Archive for April, 2017
$HYGS Selected as Technology Provider for SunLine Transit Agency
Largest Renewable Hydrogen Fueling Station in the U.S. and Power Modules for Buses
MISSISSAUGA, Ontario, April 21, 2017 — Hydrogenics Corporation (NASDAQ:HYGS) (TSX:HYG) (“Hydrogenics” or “the Company”), a leading developer and manufacturer of hydrogen generation and hydrogen-based fuel cell modules, today announced that it has been selected to be the technology provider for the SunLine Transit Agency, covering heavy duty fuel cell power modules and PEM HyLyzer™ electrolysis equipment, to enable zero-emission public transit. Funded by a major grant award from California Climate Investments and the California Air Resources Board (“CARB”), Hydrogenics will supply SunLine with five CelerityPlus™ power modules to be integrated into New Flyer fuel cell buses. Hydrogenics will also upgrade SunLine’s heavy duty fueling station with a new 1.5 megawatt PEM electrolyzer for onsite hydrogen fuel generation – making it the largest renewable hydrogen fueling facility in the United States. The station will produce up to 400 kilograms of hydrogen daily and be capable of fueling 15 buses per day.
“As the only hydrogen technology company that can offer both fuel cell power systems and clean onsite hydrogen generation, we are pleased to bring our advanced technology to this state-of-the-art project in California,” stated Daryl Wilson, President and CEO of Hydrogenics. “SunLine has been at the forefront of clean energy transportation in the region, and we look forward to being a part of implementing this zero-emission vehicle initiative.”
This is the first bundled hydrogen fleet and fuel project secured by a transit agency where funding has been received for both the heavy duty fuel cells and infrastructure for onsite renewable hydrogen generation supplied by the same technology provider. Successful deployment of this project will help remove barriers due to lack of hydrogen infrastructure and accelerate mass adoption of fuel cell buses within the transit industry.
The SunLine Fuel Cell Buses and Hydrogen Onsite Generation Refueling Station Pilot Commercial Deployment Project is part of California Climate Investments, a statewide program that puts billions of cap-and-trade dollars to work reducing greenhouse gas emissions, strengthening the economy and improving public health and the environment—particularly in disadvantaged communities. The cap-and-trade program also creates a financial incentive for industries to invest in clean technologies and develop innovative ways to reduce pollution. California Climate Investment projects include affordable housing, renewable energy, public transportation, zero-emission vehicles, environmental restoration, more sustainable agriculture, recycling and much more. At least 35 percent of these investments are made in disadvantaged and low-income communities. For more information, visit California Climate Investments (https://arb.ca.gov/caclimateinvestments.)
About Hydrogenics
Hydrogenics Corporation is a world leader in engineering and building the technologies required to enable the acceleration of a global power shift. Headquartered in Mississauga, Ontario, Hydrogenics provides hydrogen generation, energy storage and hydrogen power modules to its customers and partners around the world. Hydrogenics has manufacturing sites in Germany, Belgium and Canada and service centers in Russia, Europe, the US and Canada.
Forward-looking Statements
This release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, and under applicable Canadian securities law. These statements are based on management’s current expectations and actual results may differ from these forward-looking statements due to numerous factors, including: our inability to increase our revenues or raise additional funding to continue operations, execute our business plan, or to grow our business; inability to address a slow return to economic growth, and its impact on our business, results of operations and consolidated financial condition; our limited operating history; inability to implement our business strategy; fluctuations in our quarterly results; failure to maintain our customer base that generates the majority of our revenues; currency fluctuations; failure to maintain sufficient insurance coverage; changes in value of our goodwill; failure of a significant market to develop for our products; failure of hydrogen being readily available on a cost-effective basis; changes in government policies and regulations; failure of uniform codes and standards for hydrogen fuelled vehicles and related infrastructure to develop; liability for environmental damages resulting from our research, development or manufacturing operations; failure to compete with other developers and manufacturers of products in our industry; failure to compete with developers and manufacturers of traditional and alternative technologies; failure to develop partnerships with original equipment manufacturers, governments, systems integrators and other third parties; inability to obtain sufficient materials and components for our products from suppliers; failure to manage expansion of our operations; failure to manage foreign sales and operations; failure to recruit, train and retain key management personnel; inability to integrate acquisitions; failure to develop adequate manufacturing processes and capabilities; failure to complete the development of commercially viable products; failure to produce cost-competitive products; failure or delay in field testing of our products; failure to produce products free of defects or errors; inability to adapt to technological advances or new codes and standards; failure to protect our intellectual property; our involvement in intellectual property litigation; exposure to product liability claims; failure to meet rules regarding passive foreign investment companies; actions of our significant and principal shareholders; dilution as a result of significant issuances of our common shares and preferred shares; inability of US investors to enforce US civil liability judgments against us; volatility of our common share price; and dilution as a result of the exercise of options; and failure to meet continued listing requirements of Nasdaq. Readers should not place undue reliance on Hydrogenics’ forward-looking statements. Investors are encouraged to review the section captioned “Risk Factors” in Hydrogenics’ regulatory filings with the Canadian securities regulatory authorities and the US Securities and Exchange Commission for a more complete discussion of factors that could affect Hydrogenics’ future performance. Furthermore, the forward-looking statements contained herein are made as of the date of this release, and Hydrogenics undertakes no obligations to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release, unless otherwise required by law. The forward-looking statements contained in this release are expressly qualified by this.
For further information, contact: Bob Motz, Chief Financial Officer Hydrogenics Corporation (905) 361-3660 investors@hydrogenics.com Chris Witty Hydrogenics Investor Relations (646) 438-9385 cwitty@darrowir.com
$RNVA Big South Fork Medical Center Moves Closer to Opening
WEST PALM BEACH, FL –(April 21, 2017) – Rennova Health, Inc. (NASDAQ: RNVA) (NASDAQ: RNVAZ) (“Rennova” or the “Company”), a vertically integrated provider of industry-leading diagnostics and supportive software solutions to healthcare providers, announced today that the Centers for Medicare and Medicaid Services (CMS) has concluded its review of the application submitted by its subsidiary Big South Fork Medical Center (Legal Name: Scott Community Hospital, Inc.) requesting enrollment in the Medicare program as a Hospital. CMS has confirmed that it has issued a recommendation for approval to the Tennessee State Agency and the CMS Regional Office (RO).
Approval will enable the hospital to open for business. The next step of the Medicare enrollment process involves a site visit or survey by the State Survey Agency or another accrediting organization to ensure compliance with the Conditions of Participation for the Hospitals provider. The visiting CMS RO will complete the certification and issue the final determination.
The Hospital was also granted a Medicaid license on April 8, 2017 (retroactively effective January 13, 2017) by the State of Tennessee Department of Finance and Administration, Division of Health Care Finance and Administration, Bureau of Tenncare. It is an important development for the Hospital, allowing Big South Fork Medical Centre to contract with TennCare Managed Care Organizations.
“This is one of the most important milestones to be overcome to open the Hospital to patients,” said Seamus Lagan, chief executive officer of Rennova Health. “We believe that this Hospital creates an exciting opportunity for Rennova to provide a needed service to patients and in turn have a more predictable and reliable revenue stream. We look forward to this Hospital opening and exploring other opportunities in the same sector.”
Big South Fork Medical Center is a rural hospital with 25 beds, a 24/7 emergency department, operating rooms and a laboratory that provides a range of ancillary diagnostic services. The purchase includes a 52,000-sq. ft. hospital building and a 6,300-sq. ft. professional building on approximately 4.3 acres. It is on track to partially open during the second quarter of 2017, and be fully operational during the third quarter of this year.
About Rennova Health, Inc.
Rennova provides industry-leading diagnostics and supportive software solutions to healthcare providers, delivering an efficient, effective patient experience and superior clinical outcomes. Through an ever-expanding group of strategic brands that work in unison to empower customers, we are creating the next generation of healthcare. For more information, please visit www.rennovahealth.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Actual results may differ from expectations and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Additional information concerning these and other risk factors are contained in the Company’s most recent filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.
Contacts:
Rennova Health
Sebastien Sainsbury
561-666-9818
ssainsbury@rennovahealth.com
Investors
LHA
Kim Golodetz
212-838-3777
Kgolodetz@lhai.com
or
Bruce Voss
310-691-7100
Bvoss@lhai.com
$OPTT Announces the Deployment of its PB3 PowerBuoy in Japan
PENNINGTON, N.J., April 21, 2017 — Ocean Power Technologies, Inc. (Nasdaq:OPTT) announced today that a PB3 PowerBuoy was deployed off the coast of Kozu-shima Island in Japan as part of its first lease agreement with Mitsui Engineering and Shipbuilding (“MES”).
The PB3 was shipped to Japan in February and arrived in Tokyo on March, 18th, 2017. Upon standard customs processing, the PB3 was transported to Kozu-shima Island where it was staged dockside, and where standard pre-deployment functional checks and preparations were carried out. The deployment of the PB3 and its moorings was completed by a joint team of Penta-Ocean Construction and MES. OPT supported MES with the mooring system specifically for the harsh ocean conditions of Kozu-shima Island.
George H. Kirby, President and Chief Executive Officer at OPT, stated: “This is an exciting time for OPT as we initiate this lease and deploy the PB3 in Japanese waters for the first time. The deployment went well and the PB3 has already exceeded two thousand Watts of peak power. We’re looking forward to leveraging this opportunity to bring our PowerBuoys to Japan and other parts of East Asia.”
OPT’s PB3 is a reliable and persistent integrated power and communication platform for remote offshore applications such as subsea and ocean-surface surveillance for security and defense, subsea production operations for oil and gas, and subsea drone docking stations used in the defense and oil and gas markets. Customers can oftentimes lower operational costs by replacing expensive on-site vessels with a PB3 PowerBuoy, allowing for remote offshore subsea monitoring and control from land-based operations. The PB3 can also provide substantial power to remote offshore sites when replacing lower-powered solar and battery buoys, oftentimes enabling real-time operational decision making through cellular or satellite communications which is standard on the PB3.
The lease agreement calls for a 6-month deployment with the possibility of extension. Throughout its planned deployment, the performance of the PB3 will be monitored with the intent of demonstrating its capabilities for a range of applications.
Mr. Toshihiko Maemura, Manager of the Renewable Energy Project Group of MES, stated, “We are pleased to see the excellent progress of this project. Our collaboration with OPT has been exemplary and we are excited to see the PB3 operating well in Japanese waters. We are looking forward to a successful ocean demonstration in order to confirm effect of our resonance control and durability of our mooring system.”
For more information and pictures of the Japan deployment, please visit the media page of our website at www.oceanpowertechnologies.com.
About Ocean Power Technologies
Headquartered in New Jersey, Ocean Power Technologies aspires to transform the world through durable, innovative and cost-effective ocean energy solutions. Our PB3 PowerBuoy uses ocean waves to provide clean, reliable and persistent electric power and real-time communications for remote offshore applications in markets such as oil and gas, defense, security, ocean observing, telecommunications and more. To learn more, visit www.oceanpowertechnologies.com
Forward-Looking Statements
This release may contain “forward-looking statements” that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
Company Contacts: Investor Relations Andrew Barwicki Phone: 516-662-9461 Chief Financial Officer Matthew T. Shafer Phone: 609-730-0400
$GEVO Enters into Exchange Agreement with Whitebox
Senior Secured Lender Agrees to Exchange into New Notes with Maturity Date in 2020
ENGLEWOOD, Colo., April 20, 2017 — Gevo, Inc. (NASDAQ:GEVO), announced today that WB Gevo, Ltd. (“Whitebox”), the holder of the Company’s issued and outstanding Senior Secured Convertible Notes, due June 23, 2017 (the “2017 Notes”), and the Company have entered into an Exchange and Purchase Agreement (the “Purchase Agreement”) pursuant to which Whitebox has agreed to exchange (the “Exchange”) all $16.5 million of the existing 2017 Notes for the Company’s newly created 12.0% Senior Secured Convertible Notes due 2020 (the “2020 Notes”). The Exchange and the issuance of the 2020 Notes require stockholder approval.
The key terms of the 2020 Notes are as follows:
- Maturity Date: The 2020 Notes will mature on March 15, 2020.
- Interest: The 2020 Notes will accrue interest at 12% per annum, with 10% payable in cash and 2% payable as Payment in Kind (“PIK”) interest. The PIK interest is paid by increasing the principal amount of the 2020 Notes by the amount of PIK interest due.
- Conversion and Conversion Price: The 2020 Notes are convertible, at the option of the holders, into shares of the Company’s common stock. The 2020 Notes will have an initial conversion price (the “Conversion Price”) equal to the lesser of (i) $1.196 per share, or (ii) a premium of 15% to the closing price of the Company’s common stock on the date of the Exchange.
- Conversion Price Reset and Adjustments: Upon certain equity financing transactions by the Company, the holders will have a one-time right to reset the Conversion Price (i) in the first 90 days following the Exchange, at a 25% premium to the common stock price in the equity financing and (ii) after 90 and before 180 days following the Exchange, at a 35% premium to the common stock share price in the equity financing.
- Holder Option: The holders have an option, subject to certain conditions, to purchase up to an additional $5.0 million aggregate principal amount of 2020 Notes within 90 days of the closing of the exchange contemplated by the Purchase Agreement.
The Exchange and the issuance of the 2020 Notes requires stockholder approval and will be voted on at the Company’s Annual Meeting of Stockholders scheduled for June 15, 2017.
“We are very pleased to have signed the Purchase Agreement with Whitebox. Over the past year, we have been working hard to restructure our balance sheet and put ourselves in a stronger financial position that would enable us to move ahead with our strategic initiatives. Resolving our debt situation with Whitebox was paramount to this effort. Over the past year, we have been able to strengthen our cash position while significantly decreasing the principal balance of our 2022 Notes, which gave us the flexibility to work with Whitebox and generate a solution that we believe will benefit all of Gevo’s stakeholders and give ourselves more runway to complete our goals, namely to continue to execute our growth plan of building out our Luverne plant to serve Gevo’s core jet fuel, renewable gasoline and isobutanol markets,” said Dr. Patrick Gruber, Gevo’s Chief Executive Officer.
“With clarity on our balance sheet, we believe we will be in an improved position to develop key customer relationships and negotiate better deals for Gevo and our stockholders. I want to be clear that we still need to explore financing options to expand Luverne, but we expect this new capital structure to provide us with additional flexibility that we did not have previously. We continue to look to 2017 as a pivotal year for Gevo and remain excited about the opportunity in front of us,” Mr. Gruber continued.
A Current Report on Form 8-K will be filed today with the U.S. Securities and Exchange Commission that will contain a more detailed description of the terms of the Purchase Agreement, the Exchange and the 2020 Notes and will include a copy of the Purchase Agreement and the form of indenture pursuant to which the 2020 Notes would be issued.
About Gevo
Gevo is a leading renewable technology, chemical products, and next generation biofuels company. Gevo has developed proprietary technology that uses a combination of synthetic biology, metabolic engineering, chemistry and chemical engineering to focus primarily on the production of isobutanol, as well as related products from renewable feedstocks. Gevo’s strategy is to commercialize bio-based alternatives to petroleum-based products to allow for the optimization of fermentation facilities’ assets, with the ultimate goal of maximizing cash flows from the operation of those assets. Gevo produces isobutanol, ethanol and high-value animal feed at its fermentation plant in Luverne, Minnesota. Gevo has also developed technology to produce hydrocarbon products from renewable alcohols. Gevo currently operates a biorefinery in Silsbee, Texas, in collaboration with South Hampton Resources Inc., to produce renewable jet fuel, octane, and ingredients for plastics like polyester. Gevo has a marquee list of partners including The Coca-Cola Company, Toray Industries Inc. and Total SA, among others. Gevo is committed to a sustainable bio-based economy that meets society’s needs for plentiful food and clean air and water.
Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include statements relating to the Exchange, the Purchase Agreement, the 2020 Notes, whether Gevo’s stockholders will approve the Exchange and the 2020 Notes and whether the transactions contemplated by the Purchase Agreement will be completed, are made on the basis of the current beliefs, expectations and assumptions of the management of Gevo and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Gevo undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Gevo believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Gevo in general, see the risk disclosures in the Annual Report on Form 10-K of Gevo for the year ended December 31, 2016, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the U.S. Securities and Exchange Commission by Gevo.
Media Contact David Rodewald The David James Agency, LLC +1 805-494-9508 gevo@davidjamesagency.com Investor Contact Shawn M. Severson EnergyTech Investor, LLC +1 415-233-7094 gevo@energytechinvestor.com @ShawnEnergyTech www.energytechinvestor.com
$ATRA Positive Interim Results from Ongoing Phase 1 Trial of ATA188 Version
Encouraging Clinical Improvements Correlate with EBV Reactivity
Presentation Selected for Emerging Science and Conference Press Programs by AAN
SOUTH SAN FRANCISCO, Calif., April 20, 2017 — Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today announced that its collaborating investigators at the Queensland Institute of Medical Research (QIMR Berghofer) and The University of Queensland are reporting interim Phase 1 trial results from the autologous version of ATA188, or autologous ATA188, in patients with primary or secondary progressive MS (PPMS and SPMS, respectively), at the 69th AAN Annual Meeting in Boston, Massachusetts from April 22-28, 2017. Autologous ATA188 is a targeted Epstein-Barr virus (EBV)-specific cytotoxic T lymphocyte (CTL) product candidate that selectively targets specific antigens of EBV that are believed to be important for the potential treatment of MS. Studies suggest that EBV positive B-cells and plasma cells in the central nervous system (CNS) have the potential to catalyze an autoimmune response and MS pathophysiology. Atara Bio believes that selectively targeting and eliminating EBV positive B-cells and plasma cells has the potential to benefit patients with MS.
The Phase 1 trial is designed to enroll ten patients, including five with PPMS and five with SPMS. In the trial, patients receive four escalating doses of autologous ATA188 over six weeks and are followed for an additional twenty weeks after the last dose. The objectives of the trial were first, to assess the safety and tolerability of autologous ATA188 in patients with progressive MS; second, document preliminary evidence of efficacy through the evaluation of both clinically measured and patient reported changes in MS symptoms during and following treatment; and third, to generate autologous ATA188 at clinical scale from the blood of patients with progressive MS.
Dr. Michael Pender, M.D., an honorary senior principal research fellow at QIMR Berghofer, and his colleagues are reporting the following interim clinical results from the trial:
- Six patients treated to date – four with SPMS, two with PPMS
- Three of six patients, including two with SPMS and one with PPMS, experienced improvements in MS symptoms as measured by patient reported and objective clinical evaluations
- All three patients with observed clinical improvement showed commencement of improvement two to eight weeks after initiation of T-cell therapy, including reductions in fatigue and gains in quality of life, ability to perform activities of daily living, and manual dexterity
- No patient in the trial experienced progression of disability; there was no worsening in EDSS
- Encouraging clinical improvements through 26 weeks correlate with CTL reactivity against target EBV antigens (EBV reactivity)
- A patient with SPMS (EBV reactivity of 47%) experienced improvements in disability, mobility, musculoskeletal function, and fatigue:
- Expanded Disability Status Scale (EDSS) score improved from 6.5 at baseline to 6.0 following treatment
- Increased walking distance with walker from 100 meters at baseline to 1,500 meters; Able to walk 100 meters with unilateral assistance following treatment
- Improvement in lower extremity muscle tone
- Reduction in fatigue from 60 at baseline to 9 on the fatigue severity scale (FSS) following last study visit (the FSS provides scores in the range from 9-63)
- Nocturia episodes reduced by 80%
- A patient with PPMS (EBV reactivity of 15%) experienced improvements in vision, bladder function, and musculoskeletal function:
- Improved color vision and visual acuity
- Nocturia episodes reduced by 75%
- Clonus with sudden movement resolved and lower extremity spasms improved
- Vertigo resolved
- One gadolinium (Gd) enhancing lesion at baseline to 2 following treatment
- A patient with SPMS (EBV reactivity less than 1%) showed improvements in radiographic and biochemical markers as well as proprioception:
- Reduction in intrathecal immunoglobulin G
- Elimination of Gd-enhancing lesions present at baseline
- Positive to negative Romberg test
- A patient with SPMS (EBV reactivity of 47%) experienced improvements in disability, mobility, musculoskeletal function, and fatigue:
- Of the three patients without clinically observed improvements, two had EBV reactivity of less than 1% and the third patient, with EBV reactivity of 10%, reported increased productivity, which could not be confirmed objectively
- No significant adverse events were observed; one patient experienced transient dysgeusia
The AAN 2017 poster presentation, titled “Symptomatic and objective clinical improvement in progressive multiple sclerosis patients treated with autologous Epstein–Barr virus-specific T cell therapy: Interim results of a phase I trial,” will take place Wednesday, April 26, from 8:30 am to 7:00 pm ET in Exhibit Hall B1 at the Boston Exhibition and Convention Center in Boston, Massachusetts.
“The clinical data reported by Dr. Pender, Dr. Khanna and their colleagues from the first prospective trial of EBV-specific T-cell therapy in MS suggest that it is possible to achieve objective clinical improvements in MS patients with advanced disease by targeting EBV,” said Chris Haqq M.D., Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Atara Bio. “The observed clinical improvements in patients with the highest levels of EBV reactivity support the hypothesis that targeting EBV positive B-cells and plasma cells may be an effective therapeutic strategy in the treatment of MS. We look forward to additional development with both the autologous and allogeneic versions of ATA188 to further evaluate the potential therapeutic utility of targeting EBV in the treatment of MS.”
“This clinical trial directly follows our previously reported findings from a patient with SPMS who showed a durable response to autologous EBV-CTL therapy that lasted for more than three years,” said Professor Rajiv Khanna, Coordinator of QIMR Berghofer’s Centre for Immunotherapy and Vaccine Development. “At QIMR Berghofer, we have focused for years on elucidating the role of EBV in human disease, and we are excited to be working with Atara Bio to help realize the promise of expanding immunotherapy beyond oncology to autoimmune conditions.”
“We believe that 2017 will be a pivotal year for Atara Bio,” said Isaac Ciechanover, President and CEO of Atara Bio. “We look forward to the further development of autologous ATA188 for patients with MS and to our expected initiation of both the Phase 1 allogeneic ATA188 trial as well as our Phase 3 trials of ATA129 in the second half of the year.”
In October 2015, Atara Bio obtained an exclusive, worldwide license to develop and commercialize allogeneic CTLs directed against EBV that utilize the QIMR Berghofer technology, including ATA188. Under the license agreement, Atara Bio also received an option to exclusively license the autologous version of ATA188.
About ATA188
EBV is associated with a wide range of hematologic malignancies and solid tumors, as well as certain autoimmune conditions such as multiple sclerosis. T-cells are a critical component of the body’s immune system and can be harnessed to counteract viral infections, cancers, and certain autoimmune disorders. By focusing the T-cells on specific proteins involved in the disease, the power of the immune system can be employed to combat the condition. ATA188 utilizes a technology in which T-cells are educated to recognize specific antigens of EBV that are implicated in MS. In the context of MS, ATA188 finds and eliminates EBV-infected B-cells and plasma cells in the central nervous system that may catalyze autoimmune response and MS pathophysiology.
About Progressive Multiple Sclerosis
Progressive Multiple Sclerosis (PMS) is a severe disease with few therapeutic options. PMS comprises two conditions, both characterized by persistent progression and worsening of MS symptoms and physical disability over time. This is distinct from Relapsing Remitting MS (RRMS) where people have flares of the disease that are followed by periods of recovery and quiescence during which the disease does not progress. The first form of PMS, Primary Progressive MS (PPMS) occurs when people have a progressive disease course from the day of diagnosis. The second condition is Secondary Progressive MS (SPMS) that initially begins as RRMS but once patients start to have continuous progression of their disease, they have developed SPMS. There is substantial unmet medical need for new and effective therapies for patients with PMS. Most of the treatment options that work well in reducing the flares in RRMS have not been shown to be effective in slowing or reversing the progression of disability in PMS.
About Atara Biotherapeutics’ Allogeneic Cellular Therapy Platform
Atara Bio’s cellular therapy platform provides healthy immune capability to a patient and arms the immune system to precisely target and combat disease. Cells derived from healthy donors are manufactured in advance and stored as inventory so that a customized unit of cells can be chosen for each patient. The cells are ready to infuse in approximately 3 to 5 days. Once administered, the cells home to their target, expand in-vivo to eliminate diseased cells, and eventually recede. This versatile platform can be directed towards a broad array of disease causing targets and has demonstrated clinical proof of concept across both viral and non-viral targets in conditions ranging from liquid and solid tumors to infectious and autoimmune diseases. The Company has pursued prospective feedback from health authorities on both manufacturing and clinical trial design. Atara Bio’s lead product candidate, ATA129, has the potential to be the first commercial allogeneic T-cell therapy for a viral target implicated in cancer.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on allogeneic T-cell therapies for cancer, autoimmune, and infectious disease. Atara Bio’s T-cell product candidates harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The Company’s initial clinical stage T-cell product candidates include Epstein-Barr virus targeted Cytotoxic T-cells (EBV-CTL), or ATA129, Cytomegalovirus targeted Cytotoxic T-cells (CMV-CTL), or ATA230, and Wilms Tumor 1 targeted Cytotoxic T-cells (WT1-CTL), or ATA520. These product candidates have demonstrated the potential to have therapeutic benefit in a number of clinical indications including hematologic malignancies, solid tumors, and refractory viral infections. The Company is also developing a next generation of T-cell product candidates utilizing a technology to selectively enhance a T-cell’s ability to target specific viral proteins implicated in a disease. The Company’s ATA188 product candidate leverages this technology. Initial clinical investigations employing this approach will focus on multiple sclerosis and other virally mediated cancers and infections.
Forward-Looking Statements
This press release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: the clinical development of ATA188 and Atara Bio’s other product candidates, Atara Bio’s collaboration with QIMR Berghofer and the timing, design and results of clinical trials, including the Phase 1 trial sponsored by QIMR Berghofer, further development of autologous ATA188 and Atara Bio’s proposed Phase 1 trial of allogeneic ATA188 for patients with MS and Phase 3 trials utilizing ATA129. Because such statements deal with future events and are based on Atara Bio’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed under the heading “Risk Factors” in Atara Bio’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 9, 2017, including the documents incorporated by reference therein, and subsequent filings with the SEC. Except as otherwise required by law, Atara Bio disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
INVESTOR & MEDIA CONTACTS: Investors: John Craighead, Atara Bio 650-491-5806 jcraighead@atarabio.com Steve Klass, Burns McClellan 212-213-0006 x331 sklass@burnsmc.com Media: Justin Jackson, Burns McClellan 212-213-0006 x327 jjackson@burnsmc.com
$HEAR Adds Industry Veteran to its Board of Directors
Eleven Ventures Partner Gregory Ballard Joins Turtle Beach Board of Directors
SAN DIEGO, April 20, 2017 — Leading console gaming headset and audio accessory maker Turtle Beach Corporation (NASDAQ: HEAR) today announced the appointment of Gregory Ballard to its board of directors, effective April 18, 2017.
Ballard is currently a general partner with San Francisco-based Eleven Ventures, an operationally focused, seed venture investment fund. Prior to joining Eleven Ventures, Ballard served as a senior vice president for Mobile and Social Games at Warner Bros. from 2010 until 2016, and before that he was CEO of Glu Mobile, a publicly traded mobile game company. Additionally, since 2008 he has served as a director on the board of directors for DTS Inc., which was recently acquired by Tessera Technologies.
With his new appointment to the Turtle Beach board, Ballard brings more than three decades of leadership experience in the audio, consumer electronics, gaming and digital entertainment industries. This includes 11 years of experience in audio and consumer hardware as a board member or CEO with DTS, SonicBlue, and Pinnacle Systems and 13 years’ experience in gaming and as a board member, CEO or senior executive with Warner Bros., Glu Mobile, THQ, and Capcom. Ballard earned a JD degree from Harvard Law School.
“We’re very pleased to have Greg join the Turtle Beach board,” said Ron Doornink, chairman of the board, Turtle Beach Corporation. “He is a perfect addition given his strong background in audio hardware and gaming, and his extensive board experience over the past decade in pertinent industries and companies will enable him to jump right in.”
Turtle Beach CEO Juergen Stark commented: “In addition to his very relevant experience, Greg has a rich background with smaller companies and entrepreneurial efforts. It was very evident from our discussions that he has a strong passion for audio and gaming, so I’m looking forward to working with him.”
Commenting on his appointment, Ballard said: “I’ve followed Turtle Beach for many years because of their strong brand and industry leadership, and have always admired the company’s commitment to innovation and quality. I look forward to diving deeper into the company’s vision for its future products and working with the board to further those efforts.”
For more information on the latest Turtle Beach products and accessories, visit www.turtlebeach.com and be sure to follow Turtle Beach on Facebook, Twitter and Instagram.
About Turtle Beach Corporation
Turtle Beach Corporation (http://corp.turtlebeach.com) designs innovative, market-leading audio products. Under its award-winning Turtle Beach brand (www.turtlebeach.com), the Company is the clear market share leader with its wide selection of acclaimed gaming headsets for use with Xbox One and PlayStation®4, as well as personal computers and mobile/tablet devices. Under the HyperSound brand (www.hypersound.com), the Company markets pioneering directed audio solutions that have applications in digital signage and kiosks, consumer electronics and hearing healthcare. The Company’s shares are traded on the NASDAQ Exchange under the symbol: HEAR.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking information and statements within the meaning of the federal securities laws. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events. Statements containing the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “project”, “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Forward-looking statements are based on management’s current belief, as well as assumptions made by, and information currently available to, management.
While the Company believes that its expectations are based upon reasonable assumptions, there can be no assurances that its goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect actual results and may cause results to differ materially from those expressed in forward-looking statements made by the Company or on its behalf. Some of these factors include, but are not limited to, risks related to the Company’s liquidity, the substantial uncertainties inherent in the acceptance of existing and future products, the difficulty of commercializing and protecting new technology, the impact of competitive products and pricing, general business and economic conditions, risks associated with the expansion of our business including the implementation of any businesses we acquire, our indebtedness, the outcome of our HyperSound strategic review process and other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and the Company’s other periodic reports. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the Securities and Exchange Commission, the Company is under no obligation to publicly update or revise any forward-looking statement after the date of this release whether as a result of new information, future developments or otherwise.
$MVIS Big Development and Supply Contract for Laser Beam Scanning System
Contract includes $24 million for non-recurring development fees and other items and includes an upfront payment
MicroVision, Inc. (NASDAQ: MVIS), a leader in innovative ultra-miniature projection display and sensing technology, today announced that it has signed a significant contract with a major technology company to develop a Laser Beam Scanning (LBS) display system and to produce MicroVision specific components.
Under this agreement, MicroVision would develop a new generation of MEMS1, ASICs2 and related firmware for a high resolution, LBS based product the technology company is planning to produce. MicroVision would receive up to $24 million including $14 million in fees for development work that is expected to span 21 months and an upfront payment for other items. The development fees would be paid contingent on completion of milestones in 2017 and 2018. Further details on the milestone timing, amounts related to the milestones, quantity of components and other details of the contract are not being made public.
“We believe the LBS display markets have tremendous opportunity for growth, and we are extremely pleased that a major technology company has decided to work with MicroVision and our PicoP® scanning technology in the development of its product,” said Alexander Tokman, president and CEO of MicroVision. “We believe that our systems expertise and the ability of our patented LBS technology to create a display that produces high resolution images from a low power, small form factor engine were key contributors to winning this business.”
MicroVision’s patented PicoP® scanning technology is well suited to support a wide array of applications including pico projection, interactive pico projection, 3D LiDAR sensing for applications such as advanced driver assistance systems (ADAS), robotics and industrial applications, and Augmented and Virtual Reality (AR/VR).
1 Micro-electrical mechanical systems (MEMS)
2 Application-specific integrated circuits (ASICS)
About MicroVision
MicroVision is the creator of PicoP® scanning technology, an ultra-miniature laser projection and sensing solution based on the laser beam scanning methodology pioneered by the company. MicroVision’s platform approach for this advanced display and sensing solution means that it can be adapted to a wide array of applications and form factors. It is an advanced solution for a rapidly evolving, always-on world. Extensive research has led MicroVision to become an independently recognized leader in the development of intellectual property. MicroVision’s IP portfolio has been recognized by the Patent Board as a top 50 IP portfolio among global industrial companies and has been included in the Ocean Tomo 300 Patent Index. The company is based in Redmond, Wash.
For more information, visit the company’s website at www.microvision.com, on Facebook at www.facebook.com/MicroVisionInc or follow MicroVision on Twitter at @MicroVision.
MicroVision and PicoP are trademarks of MicroVision, Inc. in the United States and other countries. All other trademarks are the properties of their respective owners.
Forward-Looking Statements
Certain statements contained in this release, including those relating to future non-recurring and other payments, benefits of the announced agreement, performance of obligations of the company under the announced agreement, future product and product applications, market growth, and operating results are forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to differ materially from those projected in the company’s forward-looking statements include the following: our ability to timely meet the milestones under and otherwise comply with the terms of the announced agreement, the performance of the technology company of its obligations under the announced agreement, our ability to raise additional capital when needed; products incorporating our PicoP® scanning technology may not achieve market acceptance, commercial partners may not perform under agreements as anticipated, we may be unsuccessful in identifying parties interested in paying any amounts or amounts we deem desirable for the purchase or license of IP assets, our or our customers failure to perform under open purchase orders; our financial and technical resources relative to those of our competitors; our ability to keep up with rapid technological change; government regulation of our technologies; our ability to enforce our intellectual property rights and protect our proprietary technologies; the ability to obtain additional contract awards; the timing of commercial product launches and delays in product development; the ability to achieve key technical milestones in key products; dependence on third parties to develop, manufacture, sell and market our products; potential product liability claims; and other risk factors identified from time to time in the company’s SEC reports, including the company’s Annual Report on Form 10-K filed with the SEC. Except as expressly required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in circumstances or any other reason.
MicroVision, Inc.
Dawn Goetter, 425-882-6629 (investors)
ir@microvision.com
or
Nicole Cobuzio, 732-212-0823 ext. 102 (media)
nicolec@lotus823.com
$IMNP Signs LOI with Pint Pharma Over Ceplene in Latin America
NEW YORK, April 20, 2017 — Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (“Immune” or “Immune Pharma”) announced today that it has entered into a letter of intent with Pint Pharma GmnH, a pharmaceutical company focused on Latin America and other markets (“Pint”), which binds the parties to seek agreement regarding an exclusive license by Pint of the rights to commercialize Ceplene throughout Latin America, including Argentina, Brazil, Chile, Colombia and Mexico. Immune and Pint target closing a final agreement within 30 days. Pursuant to the anticipated final agreement, Pint will be responsible for registration of Ceplene in Latin American countries based on the existing European marketing authorization and will carry out the full commercialization of the licensed product in the territory, including Ceplene registration, pricing and reimbursement, and sales and marketing activities.
In conjunction with the anticipated final agreement, Pint will make an investment of $4 million into Immune Pharma’s oncology subsidiary, Cytovia, Inc. to be used by Cytovia exclusively for oncology related activities.
Ceplene has been approved in Europe for the maintenance of first remission in patients with Acute Myeloid Leukemia (AML) in combination with interleukin-2 (IL-2). According to Pint, there are approximately 10,000 new cases of AML diagnosed per year in Latin America and there is currently no approved treatment for the maintenance of AML remission.
“We are excited about the possibility of partnering with Pint Pharma, a market leader in Latin America with strong commercialization capabilities in the field of oncology. Pint Pharma’s desire to bring Ceplene/IL-2 immunotherapy to patients in Latin America complements our strategy,” said Dr Daniel Teper, CEO of Immune.
“Adding Ceplene to our portfolio of products will further leverage our experience and presence in the oncology field in Latin America,” said David Munoz, Chief Executive Office at Pint. “We are delighted to potentially have Immune as a committed partner to help strengthen our product portfolio.”
Dr. Massimo Radaelli, Executive Chairman of Pint Pharma, has served as an independent director of Ariad Pharmaceuticals Inc. until 2016. He has held the position of President and CEO of Dompe International SA and previously held senior executive positions at Roche, Menarini and DuPont Merck.
“We are very enthusiastic about this potential partnership with Immune and Cytovia which is developing much needed therapies in oncology,” said Dr. Radaelli. “We believe we can leverage the high unmet need for relapse preventive immunotherapy to potentially accelerate the registration and commercial availability of Ceplene in Latin America for patients suffering from AML.”
About Ceplene
Ceplene (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). It has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival while maintaining good quality of life during treatment. Ceplene acts by enhancing the immunostimulatory effect of IL-2 and countering ROS-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research in 2016 confirmed the safety and efficacy of Ceplene in the international study that supported European approval.
About Acute Myeloid Leukemia (AML)
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis and typically become free of detectable leukemia, achieving “complete remission.” However, within 1-2 years, the majority (75-80%) of adult patients will experience a relapse of leukemia, with a survival prognosis of 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. The prognosis following first remission is poor and there are no other effective remission therapies currently available. AML represents an orphan condition with high unmet need.
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune’s lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn’s disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory liver disease. Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune’s oncology subsidiary, Cytovia, plans to develop Ceplene for maintenance remission in AML in combination with IL-2. Additional oncology pipeline products include Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc., Immune’s pain and neurology subsidiary, houses AmiKet™ and AmiKet™ Nano™, pipeline products for the treatment of neuropathic pain. For more information, visit Immune’s website at www.immunepharma.com, the content of which is not a part of this press release.
About Pint Pharma
Pint Pharma is a private, Latin American focused pharmaceutical company, devoted to the development, registration and commercialization of specialty based treatments. Pint Pharma benefits from leaders with extensive experience in the pharmaceutical sector and who are based strategically throughout Latin America and Europe. Pint Pharma has a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma strives to be the first Pan-Latin American provider of innovative and high value-added treatments within Rare Diseases, Specialty Care and Oncology.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal” or the negative of those words or other comparable words to be uncertain and forward-looking. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. Forward-looking statements also include, among others, statements regarding the prospective agreement to license Ceplene and Pint Pharma’s commitment and ability to bring Ceplene/IL-2 immunotherapy to patients in Latin America.These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that either party will ever enter into a definitive agreement to license Ceplene with each other or any other party, for Immune to obtain equity financing from Pint Pharma, or that Immune will realize any of the anticipated benefits of such a transaction should it occur. Additional factors that may cause actual results or developments to differ materially include, but are not limited to: the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern; the risks associated with our ability to continue to meet our obligations under our existing debt agreements; the risk that clinical trials for bertilimumab, Ceplene, Azixa, AmiKet, AmiKet Nano, LidoPain or NanoCyclo will not be successful; the risk that bertilimumab, AmiKet or compounds arising from our NanomAbs program will not receive regulatory approval or achieve significant commercial success; the risk that we will not be able to find a partner to help conduct the Phase III trials for AmiKet on attractive terms, on a timely basis or at all; the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later-stage clinical trials; the risk that we will not obtain approval to market any of our product candidates; the risks associated with dependence upon key personnel; the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; and risks associated with our ability to protect our intellectual property; risks associated with the contemplated transaction with NPT. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings, which are available at www.sec.gov or at www.immunepharma.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors. We expressly disclaim any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
$VUZI Unveils Three New European “Vuzix Industrial Partners” Into its (VIP) Program
ROCHESTER, N.Y., April 19, 2017 — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or, the “Company”), a leading supplier of Smart Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets, is pleased to announce three more of its new European Vuzix Industrial Partners (VIP); Augumenta, DOSCO and Brochesia. These three new VIP partners further expand Vuzix’ sales channels in Europe.
Augumenta, the first of our three new VIPs, is headquartered in Finland and develops Industry 4.0 applications for enterprises. Their application suite, is fully configurable using their Augumenta Studio tool, and empowers users with real-time access to critical factory data. It also has the ability to control machines and production lines without accessing a control station, resulting in shorter problem-solving times and improved shop floor efficiencies. These products, together with Augumenta Interaction Platform SDK, turn smart glasses, like the Vuzix M300, into productivity tools for companies looking to improve their bottom lines. A demonstration of Augumenta’s Interactive Platform interface can be viewed at the following link: https://vimeo.com/101294487.
“We started our smart glass journey by introducing an interaction SDK that brought gesture controls and virtual keypads to the hands of enterprise developers,” said Tero Aaltonen, Augumenta CEO. “We are now expanding our offering by introducing a suite of ready-made applications and a configuration tool that allows our customers to quickly adopt and integrate Augumenta software with their existing IT systems. Vuzix M300 Smart Glasses play an important role in this game with their rugged design and impressive battery life, and we’re proud to promote them as the primary device for our SmartAlert product.”
The second VIP, DOSCO GmbH, is headquartered in Germany and develops applications and systems for technical documentation and support of workers in service and production functions with smart glasses. DOSCO’s Skill Chat connects workers in service and production environments with remote support experts. This video chat application provides a perfect means for aimed support allowing the worker’s hands to remain free and ready for operations, leading to shorter work interruptions and decreased downtime of hardware components. Skill Task provides the worker with step by step instructions of the task to be performed. DOSCO’s Skill Task solution also supports additional functions like QR code detection, photo and voice notes as well as video chat, all offering further support and increased quality assurance.
“Being part of the VIP program gives us direct access to the resources of Vuzix and will significantly support the development and distribution of our solutions for smart glasses, in particular for the new M300,” commented Robert Erfle, Managing Director of DOSCO.
And our third new VIP is Brochesia, headquartered in Rome, Italy. They develop innovative solutions for wearable devices to improve efficiency in business sectors such as manufacturing, health services, logistics, constructions, training, and more. Brochesia offers customers a comprehensive line of hands-free solutions for customers including; remote services, warehouse management, medical support, live streaming and video recording and survey activities.
“Being a Vuzix VIP Partner grants Brochesia early access to the latest Vuzix smart glasses and SDK packages enabling us to upgrade and test our solutions to support e.g. the latest available technologies such as the M300 devices,” commented Christian Salvatori Chief Technology Officer of Brochesia.
“We continue to selectively add leading smart glasses application providers to our Vuzix Industrial Partners (VIP) program,” said Paul J. Travers, President and Chief Executive Officer at Vuzix. “By working with Vuzix, companies like Augumenta, DOSCO and Brochesia provide an invaluable advantage to their customers’ competitive edge in the marketplace. We are thrilled to partner with them as we expand shipments of our next generation M300 Smart Glasses alongside these hands-free enterprise applications.”
About Vuzix Corporation
Vuzix is a leading supplier of Smart-Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets. The Company’s products include personal display and wearable computing devices that offer users a portable high quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 51 patents and 41 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2017 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY, Oxford, UK and Tokyo, Japan.
Forward-Looking Statements Disclaimer
Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward-looking statements contained in this release relate to, among other things, the success and future business generated with the three new VIPs, and the Company’s leadership in the Video Eyewear, VR and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” and MD&A sections of the Company’s Annual Reports and Quarterly Reports filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
Media and Investor Relations Contact:
Matt Margolis, Director of Corporate Communications and Investor Relations, Vuzix Corporation matt_margolis@vuzix.com Tel: (585) 359-5952
Andrew Haag, Managing Partner, IRTH Communications
vuzi@irthcommunications.com Tel: (866) 976-4784
Vuzix Corporation, 25 Hendrix Road, Suite A, West Henrietta, NY 14586 USA,
Investor Information – IR@vuzix.com www.vuzix.com
For further sales, and product information, please visit:
North America:
http://www.vuzix.com/contact/
Europe/UK:
https://www.vuzix.eu/contact/
$STAF to Host Earnings Conference Call for FY16 Results, on April 20, 2017
Management Team to Discuss Financial Results, Latest Developments and the Company’s Growth Initiatives
NEW YORK, NY–(April 19, 2017) – Staffing 360 Solutions, Inc. (NASDAQ: STAF), a public company executing an international buy-and-build strategy through the acquisition of staffing organizations in the United States and the United Kingdom, today announced that the Company will host its earnings conference call on Thursday, April 20, 2017 at 9:00 am Eastern Time. As previously announced, the Company’s Form 10-K/T and earnings release were issued last week, for the fiscal year and transition period ended December 31, 2016.
Speakers on the conference call will include: Brendan Flood, Executive Chairman; Matt Briand, President and Chief Executive Officer; David Faiman, Chief Financial Officer; and Darren Minton, Executive Vice President of Staffing 360 Solutions. The conference call will include a Q&A session where investors will have the opportunity to ask questions of the senior management team.
“We are looking forward to hosting our upcoming earnings conference call,” stated Brendan Flood, Executive Chairman of Staffing 360 Solutions. “Since the beginning of the year, there has been a significant amount of activity over a relatively short period of time, especially considering our $9.0 million of recent funding, which has helped to strengthen our balance sheet. We encourage investors to dial in to the call to hear more about our recent developments, gain additional insight into our financial results, and understand our strategic initiatives as we position ourselves for continued growth in 2017.”
The teleconference can be accessed by dialing 877.407.0778 within the United States, 800.756.3429 within the UK, or 201.689.8565 internationally. Please dial in 10 minutes prior to the beginning of the call. There will be a playback of the teleconference available until May 19, 2017. To listen to the playback, dial 877.481.4010 within the United States or 919.882.2331 internationally and use replay ID number: 10331.
The conference call will be simultaneously webcast and available at:
http://www.investorcalendar.com/event/175845
About Staffing 360 Solutions, Inc.
Staffing 360 Solutions, Inc. (NASDAQ: STAF) is a public company in the staffing sector engaged in the execution of an international buy-and-build strategy through the acquisition of domestic and international staffing organizations in the United States and the United Kingdom. The Company believes the staffing industry offers opportunities for accretive acquisitions that will drive its annual revenues to $300 million. As part of its targeted consolidation model, the Company is pursuing acquisition targets in the finance and accounting, administrative, engineering and IT staffing space. For more information, please visit: www.staffing360solutions.com.
Follow Staffing 360 Solutions on Facebook, LinkedIn and Twitter.
Forward-Looking Statements
Certain matters discussed within this press release are forward-looking statements. These statements may be identified by words such as “expect,” “look forward to,” “anticipate” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “project” or words of similar meaning. Although Staffing 360 Solutions, Inc. believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein, including the goal of achieving annualized revenues of $300 million, due to the Company’s ability to successfully raise sufficient capital on reasonable terms or at all, to consummate additional target acquisitions, to successfully integrate any newly acquired companies, to organically grow its business, to successfully defend any potential future litigation, changes in local or national economic conditions, the Company’s ability to comply with its contractual covenants, including in respect of its debt, as well as various additional risks, many of which are unknown at this time and generally out of the Company’s control, and which are detailed from time to time in Staffing 360 Solutions’ reports filed with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Staffing 360 Solutions does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
Corporate Investor Contact:
Staffing 360 Solutions, Inc.
Darren Minton
Executive Vice President
+1.646.507.5712
Email contact
Financial Contact:
Staffing 360 Solutions, Inc.
David Faiman
Chief Financial Officer
+1.646.507.5711
Email contact
$AIRI 10-K, Receipt of a Listing Deficiency Letter from NYSE MKT
HAUPPAUGE, N.Y., April 19, 2017 —
Air Industries Group (NYSE MKT:AIRI) – Air Industries Group (“Air Industries” or the “Company”), an integrated manufacturer of precision equipment assemblies and components for leading aerospace and defense prime contractors, announced today that, on April 18, 2017, the Company received notice from the staff of NYSE MKT LLC (the “NYSE” or the “Exchange”) that it was not in compliance with Sections 134 and 1101 of the NYSE Company Guide, as a result of the Company’s inability to timely file its Annual Report on Form 10-K for the fiscal year ended December 31, 2016. The letter also states that the Company’s failure to timely file such Annual Report on Form 10-K is a material violation of its listing agreement with the Exchange and, therefore, pursuant to Section 1003(d) of the Company Guide, the Exchange is authorized to suspend and, unless prompt corrective action is taken, remove the Company’s securities from the Exchange.
The Company filed the delinquent Annual Report on Form 10-K today
The Exchange has informed the Company that, in order to maintain its listing on the Exchange following the failure to timely file the Annual Report on Form 10-K, the Company must, by May 18, 2017, submit a plan of compliance (the “Plan”) addressing how it intends to regain compliance with Sections 134 and 1101 of the Company Guide by October 18, 2017 (the “Plan Period”).
If the Plan is accepted, the Company will be able to continue its listing during the Plan Period, during which time the Company will be subject to periodic review to determine whether it is making progress consistent with the Plan. The letter from the Exchange advised that if the Company is not in compliance with the continued listing standards of the Company Guide by October 18, 2017 with respect to the delayed Annual Report on Form 10-K, or if the Company does not make progress consistent with the Plan during the Plan Period, then the Exchange staff will initiate delisting proceedings as appropriate.
The Company believes that with the filing of the delinquent Annual Report on Form 10-K it is in full compliance with the NYSE Company Guide.
ABOUT AIR INDUSTRIES GROUP
Air Industries Group (AIRI) is an integrated manufacturer of precision equipment assemblies and components for leading aerospace and defense prime contractors. Air Industries operates in three segments: Complex Machining of aircraft landing gear and flight controls, Aerostructures & Electronics, and Turbine & Engine products.
Certain matters discussed in this press release are ‘forward-looking statements’ intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace, the ability to realize firm backlog and projected backlog, cost cutting measures, potential future results and acquisitions, are examples of such forward-looking statements. The forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of projects due to variability in size, scope and duration, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Air Industries Group 631.881.4913 ir@airindustriesgroup.com
$SRNE Announces Closing of Public Offering of Common Stock
SAN DIEGO, April 19, 2017 — Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, today announced the closing of its previously announced underwritten public offering of 23,625,084 shares of its common stock at a public offering price of $2.00 per share, before deducting underwriting discounts and commissions and estimated offering expenses payable by Sorrento. The net proceeds to Sorrento from this offering were approximately $43.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
Cantor Fitzgerald & Co. acted as the lead book-running manager for the offering. FBR Capital Markets & Co. acted as a joint book-running manager. Oppenheimer & Co. and Aegis Capital Corp. acted as co-lead managers and Joseph Gunnar & Co., Rodman & Renshaw and Roth Capital Partners acted as co-managers.
The securities described above were offered by Sorrento pursuant to a shelf registration statement on Form S-3 (File No. 333-199849) previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on December 3, 2014. A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC on April 14, 2017 and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by telephone at 212-829-7122, or by e-mail at prospectus@cantor.com.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. Sorrento’s lead product candidates include immunotherapies focused on the treatment of both solid tumors and hematological malignancies, as well as late stage pain products.
Forward-Looking Statements
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the amount of proceeds expected from the offering and other matters that are described in Sorrento’s most recent periodic reports filed with the SEC, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2016, as amended, and the final prospectus supplement related to the offering filed with the SEC on April 14, 2017, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
All other trademarks and trade names are the property of their respective owners.
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.
$SNGX Ricin Toxin Vaccine RiVax Program Efficacy Results to be Presented
PRINCETON, N.J., April 19, 2017 — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that results from its ricin toxin vaccine (RiVax™) development program will be presented at the 20th Annual Conference on Vaccine Research, being held April 24-26 in Bethesda, Md.
“Serum Antibody Profiling following Vaccination Reveals a Correlate of Immunity to Ricin Toxin” will be presented by Jennifer Yates, Ph.D., New York State Department of Health, Wadsworth Center and attended by Oreola Donini, Ph.D., Chief Scientific Officer of Soligenix, on April 25 at 2:15 p.m. Eastern time.
RiVax™ is the Company’s proprietary vaccine candidate for the prevention of exposure to ricin toxin that utilizes a unique antigen that is completely devoid of the toxic activity of ricin. When formulated with ThermoVax®, Soligenix’s proprietary vaccine heat stabilization technology, RiVax™ has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models.
In collaboration with the New York State Department of Health and the laboratory of Nicholas Mantis, Ph.D., Soligenix has been investigating immune correlates of protection in sera of animals vaccinated with RiVax™. The findings demonstrate that: 1) the ThermoVax® thermostabilization process significantly enhances the stability of the RiVax™ antigen; 2) degradation in the antigen can be measured with specific monoclonal antibodies; and 3) these same monoclonal antibodies can be used to probe the immune profile of vaccinated mice and primates and predict their survival to subsequent ricin exposure challenge.
These findings are expected to facilitate the potential approval of the RiVax™ product under the U.S. Food and Drug Administration (FDA) “Animal Rule” and represent a significant step forward in the understanding of ricin toxin immunology. This work was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, via Contract #HHSN272201400039C.
About the Annual Conference on Vaccine Research
In its 20th year, the Annual Conference on Vaccine Research is offered by the National Foundation of Infectious Diseases and brings together experts from around the world, including healthcare professionals, researchers, public health experts and industry. The 2017 conference includes a diverse range of topics including therapeutic vaccines and the use of novel technologies to fight emerging infectious diseases. Details regarding the annual conference can be found here.
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact it is readily extracted from by-products of castor oil production. Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids. The U.S. Centers for Disease Control and Prevention (CDC) estimates the lethal dose in humans is about the size of a grain of salt. Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. Ricin is especially toxic when inhaled. Ricin works by entering cells of the body and preventing the cells from making the proteins it needs. Without the proteins, cells die, which is eventually harmful to the entire body.
There are currently no effective treatments for ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
About RiVax™
RiVax™ is Soligenix’s proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax™, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax™ contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.
To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was subsequently formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine. Vaccination with the thermostabilized Alum-adjuvanted RiVax™ formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin. The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.
Heat stabilization of RiVax™ is achieved with the Company’s proprietary ThermoVax® technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. By employing ThermoVax® during the final formulation of RiVax™, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The development of RiVax™ has been sponsored through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the FDA, which were granted to Soligenix and to the University of Texas Southwestern (UTSW) where the vaccine protein originated. To date, Soligenix, Ellen Vitetta, Ph.D. and her colleagues at UTSW have collectively received approximately $25 million in funding from NIAID for development of RiVax™ and related vaccine technologies. RiVax™ potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack. RiVax™ has received orphan drug designation from the FDA.
As a new chemical entity, an FDA approved RiVax™ vaccine has the potential to qualify for a biodefense Priority Review Voucher, which allows the holder accelerated review of a drug application. Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs are transferable and can be sold, with sales in recent years varying from between $125 million to $350 million.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201).
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to timing or success of the preclinical/clinical trials of RiVax™, that RiVax™ will be approved for the PRV program or the amount for which a PRV for RiVax™ can be sold. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
$NWMH Reports Full-Year 2016 Results, Triple-Digit Revenue Growth
HERNANDO, FL–(Apr 19, 2017) – National Waste Management Holdings, Inc. (OTC: NWMH) (“National Waste”) today announces financial results for the full year ended December 31, 2016, demonstrating continued revenue growth and strength in acquisition-based growth strategy.
Full-year 2016 Highlights:
- Revenues for the twelve months ended December 31, 2016, increased 161% to $6.3 million;
- Cash flows from operating activities for the twelve months ended December 31, 2016, increased to over $1.0 million;
- Acquired Northeast Data and Recycling, LLC and Sivart Services, LLC during the year ended December 31, 2016;
- Continued to see positive results from acquisitions of WRE and Gateway;
- Engaged corporate communications firm to increase shareholder dialogue and transparency;
- Appointed as CFO, Dali Kranzthor, and expanded board of directors;
- Upgraded technology to improve efficiency and reporting
Louis Paveglio, CEO of National Waste Management Holdings Inc., stated, “We executed a number of achievements throughout 2016, and are pleased to report the positive impacts of these initiatives in several respects. Our significant increase in full-year revenues was driven by the performances of companies within our growing acquisition portfolio and subsequent vertical market reach. Additionally, we enjoyed the impact of a stronger economy, an expanded customer base, and an increase in construction activity in Florida — all of which also contributed to our top-line growth.”
Revenue for the 12 months ended December 31, 2016, increased 161% to $6.3 million, as compared to revenue of $2.4 million reported for the full year ended December 31, 2015. This increase is due to a stronger national economy, better utilization of resources, the WRE and Gateway acquisitions during 2015, and the May 2016 acquisition of Sivart, which added Cooperstown, New York, to National Waste’s geographical footprint in Upstate New York.
Net loss for the twelve months ended December 31, 2016, was $(765,208), as compared to a net loss of $(132,503) for the comparable period of 2015. Depreciation and amortization expense increased to $1.0 million during 2016, as compared to $271,311 in 2015. Adjusted earnings after adding back non-cash depreciation and amortization expense and a one-time non-cash impairment charge related to intangible assets of $159,977 in 2016 were $460,912 and $138,808, an increase of $322,104, or 232%. The increased adjusted earnings is attributable to the acquisitions of WRE and Gateway in 2015, Sivart in 2016, and increased operations at the Central Florida landfill.
“We continue to see exponential growth from our aggressive acquisition strategy as we pursue a strong pattern of vertical expansion,” says National Waste CFO Dali Kranzthor. “Our commitment to increased corporate and shareholder value is evidenced through the steps we took throughout 2016 to position National Waste Management as a market leader in 2017 and beyond.”
About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.
This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.
Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact
$XOMA Presents Positive Data from PTH1R Monoclonal Antibody Program
Unmet medical needs in parathyroid hormone-related hypercalcemia contribute to potential partnering value of overall portfolio
BERKELEY, Calif., April 18, 2017 — XOMA Corporation (Nasdaq:XOMA), a pioneer in the discovery and development of therapeutic antibodies, announced today the presentation of positive data from pre-clinical studies investigating the activity of its anti-PTH1R antagonist monoclonal antibody (mAb). The antibody is a potential first-in-class therapeutic agent for the treatment of hyperparathyroidism (HPT) and humoral hypercalcemia of malignancy (HHM). These presentations were made at the American Association for Cancer Research (AACR) and the Endocrine Society (ENDO) annual meetings.
The PTH1R receptor is part of the B GPCR family and is the primary receptor of two ligands, parathyroid hormone (PTH) and parathyroid related protein (PTHrP). Hypercalcemia can occur when elevated levels of PTH, as seen in primary HPT, or elevated levels of PTHrP, as seen in HHM, lead to excessive activation of the PTH1R receptor. A potent and long-acting receptor antagonist could reverse hypercalcemia in all these conditions.
“Consistent with our new strategy, we are seeking partners with a deep commitment to and an expertise in drug development who are interested in licensing this first-in-class antibody and taking it through the clinical development process,” said Jim Neal, Chief Executive Officer of XOMA. “There is a real need for better therapies that address hypercalcemia induced by hyperparathyroidism, and we are encouraged by these data, which demonstrate the efficacy of our anti-PTH1R approach as a potential treatment for patients suffering from HPT and HHM.”
Data presented at the AACR and ENDO conferences between April 1-4, 2017 showed:
- PTH1R antagonism in vitro by the anti-PTH1R mAb translated to potent in vivo activity
- XOMA’s anti-PTH1R antagonist mAb has the potential to become a first-in-class therapy for HHM, as the data demonstrated it ameliorated hypercalcemia and associated morbidities in pre-clinical models
- XOMA’s antibody libraries enabled the discovery of functional antibodies against a very complex target – i.e. the G-Protein Coupled PTH1Receptor
- A high affinity fully human mAb to PTH1R has been selected and characterized
- Proprietary antibody engineering resulted in antibodies with improved potency and manufacturing characteristics
“While hyperparathyroidism is a classic endocrine disorder, HHM spans both endocrine and oncology specialties. HHM is a life-threatening complication of many advanced cancers and is caused by tumor secretion of the PTH1R ligand, PTH-related peptide, which causes high calcium. Since current treatments often fall short of correcting hypercalcemia and many cancer patients die from such high calcium and associated metabolic complications, PTH1R antibodies could prove beneficial for the treatment of this devastating condition,” said John Wysolmerski, MD, Professor of Medicine and Associate Section Chief for Research in the Section of Endocrinology and Metabolism, Yale School of Medicine.
The complete presentations can be found online at www.xoma.com/content/pipeline/publications.htm.
About XOMA’s PTH1R Monoclonal Antibodies Program
XOMA has developed unique functional antibody antagonists targeting PTH1R, a G-protein-coupled receptor involved in the regulation of calcium metabolism. These antibodies have shown promising efficacy in in vivo studies and potentially could address high unmet medical needs, including primary hyperparathyroidism (PHPT) and humoral hypercalcemia of malignancy (HHM). Some secondary and tertiary HPT cases are additionally challenging to manage via current pharmacological approaches and may be well-addressed by XOMA’s anti-PTH1R antibody.
About XOMA Corporation
XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses the Company has in place with other biotech and pharmaceutical companies. Many of these licenses are the result of the Company’s pioneering efforts in the discovery and development of antibody therapeutics. There are more than 20 such programs that are fully funded by partners and could produce milestone payments and royalty payments in the future. To maximize its value in a licensing transaction, XOMA continues to invest in X358, an allosteric monoclonal antibody that reduces insulin receptor activity, as the antibody could be a potential treatment for hyperinsulinism. For more information, visit www.xoma.com.
Forward-Looking Statements
Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding: the potential for XOMA’s anti-PTH1R antagonist monoclonal antibody; the potential of XOMA’s portfolio of partnered programs and licensed technologies generating milestone and royalty proceeds over time; and statements that otherwise relate to future periods. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Potential risks to XOMA meeting these expectations are described in more detail in XOMA’s most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA’s prospects. Any forward-looking statement in this press release represents XOMA’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
Investor contact: Luke Heagle Pure Communications +1 910-726-1372 lheagle@purecommunications.com Media contact: Colin Sanford Pure Communications +1 415-946-1094 csanford@purecommunications.com
$RARE Kyowa Kirin Positive 24-week Data Phase 3 Study of #Burosumab
NOVATO, California, LONDON and TOKYO, April 18, 2017 —
Study met primary endpoint of serum phosphorus response and key secondary endpoint of stiffness improvement
Ultragenyx to host conference call today at 4:30pm ET (USA) to discuss results
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) and Kyowa Kirin International PLC, a wholly owned subsidiary of Kyowa Hakko Kirin, today announced positive 24-week data from the randomised, double-blind, placebo-controlled Phase 3 study of burosumab (KRN23) in adults with X-linked hypophosphatemia (XLH). Patients treated with burosumab demonstrated a statistically significant improvement in serum phosphorus levels, with 94% of patients achieving normal levels compared to 8% on placebo (p<0.0001). Patients treated with burosumab also achieved a statistically significant improvement in stiffness and strong trends in improvements in physical function and pain. Adverse events were consistent with what has been previously observed in open label studies in adults and children. Ultragenyx is conducting the study under a collaboration and licence agreement with Kyowa Hakko Kirin. Burosumab is being developed by Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International.
“These data demonstrate a clinical improvement in patients treated with burosumab and support the potential for treatment of adults,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “When combined with a favourable safety profile and a strong serum phosphorus response, we believe these clinical data should support regulatory submissions in adults with XLH, and we look forward to discussing our filing plans with the U.S. FDA.”
“This study provides valuable additional placebo controlled data to that already obtained from the global clinical development program for pediatric and adult patients with XLH,” said Mitsuo Satoh, Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin. “I believe burosumab has the potential to be an effective treatment option for patients with XLH.”
“We are pleased that the data from this adult Phase 3 study supports the safety and efficacy of burosumab and look forward to progressing our discussions with the regulatory bodies in Europe and the US,” said Dr. Tom Stratford, President and CEO of KKI.
Efficacy Results
The study enrolled 134 patients, randomised 1:1 to burosumab at a dose of 1 mg/kg or placebo every four weeks for 24 weeks. The study met the primary endpoint of increasing serum phosphorus levels as 94% of patients treated with burosumab (n=68) achieved serum phosphorus levels above the lower limit of normal and maintained levels in the low normal range through 24 weeks, compared to 8% in the placebo arm (n=66; p<0.0001).
There were three pre-specified key secondary endpoints, including stiffness and physical function, both measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®), and pain measured by the Brief Pain Inventory Question 3 (BPI Q3; pain at its worst in the last 24 hours). At week 24 stiffness improved by a mean score of 7.87 points for patients treated with burosumab compared to a 0.25 point worsening among patients in the placebo group (mean difference of 8.12; p=0.0122). Physical function improved by 3.11 points for patients treated with burosumab compared to a 1.79 point worsening among patients in the placebo group (mean difference of 4.90 points; p=0.0478). Pain score improved by 0.79 for patients treated with burosumab compared to a 0.32 improvement among patients in the placebo group (mean score difference of 0.46 points; p=0.0919). Results were directionally consistent towards improvement across all three key secondary endpoints. After pre-planned multiplicity adjustment, the improvement in stiffness among patients treated with burosumab remained statistically significant at the less than the 0.0167 threshold, while physical function and pain scores demonstrated strong trends.
Safety Results
There was no difference in the overall frequency of treatment emergent adverse events, treatment related adverse events and serious adverse events between the two treatment groups. The most common (>10%) adverse events in patients treated with either burosumab or placebo were back pain (burosumab 15%, placebo 9%), nasopharyngitis (burosumab 13%, placebo 9%), tooth abscess (burosumab 13%, placebo 8%), injection site reactions (burosumab 12%, placebo 12%), headache (burosumab 12%, placebo 8%), restless legs syndrome (burosumab 12%, placebo 8%), dizziness (burosumab 10%, placebo 6%), nausea (burosumab 10%, placebo 9%), arthralgia (burosumab 9%, placebo 24%), pain in extremity (burosumab 7%, placebo 15%) and oropharyngeal pain (burosumab 2%, placebo 11%). There was no evidence of hypersensitivity reactions to injections. There were two serious adverse events in each treatment group, none of which were considered treatment-related. No differences between groups were observed in serum intact parathyroid hormone levels or ectopic mineralisation as assessed by renal ultrasounds or echocardiograms.
Of the 134 patients enrolled in the study, one patient in the burosumab arm discontinued treatment during the 24-week double-blind treatment period due to consent withdrawal. There have been no deaths in the study.
About the Phase 3 Adult XLH Program
This Phase 3 study is a randomised, double-blind, placebo-controlled clinical study designed to assess the efficacy and safety of burosumab administered every four weeks in 134 adult XLH patients in the US, EU, Canada, Japan, and Korea. The primary endpoint of the study is the percentage of patients who achieved average serum phosphorus levels in the normal range over 24 weeks. The three key secondary endpoints are pain measured by BPI Q3, stiffness and physical function, both measured by WOMAC®. After 24 weeks, all patients receive burosumab through the extension period of the study.
Ultragenyx is conducting a second, fully-enrolled open-label bone quality Phase 3 study in 14 adult XLH patients evaluating the improvement in osteomalacia, the underlying bone pathology of XLH, via bone biopsy. The bone quality study complements the phosphate and patient symptom data from the larger Phase 3 XLH study by evaluating the effect of burosumab more directly on the bone.
About Burosumab (KRN23)
Burosumab is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23). FGF23 is a hormone that reduces serum levels of phosphorus and active vitamin D by regulating phosphate excretion and active vitamin D production by the kidney. Burosumab is being developed by Ultragenyx and Kyowa Hakko Kirin to treat XLH and tumor-induced osteomalacia (TIO), diseases characterized by excess levels of FGF23. Phosphate wasting in XLH and TIO is caused by excessive levels and activity of FGF23. Burosumab is designed to bind to and thereby inhibit the biological activity of FGF23. By blocking excess FGF23 in patients with XLH and TIO, burosumab is intended to increase phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.
A clinical program studying burosumab in adults and pediatric patients with XLH is ongoing. Burosumab is also being developed for TIO, a disease characterized by typically benign tumors that produce excess levels of FGF23, which can lead to severe osteomalacia, fractures, bone and muscle pain, and muscle weakness.
Details of Ultragenyx Conference Call
Ultragenyx will host a conference call today, Tuesday, April 18, 2017 at 4:30pm ET (USA), during which Dr. Kakkis will discuss the topline data. The live and replayed webcast of the call will be available through the company’s website at http://ir.ultragenyx.com/events.cfm. To participate in the live call by phone, dial 855-797-6910 (USA) or 262-912-6260 (international) and enter the passcode 10146009. The replay of the call will be available for one year.
About Ultragenyx
Ultragenyx is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The company is led by a management team experienced in the development and commercialisation of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company’s website at http://www.ultragenyx.com.
About Kyowa Kirin
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.
Kyowa Kirin International PLC (KKI) is a wholly owned subsidiary of Kyowa Hakko Kirin and is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in Europe and the United States. KKI is headquartered in Scotland.
You can learn more about the business at: http://www.kyowa-kirin.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Ultragenyx’s expectations regarding ongoing or additional studies for its product candidates and timing regarding these studies, potential indications for its product candidates, discussions with the FDA and sufficiency for, and timing of, regulatory submissions, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of our regulatory filings and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of our drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Ultragenyx’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 17, 2017, and its subsequent periodic reports filed with the Securities and Exchange Commission.
$MTFB Announces Positive Results for Iclaprim, in the REVIVE-1 Phase 3 Study
- Iclaprim met the primary endpoint
- Iclaprim was well tolerated in the study
- Data from the second Phase 3 ABSSSI Trial, REVIVE-2, expected in the second half of 2017
- NDA submission expected in the first half of 2018
- Company to host conference call today at 8:00 am EDT, 1:00 pm BST
NEW YORK, April 18, 2017 — Motif Bio plc (Motif) (NASDAQ:MTFB), (NASDAQ:MTFBW), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced positive topline results from REVIVE-1, a global Phase 3 clinical trial of its investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (ABSSSI).
Iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure (TOC) endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
Time point | Endpoint | Iclaprim N=298 |
Vancomycin N=300 |
% Difference (95% CI) |
||||||||||
ETP | Early Clinical Response (ECR)* | 241 (80.9%) | 243 (81.0%) | -0.13 (-6.42, 6.17) |
||||||||||
TOC | Clinical cure | 251 (84.2%) | 261 (87.0%) | -2.77 (-8.39, 2.85) |
*≥20% reduction of lesion area at 48-72 hours
In an analysis of a pre-specified secondary endpoint, 60.4% of patients receiving iclaprim demonstrated resolution or near resolution at end of therapy (EOT), compared to 58.3% of patients receiving vancomycin (treatment difference: 2.07%, 95% CI: -5.80% to 9.94%). In another pre-specified secondary endpoint analysis, using a modified clinical cure TOC endpoint defined by a ≥90% reduction in lesion size at TOC, no increase in lesion size since ETP and no requirement for additional antibiotics, clinical cure was seen in 68.5% of patients receiving iclaprim and 73.0% of patients receiving vancomycin (treatment difference: -4.54%, 95% CI: -11.83% to 2.74%).
Graham Lumsden, Chief Executive Officer of Motif Bio commented, “The successful completion of REVIVE-1 is a significant achievement for Motif Bio. I would like to thank the patients and physicians that participated in this important study. We believe that iclaprim, if approved, could be an important option for patients with ABSSSI, especially for patients with severe infections who may also have kidney disease with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in renally impaired patients. It is estimated that up to 26% of the 3.6 million ABSSSI patients hospitalized annually in the U.S. have kidney disease.”
William D. O’Riordan M.D., FACEP, Chief Medical Officer, eStudySite commented, “Following the positive outcome in this clinical trial, the differentiated mechanism, potency, spectrum, safety and efficacy of iclaprim, if approved, could provide a valuable new antibiotic treatment option that is urgently needed to offset the rising problem of bacterial resistance.”
Data from REVIVE-2, the second Phase 3 trial, which uses an identical protocol to REVIVE-1 but has different trial centers, are expected in the second half of 2017 and submission of a New Drug Application (NDA) for iclaprim for the treatment of ABSSSI is anticipated in the first half of 2018.
Iclaprim has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI and hospital acquired bacterial pneumonia (HABP), which enables Priority Review following submission of a NDA. If approved, it is anticipated that iclaprim will be eligible to receive 10 years of market exclusivity in the U.S. from the date of approval. The FDA has also granted Fast Track designation for iclaprim.
REVIVE-1 Overview and Adverse Event (AE) Summary
REVIVE-1 is a 600-patient double-blinded, active-controlled, global, multicenter trial, in patients with ABSSSI that compares the safety and efficacy of an 80mg intravenous dose of iclaprim with a 15mg/kg intravenous dose of vancomycin. Treatments were administered every 12 hours for 5 to 14 days.
Iclaprim was well tolerated in the study, with most adverse events categorized as mild.
Iclaprim N=293 |
Vancomycin N=297 |
||||||
TEAEs (Treatment Emergent Adverse Events) | 151 (51.5%) | 128 (43.1%) | |||||
Study drug related TEAEs | 57 (19.5%) | 53 (17.8%) | |||||
TEAEs leading to discontinuation of study drug | 8 (2.7%) | 13 (4.4%) | |||||
TEAE-related SAEs (Serious AEs) | 8 (2.7%) | 12 (4.0%) | |||||
Deaths | 0 (0.0%) | 1 (0.3%) |
Motif Bio plans to present the full data from this study at an upcoming scientific forum.
Conference call details
Motif Bio management will host a conference call regarding this announcement at 8:00 am EDT, 1:00 pm BST, on Tuesday, April 18, 2017. The call may be accessed by dialing (866) 219-5264 for callers in the U.S., +1-703-736-7410 for callers outside the U.S., using the conference ID number 6665100. A live webcast of the call will be available from the investor relations section of the company’s website at www.motifbio.com, and will be archived there for 30 days.
About iclaprim
Iclaprim is a potential novel antibiotic, designed to be effective against bacteria that have developed resistance to other antibiotics, including trimethoprim. Iclaprim exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including methicillin sensitive Staphylococcus aureus (MSSA) and methicillin resistant Staphylococcus aureus (MRSA). The MIC90 of iclaprim was lower than most comparators including vancomycin and linezolid, standard of care therapies used in serious and life-threatening Gram-positive hospital infections. To date, iclaprim has been studied in over 900 patients and healthy volunteers. Iclaprim is administered intravenously at a fixed dose, with no dosage adjustment required in patients with renal impairment, or in obese patients. This may help reduce overall hospital treatment costs, especially in renally impaired patients.
About Motif Bio plc www.motifbio.com
Motif Bio is a clinical-stage biopharmaceutical company, engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalized patients caused by multi-drug resistant bacteria. Our lead product candidate, iclaprim, is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), infections often caused by MRSA (methicillin resistant Staphylococcus aureus). Having completed the REVIVE-1 trial, patients are currently being enrolled and dosed in a second global Phase 3 clinical trial (REVIVE-2) with an intravenous formulation of iclaprim, for the treatment of ABSSSI. Data readout for REVIVE-2 is expected in the second half of 2017.
Forward-Looking Statements
This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Motif Bio believes that these factors include, but are not limited to, (i) the timing, progress and the results of clinical trials for Motif Bio’s product candidates, (ii) the timing, scope or likelihood of regulatory filings and approvals for Motif Bio’s product candidates, (iii) Motif Bio’s ability to successfully commercialize its product candidates, (iv) Motif Bio’s ability to effectively market any product candidates that receive regulatory approval, (v) Motif Bio’s commercialization, marketing and manufacturing capabilities and strategy, (vi) Motif Bio’s expectation regarding the safety and efficacy of its product candidates, (vii) the potential clinical utility and benefits of Motif Bio’s product candidates, (viii) Motif Bio’s ability to advance its product candidates through various stages of development, especially through pivotal safety and efficacy trials, and (ix) Motif Bio’s estimates regarding the potential market opportunity for its product candidates. More detailed information about the risks and uncertainties affecting Motif Bio plc is contained under the heading “Risk Factors” in Motif Bio plc’s registration statement on Form F-1 filed with the SEC, which is available on the SEC’s web site, www.sec.gov. Motif Bio plc undertakes no obligation to update or revise any forward-looking statements.
For further information please contact: Motif Bio plc Contact: Graham Lumsden Chief Executive Officer ir@motifbio.com Investor Contact: Patricia L. Bank Westwicke Partners 415-513-1284 patti.bank@westwicke.com
$NVLS and Alpine Immune Sciences, Inc. Agree to Combine
– Plan to Accelerate Development of Novel Immunotherapies Focused on Inflammation and Immuno-Oncology –
– Combined Company Well Capitalized with $90 Million in Funding to Advance Discovery and Development –
– Existing Investors OrbiMed Advisors, Frazier Healthcare Partners and Alpine BioVentures Will Invest $17 Million Immediately Prior to The Closing –
– Conference Call on April 18, 2017 at 4:30 pm ET –
Nivalis Therapeutics, Inc. (NASDAQ: NVLS) and Alpine Immune Sciences, Inc., a privately-held biotechnology company developing novel therapies using its next-generation immune system modulation platform, today jointly announced they have entered into a definitive merger agreement under which Alpine will merge with a wholly-owned subsidiary of Nivalis in an all-stock transaction. The merger will result in a combined company with a novel protein-based discovery platform focused on inflammation and immuno-oncology.
Alpine is focused on developing novel protein-based therapies using its variant immunoglobulin domain (vIgD™) platform technology. The vIgD platform is designed to create novel therapeutics that modulate multiple therapeutic targets, including many present in the immune synapse. Alpine’s vIgDs are developed via a unique process known as directed evolution which can produce proteins capable of either enhancing or diminishing an immune response, creating a platform applicable to both oncology and inflammatory diseases. Alpine plans to initiate a Phase 1 clinical trial with its first compound, a dual ICOS/CD28 antagonist engineered for use in autoimmune and inflammatory diseases, in the second half of 2018.
“We believe this transaction with Alpine is an exciting path forward to advance important new therapies for patients and to create significant value for shareholders,” said Howard Furst, Chairman of the Board of Nivalis. “Alpine, which has discovered novel ways to target the immune synapse, is led by a solid and experienced management team that has successfully brought immunotherapies to market.”
“This merger provides a unique opportunity to accelerate the development of our novel immunotherapy platform focused on both inflammation and immuno-oncology,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine Immune Sciences. “We look forward to building on our early success by taking multiple novel programs into the clinic to help patients with significant medical needs.”
Nivalis’ financial advisor for the transaction is Ladenburg Thalmann & Co. Inc., and Nivalis’ legal advisors are Latham & Watkins LLP and Ballard Spahr LLP. Alpine’s legal advisors are Sidley Austin LLP and Ascent Law Partners LLP.
About the Proposed Transaction
On January 3, 2017, Nivalis announced the initiation of a process to explore and review a range of strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. As part of that process, bids were solicited from interested parties and over eighty interested parties submitted a proposal to enter into a strategic transaction with Nivalis. After a thorough review of each alternative and extensive negotiation with Alpine Immune Sciences, Nivalis’ board of directors unanimously decided to approve and enter into a definitive merger agreement with Alpine.
Frazier Healthcare Partners, Alpine BioVentures, and OrbiMed Advisors will invest a combined additional $17 million into Alpine Immune Sciences prior to the close of the transaction based on a valuation of Alpine which is consistent with that used to calculate the exchange ratio under the merger agreement. Following the merger, current Alpine shareholders will own approximately 74 percent of the combined company and current Nivalis shareholders will own approximately 26 percent of the combined company. The exchange ratio is based on a valuation of Nivalis equal to $50 million, which includes approximately $44 million in cash expected to be held by Nivalis at the time of closing. The combined company is expected to have approximately $90 million in cash and cash equivalents at the closing of the transaction.
The transaction has been approved by the board of directors of both companies. The merger is expected to close in the third quarter of 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of other customary conditions.
Management and Organization
Mitchell H. Gold, M.D., Alpine’s Executive Chairman and Chief Executive Officer, will become the Chairman and Chief Executive Officer of the combined company. Following the merger, the board of directors of the combined company will expand to seven seats with two representatives from Nivalis.
Upon closing of the transaction, the name of the combined company will become Alpine Immune Sciences, Inc. and shares of the combined company’s common stock will trade on the NASDAQ Global Market.
Conference Call and Webcast
Dr. Gold and R. Michael Carruthers, interim president and chief financial officer of Nivalis, will host a conference call and simultaneous webcast to discuss the proposed transaction on April 18, 2017, at 4:30 p.m. Eastern Time. The webcast can be accessed by visiting the Investors section of Nivalis’ website at ir.nivalis.com. Alternatively, please call 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). The conference ID number is 13660534. The webcast will be archived on Nivalis’ website for at least 30 days.
About Nivalis Therapeutics, Inc.
Nivalis Therapeutics, Inc. (http://www.nivalis.com) is a pharmaceutical company that has historically been focused on the discovery and development of product candidates for patients with cystic fibrosis, or CF. The Company’s development candidates selectively target an enzyme known as S-nitrosoglutathione reductase (GSNOR). GSNOR regulates levels of an endogenous protein known as S-nitrosoglutathione, or GSNO. Depleted levels of GSNO have been associated with CF, asthma, inflammatory bowel diseases and certain cardiovascular diseases. Following recent disappointing results of a Phase 2 clinical trial of its lead product candidate, cavosonstat, in CF, Nivalis determined to not pursue the development of this compound in CF and to wind down its research and development activities while devoting its efforts to investigating and evaluating strategic alternatives.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. was founded in 2015 and is focused on developing novel protein-based immunotherapies using its proprietary variant immunoglobulin domain (vIgD™) platform technology. The vIgD platform is designed to interact with multiple targets, including many present in the immune synapse. Alpine’s vIgDs are developed using a unique process known as directed evolution, which can produce proteins capable of either enhancing or diminishing an immune response and thereby may apply therapeutically to both oncology and inflammatory diseases. Alpine has also developed its transmembrane immunomodulatory protein (TIP™) technology, based on the vIgD platform, to enhance engineered cellular therapies. In October 2015, Alpine signed a worldwide research and license agreement with Kite Pharma, Inc. (NASDAQ:KITE) for up to $535 million in up front and potential milestone payments and in addition, royalties on resulting sales. The agreement allows Kite access to certain targets developed using Alpine’s TIP™ platform. For more information, visit www.alpineimmunesciences.com/.
Forward-Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning Nivalis, Alpine, the proposed transaction and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Nivalis, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risk that the conditions to the closing of the transaction are not satisfied, including the failure to timely or at all obtain stockholder approval for the transaction; uncertainties as to the timing of the consummation of the transaction and the ability of each of Nivalis and Alpine to consummate the transaction; risks related to Nivalis’ ability to correctly estimate its operating expenses and its expenses associated with the transaction; risks related to the market price of Nivalis’ common stock relative to the exchange ratio; the ability of Nivalis or Alpine to protect their respective intellectual property rights; competitive responses to the transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Nivalis’ most recent Annual Report on Form 10-K, and Nivalis’ recent Quarterly Report on Form 10-Q and Current Reports on Form 8-K filed with the SEC. Nivalis can give no assurance that the conditions to the transaction will be satisfied. Except as required by applicable law, Nivalis undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the United States Securities Act of 1933, as amended. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.
Participants in the Solicitation
Nivalis and Alpine, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Nivalis’ directors and executive officers is included in Nivalis’ Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on February 13, 2017, and the proxy statement for Nivalis’ 2017 annual meeting of stockholders, filed with the SEC on April 6, 2017. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the transaction when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated below.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transaction between Nivalis and Alpine, Nivalis intends to file relevant materials with the SEC, including a registration statement that will contain a proxy statement and prospectus. NIVALIS URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT NIVALIS, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Nivalis with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Nivalis with the SEC by contacting Investor Relations by mail at Attn: Investor Relations, 3122 Sterling Circle, Boulder, Colorado, 80301. Investors and stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.
For Alpine Immune Sciences, Inc.
Jennifer Paganelli, 347-658-8290
jpaganelli@w2ogroup.com
$IDXG Coverage of ThyraMIR® with UnitedHealthcare
PARSIPPANY, N.J., April 18, 2017 — Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (the “Company”), a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services, today announced that UnitedHealthcare, the largest health plan in the United States, has agreed to cover Interpace’s ThyraMIR® test used in assessing indeterminate thyroid nodule fine needle aspirate (FNA) biopsies. The coverage is now in effect and is subject to members’ specific benefit plan design. The UnitedHealthcare policy decision is consistent with the National Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Guidelines, which recommend that clinicians consider the use of molecular testing to identify patients with indeterminate cytopathology results whose nodules are actually benign and can thus avoid surgery. Interpace is not currently a contracted, in-network lab provider with UnitedHealthcare. Interpace’s ThyGenX® and ThyraMIR assays are now covered for approximately 250 million patients nationwide, including through Medicare, National, and Regional health plans. Medicare approved coverage for ThyraMIR in January 2016 (LCD L35396).
ThyGenX – ThyraMIR represents the only test in the market that combines the rule-in properties of next-generation sequencing of a patient’s DNA and RNA, with rule-out capabilities of a micro-RNA classifier to provide physicians with clinically actionable test results. Based on current performance, over 80% of the Company’s total cases are reflexed to ThyraMIR for additional assessment. The Company first launched ThyraMIR on April 15, 2015 making it available to Endocrinologists and Pathologists throughout the country. Since then, the Company has conducted over 5,000 ThyraMir tests for nearly 400 physicians and hospitals.
According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the U.S., tripling in the past three decades. Most physicians have traditionally recommended thyroid surgery where thyroid nodule biopsy results are indeterminate, not clearly benign or malignant following traditional cytopathology review; however, 70%-80% of these surgical outcomes are ultimately benign. Molecular testing using ThyGenX – ThyraMIR has been shown to reduce the rate of unnecessary surgeries in indeterminate cases.
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests: PancraGEN®, for the evaluation of pancreatic cysts and assessment of risk of concomitant or subsequent cancer; ThyGenX®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; and ThyraMIR®, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace’s mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. For more information, please visit Interpace Diagnostics’ website at www.interpacediagnostics.com.
About Thyroid Nodules, ThyGenX and ThyraMIR Testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
Forward Looking Information
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the Company’s ability to adequately finance the business, its ability to restructure its debt and other obligations, the market’s acceptance of its molecular diagnostic tests, its ability to retain or secure reimbursement, its ability to secure additional business and generate higher profit margins through sales of its molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments and its ability to maintain its NASDAQ listing. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company’s filings with the SEC, including without limitation, the Annual Report on Form 10-K filed with the SEC on March 31, 2017. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
CONTACTS:
Interpace Diagnostics
Investor Relations:
Paul Kuntz
Redchip
Paul@Redchip.com
$TRCH Announces Private Placement of $8 Million in Unsecured Promissory Notes
PLANO, TX–(April 17, 2017) – Torchlight Energy Resources, Inc. (TRCH) (“Torchlight” or the “Company”), today announced the closing of $8 million in unsecured 12% promissory notes through a private placement. The promissory notes bear interest at the rate of 12% per annum and mature on April 10, 2020, with interest payable monthly and a lump sum payment of outstanding principal due on maturity. The notes were issued at a purchase price of 94.25% of the principal amount, resulting in net proceeds of $7.54 million. In addition to the 12% cash interest, the notes will earn a common stock PIK at the rate of 2.5% annually.
The proceeds from the notes will be used to redeem the $3.6 million of subordinated notes outstanding and to finance two horizontal wells in the Company’s Hazel Project located in the Midland Basin, as well as for general corporate purposes.
“We are pleased to obtain this debt financing which should address our capital needs all the way into 2018,” stated John Brda, Torchlight Energy’s CEO. “We believe the terms of this debt are favorable to the Company, and will allow us to retire existing debt and add significant production in our Hazel Project through two new horizontal wells.”
About Torchlight Energy
Torchlight Energy Resources, Inc. (NASDAQ: TRCH), based in Plano, Texas, is a high growth oil and gas Exploration and Production (E&P) company with a primary focus on acquisition and development of highly profitable domestic oil fields. The company has assets focused in West and Central Texas where their targets are established plays such as the Permian Basin. For additional information on the Company, please visit www.torchlightenergy.com.
Forward Looking Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve risks and uncertainties that could cause actual results to differ materially from those described in such statements. Such forward-looking statements involve known and unknown risks and uncertainties, including risks associated with the Company’s ability to obtain additional capital in the future to fund planned expansion, the demand for oil and natural gas, general economic factors, competition in the industry and other factors that could cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. The Company is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Investor Relations Contact
Derek Gradwell
MZ Group
SVP Natural Resources
Phone: 512-270-6990
Email: dgradwell@mzgroup.us
Web: www.mzgroup.us
$RPRX New U.S. Patent for Treatment Using Off Drug Intervals
THE WOODLANDS, Texas, April 17, 2017 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced the issuance of a new patent, U.S. Patent number 9,616,074 (the ‘074 patent), that bolsters the Company’s intellectual property relating to Proellex® (telapristone acetate). The ‘074 patent, which expires in 2027, relates to the use of Selective Progesterone Receptor Modulators (SPRM), in particular Telapristone Acetate (Proellex®) or Ulipristal Acetate, with an Off Drug Interval (ODI) for the treatment of estrogen-dependent hyperproliferative uterine conditions, such as uterine fibroids and endometriosis. Under the terms of the patent, ODI is defined as daily administration of the SPRM for a period of time, followed by an ODI sufficient for the patient to menstruate and then by another period of administration of the SPRM.
About Repros Therapeutics Inc.®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Forward-Looking Statements
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to the Company’s pipeline and plans for growth, and are subject to such risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com.
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
$WPRT to Sell its APU Assets for USD$70 million, Definitive
~Sale in-line with previously announced portfolio review~
VANCOUVER, April 17, 2017 – Westport Fuel Systems Inc. (“Westport Fuel Systems“) (TSX:WPRT / Nasdaq:WPRT) today announced that it has entered into a definitive agreement to sell the assets of its Auxiliary Power Unit (“APU“) business for $70 million United States dollars, subject to certain customary adjustments. The transaction is expected to close within a few weeks. The divestiture is consistent with Westport’s strategy to streamline its business and product lines and focus on alternative fuel solutions for the transportation and automotive industries.
“We are pleased to have completed this transaction as part of our portfolio review that began with the closing of the merger with Fuel Systems in June of 2016” stated Nancy Gougarty, CEO of Westport Fuel Systems. “After a careful assessment of the APU product line and its fit with the other Westport Fuel Systems businesses, we decided it made the most sense for our shareholders to pursue this sale.”
J.P. Morgan acted as financial advisor for Westport Fuel Systems on the transaction.
About Westport Fuel Systems
At Westport Fuel Systems, we are driving innovation to power a cleaner tomorrow. We are inventors, engineers, manufacturers and suppliers of advanced clean-burning fuel systems and components that can change the way the world moves. Our technology delivers performance, fuel efficiency and environmental benefits to address the challenges of global climate change and urban air quality. Headquartered in Vancouver, Canada, we serve our customers in more than 70 countries with leading global transportation and industrial application brands. At Westport Fuel Systems, we think ahead. For more information, visit www.wfsinc.com.
$MOCO to be Acquired by $AME
BERWYN, Pa. and MINNEAPOLIS, April 17, 2017 — AMETEK, Inc. (NYSE:AME) and MOCON, Inc. (NASDAQ:MOCO) announced that they have entered into a definitive merger agreement under which AMETEK will acquire all of the outstanding shares of common stock of MOCON at a price of $30 per share in cash, which represents a premium of 39% to MOCON’s closing share price on April 13, 2017. The aggregate enterprise value of the transaction is approximately $182 million, taking into account MOCON’s outstanding equity awards and net cash to be acquired in the transaction. The transaction was unanimously approved by the Board of Directors of MOCON.
Founded in 1963 and headquartered in Minneapolis, MN, MOCON is a leading provider of laboratory and field gas analysis instrumentation to research laboratories, production facilities and quality control departments in food and beverage, pharmaceutical, and industrial applications. For the calendar year ending December 31, 2016, MOCON had sales of approximately $63 million.
“MOCON is an excellent company that has tremendous synergy with AMETEK,” comments David A. Zapico, AMETEK Chief Executive Officer. “They are the global leader in gas analysis instrumentation for package and permeation testing. Its products and technologies nicely complement our existing gas analysis instrumentation business and provides us with opportunities to expand into the growing food and pharmaceutical package testing market.”
“We believe this transaction creates significant value for our shareholders and provides long-term benefits for our customers and employees,” said Robert L. Demorest, MOCON President and Chief Executive Officer. “By joining a larger global enterprise, MOCON will have the resources to expand our market leading gas analysis products and technologies. We look forward to joining the outstanding team at AMETEK.”
The closing of the transaction is subject to customary closing conditions, including the approval of MOCON’s shareholders and applicable regulatory approvals. The transaction is expected to be completed in the late second quarter or third quarter of calendar year 2017.
About AMETEK
AMETEK is a leading global manufacturer of electronic instruments and electro-mechanical devices with annual sales of approximately $4.0 billion. AMETEK’s Corporate Growth Plan is based on Four Key Strategies: Operational Excellence, Strategic Acquisitions, Global & Market Expansion and New Products. AMETEK’s objective is double-digit percentage growth in earnings per share over the business cycle and a superior return on total capital. The common stock of AMETEK is a component of the S&P 500 Index.
About MOCON
MOCON is a leading provider of detectors, instruments, systems and consulting services to research laboratories, production facilities, and quality control and safety departments in the medical, pharmaceutical, food and beverage, packaging, environmental, oil and gas and other industries worldwide.
Additional Information and Where to Find It
This document may be deemed to be solicitation materials in respect of the proposed acquisition of MOCON by AMETEK. In connection with the proposed merger, MOCON will file with the SEC and furnish to MOCON’s shareholders a proxy statement and other relevant documents. This filing does not constitute a solicitation of any vote or approval. MOCON SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER.
Investors will be able to obtain a free copy of documents filed with the SEC at the SEC’s website at www.sec.gov. In addition, investors may obtain a free copy of MOCON’s filings with the SEC from MOCON’s website at www.mocon.com or by directing a request to: MOCON, Inc., 7500 Mendelssohn Avenue North, Minneapolis, MN; Attention: Elissa Lindsoe, Chief Financial Officer.
Participants in the Solicitation
MOCON and its directors, executive officers and certain other members of management and employees of MOCON may be deemed “participants” in the solicitation of proxies from shareholders of MOCON in favor of the proposed merger. Information regarding the persons who may, under the rules of the SEC, be considered participants in the solicitation of the shareholders of MOCON in connection with the proposed merger will be set forth in the proxy statement and the other relevant documents to be filed with the SEC. You can find information about MOCON’s executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed with the SEC on March 9, 2017, and in its definitive proxy statement filed with the SEC on Schedule 14A on April 13, 2016.
Forward-looking Information
Statements in this news release relating to future events are “forward-looking statements.” Forward-looking statements are subject to various factors and uncertainties that may cause actual results to differ significantly from expectations. Forward-looking statements in this news release include, but are not limited to, statements about the benefits of the merger; potential synergies and the timing thereof; the expected timing of the completion of the merger; and the combined company’s plans, objectives, expectations and intentions with respect to future operations, products and services. Each forward-looking statement contained in this news release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, but are not limited to, the following: (1) MOCON may be unable to obtain shareholder approval as required for the merger; (2) conditions to the closing of the merger, including the obtaining of required regulatory approvals, may not be satisfied; (3) the merger may involve unexpected costs, liabilities or delays; (4) the business of MOCON may suffer as a result of uncertainty surrounding the merger; (5) the outcome of any legal proceedings related to the merger; (6) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (7) the ability to recognize benefits of the merger; (8) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; (9) other risks to consummation of the merger, including the risk that the merger will not be consummated within the expected time period or at all; (10) general industry and economic conditions; and (11) the risks described from time to time in AMETEK’s and MOCON’s filings with the U.S. Securities and Exchange Commission, including their most recent reports on Form 10-K, 10-Q and 8-K. You are encouraged to read AMETEK’s and MOCON’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. AMETEK and MOCON disclaim any intention or obligation to update or revise any forward-looking statements.
CONTACT: MOCON, Inc. Investor Contact: Elissa Lindsoe, 763-493-6370 CFO www.mocon.com or Three Part Advisors, LLC Steven Hooser, 214-872-2710 Investor Relations shooser@threepa.com
$CBLI Announces Commencement of In Vivo Biocomparability Study
BUFFALO, NY–(Apr 17, 2017) – Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of a side-by-side analytical comparison of two formulations of entolimod. The FDA agreed with CBLI that these data indicate the in vitro analytical comparability of the formulations. Based on the outcome of its review, the FDA has provided CBLI with its consent for initiation of an in vivo biocomparability study of these formulations in non-human primates (NHP).
The objective of the in vivo biocomparability study is to compare the historical drug formulation used in prior nonclinical and clinical studies versus the to-be-marketed drug formulation of entolimod submitted for approval under CBLI’s application for pre-Emergency Use Authorization (pre-EUA). Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological or nuclear attack.
“We are excited to have received agreement from the FDA to commence the in vivo biocomparability study,” continued Yakov Kogan, PhD, MBA, Chief Executive Officer. “Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier.”
The planned biocomparability study is funded in part by the Department of Defense (DoD) Joint Warfighter Medical Research Program (JWMRP) contract award number W81XWH-15-C-0101 to CBLI. The DoD JWMRP contract is valued at up to $9.2 million and supports further development of entolimod as a medical radiation countermeasure.
Disclaimer
The mention of any specific companies, commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government. The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company’s proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, immuno-oncology, and vaccines. The company’s most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome, an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company’s website at http://www.cbiolabs.com.
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that do not relate strictly to historical or current facts. Words and phrases such as “potential,” “may,” “future,” “will,” “plan,” “anticipate,” “believe,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the company’s future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, research and clinical analyses and trials, regulatory approvals or the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
Factors that could contribute to such differences include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the company’s plans and expectations with respect to future clinical trials and commercial scale-up activities; the company’s ability to attract collaborators with development, regulatory and commercialization expertise and the financial risks related to those relationships; the company’s ability to comply with its obligations under license agreements; the company’s inability to obtain regulatory approval in a timely manner or at all; the commercialization of the company’s product candidates, if approved; the company’s plans to research, develop and commercialize its product candidates; future agreements with third parties in connection with the commercialization of any approved product; the size and growth potential of the markets for the company’s product candidates, and its ability to serve those markets; the rate and degree of market acceptance of the company’s product candidates; the company’s history of operating losses and the potential for future losses, which may lead the company to not be able to continue as a going concern; regulatory developments in the United States and foreign countries; the performance of the company’s third-party suppliers and manufacturers; and the success of competing therapies that are or may become available. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. Any forward-looking statements speak only as of the date on which such statements are made, and the company undertakes no obligation to update any forward-looking statement to reflect events or circumstances occurring or arising after the date on which such statement is made, except as may be required by law. See also the “Risk Factors” and “Forward-Looking Statements” described in the company’s periodic filings with the Securities and Exchange Commission.
Contacts:
Cleveland BioLabs, Inc.
C. Neil Lyons
Chief Financial Officer
T: 301-675-4570
E: nlyons@cbiolabs.com
$EXPI Supports Accelerated Growth with the Addition of Four Industry Veterans to Management
Former DocuSign, Zillow executives among those bringing expertise to eXp’s rapidly expanding cloud-based brokerage
BELLINGHAM, WA–(April 17, 2017) – eXp World Holdings, Inc. (OTCQB: EXPI), the holding company for eXp Realty LLC, The Agent-Owned Cloud Brokerage®, today announced the addition of industry veterans Kee Wah Chung, Kathy Gordon, Scott Petronis and Mitch Robinson to its management team.
“Our daily objective is to be the most agent-centric brokerage firm in the world,” said Russ Cofano, President and General Counsel of eXp World Holdings. “Adding Kee Wah, Kathy, Scott and Mitch to our stellar team will allow us to provide new and exciting services for both current and future agents on the eXp platform. Our ability to attract top talent is further enabled by our accelerating growth, as evidenced by our year-over-year agent growth of over 200 percent when we surpassed the 3,000 agent mark in mid-March.”
The four industry veterans joining eXp Realty’s management team include:
KEE WAH CHUNG
Kee Wah Chung joins eXp Realty as Vice President of Agent Experience. Kee Wah will lead the continued buildout of an exceptional end-to-end Agent Experience though a robust service-delivery model for onboarding new agents, providing transaction management services, and supporting agents via eXp tools and systems. Kee Wah previously worked as Director of the Real Estate Customer Success Program for DocuSign. There, he created the first real estate-focused team to drive a world-class customer experience for onboarding brokers, agents, and staff.
KATHY GORDON
Kathy Gordon, who has nearly two decades of experience in the industry, joins eXp Realty as Vice President, Brokerage Operations. In this position, she will deliver value to eXp agents through the support of eXp’s state administrative brokers, the administration of eXp’s brokerage policies and procedures, and license law and regulatory compliance. She also will serve as liaison with eXp’s legal resources and risk management programs. Kathy previously was Broker of Record at one of Keller Williams’ largest firms, with nearly 3000 agents. She also served as the Director of Compliance and Risk Mitigation for her region, while coaching/consulting multiple offices in areas of compliance, risk mitigation, operations, and leadership.
SCOTT PETRONIS
As eXp Realty’s new Chief Product and Technology Officer, Scott Petronis will lead the delivery of strategic agent-centric solutions that power the business and its rapidly growing agent base. Scott has more than 20 years of experience in delivering software and SaaS products for businesses and consumers. Most recently, Scott headed up products and technology for Onboard Informatics, a leading provider of data and technology solutions to U.S. real estate brokerage firms. For the past five years, Scott has been a fixture in industry technology initiatives through his work with the Real Estate Standards Organization (RESO), including leading the Web API initiative as the Chair of the Transport Workgroup. In that role, he drove agreement on a new standard that allows companies to more rapidly innovate solutions for the real estate industry.
MITCH ROBINSON
In his new role as Senior Vice President, Marketing and Communications for eXp Realty, Mitch Robinson is responsible for branding, external and internal communications, digital and social media, events (both live and within eXp World, the company’s fully immersive 3D Cloud Campus). Robinson was an early employee at Expedia before joining the online real estate marketplace Zillow. As the leader of Zillow’s trade marketing team, Mitch spearheaded marketing initiatives working with real estate agents, brokers, MLSs, rental professionals, and builders. In this role, he blended technology innovation with a deep appreciation for the ways in which agents can be successful in an industry ripe for disruption.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. (OTCQB: EXPI) is the holding company for eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an attractive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers real estate professionals within its ranks opportunities to earn company stock for production and contributions to overall company growth.
For more information, please visit the Company’s Twitter, LinkedIn, Facebook, YouTube, or visit www.eXpRealty.com.
Safe Harbor Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Mitch Robinson
SVP, Marketing and Communications
Email contact
$PME Declares Quarterly Cash Dividend For the Second Quarter 2017
FUZHOU, China, April 13, 2017 — Pingtan Marine Enterprise Ltd. (Nasdaq: PME), (“Pingtan,” or the “Company”) a global fishing company based in the People’s Republic of China (PRC), today announced that the Company has declared a quarterly cash dividend of $0.01 per share of common stock outstanding, payable in cash on or about May 15, 2017 to shareholders of record on April 30, 2017. This marks the tenth consecutive quarterly dividend paid by Pingtan. The Company intends to continue paying a cash dividend on a quarterly basis, and expects to adjust its quarterly dividend rate in accordance with its earnings performance.
About Pingtan
Pingtan is a global fishing company engaging in ocean fishing through its subsidiary, Fujian Provincial Pingtan County Ocean Fishing Group Co., Ltd., or Pingtan Fishing.
Business Risks and Forward-Looking Statements
This press release contains forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933 and the Securities Exchange Act of 1934, including statements about the Company’s expectation that it currently intends to continue paying dividends on a quarterly basis. Although forward-looking statements reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Risks include anticipated growth and growth strategies; need for additional capital and the availability of financing; our ability to successfully manage relationships with customers, distributors and other important relationships; technological changes; competition; demand for our products and services; the deterioration of general economic conditions, whether internationally, nationally or in the local markets in which we operate; operational, mechanical, climatic or other unanticipated issues that adversely affect the production capacity of the Company’s fishing vessels and their ability to generate expected annual revenue and net income; legislative or regulatory changes that may adversely affect our business; and other risk factors contained in Pingtan’s SEC filings available at www.sec.gov, including Pingtan’s most recent Annual Report on Form10-K and Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. Pingtan undertakes no obligation to update or revise any forward-looking statements for any reason.
CONTACT:
Roy Yu
Chief Financial Officer
Pingtan Marine Enterprise Ltd.
Tel: +86 591 87271753
ryu@ptmarine.net
INVESTOR RELATIONS:
The Equity Group Inc.
Adam Prior, Senior Vice President
Tel: (212) 836-9606
aprior@equityny.com
In China
Katherine Yao, Senior Associate
Tel: +86 10 6587 6435
kyao@equityny.com
$EYES Argus II Retinal Prosthesis Implanted in First Patient in Asia
-Underscores Second Sight’s Commitment to Expansion in Asia–
Second Sight Medical Products, Inc. (NASDAQ:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to provide some useful vision to blind patients, today announced that the Argus® II Retinal Prosthesis System (“Argus II”) has been implanted in the first patient in Asia through an exclusive distribution partnership with Orient Europharma Co., Ltd. (OEP) and with charitable support from the Hong-Lu Foundation in Taiwan. The Argus II was provided under special import permits authorized by the Taiwan Food and Drug Administration (TFDA).
The surgical procedure was performed by Dr. Yih-Shiou Hwang and his team at Chang Gung Memorial Hospital (CGMH), in Linkou, Taiwan in a 40-year-old patient who suffers from blindness caused by retinal degeneration. Dr. Paulo Stanga, Consultant, Ophthalmologist & Vitreoretinal Surgeon at the Manchester Royal Eye Hospital, UK supervised the implantation.
“We are very pleased to expand the availability of the Argus II to Asia as we continue to offer our technology to patients with Retinitis Pigmentosa (RP), providing them with the potential opportunity to lead more independent lives,” said Will McGuire, President and CEO of Second Sight. “We look forward to supporting broader access to the Argus II to patients with RP throughout Asia and the other regions we serve.”
About the Argus II Retinal Prosthesis System
Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina’s remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread approval, and is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom, and the U.S.
About Second Sight
Second Sight’s mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed and manufactures the Argus® II Retinal Prosthesis System. Second Sight is currently conducting a trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ I Visual Cortical Prosthesis that is intended to restore some vision to individuals who are blind due to many causes other than preventable or treatable conditions. U.S. Headquarters are in Sylmar, CA, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.
About Orient Europharma (OEP)
Orient Europharma. Co., Ltd. (4120.TT) Headquartered in Taipei, Taiwan, is a specialty pharmaceutical company focused on the manufacturing, marketing and distribution of both ethical and OTC products. OEP stands among top 30 pharmaceutical companies in both Taiwan and the Philippines based on IMS surveys, with an annual turnover of $150 million U.S. dollars. With subsidiaries across Asia and a strong sales network of 360 dedicated and experienced sales representatives covering CNS, CV, oncology, ophthalmology, respiratory and women’s health, OEP has the ability and expertise to commercialize products throughout the region. The key to OEP’s success lies in the enthusiasm and professionalism of its employees, who take pride in their in day-to-day work knowing their contributions make a difference to patients.
Safe Harbor
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 and Exchange Act of 1934, as amended, which are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements.” These statements may be identified by words such as “estimates,” “anticipates,” “projects,” “plans,” or “planned,” “seeks,” “may,” “will,” “expects,” “intends,” “believes,” “should” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future 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 Annual Report on Form 10-K as filed on March 16, 2017, and our other reports filed from time to time with the Securities and Exchange Commission. 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.
Investor Relations:
Institutional Investors
In-Site Communications, Inc.
Lisa Wilson, 212-452-2793
President
lwilson@insitecony.com
or
Individual Investors
MZ North America
Greg Falesnik, 949-385-6449
Managing Director
greg.falesnik@mzgroup.us
or
Media:
Pascale Communications, LLC
Allison Howell, 412-228-1678
Senior Account Director
allison@pascalecommunications.com
$FCSC to Present at 7th Annual World Orphan Drug Congress USA 2017
EXTON, Pa., April 13, 2017 — Fibrocell Science, Inc. (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that John Maslowski, Chief Executive Officer, will present at the 7th Annual World Orphan Drug Congress USA on Friday, April 21 at 2:30 pm EDT in Washington, D.C., and the Alliance for Regenerative Medicine’s (ARM) 5th Annual Cell & Gene Therapy Investor Day on Thursday, April 27 at 4:15 pm EDT in Boston, Massachusetts.
A live webcast of Fibrocell’s presentation at ARM’s Cell & Gene Therapy Investor Day will be available under the investor relations section of the Company’s website at www.fibrocell.com/investors/events and archived for 30 days. Please visit Fibrocell’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, has begun a Phase I/II trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of linear scleroderma. In addition, Fibrocell has a third program in the research phase for the treatment of arthritis and related conditions. Fibrocell’s gene therapy portfolio is being developed in collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology. For more information, visit http://www.fibrocell.com or follow Fibrocell on Twitter at @Fibrocell.
Trademarks
Fibrocell, the Fibrocell logo and Fibrocell Science are trademarks of Fibrocell Science, Inc. and/or its affiliates. All other names may be trademarks of their respective owners.
Investor & Media Relations Contact: Karen Casey 484.713.6133 kcasey@fibrocell.com
$MICT and India’s Cyient Team Up
The two will jointly bid on Aerospace and Defense contracts under Indo-Israeli Aerospace and Defense procurement agreement
MONTVALE, N.J., April 13, 2017 — Micronet Enertec Technologies, Inc. (NASDAQCM: MICT), announced today that its wholly-owned subsidiary, Enertec Systems 2001 Ltd. (Enertec), entered into a Teaming Agreement with Cyient DLM Private Limited (NSE: CYIENT.NS) based in India to jointly pursue contracts with Israeli Aerospace and Defense companies that have offset obligations in India. These obligations are based on an ongoing Aerospace and Defense trade agreement between the governments of India and Israel.
India and Israel have strong trade ties, with the value of Aerospace and Defense contracts between the countries totaling over $9 billion between 1999 and 2009. India is the largest purchaser of Israeli Aerospace and Defense equipment, currently estimated at a rate of over $2 billion per year. Israel is India’s second largest Aerospace and Defense supplier. Per the inter-governmental trade agreement between the two countries, and in accordance with India’s Aerospace and Defense Procurement Procedures (DPP), any Indian purchase of foreign military equipment over a certain amount necessitates an offset procurement of 30% of its value by the Israeli government.
Cyient is an Indian Aerospace and Defense company focused on engineering, networks and operations, established in 1991. It has over 12,000 employees across 38 global locations and was featured among the top 30 outsourcing companies in the world during 2014.
Based on the Teaming Agreement, Enertec and Cyient will jointly bid on Aerospace and Defense contracts that are part of any required offset pursuant to the DPP. Enertec will lead planning and design, while Cyient will lead procurements and production in India, thereby meeting offset requirements.
“One of Enertec’s largest Aerospace and Defense customers just received a $1.1 billion contract approved by the Indian government. This substantial contract is one part of a $3 billion agreement between India and Israel’s top Aerospace and Defense contractors. Trade contracts of this magnitude increases the need for more offset transactions, whereby Israel is obligated to purchase Aerospace and Defense services from India. By teaming up with India-based Cyient, Enertec is well positioned to potentially benefit from this trade opportunity, while having the ability to tackle larger scale projects,” stated David Lucatz, CEO and Chairman of Micronet Enertec Technologies Inc.
About Micronet Enertec Technologies, Inc.
Micronet Enertec Technologies, Inc. (NASDAQCM: MICT) provides high tech solutions for severe environments and the battlefield, including missile defense technologies for Aerospace & Aerospace and Defense and rugged mobile devices for the growing commercial Mobile Resource Management (MRM) market. MICT designs, develops, manufactures and supplies customized Aerospace and Defense computer-based systems, simulators, automatic test equipment and electronic instruments, addressing the Aerospace and Defense industry. Solutions and systems are integrated into critical systems such as command and control, missile fire control, maintenance of Aerospace and Defense aircraft and missiles for the Israeli Air Force, Israeli Navy and by foreign Aerospace and Defense entities. MICT’s MRM division develops, manufactures and provides mobile computing platforms for the mobile logistics management market in the U.S., Europe and Israel. American-manufactured systems are designed for outdoor and challenging work environments in trucking, distribution, logistics, public safety and construction.
Forward-looking Statements
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. These forward-looking statements include, but are not limited to, those statements regarding Enertec’s plan to pursue contracts with Israeli defense companies that have offset obligations in India pursuant to its Teaming Agreement with Cyient and Enertec’s position to potentially benefit and tackle larger scale projects. Such forward-looking statements and their implications involve known and unknown risks, uncertainties and other factors that may cause actual results or performance to differ materially from those projected. The forward-looking statements contained in this press release are subject to other risks and uncertainties, including those discussed in the “Risk Factors” section and elsewhere in the Company’s annual report on Form 10-K for the year ended December 31, 2016 and in subsequent filings with the Securities and Exchange Commission. Except as otherwise required by law, the Company is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
$TROV Announces the Addition of Dr. Sandra Silberman to its Clinical Advisory Board
SAN DIEGO, April 13, 2017 — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, announced today that Dr. Sandra Silberman, a leading clinical researcher in hematology/oncology, has joined Dr. Jorge Cortes, Dr. Philip Janku and Dr. David Berz, as a member of Trovagene’s Clinical Advisory Board (CAB). Dr. Silberman has extensive experience in the development of novel therapies for the treatment of hematologic cancers and will work with Trovagene through the clinical development process for PCM-075, an oral and highly selective polo-like kinase 1 (PLK1) inhibitor for the treatment of acute myeloid leukemia (AML).
“We are thrilled to have Dr. Silberman join our Clinical Advisory Board,” said Bill Welch, Chief Executive Officer of Trovagene. “We are fortunate to have access to these industry leading physicians for guidance and collaboration as we work to achieve our goal to transform oncology with the development of precision cancer therapeutics.”
Trovagene recently gained exclusive global development and commercialization rights for PCM-075 from Nerviano Medical Sciences, S.r.l., a major European oncology research and development company. A Phase 1 safety study of PCM-075 has already been successfully completed in patients with advanced metastatic cancers with data indicating an acceptable safety profile as well as antitumor activity. Trovagene believes that PCM-075 has pharmacokinetic and pharmacodynamic properties that provide advantages and may show improvement in clinical benefits over an earlier PLK1 inhibitor, for the treatment of patients with AML.
Trovagene plans to submit an investigational new drug (IND) application to the FDA in the second quarter of 2017. This submission will include a Phase 1/2 clinical protocol that will identify the safety of PCM-075 in AML patients, provide a preliminary assessment of response, study the effect of different clinical dosing regimens, as well as explore the potential of correlative biomarker analyses to select patients more likely to respond.
“I am excited to join Trovagene’s Clinical Advisory Board,” said Dr. Silberman. “I look forward to contributing my experience gained from leading the clinical development of imatinib (Gleevec®), the first targeted therapy for chronic myelogenous leukemia, to the development process for PCM-075.”
Background on Clinical Advisory Board Members
Jorge Eduardo Cortes, MD
Dr. Cortes is a Deputy Chair and Professor of medicine in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston Texas where he directs the CML Program. He is chief editor of Hematological Malignancies Reports and Clinical Leukemia and serves in the Editorial Board of the Journal of Clinical Oncology, Leukemia, Clinical Cancer Research, Leukemia and Lymphoma and the American Journal of Hematology. Over the course of his 25-year career specializing in leukemia research, Dr. Cortes served several prestigious academic appointments at the University of Texas, including associate professor in the Department of Leukemia at the Graduate School of Biomedical Sciences and Chair of the CML section at the MD Anderson Cancer Center. He has received numerous awards including the Faculty Scholar Award from MD Anderson Cancer Center in 2003, the Annual Celgene Young Investigator Achievement Award for Clinical Research in Hematology in 2005, The Dr. John J. Kenny Award from The Leukemia & Lymphoma Society in 2006, the Service to Mankind Award from The Leukemia & Lymphoma Society in 2007 and the Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research from MD Anderson Cancer Center in 2007.
Filip Janku, MD, PhD
Dr. Janku serves as an Assistant Professor in the Department of Investigational Cancer Therapeutics (Phase I Program) at MD Anderson Cancer Center. Dr. Janku’s research focuses on proof-of-concept clinical trials that possess a pivotal correlative component especially those involving liquid biopsies, molecular profiling of cell-free DNA, the PI3K/AKT/mTOR pathway and therapeutic use of oncolytic bacteria. Dr. Janku received multiple awards for his research efforts, including Sidney Kimmel Scholar award, several ASCO Merit Awards as well as an American Association for Cancer Research Scholar-in-Training Award.
Sandra L. Silberman, MD, PhD
Dr. Silberman is an independent industry consultant, who has advised many major companies, including Bristol-Myers Squibb, AstraZeneca, Imclone, and Roche, in their various oncology programs. She began her career in clinical development at Pfizer, Inc., where she initiated the company’s first program in clinical oncology and oversaw the introduction of erlotinib (Tarceva®) into clinical trials. She led the global development of Gleevec®, an innovative drug and the first targeted therapy for chronic myelogenous leukemia (CML), while she was at Novartis Clinical Research. Dr. Silberman was Vice President, Global Head of Translational Medicine and Innovation at Quintiles Transnational, a premier clinical research organization. She was also the Vice President and Global Head of Oncology at Eisai Medical Research, and at present consults for a number of other oncology biotechnology companies. She is currently an attending physician in the Duke Hematology/Oncology Fellowship program at the VAMC in Durham, NC.
David Berz, MD, PhD, MPH
Dr. David Berz is triple Board Certified in Internal Medicine, Hematology and Oncology. Dr. Berz has many years of extensive experience in the field of oncology, including private practice and clinical research, and is currently a scientist at City of Hope. Dr. Berz specializes in thoracic/lung malignancies, melanoma, and cancer immune-therapy. He is a member of the Melanoma Research Society and the Multidisciplinary Malignant Melanoma Committee at City of Hope. Dr. Berz is also a member of the American Society of Clinical Oncology and the American Society of Hematology.
About Trovagene, Inc.
Trovagene is a biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics. Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies. Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics. For more information, please visit www.trovagene.com.
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 words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Trovagene Contact
Vicki Kelemen
Sr. Director, Communications
858-952-7652
vkelemen@trovagene.com
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