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(MELA) MelaFind System Enabled Insurance Reimbursement Process
IRVINGTON, N.Y., July 10, 2014 — MELA Sciences, Inc. (Nasdaq:MELA), announced today that it has taken the first step in the process of seeking insurance reimbursement for its Multi-Spectral Digital Skin Lesion Analysis (MSDSLA) procedure that is performed by dermatologists utilizing the MelaFind® system as an aid in the detection of melanoma. The company has submitted an application for a Current Procedural Terminology (CPT®) code, which is necessary for Medicare Part B reimbursement by the Centers for Medicare and Medicaid Services (CMS). MSDSLA could be eligible for payment under Part B as early as January 1, 2016. The company will also commence efforts to obtain reimbursement from private insurance companies as the CMS review process proceeds.
CPT codes are determined by the American Medical Association (AMA) under a rigorous review process. Currently, there is no CPT code available for the MelaFind process. The AMA’s CPT Editorial Panel ultimately decides whether to accept a new code, and will refer a new code to the AMA’s Relative Value Scale Update Committee (RUC). The RUC determines the relative value of physician work within the procedure or service and makes a recommendation to CMS. CMS then establishes the appropriate reimbursement level for the service. Obtaining Medicare reimbursement is critical in order to secure reimbursement from other public and private insurers.
Rose Crane, President and CEO of MELA Sciences, commented, “Our CPT application is the first concrete step in achieving our goal of obtaining insurance reimbursement for physician use of the MelaFind system. MelaFind’s ability to improve diagnostic accuracy without increasing the number of biopsies, as demonstrated with the data presented at the 2014 American Dermoscopy Association Meeting is very meaningful to both patients and physicians and ultimately can save costs in the healthcare system. We believe our application makes a compelling argument in favor of receiving the CPT code and for obtaining reimbursement from CMS.”
The poster presentation at the meeting measured the impact of the MelaFind information on a dermatologist’s decision to biopsy high risk lesions. The biopsy sensitivity of dermatologists (a measure of the percentage of lesions correctly identified as melanoma) increased from 68% to 89% with the addition of the MelaFind probability information, and specificity (a measure of the percentage of lesions correctly identified as not being melanoma) increased from 39% to 54%. The average percentage of benign lesions selected for biopsy decreased from 61% to 46%. The p-value in all three measurements was statistically significant at p<0.001. There was a non-significant change in the percentage of total lesions selected for biopsy.
About MelaFind www.melafind.com
MelaFind is the first and only medical device with FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union designed to assist dermatologists in the evaluation and diagnosis of melanoma at its most curable stage. The MelaFind® system utilizes innovative software driven technology and state-of-the-art 3-D optical imaging to non-invasively extract data 2.5 mm below the skin surface from patient’s pigmented ambiguous moles and objectively analyzes them with proprietary algorithms. MelaFind provides important additional perspective to physicians via 3-D spectral images and 100% objective data analysis to help them better understand the structural disorganization of a patient’s pigmented ambiguous moles (before cutting the skin) during the evaluation and diagnosis process for melanoma.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical technology company dedicated to designing and developing innovative software-driven technology for the clinical early detection and prevention of skin cancer. MELA Sciences conducted the largest, positive prospective study ever done on the melanoma disease, and is the first and only medical technology company to receive both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union for a device of this nature.
Safe Harbor
This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and may contain words such as “seeks,” “look forward,” and “there seems” that suggest future events or trends. These statements, including our expectations regarding our ability to obtain a CPT code and appropriate reimbursement for our MelaFind system, are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties set forth in the company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com.
CONTACT: Media Diana Garcia Redruello MELA Sciences, Inc. 212-518-4226 dgarcia@melasciences.com Investors Andrew McDonald LifeSci Advisors, LLC 646-597-6987 Andrew@LifeSciAdvisors.com
(SPNC) AngioScore Launches New 200 mm Length AngioSculpt® Scoring Balloon Catheters
Longer Balloons Used for the Treatment of Peripheral Artery Disease (PAD) Above-The-Knee (ATK); Incorporates Novel Scoring Element
COLORADO SPRINGS, Colo., July 9, 2014 — The Spectranetics Corporation (Nasdaq:SPNC) today announced that its wholly-owned subsidiary, AngioScore, Inc., developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, launched its new 200 mm length AngioSculpt® PTA Scoring Balloon Catheters for the treatment of Peripheral Artery Disease (PAD) above-the-knee (ATK).
The new AngioSculpt catheters received U.S. Food and Drug Administration (FDA) 510(k) clearance to be marketed for the dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. They are not approved for use in the coronary or neuro-vasculature.
The catheters incorporate 200 mm balloons in diameters of 4.0, 5.0 and 6.0 mm with a novel scoring element specifically designed for these longer balloons. The devices are expected to be particularly useful in treating the typical complex and long lesions found above-the-knee.
“These new longer scoring balloons extend the capability of the AngioSculpt in treating the most challenging femoro-popliteal lesions safely and efficiently and will be a very important addition to the armamentarium of physicians treating complex endovascular disease,” said Nelson L. Bernardo, MD, medical director of the Peripheral Vascular Laboratory, MedStar Heart Institute, MedStar Washington Hospital Center.
The AngioSculpt balloon catheter was developed by AngioScore, Inc., which was acquired June 30, 2014, by The Spectranetics Corporation. Scott Drake, President and CEO of Spectranetics states that, “We are proud to introduce a viable new product to treat PAD so quickly following the joining of our two companies. At Spectranetics, we focus on solutions for the sickest and trickiest patient population. Now, united with AngioScore, we continue our commitment to provide solutions to cross, prep and treat the most complex morphologies associated with coronary and peripheral diseases.”
Thomas R. Trotter, president of Spectranetics’ AngioScore subsidiary, added, “The treatment of PAD is a rapidly growing segment of the interventional cardiovascular market. Worldwide, over 1 million percutaneous peripheral endovascular procedures are performed annually, and the PAD market continues to demonstrate significant growth due to improved diagnosis and the increasing prevalence of important risk factors such as adult onset diabetes mellitus. We believe that the AngioSculpt line of scoring balloon catheters is particularly useful in treating this very challenging and serious disease.”
About Spectranetics
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
The Company’s Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee as well as AngioSculpt® scoring balloon used in both peripheral and coronary procedures. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit http://www.spectranetics.com
About AngioScore
AngioScore, Inc., a Spectranetics company, was acquired in June 2014 by The Spectranetics Corporation in Colorado Springs, Colo. Spectranetics is a leading maker of single-use medical devices used in minimally invasive cardiovascular procedures.
AngioScore Inc. designs, develops, manufactures and markets scoring balloon catheters to treat cardiovascular and peripheral artery diseases. The company was founded in 2003 and is based in Fremont, Calif.
For more information, visit http://www.angioscore.com
About AngioSculpt Scoring Balloon Catheters
AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty balloon catheters to treat both coronary and peripheral artery disease. Their innovative nitinol scoring elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while minimizing “geographic miss” through their unique anti-slippage properties. AngioSculpt balloon catheters combine the versatility and effectiveness of a new technology with the simplicity and deliverability of traditional high-performance balloon catheters.
AngioSculpt devices have been used in over 350,000 procedures worldwide, achieving an outstanding performance record in the treatment of both coronary and peripheral artery disease.
CONTACT: COMPANY CONTACT The Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 INVESTOR CONTACT Westwicke Partners Lynn Pieper (415) 202-5678 lynn.pieper@westwicke.com
(LXRX) And JDRF Collaborate For Phase 2 Clinical Trial Of LX4211 In Type 1 Diabetes
Trial to Evaluate Efficacy and Safety of LX4211 in Younger Population
THE WOODLANDS, Texas, July 9, 2014 — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that JDRF, the world’s largest non-profit supporter of type 1 diabetes (T1D) research, will provide funding to support a Phase 2, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of LX4211 in a younger population with T1D. Up to 76 individuals with T1D, younger than 30 years of age and with HbA1c levels greater than 9.0%, are expected to be randomly assigned to receive either placebo or a once daily 400mg dose of LX4211 and complete the 12-week treatment period. The primary objective of this study is to demonstrate the superiority of LX4211 versus placebo as adjunct to insulin treatment on HbA1c reduction at 12 weeks as well as several secondary endpoints, including reduced variability in blood glucose levels and lower insulin needs.
“JDRF has a strategic T1D research plan designed to deliver a sustained stream of new life-changing therapies, so we are pleased to collaborate with Lexicon on the development of LX4211 in T1D,” said Sanjoy Dutta, Ph.D., JDRF’s assistant vice president, translational development. “This collaboration is part of JDRF’s Glucose Control Research Program whose goal is to develop and deliver improved insulin and non-insulin adjunct therapies that progressively improve glucose and overall metabolic control in individuals with T1D. We believe that LX4211’s dual SGLT1/SGLT2 inhibitory mechanism offers an innovative and exciting opportunity to deliver on this goal and address an important unmet medical need in those with T1D struggling to achieve optimal glucose control target levels.”
“The results from our previous Phase 2 study of LX4211 in type 1 diabetes have encouraged us to also explore its potential application in this younger population for whom managing glucose variability is an especially difficult challenge and in which the significant majority are unable to achieve HbA1c targets,” said Pablo Lapuerta, M.D., Lexicon’s executive vice president and chief medical officer. “Importantly, we hope to continue to see improvement in glycemic control with a longer treatment period combined with reductions in the amount of insulin required and related improvements in quality of life in this population of high unmet medical need. This study complements our ongoing preparations for Phase 3 in type 1 diabetes, which are proceeding, as well as our plans for LX4211 in type 2 diabetes.”
LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to lower blood glucose levels through two insulin-independent mechanisms of action. In a previous Phase 2 clinical trial of LX4211 in type 1 diabetes, LX4211 treatment was shown to reduce mean HbA1c by 0.55% compared to a reduction of only 0.06% with placebo (p=0.002) over a four-week treatment period. At the same time, LX4211 reduced the total daily mealtime bolus insulin dose by 32% compared to 6% for placebo (p=0.007), while reducing variability in blood glucose levels. These improvements were accompanied by significantly more time spent in the target glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range, and no increase in hypoglycemia.
About Type 1 Diabetes
Type 1 diabetes is a serious condition affecting more than one million people in the United States, both children and adults. Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the pancreas. Insulin is a required treatment, with few additional treatment options. The effectiveness of insulin is limited by concerns about potentially serious hypoglycemia; therefore, most patients with type 1 diabetes do not achieve their targets for glucose control. In addition, insulin therapy does not necessarily prevent the possibility of the disease’s serious complications, which may include kidney failure, blindness, nerve damage, heart attack and stroke. As an oral agent, LX4211 is designed to delay the absorption of glucose in the gastrointestinal tract and enhance glucose excretion in the kidney, allowing glucose control to improve and insulin doses to be reduced.
About Lexicon
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF’s goal is to progressively remove the impact of T1D from people’s lives until we achieve a world without T1D. JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, regulatory influence, and a working plan to better treat, prevent, and eventually cure T1D. As the largest charitable supporter of T1D research, JDRF is currently sponsoring $568 million in scientific research in 17 countries. For additional information about JDRF, please visit www.jdrf.org.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX4211, characterizations of the results of and projected timing of clinical trials of LX4211, and the potential therapeutic and commercial potential of LX4211. The press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to meet its capital requirements, successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
(AAU) Completes Infill Drilling Program, Hits 62.00 Meters of 0.96 g/t Au, 76.4 g/t Ag
VANCOUVER, BRITISH COLUMBIA–(Jul 9, 2014) – Almaden Minerals Ltd. (“Almaden” or “the Company”) (TSX:AMM)(NYSE MKT:AAU) is pleased to announce the results from Almaden’s ongoing 2014 Ixtaca Zone drill program at the Company’s 100% owned Tuligtic project, Mexico. Recently the company released a positive PEA on the Ixtaca deposit (see news release dated April 16th, 2014). The mineral resources incorporated into the PEA mine plan were comprised of 29% Measured, 55% Indicated and 16% Inferred. The results reported today are from drilling carried out subsequent to the 2014 resource update and PEA and designed to upgrade resources remaining in the inferred category to the higher confidence measured and indicated categories. Infill drilling is now complete and the Company’s 2014 drilling is currently focussed on exploring the large and highly prospective Tuligtic concession for gold-silver deposits. Highlights from the holes released today include the following intercepts (a more complete list of intercepts is shown in the table below):
Hole TU-14-413 CHEMALACO ZONE SECTION 49950 NORTH, 070 Az, -30 dip |
102.25 meters @ 0.32 g/t gold and 33.7 g/t silver (1.0 g/t gold equivalent) |
Including 9.25 meters @ 1.11 g/t gold and 83.4 g/t silver (2.8 g/t gold equivalent) |
Including 2.00 meters @ 1.30 g/t gold and 63.6 g/t silver (2.6 g/t gold equivalent) |
Hole TU-14-414 CHEMALACO ZONE SECTION 49950 NORTH, 070 Az, -55 dip |
19.50 meters @ 0.40 g/t gold and 15.9 g/t silver (0.7 g/t gold equivalent) |
Including 1.50 meters @ 1.65 g/t gold and 55.8 g/t silver (2.8 g/t gold equivalent) |
45.25 meters @ 0.27 g/t gold and 16.0 g/t silver (0.6 g/t gold equivalent) |
Hole TU-14-415 CHEMALACO ZONE SECTION 50025 NORTH, 070 Az, -48 dip |
57.50 meters @ 0.46 g/t gold and 48.6 g/t silver (1.4 g/t gold equivalent) |
Hole TU-14-417 CHEMALACO ZONE SECTION 50125 NORTH, 070 Az, -30 dip |
61.65 meters @ 0.77 g/t gold and 36.2 g/t silver (1.5 g/t gold equivalent) |
Including 24.50 meters @ 1.48 g/t gold and 38.6 g/t silver (2.3 g/t gold equivalent) |
Hole TU-14-418 CHEMALACO ZONE SECTION 49950 NORTH, 250 Az, -83 dip |
213.00 meters @ 0.60 g/t gold and 48.2 g/t silver (1.6 g/t gold equivalent) |
Including 62.00 meters @ 0.96 g/t gold and 76.4 g/t silver (2.5 g/t gold equivalent) |
Hole TU-14-419 CHEMALACO ZONE SECTION 50050 NORTH, 070 Az, -75 dip |
23.25 meters @ 0.27 g/t gold and 64.9 g/t silver (1.6 g/t gold equivalent) |
37.00 meters @ 0.37 g/t gold and 70.4 g/t silver (1.8 g/t gold equivalent) |
Hole TU-14-420 CHEMALACO ZONE SECTION 50050 NORTH, 070 Az, -50 dip |
49.60 meters @ 0.27 g/t gold and 21.1 g/t silver (0.7 g/t gold equivalent) |
Including 8.50 meters @ 0.85 g/t gold and 54.1 g/t silver (1.9 g/t gold equivalent) |
J.D. Poliquin, chairman of Almaden stated, “Today’s holes once again show the continuity of this part of the Ixtaca deposit. The infill drilling program, designed to upgrade the confidence of our resource base is now complete. We are now focussed on exploring other areas within our high prospective 14,000 hectare concession, which holds the potential for additional entirely separate gold-silver discoveries.”
Hole # | From (m) | To (m) | Interval (m) | Au (g/t) | Ag (g/t) | AuEq (g/t) | AgEq (g/t) | SECTION | |||||||
TU-14-413 | 185.00 | 287.25 | 102.25 | 0.32 | 33.7 | 1.0 | 50 | 49950N | |||||||
including | 223.25 | 232.50 | 9.25 | 1.11 | 83.4 | 2.8 | 139 | ||||||||
including | 238.50 | 240.50 | 2.00 | 1.30 | 63.6 | 2.6 | 129 | ||||||||
TU-14-413 | 303.50 | 311.60 | 8.10 | 0.41 | 10.8 | 0.6 | 31 | ||||||||
TU-14-414 | 211.50 | 231.00 | 19.50 | 0.40 | 15.9 | 0.7 | 36 | 49950N | |||||||
including | 225.25 | 226.75 | 1.50 | 1.65 | 55.8 | 2.8 | 138 | ||||||||
TU-14-414 | 260.25 | 305.50 | 45.25 | 0.27 | 16.0 | 0.6 | 29 | ||||||||
including | 272.50 | 274.50 | 2.00 | 0.59 | 35.5 | 1.3 | 65 | ||||||||
including | 284.00 | 285.50 | 1.50 | 0.69 | 104.6 | 2.8 | 139 | ||||||||
TU-14-415 | 238.00 | 295.50 | 57.50 | 0.46 | 48.6 | 1.4 | 71 | 50025N | |||||||
including | 245.50 | 285.50 | 40.00 | 0.61 | 64.8 | 1.9 | 95 | ||||||||
including | 245.50 | 249.50 | 4.00 | 1.04 | 105.3 | 3.1 | 157 | ||||||||
including | 252.50 | 274.50 | 22.00 | 0.57 | 79.4 | 2.2 | 108 | ||||||||
TU-14-417 | 131.35 | 193.00 | 61.65 | 0.77 | 36.2 | 1.5 | 75 | 50125N | |||||||
including | 162.00 | 186.50 | 24.50 | 1.48 | 38.6 | 2.3 | 113 | ||||||||
including | 179.86 | 183.00 | 3.14 | 7.75 | 29.5 | 8.3 | 417 | ||||||||
TU-14-418 | 55.00 | 268.00 | 213.00 | 0.60 | 48.2 | 1.6 | 78 | 49950N | |||||||
including | 115.00 | 124.00 | 9.00 | 0.46 | 170.8 | 3.9 | 194 | ||||||||
including | 143.00 | 205.00 | 62.00 | 0.96 | 76.4 | 2.5 | 125 | ||||||||
including | 146.00 | 152.45 | 6.45 | 1.57 | 153.0 | 4.6 | 232 | ||||||||
including | 157.75 | 163.60 | 5.85 | 1.58 | 118.6 | 4.0 | 198 | ||||||||
including | 176.00 | 178.00 | 2.00 | 3.31 | 138.8 | 6.1 | 304 | ||||||||
including | 199.50 | 202.00 | 2.50 | 2.41 | 162.3 | 5.7 | 283 | ||||||||
TU-14-419 | 52.00 | 122.50 | 70.50 | 0.17 | 33.7 | 0.8 | 42 | 50050N | |||||||
including | 92.25 | 115.50 | 23.25 | 0.27 | 64.9 | 1.6 | 79 | ||||||||
including | 110.00 | 115.50 | 5.50 | 0.34 | 114.4 | 2.6 | 131 | ||||||||
TU-14-419 | 131.00 | 168.00 | 37.00 | 0.37 | 70.4 | 1.8 | 89 | ||||||||
including | 161.75 | 165.00 | 3.25 | 2.50 | 420.8 | 10.9 | 546 | ||||||||
TU-14-419 | 189.00 | 194.00 | 5.00 | 0.20 | 39.1 | 1.0 | 49 | ||||||||
TU-14-420 | 52.40 | 102.00 | 49.60 | 0.27 | 21.1 | 0.7 | 34 | 50050N | |||||||
including | 81.00 | 89.50 | 8.50 | 0.85 | 54.1 | 1.9 | 97 | ||||||||
TU-14-420 | 114.00 | 186.00 | 72.00 | 0.25 | 22.1 | 0.7 | 35 | ||||||||
including | 212.00 | 223.00 | 11.00 | 0.14 | 12.2 | 0.4 | 19 |
Below is a plan map and relevant sections which will be posted to the Company’s website (www.almadenminerals.com).
About the Ixtaca Project
The 100% owned Ixtaca zone is a blind discovery made by the Company in 2010 on claims staked by the Company. On January 31, 2013 the Company announced a maiden resource on the Ixtaca Zone. Since that time drilling has been focused on expanding and infilling the known mineralization. An updated resource statement was reported on January 22, 2014 and formed the base for the maiden Preliminary Economic Assessment (“PEA”), the results of which were reported on April 16, 2014 and are detailed in a technical report entitled “Preliminary Economic Assessment Technical of the Ixtaca Deposit”, which is available on Almaden’s website at www.almadenminerals.com or under Almaden’s profile on SEDAR at www.sedar.com. The Preliminary Economic Assessment outlines one concept for the development of a potentially large scale, long life, low cost open pit gold-silver mining operation based on the estimated mineral resource. The conclusions and recommendations of the PEA are that the Ixtaca deposit may be economically viable and the Company should proceed to a Pre-Feasibility study (“PFS”). Apart from exploration drilling, work underway currently includes all the necessary engineering and environmental studies to support the completion of a PFS. These include geomechanical and geotechnical drilling, additional metallurgical studies, environmental baseline monitoring such as flora and fauna studies, climate monitoring, water quality sampling and surface water hydrology monitoring, a geochemistry program, and engineering studies. At present the Company has redirected drilling efforts to the exploration of high priority epithermal targets outside of the Ixtaca zone but within the project boundaries.
The Ixtaca deposit and any potential mining operation would be located in an area previously logged or cleared with negligible to no current land usage. The Company has employed up to 70 people in its drilling program who live local to the Ixtaca deposit. Local employees make up virtually all the drilling staff, who have been trained on the job to operate the Company’s wholly owned drills. The Company has implemented a comprehensive science based and objective community relations and education program for employees and all local stakeholders to transparently explain the exploration program underway as well as the potential impacts and benefits of any possible future mining operation at Ixtaca. The Company regards the local inhabitants to be major stakeholders in the Ixtaca deposit’s future along with the Company’s shareholders. Every effort is being made to create an open and clear dialogue with our stakeholders to ensure that any possible development scenarios that could evolve from the PEA are properly understood and communicated throughout the course of the Company’s exploration and development program. The Company invites all interested parties to visit www.almadenminerals.com to find out more about our community development, education and outreach programs.
Technical Details of the Ixtaca Drilling Program
The Main Ixtaca and Ixtaca North Zones of veining are interpreted to have a north-easterly trend. Holes to date suggest that the Main Ixtaca and Ixtaca North Zones are sub vertical with local variations. This interpretation suggests that true widths range from approximately 35% of intersected widths for a -70 degree hole to 94% of intersected widths for a -20 degree hole. The drilling completed to date has traced mineralisation over 1,000 meters along this northeast trend. The Chemalaco (Northeast Extension) Zone strikes roughly north-south (340 azimuth) and dips at 55 degrees to the west. This interpretation suggests that true widths range from approximately 82% of intersected widths for a -70 degree hole to 99% of intersected widths for a -40 degree hole.
Mr. Norm Dircks, P.Geo., a qualified person (“QP”) under the meaning of NI 43-101, is the QP and project manager of Almaden’s Ixtaca program and reviewed the technical information in this news release. The analyses reported were carried out at ALS Chemex Laboratories of North Vancouver using industry standard analytical techniques. For gold, samples are first analysed by fire assay and atomic absorption spectroscopy (“AAS”). Samples that return values greater than 10 g/t gold using this technique are then re-analysed by fire assay but with a gravimetric finish. Silver is first analysed by Inductively Coupled Plasma – Atomic Emission Spectroscopy (“ICP-AES”). Samples that return values greater than 100 g/t silver by ICP-AES are then re analysed by HF-HNO3-HCLO4 digestion with HCL leach and ICP-AES finish. Of these samples those that return silver values greater than 1,500 g/t are further analysed by fire assay with a gravimetric finish.
Blanks, field duplicates and certified standards were inserted into the sample stream as part of Almaden’s quality assurance and control program which complies with National Instrument 43-101 requirements. Gold equivalent (“AuEq” or “Gold Eq.”) and silver equivalent (“AgEq” or “Silver Eq.”) values were calculated using silver to gold ratios of 50 to 1. The ratio of 50 to 1 was used for the sake of consistency with past news releases. Intervals that returned assays below detection were assigned zero values. Metallurgical recoveries and net smelter returns are assumed to be 100% for these calculations.
Cautionary Note concerning estimates of Measured, Indicated and Inferred Mineral Resources
This news release uses terms that comply with reporting standards in Canada and certain estimates are made in accordance with Canadian National Instrument 43-101 (“NI 43-101”). NI 43-101 is a rule developed by the Canadian Securities Administrators that establishes Canadian standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission (“SEC”), and mineral resource information contained herein may not be comparable to similar information disclosed by United States companies.
This news release uses the terms “measured mineral resources”, “indicated mineral resources” and “inferred mineral resources” to comply with reporting standards in Canada. We advise United States investors that while such terms are recognized and required by Canadian regulations, the SEC does not recognize them. United States investors are cautioned not to assume that any part or all of the mineral deposits in such categories will ever be converted into mineral reserves under SEC definitions. These terms have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. Therefore, United States investors are also cautioned not to assume that all or any part of the “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” exist. In accordance with Canadian rules, estimates of “inferred mineral resources” cannot form the basis of pre-feasibility or other economic studies. It cannot be assumed that all or any part of the “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” will ever be upgraded to a higher category.
About Almaden
Almaden is a well-financed mineral exploration company working in North America. The company has assembled mineral exploration projects, including the Ixtaca Zone and the Tuligtic project, through its grass roots exploration efforts. While the properties are largely at early stages of development they represent exciting opportunities for the discovery of significant gold, silver and copper deposits as evidenced at Ixtaca. Almaden’s business model is to find and acquire mineral properties and develop them by seeking option agreements with others who can acquire an interest in a project by making payments and exploration expenditures. Through this means the company has been able to expose its shareholders to discovery and capital gain without the funding and consequent share dilution that would be required if the company were to have developed these projects without a partner. The company intends to expand this business model, described by some as prospect generation, by more aggressively exploring several of its projects including the Ixtaca Zone.
On Behalf of the Board of Directors
Morgan J. Poliquin, Ph.D., P.Eng., President, CEO and Director
Almaden Minerals Ltd.
Neither the Toronto Stock Exchange (TSX) nor the NYSE MKT have reviewed or accepted responsibility for the adequacy or accuracy of the contents of this news release which has been prepared by management.. Except for the statements of historical fact contained herein, certain information presented constitutes “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and Canadian securities laws. Such forward-looking statements, including but not limited to, those with respect to potential expansion of mineralization, potential size of mineralized zone, and size and timing of exploration and development programs, estimated project capital and other project costs and the timing of submission and receipt and availability of regulatory approvals involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of Almaden to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks related to international operations and joint ventures, the actual results of current exploration activities, conclusions of economic evaluations, uncertainty in the estimation of mineral resources, changes in project parameters as plans continue to be refined, environmental risks and hazards, increased infrastructure and/or operating costs, labour and employment matters, and government regulation and permitting requirements as well as those factors discussed in the section entitled “Risk Factors” in Almaden’s Annual Information form and Almaden’s latest Form 20-F on file with the United States Securities and Exchange Commission in Washington, D.C. Although Almaden has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Almaden disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required pursuant to applicable securities laws. Accordingly, readers should not place undue reliance on forward-looking statements.
To view the maps associated with this release, please visit the following link: http://file.marketwire.com/release/956477_maps.pdf.
Almaden Minerals Ltd.
604.689.7644
info@almadenminerals.com
www.almadenminerals.com
(NUVA) to Participate in the 21st Annual International Meeting on Advanced Spine Techniques
SAN DIEGO, CA–(Jul 9, 2014) – NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce its participation at the 21st International Meeting on Advanced Spine Techniques (IMAST) from Wednesday, July 16 to Friday, July 18, 2014, in booth #6 at the Valencia Convention Centre in Valencia, Spain.
Sponsored by the Scoliosis Research Society, IMAST gathers more than 1,000 world renowned spine surgeons and industry leaders to present and discuss innovative research and advanced spine technologies. The Scoliosis Research Society has gained recognition as one of the world’s premier spine societies committed to research and education in the field of spine deformities.
“We are thrilled to have the opportunity to showcase our innovative, procedurally integrated solutions to leading spine surgeons at IMAST,” said Pat Miles, NuVasive President of Global Products and Services. “At this year’s meeting, we will focus our educational efforts around advanced applications of XLIF® as well as Anterior Column Realignment (ACR™) of the spine.”
As an IMAST diamond sponsor, NuVasive is scheduled to participate in the following events:
- NuVasive Exhibit Booth #6: The NuVasive exhibit booth will feature a number of innovative, minimally disruptive products and procedures, including: XLIF, XLIF ACR, Precept®, Armada®, MAS® PLIF, AttraX® Putty, CoRoent Small Interlock™, NuVasive Helix-Revolution™, PCM®, VuePoint® II OCT, Bendini®, and NVM5®.
- NuVasive® Hands-on Workshops:
- XLIF for Deformity and Advanced Applications
Wednesday, July 16th from 17:00-19:00
Presented by Behrooz Akbarnia, M.D., Luiz Pimenta, M.D., and William Smith, M.D. - Anterior Column Realignment (ACR): Techniques to Restore Global Alignment
Thursday, July 17th from 12:25-13:25
Presented by Regis Haid, M.D., Christopher Shaffrey, M.D., and Juan Uribe, M.D.
- XLIF for Deformity and Advanced Applications
Click here to download the complete IMAST program.
Click here to download the IMAST Mobile and Online application.
About IMAST:
The International Meeting on Advanced Spinal Techniques (IMAST), sponsored by the Scoliosis Research Society, provides an international scientific forum for spine professionals to stay up-to-date on emerging new technologies and techniques. For three days, spine surgeons and other allied health professionals from around the world discuss, debate, and demonstrate recent advances in spine surgery.
About NuVasive
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $8.7 billion global spine market.
NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company’s principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS provides safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
Having pioneered the lateral approach to spine fusion, NuVasive continues to be at the forefront of the spine industry’s shift toward less invasive solutions. The Company’s dedication to innovation continues to spawn game-changing technology such as the XLIF Decade™ plate for single-approach fixation through a lateral incision, the PCM® motion-preserving disc for the cervical spine, XLIF® Corpectomy for tumor and trauma, and the Armada® posterior fixation system, which treats adult degenerative scoliosis in a less invasive fashion. The Company has also developed procedurally integrated solutions that completely redefine and improve upon traditional techniques like TLIF, PLIF, Posterior Fixation, and ALIF. NuVasive solutions are increasingly being adopted internationally, as the Company lays the groundwork to continue growing as a global business and to offer industry-leading, Absolutely Responsive customer service to surgeons worldwide. NuVasive is focused on becoming a $1 Billion Start-up™; taking market share by maintaining a commitment to Superior Clinical Outcomes, Speed of Innovation, and Absolute Responsiveness®.
About Our Products and Procedures
Spine surgeries carry inherent risks and potential complications, which should be discussed between patient and surgeon. Complications vary in severity, including the possibility of death, and can result from surgery in general (e.g., infection or bleeding requiring transfusion), from the approach to the pathology (e.g., vascular, organ or other soft-tissue injury, or injuries to the motor or sensory nerves), spine surgery related complications (e.g., re-operation required for malpositioned hardware or inadequate decompression) and medical related issues (e.g., due to other co-morbidities such as diabetes, heart disease, lung disease, use of steroids, and/or smoking).
Complications can also manifest later in the postoperative period, which may require additional procedures (e.g., delayed wound healing, infection, migration or failure of the implants, fracture or settling of the bone, failed fusion).
The XLIF procedure, like any other surgical procedure, is not without risks. Possible complications include, but are not limited to: persistent pain, infection, muscle weakness, vascular injury (injury of the blood vessels), neurologic (nerve or spinal cord) injury, urinary tract infection, stroke, pneumonia, deep vein thrombosis (clotting), and further progression of existing spinal disease. In general, however, complications are uncommon. A discussion detailing all potential risks of the XLIF procedure, or any procedure, should take place between patient and physician.
It is important to reiterate that planning for spine surgery should include detailed discussion between patient and surgeon concerning potential complications associated with current spine surgery treatment options.
The information provided in this press release is for general educational information only. Information you read in this press release cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical advice as part of this press release. You should also talk to your healthcare professional for diagnosis and treatment.
NuVasive cautions you that statements included in this press release or during IMAST that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s minimally disruptive surgical products by spine surgeons, development and acceptance of new products or product enhancements, expansion of our network of sales representatives, and the other risks and uncertainties described in NuVasive’s press releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
Investor Contact:
Tina Jacobsen
NuVasive, Inc.
858-320-5215
Email Contact
Media Contact:
Kristine Simmons
NuVasive, Inc.
858-361-9536
Email Contact
(AMOV) selects Alcatel-Lucent’s LTE overlay technology for its 4G rollout in the Dominican Republic
Claro subsidiary to provide access to new services subscribers demand
PARIS, July 9, 2014 — America Movil, the world’s third largest wireless service provider, has selected Alcatel-Lucent (Euronext Paris and NYSE: ALU) to rollout a 4G LTE network in the Dominican Republic.
Alcatel-Lucent is supplying the America Movil subsidiary Claro Dominican Republic with its 4G LTE network overlay solution, enabling faster deployment of ultra-broadband mobile access services including high-definition video and video-on-demand, 10 times-faster high-speed navigation, high definition videoconferencing and online gaming.
The new 4G LTE overlay network, the latest stage in America Movil’s Latin American 4G rollout, will cover most of the Dominican Republic’s territory and serve up to 80% of its population.
The first stage of the deployment, which is already operational, includes coverage of the major cities in the country.
Key Facts:
- Deployment of Alcatel-Lucent’s 4G LTE overlay solution includes Alcatel-Lucent’s LTE Radio Access Network, 9471 Wireless Mobility Manager, and the 5620 Service Aware Manager (SAM).
- The network is part of America Movil’s 4G LTE Latin American rollout, which began with Claro Puerto Rico in 2012.
- Earlier this year Alcatel-Lucent and America Movil announced an end-to-end 4G LTE overlay deployment with Claro Uruguay.
Quotes:
Omar Acosta, Claro Dominican Republic Marketing Director, said: “With the deployment of our new 4G LTE network, we are definitely ready to make an evolution in the services we offer our customers. Dominicans can now enjoy multiple benefits of the highest mobile broadband speed, in the largest and strongest network of our country. We are pleased to count on an experienced and high-class supplier such as Alcatel-Lucent to help us in this project.”
Javier Rey, Alcatel-Lucent Sales Vice President in charge of the America Movil account, said: “By awarding us this new market, along with the ones with Claro Puerto Rico and Claro Uruguay, Alcatel-Lucent has become a strategic LTE supplier with one of the world’s top service providers and is a great opportunity to become a trusted partner throughout the region. We look forward to additional deployments in this region as frequencies become available.”
About Claro
CLARO Dominican Republic is a subsidiary of America Movil, S.A.B. de C.V. BMV: AMX [NYSE: AMX]. [NASDAQ: AMOV] [LATIBEX: XAMXL], the leading provider of telecommunications services in Latin America, with business in 16 countries of the American continent.
Claro Dominican Republic is the leading telecommunications full service provider in the country, with the largest and most efficient network on the market, over which their customers are able to enjoy high-end handsets functionalities and innovative services such as video calls and broadband. It is also the only company that offers a digital television service over Internet Protocol (IPTV). Its almost 6 million customers in the country makes it the industry leader. More information available at www.claro.com.do
The brand Claro is present in Argentina, Brasil, Chile, Colombia, Costa Rica, Republica Dominicana, Ecuador, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Paraguay, Peru, Puerto Rico and Uruguay
ABOUT ALCATEL-LUCENT (EURONEXT PARIS AND NYSE: ALU)
We are at the forefront of global communications, providing products and innovations in IP and cloud networking, as well as ultra-broadband fixed and wireless access to service providers and their customers, and to enterprises and institutions throughout the world. Underpinning us in driving the industrial transformation from voice telephony to high-speed digital delivery of data, video and information is Bell Labs, an integral part of the Group and one of the world’s foremost technology research institutes, responsible for countless breakthroughs that have shaped the networking and communications industry. Our innovations have resulted in our Group being recognized by Thomson Reuters as a Top 100 Global Innovator, as well as being named by MIT Technology Review as amongst 2012’s Top 50 “World’s Most Innovative Companies”. We have also been recognized for innovation in sustainability, being named Industry Group Leader in the Technology Hardware & Equipment sector in the 2013 Dow Jones Sustainability Indices review, for making global communications more sustainable, affordable and accessible, all in pursuit of the Group’s mission to realize the potential of a connected world.
With revenues of Euro 14.4 billion in 2013, Alcatel-Lucent is listed on the Paris and New York stock exchanges (Euronext and NYSE: ALU). The company is incorporated in France and headquartered in Paris.
For more information, visit Alcatel-Lucent on: http://www.alcatel-lucent.com, read the latest posts on the Alcatel-Lucent blog http://www.alcatel-lucent.com/blog and follow the Company on Twitter: http://twitter.com/Alcatel_Lucent.
(GSIT) Commencement of a $25 Million Modified Dutch Auction Tender Offer
SUNNYVALE, CA–(Jul 9, 2014) – GSI Technology, Inc. (NASDAQ: GSIT) (the “Company”) announced today that it is commencing a modified “Dutch auction” self-tender offer to repurchase for cash shares of its common stock up to an aggregate purchase price of $25 million. The tender offer begins today, July 9, 2014, and will expire at 5:00 p.m., New York City time, on August 6, 2014, unless extended or earlier terminated by the Company. Under the terms of the proposed tender offer, the Company’s stockholders will have the opportunity to tender some or all of their shares at a price within the range of $6.50 to $6.70 per share.
A modified “Dutch auction” self-tender allows stockholders to indicate how many shares and at what price within the Company’s specified range (in increments of $0.10 per share) they wish to tender. Based on the number of shares tendered and the prices specified by the tendering stockholders, the Company will determine the lowest per share price within the range of tenders that will enable the Company to buy $25 million in shares, or such lower amount depending on the number of shares that are properly tendered and not properly withdrawn. All shares accepted for payment will be paid the same price, regardless of whether a stockholder tendered such shares at a lower price within the range. If the tender offer is fully subscribed, then shares of common stock having an aggregate purchase price of $25 million will be purchased, representing approximately 13.6 percent to 14.0 percent of the Company’s issued and outstanding shares as of June 30, 2014, depending on the purchase price payable for those shares pursuant to the tender offer.
The Company will use a portion of its available cash to fund the repurchase of shares in the tender offer. The tender offer is not conditioned upon obtaining financing or any minimum number of shares being tendered; however, the tender offer is subject to a number of other terms and conditions, which are specified in the offer to purchase.
The offer to purchase, the related letter of transmittal and the other tender offer materials will be mailed to the Company’s stockholders shortly. Stockholders should read those materials carefully when they become available because they will contain important information, including the terms and conditions of the tender offer. The Company’s directors and executive officers have advised the Company that they do not intend to tender their shares in the tender offer.
While the Company’s Board of Directors has approved the making of the tender offer, none of the Company, its Board of Directors, the dealer manager, the depositary, or the information agent make any recommendation to any stockholder as to whether to tender or refrain from tendering any shares or as to the price or prices at which stockholders may choose to tender their shares. The Company has not authorized any person to make any such recommendation. Stockholders must decide whether to tender their shares and, if so, how many shares to tender and at what price or prices. In doing so, stockholders should carefully evaluate all of the information in the offer to purchase, the related letter of transmittal, and the other tender offer materials, when available, before making any decision with respect to the tender offer, and should consult their own financial and tax advisors.
Needham & Company will serve as the dealer manager for the tender offer. The information agent for the tender offer is MacKenzie Partners, Inc., and the depositary is Computershare. Stockholders who have questions or would like additional copies of the tender offer documents, when available, may call the information agent at (800) 903-3268. Banks and brokers may call (212) 929-5500.
About GSI Technology
Founded in 1995, GSI Technology, Inc. is a leading provider of high-performance static random access memory, or SRAM, products primarily incorporated in networking and telecommunications equipment. Headquartered in Sunnyvale, California, GSI Technology is ISO 9001 certified and has worldwide factory and sales locations. For more information, please visit www.gsitechnology.com.
Tender Offer Statement
This press release is for informational purposes only and is neither an offer to buy nor the solicitation of an offer to sell, any shares of the Company’s common stock. The tender offer will be made only pursuant to the offer to purchase, the related letter of transmittal and the other tender offer materials, which will be mailed to stockholders upon commencement of the tender offer. Stockholders should read the offer to purchase, the related letter of transmittal and the other tender offer materials carefully when they become available because they will contain important information, including the terms and conditions of the tender offer and complete instructions on how to tender shares of the Company’s common stock. The Company is filing a Tender Offer Statement on Schedule TO with the Securities and Exchange Commission (the “SEC”) that includes the offer to purchase, the related letter of transmittal and the other tender offer materials. Stockholders may obtain free copies of the offer to purchase the related letter of transmittal and the other tender offer materials once filed with the SEC at the SEC’s website at www.sec.gov
Forward-Looking Statements
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding GSI Technology’s expectations, beliefs, intentions, or strategies regarding the future. All forward-looking statements included in this press release are based upon information available to GSI Technology as of the date hereof, and GSI Technology assumes no obligation to update any such forward-looking statements. Forward-looking statements involve a variety of risks and uncertainties, which could cause actual results to differ materially from those projected. These risks include the possibility that stockholders may not elect to tender their shares in the tender offer; the risk that one or more conditions to the completion of the tender offer (as set forth in the offer to purchase) will not be satisfied; and the risk of adverse developments or changes in the securities markets. Further information regarding other risks relating to GSI Technology’s business is contained in the Company’s filings with the Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in such filings.
GSI Technology, Inc.
Douglas Schirle
Chief Financial Officer
408-331-9802
(RICK) Announces 3Q14 Club & Restaurant Sales
– Total Club & Restaurant Sales Hit Record $33.1 Million – Up 18.3% Year over Year – Same Store Sales Up 5.1% Year over Year
HOUSTON, July 8, 2014 — Rick’s Cabaret International, Inc. (NasdaqGM: RICK) today announced total sales at adult clubs and sports bar/restaurants for the third fiscal quarter ended June 30, 2014. The figures do not include the Company’s internet or media divisions. The Company also announced legal settlements reached during 3Q14. Rick’s expects to announce 3Q14 results on August 11, 2014.
Sales
- 3Q14 total adult club and sports bar/restaurant sales hit a record $33.1 million, up 18.3% from $27.9 million in the year ago quarter. There were 43 units versus 37 in the year ago quarter. Sales were positively impacted by the performance of adult clubs acquired and sports bar/restaurants launched within the past year, as well as sales growth at existing adult clubs.
- 3Q14 same store sales were $28.9 million, up 5.1% from $27.5 million in the year ago quarter. Nearly all of major brands showed year over year improvement, with the primary exception of three out of the four Club Onyx units. New Club Onyx format and management changes, however, have significantly reduced the percentage year over year revenue decline compared to previous quarters this fiscal year. Excluding Onyx units, same store sales would have been up 6.9%.
- 3Q14 total sales benefited from a full quarter of the new Vivid Cabaret New York adult club in Manhattan and the new Bombshells sports bar/restaurant in Webster, TX, and initial revenues from the late June opening of a Bombshells in Austin, TX. Sales at adult clubs open more than a year continued to reflect the success of Rick’s post-recession strategy of increasing patronage from bigger ticket, higher margin customers.
- For the nine months ended June 30, 2014, total club and restaurant sales of $94.7 million increased 14.0% year over year and same store sales increased 1.5% to $82.4 million.
Legal Settlements
In May, Rick’s estimated $2-$3 million in higher pre-opening and legal costs across 3Q14 and 4Q14, reflecting in part the Company’s strategy to settle a number of lawsuits. Today, Rick’s is announcing that it has settled several of these lawsuits, as well as other small claims. This will result in approximately $3.2 million in one-time legal charges in 3Q14. The settlements include:
- A dispute over the name “Ricky Bobby’s” for one of Rick’s restaurants. The settlement cost $20,000. Rick’s will change the name of the establishment to “Pole Position Sports Saloon and Restaurant.”
- A major dram shop case. Dram shop liability refers to the body of law governing the liability of taverns, liquor stores and other commercial establishments that serve alcoholic beverages. To offset the cost, Rick’s plans to file for reimbursement from the court overseeing the dissolution of Rick’s former insurance company.
- All claims from the State of Nevada over taxes related to Rick’s former Las Vegas adult club.
In addition, Rick’s is announcing that pre-opening costs should total approximately $195,000 in 3Q14.
CEO Comment
Eric Langan, President and CEO, commented, “We are very pleased with our overall sales performance as well as our ability to settle these lawsuits and claims generally in line with our plans.
“In accordance with our guidance, club and restaurant sales continued to grow in 3Q14 instead of falling off from the seasonally large 2Q14. We continue to be excited about the potential for our new Vivid Cabaret, which was No. 3 in sales for the third quarter, and its positive effect on our flagship Rick’s Cabaret New York, where sales increased more than 6% year over year. Men’s Mag Daily (http://mensmagdaily.com/) recently named Rick’s Cabaret in Manhattan as the ‘Best Gentlemen’s Club in New York.’ Meanwhile, Club Onyx units are starting to improve. And we continue to see great potential for our restaurants, which represented close to 8% of 3Q14 total sales.
“Looking ahead, 4Q14 should benefit from a full quarter of the new Bombshells in Austin, and, assuming schedules stay on track, the opening sometime during the quarter of a Rick’s Cabaret in Odessa, the capital of fracking in Texas, and two new Bombshells in the Houston area.”
About Rick’s Cabaret
With 43 units, Rick’s Cabaret International, Inc. (NasdaqGM: RICK) is the leading hospitality company operating adult gentlemen’s clubs and sports bar/restaurants in the US. Adult clubs in New York City, Los Angeles, Miami, Philadelphia, Charlotte, Dallas/Ft. Worth, Houston, Minneapolis, Indianapolis and other cities operate under brand names such as “Rick’s Cabaret,” “XTC,” “Club Onyx,” “Vivid Cabaret,” “Jaguars” and “Tootsie’s Cabaret.” Sports bar/restaurants, which also feature live entertainment, operate under the brand names “Bombshells” and “Pole Position.”
For More Information
- Web: http://www.ricksinvestor.com
- Twitter: https://twitter.com/rickscabaretinc
- Facebook: https://www.facebook.com/rickscabaretintl
Forward-looking Statements
This press release may contain forward-looking statements that involve a number of risks and uncertainties that could cause the company’s actual results to differ materially from those indicated in this press release, including the risks and uncertainties associated with operating and managing an adult business, the business climates in cities where it operates, the success or lack thereof in launching and building the company’s businesses, risks and uncertainties related to the operational and financial results of our Web sites, conditions relevant to real estate transactions, and numerous other factors such as laws governing the operation of adult entertainment businesses, competition and dependence on key personnel. Rick’s has no obligation to update or revise the forward-looking statements to reflect the occurrence of future events or circumstances.
(TISA) to Acquire U.S.-Based Cloud Software and Solutions Company eGistics
NEW YORK and TEL AVIV, Israel, July 8, 2014 — Top Image Systems, Ltd. (Nasdaq:TISA)
Acquisition to deliver on numerous TIS strategic growth initiatives:
- Reinforce growth of TIS Americas via additional U.S. office and tripling of U.S. headcount to over 65
- Extend cloud and SaaS capabilities
- Bring major customers including 4 of top 5 U.S. banks
- Expand addressable market opportunity through alignment of complementary product offerings
- Enable new solutions and increase subscription-based revenues by combining the TIS eFLOW® platform and mobile imaging functionalities with the eGistics product line
Transaction to provide meaningful financial benefits:
- eGistics 2013 revenues of $10.6 million, added to TIS 2013 revenues of $29 million
- Enhance pro forma profitability as eGistics realized 2013 EBITDA of $1.52 million
- Grow subscription-based revenue from predominantly SaaS transactions; increase visibility thanks to recurring revenue reaching 49% of pro forma 2013 revenues
- Increase TIS Americas revenues to 38% of pro forma 2013 revenues, diversifying TIS global revenue streams
- Expect increase in TIS non-GAAP earnings per share in 2014 and beyond due to this transaction, which is expected to be accretive
Top Image Systems, Ltd. (Nasdaq:TISA), a leading Enterprise Content Management (ECM) and Business Process Management (BPM) solutions and Mobile Imaging Platform (MIP) provider, today announced that it has signed a definitive agreement to acquire eGistics, a leading privately-owned provider of cloud-based solutions to the banking and payments market, in a transaction valued at approximately $18 million. Under the terms of the agreement, TIS will pay for the acquisition 50% in cash and 50% in TIS shares. The acquisition, which is subject to customary closing conditions, is expected to close in Q3.
Based in Dallas, Texas, eGistics provides advanced image and data solutions that enable business process automation by optimizing the storage, management and delivery of business-critical information across a wide range of applications. The iRemit remittance management portal, available via the CloudDocs platform, is a smart process application that enables remittance processing in the cloud. The data is processed and stored in the secure, on-demand cloud-based CloudDocs framework, which offers world-class physical and cyber security, utilizing multiple encryption technologies and best-in-class intrusion detection.
“This is a milestone acquisition for Top Image Systems, as it creates a compelling combination from strategic, geographic, technological and financial perspectives,” said Izhak Nakar, Top Image Systems Founder & Executive Chairman. “Not only will this immediately accretive acquisition accelerate our growth rate and add incremental profitability, but it will also expand our addressable market, accelerate our aggressive expansion in the United States, and add a world class installed base of major U.S. customers to whom we can cross-sell a more comprehensive solution, including our high-growth mobile apps. Four of the five top banks in the U.S., two of the largest remittance processors and several leading U.S. enterprises already trust eGistics for cloud-based document and data management solutions.”
Cloud-based Solutions that Complement TIS Offerings
A key driver for the acquisition was eGistics’ secure and compliant cloud infrastructure, which aligns with TIS’ cloud-centric growth strategy. TIS will leverage eGistics’ cloud-based on-demand CloudDocs infrastructure to roll out on-demand smart processing applications for processes such as Invoice Processing, Digital Mailroom, BillPay, Account Opening, Enrollment, Mortgage Processing and Employee Onboarding (HR), all in the cloud. Following the acquisition, TIS will extend its software portfolio to include additional smart process applications for banking and payment processing, while in parallel offering eFLOW INVOICE, Digital Mailroom and TIS mobile imaging applications to the existing eGistics’ customer base. These cloud-based applications will further promote TIS’ mobile imaging solutions by easily integrating them with the CloudDocs infrastructure, where TIS will host eFLOW for efficient backend processing.
“This transaction will also provide TIS with an additional distribution vehicle for offering our native mobile capture applications to large U.S. financial institutions which we did not have before, creating a significant business opportunity,” explains Michael Schrader, TIS COO. “A key strength and differentiator for TIS’ flagship eFLOW platform is its ability to be quickly and easily configured and integrated with a large number of ERP, CRM and line-of-business applications. The acquisition of eGistics will strengthen this competitive advantage, augmenting our ability to develop powerful, on-demand smart process applications with embedded mobile capture functionality on the eFLOW platform within a stable and secure cloud-based environment. We see the intelligent data recognition market moving to the cloud, and our vision is to leverage the broad availability of the cloud platform to bring these capabilities to many more clients by providing them with full end-to-end cloud-based solutions that combine simplified capture operations, transaction-based pricing and significantly reduced implementation efforts. This acquisition begins to make this vision a reality, creating a formidable technological advantage for TIS going forward.”
“Not only does eGistics share a synergistic customer base with TIS, but also a common technology stack that we can build upon to further revenue growth for the combined company,” commented Robert Lund, Chairman and Chief Executive Officer of eGistics. “The companies share a vision of creating both horizontal and vertical-based smart applications that optimize the capture, classification, validation, storage, management and delivery of business-critical information.”
“We are excited about the combination of eGistics’ cutting-edge cloud platform and blue chip clients in the U.S. financial sector with TIS’ best-in-class enterprise capture and workflow solutions, mobile imaging portfolio and diverse global installed base,” stated Don Dixon, a member of the eGistics Board of Directors and Managing Director and Co-Founder of Trident Capital, the largest shareholder of eGistics. “We believe the combination will have a very positive reception within the eGistics customer base and in the marketplace.” Following the closing of the transaction, Mr. Dixon will become a member of the TIS Board of Directors.
Strengthens TIS Presence in Strategically Important U.S. Market
The acquisition of eGistics will significantly expand TIS’ presence in the U.S. The combined company expects to grow revenues by cross-selling native solutions to the existing installed base. In addition, the combination will expand the physical presence of TIS in the United States, adding an office in Dallas and growing its U.S. based headcount to over 65.
“As a result of this powerful strategic combination, TIS Americas will be the largest business unit in terms of revenues,” added Mr. Nakar. “Reinforcing our commitment to growing our presence in the U.S. market, the acquisition significantly accelerates this important strategic initiative, giving us tremendous talent, two offices, and a more comprehensive suite of offerings to cross-sell to a broad installed base.”
Canaccord Genuity acted as exclusive financial advisor to Top Image Systems in connection with the transaction and Needham & Company acted as financial advisor to eGistics. Schwell Wimpfheimer & Associates LLP and Choate Hall & Stewart LLP acted as legal advisors to Top Image Systems and Wilson Sonsini Goodrich & Rosati acted as legal advisor to eGistics.
About eGistics, Inc.
eGistics is a leading provider of private cloud solutions that streamline payments business processes. The eGistics private cloud solution automates the capture, management and delivery of documents and data in a highly secure, highly scalable and compliant environment. Today, the eGistics private cloud solution supports paper and electronic transaction processes for many of the largest financial institutions and third-party processors in the U.S. To learn more, visit www.egisticsinc.com.
About Top Image Systems
Top Image Systems™ (TIS™) Ltd. is a leading innovator of enterprise solutions for managing and validating content entering organizations from various sources. Whether originating from mobile, electronic, paper or other sources, TIS’ solutions deliver content across enterprise applications. TIS’ eFLOW Platform is a common platform for the company’s solutions which is marketed in more than 40 countries through a multi-tier network of distributors, system integrators, value-added resellers and strategic partners. Visit the company’s website at http://www.TopImageSystems.com for more information.
Caution Concerning Forward-Looking Statements
Certain matters discussed in this news release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results expressed or implied in those forward looking statements. Words such as “will,” “expects,”, “anticipates,” “estimates,” and words and terms of similar substance in connection with any discussion of future operating or financial performance identify forward-looking statements. These statements are based on management’s current expectations or beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially including, but not limited to, the satisfaction of the closing conditions in the acquisition agreement, the timing of the closing of the acquisition, the ability to retain the customers, employees and business relationships of eGistics after the closing, risks in product development, approval and introduction plans and schedules, rapid technological change, customer acceptance of new products, the impact of competitive products and pricing, the lengthy sales cycle, proprietary rights of TIS and its competitors, risk of operations in Israel, government regulation, litigation, general economic conditions and other risk factors detailed in the Company’s most recent annual report on Form 20-F and subsequent filings with the United States Securities and Exchange Commission. We are under no obligation to, and expressly disclaim any obligation to, update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: TIS Company Press Contact: Randy Davis eGistics, Inc. rdavis@egisticsinc.com +1 214 256 4635 TIS Company Press Contact: Shelli Zargary Director of Corporate Marketing and Investor Relations, Top Image Systems Ltd. shelli.zargary@topimagesystems.com +972 3 767 9114 TIS Investors: James Carbonara Regional Vice President, Hayden IR james@haydenir.com + 1 646 755 7412
(NEO) Completes Acquisition of Path Logic
Adds Specialized Anatomic Pathology Services
FORT MYERS, Fla., July 8, 2014 — NeoGenomics, Inc. (NASDAQ: NEO),a leading provider of cancer-focused genetic testing services, today announced that it has acquired Path Labs, LLC d/b/a Path Logic. Path Logic is a leading provider of specialized anatomic pathology services to Hospitals and physicians in Northern California. Path Logic provides high-quality Anatomic Pathology services with significant expertise in the sub-specialties of renal pathology, dermatopathology, women’s health and gastrointestinal and genitourinary pathology.
For 2013, Path Logic reported revenue of approximately $10 million and employed approximately 65 people. The acquisition purchase price was $6.0 million. The transaction includes Path Logic’s main laboratory in West Sacramento, California as well as satellite facilities in Santa Ana and Fresno California. Path Logic will operate as a wholly-owned subsidiary of NeoGenomics to provide specialized anatomic pathology services for NeoGenomics’ clinical trials and pathology clients across the country.
Douglas M. VanOort, NeoGenomics Chairman and CEO, commented, “Path Logic has earned a reputation as one of the highest quality Anatomic Pathology Laboratories in California. The staff of outstanding specialized Pathologists, with capabilities in Dermatopathology, Nephropathology, Women’s Health and GI/GU Pathology will further build and diversify NeoGenomics’ specialized testing as a ‘one-stop shop’ for highly specialized AP testing services. With this expanded capability, both our clinical trial clients and our hospital and pathology-based clients will have access to an expanded product line and consulting expertise.”
Mr. VanOort continued, “We estimate that $3-4 million of revenue synergies can be realized in relatively short order as a result of our existing customers and Path Logic’s customers having access to each other’s testing menus and capabilities. In addition, as redundant costs are eliminated during the remainder of this year, we expect the acquisition of Path Logic to be accretive to our earnings within six months.”
About NeoGenomics, Inc.
NeoGenomics, Inc. is a high-complexity CLIA–certified clinical laboratory that specializes in cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry. The company’s testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology and molecular genetic testing. Headquartered in Fort Myers, FL, NeoGenomics has labs in Nashville, TN, Irvine, CA, Tampa, FL and Fort Myers, FL. NeoGenomics services the needs of pathologists, oncologists, other clinicians and hospitals throughout the United States. For additional information about NeoGenomics, visit http://www.neogenomics.com.
Interested parties can also access investor relations material from Hawk Associates at http://www.hawkassociates.com or neogenomics@hawk.com and from Zack’s Investment Research at http://www.zacks.com or scr@zacks.com.
Forward Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements. These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward looking statements, Actual results could differ materially from such statements expressed or implied herein. Factors that might cause such a difference include, among others, the company’s ability to continue gaining new customers, offer new types of tests, and otherwise implement its business plan. As a result, this press release should be read in conjunction with the company’s periodic filings with the SEC.
(LTS) Acquires Dalton Strategic Investment Services
Securities America, a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE MKT: LTS), has announced that Dalton Strategic Investment Services Inc. in Knightstown, Ind., has become a branch of the independent broker-dealer. Dalton Strategic Investment Services has approximately 60 advisors in 18 states and $950 million in client assets.
“This business has become increasingly challenging for smaller broker-dealers,” said Jim Nagengast, Securities America chief executive officer and president. “We welcome the advisors from Dalton Strategic Investment Services and look forward to helping them grow through our expertise in advisory business, retirement income planning, practice management and technology.”
Steve Dalton, who founded Dalton Strategic Investment Services in 1988, said the company intends to wind down operations and that most of its advisors, who collectively generate about $7 million in annual revenue, have moved to Securities America.
“We evaluated 10 other broker-dealers before choosing Securities America as the right partner for our future success,” Dalton said. “The cultural fit, technology and practice management support Securities America provides will help us grow our business and develop our advisors, and serve as a strong value proposition for recruiting additional advisors.”
Securities America has partnered with several smaller broker-dealers in recent years to help them become super branches with the company. In 2013, Securities America added 30 advisors from Eagle One Investments in Washington, Iowa. In 2012, the company transitioned 140 advisors from Investors Security Company Inc. In 2010, the company transitioned 45 advisors from Equitas and 40 from ePlanning. In 2009, Securities America acquired broker-dealer Brecek & Young Associates from Security Benefit Corp., adding 260 advisors.
“Through our extensive experience in collaborating with small firms, Securities America has developed meticulous processes and automation specifically for creating a smooth transition experience for the advisors,” Nagengast said. “Our conversations with smaller BDs have increased, and we are looking for additional opportunities in this space. These firms most often cite compliance costs, technology costs and business development as their reasons to consider joining a larger broker-dealer. Securities America excels in all of these areas, with a customer-focused culture that advisors find familiar and comfortable.”
About Securities America
Securities America is one of the nation’s largest independent broker-dealers with more than 1,800 independent advisors responsible for $54 billion in client assets.
Advisory services offered through Securities America Advisors, Inc., an SEC Registered Investment Advisory Firm. Securities offered through Securities America, Inc., member FINRA/SIPC. Securities America is not affiliated with any other entity named.
(GBIM) Closing of IPO and Full Exercise of Underwriter’s Overallotment Option
LOUISVILLE, Colo., July 8, 2014 — GlobeImmune, Inc. (Nasdaq:GBIM), today announced the closing of its previously announced initial public offering of 1,725,000 shares of its common stock at a price to the public of $10.00 per share, which includes 225,000 shares of common stock sold pursuant to the full exercise of the underwriter’s overallotment option. The gross proceeds to GlobeImmune from the initial public offering were $17,250,000, before deducting underwriting discounts and commissions and other offering expenses. Shares of GlobeImmune, Inc. trade on the NASDAQ Capital Market under the ticker symbol “GBIM.”
Aegis Capital Corp. acted as sole book-running manager for the offering.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 1, 2014. The offering was made by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, via telephone: 212-813-1010, or via e-mail: prospectus@aegiscap.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
CONTACT: GLOBEIMMUNE CONTACT: Timothy C. Rodell, M.D. Chief Executive Officer and President T: 303-625-2820 information@globeimmune.com INVESTOR CONTACT: Susan Noonan S.A. Noonan Communications, LLC T: 212-966-3650 susan@sanoonan.com MEDIA CONTACTS: Lena Evans or Tony Russo, Ph.D. Russo Partners LLC T: 212-845-4262 or 212-845-4251 lena.evans@russopartnersllc.com tony.russo@russopartnersllc.com
(NURO) FDA Clears Wearable Technology for Over-the-Counter Use
NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its wearable technology for treatment of chronic pain received 510(k) clearance (K140333) from the U.S. Food and Drug Administration (FDA) for over-the-counter use.
The Company is in late stage development of a consumer oriented chronic pain treatment product. The device is based on wearable technology, presently deployed in the Company’s SENSUS® Pain Management System, that utilizes comfortable, non-invasive electrical stimulation of sensory nerves to induce safe and effective pain relief. It is lightweight and can be worn during the day while active, and at night while sleeping. This 510(k) clearance allows the Company to market the over-the-counter device through retail distribution channels without a prescription requirement.
“Patient response to SENSUS, our prescription wearable device for treatment of chronic pain, has been very positive since it was launched in early 2013. We believe that there is a substantial consumer market for an over-the-counter version of this technology,” said Shai N. Gozani, M.D., Ph.D., President and Chief Executive Officer of NeuroMetrix. “The ability to offer both prescription and over-the-counter products will give us maximal market exposure and allow us to reach more people with chronic pain. We anticipate a commercial launch in 2015.”
About NeuroMetrix
NeuroMetrix is an innovative health-care company that develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders. The Company has a major focus on diabetic neuropathies, which affect over 50% of people with diabetes. If left untreated, diabetic neuropathies trigger foot ulcers that may require amputation and cause disabling chronic pain. The annual cost of diabetic neuropathies has been estimated at $14 billion in the United States. The Company markets the SENSUS device for treating chronic pain, focusing on physicians managing patients with neuropathic pain such as painful diabetic neuropathy. The Company also markets DPNCheck®, which is a rapid, accurate, and quantitative point-of-care test for peripheral neuropathies such as diabetic neuropathy. This product is used to detect neuropathies at an early stage and to guide treatment. For more information, please visit http://www.SENSUSRx.com or http://www.NeuroMetrix.com.
(KNDI) JV, $31.8M Energy Vehicle Subsidies From Chinese Central Government
JINHUA, China, July 7, 2014 — Kandi Technologies Group, Inc. (the “Company” or “Kandi”) (Nasdaq:KNDI), today announced that the manufacturing subsidiary of Kandi Brand electric vehicles, Kandi Electric Vehicles Group Co., Ltd. (the “JV Company”) has received a national subsidy of RMB197 million (approximately US$31.8 million) for sales of over 3,000 Electric Vehicles (“EVs”) between June and December in 2013 and sales of over 1,000 EVs during the first quarter of 2014. The subsidy payment includes the 2013 year-end subsidy and advance subsidy payment for the first quarter of 2014. The JV Company is a 50/50 joint venture between Kandi and Shanghai Maple Guorun Automobile Co., Ltd., a 99% owned subsidiary of Geely Automobile Holdings Ltd., one of China’s largest automakers.
Additionally, the city of Hangzhou, where the Company has launched its innovative short-term EV rental and long-term EV leasing program, is expected to announce its local subsidy policy for new energy vehicles in the near future.
Mr. Hu Xiaoming, Chairman and Chief Executive Officer of Kandi, commented, “This first subsidy payment to the JV Company will greatly benefit Kandi and will permit the Company to accelerate both EV sales and the implementation of existing EV programs, while expanding the development of potential EV projects in other major Chinese cities.”
Mr. Hu continued, “The recently published Notice of ‘Continuous Promotion and Application of New-Energy Vehicles,’ issued by The Ministry of Finance, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, and the National Development and Reform Commission (the “Four Ministries”), has again demonstrated a renewed focus by the central government on providing subsidies to new energy vehicle manufacturers. According to the Notice, the Central government makes advance subsidy payments directly to the manufacturers upon the agencies’ review and approval of subsidy payment applications submitted by manufacturers at the end of April, July and October each year, and settles payments annually. We are confident the increased frequency of subsidy payments under the new payment schedule will help improve our cash flow and profitability, while we speed up our growth plan to become the leading pure EV manufacturer and solution provider in China.”
About Kandi Technologies Group, Inc.
Kandi Technologies Group, Inc. (Nasdaq:KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicles. Kandi has established itself as one of the world’s largest manufacturers of pure electric vehicles (EVs), Go-Kart vehicles, and tricycle and utility vehicles (UTVs), among others. More information can be viewed at its corporate website is http://www.kandivehicle.com. Kandi routinely posts important information on its website.
Safe Harbor Statement
This press release contains certain statements that may include “forward-looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on the SEC’s website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CONTACT: Kandi Technologies Group, Inc. Ms. Kewa Luo Phone: 1-212-551-3610 Email: IR@kandigroup.com
(MARK) Joshua Fruhlinger Joins Remark Media To Run Content Division
LAS VEGAS, July 7, 2014 — Remark Media, Inc. (Nasdaq: MARK) (“Remark Media” or the “Company”), today announced that veteran content executive Joshua Fruhlinger has joined Remark Media to run the rapidly-growing firm’s content operations. He was previously Head of Digital at TMZ and, previous to that, was Editorial Director for AOL Tech, where he oversaw operations at Engadget, Joystiq, and TUAW.
Fruhlinger joins Remark Media during a period of rapid growth. Remark Media owns multiple lifestyle channels which include health & wellness, travel, fashion, and sports verticals.
“Remark’s content properties are poised to become number-one destinations in all of their verticals,” Fruhlinger says. “The talent is in place and more is anticipated. The publishing technology is top-notch. I can’t think of a better place for me at this stage in my career. This is going to be fun. In the future you’ll hear us mentioned in the same breath as Gawker, Vox, even AOL and Yahoo.”
Joshua will join CEO Kai-Shing Tao along with a talented crew of executives and content producers. “We are excited to have Joshua join the Remark Media team,” says Tao. “He brings a combination of distinguished digital content experience with a strong entrepreneurial spirit that is very core to our culture. He will immediately help build our current content portfolio as well as future brands as we continue to target the 18-34 year old demographic.”
While at TMZ, Fruhlinger oversaw digital content and production operations. During his tenure there, he created 13 new content franchises, overhauled the news organization’s publishing workflow, and ultimately saw a 25% increase in digital engagement across web and mobile. Previous to that, he helmed AOL’s technology new organization, where he helped the company not only grow audience but also monetize content while maintaining editorial integrity at the world’s top technology news destinations. He also contributes regularly to the Wall Street Journal and GQ.
About Remark Media
Remark Media, Inc. (Nasdaq: MARK) is a global media company that owns and operates a portfolio of assets focused on the 18-to-34-year-old (otherwise known as “The Millennials” or “Gen Y”) demographic across a variety of lifestyle verticals. These include fashion, sports, travel, entertainment, health and wellness, personal finance, and informational know-how.
Remark Media’s assets presently include: (i) Bikini.com, an aspirational lifestyle and ecommerce destination for the beach globetrotter; (ii) Roomlia, a mobile hotel booking app that provides a superior user travel experience while balancing the needs of hotel owners; (iii) HowStuffWorks China and Brazil, locally known as BoWenWang and Comotudofunciona, respectively; (iv) PPTV Boxing, the first ever digital boxing channel in China launched in partnership with PPTV, China’s largest leading online TV service; and (v) Banks.com, US Tax Center at www.irs.com, FileLater.com, and TaxExtension.com, a suite of digital sites focused on personal finance. Additionally, Remark Media is a founding partner and equity owner of Sharecare, Inc. Created by Jeff Arnold, founder of WebMD, and Dr. Mehmet Oz, in partnership with Harpo Productions, Sony Pictures Television, and Discovery Communications, Sharecare is a highly searchable social healthcare platform organizing and answering the questions of health.
The Company is headquartered in Las Vegas with operations in Beijing and Sao Paulo. Remark Media is listed on The NASDAQ Capital Market under the ticker MARK.
Forward-looking Statements
This press release contains “forward-looking statements,” as defined in Section 27A of the Securities Act of 1993, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be in the future tense, and often include words such as “anticipate”, “expect”, “project”, “believe”, “plan”, “estimate”, “intend”, “will” and “may”. These statements are based on current expectations, but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Remark Media. Relevant risks and uncertainties include those referenced in Remark Media’s filings with the SEC, and include but are not limited to: our losses and need to raise capital; successfully developing and launching the Boxing Channel; reliance on third parties such as PPTV; ability to procure content and monetize audiences; restrictions on intellectual property under agreements with third parties; challenges inherent in developing an online business; reliance on key personnel; risks of business in foreign countries, notably China and Brazil, including obtaining regulatory approvals and adjusting to changing political and economic policies; governmental laws and regulations, including unclear and changing laws and regulations related to the internet sector in foreign countries, especially China; general industry conditions and competition; and general economic conditions, such as advertising rate, interest rate and currency exchange rate fluctuations. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. Remark Media assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.
Contact:
Douglas Osrow
+1 (702) 701-9514 ext. 3025
(GRH) Declares Monthly Cash Dividend on 10% Series C Cumulative Preferred Stock
GreenHunter Resources, Inc. (NYSE MKT: GRH) (NYSE MKT: GRH.PRC) (the “Company”), announced today that it has declared a monthly cash dividend on the Company’s 10.0% Series C Cumulative Perpetual Preferred Stock (“Series C Preferred Stock”).
The dividend on the Series C Preferred Stock, which is for the month of July, is payable on July 31, 2014, to holders of record at the close of business on July 18, 2014. The payment will be 10.0% annualized per share, which is equivalent to approximately $0.208333 per share, based on the $25.00 per share liquidation preference of the Series C Preferred Stock.
About GreenHunter Resources, Inc.
GreenHunter Resources, Inc., through its wholly-owned subsidiaries, GreenHunter Water, LLC, GreenHunter Environmental Solutions, LLC, and GreenHunter Hydrocarbons, LLC, provides Total Water Management Solutions™/Oilfield Fluid Management Solutions™ in the oilfield and its shale plays of the Appalachian Basin. GreenHunter Water continues to expand its services package by increasing down-hole injection capacity with Class II salt water disposal wells and facilities, with the launch of next-generation modular above-ground frac water storage tanks (MAG Tank™), and with advanced water hauling – including a growing fleet of DOT rated 407 trucks, for hauling condensates and water with the presence of condensates. GreenHunter Water has also spearheaded the movement to barge brine water, as barging is the safest and most cost-effective mode of transport.
GreenHunter Environmental Solutions, LLC offers onsite environmental solutions at the well pad and facilities, with a service package that includes tank and rig cleaning, liquid and solid waste removal/remediation, solidification, and spill response. An understanding that an interconnected suite of services is key to E&P waste stream management shapes GreenHunter Resources’ comprehensive end-to-end approach to services.
GreenHunter Hydrocarbons, LLC offers transportation of hydrocarbons (oil, condensate, and NGLs) and will soon offer storage, processing, and marketing of hydrocarbons (oil, condensate, and NGLs) in the Appalachian region, leveraging off of our existing asset base and infrastructure, which includes up to six different barge terminal locations, presently owned or leased by GreenHunter Resources.
For a visual animation of the Class II Salt Water Disposal well development and completion technique that is being utilized in GreenHunter Water’s Appalachia SWD program, navigate to the video by clicking on “Salt Water Disposal Animation” button on the Operations tab at GreenHunterEnergy.com or click here.
Additional information about GreenHunter Water may be found at www.GreenHunterWater.com.
Forward-Looking Statements
Any statements in this press release about future expectations and prospects for GreenHunter Resources and its business and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the substantial capital expenditures required to fund its operations, the ability of the Company to implement its business plan, government regulation and competition. GreenHunter Resources undertakes no obligation to update these forward-looking statements in the future.
(RVLT) Provides Business Update
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a leading provider of advanced LED lighting solutions, today provided a business update for the second quarter of 2014.
Revenue in the second quarter of 2014, which includes approximately two months of the recently completed Value Lighting acquisition, is expected to be approximately $17.5 million, as compared to $7.4 million in the second quarter of 2013. The Company expects third quarter revenue to be in the $24-$26 million range, and second half 2014 revenue to be in the $55-$60 million range.
“We continued to make significant progress in the second quarter as we converted our sales pipeline to customers and commenced several large and strategic LED retrofit projects,” said Robert V. LaPenta, Chairman and Chief Executive Officer, Revolution Lighting Technologies. “The integration of Value Lighting continues to progress and is leading to new opportunities and market penetration in the multifamily residential housing sector. Demand for our LED lighting solutions is strong, our sales pipeline is robust and we are well-positioned for accelerated growth throughout the remainder of the year and beyond.”
The Company will issue a full earnings report for the second quarter of 2014 in early August.
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. is a leader in the design, manufacture, marketing, and sale of light emitting diode (LED) lighting solutions focusing on the industrial, commercial and government markets in the United States, Canada, and internationally. Through advanced technology and aggressive new product development, Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive advanced product platform. The company goes to market through its Seesmart brand, which designs, engineers and manufactures an extensive line of high-quality interior and exterior LED lamps and fixtures; Lighting Integration Technologies Inc., which sells and installs Seesmart products; Lumificient, which supplies LED illumination for the signage industry; Relume Technologies, a leading manufacturer of outdoor LED products; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting Technologies markets and distributes its product through a network of independent sales representatives and distributors, as well as through energy savings companies, national accounts and its wholly owned subsidiary, Value Lighting, a leading supplier of lighting solutions to the multifamily residential housing sector and new construction marketplace across the U.S. Revolution Lighting Technologies trades on the NASDAQ under the ticker RVLT. For additional information, please visit: www.rvlti.com.
Cautionary Statement for Forward-Looking Statements
Certain of the above statements contained in this press release are forward-looking statements that involve a number of risks and uncertainties, including statements relating to our business pipeline and sales opportunities, and our revenue and Adjusted EBITDA outlook for the second quarter and full year 2014. Such forward-looking statements are within the meaning of that term in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Reference is made to Revolution Lighting’s filings under the Securities Exchange Act for additional factors that could cause actual results to differ materially, including our history of losses, customer concentration risks, the potential for future dilution to our existing common stockholders, our status as a controlled company, the risk that demand for our LED products fails to emerge as anticipated, the availability of financing for our customers, competition from larger companies, and risks relating to third party suppliers and manufacturers, as well as the other Risk Factors described in Item 1A of our Form 10-K for the fiscal year ended December 31, 2013. Revolution Lighting Technologies, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those indicated in the forward-looking statements as a result of various factors. Readers are cautioned not to place undue reliance on these forward-looking statements.
(GENE) Provides BREVAGen™ Revenue Update
MELBOURNE, AUSTRALIA–(Jul 7, 2014) – Molecular diagnostics company Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE) is pleased to announce that the number of BREVAGen™ test samples received during the quarter ended June 30, 2014 returned to levels achieved in late CY13. Total patient samples received during the quarter were 1,096, representing 37% growth over the March 2014 quarter (800 samples).
As mentioned in previous communications, the start of CY14 brought severe winter weather across large parts of the U.S. and this restricted patient and physician physical access to medical centers and willingness to attend for anything other than urgent medical care. Further to this challenge, the holiday period coincided with the introduction of the Affordable Care Act under ObamaCare, which created uncertainty in patients’ understanding of their out of pocket expense liability that also restricted the uptake of BREVAGen™. With these factors removed, the Company saw a return of patients to doctors’ offices and improved preparedness to make preventive care decisions.
The June quarter completes the 2014 financial year for Genetic Technologies, with 3,935 samples received in the financial year, more than doubling the 1,547 received in the previous corresponding period.
Genetic Technologies benefited during the quarter from an increased focus on breast centres, radiology groups and high population, health-conscious territories, and this activity is anticipated to result in further growth over the coming quarters.
Furthermore, the company is on target to release the next generation BREVAGen™ test in Q4 CY14. The new version of BREVAGen™ incorporates an expanded SNP panel, providing an increase in predictive power. Importantly, it will also be validated in African American and Hispanic populations, thereby increasing the applicable market and simplifying the marketing process for BREVAGen™ in clinics and breast centres.
About Genetic Technologies Limited
Genetic Technologies was an early pioneer in recognizing important new applications for “non-coding” DNA (Deoxyribonucleic Acid). The Company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all species. Its business strategy is the global commercialization of its patents through an active out-licensing program and the global expansion of its oncology and cancer management diagnostics portfolio. Genetic Technologies is an ASX and NASDAQ listed company with operations in the USA and Australia. For more information, please visit www.gtglabs.com.
Safe Harbor Statement
Any statements in this press release that relate to the Company’s expectations are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act. The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees. Since this information may involve risks and uncertainties and are subject to change at any time, the Company’s actual results may differ materially from expected results. Additional risks associated with Genetic Technologies’ business can be found in its periodic filings with the SEC.
FOR FURTHER INFORMATION PLEASE CONTACT
Ms. Alison Mew
Chief Executive Officer
Genetic Technologies Limited
Phone: +61 3 8412 7000
Candice Knoll
(USA)
Blueprint Life Science Group
+1 (415) 375 3340, Ext. 105
(CAMT) Unveils Eagle – Next Generation Semiconductor Product Line
The Eagle product line is designed to support the emerging Advanced Packaging market
MIGDAL HAEMEK, Israel, July 7, 2014 —
Camtek Ltd. (NASDAQ and TASE: CAMT) today announced the launch of its next generation Semiconductor Inspection and Metrology platform, at the Semicon West tradeshow which will start tomorrow, July 8, in San Francisco.
The Eagle product line is designed to support the fast growing Advanced Packaging market using cutting edge technologies, both software and hardware, that deliver unparalleled 2D and 3D inspection and metrology capabilities on the same platform.
Ramy Langer, Vice President and Head of Camtek’s Semiconductor Division, commented, “This new product line will strengthen our leading position in the Semiconductor backend market, taking advantage of our expertise in bump inspection and metrology. The Advanced Packaging market in particular uses a wide spectrum of bump types and sizes. Our outstanding capabilities in the inspection and metrology of current and next-generation bumps, down to 2µm, will give our customers a competitive edge in this emerging market.”
Continued Mr. Langer: “We have already received early orders for the new product from leading Semiconductor device manufacturers. We see this as a vote of confidence in our technology capabilities to deliver fast, accurate and unrivalled 2D and 3D inspection and metrology capabilities, supporting the industry roadmap.”
ABOUT CAMTEK LTD.
Camtek Ltd. provides automated and technologically advanced solutions dedicated to enhancing production processes, increasing products yield and reliability, enabling and supporting customer’s latest technologies in the Semiconductors, Printed Circuit Boards (PCB) and IC Substrates industries.
Camtek addresses the specific needs of these interconnected industries with dedicated solutions based on a wide and advanced platform of technologies including intelligent imaging, image processing and functional 3D inkjet printing.
This press release is available at http://www.camtek.co.il
This press release may contain projections or other forward-looking statements regarding future events or the future performance of the Company. These statements are only predictions and may change as time passes. We do not assume any obligation to update that information. Actual events or results may differ materially from those projected, including as a result of changing industry and market trends, reduced demand for our products, the timely development of our new products and their adoption by the market, increased competition in the industry, intellectual property litigation, price reductions as well as due to risks identified in the documents filed by the Company with the SEC.
CAMTEK LTD.
Moshe Eisenberg, CFO
Tel: +972-4-604-8308
Mobile: +972-54-900-7100
moshee@camtek.co.il
INTERNATIONAL INVESTOR RELATIONS
CCG Investor Relations
Ehud Helft / Kenny Green
Tel: (US) +1-646-201-9246
camtek@ccgisrael.com
(LIVE) Expands Reach, Now in 50 U.S. Cities
LAS VEGAS, July 2, 2014 – LiveDeal Inc. (NASDAQ:LIVE) (“LiveDeal” or the “Company”), a publicly traded company that operates livedeal.com, a geo-location based mobile marketing platform that enables restaurants to publish “real-time” and “instant offers” to nearby consumers, today announces that the company now features deals in 50 cities throughout the United States, demonstrating its utility to restaurants to help drive traffic during non-peak hours.
“Our original campaign, which was centered around 35 key U.S. cities, has proven successful beyond what we could have expected, as we are now offering restaurant deals in 50 U.S. cities. Restaurants are recognizing the value that LiveDeal’s “deal engine” provides them in helping drive non-peak hour traffic, and their customers seem to be responding as well,” said Jon Isaac, CEO of LiveDeal, Inc. “We continue to expand our reach, and are poised to potentially become the leading engine that restaurants rely on to keep people coming back.”
About LiveDeal, Inc.
LiveDeal Inc. provides marketing solutions that boost customer awareness and merchant visibility on the Internet. LiveDeal operates a deal engine, which is a service that connects merchants and consumers via an innovative platform that uses geo-location, enabling businesses to communicate real-time and instant offers to nearby consumers. In November 2012, LiveDeal commenced the sale of marketing tools that help local businesses manage their online presence under the Company’s Velocity Local™ brand. LiveDeal continues to actively develop, revise, and evaluate these products and services and its marketing strategies and procedures. For more information, visit www.livedeal.com.
Forward-Looking and Cautionary Statements
This press release contains “forward-looking” statements that are based on present circumstances and on LiveDeal’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements, including any statements regarding the plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance, are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. Forward-looking statements are made only as of the date of this release and LiveDeal does not undertake and specifically declines any obligation to update any forward-looking statements. Readers should not place undue reliance on these forward-looking statements.
LiveDeal, Inc.
Terry Johnston, Media Relations
855-531-4715
press@livedeal.com
http://livedeal.com/pressroom
(SINO) Announces Closing of Public Offering of Common Stock
NEW YORK, July 2, 2014 — Sino-Global Shipping America, Ltd. (NasdaqCM: SINO) (“Sino-Global” or the “Company”), an international shipping agency and logistic services provider, today announced the closing of its previously announced underwritten public offering of 572,000 registered shares of its common stock, without par value per share, at a price to the public of $1.76 per share. The underwriter partially exercised the over-allotment and purchased an additional 75,000 shares. The total number of shares sold in the offering including such over-allotment shares was 647,000 shares of common stock.
The Company intends to use the net proceeds of the offering for strategic investments, acquisitions and general corporate purposes.
National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (OTCBB: NHLD), acted as sole book-running manager for the offering. The Company offered and sold these securities pursuant to its existing shelf registration statement (File No. 333-194211), including a base prospectus, as declared effective by the Securities and Exchange Commission (the “SEC”) on April 15, 2014.
A final prospectus supplement describing the terms of the offering was filed with the SEC and formed a part of the effective registration statement. Copies of the prospectus supplement and the accompanying base prospectus may be obtained by contacting the book-running manager at the following address:
National Securities Corporation
410 Park Ave, 14th Floor
New York, NY 10022
Attn: Kim Addarich
Telephone: (212)-417-8164
Email: prospectusrequest@nationalsecurities.com
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Sino-Global Shipping America, Ltd, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Sino-Global Shipping America, Ltd.
Founded in the United States of America (“US”) in 2001, Sino-Global Shipping America, Ltd. is a Virginia corporation with its primary US operations in New York. The company provides its customers with comprehensive yet customized shipping agency, shipping and chartering, and inland transportation management services. As a general shipping agent, the Company serves ships coming to and departing from a number of countries and regions, including China, Australia, South Africa, Brazil, New Zealand, and Canada. It has signed strategic agreements with Qingdao Zhenghe Shipping Group Limited to jointly explore mutually beneficial business development opportunities; the China United Tally Co., Ltd. to develop third-party verification services at ports in China; and China Ocean Shipping Agency to develop their shipping agency business in China and internationally. For more information, please visit www.sino-global.com.
Safe Harbor Statements
This press release contains forward-looking statements regarding future events and financial performance. In some cases, you can identify these statements by words such as “may,” “might,” “will,” “should,” “except,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” the negative of these terms and other comparable terminology. These statements involve a number of risks and uncertainties and are based on numerous assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. There are or may be important factors that could cause our actual results to materially differ from our historical results or from any future results expressed or implied by such forward looking statements. These factors include, but are not limited to, those discussed under the section entitled “Risk Factors” in our Form S-3/A, which is available at the U.S. Securities and Exchange Commission website at www.sec.gov. The forward-looking statements in this press release are based upon management’s reasonable belief as of the date hereof. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Sino-Global Shipping America, Ltd. Contact:
Mr. Anthony S. Chan, CPA
Executive Vice President and Acting CFO
+ 1-718-888-1814
(JAZZ) To Acquire Rights To Defibrotide In The Americas
— Jazz Pharmaceuticals to own worldwide rights to defibrotide at closing
— Investor conference call to be held today, July 2 at 8:30 AM EDT/1:30 PM IST
DUBLIN, July 2, 2014 — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) under which a subsidiary of Jazz Pharmaceuticals plc (Jazz) will acquire from Sigma-Tau rights to defibrotide in the United States (U.S.) and all other countries in the Americas. Sigma-Tau holds rights to market defibrotide in the Americas under an agreement with Gentium S.p.A., which was acquired by Jazz earlier this year. Defibrotide is a novel product that is marketed by Jazz in the European Union (EU) under the name Defitelio® for the treatment of severe hepatic veno-occlusive disease (VOD) in patients over one month of age undergoing hematopoietic stem cell transplantation (HSCT) therapy. In the U.S., Jazz is working with the Food and Drug Administration (FDA) on the regulatory pathway for submission of a New Drug Application (NDA) for the potential approval of defibrotide to treat patients with severe VOD.
As part of the agreement, Sigma-Tau would receive an upfront payment of $75 million upon closing of the transaction. Sigma-Tau would be eligible to receive milestone payments of $25 million upon the acceptance for filing by the FDA of the first NDA for defibrotide for VOD and up to an additional $150 million based on the timing of potential FDA approval of defibrotide for VOD. Jazz expects to fund the transaction with cash on hand and that the transaction will close during the third quarter of 2014, subject to customary closing conditions, including expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
“The acquisition of the remaining worldwide rights to defibrotide is a strong strategic fit with our specialty focus and would continue the momentum of our recent launch of Defitelio in the EU, further leveraging our global clinical and commercial expertise in hematology/oncology,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. “This transaction supports our mission to improve care for patients with serious medical conditions, and we remain committed to making targeted investments to develop and bring to market differentiated treatments for patients.”
“This transaction would not only strengthen our global presence, but also demonstrate our commitment to diversify and expand our U.S. commercial portfolio with meaningful new therapies,” said Russell Cox, executive vice president and chief operating officer of Jazz Pharmaceuticals plc. “We look forward to ongoing discussions with the FDA as we continue our efforts toward submission of an NDA for defibrotide in the U.S. Patients in the U.S. with severe VOD have a critical unmet medical need, and we believe that defibrotide has the potential to become an important treatment option for these patients.”
About Defitelio®▼ (defibrotide)
In October 2013, the European Commission granted marketing authorization under exceptional circumstances for Defitelio®▼ (defibrotide) for the treatment of severe VOD in HSCT therapy. It is indicated in patients over one month of age. Defitelio is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.
In addition to its existing approved indication in the EU, defibrotide has the potential to be developed for approval in countries outside the EU and in other indications. Defibrotide has been granted orphan drug designation to treat and prevent VOD by the FDA, by the European Medicines Agency (EMA) and by the Korean Ministry of Food and Drug Safety (MFDS), orphan drug designation for the treatment of VOD by the Commonwealth of Australia-Department of Health, and Fast Track designation to treat severe VOD by the FDA.
In the EU, please consult the Defitelio summary of product characteristics before prescribing, particularly in relation to use of medicinal products that increase the risk of hemorrhage, concomitant systemic anticoagulant therapy, medicinal products that affect platelet aggregation, use in patients who have or develop clinically significant acute bleeding requiring blood transfusion, and patients who have hemodynamic instability.
▼ This medicinal product is subject to additional monitoring.
About VOD
Hepatic veno-occlusive disease (VOD) is an early complication in patients undergoing HSCT therapy. In its severe form, VOD can be life-threatening and is associated with multi-organ failure and is fatal in over 80% of patients.1,2 HSCTs are performed with curative intent in patients with hematological malignancies, selected solid tumors and some non-malignant disorders, such as serious hemoglobinopathies.3,4 Studies have reported a wide range of incidence rates for VOD, suggesting that 5-15% of patients undergoing HSCT develop VOD.2,5,6
Conference Call Information
Jazz Pharmaceuticals will host a conference call and live audio webcast today at 8:30 a.m. EDT/1:30 p.m. IST to discuss this transaction and related matters. Interested parties may access the live audio webcast and slide presentation via the Investors & Media section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for one week.
Audio Webcast/Conference Call:
U.S. Dial-In Number: +1 866 543 6403
Outside the U.S. Dial-In Number: +1 617 213 8896
Passcode: 11784518
A replay of the conference call will be available through July 9, 2014 and accessible through one of the following telephone numbers and entering the passcode:
Replay U.S. Dial-In Number: +1 888 286 8010
Replay Outside the U.S. Dial-In Number: +1 617 801 6888
Passcode: 47229125
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing differentiated products that address unmet medical needs. The company has a diverse portfolio of products and/or product candidates in the areas of sleep, hematology/oncology, pain and psychiatry. The company’s U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, Versacloz® (clozapine) oral suspension, FazaClo® (clozapine, USP) HD and FazaClo LD. Jazz Pharmaceuticals also has a number of products marketed outside the U.S., including Erwinase® and Defitelio® (defibrotide). For more information, please visit www.jazzpharmaceuticals.com.
“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated closing of the acquisition of rights to defibrotide in the U.S. and all other countries in the Americas and the timing and benefits thereof, the therapeutic and commercial potential of defibrotide, planned future discussions with the FDA concerning the regulatory pathway for submission of an NDA for defibrotide, the potential acceptance for filing of and potential approval of an NDA for defibrotide, potential future development of defibrotide for approval in countries outside the EU and in other indications, the company’s pipeline and portfolio growth strategy, including potentially bringing new therapies to market, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the company’s ability to complete the acquisition of defibrotide rights from Sigma-Tau on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of closing conditions; the company’s ability to successfully manage the risks associated with integrating defibrotide into the company’s product portfolio; the possibility that Jazz Pharmaceuticals may fail to realize the anticipated benefits (commercial or otherwise) from the acquisition of defibrotide rights from Sigma-Tau; the inherent uncertainty associated with the regulatory approval process, including the risks that Jazz Pharmaceuticals may be required to conduct additional time-consuming and costly clinical trials in order to obtain any regulatory approval of defibrotide in the U.S. and that Jazz Pharmaceuticals may otherwise be unable to obtain or maintain any regulatory approvals for defibrotide in the U.S. or in other countries outside of the EU; the difficulty and uncertainty of pharmaceutical product development, including the timing and cost thereof; risks related to effectively commercializing defibrotide, including uncertainty of the future sales of and revenue from defibrotide following regulatory approval, if any, in the U.S., and in other indications; the company’s ability to identify and acquire, in-license or develop additional products or product candidates to grow its business; possible restrictions on the company’s ability and flexibility to pursue certain future opportunities as a result of its substantial outstanding debt obligations; other risks related to future opportunities and plans; and those other risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 and future filings and reports by the company. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
References:
1. Carreras E. Chapter 11: Early complications after HSCT. EBMT-ESH Handbook 2012
2. Coppell JA et al. Biol Blood Marrow Transplant. 2010;16:157–168
3. Tsakiris DA & Tichelli A. Best Pract Res Clin Haematol. 2009;22:137–145
4. Majhail NS et al. Bone Marrow Transplant. 2013;48:294–300
5. Carreras E et al. Blood. 1998;92(10)3599-604
6. Corbaciouglu S et al. Lancet. 2012;379(9823):131-9.
(VIMC) Announces Winning of Competitive Bid in Handan City of Hebei Province
BEIJING, July 2, 2014 — Vimicro International Corporation (NASDAQ: VIMC) (“Vimicro” or the “Company”), a leading video surveillance technology and solution provider, today announced that it has won a competitive bid for the provision of SVAC-compliant video surveillance products to Handan Municipal Government in Hebei Province, with an estimated contract size of RMB 23 million, or USD $ 3.7 million approximately.
“We are pleased to have won the bid in Handan of Hebei Province. Following the adoption of SVAC in Baoding City, Handan is the second city in Hebei to adopt SVAC national video surveillance technology standard. China is launching a nationwide, hierarchical and full-coverage video surveillance network — ‘Skynet’, which will employ big data analysis and cloud computing to link towns, cities and provinces. SVAC national standard promulgated in 2011 is expected to be incorporated in the ‘Skynet’ project that is being rolled out on a nation-wide basis,” commented Dr. John Deng, Vimicro’s Chairman and CEO. “As one of the only two co-leading developers of SVAC national standard and the only SVAC-compliant video surveillance technology and solution provider, Vimicro will continue to leverage its first-mover advantages to capitalize on the megatrend of SVAC national standard adoption by the government, to further establish itself as a leading player in China’s video surveillance market.”
About Vimicro International Corporation
Vimicro International Corporation (NASDAQ: VIMC) is a leading video surveillance technology and solution provider that designs, develops and markets a full range of video surveillance products and solutions to governments, private enterprises, and consumers in China. Vimicro co-developed SVAC (Surveillance Video and Audio Coding), the national video surveillance technological standard, which demonstrates its unique strengths in proprietary multimedia IC technology, making it a leader in China’s fast-growing security and surveillance market. Vimicro is headquartered in Beijing, China and has subsidiaries and offices throughout China and in Silicon Valley. Vimicro’s ADSs each represent four ordinary shares and are traded on the NASDAQ Global Market exchange under the ticker symbol “VIMC.”
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Among other things, the quotations from management in this announcement, as well as Vimicro’s expectations and forecasts, contain forward-looking statements. Vimicro may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission on forms 20-F and 6-K, etc., in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Vimicro’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the Company’s ability to develop and sell new mobile multimedia products; the expected growth of the mobile multimedia market; the Company’s ability to increase sales of notebook camera multimedia processors; the Company’s ability to retain existing customers and acquire new customers and respond to competitive market conditions; the Company’s ability to respond in a timely manner to the evolving multimedia market and changing consumer preferences and industry standards and to stay abreast of technological changes; the Company’s ability to secure sufficient foundry capacity in a timely manner; the company’s ability to effectively protect its intellectual property and the risk that it may infringe on the intellectual property of others; and cyclicality of the semiconductor industry. Further information regarding these and other risks is included in Vimicro’s annual report on Form 20-F filed with the Securities and Exchange Commission. Vimicro does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of the date hereof, and Vimicro undertakes no duty to update such information, except as required under applicable law.
Contact:
Vimicro International Corporation
Ms. Daisy Wang, IR Manager
Phone: +8610-5884-8898 Ext: 3036
E-mail: ir@vimicro.com
(ZGNX) Update on Development of Abuse Deterrent Formulations of Zohydro
Application for Next Generation of Zohydro(R) ER to be Filed by October 2014
SAN DIEGO, July 2, 2014 — Zogenix, Inc. (Nasdaq:ZGNX) today announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII. Zohydro ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the U.S. Food and Drug Administration (FDA), Zogenix expects to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration.
If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product’s abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling. As of today, only one of more than thirty extended-release/long-acting opioid analgesics has abuse deterrent properties described in FDA-approved labeling for making abuse via injection more difficult and reducing abuse via the nasal route based on the draft Guidance for Industry.
Zogenix also recently selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. Like the next-generation formulation, this proprietary tablet technology is designed to meet FDA’s stated goal of encouraging scientific and clinical research that will advance the development of abuse deterrent technologies to address opioid medication misuse and abuse. The innovative tablet formulation of Zohydro ER incorporates multiple features to maintain the extended-release property of the medication when crushed or chewed, reducing one of the ways in which opioids are abused through oral ingestion, as well other features to address abuse by injection or nasal administration.
The company is targeting a new drug application (NDA) submission for this tablet formulation during the first half of 2016, which will reference the approved NDA for Zohydro ER with respect to previous findings of safety and efficacy. The tablet formulation is designed to have the same hydrocodone release profile as the currently approved capsule formulation of Zohydro ER when used as intended, greatly simplifying its development program.
“We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients,” said Stephen Farr, Ph.D., President of Zogenix. “This dual approach will allow us to potentially launch our next generation of Zohydro ER Extended-Release Capsules in early 2015, followed by the tablet formulation with advanced proprietary abuse deterrent technology in 2016. We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain.”
In addition to working with FDA to integrate abuse deterrent properties into Zohydro ER, Zogenix strongly supports more comprehensive approaches to addressing the public health challenge of prescription drug abuse. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids. The company has implemented novel initiatives, such as providing Zohydro ER patients free locking pill bottle caps and discounts for safe-storage units to help prevent other people from gaining access to their medications. Prior to the availability of Zohydro ER, Zogenix established an independent External Safe Use Board to assess and make recommendations on surveillance programs and data collection related to misuse and diversion of the product.
Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an extended-release hydrocodone for around-the clock management of severe chronic pain and who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.
About Zohydro® ER
INDICATION
ZOHYDRO® ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve ZOHYDRO ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
ZOHYDRO ER is not indicated for use as an as-needed analgesic.
Please click here to see the ZOHYDRO ER professional product labeling for the complete boxed warning and safety information.
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL
- ZOHYDRO ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions.
- Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow ZOHYDRO ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
- Accidental consumption of ZOHYDRO ER, especially in children, can result in fatal overdose of hydrocodone.
- For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
- Instruct patients not to consume alcohol or any products containing alcohol while taking ZOHYDRO ER because co-ingestion can result in fatal plasma hydrocodone levels.
IMPORTANT SAFETY INFORMATION
ZOHYDRO ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in ZOHYDRO ER.
ZOHYDRO ER contains hydrocodone, a Schedule II controlled substance. As an opioid, ZOHYDRO ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as ZOHYDRO ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. The most common adverse reactions associated with ZOHYDRO ER (≥2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor.
For more information about Zohydro ER, please visit: www.ZohydroEr.com or the Zohydro ER REMS website at www.ZohydroERREMS.com.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.
For more information about Zogenix, please visit: www.Zogenix.com.
Forward-Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the potential to develop abuse deterrent formulations of Zohydro ER, the timing of regulatory submissions and potential FDA approvals. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Zogenix’s business, including, without limitation: risks and uncertainties associated with the development and regulatory approval of an abuse deterrent formulation and Zogenix’s reliance on Altus and its drug delivery platform in such development efforts; unexpected adverse side effects or inadequate therapeutic efficacy of the abuse deterrent formulations that could limit approval and/or commercialization, or that could result in recalls or product liability claims; public concern regarding the safety of drug products such as Zohydro ER and the impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER in particular; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for an abuse deterrent formulation of Zohydro ER; and other risks detailed in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. 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.
Zohydro® ER is a registered mark of Zogenix, Inc.
FPR
CONTACT: Investors Zack Kubow |The Ruth Group 646.536.7020 | zkubow@theruthgroup.com Media David Polk | Chandler Chicco Companies 310.309.1029 | DPolk@chandlerchiccocompanies.com
(CTIC) Completes Recruitment in Pivotal Phase 3 for Pacritinib in Myelofibrosis
-Top-line Results Expected in Early 2015- -CTI Expects to Receive $20 Million Development Milestone Payment from Baxter-
SEATTLE, July 1, 2014 — CTI BioPharma Corp. (CTI or the Company) (NASDAQ and MTA: CTIC) announced today that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of myelofibrosis. Under the development and commercialization agreement for pacritinib with Baxter International, Inc. (Baxter), CTI expects to receive a $20 million development milestone payment in connection with the first treatment dosing of the last patient enrolled in PERSIST-1. CTI expects to achieve this milestone and receive payment by mid-third quarter 2014.
“The PERSIST-1 clinical trial evaluating pacritinib, a novel JAK2/FLT3 inhibitor, is the most inclusive study of myelofibrosis patients seen in routine clinical practice to date,” said Claire Harrison, M.D., Consultant Hematologist, Guy’s and St. Thomas’ NHS Foundation Trust, Guy’s Hospital, London, United Kingdom and one of the principal investigators for PERSIST-1. “Previous randomized clinical trials have excluded patients with low platelet counts (below 50,000-100,000 per microliter (uL)) despite almost 30 percent of all myelofibrosis patients having disease-related thrombocytopenia. Currently available JAK1/JAK2 inhibitors are associated with treatment-emergent myelosuppression, including thrombocytopenia as a side effect of their therapy requiring reduced doses and sometimes early cessation of treatment when used in patients with disease-related thrombocytopenia. These patients represent an unmet medical need; a non-myelosuppressive JAK2 inhibitor would represent a significant advancement in the treatment of this chronic disease.“
The PERSIST-1 trial is the first of two Phase 3 trials in the pacritinib development program in myelofibrosis. The second Phase 3 trial, PERSIST-2, is currently evaluating pacritinib for the treatment of patients with low platelet counts compared to best available therapy, including approved JAK2 inhibitors at their recommended dose and schedule for myelofibrosis patients with thrombocytopenia. The two clinical trials are intended to support an anticipated New Drug Application (NDA) regulatory submission in the U.S. in late 2015, followed by an anticipated Marketing Authorization Application (MAA) in Europe in 2016.
“Completing recruitment in the PERSIST-1 trial is a significant milestone in our development program for pacritinib, and we look forward to reporting top-line results in early 2015,” said James A. Bianco, M.D., President and CEO of CTI BioPharma. “The high physician and patient interest in participating in this trial underscores the need for new, effective and less toxic treatment options for patients with myelofibrosis.”
The PERSIST-1 trial was designed to enroll approximately 320 patients and is a randomized, open-label, multicenter trial comparing the efficacy and safety of pacritinib with that of best available therapy, other than JAK inhibitors, in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts. The primary endpoint is the percentage of patients achieving a greater than or equal to 35 percent reduction in spleen volume measured by MRI or CT at 24 weeks of treatment.
Pacritinib Development Program in Myelofibrosis
Based on pacritinib’s efficacy and tolerability profile demonstrated to date, CTI is pursuing a broad approach to advancing this therapy for myelofibrosis patients by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the ongoing PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial.
In March 2014, CTI announced the initiation of the PERSIST-2 trial, which will evaluate pacritinib in patients with myelofibrosis whose platelet counts are less than or equal to 100,000/uL. The trial is designed to enroll up to 300 patients in North America, Europe, Australia, New Zealand and Russia. In October 2013, CTI reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment for the PERSIST-2 trial, which is a written agreement between CTI and the FDA regarding the planned design, endpoints and statistical analysis approach of the trial to be used in support of a potential NDA submission.
More details on the PERSIST-1 and PERSIST-2 trials can be found at www.clinicaltrials.gov.
About Pacritinib
Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anemia than has been seen in currently approved and in-development JAK inhibitors.
In November 2013, CTI and Baxter entered into a worldwide license agreement to develop and commercialize pacritinib in which CTI and Baxter will jointly commercialize pacritinib in the United States and Baxter has exclusive commercialization rights for all indications outside the United States.
About Myelofibrosis
Myelofibrosis is classified as a myeloproliferative neoplasm and is a chronic bone marrow disorder. Myelofibrosis is caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response, scarring the bone marrow and limiting its ability to produce red blood cells, prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain.
About CTI BioPharma
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI’s lead product candidate that is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding CTI’s expectations with respect to the development of CTI and its product and product candidate portfolio, the expected attainment of the milestone involving the first treatment dosing of the last patient enrolled in PERSIST-1 and the expected receipt and timing of the associated $20 million development milestone payment from Baxter, the projected timing of the availability of top-line data for the PERSIST-1 trial, the incidence rate of myelofibrosis patients having disease-related thrombocytopenia, the expected enrollment for the PERSIST-2 trial, expected efficacy and potential benefits of pacritinib and the ability of the PERSIST-1 and PERSIST-2 trials to support a potential NDA and MAA submission for pacritinib in 2015 and 2016, respectively. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that preclinical and clinical trials will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities or will not be in a position to submit regulatory submissions as or when projected, risks related to the costs of developing pacritinib and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.
Contacts:
Monique Greer
+1 206-272-4343
mgreer@ctibiopharma.com
Ed Bell
+1 206-282-7100
ebell@ctibiopharma.com
In Europe: CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 94751572
lvilla@cti-lifesciences.com
(IPAS) Sells Unity Business Unit to Tolt Solutions for $28.2 Million
Divestiture Allows iPass to Focus on Its Growing Mobile Wi-Fi Business
REDWOOD SHORES, CA–(Jul 1, 2014) – iPass Inc. (NASDAQ: IPAS), the global Wi-Fi roaming leader, announced today it has completed the successful sale of its Unity Managed Network Services business unit for $28.2 million to Tolt Solutions. This marks the culmination of a competitive process initiated in February 2014, providing increased value to iPass shareholders and a natural transition for Unity customers.
“We are pleased with the process and the outcome and we believe Tolt makes an ideal home for the Unity business and its customers,” said Evan Kaplan, President and CEO of iPass. “The sale of Unity enables us to focus exclusively on our Wi-Fi Open Mobile business. With annual Open Mobile revenue growth of 77% in 2013, iPass is well positioned to leverage our unique assets and strengthened balance sheet to drive consistent growth in the expanding market for global Wi-Fi.”
Connectivity has become central to people’s personal and business lives as evidenced by the dramatic rise in data consumption. The vast majority of that consumption is on Wi-Fi networks driven by rapid growth in public Wi-Fi deployments and the widespread availability of Wi-Fi on connected devices. The iPass Business Traveler 2.0 service and Open Mobile offerings are positioned to help people easily and cost effectively get connected on Wi-Fi. Growing from several thousand users a few years ago, today the service is used by over 1.6 million people a year to get connected in airports, airplanes, trains, hotels, and public venues around the globe.
This transaction marks a new stage for iPass. With a singular focus on Wi-Fi mobility, the company plans to further expand its market leading 2.7 million hotspot Wi-Fi network, enhance its industry leading global authentication fabric, and introduce significant improvements to its iOS, Android and Windows user experiences. In addition, the company will continue to expand its customer base and build deeper relationships with its over 700 current customers including enterprises like Cisco, Oracle, SAP and Nestle as well as service providers like Deutsche Telekom, Orange and Telstra.
Guidance Update. iPass is reaffirming its guidance for second quarter 2014 results for the entire Company, including Unity, as described in its first quarter press release of May 7, 2014. iPass intends to discuss this transaction in detail on its upcoming second quarter 2014 conference call in early August.
About iPass Inc.
iPass enables business travelers to stay connected by providing them with cost-effective and convenient global Wi-Fi access across smartphones, tablets and laptops. Founded in 1996, iPass (NASDAQ: IPAS) is the world’s largest commercial Wi-Fi network, covering over 120 countries and territories and selling to over 700 large corporations and telecom service providers around the world. Through its cloud-based delivery model, iPass connects business travelers to over 2.7 million commercial grade hotspots in airports, airplanes, hotels and public areas along with access to millions of additional community hotspots. With the growing need for fast, high bandwidth connectivity, iPass lets business travelers stay close to what matters most while on the road including access to video, unified communications, web conferencing and other cloud based apps.
For more information, please visit www.iPass.com and the iPass blog, Smarter Connections.
Find iPass on:
Twitter: @iPass: twitter.com/ipass
Facebook: https://www.facebook.com/ipass
About Tolt Solutions
Tolt Solutions is the leading retail-focused IT expert, delivering innovative technology solutions and managed services for your business both today and tomorrow. Celebrating over 40 years of innovation, we identify, define, deploy, and manage IT solutions that drive increased sales, lowers costs, and improve overall customer satisfaction. Our comprehensive service offering and national footprint provides customers with a single point-of-contact for their in-store technology needs. For more information, please visit our website www.toltsolutions.com.
Cautionary Information About Forward-Looking Statements
The statements in this press release regarding the benefits that iPass expects to receive from the sale of Unity, including its belief that its ability to focus its attention on its Wi-Fi Open Mobile business will help maximize value creation, that it will seek to exploit its competitive advantages and balance sheet to derive growth in the expanding market for global Wi-Fi, that it will be able to focus on building deeper relationships with its over 700 enterprise customers as well as expanding both its OME and OMX customer bases and its reiteration of its second quarter guidance, are forward-looking statements. Actual results may differ materially from the expectations contained in these statements due to a number of risks and uncertainties, including the following: the risk that its focus on the Wi-Fi Open Mobile business will not achieve the results iPass expects due to unforeseen reasons; the risk that demand for Wi-Fi Open Mobile services does not grow as iPass expects; the risk that strong competition in the market for Wi-Fi services could reduce demand for iPass’ services; and the fact that iPass’ second quarter has just ended and iPass has not yet closed its financial accounting records for the quarter, and so actual results may differ from those expected. Detailed information about these and other risk factors that could potentially affect iPass’ business, financial condition and results of operations are included in iPass’ Current Report on Form 10-Q filed with the SEC on May 8, 2014, and available at the SEC’s Web site at www.sec.gov and the company’s website at http://investor.ipass.com. iPass undertakes no responsibility to update the information in this press release if any forward-looking statement later turns out to be an inaccurate prediction of the actual results.
(AGEN) Brain Cancer Vaccine Shows Extended Survival in Phase 2
Agenus Inc. (NASDAQ: AGEN), announced final results from a single-arm, multi-institutional, open-label, Phase 2 study showing that patients with newly diagnosed glioblastoma multiforme (GBM) who received Agenus’ Prophage autologous cancer vaccine added to the standard of care treatment, lived nearly twice as long as expected. In this Phase 2 study, 50% of the patients lived for two years, an encouraging result for a cancer that often kills patients within one year 1-7. Prophage patients demonstrated a median overall survival of approximately 24 months and 33% of patients remain alive at 2 years and continue to be followed for survival.
“These data suggest that Prophage is generating an effective immune response which is translating into an extension in survival far beyond what is historically seen in patients with GBM. These data provide the impetus for a definitive, randomized clinical trial,” said Andrew Parsa, MD, PhD,Principal Investigator of the study and the Michael J. Marchese Professor and Chair of the Department of Neurological Surgery at the Feinberg School of Medicine at Northwestern University. “Glioblastoma tumors are often resistant to standard therapies and the extended progression-free survival and proportion of long-term survivors is very encouraging.”
In addition to the long-term survival data, vaccine treated patients had a median progression-free survival (PFS) of nearly 18 months, approximately two to three-times longer than patients treated with radiation and temozolomide alone1. Importantly, 22% of patients were alive and without progression at 24 months and continue to be followed for survival.
Interestingly, the response to Prophage seems to be more pronounced in those patients with less expression of the checkpoint ligand PDL-1 on the white blood cells, suggesting that combinations of Prophage with checkpoint modulators like PD-1 antagonists might make Prophage even more effective in a greater percentage of patients with GBM.
“We believe that Prophage may play an important role in changing the treatment paradigm for patients with GBM,” said Garo Armen, PhD, CEO and chairman of Agenus Inc. “We are exploring partnerships for Phase 3 studies of Prophage in GBM. Additionally, we are excited about the potential combinations of Prophage with PD-1 antagonists and other checkpoint modulators in GBM.”
Prophage is an autologous cancer vaccine, and each patient receives vaccine prepared from their own surgically resected tumor. As a result, the vaccine appears to help stimulate the patient’s immune system to attack the tumor based on the spectrum of mutant proteins expressed by their own tumor. Since most cancers result from an accumulation of random mutations, which produce different mutant proteins in each patient, this approach is intended to individually tailor each patient’s vaccine to optimally target the immune attack to that patient’s actual tumor.
Phase 2 Prophage Study in Newly Diagnosed GBM
The Phase 2 single-arm trial of Prophage in patients with newly diagnosed GBM undergoing gross total resection includes 46 patients treated at eight centers (UCSF, Columbia, UPENN, Miami, Valley Hospital, Northern Westchester Hospital, Oklahoma, Johns Hopkins, and Northwestern) across the US. Patients were treated with surgical resection, radiation and temozolomide as the standard of care in addition to Prophage vaccination. The cohort was comparable to patients with surgically resectable newly diagnosed GBM on prognostic factors such as age, Karnofsky Performance Score, and MGMT methylation status. Analyses of data collected to date show more than 50% of the patients were alive at two years and patients continued to be followed. These results indicate considerable improvement when compared to expectations for patients treated with the standard of care (gross total resection plus radiation and temozolomide), which is 26% of patients alive at 24 months.1
Median overall survival (OS), the primary endpoint of the trial, is 23.8 months and remains durable in patients treated with Prophage. For the standard of care alone, median OS survival rate is 14.6 months.1 PFS data remains durable with previous reports with a median PFS of 17.8 months and nearly 22% of patients alive without progression at 24 months.
The Phase 2 recurrent and newly diagnosed trials are being sponsored by Dr. Parsa and primarily have been supported through funding from the American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society, and National Cancer Institute Special Programs of Research Excellence. Dr. Parsa has not received any financial support or expense reimbursement for this work or for consulting activities on behalf of Agenus. He does not have an equity interest in Agenus or a financial relationship with the company.
About Glioblastoma Multiforme (GBM)
The incidence rates of primary malignant brain and central nervous system cancers have increased over the last three decades.8 The American Cancer Society estimates that more than 23,000 malignant tumors of the brain or spinal cord will be diagnosed during 2013 in the US, and that more than 14,000 people will die from these tumors. 9 GBM is the most common primary malignant brain tumor and accounts for the majority of diagnoses. It has been associated with a particularly poor prognosis, with survival rates at one and five years equaling 33.7% and 4.5%, respectively.10 The current standard of care for patients with newly diagnosed GBM is surgical resection followed by fractionated external beam radiotherapy and systemic temozolomide11 resulting in a median OS of 14.6 months12 based on data from a randomized Phase 3 trial. Although this treatment can prolong survival, it is not curative and the vast majority of patients with GBM experience recurrent disease, with a median time to recurrence of seven months.13 From the time of recurrence, the median survival is three to nine months.1-7 Current treatment options for patients with recurrent GBM, include surgery, chemotherapy (i.e., CCNU, temozolomide), bevacizumab, and radiotherapy.
About Prophage Series Vaccines
Prophage Series vaccines are individualized cancer vaccines derived from each patient’s own tumor. As a result of its individualized nature, each Prophage Series vaccine contains the precise signals (antigenic fingerprint) of the patient’s particular cancer and allows the body’s immune system to target only cells bearing this specific fingerprint. Such high precision in immunological targeting represents a distinctly different method for treating cancer compared to conventional anti-cancer treatments such as chemotherapy or radiation therapy. These conventional therapies cause side effects, which are sometimes debilitating.
Prophage Series vaccines are based on Agenus’ heat shock protein platform technology. For more information about Prophage Series vaccines and Agenus’ heat shock protein platform, please visit http://agenusbio.com/science/prophage.php.
About Agenus
Agenus is an immuno-oncology company developing a portfolio of checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery engine Retrocyte Display® is used to generate fully human therapeutic antibody drug candidates. The Retrocyte Display platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. The company’s QS-21 Stimulon® adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+. For more information, please visit www.agenusbio.com.
Forward-Looking Statement
This press release contains forward-looking statements, including statements regarding clinical trial activities, the publication of data, and the potential application of the Company’s technologies and product candidates in the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended March 31, 2014. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.
References
1. Ballman KV, Buckner JC, Brown PD, et al. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol. 2007;9:29–38.
2. Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10:162–170.
3. Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials. J ClinOncol. 1999;17:2572–2578.
4. Friedman HS, Prados MD, Wen PY, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27:4733–4740.
5. Kreisl TN, Kim L, Moore K, et al. Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. J Clin Oncol. 2009;27:740–745.
6. Vredenburgh JJ, Desjardins A, Herndon JE 2nd, et al. Bevacizumab plus irinotecan in recurrent glioblastoma multiforme. J Clin Oncol. 2007;25:4722–4729.
7. Sathornsumetee S, Desjardins A, Vredenburgh JJ, et al. Phase II trial of bevacizumab and erlotinib in patients with recurrent malignant glioma. Neuro Oncol. 2010;12:1300–1310.
8. Maher EA, McKee AC. In: Atlas of diagnostic oncology. 3. Skarin AT, Canellos GP, editor. London: Elsevier Science; 2003. Neoplasms of the central nervous system; pp. 5–10.
9. http://www.cancer.gov/cancertopics/pdq/treatment/adultbrain/HealthProfessional/page1
10. Central Brain Tumor Registry of the United States (CBTRUS) 2010 CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2004-2006. http://www.cbtrus.org/reports/reports.html
11. National Comprehensive Cancer Network clinical practice guidelines in oncology-central nervous system cancers. v.1.2010.
12. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. NEngl J Med, 2005. 352(10): p. 987-96.
13. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging consensus on its benefits. Neurology. 2007;68(21):1762–1763. doi: 10.1212/01.wnl.0000266866.13748.a9.
(TSPT) and Paratek Pharmaceuticals Sign Merger Agreement
Merger to result in NASDAQ-listed biopharmaceutical company whose lead asset is a novel Phase 3-ready, oral and intravenous antibiotic drug candidate designed to address the treatment needs of patients with serious community-acquired bacterial infections. Upon the closing of the merger, Paratek stockholders will acquire in the aggregate approximately 89.6 percent of the outstanding capital stock of Transcept in exchange for their shares in Paratek, and Paratek will become a wholly owned subsidiary of Transcept. Transcept stockholders will retain their existing equity in Transcept for an aggregate ownership stake of approximately 10.4 percent. Combined organization expects to be capitalized with cash and cash equivalents of between approximately $108 million and $111 million at the closing of the transaction, comprised of between approximately $15 million and $18 million of cash on hand at Transcept and Paratek and an additional approximately $93 million from a broad investor syndicat
BOSTON, Mass., and POINT RICHMOND, Calif., July 1, 2014 — Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) and Paratek Pharmaceuticals, Inc., a privately-held biopharmaceutical company, announced today that they have entered into a definitive merger agreement under which the stockholders of Paratek will become the majority owners of Transcept and the operations of Transcept and Paratek will be combined. As part of the proposed transaction, new investors (including The Baupost Group, Abingworth LLP, and other institutional investors); certain Transcept stockholders (including InterWest Ventures and Roumell Asset Management); and certain Paratek stockholders (including Omega Funds, HBM Healthcare Investments and Aisling Capital) will invest approximately $93 million in the combined organization.
Glenn Oclassen, Chief Executive Officer and Chairman of the Transcept Board, commented: “Following Transcept’s recent June 3, 2014 special cash dividend of approximately $25.4 million, this transaction with Paratek reflects the continued commitment of Transcept’s Board of Directors and management team to deliver value to Transcept’s stockholders. Under the proposed transaction, Transcept’s stockholders will maintain a meaningful equity ownership stake in Transcept, which will refocus its operations as a late-stage therapeutics company with product candidates we believe possess significant commercial potential. The transaction also provides for our stockholders an additional special cash dividend and the opportunity to realize any upside potential from our INTERMEZZO and TO-2070 assets.”
Michael Bigham, Chief Executive Officer and Chairman of the Paratek Board of Directors, commented: “Antibiotic resistance continues to be a growing public health concern worldwide. This transaction provides the financial support necessary for the Phase 3 development of our lead product candidate, Omadacycline, which is an important new once daily, oral and intravenous, broad-spectrum antibiotic for serious community-acquired infections. Omadacycline was designed specifically to address the mechanisms by which bacteria develop resistance to existing antibiotics. The combined organization will have the resources to initiate and complete our planned Phase 3 registration program, as agreed with FDA per Special Protocol Assessments, for both Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-acquired Bacterial Pneumonia (CABP). We will also explore additional potential indications including urinary tract infections (UTI).”
In a joint statement made by Paratek’s lead investors, Richard Lim, Partner at Omega Funds and Matthias Fehr, Partner at HBM Partners, said, “This transaction establishes a well-capitalized public company within which the management of Paratek may progress its late-stage drug pipeline through its pivotal studies. We are excited about the prospects for omadacycline to address the growing need for efficacious, safe and convenient oral and intravenous antibiotic drugs.”
About the Transaction
Paratek stockholders will receive newly issued shares of common stock of Transcept in connection with the merger contemplated by the merger agreement. Transcept will issue approximately 167.5 million new shares of its common stock to Paratek stockholders under the exchange ratio formula defined in the merger agreement. Upon the closing of the merger, existing Paratek equity holders are expected to own approximately 37.9 percent of Transcept, the persons investing in Paratek as of immediately prior to the closing of the merger are expected to own approximately 51.7 percent of Transcept, and existing Transcept equity holders are expected to own approximately 10.4 percent of Transcept, each on a fully-diluted basis. The exchange ratio is defined in the merger agreement and is subject to potential adjustments.
The merger agreement also contains further details with respect to a) the cash to be reserved for anticipated merger and holdback expenses of Transcept including patent enforcement expense obligations relating to INTERMEZZO; b) how further payments or royalty payments, if any, that are received relating to the sale of INTERMEZZO and TO-2070 assets will be disbursed to Transcept stockholders of record immediately prior to the Closing; and c) the excess cash that Transcept will distribute via an additional special cash dividend also to such Transcept stockholders of record immediately prior to the Closing.
The executive officers of Transcept will resign from their positions with Transcept upon the closing of the merger, and the executive officers of Paratek will assume their respective positions in Transcept. Paratek Pharmaceuticals, Inc. today announced that Michael F. Bigham, Partner at Abingworth LLP, has been appointed as Chairman of the Board of Directors and Chief Executive Officer. In addition, Dr. Evan Loh, Chief Medical Officer (CMO) at Paratek, has been promoted to President and CMO and will continue to serve on the Board of Directors.
Following the closing of the merger, the Board of Directors of Transcept is expected to consist of a total of seven members, two of whom will be designated by Transcept prior to the closing of the merger, and five of whom will similarly be designated by Paratek (and which will include the Chief Executive Officer of the combined organization).
The boards of directors of both Transcept and Paratek have unanimously approved the proposed transaction, which is subject to customary closing conditions, including approval by the stockholders of each of Transcept and Paratek. Transcept stockholders holding approximately 43 percent of its outstanding common stock have agreed to vote in favor of the transaction, and a majority of Paratek stockholders, have also agreed to vote in favor of the transaction. Subject to regulatory approvals and customary closing conditions, the transaction is currently expected to close during the second half of 2014.
If the transaction is consummated, Transcept’s name will be changed to Paratek Pharmaceuticals, Inc., and Transcept intends to apply to change its ticker symbol on The NASDAQ Global Market to “PRTK”.
Transcept was advised in the transaction by Leerink Partners, LLC and Paratek was advised by Ladenburg Thalmann & Co. Latham & Watkins LLP served as legal counsel to Transcept and Pepper Hamilton LLP served as legal counsel to Paratek. Cooley LLP and Ropes & Gray LLP served as legal counsels to certain investors.
About Paratek
Paratek is a biopharmaceutical company focused on the development, and commercialization of innovative antibiotics. Paratek’s lead product candidate, omadacycline, is a novel tetracycline-derived, broad-spectrum antibiotic being developed in both oral tablet and intravenous formulations for use as a first-line monotherapy antibiotic for acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), urinary tract infections (UTI) and other serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has received Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration for both the oral and intravenous formulations in all three of these infectious disease categories. Omadacycline has Special Protocol Assessment agreements with the U.S. Food and Drug Administration for the phase 3 trials planned in ABSSSI and CABP.
Paratek’s second product candidate, WC 3035, is a novel tetracycline-derived compound, with dual narrow-spectrum antibacterial and potent anti-inflammatory activity, for the treatment of acne and rosacea in the community setting. Paratek has licensed rights to WC 3035 for the treatment of acne and rosacea in the United States to a subsidiary of Actavis (formerly Warner Chilcott), while retaining rights in the rest of the world. Actavis is responsible for the clinical development of WC 3035 for the treatment of acne in the United States. A phase 3 program in moderate-severe acne is expected to be initiated in the second half of 2014 for WC 3035.
About Omadacycline
Omadacycline is a novel tetracycline-derived, broad-spectrum antibiotic being developed for use as a first-line empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as ABSSSI, CABP, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline was designed to provide broad spectrum activity, and possibly shorter hospital stays by allowing for the completion of therapy at home with an oral formulation, thereby potentially positioning omadacycline to become the primary antibiotic choice of physicians for the treatment of community-acquired bacterial infections. Omadacycline was designed with the following characteristics:
- Available in both once-daily IV and oral formulations: to enable reliable step-down therapy so that a patient could be discharged from the hospital more quickly to recover at home using an oral formulation of the same antibiotic
- Active against a broad-spectrum of bacteria, with projected coverage against nearly every type of community-acquired bacterial infection
- Well tolerated: based on clinical studies in more than 700 patients and subjects to date the drug candidate has demonstrated a favorable safety and tolerability profile
- Able to overcome bacterial resistance: omadacycline has demonstrated in vitro and in vivo activity against a wide spectrum of common bacterial pathogens resistant to currently used antibiotics.
About Transcept
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. Trancept’s remaining product development candidate is TO-2070, a novel rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug, which Transcept has developed through the completion of preclinical safety studies but has not initiated a Phase 1 human pharmacokinetic study. Transcept developed Intermezzo® from concept to its approval by the FDA in 2011. Purdue holds commercialization and development rights for Intermezzo in the United States. For further information about Transcept, please visit www.transcept.com. For information about Intermezzo, please visit www.MyIntermezzo.com.
Safe Harbor
Additional Information about the Merger and Where to Find It
In connection with the merger, Transcept and Paratek intend to file relevant materials with the Securities and Exchange Commission, or the SEC, including a registration statement on Form S-4 that will contain a prospectus and a joint proxy statement. Investors and security holders of Transcept and Paratek are urged to read these materials when they become available because they will contain important information about Transcept, Paratek and the merger. The proxy statement, prospectus and other relevant materials (when they become available), and any other documents filed by Transcept with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by Transcept by directing a written request to: Transcept Pharmaceuticals, Inc., 1003 W. Cutting Blvd., Suite #110, Point Richmond, California 94804, Attention: Investor Relations. Investors and security holders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the merger.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Participants in the Solicitation
Transcept and its directors and executive officers and Paratek and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Transcept in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of Transcept is also included in Transcept Annual Report on Form 10-K for the year ended December 31, 2013, which was filed with the SEC on March 14, 2014. This document is available free of charge at the SEC web site (www.sec.gov) and from Investor Relations at Transcept at the address described above.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the structure, timing and completion of our merger with Paratek, including any dividend in connection therewith; our continued listing on NASDAQ after the merger; our expectations regarding the capitalization, resources and ownership structure of the combined organization; the timing and nature of the planned equity investment and bridge loan in connection with the merger; possible future royalties on INTERMEZZO sales and potential proceeds from any sale of INTERMEZZO and TO-2070 assets; the nature, strategy and focus of the combined organization; the development and commercial potential of any product candidates, including Omadacycline; the executive and board structure of the combined organization; and expectations regarding voting by Transcept and Paratek stockholders. Transcept and/or Paratek may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our 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, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Transcept makes, including the risks described in the “Risk Factors” section of Transcept periodic reports filed with the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments Transcept may enter into or make. Transcept does not assume any obligation to update any forward-looking statements, except as required by law.
Conference Call Information
A conference call and webcast will be held on July 1, 2014, 8am ET to be led by Dr. Loh and Mr. Oclassen, to discuss the proposed transaction.
Dial-in (U.S.): (877) 638-4558
Dial-in (International): (914) 495-8537
The webcast can be accessed on the Investors page of the Transcept website at www.transcept.com and will be available for replay until close of business on September 30, 2014.
Contacts:
Paratek Pharmaceuticals, Inc.
Evan Loh
President and Chief Medical Officer
(617) 275-0040 x223
eloh@Paratekpharm.com
Transcept Pharmaceuticals, Inc.
Leone Patterson
Vice President, Chief Financial Officer
(510) 215-3500
lpatterson@transcept.com
(SLXP) Statistically Significant Primary Endpoint Results Rifaximin for IBS
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful outcome of TARGET 3 – a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of repeat treatment with rifaximin 550 mg TID (three times daily) for 14 days in subjects with irritable bowel syndrome with diarrhea, or IBS-D, who respond to an initial treatment course with rifaximin 550 mg TID for 14 days. In the study a statistically significant greater proportion of rifaximin treated subjects (as compared to placebo) responded to repeat treatment as assessed by the composite primary endpoint of IBS-related abdominal pain and stool consistency during the 4 week treatment-free follow-up period (Primary Evaluation Period, or PEP) in the Double Blind Repeat Treatment Phase.
“We are pleased that the outcome of TARGET 3 provides prospective controlled data to support the efficacy of repeat treatment with rifaximin,” stated Bill Forbes, PharmD, Executive Vice President, Medical, Research and Development and Chief Development Officer, Salix. “These data should provide adequate information for the basis of the product labeling used to guide patients and their health care providers on how to safely and most effectively administer repeat treatment of rifaximin in patients with IBS-D. Additionally, the outcome of TARGET 3 serves to corroborate the results of TARGET 1 and TARGET 2, the confirmatory Phase 3 trials for our supplemental New Drug Application seeking marketing approval for rifaximin as a treatment option for irritable bowel syndrome with diarrhea.”
About XIFAXAN 550 mg
Indication:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® (rifaximin) 550 mg tablets are contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is increased systemic exposure in patients with more severe hepatic dysfunction. The clinical trials were limited to patients with MELD scores < 25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
Concomitant administration of drugs that are P-glycoprotein (P-gp) inhibitors with XIFAXAN can substantially increase the systemic exposure to XIFAXAN. Caution should be exercised when concomitant use of XIFAXAN and a P-gp inhibitor such as cyclosporine is needed. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to XIFAXAN.
Based on animal data, XIFAXAN may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.
The most common adverse reactions occurring in ≥ 10% of patients and at a higher incidence than placebo in the clinical study were peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%).
XIFAXAN 550 mg is licensed by Alfa Wassermann S.p.A. to Salix Pharmaceuticals, Inc.
Please see complete Prescribing Information for XIFAXAN.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and commercialize them through the Company’s 500-member specialty sales force.
Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP”.
For more information, please visit our Website at www.salix.com or contact Salix at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma). Information on our Twitter feed, Facebook page and web site is not incorporated in our filings with the SEC.
The statements in this press release that are not historical fact are or might constitute projections and other forward-looking statements regarding future events. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, our expectations might not be attained. Forward-looking statements are just predictions and are subject to known and unknown risks and uncertainties that could cause actual events or results to differ materially from current expectations. Factors that could cause actual events or results to differ materially from those described in this press release include, among others: the unpredictability of the duration and results of regulatory review of New Drug Applications, Biologics License Agreements and Investigational NDAs, including risk that XIFAXAN (rifaximin) 550 mg will not receive the necessary regulatory approvals; the risk that products, including XIFAXAN (rifaximin) 550 mg (if approved), will not be accepted by the market or otherwise be commercially successful; the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; payer coverage for approved products; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; post-marketing approval regulation, including the ongoing Department of Justice investigation of Salix’s marketing practices; revenue recognition and other critical accounting policies; the need to acquire new products; general economic and business conditions and other factors. For additional information about the factors that could cause actual results to differ materially from forward-looking statements, please see Salix’s latest Form 10-Q and Form 10-K filed with the U.S. Securities and Exchange Commission. You should not place undue reliance on forward-looking statements, which speak only as of the date of this release. Except as is required by law, Salix expressly disclaims any obligation to publicly release any revisions to forward-looking statements to reflect events after the date of this release.
(VNRX) Announces New Chief Financial Officer
NAMUR, Belgium, July 1, 2014 — VolitionRx Limited (OTCQB: VNRX), a life sciences company, today announces the appointment of a new Chief Financial Officer (CFO), Mike O’Connell. Mr. O’Connell will take on this key role as VolitionRx works towards securing a listing on a senior US stock exchange.
Mike O’Connell is presently the CEO of Isosceles, a business accounting and HR consultancy which he founded in 2001 to provide high-quality accounting services to entrepreneurial companies of all sizes. He has held CFO and Financial Director (FD) roles at a number of private to public companies with multimillion dollar turnovers, including the role of CFO at InsightSoftware.com and FD at Pacific Group PLC. Mr. O’Connell was educated at Imperial College London before qualifying as a Chartered Accountant with Ernst and Young in London.
Cameron Reynolds, CEO of VolitionRx, said, “We are sorry to lose Malcolm Lewin; he has been an important member of the team since our inception. Mike O’Connell brings with him significant expertise in senior financial roles, in both UK and US companies.”
“I’m excited to be joining VolitionRx as CFO,” added Mike O’Connell. “It’s a fantastic company with such a promising technology, and I look forward to working with the team as we work towards an uplist to a senior US stock exchange.”
About VolitionRx
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present.
VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the US and ultimately, worldwide.
Visit VolitionRx’s website (www.volitionrx.com) or connect with us on Twitter, LinkedIn, Facebook or YouTube.
Media Contacts:
Charlotte Reynolds, VolitionRx
Telephone: +44 (0) 795 217 7498
Email: charlotte.reynolds@volitionrx.com
Eleanor Stuart, Racepoint Global
Telephone: +44 (0) 208 811 2124
Email: eleanor.stuart@racepointglobal.com
Investor Contact:
Scott Powell, VolitionRx
Telephone: +1 917 721 9480
Email: s.powell@volitionrx.com
Safe Harbor Statement
Statements in this press release may be “forward-looking statements”. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” and similar expressions, as they relate to the Company, its business or management, identify forward-looking statements. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Actual outcomes and results may, and probably will, differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including those described above and those risks discussed from time to time in the Company’s filings with the Securities and Exchange Commission.
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