Archive for May, 2016
(EDIT) greement with Cystic Fibrosis Foundation Therapeutics
Editas to Receive up to $5 Million Award to Fund Genome Editing Research
CAMBRIDGE, Mass., May 16, 2016 — Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, today announced a three-year agreement with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation, in which CFFT will pay up to $5 million to Editas Medicine to support the discovery and development of CRISPR/Cas9-based medicines for the treatment of cystic fibrosis (CF). In addition, Editas will access CFFT’s extensive network of CF scientific advisors and clinical researchers.
“We are delighted to work with Cystic Fibrosis Foundation Therapeutics to discover and develop medicines for people with cystic fibrosis,” said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. “While significant medical and scientific progress has been made in recent years, a great deal of work remains. I’m hopeful that our genome editing approach will one day create important new therapies that can address the genetic mutations that cause this disease.”
“We believe that the CRISPR approach to gene editing holds significant promise for repairing the underlying cause of cystic fibrosis,” said Preston W. Campbell III, M.D., President and Chief Executive Officer, CF Foundation. “We’re pleased to work with Editas Medicine and are excited by the possibilities of what can be accomplished on behalf of people with CF.”
The gene that causes CF encodes the cystic fibrosis transmembrane conductance regulator protein (CFTR), which helps maintain the water balance within the lung and in other tissues. Mutations in this gene lead to problems with the flow of fluids and salt into and out of cells. This causes a thick buildup of mucus in the lungs, pancreas and other organs. The mucus clogs the airways and traps bacteria, leading to chronic infections and inflammation of the airways. There are more than 1,800 known mutations within the CFTR gene. As part of this agreement, Editas Medicine will explore targeting both common mutations as well as mutations not addressed by conventional approaches.
About Editas Medicine
Editas Medicine is a leading genome editing company dedicated to treating patients with genetically defined diseases by correcting their disease-causing genes. The Company was founded by world leaders in genome editing, and its mission is to translate the promise of genome editing science into a broad class of transformative genomic medicines to benefit the greatest number of patients.
Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact Dan Budwick Pure Communications, Inc. (973) 271-6085 dan@purecommunicationsinc.com Investor Contact Jesse Baumgartner Stern Investor Relations, Inc. (212) 362-1200 jesse@sternir.com
(EPIX) Reports Financial Results for the Second Quarter Ended March 31, 2016
HOUSTON and VANCOUVER, May 13, 2016 – ESSA Pharma Inc. (“ESSA” or the “Company”) (TSX: EPI, NASDAQ: EPIX) today reported financial results for the second quarter and three months ended March 31, 2016. Amounts, unless specified otherwise, are expressed in United States dollars and in accordance with International Financial Reporting Standards (“IFRS”).
Second Quarter Highlights and Corporate Update
Financings
The Company completed two private placements during the period in for gross proceeds of approximately $15 million (“January 2016 Financing”) and $5 million (“March 2016 Financing”). The net proceeds of these financings will be used for general corporate purposes and expenses related to the Phase 1/2 clinical trials.
Information regarding the structure of the financings are provided in the news releases dated January 14, 2016 and March 21, 2016.
Enhanced Management Team and Corporate Appointments
Dr. David R. Parkinson was appointed as the company’s President and Chief Executive Officer on January 7th, 2016, bringing significant drug development and business experience to the Company.
On closing of the January 2016 Financing, Scott Requadt, Managing Director of Clarus Ventures, LLC, was appointed to the board of directors.
At the Annual General and Special Meeting of Shareholders held on March 10, 2016, the shareholders re-elected board members David R. Parkinson, Richard M. Glickman, Marianne Sadar, Raymond Andersen, Gary Sollis, Franklin M. Berger and Scott Requadt.
Phase 1/2 Clinical Trial
The Company continues to enroll patients in the Phase 1 dose escalation portion of the clinical study of EPI-506 as a treatment for metastatic castration-resistant prostate cancer (“mCRPC”). The study is being conducted at 5 sites in the United States and Canada.
In the Phase 1/2 clinical trial, ESSA intends to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics, and efficacy of EPI-506 in prostate cancer patients who have failed abiraterone or enzalutamide or both, the current standard-of-care drugs in mCRPC.
Summary Results
ESSA recorded a net loss of $11.0 million ($0.41 per Common Share) for the three months ended March 31, 2016, compared to a net loss of $3.5 million ($0.20 per Common Share) for the three months ended March 31, 2015.
Research and Development (“R&D”) expenditures for the three month period were $2.5 million compared to $2.5 million for 2015. The R&D expenditures for the three months ended March 31, 2015 included recognition of recoveries of $0.2 million from a grant from the Cancer Prevention and Research Institute of Texas (“CPRIT”).
R&D expenditures in the period are primarily related to manufacturing and clinical costs as the Company transitions into the clinical development stage with respect to clinical candidate EPI-506. In the previous quarter ended December 31, 2015, the Company commenced enrolling patients into its Phase 1/2 clinical trial. The composition of R&D costs has therefore evolved from preclinical and Investigational New Drug (“IND”) application work in the quarter ended March 31, 2015 to include clinical, manufacturing and additional staff salaries in the period ending March 31, 2016. The Company received approval from the U.S. Food and Drug Administration for its IND application in September 2015 and a ‘no objection letter’ in November 2015 from the Health Protection Branch of Health Canada for its application for Clinical Trial Authorization.
General and administration expenditures for the three months ended March 31, 2016 were $1.9 million compared to $1.3 million for the comparative period. The increase was primarily due to increased activity as a public corporate entity, and additional general and administrative expenditures to support the clinical development of EPI-506.
Liquidity and Outstanding Share Capital
Working capital as at March 31, 2016 was $15.7 million. During the quarter, the Company closed the January 2016 Financing and March 2016 Financing, which management believes provides sufficient funds to execute the Company’s Phase 1 portion of the Phase 1/2 clinical trial, prior to the receipt of the third and final advance of funds from CPRIT in the amount of $5.4 million or the exercise of any warrants associated with the January 2016 Financing. The Phase 1 portion is anticipated to complete in the second half of calendar 2016. Management continues to consider sources of additional financing which would assure continuation of the Company’s operations and research programs.
As of March 31, 2016 and the date of this release, the Company had 29,075,889 Common Shares issued and outstanding, 3,793,519 Common Shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of CAD$2.69 per share, and 7,099,542 Common Shares issuable upon the exercise of outstanding warrants at a weighted-average exercise price of $3.27 per share.
About ESSA Pharma Inc.
ESSA Pharma is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration resistant prostate cancer (“CRPC”) in patients whose disease is progressing despite treatment with current therapies. ESSA believes that its product candidate, EPI-506, can significantly expand the interval of time in which patients suffering from CRPC can benefit from hormone-based therapies. EPI-506 acts by disrupting the androgen receptor (“AR”) signaling pathway, which is the primary pathway that drives prostate cancer growth. We have shown that EPI-002, the primary metabolite of EPI-506, prevents AR activation by binding selectively to the N-terminal domain (“NTD”) of the AR. A functional NTD is essential for activation of the AR. Blocking the NTD prevents activation of the AR by all of the three known mechanisms of activation. In pre-clinical studies, blocking the NTD has demonstrated the capability to overcome the known AR-dependent mechanisms of CRPC. ESSA was founded in 2009 and is located in Houston Texas, and Vancouver, British Columbia.
About Prostate Cancer
Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone (for example, ADT), disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease (mCRPC) and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past five years; despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including abiraterone or enzalutamide, or those that have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in vitro and in vivo studies, ESSA’s novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and/or Canadian securities laws 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 in this news release include, but are not limited to, statements regarding the use of the net proceeds of the January 2016 Financing and the March 2016 Financing, the sufficiency of ESSA’s funds to execute the Phase 1 portion of the Phase 1/2 clinical trial, the anticipated timing of the Phase 1 portion and possible future financings by ESSA.
Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various material assumptions, including but not limited to the accuracy of ESSA’s financial projections and the Phase 1 portion of the Phase 1/2 clinical trial proceeding as expected.
Forward-looking information is developed based on assumptions about such risks, uncertainties and other factors including, among others, the factors discussed in or referred to under the heading “Risk Factors” in ESSA’s Annual Report on Form 20-F for the year ended September 30, 2015 which is available under ESSA’s profile on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable law. Readers are cautioned against attributing undue certainty to forward-looking statements.
(TROV) Clinical Data Revelas KRAS Mutation Detection/Mapping Capabilities
92.9% of metastatic pancreatic cancer patients determined to be KRAS positive using Trovagene’s Precision Cancer Monitoring assay
SAN DIEGO, May 13, 2016 — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that clinical study results featuring the Company’s Precision Cancer Monitoring® (PCM) platform were presented at the 2016 AACR Special Pancreatic Cancer Meeting in Orlando, Florida. The poster, entitled Detection and Quantification of ctDNA KRAS Mutations from Patients with Unresectable Pancreatic Cancer, was presented by Fernando Blanco, Ph.D., medical science liaison at Trovagene.
Highlights from the poster include:
- Detection rate of circulating tumor DNA (ctDNA) KRAS in 210-patient study closely matches the published prevalence of KRAS mutations in pancreatic cancer (~90%)
- ctDNA KRAS levels can be used to distinguish between locally advanced and metastatic cancer (p<0.0001), suggesting an improved biomarker for disease differentiation
- Longitudinal monitoring of KRAS can be informative in determining responsiveness to therapy and to predict disease progression months in advance of imaging
- The dataset is the largest prospective study exploring ctDNA KRAS in unresectable pancreatic cancer
“In this data set, we have shown the ability to detect KRAS mutations in pancreatic cancer patients with high sensitivity from a liquid biopsy,” stated Julia Johansen, M.D., University of Copenhagen, Denmark and Lead Investigator. “The quantitative assessment of KRAS mutational load using ctDNA at baseline and over time has potential to become an important biomarker in the treatment of metastatic pancreatic cancer, given a high correlation to disease status and the reliability challenges with CA19-9, a biomarker often used in practice to monitor patients with metastatic cancer for progression.”
“This large prospective study demonstrates the high sensitivity of our KRAS assay, and the ability to determine mutational status without the need for tissue biopsy,” added Erlander. “Metastatic pancreatic cancer is among the most deadly cancer types, and our assay can assist physicians in determining the aggressiveness of a patient’s disease, and provide useful information such that therapy may be tailored accordingly.”
About Pancreatic Cancer and KRAS Mutations
Pancreatic cancer is one of the deadliest human malignancies. According to the American Cancer Association, approximately 53,000 Americans will be diagnosed with pancreatic cancer this year, and roughly 42,000 will die from the disease. While little progress has been made in its treatment over the past several decades, advances in the understanding of the disease’s biology provide new potential opportunities for treatment. An estimated 90% of pancreatic cancers harbor somatic KRAS G12/G13 mutations. Such mutations are hallmarks of late-stage disease, and the presence of circulating tumor DNA (ctDNA) KRAS mutations at diagnosis has prognostic implications. Accurate identification of both the presence of ctDNA KRAS mutations and quantification of the number of ctDNA KRAS mutant copies could be an improved therapeutic response biomarker over CA19-9, which is known to be uninformative in certain patients with pancreatic cancer.
About Trovagene’s Precision Cancer Monitoring platform
Trovagene’s urine and blood-based BRAF, KRAS and EGFR oncogene mutation assays are now available to healthcare providers for detection and or monitoring of tumor dynamics in their patients before, during and after treatment. Physicians interested in utilizing these tests should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/our-tests.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s Precision Cancer Monitoring® platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that our Precision Cancer Monitoring® platform will be utilized by oncologists or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2015 and its other periodic reports filed with the Securities and Exchange Commission.
Trovagene Contacts
Investor Relations | Media Relations | |
David MoskowitzVice President, Investor Relations | Jody LoMenzoCorporate Practice Counsel | |
Trovagene, Inc. | Inventiv Health Public Relations | |
858-952-7593 | 212-364-0458 | |
ir@trovagene.com | Jody.LoMenzo@inventivhealth.com |
(FNJN) to Host Shareholder Update Conference Call on May 16th at 1:30 PM PST
Management to Participate at Upcoming Investor Conferences
EAST PALO ALTO, CA–(May 13, 2016) – Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, will host a conference call to update stockholders and analysts on recent events including its first quarter results, upcoming catalysts in its licensing and enforcement programs, and its Series A Preferred Stock financing. The call is scheduled for 1:30 pm PST on May 16, 2016.
Analysts, investors, and other interested parties may access the conference call by dialing 1-855-327-6837. International callers can access the call by dialing 1-631-891-4304. A live webcast can be accessed on the IR section of Finjan’s website http://ir.finjan.com. An archived audio replay of the conference call will be available for 2 weeks beginning at 4:30 pm Pacific Time on May 16, 2016 and can be accessed by dialing 1-877-870-5176 and providing access code 10001218. International callers can access the replay by dialing 1-858-384-5517. The call will be archived on Finjan’s investor relations website.
Management will also be participating and available for meetings at several upcoming investor conferences. Please contact your conference representative or Vanessa Winter, Director of IR at Finjan, to arrange an in-person meeting at any of the following events.
The 7th Annual B. Riley Conference on May 25 in Los Angeles, California. Finajn’s presentation is scheduled for 1:30 pm PST. A live webcast of the presentation can be found on the Finjan IR calendar at http://ir.finjan.com/ir-calendar.
The 2016 Marcum Microcap Conference on June 1 and 2 in New York. Finjan management is scheduled to present on June 1 at 9:30 am EST. A live webcast of the presentation can be found on the Finjan IR calendar at http://ir.finjan.com/ir-calendar.
The 6th Annual LD Micro Invitational will take place from June 7 through 9 in Los Angeles, California. Finjan Management is scheduled to present on June 8 at 9:30 am PST. A live webcast of the presentation can be found on the Finjan IR calendar at http://ir.finjan.com/ir-calendar.
ABOUT FINJAN
Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.
Follow Finjan Holdings, Inc.:
Twitter: @FinjanHoldings
LinkedIn: linkedin.com/company/finjan
Investor Contact:
Vanessa Winter
Director of Investor Relations
Finjan Holdings
Alan Sheinwald or Valter Pinto
Capital Markets Group LLC
(650) 282-3245
investors@finjan.com
(NVDA) Announces Upcoming Events for Financial Community
SANTA CLARA, CA–(May 13, 2016) – NVIDIA (NASDAQ: NVDA) will present at the following events for the financial community:
Citi – 2016 Car of the Future Symposium
Thursday, May 19, 11:15 a.m. Eastern time
New York Palace Hotel, 455 Madison Ave., New York
Bank of America Merrill Lynch – 2016 Global Tech Conference
Wednesday, June 1, 9:15 a.m. Pacific time
The Ritz-Carlton Hotel, 600 Stockton St., San Francisco
Stifel – Technology, Internet & Media Conference 2016
Monday, June 6, 3:35 p.m. Pacific time
The Fairmont Hotel, 950 Mason St., San Francisco
Interested parties can listen to live audio webcasts of NVIDIA’s presentations at these events, available on the NVIDIA website at www.nvidia.com/investor. A replay of the webcasts will be available for seven days afterward.
Keep Current on NVIDIA
Subscribe to the NVIDIA blog, follow us on Facebook, Google+, Twitter, LinkedIn and Instagram, and view NVIDIA videos on YouTube and images on Flickr.
About NVIDIA
NVIDIA (NASDAQ: NVDA) is a computer technology company that has pioneered GPU-accelerated computing. It targets the world’s most demanding users — gamers, designers and scientists — with products, services and software that power amazing experiences in virtual reality, artificial intelligence, professional visualization and autonomous cars. More information at http://nvidianews.nvidia.com/.
© 2016 NVIDIA Corporation. All rights reserved. NVIDIA and the NVIDIA logo are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Other company and product names may be trademarks of the respective companies with which they are associated. Features, pricing, availability, and specifications are subject to change without notice.
For further information, contact:
Arnab Chanda
Investor Relations
NVIDIA Corporation
(408) 566-6036
achanda@nvidia.com
Robert Sherbin
Corporate Communications
NVIDIA Corporation
(408) 566-5150
rsherbin@nvidia.com
(GSAT) Statement Regarding Commission Circulation of an Order in IB Docket No. 13-213
COVINGTON, La., May 13, 2016 — The Office of the Chairman of the Federal Communications Commission has informed Globalstar, Inc. (NYSE MKT:GSAT) that an Order in Docket No. 13-213 has been circulated and is now pending action by the full Commission.
L. Barbee Ponder, Globalstar’s General Counsel & Vice President Regulatory Affairs, commented, “The Commission’s staff has spent a tremendous amount of time and effort on this lengthy proceeding. We look forward to the Commission adopting a final order authorizing Globalstar’s TLPS.”
Additional information regarding the proceeding will be provided in the near future.
About Globalstar, Inc.
Globalstar is a leading provider of mobile satellite voice and data services, leveraging the world’s newest mobile satellite communications network. Customers around the world in industries like government, emergency management, marine, logging, oil & gas and outdoor recreation rely on Globalstar to conduct business smarter and faster, maintain peace of mind and access emergency personnel. Globalstar data solutions are ideal for various asset and personal tracking, data monitoring and SCADA applications. The Company’s products include mobile and fixed satellite telephones, the innovative Sat-Fi satellite hotspot, Simplex and Duplex satellite data modems, tracking devices and flexible service packages. For more information, visit www.globalstar.com.
Note that all SPOT products described in this press release are the products of SPOT LLC, which is not affiliated in any manner with Spot Image of Toulouse, France or Spot Image Corporation of Chantilly, Virginia. For more information, visit www.globalstar.com.
Investor Contact Information: Email: investorrelations@globalstar.com Phone: (985) 335-1538 Media Contact Information: Email: allison.hoffman@globalstar.com
(EXPI) Reports Record Revenue and Growth for First Quarter
Revenue and Agent Count Both Up Over 100%
BELLINGHAM, WA–(May 13, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI), today released its first quarter financial results.
Financial Highlights
- Revenues for the quarter of $7,142,812, up 107% from $3,449,241 year over year;
- Agent Count for Real Estate Division up 106% over Q1 2015 to 1,104 agents
- Net Loss for the period was $619,867 – mostly attributable to stock options issued prior to 2013
- Cash on Hand at end of period up 114% vs 1 year ago
The increase in revenue is a direct result of the increased sales agent base and higher sales volume realized by the Company’s real estate brokerage division, eXp Realty, The Agent-Owned Cloud Brokerage™. Today, eXp Realty has more than 1,240 real estate professionals across 38 states and Alberta, Canada.
Glenn Sanford, the Company’s Chairman and Chief Executive Officer, commented on the Company’s performance, “It is extremely gratifying to see the value proposition of eXp Realty being embraced by an ever increasing number of forward-thinking agents and brokers. Our internal mantra of ‘We want the value proposition of eXp Realty to be so good that it would be irresponsible for an agent and broker to hang their license anywhere else’ has and will continue to drive innovation around the Agent/Owner model. The fact that our growth is accelerating in both agent count and the percentage of overall growth is a testament to our continued iterations around the broker and agent value proposition. We are also excited about the journey of extending this mantra into other related industries, most notably mortgage with First Cloud Mortgage, Inc. which reported its first revenues this quarter as well.”
The filed 10-Q for eXp World Holdings, Inc. can be found at: https://www.sec.gov/Archives/edgar/data/1495932/000101968716006242/expworld_10q-033116.htm
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 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, New Mexico and Texas. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.
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 eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.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
(KTOV) Receives Pre-NDA Response From FDA for KIT-302, Supporting NDA Submission
Kitov expects to submit New Drug Application to FDA at the end of 2016 for KIT-302 – a fixed dose combination that simultaneously treats osteoarthritis pain and hypertension
TEL-AVIV, Israel, May 12, 2015 — Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced it has received, from the U.S. Food and Drug Administration (FDA), meeting minutes from its recent pre-New Drug Application meeting for KIT-302 . Based on the details of the FDA’s response, Kitov is on track to submit the NDA for marketing approval of KIT-302 by the end of 2016.
The meeting, which took place on April 11, 2016, had been requested by Kitov to seek FDA concurrence that the NDA content will meet the agency’s requirements for NDA submission.
The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission. Furthermore, based on the minutes, the Company will include additional information as part of the planned NDA submission, such as market data and a medical literature review on the use of amlodipine and celecoxib in animals. The FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint.
“These minutes bring us closer to submitting an NDA to the FDA for KIT-302 via the 505(b)(2) path at the end 2016, as currently planned. This paves the way for potential regulatory approval in 2017,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.
A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.
Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s pipeline currently features two combination drugs intended to treat osteoarthritis pain and hypertension simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. Lowering development risk and cost through rapid and efficient regulatory approval of novel late-stage therapeutics, Kitov delivers rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information, the content of which is not part of this press release, visit www.kitovpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements involve certain risks and uncertainties, including, among others, the risk that drug development involves a lengthy and expensive process with uncertain outcome; the Company’s ability to successfully develop and commercialize its pharmaceutical product; the length, progress and results of any clinical trials; the introduction of competing products; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals to commercialize the Company’s products; the lack of sufficient funding to finance the clinical trials; the difficulty of predicting actions of the USA FDA; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; or changes in the global pharmaceutical industry. . Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Kitov Pharmaceuticals Holdings Ltd.’s Registration Statement on Form F-1 filed with the SEC, which is available on the SEC’s website, www.sec.gov.
Contact:
Simcha Rock
Chief Financial Officer
+972-2-6254124
Simcha@kitovpharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6989
bob@LifeSciAdvisors.com
(HCKT) Announces $5 Million Increase To Share Repurchase Program Authorization
The Hackett Group, Inc. (NASDAQ: HCKT), a global intellectual property-based strategic consultancy and leading enterprise benchmarking and best practices implementation firm, today announced that its Board of Directors increased the authorization under its share repurchase program by an additional $5 million. As of Tuesday, May 10, 2016, the company had approximately $3.1 million available under the Company’s share repurchase program.
Under the share repurchase plan, The Hackett Group may buy back shares of its outstanding common stock either on the open market or through privately negotiated transactions subject to market conditions and trading restrictions. This share repurchase program does not obligate the company to repurchase any shares and may be modified, suspended, or terminated by the company at any time.
About The Hackett Group
The Hackett Group (NASDAQ: HCKT) is an intellectual property-based strategic consultancy and leading enterprise benchmarking and best practices implementation firm to global companies. Services include business transformation, enterprise performance management, working capital management, and global business services. The Hackett Group also provides dedicated expertise in business strategy, operations, finance, human capital management, strategic sourcing, procurement, and information technology, including its award-winning Oracle EPM and SAP practices.
The Hackett Group has completed more than 11,000 benchmarking studies with major corporations and government agencies, including 93% of the Dow Jones Industrials, 86% of the Fortune 100, 87% of the DAX 30 and 52% of the FTSE 100. These studies drive its Best Practice Intelligence Center™ which includes the firm’s benchmarking metrics, best practices repository, and best practice configuration guides and process flows, which enable The Hackett Group’s clients and partners to achieve world-class performance.
More information on The Hackett Group is available at: www.thehackettgroup.com, info@thehackettgroup.com, or by calling (770) 225-3600.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve known and unknown risks, uncertainties and other factors that may cause The Hackett Group’s actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements. Factors that impact such forward-looking statements include, among others, the ability of our products, services, or offerings mentioned in this release to deliver the desired effect, our ability to effectively integrate acquisitions into our operations, our ability to retain existing business, our ability to attract additional business, our ability to effectively market and sell our product offerings and other services, the timing of projects and the potential for contract cancellations by our customers, changes in expectations regarding the business consulting and information technology industries, our ability to attract and retain skilled employees, possible changes in collections of accounts receivable due to the bankruptcy or financial difficulties of our customers, risks of competition, price and margin trends, foreign currency fluctuations, changes in general economic conditions and interest rates, our ability to obtain debt financing through additional borrowings under an amendment to our existing credit facility as well as other risks detailed in our Company’s Annual Report on Form 10-K for the most recent fiscal year filed with the Securities and Exchange Commission. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
The Hackett Group, Inc.
Robert A. Ramirez, CFO, 305-375-8005
rramirez@thehackettgroup.com
(MARA) Erich Spangenberg Joins Marathon Patent Group Management Team
Renowned IP Industry Veteran Will Focus on European and Asian Opportunities
LOS ANGELES, CA–(May 12, 2016) – Marathon Patent Group, Inc. (NASDAQ: MARA) (“Marathon”), a patent licensing and commercialization company, announced today that it has named Erich Spangenberg its Director of Acquisitions, Licensing, and Strategy. Mr. Spangenberg will primarily focus on acquisitions, licensing, alliances and strategy for Marathon, with an emphasis on Marathon’s expansion into Asia and Europe.
Doug Croxall, CEO and Chairman of Marathon stated, “Erich is well known in the IP industry and was always my top choice to advise on strategy. We have known each other for years and work well together. I have also asked Erich to join our recently formed Asset Management Committee which reviews and makes final recommendations to the Board of Directors on all patent acquisitions and other significant transactions.”
Erich Spangenberg commented, “The patent market is in turmoil and under incredible pressure, so this is exactly the time I want to jump back in and join Doug and the rest of the Marathon team at what I believe is a historic point of opportunity in the patent market.”
Mr. Spangenberg continued, “I plan to spend the majority of my time on the ground in Europe and Asia working primarily with large corporate patent owners on various monetization opportunities. We are also working on new and significant opportunities beyond traditional licensing that potentially offer very attractive returns. It is my belief that focused monetization efforts in Asia and Europe can contribute significantly to future top and bottom line growth at Marathon.”
Spangenberg is the founder and former CEO of IP Navigation Group (IPNav). He is also the founder and former CEO of nXn Partners (predictive analytics). Mr. Spangenberg was previously a partner at the prestigious law firm, Jones Day, as well as an investment banking executive at Donaldson, Lufkin & Jenrette. He is regularly quoted and featured in major news and industry trade publications and his influence in the IP space has resulted in numerous industry recognitions.
About Marathon Patent Group
Marathon is a patent licensing and commercialization company. The Company acquires patents from a wide-range of patent holders from individual inventors to Fortune 500 companies. Marathon’s strategy of acquiring patents that cover a wide-range of subject matter allows the Company to achieve diversity within its patent asset portfolio. Marathon generates revenue with its diversified portfolio through actively managed concurrent patent rights enforcement campaigns. This approach is expected to result in a long-term, diversified revenue stream. The Company’s commercialization division is focused on the full commercialization lifecycle which includes discovering opportunities, performing due diligence, providing capital, managing development, protecting and developing IP, assisting in execution of the business plan, and realizing shareholder value. To learn more about Marathon Patent Group, visit www.marathonpg.com.
Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
CONTACT INFORMATION
Marathon Patent Group
Jason Assad
678-570-6791
Jason@marathonpg.com
(MGT) Acquires Ownership Interest in Technology Incubator Round House
Provides MGT with Valuable Pipeline, Including Equity in RecMed
HARRISON, N.Y., May 12, 2016 — MGT Capital Investments, Inc. (NYSE MKT: MGT) announced today that it has acquired a Membership Interest in The Round House LLC, an Alabama-based technology incubator, offering co-working space, accelerator services and angel investment. Located a few miles from Auburn University, Round House was founded by Kyle Sandler, a successful serial entrepreneur with eight years of experience at Google and three major successful technology exits. With an experienced executive team, Round House has attracted top entrepreneurs from Google, E-Nable, Rockstar Games, American Express, and many more companies. Round House offers start-ups a creative and collaborative environment along with two-way Gigabit internet access, 3-D printers and a full-time “community engineer.”
Among the companies in which Round House has equity ownership is RecMed First Aid, founded by a local teenager, Taylor Rosenthal. This past Monday, Taylor became the youngest person to exhibit at TechCrunch Disrupt in New York. He has been featured on numerous national media outlets in the past several days, and Taylor has stated that RecMed is being courted by some large retail and healthcare companies.
Several companies within the Round House portfolio are cybersecurity related, offering MGT an early look into potentially disruptive technologies in file sharing, chat and other applications.
About MGT Capital Investments, Inc.
MGT and its subsidiaries are principally engaged in the business of acquiring, developing and monetizing intellectual property assets. MGT’s portfolio currently includes social casino and gaming platforms, and ownership stakes in DraftDay.com, a top daily fantasy sports wagering platform and DraftDay Fantasy Sports, Inc. operator of an online entertainment marketing and rewards platform.
MGT also recently announced the acquisition of certain technology and assets from D-Vasive Inc., a provider of leading edge anti-spy software. In conjunction with the acquisition, The Company also announced the proposed appointment of John McAfee as Executive Chairman and Chief Executive Officer. Further, MGT Capital also intends to change its corporate name to John McAfee Global Technologies, Inc. Closing of the acquisition is contingent on customary conditions including approval by MGT’s stockholders.
Forward–looking Statements
This press release contains forward–looking statements. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions are intended to identify “forward–looking statements.” MGT’s financial and operational results reflected above should not be construed by any means as representative of the current or future value of its common stock. All information set forth in this news release, except historical and factual information, represents forward–looking statements. This includes all statements about the Company’s plans, beliefs, estimates and expectations. These statements are based on current estimates and projections, which involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward–looking statements. These risks and uncertainties include issues related to: rapidly changing technology and evolving standards in the industries in which the Company and its subsidiaries operate; the ability to obtain sufficient funding to continue operations, maintain adequate cash flow, profitably exploit new business, license and sign new agreements; the unpredictable nature of consumer preferences; and other factors set forth in the Company’s most recently filed annual report and registration statement. Readers are cautioned not to place undue reliance on these forward–looking statements, which reflect management’s analysis only as of the date hereof. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof. Readers should carefully review the risks and uncertainties described in other documents that the Company files from time to time with the U.S. Securities and Exchange Commission.
(HTGM) Research Collaboration Agreement with Bristol-Myers Squibb
TUCSON, Ariz., May 12, 2016 — HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced a research collaboration agreement with Bristol-Myers Squibb (NYSE:BMY) to evaluate the potential for immuno-oncology molecular profiling in multiple tumor types. The collaboration between HTG and Bristol-Myers Squibb will utilize the next generation sequencing (NGS)-based HTG EdgeSeq system as a tool for use in support of Bristol-Myers Squibb’s translational research activities.
“We believe this collaboration will provide many benefits to Bristol-Myers Squibb’s immuno-oncology development programs and further add to HTG’s industry leadership in the development of NGS-based molecular diagnostic assays toward the goal of precision medicine. This collaboration is the result of a long-standing Bristol-Myers Squibb/HTG relationship and we are excited to continue as a partner with Bristol-Myers Squibb’s translational research team,” said John Lubniewski, HTG’s Chief Business Officer.
Under the terms of the agreement, HTG will provide Bristol-Myers Squibb access to its NGS-based HTG EdgeSeq system and the companies will collaborate to develop tools for use for molecular profiling research for immuno-oncology.
“Immuno-oncology is a very important business segment for us and this agreement and the expansion of our relationship with BMS is a validation of our HTG EdgeSeq technology and value proposition,” stated TJ Johnson, President and CEO of HTG Molecular Diagnostics. “We firmly believe in the potential of immuno therapies in treating cancer patients and we are honored to be chosen as a profiling partner for Bristol-Myers Squibb, a recognized leader in this space.”
About HTG:
Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.
Safe Harbor Statement:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected benefits of our agreement with BMS, the role that immuno-oncology molecular profiling will have in clinical settings, including precision medicine, the potential of immunotherapy treatments, and our business and the capabilities of our technology. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with the process of developing and commercializing immuno-oncology applications and biomarker panels. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact: Westwicke Partners Jamar Ismail Phone: 415-513-1282 Email: jamar.ismail@westwicke.com TJ Johnson President / CEO HTG Molecular Diagnostics Phone: 520-547-2827 x130 Email: tjjohnson@htgmolecular.com
(CNCK) Partners With ATLETO to Promote a Tailored Sports Experience for a Healthier Life
LOS ANGELES CA–(May 12, 2016) – Content Checked Holdings, Inc. (OTCQB: CNCK) (“Content Checked”), a creator of mobile applications for people with dietary restrictions, today announced a partnership with ATLETO, a social sports app that connects everyday athletes. The partnership will entail a cross-promotional marketing campaign highlighting both apps as a platform for users to stay on top of their health and fitness needs.
“Partnering with ATLETO is a natural fit since its platform aligns with our philosophy of fostering a community of like-minded individuals who commit to bettering their lives,” said Kris Finstad, CEO and co-founder of Content Checked. “We want to educate our audience and introduce them to platforms developed to help users make healthier choices easily, and we happily promote everything ATLETO stands for.”
Content Checked is committed to improving the lives of individuals with dietary restrictions by providing a suite of apps that give a nutritional breakdown of packaged food items and suggests healthier alternatives. Through the marketing campaign, Content Checked will leverage its social media audience to endorse ATLETO, encourage downloads, and drive brand awareness with its team backed by certified nutritionists and health experts. Conversely, ATLETO will support Content Checked via promotional posts across of all its social channels to further elevate Content Checked’s brand amongst everyday athletes.
“Content Checked’s technology has significantly improved the health of individuals and we aim to provide such a significant impact to our own community of athletes,” said Peter Dalgas, CMO and co-founder of ATLETO. “Our complementary visions create a symbiotic relationship and we’re eager to share with our community the benefits of Content Checked’s family of apps.”
The ATLETO app matches users with other athletes based on location, skill level and frequency, to provide the best athletic experience possible. The app matches users with the most popular sports including: basketball, golf, soccer, tennis, and volleyball. The app includes fitness and workout activities like cycling, running, and yoga with new additions daily. ATLETO is currently focusing its efforts on a soft launch in Los Angeles, Miami and New York City.
About ATLETO
ATLETO is a social sports app that creates best matches for everyday athletes by sport, skill level, location, frequency and other parameters to provide the best experience possible. The founders of ATLETO wanted to create a platform for members to connect and collect new and existing friends who play sports — and to coordinate their sporting activities. For more information, please visit http://www.atletosports.com, or download their app in Apple’s App Store®.
About Content Checked
Content Checked Holdings, Inc. (www.contentchecked.com) has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications. ContentChecked and MigraineChecked are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for over 70% of conventional U.S. food products.
Each app gives consumers the ability to scan a product’s bar code and determine if it is safe for consumption based on their allergy settings. The apps will recommend a suitable alternative if a product does contain one or more of a user’s allergens. This enables the applications to meet the needs of millions of people in the U.S. In the U.S. alone, there are more than 15 million people who suffer from food allergies and 38 million people who suffer from migraines and chronic headaches. The food allergy and intolerances market has been valued at approximately US$13 billion in 2015. As a result, Content Checked has created a pivotal way for food manufacturers and producers to showcase their products to consumers who are actively seeking them at the point of purchase.
Content Checked has created a robust database of allergens, migraine triggers and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database, updated regularly. All applications serve as easy shopping tools for consumers to decipher often misleading food labels and receive recommendations for healthier alternative products as they shop in real time. Content Checked’s mission is to offer fast, reliable and efficient mobile apps that help consumers make more informed purchasing decisions and live healthier lives in accordance to their dietary preferences.
For more information on the Company, please visit its social media channels via Facebook (www.facebook.com/contentchecked), (www.facebook.com/migrainechecked) and (www.facebook.com/sugarchecked); Instagram (www.instagram.com/contentchecked), (www.instagram.com/migrainechecked) and (www.instagram.com/sugarchecked); or
YouTube (www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ).
Media Contact:
Aly Crea
aly@pmcgroup.com
310-777-7546
(EFOI) Names Human Resources Veteran Gail Thakarar Chief People Officer
NEW YORK, May 11, 2016 — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, announced today that Gail Thakarar joined the company as its Chief People Officer. To advance the company’s business strategies and growth goals, in this role, Ms. Thakarar is responsible for leading, developing and expanding the company’s human resources infrastructure, which includes talent acquisition, leadership development, employee engagement, culture enrichment, organizational design and compensation and benefits.
Ms. Thakarar has a strong track record of building and leading complex and global human resources operations for large as well as high-growth entrepreneurial corporations. Her past successes include growing and improving human capital management functions for companies across various industries, resulting in significantly enhanced shareholder value. Ms. Thakarar gained her extensive global experience as a top human resources executive for several Fortune 500 companies, notably General Electric, Glaxo Smith Kline, The Mony Group (acquired by AXA Financial), Countrywide Financial Corporation and Occidental Petroleum. Most recently, she was the Chief Human Resources Officer with AMC Health, a leading provider of virtual care solutions for at-risk populations. She holds an undergraduate degree in Accounting from The University of Bombay, India, and an MBA in Human Resources from the University of Pennsylvania’s Wharton School.
“We are absolutely proud and pleased to have Gail as part of our leadership team as we look to dramatically strengthen our people capacities and capabilities to facilitate and accelerate our expansion in the U.S. and internationally,” said James Tu, Chairman, President & Chief Executive Officer of Energy Focus, Inc. “Energy Focus believes deeply in attracting, growing and retaining the best talent to enable the company to become the most trusted LED lighting brand in our dedicated markets. Gail brings to us not only a trove of experience and expertise in global talent acquisition and development, but also proven wisdom to build sustainable, scalable and transformational human resources operations from massive conglomerates to technology startups. We very much look forward to her positive and powerful contributions to lay the critical cultural and people foundation for the next phase of our growth.”
“I’m truly thrilled to have joined Energy Focus as a member of its dynamic leadership team,” stated Ms. Thakarar. “I look forward to supporting and contributing to the company’s vision to build an impactful organization by creating triple-bottom-line benefits that encompass people, planet and profit for its stakeholders as well as its customers.”
About Energy Focus, Inc.:
Energy Focus, Inc. is a leading provider of energy efficient LED lighting products and a developer of energy efficient lighting technology. Our LED lighting products provide energy savings, aesthetics, safety and maintenance cost benefits over conventional lighting. Our long-standing relationship with the U.S. Government continues to enable us to provide energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets. Customers include national, state and local U.S. government agencies as well as Fortune 500 companies and many other commercial and industrial clients. World headquarters are located in Solon, Ohio with additional offices in Washington, D.C., New York City and Taiwan. For more information, see our web site at www.energyfocusinc.com.
Investor Contacts: Energy Focus, Inc. Marcia J. Miller, Chief Financial Officer (440) 715-1300 ir@energyfocusinc.com Darrow Associates, Inc. Peter Seltzberg, Managing Director (516) 419-9915 pseltzberg@darrowir.com
(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
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