerful support to massive amounts of data. Moxian has demonstrated its full trust in Oracle by adopting a variety of our solutions, and we look forward to our future cooperation with the company.”
Supporting Resources
About Moxian, Inc.
Moxian engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. Our products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. We design our products and services to allow our merchant clients to run advertising campaigns and promotions targeting their customers. Our platform is also designed to entice users to return frequently and to encourage new consumer users to subscribe our website.
About Oracle
Oracle offers a comprehensive and fully integrated stack of cloud applications and platform services. For more information about Oracle, visit oracle.com.
Trademarks
Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.
Contact Info
Lilian Li
Oracle
+86.10.65356855
Email Contact
Nicolas Lin
Moxian.Inc
+86.0755.66803251
Email Contact
(MGRC) to Present at the Oppenheimer 11th Annual Industrial Growth Conference
LIVERMORE, Calif., May 04, 2016 — McGrath RentCorp (Nasdaq:MGRC), a diversified business to business rental company, today announced that it will participate in the Oppenheimer 11th Annual Industrial Growth Conference at the Westin New York Grand Central in New York, NY on Tuesday, May 10, 2016. McGrath’s President and CEO, Dennis Kakures, and Senior Vice President and CFO, Keith Pratt, will present at 1:45 p.m. ET.
Simultaneous webcast and presentation slides will be available in the Investor Relations section of the Company’s website at http://mgrc.com/Investor/EventsAndArchive. A replay will be available for approximately 90 days on the company’s website shortly after completion of the presentation.
About McGrath RentCorp
Founded in 1979, McGrath RentCorp is a diversified business-to-business rental company. The Company’s Mobile Modular division rents and sells modular buildings to fulfill customers’ temporary and permanent classroom and office space needs in California, Texas, Florida, and the Mid-Atlantic from Washington D.C. to Georgia. The Company’s TRS-RenTelco division rents and sells electronic test equipment and is one of the leading rental providers of general purpose and communications test equipment in the Americas. The Company’s Adler Tank Rentals subsidiary rents and sells containment solutions for hazardous and nonhazardous liquids and solids with operations today serving key markets throughout the United States. In 2008, the Company entered the portable storage container rental business under the trade name Mobile Modular Portable Storage. Today, the business is located in the key markets of California, Texas, Florida, Northern Illinois, New Jersey and most recently entered the North Carolina region. For more information on McGrath RentCorp and its operating units, please visit our websites:
Corporate – www.mgrc.com
Tanks and Boxes – www.adlertankrentals.com
Modular Buildings – www.mobilemodular.com
Portable Storage – www.mobilemodularcontainers.com
Electronic Test Equipment – www.trs-rentelco.com
School Facilities Manufacturing – www.enviroplex.com
FOR INFORMATION CONTACT: Keith E. Pratt Chief Financial Officer 925-606-9200 investor@mgrc.com
(GIGA) Microsource Business Unit Regains AS9100C Quality Certification
SAN RAMON, Calif., May 04, 2016 — Giga-tronics Incorporated (Nasdaq:GIGA) announced today that its Microsource Business Unit regained AS9100C certification of its Supplier Quality Management System. The AS9100C Certification is commonly required in the aircraft manufacturing industry. The Company’s Microsource division sells components used on military aircrafts to two major customers that require such certification. During the lapse in certification the Company worked with one of the major customers to allow continued shipping and orders. The Company was pursuing a similar solution with the second customer, but this is no longer required with the regained certification.
All of Giga-tronics, including the Microsource Business Unit, regained ISO 9001:2008 certification of its Supplier Quality Management System late last year.
John Regazzi, President and CEO of Giga-tronics, said “Regaining these quality certifications was a Company wide effort, and I’d like to congratulate all of our employees. I’d also would like to thank our customers for working with us during the lapse of certification.”
Giga-tronics is a publicly held company, traded on the NASDAQ Capital Market under the symbol “GIGA.” Giga-tronics produces instruments, subsystems and sophisticated microwave components that have broad applications in defense electronics, aeronautics and wireless telecommunications.
This press release contains forward-looking statements concerning operating results, future orders, and sales of new products, shippable backlog within a year, long term growth, shipments, product line sales, and customer acceptance of new products. Actual results may differ significantly due to risks and uncertainties, such as: delays in customer orders for the new Advanced Signal Generation System and our ability to manufacture it; receipt or timing of future orders, cancellations or deferrals of existing or future orders; our need for additional financing; the volatility in the market price of our common stock; and general market conditions. For further discussion, see Giga-tronics’ most recent annual report on Form 10-K for the fiscal year ended March 28, 2015 Part I, under the heading “Risk Factors” and Part II, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Contact: Steven D. Lance Vice President of Finance/Chief Financial Officer slance@gigatronics.com (925) 302-1056
(STXS) to Highlight New Clinical Results and Automation Enhancements at Heart Rhythm 2016
ST. LOUIS, May 04, 2016 — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that it will participate in the 37th Annual Heart Rhythm Society (HRS) Scientific Sessions, May 4-7, 2016 in San Francisco. During its 12th consecutive appearance at HRS, the Company will share results of recently published clinical studies, new technology enhancements, user experiences, and simulations of its computer-controlled mapping and lesion formation capabilities at Booth #1631.
“We are excited to bring together expert users of our remote magnetic navigation platform and physicians searching for treatment options that provide improved outcomes for complex cardiac arrhythmias with a lower risk of adverse events and reduced fluoro exposure to patients and physicians,” said William C. Mills, Stereotaxis Chief Executive Officer. “Inspired by an abundance of clinical data and empirical evidence, hospitals and physicians worldwide are turning to our magnetic navigation and automation solutions to strengthen their leadership in cardiac rhythm management by simplifying and significantly enhancing therapy delivery, especially in the complex clinical setting of ventricular arrhythmias.”
In the HRS Rhythm Theatre on Friday, May 6, Stereotaxis will host a lunch symposium featuring the latest insights and clinical research by experienced users. Chaired by Dr. Mauricio Arruda (University Hospitals Case Medical Center), who has completed more than 1,200 procedures using the Niobe® remote magnetic navigation system, the session will provide impressive clinical results of the Niobe system in the treatment of ischemic and non-ischemic ventricular tachycardia (VT) patients, and a discussion of the Company’s multi-center, randomized, superiority study of VT ablation outcomes. Guest speakers include Dr. Luigi Di Biase (Albert Einstein College of Medicine at Montefiore Hospital), Dr. Hiroshi Nakagawa (Oklahoma University Medical Center), and Dr. Tamas Szili-Torok (Erasmus Medical Center).
Dr. Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, recently spoke to EP Lab Digest about the value and potential of remote magnetic navigation in electrophysiology for its May issue, which will be available at HRS. In the article, Dr. Natale said, “The people that have actually invested the time to become proficient with remote magnetic navigation and its learning curve, and addressed the differences between magnetic and manual navigation, love this technology and find it difficult when magnetic navigation cannot be used in a procedure.” Dr. Natale is serving as global principal investigator for the Company’s MAGNETIC-VT multi-center randomized study, which he believes could establish remote magnetic navigation as the “gold standard” for certain VT procedures.
In its exhibit space, Stereotaxis will highlight the latest innovations to its Niobe system including the next generation user interface, which includes new features such as improved catheter tip-to-tissue contact confirmation based on bipolar impedance information. During the HRS Rhythm Theatre on Friday, May 6, Dr. Hiroshi Nakagawa will also share the development progress for the lesion assessment and prediction tool called Magnetic Ablation Index. Each of these software features can provide valuable information to physicians while they are ablating tissue and also furthers the ongoing efforts to fully automate the execution of physician-defined ablation strategies. Finally, the Company will unveil its newly developed, software-based simulation platform for physician training, alongside a modeled beating heart phantom that demonstrates the mechanics of its technologies in effective lesion creation – paramount to acute and long-term success – within the most difficult to reach and navigate regions of the heart.
About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
Company Contact: Martin C. Stammer Chief Financial Officer 314-678-6155 Investor Contact: Todd Kehrli / Jim Byers MKR Group, Inc. 323-468-2300 stxs@mkr-group.com
(EBIO) Genetic Stratification of Drug Response in IL-1 Implicated Eye Diseases
Interleukin Genetics Utilizes Genetic Patterns in Investigational Drug Response Evaluation
WALTHAM, Mass., May 04, 2016 — Interleukin Genetics, Inc. (OTCQB:ILIU), a life sciences company focused on developing and marketing proprietary genetic tests for chronic diseases and health-related conditions, announced today that Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, presented new data from post hoc analyses on the influence of Interleukin’s IL-1 genetic patterns on response to isunakinra (EBI-005) in severe allergic conjunctivitis and severe dry eye study subjects. The data were presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, Washington.
“Working with Eleven Biotherapeutics to evaluate subjects in its Phase 3 study for the two ophthalmic indications was an exciting opportunity to demonstrate our unique ability to utilize IL-1 genetic patterns to help assess clinical response to a novel interleukin-1 receptor inhibitor in allergic conjunctivitis and dry eye,” said Ken Kornman, Chief Scientific Officer of Interleukin Genetics. “The IL-1 genetic pattern data showed that isunakinra treated subjects had a differential clinical response relative to vehicle control. These findings are consistent with previously published results showing that IL-1 genetic patterns identified individuals who were more likely to respond to another IL-1 blocking drug, anakinra, in rheumatoid arthritis.”
The Posters being presented by researchers from Eleven Biotherapeutics are:
“Phase 3 Multi-Center Trial Evaluating the Efficacy, Safety and Tolerability of Isunakinra (EBI-005) in Subjects with Moderate to Severe Allergic Conjunctivitis”
Date and Time: May 1, 2016, 8:30 a.m. to 10:15 a.m. (PT)
Abstract Number: 2307-C0121
Session: Allergic Conjunctivitis / Corneal Immunology and Infection
“A Phase 3 Multi-Center, Randomized Controlled Evaluation of the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Dry Eye”
Date and Time: May 3, 2016, 8:30 a.m. to 10:15 a.m. (PT)
Abstract Number: 2874-A0083
Session: Dry Eye II
The utilization of the IL-1 genetic patterns may facilitate clinical development and commercial deployment of IL-1 inhibitors and drugs operating downstream of IL-1 since the IL-1 genetic patterns have been shown to differentiate individuals at the clinical level in terms of responses to inflammatory challenges or responses to IL-1 blocking drugs.
About Interleukin Genetics
Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic diseases and health-related conditions. The products empower individuals and their healthcare providers to manage existing health and wellness through genetics-based insights and actionable guidance. Interleukin Genetics leverages its research, intellectual property, and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The company markets its tests through healthcare professionals, partnerships with health and wellness companies, and other distribution channels. Interleukin Genetics’ lead products include its proprietary PerioPredict® genetic test for periodontal disease and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvements Amendments (CLIA). For more information, please visit www.ilgenetics.com.
Forward-Looking Statements
Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that utilizing IL-1 genetic patterns to identify individuals who are more likely to respond to drugs that are intended to block IL-1 expression may facilitate the clinical development and commercial deployment of IL-1 inhibitors. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in Interleukin’s annual report on Form 10-K for the year ended December 31, 2015, and other filings with the Securities and Exchange Commission. Interleukin disclaims any obligation or intention to update these forward-looking statements.
Investor Contact: Hans Vitzthum LifeSci Advisors, LLC. (212) 915-2568 hans@lifesciadvisors.com Media Contact: Jennifer Moritz Zer0 to 5ive for Interleukin Genetics (917) 748-4006 jmoritz@0to5.com
(CNAT) Extends Positive Results with Emricasan in Phase 2 Liver Cirrhosis Clinical Trial
– Continued Directional Improvements in Key Measures of Liver Function after Six Months –
– First Drug to Demonstrate Liver Function Benefit in Patients with NASH Cirrhosis –
– Conference Call and Webcast Presentation at 8:00 a.m. ET on Thursday, May 5 –
SAN DIEGO, May 04, 2016 — Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced positive top-line results from the three-month, open-label second stage of the company’s multicenter Phase 2 clinical trial of emricasan, a first-in-class, orally active pan-caspase inhibitor, in patients with liver cirrhosis. Top-line results from the three-month placebo-controlled first stage of the trial were released in January. In the second stage, patients on emricasan in the first stage continued treatment for another three months, and patients on placebo in the first stage switched over to emricasan for three months.
- Key measures of liver function showed continued directional improvements after the second three months of treatment on emricasan in the overall patient population following previously reported favorable trends with emricasan vs. placebo after the first three months.
- Key measures of liver function showed continued directional improvements after the second three months of treatment on emricasan in a subgroup of patients with baseline Model for End-stage Liver Disease (MELD)1 scores ≥15, a prerequisite for a patient receiving a liver transplant, following previously reported statistically significant emricasan treatment effects vs. placebo after the first three months.
- Regardless of baseline MELD score, patients whose cirrhosis was caused by nonalcoholic steatohepatitis (NASH) achieved statistically significant treatment effects vs. placebo on key measures of liver function after the first three months – making emricasan the first drug to demonstrate liver function benefit in patients with NASH cirrhosis. Directional improvements continued after the second three months of treatment.
- A conference call and webcast are scheduled for 8:00 a.m. ET on Thursday, May 5, as detailed below, to discuss both the Liver Cirrhosis clinical trial results and first quarter 2016 financial results to be released before the call.
Continued Directional Improvements in Overall Patient Population
Two clinically relevant measures of liver function and prognosis, MELD score and Child-Pugh-Turcotte (Child-Pugh)2 score, along with other key liver function parameters which demonstrated favorable trends in emricasan treatment effects vs. placebo (improvement in the emricasan group vs. progression in the placebo group) in the overall patient population after three months of treatment showed continued directional improvement after six months of treatment.
| Overall Patient Population | Placebo (N=42) | Emricasan (N=44) | Month 3 p-value* |
|||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
| MELD score | 12.9 | +0.1 | 12.8 | ‒0.1 | ‒0.3 | 0.466 |
| Child-Pugh score | 6.9 | +0.1 | 6.9 | ‒0.2 | ‒0.3 | 0.124 |
| Total bilirubin (mg/dL) | 2.59 | +0.07 | 2.25 | ‒0.05 | ‒0.05 | 0.209 |
| INR | 1.31 | +0.02 | 1.33 | ‒0.02 | ‒0.04 | 0.117 |
| Albumin (g/dL) | 3.48 | +0.06 | 3.46 | +0.02 | +0.06 | 0.440 |
| *p-values for treatment effect at Month 3, based on adjusted LSMeans from the primary ANCOVA model with baseline value and treatment group; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
Key Exploratory Subgroup Results
Statistically significant emricasan treatment effects vs. placebo (improvement in the emricasan group vs. progression in the placebo group) after the first three months in a subgroup of patients with baseline MELD scores ≥15 showed continued directional improvements after the second three months.
| Baseline MELD Score ≥15 Patient Population | Placebo (N=10) | Emricasan (N=9) | Month 3 p-value* |
|||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
| MELD score | 16.3 | +0.6 | 16.0 | ‒1.6 | ‒2.8 | 0.003 |
| Child-Pugh score | 8.2 | +0.6 | 7.8 | ‒0.6 | ‒0.7 | 0.003 |
| Total bilirubin (mg/dL) | 4.30 | ‒0.06 | 3.17 | ‒0.55 | ‒0.65 | 0.029 |
| INR | 1.45 | +0.06 | 1.54 | ‒0.14 | ‒0.21 | <0.001 |
| Albumin (g/dL) | 3.19 | +0.05 | 3.41 | +0.07 | +0.10 | 0.779 |
| *p-values for treatment effect at Month 3, based on adjusted LSMeans from the secondary ANCOVA model with baseline value, treatment group, baseline MELD category, etiology, treatment and MELD category interaction, and treatment and etiology interaction; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
In patients whose liver cirrhosis was caused by NASH, statistically significant emricasan treatment effects vs. placebo (slower progression in the emricasan group than in the placebo group) on measures of liver function after the first three months showed continued directional improvement after the second three months.
| NASH Patient Population | Placebo (N=9) | Emricasan (N=11) | Month 3 p-value* |
|||
| Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
| MELD score | 12.8 | +1.0 | 13.0 | +0.3 | +0.1 | 0.029 |
| Child-Pugh score | 6.9 | +0.4 | 7.3 | ‒0.3 | ‒0.1 | 0.030 |
| Total bilirubin (mg/dL) | 2.26 | +0.39 | 2.68 | +0.09 | ‒0.03 | 0.265 |
| INR | 1.27 | +0.07 | 1.25 | +0.01 | 0.00 | 0.017 |
| Albumin (g/dL) | 3.60 | +0.11 | 3.39 | +0.05 | +0.03 | 0.645 |
| *p-values for treatment effect at Month 3, based on adjusted LSMeans from the secondary ANCOVA model with baseline value, treatment group, baseline MELD category, etiology, treatment and MELD category interaction, and treatment and etiology interaction; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
Consistent with the company’s previous 15 clinical trials, emricasan was generally well-tolerated in the Liver Cirrhosis clinical trial, and the overall safety profile was similar in the emricasan and placebo groups with regard to both serious and other adverse events.
“We were highly encouraged after the first three months of treatment, in patients with cirrhosis and impaired hepatic function, by the favorable overall trends in two clinically relevant measures of liver function and prognosis – MELD and Child Pugh scores – which clearly were driven by statistically significant improvements in the high baseline MELD score subgroup,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “The continued directional improvements in these measures of liver function after six months of treatment confirm the sustained activity of emricasan and support continued development in patients with cirrhosis. The statistically significant treatment effects in the NASH patient subgroup, which applied regardless of baseline MELD scores, offer a greater range of options for future clinical trials in patients with NASH cirrhosis.”
“We are pleased to confirm and extend the positive results from our Phase 2 Liver Cirrhosis trial,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D., “with favorable trends in measures of liver function in the overall patient population and significant treatment effects in the high-MELD population after three months, both with continued directional improvements after six months and a reassuring safety and tolerability profile consistent with our prior experience. Our Portal Hypertension trial and Liver Cirrhosis trial have demonstrated emricasan’s rapid and meaningful activity against all three potentially acceptable validated surrogate endpoints identified by the FDA (U.S. Food and Drug Administration) for clinical trials in patients with liver cirrhosis. The subgroup analysis of NASH patients in the Liver Cirrhosis trial provided the first ever demonstration in NASH cirrhosis of liver function benefit in response to drug treatment. We believe this benefit, along with our Fast Track designation by the FDA in NASH cirrhosis, provides strong support to focus on an initial registration of emricasan in NASH cirrhosis. We intend to discuss these results and plans for the ENCORE-LF clinical trial in patients with NASH cirrhosis with regulatory authorities in the coming months as we advance toward trial initiation in early 2017.”
Liver Cirrhosis Trial
The double-blind, placebo-controlled Phase 2 Liver Cirrhosis clinical trial was conducted at 26 U.S. sites and enrolled 86 patients with liver cirrhosis due to different etiologies, mild to moderate liver impairment and baseline MELD scores of 11 to 18. In the double-blind and placebo-controlled stage, patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint was change from baseline in cCK18 at three months. Secondary endpoints included changes from baseline in MELD and Child-Pugh scores, which include laboratory parameters associated with liver synthetic and excretory function, such as serum albumin levels, international normalized ratio (INR) and total bilirubin levels. In the open-label stage, all patients either on emricasan or placebo received emricasan for an additional three months.
Among the 86 subjects enrolled and dosed, liver cirrhosis etiologies included alcohol (38%), hepatitis C virus, or HCV (29%), NASH (23%), and other causes (9%). Baseline MELD scores were ≤14 in 78% of enrolled subjects and ≥15 in 22% of enrolled subjects. Baseline Child-Pugh status was A (Child-Pugh score of 5-6) in 43% of subjects and B (Child-Pugh score of 7-9) in 56% of subjects.
Conference Call/Webcast/Presentation
Conatus will host a conference call and webcast at 8:00 a.m. Eastern Time on Thursday, May 5, to discuss results from the Liver Cirrhosis trial and first quarter 2016 financial results scheduled to be announced before the call. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 1360910. An associated presentation and live and archived webcast of the call will be available in the Investors section of the company’s website at http://ir.conatuspharma.com/events.cfm.
About Emricasan Clinical Development
To date, emricasan has been studied in over 650 subjects in sixteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. The company also is evaluating emricasan’s potential longer-term effects on liver structure in its ongoing Phase 2b clinical trial in post-orthotopic liver transplant (POLT) recipients who have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection and have successfully achieved a sustained viral response following HCV antiviral therapy (POLT-HCV-SVR). In November 2015, the company announced plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints – the EmricasaN, a Caspase inhibitOR, for Evaluation, or ENCORE trials – as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis. In January 2016, Conatus announced the initiation of ENCORE-NF, the first of the ENCORE trials, a randomized, double-blind, placebo-controlled, Phase 2b clinical trial in patients with biopsy-confirmed NASH and stage 1 to 3 fibrosis using the NASH Clinical Research Network (CRN) Histologic Scoring System.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: emricasan as the first drug to demonstrate liver function benefit in patients with NASH cirrhosis; the Liver Cirrhosis trial results as support for continued development of emricasan in patients with liver cirrhosis; the ability of the Liver Cirrhosis trial results to offer a greater range of options for future clinical trials in patients with NASH cirrhosis; the support to focus on an initial registration of emricasan in NASH cirrhosis provided by the subgroup analysis of NASH patients in the Liver Cirrhosis trial; plans to discuss the Liver Cirrhosis trial results and plans for the ENCORE-LF clinical trial in patients with NASH cirrhosis with regulatory authorities and advance toward trial initiation in early 2017; plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis; and emricasan’s potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to initiate and successfully complete current and future clinical trials; the potential that further analysis of the data described herein or additional data may yield different results; Conatus’ ability to develop and implement a registration strategy and pathway for emricasan; FDA’s and other regulatory agencies’ interactions and guidance relating to the development of emricasan; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize, emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier clinical trials may not be predictive of future results; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 MELD score is a numerical value ranging from 6 (less ill) to 40 (gravely ill) calculated by a formula using three routine serum biomarkers: total bilirubin, creatinine, and INR, and used to position patients on the liver transplant waiting list. Biomarker values below 1 are rounded to 1 to avoid negative values in the MELD formula. Scores of 15 or greater are required for listing eligibility.
2 Child-Pugh score is a numerical value ranging from 5 (least severe) to 15 (most severe) calculated by totaling the individual scores on a 1-3 scale for three routine serum biomarkers: bilirubin, INR, and albumin; and two clinical factors: encephalopathy and ascites. Scores of 5-6 are classified as Child-Pugh A (mild liver impairment); scores of 7-9 are classified as Child-Pugh B (moderate liver impairment); scores of 10-15 are classified as Child-Pugh C (severe liver impairment).
MEDIA: David Schull Russo Partners, LLC (858) 717-2310 David.Schull@RussoPartnersLLC.com INVESTORS: Alan Engbring Conatus Pharmaceuticals Inc. (858) 376-2637 aengbring@conatuspharma.com
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