Archive for March, 2016

(PARN) to Present at Jefferies Animal Health Summit

OVERLAND PARK, Kan., March 31, 2016  — Parnell Pharmaceuticals Holdings Ltd (NASDAQ:PARN), a fully integrated pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions, today announced that Robert Joseph, President and Chief Executive Officer, will be presenting at the Jefferies Animal Health Summit in New York on Thursday, March 31, 2016 at 10:45 AM ET.

The corporate slide presentation will be available on the Investors/Events & Presentations section of Parnell’s website at http://investors.parnell.com at the conclusion of the event.

About Parnell

Parnell (PARN) is a fully integrated, veterinary pharmaceutical company focused on developing, manufacturing and commercializing innovative animal health solutions. Parnell currently markets five products for companion animals and production animals in 14 countries and augments its pharmaceutical products with proprietary digital technologies – FETCH™ and mySYNCH®. These innovative solutions are designed to enhance the quality of life and/or performance of animals and provide a differentiated value proposition to our customers.  Parnell also has a pipeline of 7 drug products covering valuable therapeutic areas in orthopedics, dermatology, anesthesiology, nutraceuticals and metabolic disorders for companion animals as well as reproduction and mastitis for cattle.

For more information on the company and its products, please visit www.parnell.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of the U.S. Private Securities Reform Act of 1995. Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “develops,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify forward-looking statements. Forward-looking statements represent management’s present judgment regarding future events and are subject to a number of risk and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding Parnell’s research and development activities, its ability to conduct clinical trials of product candidates and the results of such trials, as well as risks and uncertainties relating to litigation, government regulation, economic conditions, markets, products, competition, intellectual property, services and prices, key employees, future capital needs, dependence on third parties, and other factors, including those described in Parnell’s Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, on March 4, 2016, along with its other reports filed with the SEC. In light of these assumptions, risks, and uncertainties, the results and events discussed in any forward-looking statements contained in this press release might not occur. Investors are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Parnell is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events, or otherwise.

Parnell Pharmaceuticals Holdings
Robert Joseph, 913-274-2100
Robert.joseph@parnell.com
Thursday, March 31st, 2016 Uncategorized Comments Off on (PARN) to Present at Jefferies Animal Health Summit

(HART) Changes Name to Biostage, Inc. (NASDAQ: BSTG)

Name Change is Capstone of Corporate Rebranding Initiative for the Bioengineered Organ Implant Developer (www.biostage.com) – Trading Under Nasdaq Symbol “BSTG” begins April 1, 2016

HOLLISTON, Mass., March 31, 2016  — Harvard Apparatus Regenerative Technology, Inc. (NASDAQ: HART) announced today it has changed its corporate name to Biostage, Inc. and will trade under the Nasdaq symbol “BSTG” effective April 1, 2016. Concurrently, the company has launched a new web site www.biostage.com to provide greater clarity and visibility for its technology.

The name change reflects the company’s broad commitment and expertise in pioneering the development of bioengineered organ implants for the esophagus, bronchus and trachea. It also eliminates market confusion with its former parent company from which it was spun-out in November 2013.

Jim McGorry, CEO, commented, “The Biostage™ name change reflects the evolution of our focus from commercializing bioreactors and research tools to the pioneering development of bioengineered organ implants for the esophagus, bronchus, and trachea. We have changed our company name to Biostage to better communicate and differentiate our new Cellframe™ technology and strategic direction.”

The Biostage name embodies the company’s “biotechnology” focus on bioengineered implants that provide critical “staging” for the body’s innate healing processes with its new Cellframe™ technology platform. Mr. McGorry added, “Cellframe employs a process in which the patient’s own stem cells are taken from a simple adipose/fat tissue biopsy, the cells are first isolated, expanded and then seeded onto a proprietary biocompatible scaffold that mimics the natural dimensions of the damaged organ. After incubation in our proprietary bioreactor, the Cellspan implant is ready to be implanted. Cellspan implants are designed to deliver the necessary cues for triggering, guiding, and modulating the regenerative process.

“Biostage is the result of a nearly two-year corporate transformation that centered on people, research, and technologies. We put in place a deeply experienced management team and board of directors to effectively lead our team of cell biology experts, materials scientists, and engineers to develop and pursue a clearly-defined set of research, regulatory, and commercialization goals. Biostage has also expanded its research partnership base to cost-effectively add technology resources critical to our success. Collectively, these efforts allow Biostage to pursue a new approach to restoring function to damaged organs for patients who deserve better clinical solutions and improved outcomes.”

Biostage’s Initial IND to Focus on Cellspan Esophageal Implant
Biostage’s Cellframe technology features a biocompatible scaffold seeded with a recipient’s own stem cells to create Cellspan™ implants for treatment of life-threatening conditions of the esophagus, trachea, and bronchus. Key large-animal data for Biostage’s Cellspan esophageal and other implants was first announced in November 2015.

Based on its preclinical data, Biostage identified life-threatening conditions of the esophagus as the initial clinical application to advance its Cellspan esophageal implant. Biostage plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (USFDA) in late 2016, seeking to initiate clinical trials in humans.

Biostage is currently expanding its preclinical testing of its Cellspan esophageal implants in collaboration with Mayo Clinic to support its planned IND application. The company anticipates providing an update on its preclinical research collaboration mid-second quarter 2016.

Biostage Introductory Video: Cellframe Technology Animation

About Biostage, Inc.: www.biostage.com
Biostage is a biotechnology company developing bioengineered organ implants based on the company’s new Cellframe ™ technology. Biostage’s Cellframe technology uniquely combines a proprietary biocompatible scaffold with a patient’s own stem cells to create Cellspan implants. These novel implants are being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its Cellframe technology.

Cellspan implants are being advanced and tested in a preclinical collaborative study with Mayo Clinic. This testing of Biostage’s Cellspan esophageal implants is intended to expand the company’s preclinical data in support of its goal of filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in late 2016, seeking to initiate clinical trials in humans.

Forward-Looking Statements:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any Biostage products, including its Cellframe ™ technology, by the FDA, EMA, MHRA or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of Biostage products, including its Cellframe technology,  which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for the our Cellframe technology, bioreactors, scaffolds and other devices and product candidates we pursue; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Media/Investor Relations Contact:
Tom McNaughton David Collins, Bill Jones, Helen Sun
Chief Financial Officer Catalyst Global LLC
774-233-7321 212-924-9800 w; 917 734-0339 m
bstg@catalyst-ir.com
Thursday, March 31st, 2016 Uncategorized Comments Off on (HART) Changes Name to Biostage, Inc. (NASDAQ: BSTG)

(SAJA) Appoints New Strategic Alliance Manager for Program Advancement

RIVER FALLS, Wis., March 31, 2016  — Sajan, Inc. (NASDAQ: SAJA), a leading provider of global language services and translation management system technology, appoints Brett Leagjeld as the new Strategic Alliance Manager for the advancement of the Strategic Alliance Program.

Sajan’s Strategic Alliance Program was developed to establish a strategic channel-selling approach for its translation services and technology solutions (i.e. SiteSync). The breadth of Sajan’s Strategic Alliance Program is enormous and the hire of Brett Leagjeld is a move to increase Sajan’s capacity to offer valuable collaboration and strengthen the program. The program’s goal is to allow Sajan’s proprietary technology to drive true value and efficiencies that impact the bottom line. Sajan’s alliance ecosystem will include traditional channel relationships as well as strategic partnerships with prebuilt integration. As a global company, Sajan’s alliances will span the globe.

Mr. Leagjeld’s role is to manage existing channel relationships, and to expand Sajan’s alliance ecosystem. He will continue to standardize the program management processes to ensure Sajan meets and exceeds expectations of those relationships. Leagjeld has nearly 20 years’ experience in the Information Services arena with a focus in finance and 10 years developing and managing Strategic Alliances and Channel Relationships.

Jeff Kent, Vice President of Professional Services at Sajan said, “We are excited to have Brett on board to cultivate and grow this program and these relationships. Technology in this space is key, and Sajan has this technology already. It’s the ability to provide a superior technology driven solution, coupled with a standardized yet flexible approach that will enable program growth. The expansion of this program allows Sajan to offer more to the evolving industry of language services.”

About Sajan
Sajan is a leading provider of global language translation and localization services, helping clients around the world expand seamlessly into any global market. The foundation of Sajan’s solution is its industry-leading language translation management system technology, Sajan Transplicity, which provides process automation and innovative multilingual content reuse to ensure schedule predictability, higher quality and cost efficiencies for its clients. By working closely with its clients, Sajan’s experienced team of localization professionals develops tailored solutions that lend flexibility to any large or small business that truly desires to “think globally but act locally.” Based in the United States, Sajan also has offices in Ireland, Spain and Singapore. Visit Sajan online at www.sajan.com.

Thursday, March 31st, 2016 Uncategorized Comments Off on (SAJA) Appoints New Strategic Alliance Manager for Program Advancement

(WLDN) Selected for SDG&E’s Energy Efficiency Implementation

Willdan Group, Inc. (“Willdan”)(NASDAQ: WLDN) today announced that it has executed a new six-year contract with San Diego Gas & Electric Company (SDG&E) for the delivery of electricity capacity savings. Through the delivery of the contracted capacity, Willdan estimates that approximately $90 million of revenue will be recognized in the program over the six-year contract term. The capacity reduction will be achieved by implementing energy efficiency conservation measures in existing commercial buildings throughout SDG&E’s service territory. The estimated value of the contract is based on the annual delivery of capacity reduction totaling 18.5 MW by the end of the six-year term in 2024. The contract between Willdan and SDG&E must be approved by the California Public Utilities Commission (CPUC) before work can commence. Based on the expected timeline for the contract approval process, the program is expected to begin in late 2016 or early 2017, with first deliveries under the contract in 2018.

Willdan’s energy efficiency Large Commercial Custom Program will help SDG&E meet its Local Capacity Requirements (LCR) as established by the CPUC’s landmark 2014 “Track 4 Decision.” Prompted by the permanent retirement of the San Onofre Nuclear Generation Station, the decision authorized SDG&E to procure between 500 MW and 800 MW of incremental replacement capacity by 2022. Of this amount, at least 200 MW must come from “preferred resources,” including cost-effective energy efficiency, demand response, renewable resources, distributed generation, and energy storage solutions.

“We are honored to have been awarded this contract for energy efficiency services by SDG&E,” commented Tom Brisbin, President/CEO of Willdan. “Through our existing SDG&E programs in the lodging, healthcare, biotech, and small commercial business sectors, Willdan has delivered 13 MW of electricity savings to date at over 500 large commercial customer sites and 3,000 small business sites in the utility’s service area. We look forward to building on our successful delivery of peak-load reduction and energy efficiency savings to SDG&E.”

Willdan’s program is designed to target and implement specific kW-rich HVAC-related energy efficiency measures in commercial buildings. While these measures are currently offered under SDG&E’s existing energy efficiency portfolio, they have experienced low implementation rates in commercial buildings in certain markets. Willdan’s approach to increasing these rates includes innovative strategies for outreach and enrollment, delivery of customized engineering solutions, flexible financing options, and personalized customer technical support. The energy savings achieved will be incremental to the existing portfolio, which is expected to facilitate the CPUC’s approval of the agreement later this year.

“Utilities are finding energy efficiency to be a reliable, cost effective, and environmentally friendly alternative to traditional capacity procurement,” added Brisbin. “It appears that this energy efficiency LCR, as well as other LCR contracts already released by SDG&E and Southern California Edison (SCE), signify a growing trend throughout California and nationwide.”

Willdan is well positioned to follow such a trend, having delivered energy efficiency savings totaling more than 125 MW of peak load capacity reduction for utilities nationwide, including NYSERDA, Con Edison, Bonneville Power Administration, and Puget Sound Energy.

About Willdan

Willdan provides professional consulting and technical services to utilities, public agencies and private industry throughout the United States. The Company’s service offerings span a broad set of complementary disciplines that include energy efficiency and sustainability, engineering and planning, financial and economic consulting, and national preparedness. Willdan provides integrated technical solutions to extend the reach and resources of its clients, and provides all services through its subsidiaries specialized in each segment. For additional information, visit Willdan’s website at www.willdan.com.

Forward Looking Statements

Statements in this press release that are not purely historical, including statements regarding Willdan’s intentions, hopes, beliefs, expectations, representations, projections, estimates, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that Willdan will not be able to expand its services or meet the needs of customers in markets in which it operates. It is important to note that Willdan’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, a slowdown in the local and regional economies of the states where Willdan conducts business and the loss of or inability to hire additional qualified professionals. Willdan’s business could be affected by a number of other factors, including the risk factors listed from time to time in Willdan’s SEC reports including, but not limited to, the Annual Report on Form 10-K filed for the year ended January 1, 2016. Willdan cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Willdan disclaims any obligation to, and does not undertake to, update or revise any forward looking statements in this press release.

 

Willdan Group, Inc.
Stacy McLaughlin
Chief Financial Officer
Tel: 714-940-6300
smclaughlin@willdan.com
or
Investor/Media Contact
Financial Profiles, Inc.
Tony Rossi: trossi@finprofiles.com
Tel: 310-622-8221

Thursday, March 31st, 2016 Uncategorized Comments Off on (WLDN) Selected for SDG&E’s Energy Efficiency Implementation

(GNCA) Genital Herpes Immunotherapy GEN-003: Sustained Reduction of Viral Shedding Rate

– Consistent efficacy across potential Phase 3 clinical trial endpoints –

– Once-yearly or less frequent maintenance dosing expected –

– Company to host conference call at 9 a.m. ET today –

CAMBRIDGE, Mass., March 31, 2016  — Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive 12 month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.

“We are very pleased with these data, which show that GEN-003 has strong and durable effects on both HSV-2 viral activity and genital herpes clinical disease, supporting our belief that GEN-003 could become a cornerstone treatment for patients affected by this serious disease. Specifically, a single course of treatment of GEN-003 may offer benefits similar to a full year of daily administration of oral antivirals – but with greatly improved convenience,” said Chip Clark, president and chief executive officer of Genocea. “We anticipate reporting virologic efficacy data for GEN-003 from our recently-initiated Phase 2b study in the third quarter of 2016, clinical efficacy data at 6 months post dosing around the end of 2016 and conducting our end of Phase 2 meeting with the FDA in the first quarter of 2017.”

”These 12 month data highlight the potential of GEN-003 to significantly enhance the genital herpes treatment landscape,”  said Lori A. Panther, M.D., MPH, infectious diseases specialist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School.  “Because of the physical and psychological impact of this disease, both patients and treating physicians would be eager to use an effective treatment that more conveniently improves control of outbreaks. The reduction in viral shedding, which is thought to cause the epidemic spread of genital herpes, is also encouraging.”

Genocea has already advanced the two most promising doses, 60 µg per protein combined with either 50 or 75 µg of Matrix-M2TM adjuvant, from this Phase 2 dose optimization study into an ongoing Phase 2b efficacy trial. The efficacy of GEN-003 at these two dose levels over the course of the Phase 2 dose optimization trial is as follows:

  60 µg per protein /
50 µg of Matrix-M2
60 µg per protein /
75 µg of Matrix-M2
Endpoint Post
dose 3
6
months
12
months
Post dose
3
6
months
12
months
Viral shedding
rate reduction*
41%
(p<0.0001)
46%
(p<0.0001)
64%
(p<0.0001)
55%
(p<0.0001)
58%
(p<0.0001)
52%
(p<0.0001)
% patients
lesion free
68 % 36 % 30 % 68 % 30 % 21 %
Genital lesion rate reduction* 69%
(p<0.0001)
50%
(p<0.0001)
65%
(p<0.0001)
60%
(p<0.0001)
43%
(p<0.0001)
47%
(p<0.0001)

Notes:
* Rate reduction vs. pre-dosing baseline levels. Poisson mixed effect model analysis.

Genocea plans to present the full data from the Phase 2 dose optimization trial at an upcoming scientific meeting.

About the GEN-003 Phase 2 Clinical Trial
This Phase 2 study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, twelve months following dosing. No booster doses were given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over across the 6 active combinations of GEN-003 and Matrix-M2 under a separate protocol.

For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.

Conference Call
Genocea management will host a conference call and webcast today at 9 a.m. ET to describe the 12 month efficacy data from the trial across all dose groups. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 81824505). A live webcast of the conference call will be available online from the investor relations section of the Company’s website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

About GEN-003
Inducing a T cell response against HSV-2 is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T-cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licenses from Novavax, Inc. For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.

About Genital Herpes
Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.

About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus (development suspended pending further data analysis and consultation with our advisers), and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.

Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising oncology vaccine and immunotherapy product candidates; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

 

For media: 
Liz Bryan
Spectrum Science Communications
O: 202-587-2526
lbryan@spectrumscience.com 

For investors: 
Jonathan Poole
Genocea Biosciences
O: 617-876-8191
jonathan.poole@genocea.com
Thursday, March 31st, 2016 Uncategorized Comments Off on (GNCA) Genital Herpes Immunotherapy GEN-003: Sustained Reduction of Viral Shedding Rate

(ISCO) Announces 2015 Fourth Quarter and Year-End Results

CARLSBAD, CA–(March 31, 2016) – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today provided a business update and announced fourth quarter and year-end financial results for the period ended December 31, 2015.

“2015 was a milestone year for ISCO. We made significant progress in our corporate priorities and received authorization by the Therapeutics Goods Administration in Australia to initiate a Phase I dose escalation clinical trial of human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC®) in patients with moderate to severe Parkinson’s disease (PD),” stated Andrey Semechkin, Ph.D., CEO and co-Chairman of ISCO. “In addition to Parkinson’s, our scientists are currently evaluating other therapeutic indications based on our stem cell technology platform. We believe that we are on track to bring a stroke program into clinical trial using ISC-hpNSC® and develop a therapy for osteoarthritis using the patient’s own cells. We anticipate continued momentum in 2016 and look forward to reporting on our progress.”

FY 2015 Financial highlights:

  • Operating income from Lifeline Skin Care and Lifeline Cell Technology wholly owned subsidiaries of International Stem Cell Corporations combined increased by 65% to $1.67 million for the year ended December 31, 2015, compared to $1.01 million in 2014;
  • $7.55 million in revenue for the year ended December 31, 2015, an increase of 8% compared to 2014; Lifeline Skin Care sales were stable and Lifeline Cell Technology sales were up 15%. Gross margin stable at 73%;
  • Average net cash used in operating activities of $343,000 per month for the year ended December 31, 2015; the company ended 2015 with cash of approximately $532,000.

Recent Corporate Highlights

  • Received approval to start clinical trial of ISC-hpNSC® for the treatment of Parkinson’s disease in Australia;
  • Developed technology with the potential to replace cartilage for the treatment of osteoarthritis;
  • Signed a clinical service agreement for the Phase 1 clinical study in Australia with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers;
  • In its Lifeline Skin Care business, the company launched new nano-compound products. In all of tests the proprietary compounds induced up to twice the production of elastin and collagen compared to Retinoic Acid (the active form of Retinol) with none of its toxic characteristics.

2016 Anticipated Events

  • Complete dosing in Phase I clinical study in Australia;
  • Report preliminary efficacy and safety clinical trial results;
  • Report on animal studies results for the treatment of stroke;
  • Report on animal studies results for the treatment of osteoarthritis.

Presentations & Publications

In 2015, the company presented comprehensive findings of its preclinical studies in Parkinson’s disease at:

  • The American Society for Neural Therapy and Repair Annual Meeting;
  • The 2015 American Academy of Neurology Annual Meeting;
  • The 21st annual meeting of the International Society for Cellular Therapy;
  • The Society for Neuroscience Annual Meeting at Neuroscience 2015.
  • The Company published results of two proof of concept studies supporting the safety and efficacy of the company’s treatment of Parkinson’s Disease in peer-reviewed journal, Cell Transplantation.

In the first half 2016:

  • ISCO is planning to present at the American Society for Neural Therapy and Repair Annual Meeting in April.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link:

http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Safe harbor statement

Statements pertaining to anticipated developments, expected pre-clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share data)
December 31, December 31,
2015 2014
Assets
Cash and cash equivalents $ 532 $ 1,111
Accounts receivable, net of allowance for doubtful accounts of $20 and $19 at December 31, 2015 and December 31, 2014, respectively 539 453
Inventory, net 1,348 1,517
Prepaid expenses and other current assets 572 485
Restricted cash 50
Total current assets 2,991 3,616
Property and equipment, net 375 714
Intangible assets, net 3,223 2,795
Non-current inventory 489
Deposits and other assets 60 54
Total assets $ 7,138 $ 7,179
Liabilities and Stockholders’ Equity
Accounts payable $ 1,092 $ 670
Accrued liabilities 834 1,711
Related party payable 3,129 11
Advances 250 250
Fair value of warrant liability 239 4,216
Total current liabilities 5,544 6,858
Commitments and contingencies
Stockholders’ Equity
Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000 and 300,000 issued and outstanding at December 31, 2015 and December 31, 2014, respectively, with liquidation preferences of $366 and $421 at December 31, 2015 and December 31, 2014, respectively
Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 shares issued and outstanding, with liquidation preference of $4,320
Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and outstanding, with liquidation preference of $5,000 5 5
Series H-1 Convertible Preferred stock, $0.001 par value, 0 and 2,000 shares authorized at December 31, 2015 and December 31, 2014, respectively, 0 and 1,482 issued and outstanding at December 31, 2015 and December 31, 2014, respectively
Series H-2 Convertible Preferred stock, $0.001 par value, 0 and 500 shares authorized at December 31, 2015 and December 31, 2014, respectively, 0 and 500 issued and outstanding at December 31, 2015 and December 31, 2014, respectively
Common stock, $0.001 par value, 720,000,000 shares authorized at December 31, 2015 and December 31, 2014, 2,808,598 and 1,596,195 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively (1) 3 2
Additional paid-in capital 98,970 95,063
Accumulated deficit (97,384 ) (94,749 )
Total stockholders’ equity 1,594 321
Total liabilities and stockholders’ equity $ 7,138 $ 7,179
(1) See Note 1, “Reverse Stock Split”
See accompanying notes to the consolidated financial statements.
International Stem Cell Corporation and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
Years Ended
December 31,
2015 2014
Revenues
Product sales $ 7,551 $ 7,017
Total revenue 7,551 7,017
Expenses
Cost of sales 2,056 1,921
Research and development 2,707 5,386
Selling and marketing 2,637 2,785
General and administrative 4,715 5,605
Total expenses 12,115 15,697
Loss from operating activities (4,564 ) (8,680 )
Other income (expense)
Change in fair value of warrant liability 1,980 2,405
Fair value of warrant liability in excess of proceeds (1,780 )
Financing transaction costs (997 )
Warrant exchange inducement expense (3,445 )
Interest expense (11 ) (2 )
Sublease income 1 30
Miscellaneous expense (41 ) (9 )
Total other income (expense), net 1,929 (3,798 )
Loss before income taxes (2,635 ) (12,478 )
Provision for income taxes
Net loss $ (2,635 ) $ (12,478 )
Net loss applicable to common stockholders $ (2,635 ) $ (12,478 )
Net loss per common share-basic (1) $ (1.33 ) $ (9.71 )
Net loss per common share-diluted (1) $ (2.26 ) $ (10.34 )
Weighted average shares-basic (1) 1,984 1,285
Weighted average shares-diluted (1) 2,038 1,207
(1) See Note 1, “Reverse Stock Split”
See accompanying notes to the consolidated financial statements.

Contacts:

International Stem Cell Corporation
Russell Kern, PhD
Executive Vice President, CSO
Phone: 760-940-6383
Email: ir@intlstemcell.com

Media:
Alex Fudukidis
Phone: (646) 942-5632
Email: Alex.Fudukidis@russopartnersllc.com

Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com

Thursday, March 31st, 2016 Uncategorized Comments Off on (ISCO) Announces 2015 Fourth Quarter and Year-End Results

(CPST) Executives Double-Down on Cost Reduction Plan, Cancel Unvested Stock Options

CHATSWORTH, Calif., March 30, 2016  — Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST), the world’s leading clean technology manufacturer of microturbine energy systems, announced today that Capstone’s executive management team has voluntarily agreed to cancel and terminate a total of 65,509 unvested stock options that had been previously issued to them. The executive management team did not receive anything in return for the cancellation and termination of the unvested stock options. This is a part of Capstone’s ongoing cost-cutting measures and is expected to reduce the company’s stock compensation expense by approximately $667,000 that otherwise would have been recognized upon the vesting of the stock options over a weighted average period of approximately 2.3 years.

Darren Jamison, President and Chief Executive Officer of Capstone Turbine, said, “This serves as another example of our executive management team’s dedication and willingness to take proactive measures as we continue to execute our three-pronged recovery plan to reduce operating expenses, diversify and increase revenue, and improve gross margin.”

In light of multiple macroeconomic headwinds the company faced, Capstone launched an aggressive cost reduction campaign last April when it flattened its organizational structure to lower operating costs and eliminate three executive positions, which saved the company an estimated $2 million annually in salaries, equity, benefits, bonuses, and travel costs after payment of associated employee severance benefits. The company has since gone on to voluntarily suspend the executive bonus program and employee merit increases, as well as implement organizational spending cuts focused on Sales & Marketing, Research & Development, and General & Administrative expenses.

Mr. Jamison concluded, “We still have much to do and a lot of hard work ahead of us, but I am confident that our team is on track to achieve our goals as we continue to operate in a challenging business environment. We are focused on reaching EBITDA breakeven as quickly as possible as we execute our plan to lower our breakeven to a $25 million quarterly revenue level. We are extremely proud of our recent C1000 Signature Series product launch, CHP growth in the U.S. and emerging markets, and the revenue growth opportunities that we believe our new Capstone finance entity will bring us.”

About Capstone Turbine Corporation

Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST) is the world’s leading producer of low-emission microturbine systems and was the first to market commercially viable microturbine energy products. Capstone Turbine has shipped over 8,700 Capstone Microturbine systems to customers worldwide. These award-winning systems have logged millions of documented runtime operating hours. Capstone Turbine is a member of the U.S. Environmental Protection Agency’s Combined Heat and Power Partnership, which is committed to improving the efficiency of the nation’s energy infrastructure and reducing emissions of pollutants and greenhouse gases. A UL-Certified ISO 9001:2008 and ISO 14001:2004 certified company, Capstone is headquartered in the Los Angeles area with sales and/or service centers in the New York Metro Area, United Kingdom, Mexico City, Shanghai and Singapore.

The Capstone Turbine Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6212

This press release contains “forward-looking statements,” as that term is used in the federal securities laws, about the success of our strategic initiatives, reduction in operating expenses, diversification and growth of revenue, and improvement in gross margin. Forward-looking statements may be identified by words such as “expects,” “objective,” “intend,” “targeted,” “plan” and similar phrases. These forward-looking statements are subject to numerous assumptions, risks and uncertainties described in Capstone’s filings with the Securities and Exchange Commission that may cause Capstone’s actual results to be materially different from any future results expressed or implied in such statements. Capstone cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Capstone undertakes no obligation, and specifically disclaims any obligation, to release any revisions to any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

“Capstone” and “Capstone MicroTurbine” are registered trademarks of Capstone Turbine Corporation. All other trademarks mentioned are the property of their respective owners.

 

CONTACT:  Capstone Turbine Corporation
Investor and investment media inquiries:
818-407-3628
ir@capstoneturbine.com

INVESTORS:
Dian Griesel Int’l
Cheryl Schneider/Tom Caden
212-825-3210
Wednesday, March 30th, 2016 Uncategorized Comments Off on (CPST) Executives Double-Down on Cost Reduction Plan, Cancel Unvested Stock Options

(OASM) Enrollment of First Patient in Clinical Study with Docecal

Oasmia’s next-generation cancer treatment candidate Docecal, a formulation of the blockbuster docetaxel in combination with Oasmia’s patented nanoparticle-based technology XR17, has enrolled its first patient as part of a randomized Phase I clinical trial.

Uppsala, Sweden, March 30, 2016  — Oasmia Pharmaceutical AB (NASDAQ: OASM), a developer of a new generation of drugs within human and veterinary oncology, announced today that the first patient has been enrolled in the Phase I clinical study of the Company’s next-generation cancer treatment candidate Docecal, to be performed internationally. Docecal was approved for clinical trials in December, 2015.

Docecal is a nanoparticle and water-soluble formulation of docetaxel, one of the most commonly used anti-cancer substances in oncology today, in combination with the Company’s patented technology XR17. A standard treatment for multiple cancers including prostate, breast, lung and stomach, docetaxel is the most active substance in the cytostatic Taxotere(r), marketed by the global healthcare provider Sanofi-Aventis. Prior to the patent expiration in 2010, Sanofi-Aventis executed $3 billion in Taxotere sales 2009. Taxotere has continued to perform well.

About Docecal

Docecal is a water soluble formulation of docetaxel in combination with Oasmia’s patented technology XR17. Docetaxel is standard treatment for a variety of different kinds of cancers, such as prostate cancer, breast cancer, lung cancer and stomach cancer.

About Oasmia Pharmaceutical AB

Oasmia Pharmaceutical AB develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).

Julian Aleksov, Executive Chairman
Tel: +46 18 50 54 40
E-mail: julian.aleksov@oasmia.com

For media relations:
Eric Fischgrund
Tel: +1 646 699 1414
E-mail: eric@fischtankpr.com

Wednesday, March 30th, 2016 Uncategorized Comments Off on (OASM) Enrollment of First Patient in Clinical Study with Docecal

(VNR) Signs Agreement to Sell SCOOP/STACK Assets in Oklahoma

HOUSTON, March 30, 2016  — Vanguard Natural Resources, LLC (NASDAQ:VNR) (“Vanguard” or “the Company”) today announced it has entered into a definitive agreement to sell its natural gas, oil and natural gas liquids assets in the SCOOP/STACK area in Oklahoma for $280 million, subject to typical purchase price adjustments at closing, to entities managed by Titanium Exploration Partners, LLC. The effective date of the sale is January 1, 2016 and the Company anticipates closing this acquisition on or before May 18, 2016. At closing, Vanguard anticipates providing updated operating and financial guidance for 2016. Proceeds from the sale will be used to reduce borrowings under the Company’s reserve-based credit facility. RBC Richardson Barr acted as exclusive advisor to Vanguard for this transaction.

About Vanguard Natural Resources, LLC

Vanguard Natural Resources, LLC is a publicly traded limited liability company focused on the acquisition, production and development of oil and natural gas properties. Vanguard’s assets consist primarily of producing and non-producing oil and natural gas reserves located in the Green River Basin in Wyoming, the Permian Basin in West Texas and New Mexico, the Gulf Coast Basin in Texas, Louisiana, Mississippi and Alabama, the Anadarko Basin in Oklahoma and North Texas, the Piceance Basin in Colorado, the Big Horn Basin in Wyoming and Montana, the Arkoma Basin in Arkansas and Oklahoma, the Williston Basin in North Dakota and Montana, the Wind River Basin in Wyoming, and the Powder River Basin in Wyoming. More information on Vanguard can be found at www.vnrllc.com.

About Titanium Exploration Partners, LLC

Titanium Exploration Partners, LLC, is a Dallas, Texas-based oil and gas investment firm managed by Charles B. “Chip” Simmons, CEO and Peter M. Halloran, Executive Chairman and Chief Investment Officer.  Titanium’s current assets consist primarily of producing and non-producing oil and natural gas reserves located in the Eagle Ford Shale play in South Texas and in the SCOOP/STACK area in Oklahoma.  Titanium considers investments in operated and non-operated assets in all US shale plays.  See www.titaniumep.com.

Forward-Looking Statements

We make statements in this news release that are considered forward-looking statements within the meaning of the Securities Exchange Act of 1934. These forward-looking statements are largely based on our expectations, which reflect estimates and assumptions made by our management. These estimates and assumptions reflect our best judgment based on currently known market conditions and other factors. Although we believe such estimates and assumptions to be reasonable, they are inherently uncertain and involve a number of risks and uncertainties that are beyond our control. In addition, management’s assumptions about future events may prove to be inaccurate. Management cautions all readers that the forward-looking statements contained in this news release are not guarantees of future performance, and we cannot assure you that such statements will be realized or the forward-looking events and circumstances will occur. Actual results may differ materially from those anticipated or implied in the forward-looking statements due to factors listed in the “Risk Factors” section in our SEC filings and elsewhere in those filings. All forward-looking statements speak only as of the date of this news release. We do not intend to publicly update or revise any forward-looking statements as a result of new information, future events or otherwise.

INVESTOR RELATIONS CONTACT: 
Vanguard Natural Resources, LLC
Lisa Godfrey, Director of Investor Relations
832-327-2234
investorrelations@vnrllc.com
Wednesday, March 30th, 2016 Uncategorized Comments Off on (VNR) Signs Agreement to Sell SCOOP/STACK Assets in Oklahoma

(KTWO) to Present at the 15th Annual Needham Healthcare Conference

LEESBURG, Va., March 30, 2016  — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive spine technologies and techniques, today announced that the Company’s Chief Financial Officer, Greg Cole, will participate in the 15th Annual Needham Healthcare Conference at the Westin Grand Central Hotel in New York, New York. Mr. Cole will host a presentation with investors on Tuesday, April 12 at 11:20 a.m. Eastern Time.

A live audio webcast of the presentation will be provided under the ‘Events & Presentations’ section of the Company’s investor relations website at http://Investors.K2M.com/. It is recommended that listeners log on 15 minutes early in order to register and download any necessary software. An archive of the webcast will be available for replay following the conference.

About K2M

K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarters facility; or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions, voluntary corrective actions or agency enforcement actions; a recall of our products, withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials; the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.

We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward looking statements and you should not place undue reliance on our forward-looking statements.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
Wednesday, March 30th, 2016 Uncategorized Comments Off on (KTWO) to Present at the 15th Annual Needham Healthcare Conference

(STAF) Greenridge Global Issues Buy Rating and $6 Price Target

NEW YORK, NY–(March 30, 2016) – Greenridge Global Equity Research has initiated coverage on Staffing 360 Solutions, Inc. (NASDAQ: STAF), an international staffing services provider embarking on a rollup acquisition model with a near-term goal of reaching $300 million in annual revenue, with its newly released research report that includes a Buy Rating and a $6.00 price target.

Greenridge Global’s Report can be viewed at: http://tinyurl.com/h7lajjg

Staffing 360 Solutions focuses on staffing companies located in the United States and abroad in the United Kingdom that service one or more of its five pillars: Accounting & Finance, IT, Engineering, Administration and Light Industrial. Staffing 360 Solutions looks for acquisition candidates that are located in the same geographic region, have a strong owner/operator, and are larger, in size, in terms of revenue (targeting at least $20 million in annual revenue).

In Greenridge Global’s report, analyst, William Gregozeski, CFA, highlighted a number of key points to consider when reviewing Staffing 360 Solutions:

  • Staffing 360 Solutions is embarking on a roll-up strategy, having acquired seven white-collar staffing firms with a mix of cash, stock and notes/earn-outs in the last three years. Management believes it can continue building the business through organic and acquired growth, potentially becoming an attractive acquisition target by a major along the way.
  • Pending the availability of cash from a financing, management has several staffing companies in its acquisition pipeline that, if all were to close, would bring STAF over its initial target of $300 million in annual revenue.
  • Staffing 360 Solutions has an experienced management team that employs its Intelligent Integration approach to its acquisitions, which in conjunction with selecting higher margin targets in fast growing staffing segments, has yielded organic revenue growth above industry averages.
  • Staffing 360 Solutions trades at more than a two-thirds discount to comparable smaller publicly listed staffing companies and multiples paid for privately held staffing companies. We expect the Company will move more in line with its peer group in the coming quarters.
  • Trading in STAF is extremely illiquid, as it currently has roughly 350,000 shares in the float. The registration of all remaining shares and share equivalents, along with the sale of new shares should help build a more liquid market that is less subject to the big percentage swings it has seen in trading since the company’s reverse split.
  • The increase in the fully diluted share count will likely be somewhat minimized when Staffing 360 Solutions completes a placement in the coming months on account of the roughly 90,000 warrants exercisable at $18.00 expiring in the next few months and the 500,000 warrants exercisable at $20.00 expiring in one year.

William Gregozeski said in his valuation of Staffing 360 Solutions, “We are initiating coverage of Staffing 360 Solutions with a Buy rating and $6.00 target price. Despite showing above average organic industry growth rates, the Company is valued at a significant discount to its peers, especially on an EV/Revenue basis. While it looks fairly priced on a trailing EV/aEBITDA metric, we note it is skewed given STAF’s recent move to positive aEBITDA and expect the continued growth in aEBITDA will be reflected with a higher stock price. We believe the Company will continue to trade at discounts to its peers until it works through it cash obligations and increases its aEBITDA margin. Our target price is based on an EV/aEBITDA multiple of 7.0 times our forward twelve month aEBITDA estimate of $6.65 million.”

About Stock Market Media Group

Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles.

Stock Market Media Group may from time to time include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at: www.sec.gov, where you can also find all the company’s filings and disclosures. We also recommend, as a general rule, that before investing in any securities you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.

We are not a registered broker, dealer, analyst, or adviser. We hold no investment licenses and may not sell, offer to sell or offer to buy any security. Our publications about any of the companies we write about are not a recommendation to buy or sell a security.

SEC RULE 17b

COMPENSATION DISCLOSURE

Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment. In order to be in full compliance with the Securities Act of 1933, Section 17(b), we are disclosing that we were compensated $850 for content development related to Staffing 360 Solutions, Inc. by a third party via a bank wire.

For more information: www.stockmarketmediagroup.com.

Contact:
Stock Market Media Group
info@stockmarketmediagroup.com

Wednesday, March 30th, 2016 Uncategorized Comments Off on (STAF) Greenridge Global Issues Buy Rating and $6 Price Target

(DRWI) Launches eCommerce Store for Accessory Sales

Offerings include parts and accessories for network maintenance, feature and capacity upgrades, and Harmony Radio Lite

OTTAWA, CANADA–(March 30, 2016) – DragonWave Inc. (TSX:DWI)(NASDAQ:DRWI) today announced it has launched a new online eCommerce store to better serve its customers, and to streamline the ordering and delivery of parts and accessories essential to the maintenance of networks employing the company’s industry leading microwave radios. The launch of the eCommerce store opens a complementary sales channel to the company’s strong distributor and reseller network, which continues to represent the majority of DragonWave sales.

The newly launched eCommerce store is accessible from the DragonWave homepage, and provides a single access point for global customers to more easily order extended technology features and capacity upgrades, as well as place orders for DragonWave’s Harmony Radio Lite.

“In today’s competitive arena mobile operators are faced with the challenge of providing reliable and outstanding service to their customers at a time when capacity demand is growing exponentially, making network maintenance and augmentation crucial to operational efficiency,” said Greg Friesen, vice president, Product Management, DragonWave. “The new eCommerce store complements our existing sales channels and provides a means for our customers to more quickly resolve network issues, turn up higher capacity service, and ensure quality of service for their mobile users.”

About DragonWave

DragonWave® is a leading provider of high-capacity packet microwave solutions that drive next-generation IP networks. DragonWave’s carrier-grade point-to-point packet microwave systems transmit broadband voice, video and data, enabling service providers, government agencies, enterprises and other organizations to meet their increasing bandwidth requirements rapidly and affordably. The principal application of DragonWave’s products is wireless network backhaul. Additional solutions include leased line replacement, last mile fiber extension and enterprise networks. DragonWave’s corporate headquarters is located in Ottawa, Ontario, with sales locations in Europe, Asia, the Middle East and North America. For more information, visit http://www.dragonwaveinc.com.

DragonWave® is a registered trademark of DragonWave Inc.

Forward-Looking Statements

Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements as to DragonWave’s growth opportunities and the potential benefits of, and demand for, DragonWave’s products. These statements are subject to certain assumptions, risks and uncertainties, including our view of the relative position of DragonWave’s products compared to competitive offerings in the industry. Readers are cautioned not to place undue reliance on such statements. DragonWave’s actual results, performance, achievements and developments may differ materially from the results, performance, achievements or developments expressed or implied by such statements. Risk factors that may cause the actual results, performance, achievements or developments of DragonWave to differ materially from the results, performance, achievements or developments expressed or implied by such statements can be found in the public documents filed by DragonWave with U.S. and Canadian securities regulatory authorities. DragonWave assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Media Contact:
Nadine Kittle
Marketing Communications
DragonWave Inc.
nkittle@dragonwaveinc.com
613-599-9991 ext. 2262

Media Contact:
Becky Obbema
Interprose Public Relations
(for DragonWave)
Becky.Obbema@interprosepr.com
(408) 778-2024

Investor Contact:
Peter Allen
President & CEO
DragonWave Inc.
Investor@dragonwaveinc.com
613-599-9991 ext. 2222

Wednesday, March 30th, 2016 Uncategorized Comments Off on (DRWI) Launches eCommerce Store for Accessory Sales

(IDN)’s Age ID Initial Launch w/ Silver Leaf Wines & Spirits, Curbs Alcohol Sales to Minors

Alcohol Sales to Minors Deterred With Industry Leading Technology Solution

The latest innovation in threat identification and identity authentication is helping Silver Leaf Wines & Spirits prevent the illegal sale of alcohol to minors. Owner Victor Pittman is the first retailer in Mississippi to adopt Age ID® to make sure minors are not purchasing age-restricted products. Located in the Jackson suburban community of Ridgeland, Mississippi, the retailer is using Intellicheck‘s industry leading, patented technology solution to scan bar codes on driver licenses and other forms of identification to spot altered and fake IDs. Underage drinking is a threat to health and to highway safety. Intellicheck’s Age ID identifies and mitigates the potentially tragic results of this nationwide problem.

Pittman has been in the industry for 14 years and brings a unique perspective to the issues associated with the sale of age-restricted beverages to minors. He is Executive Vice President of American Beverage Licensees (ABL), the nation’s leading trade association for beer, wine and spirits retailers for 20,000 independent beverage retailers. Pittman also serves as President of the Mississippi Hospitality Beverage Association (MHBA), which advocates for over 600 independent package retailers. He regularly communicates with retailers across the state and the country that are committed to keeping their communities free from the tragedies that result far too often from underage access and consumption of alcoholic beverages. Pittman believes that sophisticated fake IDs are far too easily purchased. “Young people can go online and purchase fake IDs in minutes. It’s frustrating because it’s more than a business issue to me. This is my home and as a member of the community, I worry about our children.” He said Age ID is not only helping him and his employees make sure they are not selling age-restricted beverages to underage drinkers, but it’s also been able to catch individuals attempting to use fraudulent IDs. Pittman said Age ID has given his business yet another benefit in providing a new level of security in assuring he is complying with the regulations and laws that govern legal purchase age.

A survey by the U.S. Department of Health & Human Services’ Office of Adolescent Health revealed some sobering facts about underage drinking in Mississippi. Last updated in July 2013, the survey found that 37% of male high schoolers and 35% of their female counterparts self-reported having consumed alcohol in the 30-day period before they responded to the survey. 27% of these high school students also said they had ridden one or more times in a vehicle driven by someone who had been drinking alcohol in that same 30 day period.

According to Dr. William Roof, CEO of Intellicheck, “Retailers are facing tough challenges because the technology creating fake IDs has become so advanced it makes them extremely difficult to spot with the human eye. Age ID is an effective and inexpensive leading technology solution that provides real-time, accurate information that can prevent the sale of age-restricted products to young people and stop them from acting on decisions that can have life ending or life altering consequences.”

Intellicheck Mobilisa, Inc. (NYSE MKT:IDN), is an industry leader in threat identification and identity authentication, verification and validation solutions. Intellicheck’s Age IDidentity authentication and validation solution reads the barcode data encoded on driver licenses and government issued IDs, instantly verifying the authenticity of the ID and age information via a mobile device or with an integrated point of sale tool. Age ID draws on a comprehensive database, updated on an ongoing basis, to ensure information is timely and accurate. It provides the most up-to-date solution to the problem of spotting fake and altered IDs with its ability to read more than 200 unique DMV barcode formats from every U.S. state and Canadian province.

Intellicheck holds 25 patents pertaining to identification technology. Its real-time identity authentication and validation solutions support customers in the retail, hospitality, national defense, law enforcement, and financial markets. The Company’s products scan, authenticate and analyze components of identity documents including driver licenses, military identification cards and other government forms of identification containing magnetic stripe, barcode and smart chip information. Once extracted from the identity card, the information can be used to provide safety, security and efficiencies throughout these markets.

NOTE TO MEDIA: ONSITE DEMOS OF AGE ID AND INTERVIEWS AVAILABLE TODAY.
CALL OR TEXT SHARON SCHULTZ AT (301) 351-0109

About Intellicheck Mobilisa

Intellicheck Mobilisa is an industry leader in threat identification, identity authentication, verification and validation systems. Our technology makes it possible for our customers to enhance the safety and awareness of their facilities and people, improve customer service, and increase operational efficiencies. Founded in 1994, Intellicheck has grown to serve dozens of Fortune 500 companies including retail and financial industry clients, national defense clients at agencies, major seaports, and military bases, police departments, and diverse state and federal government agencies. For more information on Intellicheck Mobilisa, please visit http://www.intellicheck.com/.

 

Intellicheck Mobilisa, Inc.
Media and Public Relations:
Sharon Schultz, 301-351-0109
or
Investor Relations:
Gar Jackson, 949-873-2789

Tuesday, March 29th, 2016 Uncategorized Comments Off on (IDN)’s Age ID Initial Launch w/ Silver Leaf Wines & Spirits, Curbs Alcohol Sales to Minors

(GBT) Reports Recent Business Progress, Q4/FY15 Results

SOUTH SAN FRANCISCO, Calif., March 29, 2016  — Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today reported business progress and financial results for the fourth quarter and year ended December 31, 2015.

“In 2015, we successfully transformed GBT into a public company, while demonstrating clinical proof of concept for our lead program, GBT440, for the treatment of sickle cell disease,” said Ted W. Love, M.D., chief executive officer of GBT. “2016 will be focused on building on this momentum with the execution of several key milestones, including driving toward the initiation of a pivotal program with GBT440 in adults with sickle cell disease and generating results from a Phase 2a proof of concept study of GBT440 in patients with idiopathic pulmonary fibrosis.”

Recent Business Progress

Corporate

  • Appointed three new members to the Company’s Board of Directors, including Scott Morrison, a financial expert who was previously Ernst & Young’s U.S. Life Sciences Leader, Mike Bonney, previously CEO of Cubist Pharmaceuticals and a partner at Third Rock Ventures, and Glenn Pierce, M.D., Ph.D., a hematology R&D expert retired from Biogen. The Company also announced that Kevin Starr, a partner at Third Rock Ventures, retired from the Board.

Sickle Cell Disease (SCD)

  • Presented positive clinical data at the 2015 American Society of Hematology (ASH) Annual Meeting and Exposition from the ongoing Phase 1/2 clinical trial (the GBT440-001 study) supporting the potential of GBT440, an oral, anti-polymerization drug candidate that has the potential to be a disease-modifying treatment for SCD. Specifically, the data showed that GBT440 has the potential to inhibit polymerization of sickle hemoglobin, reduce red blood cell hemolysis, reduce anemia, improve tissue oxygen delivery, reduce the number of sickled red blood cells, and reduce inflammation. The results included data from 30 patients with SCD who have completed 28 days of treatment on GBT440 or placebo, and reinforce and expand on the safety and efficacy data previously reported in an initial cohort of eight patients.
  • Received orphan drug designation for GBT440 for the treatment of SCD from the U.S. Food and Drug Administration (FDA).
  • Initiated Part C of the GBT440-001 study to evaluate the effect of 90 days of treatment with GBT440 or placebo.
  • Received acceptance of two abstracts for presentation at the upcoming Sickle Cell Disease Research and Educational Symposium taking place April 14 –April 18 in Fort Lauderdale, Fla. The data will be encore presentations of the ASH data.

2016 Anticipated Milestones

Sickle Cell Disease

  • Present 90-day data in a cohort of patients with SCD from Part C of the ongoing Phase 1/2 study (GBT440-001).
  • Present data from the completion of 28 day cohorts, including 1,000 mg of GBT440, in patients with SCD from Part B of the ongoing Phase 1/2 study.
  • Initiate a Phase 2 pharmacokinetics (PK) study of GBT440 in pediatric SCD patients.
  • Initiate a pivotal program of GBT440 in adults, subject to agreement with regulatory authorities.
  • Explore the effect of GBT440 in SCD patients with HbSC and HbSbeta+ thalassemia genotypes.

Hypoxemic Pulmonary Disorders

  • Initiate a Phase 2a proof of concept study evaluating the effects of GBT440 on oxygen saturation in patients with idiopathic pulmonary fibrosis (IPF).
  • Initiate a Phase 2b IPF study, informed by the Phase 2a study results.
  • Initiate a clinical study in an acute hypoxemic pulmonary disorder, informed by the Phase 2a IPF study results.

Hereditary Angioedema

  • Complete IND-enabling toxicology studies, submit an IND, and initiate a Phase 1 study for GBT18713, an orally bioavailable kallikrein inhibitor.

Fourth Quarter and Year-End Financial Results

Cash and cash equivalents totaled $148.5 million at December 31, 2015 compared with $52.1 million at December 31, 2014, reflecting the $126.2 million of net proceeds from our initial public offering in August 2015.

Net loss and comprehensive loss for the three months ended December 31, 2015 was $15.6 million compared with $5.3 million for the same period in 2014. Net loss and comprehensive loss for the year ended December 31, 2015 was $46.4 million compared with $20.8 million for the same period in 2014. Basic and diluted net loss per share attributable to common stockholders for the three months ended December 31, 2015 was $0.53 compared with $3.27 for the same period in 2014. Basic and diluted net loss per share attributable to common stockholders for the year ended December 31, 2015 was $3.95 compared with $14.20 for the same period in 2014.

Research and development (R&D) expenses for the three months ended December 31, 2015 were $11.4 million compared with $4.1 million for the same period in 2014. R&D expenses for the year ended December 31, 2015 were $36.7 million compared with $16.3 million for the same period in 2014. The increase in R&D expenses for both comparative periods is primarily attributable to increased expenses related to the Company’s development of GBT440 for the treatment of SCD, including the ongoing Phase 1/2 clinical trial, and to the licensing of related intellectual property.

General and administrative (G&A) expenses for the three months ended December 31, 2015 were $4.2 million compared with $1.3 million for the same period in 2014. G&A expenses for the year ended December 31, 2015 were $9.7 million compared with $4.2 million for the same period in 2014. The increase in G&A expenses for both comparative periods is primarily attributable to higher employee-related costs associated with the growth of the Company’s operations and additional professional and consulting services related to being a public company.

About Global Blood Therapeutics

Global Blood Therapeutics, Inc. (GBT) is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its initial product candidate, GBT440, as an oral, anti-polymerization therapy for sickle cell disease (SCD) and is currently evaluating GBT440 in SCD patients in a randomized, placebo-controlled, double-blind Phase 1/2 clinical trial. In addition to GBT440 for the treatment of SCD, GBT is engaged in research and development activities targeted toward hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis (IPF) and other lung disorders, as well as hereditary angioedema (HAE). To learn more, please visit: www.globalbloodtx.com.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act. We intend these forward-looking statements, including statements regarding the therapeutic potential of GBT440 and our ability to receive data from our ongoing Phase 1/2 clinical study of GBT440, initiate our planned Phase 2 PK study of GBT440 in pediatric SCD patients, gain agreement from regulatory authorities on our pivotal program for GBT440 in adults, initiate our pivotal program, initiate our planned Phase 2a and Phase 2b clinical studies of GBT440 in IPF, successfully complete IND-enabling studies, submit an IND and commence a Phase 1 study of GBT18713 in hereditary angioedema, and the timing of these events, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the risks that our clinical and preclinical development activities may be delayed or terminated for a variety of reasons, that regulatory authorities may disagree with our clinical development plans or require additional studies or data to support further clinical investigation of our product candidate, and that drug-related adverse events may be observed in later stages of clinical development, along with those risks set forth in the prospectus for our initial public offering of common stock that was filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 12, 2015, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

 

GLOBAL BLOOD THERAPEUTICS, INC.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
Three Months Ended December 31, Year Ended
December 31,
2015 2014 2015 2014
Operating expenses:
Research and development $ 11,400 $ 4,063 $ 36,657 $ 16,324
General and administrative 4,198 1,251 9,736 4,187
Total operating expenses 15,598 5,314 46,393 20,511
Loss from operations (15,598) (5,314) (46,393) (20,511)
Change in fair value of Series A redeemable convertible preferred stock liability (297)
Interest income 13 1 33 1
Net loss and comprehensive loss $ (15,585) $ (5,313) $ (46,360) $ (20,807)
Net loss attributable to common stockholders $ (15,585) $ (6,214) $ (50,540) $ (23,772)
Net loss per share attributable to common stockholders, basic and diluted $ (0.53) $ (3.27) $ (3.95) $ (14.20)
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 29,317,707 1,901,322 12,806,697 1,673,919

 

 

GLOBAL BLOOD THERAPEUTICS, INC.
Condensed Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2015 2014
Assets
Current assets:
Cash and cash equivalents $ 148,502 $ 52,069
Prepaid expenses and other current assets 2,318 1,524
Total current assets 150,820 53,593
Other assets 2,254 2,163
Total assets $ 153,074 $ 55,756
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities $ 10,723 $ 2,537
Other noncurrent liabilities 1,556 384
Total liabilities 12,279 2,921
Redeemable convertible preferred stock 102,161
Total stockholders’ equity (deficit) 140,795 (49,326)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $ 153,074 $ 55,756
Tuesday, March 29th, 2016 Uncategorized Comments Off on (GBT) Reports Recent Business Progress, Q4/FY15 Results

(GALE) Phase 3 NeuVax™ Trial Achieves 70th Qualifying Disease Free Survival Event

Interim analysis results expected by the end of the second quarter

SAN RAMON, Calif., March 29, 2016  — Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced that the 70th qualifying disease free survival (DFS) event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax is a peptide immunotherapy vaccine currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials.

Based on clinical and radiological data, seventy qualifying DFS events have been confirmed by the trial’s independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. In the ensuing months, Galena will compile and submit the clinical data to the trial’s Independent Data Monitoring Committee (IDMC) to perform the Interim Analysis. The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial.

“We are pleased that we have achieved this important milestone in the PRESENT trial and that the rate of recurrences are in line with the original assumptions that led to the study design,” stated Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Reaching the 70th qualifying DFS event triggers the pre-planned Interim Analysis. We will now prepare the data package for the IDMC in order for the committee to evaluate the safety of NeuVax for all patients enrolled, perform a futility analysis, and provide its recommendation on continuing the trial.  We anticipate reaching this next milestone in the PRESENT trial at the end of the second quarter.”

Dr. Nejadnik continued, “The 70th event also represents a significant maturation of the program and is a meaningful time point as it brings us halfway to the full number of 141 events required for the primary endpoint analysis in conjunction with three years minimum follow-up. I am grateful to our clinical team, our committee’s physician experts, and our trial sites, as they have been instrumental in achieving this milestone.  With this point of progress in the trial, we are assembling our internal teams responsible for drafting our Biologics License Application.”

For the PRESENT trial, a qualifying DFS event is defined as: a recurrence of the primary breast cancer, either locally in the breast, regionally in the lymph nodes, or distantly as metastatic disease; an occurrence of another cancer; or, death from any cause. All qualifying DFS events are confirmed by the EAC. The IDMC is comprised of two medical oncologists, one cardiologist, and one statistician and will perform the Interim Analysis.

About PRESENT

PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) is an international, Phase 3 study to evaluate NeuVax plus granulocyte macrophage-colony stimulating factor (GM-CSF) versus placebo plus GM-CSF to prevent cancer recurrence.  The trial is being run under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or A3+.  The study is double blind, randomized 1:1, and is stratified by stage, type of surgery, hormone receptor status, and menopausal status. Galena enrolled a total of 758 patients who constitute the Intention to Treat (ITT) population, and the primary endpoint for the trial is disease free survival (DFS) upon reaching 141 events with 3 years minimum follow-up.  Additional information on the trial can be found here and at clinicaltrials.gov identifier: NCT01479244.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.  It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.

In addition to PRESENT, Galena also has two breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).  Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301.  NeuVax is currently in a pivotal, Phase 3 breast cancer clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302.   For more information, visit www.galenabiopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such statements include, but are not limited to, statements about the progress of the development of Galena’s product candidates, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities including the Phase 3 trial for NeuVax, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

NeuVax is a trademark of Galena Biopharma, Inc.

Contact:

Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709
ir@galenabiopharma.com

Tuesday, March 29th, 2016 Uncategorized Comments Off on (GALE) Phase 3 NeuVax™ Trial Achieves 70th Qualifying Disease Free Survival Event

(WATT) and Pegatron Agree to Integrate WattUp Wire-Free Charging Into Product Designs

Deal Accelerates the Development of an Ecosystem of WattUp-Enabled Devices, Ensuring Quality and Consistent Implementation Using Limited Energous Resources

SAN JOSE, CA–(March 29, 2016) –  Energous Corporation (“Energous” or “the Company”) (NASDAQ: WATT), the developer of WattUp®, a revolutionary wire-free charging technology for mobile and IoT devices that provides over-the-air contained power at a distance, today announced it has signed a definitive development agreement with Pegatron, a worldwide leader in electronic and computing DMS (Design and Manufacturing Service). This agreement names Pegatron as a non-exclusive partner to license the WattUp technology in both transmitter and receiver designs.

With equity of U.S. $2.7 billion, Pegatron boasts a diversified product line, including motherboards, desktop PCs, notebooks, broadband, wireless systems, game consoles, networking equipment, set-top boxes, multimedia, LCD TVs, and more. The collaboration gives Energous a leading, tier-1 OEM/ODM partner in Asia that can integrate Energous WattUp technology into applicable products in the Pegatron portfolio. Leveraging Pegatron resources will ensure quality and consistent implementation of the WattUp technology and accelerate the development, production and availability of a broader ecosystem of WattUp-enabled devices.

“We are extremely pleased to add Pegatron, a world-class tier-1 OEM/ODM, to our expanding list of WattUp licensees,” said Stephen R. Rizzone, President and CEO of Energous Corporation. “2016 is shaping up to be a breakout year for Energous as we continue to advance our key strategic partnership, focus on the Mini WattUp transmitter as our quickest path to revenue and ultimately execute on our long-term strategy of delivering wire-free power at a distance. Partnering with top-tier companies like Pegatron is a key part of our strategy to build out our ecosystem and further solidify our market-entry late this year, earlier next year.”

WattUp is a revolutionary, award-winning wire-free charging solution that delivers intelligent, scalable power via the same radio bands as a Wi-Fi router at a distance of up to 15 feet. Not only does the WattUp ecosystem enable full mobility while charging in a home, office or retail environment, Energous has an extensive partner portfolio and more than 250 patent filings protecting its technology platform. To learn more about Energous, please visit www.Energous.com.

About Pegatron Corporation
Pegatron is a leading DMS (Design and Manufacturing Service) company with extensive experience and proven capabilities in design innovations, product development, vertical integration and after-sale services. Renowned for its solid foundation of research and development in its core technologies, Pegatron boasts a diversified product line including server, notebook PCs, desktop PCs, tablets, motherboards, broadband products, smartphones, game consoles, etc. With worldwide manufacturing and service sites, Pegatron offers innovative service to customers at various locations. The Company also places great emphasis on the development of both software and hardware technologies to provide customers with total solutions and high value-added services. For more information, please visit: http://www.pegatroncorp.com.

About Energous Corporation
Energous Corporation is developing WattUp®, an award-winning wire-free charging technology that will transform the way people and industries charge and power their electronic devices at home, in the office, in the car and beyond. WattUp is a revolutionary, patent-pending solution that delivers intelligent, scalable power via the same radio bands as a Wi-Fi router. WattUp differs from current wireless charging systems in that it will deliver contained, useable power, at a distance, to multiple devices, resulting in a wire-free experience that saves users from having to remember to plug in their devices or place them on a mat. For more information, please visit www.energous.com, or follow Energous on Twitter or Facebook.

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements in this release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

IR Contact:
PondelWilkinson
Laurie Berman
Direct: 310-279-5962
ir@energous.com

Tuesday, March 29th, 2016 Uncategorized Comments Off on (WATT) and Pegatron Agree to Integrate WattUp Wire-Free Charging Into Product Designs

(OHRP) Announces SPA Agreement with US FDA and Initiation of Phase III

First of Two Planned Phase III Trials Initiated to Evaluate Squalamine (OHR-102) Combination Therapy for the Treatment of Wet AMD

NEW YORK, March 29, 2016  — Ohr Pharmaceutical, Inc. (NASDAQ:OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that it has reached an agreement on the Special Protocol Assessment (SPA) with the United States Food and Drug Administration (US FDA) on the design of the Phase III trial for its lead drug candidate, squalamine lactate ophthalmic solution, 0.2% (“Squalamine,” also known as OHR-102).  Based on the agreed upon SPA, Ohr has initiated the first of two planned Phase III global clinical studies evaluating the efficacy and safety of Squalamine, given in combination with Lucentis®, for the treatment of neovascular age-related macular degeneration (wet AMD).

“We are extremely pleased to have completed the SPA process. This agreement with the FDA enables us to move forward with the Squalamine Phase III clinical program,” commented Dr. Jason Slakter, CEO of Ohr. “The initiation of our Phase III clinical program is a monumental achievement for the company and represents an important step in our mission to develop and commercialize therapeutics for unmet medical needs in ophthalmology.”

“This is fantastic news for the retinal community and the patients in our care,” said Dr. David S. Boyer, retina specialist at Retina-Vitreous Associates Medical Group, Beverly Hills, CA, and a member of Ohr’s Scientific Advisory Board. “Based on my clinical experience, Squalamine is a promising drug with the potential to non-invasively improve visual function over the current standard of care. I look forward to the opportunity to enroll patients in this important clinical study.”

Dr. Avner Ingerman, Ohr’s Chief Clinical Officer, added, “We are working with the retinal community and Ohr’s Scientific Advisory Board to expeditiously implement a high-quality Phase III clinical development program to fully support future regulatory applications.”

The first of two randomized, double-masked, placebo-controlled trials will include approximately 165 centers in the United States and Canada and is expected to enroll approximately 650 treatment naïve subjects with wet AMD. The primary efficacy endpoint of the clinical trial is the change in visual function at nine months.

About a Special Protocol Assessment (SPA)
A Special Protocol Assessment (SPA) from the FDA is a special procedure by which the FDA provides official evaluation and written agreement that the design and planned analysis of a study adequately address the objectives necessary to support a regulatory submission. More information about the FDA’s Special Protocol Assessment process is available at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm080571.pdf

Phase III Clinical Program Design:
The comprehensive Phase III clinical program will be comprised of double-masked, placebo-controlled, multicenter, international studies of squalamine lactate ophthalmic solution, 0.2%, (“Squalamine”, also known as OHR-102) administered twice a day in subjects with newly diagnosed wet AMD, in combination with Lucentis® injections. The primary endpoint will be a measurement of visual acuity gains at nine months, with subjects followed to two years for safety. The eligibility criteria will include subjects with choroidal neovascularization (CNV) secondary to AMD. The lesions in these subjects may contain classic and/or occult CNV. The occult CNV component of these lesions must measure less than 10mm2 as assessed on fluorescein angiography.

About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (NasdaqCM:OHRP) is an ophthalmology research and development company. The company’s lead drug candidate, squalamine lactate ophthalmic solution, 0.2% (“Squalamine”, also known as OHR-102), is currently being studied as an eye drop formulation in clinical trials for back-of-the-eye diseases, including the wet form of age-related macular degeneration. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. Additional information on the company may be found at www.ohrpharmaceutical.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and we undertake no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA will approve final testing or marketing of any pharmaceutical product. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition.

LUCENTIS® (ranibizumab injection) is a registered trademark of Genentech Inc.

Contact:

Ohr Pharmaceutical Inc.	
Investor Relations		
888-388-2327			
ir@ohrpharmaceutical.com

LifeSci Advisors, LLC
Michael Wood
646-597-6983
mwood@lifesciadvisors.com
Tuesday, March 29th, 2016 Uncategorized Comments Off on (OHRP) Announces SPA Agreement with US FDA and Initiation of Phase III

(CTRV) CMX157 Outperforms Gilead’s Tenofovir AF (TAF) Against Hepatitis B

Results Confirm CMX157’s Increased Potency Versus Tenofovir and Viread® and Provide First Direct Comparison to TAF

EDISON, N.J., March 29, 2016  — ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, reported positive results from a third-party in vitro study that further validates CMX157’s profile as a highly potent anti-hepatitis B drug.  In this first head-to-head in vitro study, CMX157 compared favorably to tenofovir alafenamide fumarate (TAF), which was approved recently by the US Food and Drug Administration (FDA) as part of a four-drug combination therapy for HIV-1 (Genvoya®), and is currently under development by Gilead Sciences Inc. (GILD) for treating chronic hepatitis B infection.  ContraVir recently initiated a Phase 1/2a clinical study of CMX157, which is currently enrolling healthy volunteers and is anticipated to begin enrolling hepatitis B patients in the second quarter 2016.

The study compared the anti-hepatitis B activities of CMX157 and other tenofovir prodrugs, including tenofovir DF (Viread®), in order to profile CMX157 among this important class of antiviral therapies.  The study findings revealed that CMX157 and TAF were similarly potent against hepatitis B virus (HBV), with CMX157 trending toward higher potency (EC50 = 9.3 ± 3.6 nM vs. 32.4 ± 17.1 nM for CMX157 and TAF, respectively; and EC90 = 186 ± 53 nM vs 474 ± 261 nM for CMX157 and TAF, respectively).  Furthermore, viral rebound studies showed that CMX157 demonstrates best-in-class duration of activity.  Nine days following incubation with HBV, using two different experimental conditions, one at equimolar and one at EC90 concentrations, CMX157 showed two- to three-fold reduced viral rebound compared to TAF.  The study also confirmed earlier results, as reported previously by ContraVir, regarding the significantly increased potency of CMX157 compared to tenofovir.

About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir’s lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development.  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study.  ContraVir’s anti-Hepatitis B program is focused on CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus.  CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on ContraVir’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir’s Form 10-K for the year ended June 30, 2015, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Tiberend Strategic Advisors, Inc.
Josh Drumm (investors)
jdrumm@tiberend.com; (212) 375-2664

Claire Sojda (media)
csojda@tiberend.com; (212) 375-2686

Tuesday, March 29th, 2016 Uncategorized Comments Off on (CTRV) CMX157 Outperforms Gilead’s Tenofovir AF (TAF) Against Hepatitis B

(EIGR) Granted Orphan Medicinal Product Designation for Ubenimex

PALO ALTO, California, March 28, 2016  — Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) today announced that the European Medicines Agency (EMA) has granted Orphan Medicinal Product status to ubenimex for the treatment of pulmonary arterial hypertension (PAH).

“We are very pleased with the EMA Committee of Orphan Medicinal Products (COMP) designation of orphan status for ubenimex in PAH,” said Joanne Quan, MD, Chief Medical Officer at Eiger. “We will soon begin enrolling the LIBERTY study, a Phase 2, randomized, double-blind, placebo-controlled, multi-center study of ubenimex in PAH patients.”

About Ubenimex

Ubenimex is a well-characterized, oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase (LTA4H), the enzyme responsible for catalyzing the committed step in the formation of the pro-inflammatory mediator, LTB4. Ubenimex is approved in Japan as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku under the brand name, Bestatin™. Ubenimex is not approved for any indication in the US or Europe. Ubenimex received orphan drug designation for PAH in the US in November 2015.

About PAH

Pulmonary Arterial Hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. PAH begins when tiny arteries in the lungs, called pulmonary arterioles, become narrowed, blocked or destroyed. This makes it harder for blood to flow through the lungs, and raises pressure within the lungs’ arteries. As the pressure builds, the heart’s lower right chamber (right ventricle) must work harder to pump blood through the lungs, eventually causing the heart muscle to weaken and eventually fail. PAH is a progressive, life-threatening illness.

About Orphan Medicinal Product Designation

Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union. Orphan medicinal product designation qualifies the sponsor of the drug candidate for various development incentives, which may include fee waivers for regulatory procedures or a 10-year market exclusivity period following approval. Orphan medicinal product designation applies specifically to the active moiety and the indication for which it is granted, and is not applicable to other indications for that moiety.

About Eiger

Eiger is a clinical-stage biopharmaceutical company committed to bringing to market products for the treatment of rare diseases. The Company has built a diverse, clinical-stage portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology is clear and an effective therapy is urgently needed.

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, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not ubenimex may be further developed and approved, statements relating to the availability of cash for Eiger’s future operations, Eiger’s ability to develop its drug candidates for potential commercialization, the timing of the commencement and completion of Phase 2 trials. Eiger may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and one 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 Eiger makes, including the risks that Eiger’s planned clinical trials may be prolonged or delayed requiring Eiger to incur additional costs; that Eiger’s planned clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities; that Eiger’s product candidates may have undesirable side effects which may delay or prevent marketing approval; that, even if approved by the FDA or non-U.S. regulatory authorities, Eiger’s product candidates may not achieve broad market acceptance; and the risks described in the “Risk Factors” sections the Registration Statement on Form S-4 (file no. 333-208521) and of Eiger’s periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256,  jshaffer@eigerbio.com

Monday, March 28th, 2016 Uncategorized Comments Off on (EIGR) Granted Orphan Medicinal Product Designation for Ubenimex

(VCYT) Secures Up to $45 Million in Financing from Visium Healthcare Partners

SOUTH SAN FRANCISCO, Calif. and NEW YORK, March 28, 2016  — Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, and Visium Healthcare Partners, LP, a healthcare investment firm, today announced that they have entered into an agreement that provides up to $45 million of financing, comprising a term loan agreement and securities purchase option. On a pro forma basis, net proceeds from the new loan facility and the cash and cash equivalents as of December 31, 2015 provide Veracyte with approximately $73 million to fund the continued growth of the company’s core business.

“This agreement provides Veracyte the funding and flexibility we need to advance our business towards having three revenue generating products by the end of 2018. We have a clear path to profitability and will build the business with financial discipline and measured investments,” said Bonnie Anderson, president and chief executive officer of Veracyte.

Under and subject to the terms and conditions of the term loan agreement, Visium Healthcare Partners will initially provide gross proceeds of $25 million, of which approximately $5 million will be used to retire the company’s existing loan with Silicon Valley Bank. Up to $15 million of additional funding is available to the company, at its option, through June 2017, subject to the satisfaction of revenue milestones and certain other borrowing conditions. The agreement has a term of six years, with quarterly payments of interest only for the first four years. At Veracyte’s discretion, during the first four years, a portion of the interest payments can be deferred and paid, along with interest accrued thereon together with the principal in the final two years. Lastly, if Veracyte elects to execute an equity offering, Visium has certain rights to participate with up to $5 million of additional investment.

“With its focus on using genomics to resolve diagnostic ambiguity, Veracyte is transforming disease diagnosis, helping patients avoid unnecessary surgeries and reducing healthcare costs,” said Avinash Amin, partner at Visium Healthcare Partners. “We are particularly excited about the company’s growth trajectory as it further builds its endocrinology franchise, driven by the continued expansion of the Afirma® Gene Expression Classifier in thyroid testing, and as it applies its commercial diagnostic strategy to pulmonology. This includes the phased launch of the Percepta® Bronchial Genomic Classifier and the planned commercial introduction of its idiopathic pulmonary fibrosis test later this year.”

About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 180 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

About Visium
Visium Healthcare Partners is a healthcare investment fund focused on structured investments in growth-stage healthcare companies that have innovative, commercially-validated products and technologies. The fund targets investments of $20 million to $100 million or more and seeks to develop customized financing solutions for its partners in both public and private markets worldwide. Visium Healthcare Partners is managed by an affiliate of Visium Asset Management, LP, an alternative investment firm with approximately $7 billion in assets under management and approximately 170 employees across offices in New York, London, and San Francisco. For more information, please visit www.visiumfunds.com/funds.aspx or contact vhp@visiumfunds.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our expectations for the use of existing cash and cash equivalents and proceeds from the loan agreement, beliefs regarding the runway provided by the loan agreement, and expectations regarding the company’s growth strategy and product launch timing. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the satisfaction of funding conditions in the loan agreement, our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; our ability to launch our new product within the expected time frame, the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.

Monday, March 28th, 2016 Uncategorized Comments Off on (VCYT) Secures Up to $45 Million in Financing from Visium Healthcare Partners

(LEU) Signs Contract for American Centrifuge Work in Tennessee

Centrus Energy Corp. (NYSE MKT: LEU) announced today that it has signed a new U.S. Centrifuge Technology Advancement contract with UT-Battelle, LLC, as operator of the U.S. Department of Energy’s Oak Ridge National Laboratory (ORNL). Under the terms of the agreement, Centrus will continue to perform engineering and testing work to preserve and advance U.S.-origin uranium enrichment technology to support future national security and energy security needs. The contract totals approximately $32.3 million and runs through September 30, 2016.

“We still have critical work to do to advance the nation’s uranium enrichment capability,” said Steve Penrod, vice president of American Centrifuge for Centrus. “In Oak Ridge, we have a specialized workforce, unique assets, and technical capabilities that are essential for this important work. Over the long-term, we plan to continue advancing our technological expertise in uranium enrichment technology, operations, and manufacturing so that we are ready to deploy a commercial-scale enrichment facility when sufficient market demand recovers.”

Centrus recently completed a successful three-year demonstration of the existing American Centrifuge technology at its facility in Piketon, Ohio, with 120 machines linked together in a cascade to simulate industrial operating conditions. Informed by data from that demonstration, Centrus scientists, engineers, and operators will utilize the Company’s unique facilities in Tennessee to continue advancing the technology – identifying further improvements to reduce costs, improve manufacturability, and enhance long-term reliability of its enrichment operations. The work also ensures that critical U.S. expertise in centrifuge design, manufacturing, and operations is maintained.

In October 2015, the U.S. Department of Energy issued a report to Congress finding that the United States must restore its domestic uranium enrichment capability to meet national security needs. After evaluating a range of possible technologies, the Department found that the American Centrifuge is the “most technically advanced and lowest risk option” for doing so.

About Centrus Energy Corp.

Centrus Energy Corp. is a trusted supplier of enriched uranium fuel for commercial nuclear power plants in the United States and around the world. Our mission is to provide reliable and competitive fuel goods and services to meet the needs of our customers, consistent with the highest levels of integrity, safety, and security.

Forward-Looking Statements:

This news release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 – that is, statements related to future events. In this context, forward-looking statements may address our expected future business and financial performance, and often contain words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “will ”, “should”, “could”, “would” or “may” and other words of similar meaning. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. For Centrus, particular risks and uncertainties that could cause our actual future results to differ materially from those expressed in our forward-looking statements include, but are not limited to: risks related to the ongoing transition of our business, including uncertainty regarding the economics of and continued funding for the American Centrifuge project and the potential for a demobilization or termination of the project; the impact of enrichment market conditions, increased project costs and other factors on the economics of the American Centrifuge project; potential changes in our anticipated ownership of or role in the American Centrifuge project, including as a result of the need to raise additional capital to finance the project; the impact of actions we have taken or may take to reduce spending on the American Centrifuge project, including the potential loss of key suppliers and employees, and impacts to cost and schedule; uncertainty regarding our ability to commercially deploy competitive gas centrifuge enrichment technology; uncertainty regarding the potential for the DOE to seek to terminate or exercise its remedies under the June 2002 DOE-USEC Agreement; potential for any changes to or termination of any agreements with the U.S. government or deterioration in our relationship with the U.S. government; changes in U.S. government priorities and the availability of government funding, including loan guarantees and ongoing funding for the ORNL; the impact of government regulation by DOE and NRC; changes in the nuclear energy industry; revenue and operating results can fluctuate significantly from quarter to quarter, and in some cases, year to year; and other risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and quarterly reports on Form 10-Q, which are available on our website at www.centrusenergy.com. We do not undertake to update our forward-looking statements except as required by law.

 

Centrus Energy Corp.
Media:
Jeremy Derryberry, 301-564-3392
or
Investors:
Don Hatcher, 301-564-3460

Monday, March 28th, 2016 Uncategorized Comments Off on (LEU) Signs Contract for American Centrifuge Work in Tennessee

(SYMX) Joint Project Development, Investment Agreement w/ China Environment State Investment

  • Industry-leading SES Gasification Technology Transforms All Grades of Coal, Coal Wastes, Renewable Biomass and Industrial Wastes into Clean Syngas
  • Agreement Calls for 20 Projects in 5 Years in SES Industrial Energy Market Segments: Syngas as Industrial Fuel and Non-fuel Industrial Syngas including Hydrogen
  • Initial 4 Identified Target Projects Range from $75M to over $400M Each in Estimated Installed Costs, with Minimum of 2 Target Projects to Complete Development Work in First Year

HOUSTON, March 28, 2016  — Synthesis Energy Systems, Inc. (SES) (NASDAQ:SYMX), the global leader of full-range feedstock flexibility in advanced energy gasification technology, producing clean and economical syngas to replace expensive imported natural gas and LNG based energy, announced a strategic Joint Project Development and Investment Agreement with China Environment State Investment Co., Ltd (CESI). CESI is a state-owned enterprise established in Beijing under the China Ministry of Environmental Protection that is charged with, and funded to, develop and invest in the energy conservation and environmental protection industry. SES and CESI have agreed to develop, jointly invest, and build a total of no less than 20 projects using SES Gasification Technology (SGT) over the next five years. Further, SES and CESI are targeting to bring a minimum of two projects through development within 12 months. Equity in the projects for investment by SES and CESI is expected to be owned 51% CESI, and 49% SES through SES’s wholly owned Hong Kong subsidiary, SES Clean Energy Investment Holdings Limited. This is the first of several equity participation collaborations SES is working on with governments and leading companies in China and internationally.

SES and CESI have identified a pipeline of potential projects and intend to focus initially on four target projects: an industrial fuel syngas project in Inner Mongolia for an industrial park, which is intended to be further expanded in Phase 2 to provide compressed natural gas and liquefied natural gas for transportation fuels; an industrial hydrogen and fuel syngas project in Shandong Province; and two industrial park syngas projects, in Shandong and Hebei provinces. The projects vary in size and the estimated total installed costs of the four projects range between $75 million to over $400 million per project.

“We are excited to be working with the China Environment State Investment Company and its dynamic and forward-looking Chairman Wang Wei, and to become an integral part of the Chinese government’s mandate to develop and invest in energy conservation and environmental protection. We look forward to working together on this groundbreaking and far-ranging joint venture, to help China achieve its clean energy goals,” said Lorenzo Lamadrid, SES Chairman of the Board.

“We are building on the success of our China joint venture plants and the Aluminum Corporation of China projects now in commissioning, and broadening the SES ownership base,” said DeLome Fair, SES President and CEO. “Our clean syngas is highly attractive to multiple industries in regions where natural gas is expensive or unavailable, such as China. This agreement with China Environment State Investment Company follows our strategic industrial growth model: to deploy SES’s clean energy technology through project participation in energy markets that are large and growing. This enhances the company’s value proposition, and enhances and propels our technology and equipment sales.”

The SES and CESI target projects are in energy-based industrial market segments: syngas for fuel gas and syngas for non-fuel sales, such as hydrogen. All target projects will be based on SGT and will use gasification feedstock ranging from all grades of locally sourced coal and coal wastes, including heretofore untapped lignite or brown coal, to biomass and municipal solid wastes, or a combination thereof.

Final investment decision criteria established by the parties is anchored on projected rates of return of 20% or greater; reliable fuel supply, and reliable product offtake contracts or customers. The financing structure for the target projects is expected to be up to 30% equity, 70% debt. SES is considering third party international infrastructure funds and funding vehicles, with an SES ownership interest and limited partners who would provide the equity in return for participation, to share in SES’s equity portion. CESI is responsible for securing project debt financing at a mutually agreed interest rate for each target project. Further, once target projects have been built, the intention of the parties is to sell them at an attractive multiple to the project’s earnings in order to secure the funding required to invest in more projects. CESI, through its affiliate, Yibin Paper Industry Co, Ltd., a company listed on the Shanghai Main Board (600793), has the priority right to acquire target projects over other high bidders under the same terms.

“CESI is excited to partner with SES to invest in the clean energy sector. The SES Gasification Technology has shown unmatched, superior performance for economic, clean energy, and all target projects are encouraged by the Chinese government,” said Wang Wei, CESI Chairman. “Together with SES, we will move swiftly to complete development work within 12 months on our first two target projects. This includes submission of project feasibility studies to the relevant government authority for approval. Due in large part to the early success of SES’s Aluminum Corporation of China industrial fuel projects, we are most eager to bring this advanced clean energy technology to benefit industrial customers and Chinese citizens alike in Inner Mongolia, and Shandong and Hebei provinces, and intend to replicate this cleaner energy model throughout our country.”

Terms of the agreement call for SES to prepare each target project’s internal analysis and financial model, coordinate project feasibility studies, environmental impact evaluation, and safety evaluation, and draft agreements for product offtake and input feedstock supply. SES and CESI will jointly negotiate the investment agreement with local government and with project JV partners, if applicable. CESI will take the lead in securing government support for the projects, government project approval and project financing.

The SES and CESI equity project will initially be governed by a management committee. The parties intend to form a Master Joint Venture (MJV) company in China, once the first target projects have been secured and approvals for the MJV can be obtained.

“Our aim is to bring clean energy technology to global markets where natural gas is expensive and where cleaner energy is needed to meet growing demand. Establishing a diverse installed base of earnings generating facilities, selling syngas as an industrial fuel gas or as SNG, and providing clean power via SGT with our iGAS platform is our strategic growth strategy. This is the first of many such equity participation projects and market segments we are pursuing. We look forward to bringing Growth With Blue Skies to points far and wide across China and along its Silk Road and, indeed, to developing regions throughout the world,” said Robert W. Rigdon, SES Vice Chairman.

About Synthesis Energy Systems, Inc.

Synthesis Energy Systems (SES) is a Houston-based technology company focused on bringing clean high-value energy to developing countries from low-cost and low-grade coal, biomass and municipal wastes through its proprietary gasification technology based upon U-Gas®, licensed from the Gas Technology Institute. The SES Gasification Technology (SGT) can produce clean, low-cost syngas for power generation, industrial fuel gas, chemicals and transportation fuels, replacing expensive natural gas and LNG based energy. SGT enables Growth With Blue Skies, and greater fuel flexibility for both large-scale and efficient small- to medium-scale operations close to fuel sources. Fuel sources include low-rank, low-cost high ash, high moisture coals, which are significantly cheaper than higher grade coals, many coal waste products, biomass, and municipal waste feedstocks. For more information, please visit: www.synthesisenergy.com.

About China Environment State Investment Co., Ltd

China Environment State Investment Co., Ltd (CESI), known in China as Zhonghuan Guotou, is a state owned enterprise established in Beijing under the China Ministry of Environmental Protection. CESI is focused on energy conservation and environmental protection, is devoted to developing and investing in the energy conservation and environmental protection industry. CESI has more than ten subsidiaries under its umbrella, currently focusing on four segments: waste water treatment, utilization of solid waste, clean energy, and city centralized heating.

SES Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are our ability to develop and expand business of the Tianwo-SES joint venture in the joint venture territory; our ability to successfully partner our technology business; our ability to develop our power business unit and marketing arrangement with GE and our other business verticals, including DRI steel, through our marketing arrangement with Midrex Technologies, and renewables; our ability to successfully develop the SES licensing business; events or circumstances which result in an impairment of assets, including, but not limited to, at our ZZ Joint Venture; our ability to reduce operating costs; our ability to make distributions and repatriate earnings from our Chinese operations; our limited history, and viability of our technology; commodity prices, including in particular methanol, and the availability and terms of financing; our ability to obtain the necessary approvals and permits for future projects; our ability to raise additional capital, if any, and our ability to estimate the sufficiency of existing capital resources; the sufficiency of internal controls and procedures; and our results of operations in countries outside of the U.S., where we are continuing to pursue and develop projects. Although SES believes that in making such forward-looking statements our expectations are based upon reasonable assumptions, such statements may be influenced by factors that could cause actual outcomes and results to be materially different from those projected by us. SES cannot assure you that the assumptions upon which these statements are based will prove to have been correct.

Contact:

MDC Group
Investor Relations:
David Castaneda
Arsen Mugurdumov
414.351.9758
IR@synthesisenergy.com

Media Relations:
Susan Roush
747.222.7012
PR@synthesisenergy.com

Monday, March 28th, 2016 Uncategorized Comments Off on (SYMX) Joint Project Development, Investment Agreement w/ China Environment State Investment

(ALDR) Reports Phase 2b Trial of ALD403 Meets Primary, Secondary Endpoints

Alder Also Reports Positive Phase 1 Data Supporting Quarterly Single Injection Dosing Strategy for ALD403

Alder to Host Conference Call at 8:30 a.m. Eastern Time Today

BOTHELL, Wash., March 28, 2016  — Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), today announced positive top-line data from two clinical trials evaluating ALD403, Alder’s proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide (CGRP). Positive top-line data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12 week study period, meeting both primary and secondary efficacy endpoints.  Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.

Randall C. Schatzman, Ph.D., president and chief executive officer of Alder, commented: “Today’s ALD403 Phase 2b data confirm and expand on our previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing. Today’s data also support our quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection. With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.”

Phase 2b Clinical Trial Evaluating ALD403 in Patients with Chronic Migraine

The Phase 2b clinical trial is a double-blind, placebo-controlled, randomized, single intravenous infusion, dose ranging study in patients with chronic migraine. Patients were randomized to receive a single intravenous infusion of 10 mg, 30 mg, 100 mg or 300 mg of ALD403 or placebo (approximately 120 patients per group). The primary efficacy endpoint of the study is the change in migraine days between ALD403 and placebo as determined by the 75% responder rates over a 12-week period.  Endpoints will also be evaluated at week 24 (expected Q3 2016) and at week 48 (end of study).

Chronic migraine sufferers are defined as individuals who experience 15 or more headache days per month, of which at least 8 must be assessed as migraine days.

Key Points

  • The 300 mg and 100 mg dose levels of ALD403 met the primary efficacy endpoint of the study, a 75% reduction in migraine days over the entire 12 weeks in 33% and 31% of patients, respectively (p < 0.05).
Time
period
% Reduction in
migraine days
per month
300 mg IV
n=114
100 mg  IV
n=118
30 mg  IV
n=117
10 mg  IV
n=123
Placebo IV
n=116
Weeks 1-12 50 % 65 (57%)** 64 (54%)* 64 (55%)* 54 (44%) 47 (41%)
75 % 38 (33%)* 37 (31%)* 33 (28%) 33 (27%) 24 (21%)
100 % 9 (8%) 6 (5%) 5 (4%) 10 (8%) 3 (3%)

*(p= < 0.05)   **(p= < 0.01)

  • A single administration of ALD403 resulted in an immediate and durable mean reduction in migraine days from baseline throughout the 12 weeks at the 300 mg (p < 0.01), 100 mg (p < 0.01) and 30 mg (p < 0.05) dose levels, meeting the secondary efficacy endpoint.
  • A single administration of ALD403 at 300mg, 100mg or 30mg dose levels demonstrated a durable reduction in migraine days for the entire 12 weeks, supporting a quarterly dosing strategy.
  • The 10 mg dose of ALD403 was identified as sub-therapeutic.
  • The safety profile was consistent with earlier ALD403 clinical trials.

Phase 1 Clinical Trial Evaluating Multiple Doses of ALD403 in Healthy Volunteers

The Phase 1 clinical trial is a placebo-controlled, randomized, multi-dose, double dummy, quarterly-dosing study comparing the intravenous, subcutaneous and intramuscular routes of administration in healthy volunteers. Sixty healthy volunteers, 12 in each group, were randomized as follows:

• 100 mg ALD403 IM, placebo SC, placebo IV

• 100 mg ALD403 SC, placebo IM, placebo IV

• 100 mg ALD403 IV, placebo IM, placebo SC

• 300 mg ALD403 IM, placebo SC, placebo IV

• Placebo IM, placebo SC, placebo IV

Individuals were dosed on Day 1 and at Week 12.

The study evaluated pharmacokinetic and pharmacodynamic endpoints for the administration of ALD403 delivered via each of the three routes of administration.

Key Points

  • ALD403 provided a comparable level of suppression of peripheral CGRP biology for a full 3 months when administered via a single intravenous (100 mg), subcutaneous (100 mg) or intramuscular injection (100 mg or 300 mg).
  • ALD403 administered via subcutaneous or intramuscular routes of administration had an approximately 80% bioavailability relative to an intravenous infusion.
  • Local tolerability via all modes of administration was excellent.
  • The safety profile was consistent with earlier ALD403 clinical trials.
  • The data support a quarterly dosing strategy as a single injection by all modes of administration.

The results of this study provide an important bridge between pharmacodynamic monitoring via peripheral CGRP blockade and migraine prevention: doses (100mg and 300mg) that provided for a full 3 months of migraine prevention in the Phase 2b study of chronic migraine patients also provided 3 months of suppression of peripheral CGRP biology independent of route of administration.

Additional results, including future analysis of additional secondary endpoints, from both of these trials are expected to be presented at upcoming medical meetings and published in peer-reviewed medical journals.

Conference Call and Webcast

Alder will host a conference call at 8:30 a.m. ET today to discuss these clinical trial results. The live call may be accessed by dialing 877-430-4657 for domestic callers or 484-756-4339 for international callers and by providing conference ID number 80096426.

A simultaneous webcast with slides will be broadcast live on the investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for 30 days.

About ALD403

ALD403 is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide, or CGRP, for prevention of migraine. CGRP is a small protein with a well-established role in the initiation, mediation, transmission and heightened sensitivity to pain experienced in migraine. ALD403 was discovered by Alder scientists and has been evaluated in multiple clinical trials evaluating approximately 800 patients. In a proof-of-concept clinical trial evaluating patients with frequent episodic migraine, ALD403 demonstrated significant prevention of migraines, including complete migraine relief (100% suppression of migraine occurrence) in 27% to 41% of patients in any given month. Migraines were completely prevented in 16% of patients for the entire three-month study period. ALD403 also has a favorable emerging safety profile, demonstrating a similar level of safety to placebo, and has been well-tolerated in studies to date. Alder initiated its late-stage clinical trial program in October 2015 with PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1 (PROMISE 1), a pivotal clinical trial evaluating patients with frequent episodic migraine. Alder plans to initiate a second pivotal clinical trial, PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2), in patients with chronic migraine in the second half of 2016. Also in 2016, Alder further plans to enter late-stage clinical development of a self-injected formulation of ALD403 to complement the infusion formulations evaluated in the PROMISE 1 and 2 trials.

About Migraine

Migraine is a common neurological disorder that results in suffering caused by intense sharp or throbbing pain in the head, commonly accompanied by nausea, vomiting and high sensitivity to light and sound.  Over time, patients may be subject to an increasing frequency and severity of migraine attacks, potentially leading to significant disability.

The Migraine Research Foundation estimates that 36 million American adults and children suffer from migraines. According to the American Migraine Foundation, migraine is three times more common in women than men and affects 30% of women over a lifetime. Migraines can severely restrict normal activities and often make holding a job or maintaining a normal lifestyle difficult. The Migraine Research Foundation estimates U.S. employers lose more than $13 billion each year as a result of 113 million lost work days due to migraine.

Currently, preventive medications approved for migraine include beta blockers (such as propranolol), topiramate, sodium valproate and botulinum toxin, or Botox. Medication side-effects, such as cognitive impairment, nausea, fatigue and sleep disturbance, often limit the use of migraine medications, according to the American Migraine Foundation. The U.S. Agency for Healthcare Research and Quality reports that only about 12% of adults with frequent episodic or chronic migraine take preventive medications. Alder believes this creates a significant unmet medical need for new treatments with improved safety and efficacy that can either prevent migraines completely or reduce the frequency to a level where patients can find adequate relief from existing abortive medications.

About Alder BioPharmaceuticals

Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. ALD403, Alder’s lead pivotal-stage product candidate being evaluated for migraine prevention, is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP). CGRP is a small protein with a well-established role in the initiation, transmission and heightened sensitivity to migraine pain. Alder’s second program, ALD1613, targets adrenocorticotropic hormone (ACTH) and is intended for the treatment of Congenital Adrenal Hyperplasia or Cushing’s disease. ALD1613 is undergoing Investigational New Drug (IND)-enabling preclinical studies and an IND submission is planned for 2016. Additionally, Alder’s clazakizumab, is designed to block the pro-inflammatory cytokine IL-6 and has completed two successful Phase 2b clinical trials. Alder is seeking strategic opportunities for clazakizumab. For more information, please visit http://www.alderbio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of ALD403, ALD1613 and clazakizumab; the availability of clinical trial data; future regulatory filings and the anticipated commercialization of ALD403; the initiation of future clinical trials and studies; and the pursuit of strategic alternatives for clazakizumab.  Words such as “support,” “continues,” “potential,” “strategy,” “commitment,” “look forward,” “seeking,” “advancing,” “marketing,” “expected,” “plans,” “initiate,” “further,” “enter,” “believes,” “submit,” “intended,” “designed,” or other similar words or expressions, identify forward-looking statements, but the absence of these words or expressions does not necessarily mean that a statement is not forward-looking.  In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder’s current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of ALD403, ALD1613 and clazakizumab to demonstrate safety and efficacy in clinical testing; the availability of data at the expected times; the clinical, therapeutic and commercial value of ALD403, ALD1613 and clazakizumab; risks and uncertainties related to regulatory review and approval processes and Alder’s compliance with applicable legal and regulatory requirements; the uncertain timing and level of expenses associated with the development of ALD403, ALD1613 and clazakizumab; the sufficiency of Alder’s capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Alder’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed with the Securities and Exchange Commission (SEC) on February 23, 2016 and is available on the SEC’s website at www.sec.gov.  Additional information will also be set forth in Alder’s other reports and filings it makes with the SEC from time to time.  The forward-looking statements made in this press release speak only as of the date of this press release.  Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

 

Media Contacts:			
David Schull or Lena Evans		
Russo Partners				
(212) 845-4271				
(212) 845-4262				
david.schull@russopartnersllc.com 
lena.evans@russopartnersllc.com

Investor Relations Contact:
David Walsey
Alder Biopharmaceuticals Inc.
(425) 408-8032
dwalsey@alderbio.com
Monday, March 28th, 2016 Uncategorized Comments Off on (ALDR) Reports Phase 2b Trial of ALD403 Meets Primary, Secondary Endpoints

(MDVN) Pivotal Phase III Trial of Enzalutamide Initiated

SAN FRANCISCO, CA and TOKYO, JAPAN–(Mar 24, 2016) – Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the ARCHES (AR Inhibition with ChemoHormonal Therapy in Men with MEtastatic Castrate Sensitive Prostate Cancer) Phase III registrational trial, which will evaluate the efficacy and safety of enzalutamide with androgen deprivation therapy (ADT) versus placebo with ADT in metastatic hormone sensitive prostate cancer (mHSPC) patients, has been initiated and the first patient has been randomized.

Prostate cancer is the most commonly diagnosed cancer and the second-leading cause of cancer death in men in the United States. According to the American Cancer Society, approximately 181,000 new cases of prostate cancer will be diagnosed, and 26,000 men will die of prostate cancer in the United States in 2016.i Androgen deprivation therapy, which reduces the levels of androgens (male hormones), is the standard of care for patients with mHSPC. The ARCHES trial will investigate whether the addition of enzalutamide to ADT may benefit this patient population compared to ADT alone.

“This trial targets an important patient population as we advance the development of enzalutamide,” said Mohammad Hirmand, M.D., interim chief medical officer, Medivation. “The initiation of this trial demonstrates our ongoing commitment to fully develop enzalutamide in this serious disease.”

“Dosing of the first patient in this trial demonstrates our ongoing commitment to continuing to investigate enzalutamide,” said Claire Thom, Pharm D., senior vice president and oncology therapeutic area head, Astellas.

The global, Phase III, randomized, double-blind, placebo-controlled study, which is being led by Astellas, will evaluate the efficacy and safety of enzalutamide with ADT versus placebo with ADT in patients with mHSPC. ARCHES will enroll approximately 1,100 patients with mHSPC at approximately 250 centers globally. The primary endpoint of the trial is radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death, whichever occurs first. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, administered with ADT.

For more information about this trial, visit www.clinicaltrials.gov, trial identifier NCT02677896.

Enzalutamide is being developed through a collaboration between Medivation and Astellas. Enzalutamide, which is known by the brand name XTANDI®, is not approved for use in patients with metastatic hormone sensitive prostate cancer (mHSPC).

About XTANDI®
XTANDI (enzalutamide) capsules is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.
XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Important Safety Information
Contraindications
XTANDI is not indicated for women and is contraindicated in women who are or may become pregnant. XTANDI can cause fetal harm when administered to a pregnant woman.

Warnings and Precautions
Seizure
In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Adverse Reactions
The most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.

  • Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
  • Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.
  • Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
  • Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.

Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf?v=1

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit
www.fda.gov/medwatch or call 1800FDA1088.

About Medivation, Inc.
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit http://www.medivation.com

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.

About the Medivation/Astellas Collaboration
In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Forward-Looking Statements
This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, and involve risks and uncertainties that could cause Medivation’s actual results to differ significantly from those projected herein, including, without limitation, risks related to Medivation and Astellas’ continued collaboration and development of enzalutamide; the timing and results of the ARCHES clinical trial, which may not demonstrate enzalutamide’s safety or efficacy in combination with ADT in men with metastatic castrate sensitive prostate cancer; risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation’s enzalutamide development activities and/or the development activities of Medivation’s other product candidates; and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, or SEC, including its annual report on Form 10-K for the year ended December 31, 2015, which was filed on February 26, 2016. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

XTANDI is a registered trademark of Astellas Pharma Inc.

i American Cancer Society. Key Statistics for Prostate Cancer. 2016

Medivation Contacts:
For Media
Samina Bari
Vice President, Communications
(415) 543-3470

For Investors
Anne Bowdidge
Senior Director, Investor Relations
(650) 218-6900

Astellas Contacts:

Tyler Marciniak
Director, Communications
(847) 736-7145
Email Contact

So Sekine
Senior Manager, Investor Relations
(847) 224-9557
Email Contact

Thursday, March 24th, 2016 Uncategorized Comments Off on (MDVN) Pivotal Phase III Trial of Enzalutamide Initiated

(CRTN) Accepted as a Supplier for UK Govt. Procurement Framework, G-Cloud 7

OVERLAND PARK, Kan., March 24, 2016  — Cartesian® (NASDAQ:CRTN), a specialist provider of consulting services and managed solutions to the global communications, technology and digital media sector, has been accepted as a supplier for the United Kingdom’s (UK) latest government procurement framework, G-Cloud 7.

G-Cloud 7 is the seventh installment of the procurement framework, which allows suppliers to receive government contracts related to cloud-based services, without the need for participating in a full tender or competition procurement process. Suppliers define the services they offer on G-Cloud’s online store, the “Digital Marketplace,” which are then reviewed by the government’s agencies and departments for selection.

The framework is part of the UK’s broader initiatives to accelerate and simplify the process of cloud-based IT procurement, while making it easier for suppliers to sell their services to the public sector.

Cartesian will join a pre-approved list of providers under the ‘Specialist Cloud Services’ group, which is comprised of companies providing consulting solutions in the cloud domain. Cartesian will offer a range of cloud strategic planning services, including data analytics and cloud adoption studies. In particular, the company will help governmental organizations identify key opportunities for cloud implementation, as well as the development of a strategic roadmap toward full migration.

“For more than 25 years, we have successfully delivered strategy consulting services to some of the world’s largest companies and organizations,” said Peter Woodward, CEO of Cartesian. “By joining the G-Cloud 7 framework, we are expanding our reach in the UK public sector market, where we see a number of new large-scale opportunities to pursue. We are excited to extend our expertise toward helping the UK government develop robust cloud adoption strategies, while addressing the challenges and risks inherent in a full transition to the cloud.”

For more information about Cartesian’s services and presence in G-Cloud 7, visit the company’s website or the Digital Marketplace.

About Cartesian, Inc.
Cartesian, Inc. (NASDAQ:CRTN) is a specialist provider of consulting services and managed solutions to leaders in the global communications, technology and digital media industries. Cartesian provides consulting in strategy, execution and managed solutions to clients worldwide. The company has offices in Boston, Kansas City, London, New York, Paris, Philadelphia and Washington. For more information, visit www.cartesian.com.

 

Contact Information:

Matt Glover or Najim Mostamand
Liolios Group, Inc. 
949-574-3860
CRTN@liolios.com
Thursday, March 24th, 2016 Uncategorized Comments Off on (CRTN) Accepted as a Supplier for UK Govt. Procurement Framework, G-Cloud 7