$LPTX #Biomarker, #Efficacy Data at @curecc #ccfac #Cholangiocarcinoma 2017

CAMBRIDGE, Mass., Feb. 03, 2017  — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, announced the presentation of biomarker and top-line preliminary efficacy data from its clinical trial of DKN-01 combination therapy in patients with biliary tract cancers at the Cholangiocarcinoma Foundation 2017 Annual Meeting in Salt Lake City, UT.

Data from the study showed that Leap’s DKN-01 monoclonal antibody, an inhibitor of Dickkopf-1 (DKK1), in combination with gemcitabine and cisplatin resulted in statistically significant changes in inflammatory and anti-angiogenic biomarkers consistent with the anticipated mechanism of action of DKK1 inhibition. DKK1 is a regulator of Wnt/β-catenin signaling that can enable cancer to evade the immune system by enhancing the suppressive effects of myeloid-derived suppressor cells (MDSC) and reducing the expression of natural killer cell ligands. Additionally, DKK1 enables tumors to grow, metastasize, and promote blood vessel formation. DKN-01 is designed to help treat cancer patients by modulating Wnt/β-catenin signaling on tumor cells and MDSC to enhance immune targeting of cancer tumors and to decrease tumor cell growth and angiogenesis.

In the study to date, at the selected 300mg DKN-01 dose level, 7 of 21 evaluable patients (33%) experienced a partial response and 20 patients experienced a partial response or stable disease, representing a disease control rate of 95%. The study has recently been expanded to enroll an additional 20 patients to confirm the activity of the combination and to enhance biomarker collection and analysis. The biomarker data were reported yesterday evening by Dan G. Duda, DMD, PhD, Director of Translational Research in Gastrointestinal Radiation Oncology at Massachusetts General Hospital.

“These early data tie the promising clinical activity of DKN-01 combination therapy in patients with biliary tract cancer to pharmacodynamic biomarkers suggestive of promoting anti-tumor immunity and reducing angiogenesis. We are very encouraged by the data and look forward to expanding the study and further evaluating the biomarker activity of DKN-01 in patients with these cancers,” commented Dr. Duda.

About Leap Therapeutics
Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response. For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

FORWARD LOOKING STATEMENTS

Some of the statements in this release are 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, which involve risks and uncertainties. These statements relate to future events of Leap’s development of DKN-01, TRX518, and other programs, future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Leap 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 only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360

Chris Erdman 
MacDougall Biomedical Communications
cerdman@macbiocom.com
781-235-3060

$BBGI to #Divest Six #Radio Stations in #NC for $11 Million, in #DeLeveraging

NAPLES, Fla., Feb. 03, 2017  — Beasley Broadcast Group, Inc. (Nasdaq:BBGI) (the “Company”), a large- and mid-size market radio broadcaster, announced today that Beasley Media Group, Inc. has entered into an asset purchase agreement to sell WNCT-AM, WNCT-FM, WSFL-FM, WIKS-FM, WMGV-FM and WXNR-FM, which serve the Greenville-New Bern-Jacksonville, North Carolina market, for $11 million in cash to CMG Coastal Carolina, LLC, a subsidiary of Curtis Media Group. Beasley Broadcast Group intends to use proceeds from the divestiture to reduce debt. CMG Coastal Carolina, which is affiliated with Curtis Media Group, intends to spin-off WNCT-FM to Inner Banks Media, LLC.

Caroline Beasley, Chief Executive Officer of Beasley Broadcast Group, commented, “Since the Company’s founding in 1961, Beasley has established a long-term record of successfully optimizing its station portfolio through both strategic acquisitions and divestitures to drive returns for our shareholders. Last November we completed the accretive acquisition of Greater Media, adding 17 stations (net of divestitures) and four attractive new markets to our operating footprint. We are making continued progress with the integration of the new stations as we apply our proven strategies that focus on strong core programming and targeted localism to support ratings and market leadership. We are confident that the stations being divested will continue to offer listeners in Greenville-New Bern-Jacksonville great local programming.”

The sale of the six Greenville-New Bern-Jacksonville stations, expected to be completed in the second quarter of 2017, is subject to FCC approval and other customary closing conditions. Michael Bergner of Bergner and Company served as the broker in the transaction.

About Beasley Broadcast Group
Celebrating its 56th anniversary this year, Beasley Broadcast Group, Inc., (www.bbgi.com) was founded in 1961 by George G. Beasley who remains the Company’s Chairman of the Board.  Pro forma for the completion of announced divestitures, Beasley Broadcast Group owns and operates 63 stations (45 FM and 18 AM) in 15 large- and mid-size markets in the United States. Approximately 18.0 million consumers listen to Beasley radio stations weekly over-the-air, online and on smartphones and tablets and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text, apps and email.  For more information, please visit www.bbgi.com.

Note Regarding Forward-Looking Statements:
Statements in this release that are “forward-looking statements” are based upon current expectations and assumptions, and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995.  Words or expressions such as “intends,” “expects,” “expected,” “anticipates” or variations of such words and similar expressions are intended to identify such forward-looking statements.  Key risks are described in our reports filed with the SEC including in our Annual Report on Form 10-K for the year ended December 31, 2015 and Definitive Information Statement, as filed with the SEC on September 23, 3016.  Readers should note that forward-looking statements are subject to change and to inherent risks and uncertainties and may be impacted by several factors, including: external economic forces that could have a material adverse impact on our advertising revenues and results of operations; our radio stations may not be able to compete effectively in their respective markets for advertising revenues; we may not remain competitive if we do not respond to changes in technology, standards and services that affect our industry; our substantial debt levels; the loss of key personnel; and our failure to successfully combine our business with Greater Media’s business in the expected time frame.  Our actual performance and results could differ materially because of these factors and other factors discussed in the “Management’s Discussion and Analysis of Results of Operations and Financial Condition” in our SEC filings, including but not limited to annual reports on Form 10-K or quarterly reports on Form 10-Q, copies of which can be obtained from the SEC, www.sec.gov, or our website, www.bbgi.com.  All information in this release is as of February 3, 2017, and we undertake no obligation to update the information contained herein to actual results or changes to our expectations.

CONTACT:

B. Caroline Beasley			
Chief Executive Officer			
Beasley Broadcast Group, Inc.		
239/263-5000 or email@bbgi.com	

Joseph Jaffoni, Jennifer Neuman
JCIR
212/835-8500 or bbgi@jcir.com

$MYOS Announces $2,125,000 #RegisteredDirectOffering

$FTNT Wins 2016 #Fortinet Partner of the Year Award

Recognized for Leadership in Customer Service, Business Growth, and Security Expertise

$CBMX Appoints Preeminent #Pediatric #Neurologist Dr. #JamesWheless to #SAB

IRVINE, Calif., Feb. 02, 2017 — CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, announces that James W. Wheless, M.D., FAAP, FAAN, has joined its Scientific Advisory Board.  Dr. Wheless is Professor and Chief of Pediatric Neurology at the University of Tennessee Health Science Center, and is Director of the Neurosciences Institute and Director of Comprehensive Epilepsy Program at Le Bonheur Children’s Hospital in Memphis, Tenn.

“We are delighted to have Dr. Wheless, a renowned leader in pediatric neurology, become the newest member of our Scientific Advisory Board (SAB),” said Mark McDonough, President and Chief Executive Officer of CombiMatrix.  “Dr. Wheless brings a fresh perspective in neurology to our SAB, which has already made meaningful contributions in supporting the adoption of our tests.  We look forward to tapping into Dr. Wheless’ significant expertise as we develop strategies to further improve our market presence, expand our test portfolio and improve family health diagnostic care.”

“Major advances in pediatric neurology over the past decade have come from the adoption of newer technologies such as chromosomal microarray analysis in prenatal and pediatric testing that allows for the detection of smaller chromosomal variants over karyotyping,” said Dr. Wheless.  “Better detection of neurologic disorders is part of a comprehensive approach to improving the lives of pediatric patients and I’m delighted to provide my expertise to further support quality care.”

Dr. Wheless is a Diplomat of the American Board of Pediatrics and the American Board of Psychiatry and Neurology with special qualifications in child neurology, clinical neurophysiology and epilepsy.  He is a fellow of the American Academy of Pediatrics and the American Academy of Neurology.  He has been a member of the editorial boards of numerous peer-reviewed journals and is a current member at the Journal of Child Neurology and Neurotherapeutics.  He has written three books and more than 50 chapters related to pediatric neurology, and has authored more than 450 articles published in peer-reviewed journals and abstracts presented at scientific conferences.  He has received numerous awards and honors, including “Who’s Who in Medicine and Healthcare,” “Who’s Who in the World” and “Best Doctors in America.” Dr. Wheless received his M.D. from the University of Oklahoma, and completed residencies in pediatrics at the University of Oklahoma and in pediatric neurology at Northwestern University at Children’s Memorial Hospital in Chicago.

About CombiMatrix Corporation

CombiMatrix Corporation provides best-in-class molecular diagnostic solutions and comprehensive clinical support to foster the highest quality in patient care. CombiMatrix specializes in pre-implantation genetic diagnostics and screening, prenatal diagnosis, miscarriage analysis and pediatric developmental disorders, offering DNA-based testing for the detection of genetic abnormalities beyond what can be identified through traditional methodologies. Our testing focuses on advanced technologies, including single nucleotide polymorphism chromosomal microarray analysis, next-generation sequencing, fluorescent in situ hybridization and high resolution karyotyping.  Additional information about CombiMatrix is available at www.combimatrix.com or by calling (800) 710-0624.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. Forward-looking statements can often be identified by words such as “anticipates,” “approximates,” “expects,” “intends,” “plans,” “goal,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words and include, but are not limited to, statements regarding projected results of operations, including projected cash flow-positive operating results, management’s future business, operational and strategic plans, recruiting efforts and test menu expansion. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to: our estimates of total market sizes for the tests that we offer; our ability to grow revenue and improve gross margin; delays in achieving cash flow-positive operating results; the risk that test volumes and reimbursements level off or decline; the risk that payors decide to not cover our tests or to reduce the amounts they are willing to pay for our tests; the risk that we will not be able to grow our business as quickly as we need to; the inability to raise capital; the loss of members of our sales force; our ability to successfully expand the base of our customers, add to the menu of our diagnostic tests, develop and introduce new tests and related reports, expand and improve our current suite of diagnostic services, optimize the reimbursements received for our molecular testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, steadily increase the size of our customer rosters in all of our genetic testing markets; our ability to attract and retain a qualified sales force in wider geographies; our ability to ramp production from our sales; rapid technological change in our markets; changes in demand for our future services; legislative, regulatory and competitive developments; general economic conditions; and various other factors. Further information on potential factors that could affect our financial results is included in our Annual Report on Form 10-K, Quarterly Reports of Form 10-Q, and in other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.

$TRIL Outlines Anticipated Activities and Milestones for 2017

– Advancing the two ongoing clinical trials with TTI-621, an IgG1 SIRPaFc fusion protein targeting CD47; updated data anticipated in 2H/2017 – Expanding the CD47 franchise with TTI-622, an IgG4 SIRPaFc fusion protein with IND submission planned by end of year; targeting combination therapies – Reporting preclinical data throughout the year at various international scientific conferences – Executing plans for small molecule pipeline and commencing IO discovery program

Trillium Therapeutics Inc.
James Parsons
Chief Financial Officer
+1 416 595 0627 x232
james@trilliumtherapeutics.com
www.trilliumtherapeutics.com

Investor and Media Relations:
Mark Corbae
Canale Communications for Trillium Therapeutics
619-849-5375
mark@canalecommunications.com

$BNTC Makes Significant Progress in #Ocular Program

– Data to be presented at industry leading conferences – Development of novel viral vectors for delivery to the back of the eye – Expanded potential of developing ddRNAi technology into ocular indications

SYDNEY, Feb. 2, 2017  — Benitec Biopharma Limited (ASX:BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is pleased to announce today that it has made significant progress with the Company’s ddRNAi technology for the development of therapeutics for the treatment of ocular diseases.  Of particular importance is the output from Benitec’s collaboration with 4D Molecular Therapeutics to identify novel viral vectors for delivery to the back of the eye using direct intravitreal injection, a commercially attractive route of administration.

• Data to be presented at industry leading conferences

The results of this work will be presented by Dr David Suhy, Benitec’s Chief Scientific Officer, at the Association for Research in Vision and Ophthalmology (ARVO)-Asia meeting being held in Brisbane on February 5^th to February 8^th, and the Translational Vision Summit (TVS), being held in conjunction.  ARVO-Asia is a leading conference dedicated to eye and vision research in the Asia-Pacific region. The TVS meeting highlights “revolutionary approaches to advancing innovation in the diagnosis and treatment of eye disease”.

• Development of novel viral vectors for delivery to the back of the eye

Dr David Suhy commented, “Having a commercially attractive route of administration is a significant step forward in the program.  One of the major limitations of most ocular gene therapy applications is the use of a highly complex surgical technique called subretinal injection for delivery into the eye. We are developing viral vectors which can efficiently transduce cells within the retina following an office-friendly, intravitreal injection.  This is the same route of administration used for the standard of care treatments for Age-Related Macular Degeneration (AMD), including Lucentis® and Eylea®.

• Expanded potential of developing ddRNAi technology into ocular indications

David continued, “Being able to deliver drugs in therapeutically relevant concentrations is a key challenge in drug development.  It has taken significant time and effort, but we believe that these outcomes demonstrate the commercial applicability of having a vector that can transduce the retina following an intravitreal injection.  The AMD program is our first program in this space and we anticipate being able to build a ddRNAi franchise for other ocular indications, in particular retinal diseases, using these novel viral vectors as a key component in that platform.”

Benitec’s ddRNAi technology is a unique combination of gene silencing using RNA interference coupled with the long term therapeutic activity of gene therapy vectors. The lead ocular candidate, BB-201, is designed to treat patients with the wet form of AMD and will be featured in the ARVO-Asia presentations.

As a gene therapy approach, BB-201 has been designed for long term expression of the therapeutic short hairpin RNA from a single injection.  BB-201 is comprised of a novel adeno associated virus capsid (AAV) and a recombinant DNA cassette engineered to express steady state levels of three short hairpin RNA (shRNA) that inhibit VEGF-a, VEGF-b and PlGF, three clinically validated targets whose expression is shown to lead to the progression of the disease.

The full presentation will be posted on the Benitec website.

For further information regarding Benitec, please contact the persons below, or visit the Benitec website at www.benitec.com

About Age-Related Macular Degeneration (AMD):
AMD is a disease that has been estimated to account for 8% of blindness worldwide and has been projected to impact up to 196 million patients by 2020 and up to 288 million by 2040.  The wet form of the disease accounts for about 10% of all AMD patients but accounts for up to 90% of all the blindness. The wet form of the disease is characterised by the growth of new blood vessels into the eye, a phenomenon that has been associated with the abnormally high expression of abnormally high levels of proteins from the vascular endothelial growth factor (VEGF) family. The most commonly used standard of care treatments for AMD require an intravitreal injection into the eye as frequently as monthly or bi-monthly.  Such injections may be required indefinitely to be able to halt progression of the disease and stabilise vision.

About Benitec Biopharma Limited:
Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is a biotechnology company developing innovative therapeutics based on its patented gene-silencing technology called ddRNAi or ‘expressed RNAi’. Based in Sydney, Australia with laboratories in Hayward, California (USA), and collaborators and licensees around the world, the company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis B, wet age-related macular degeneration and OPMD. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s Disease, chronic neuropathic pain, cancer immunotherapy and retinitis pigmentosa.

Safe Harbor Statement:
This press release contains “forward-looking statements” within the meaning of section 27A of the US Securities Act of 1933 and section 21E of the US Securities Exchange Act of 1934. Any forward-looking statements that may be in the press release are subject to risks and uncertainties relating to the difficulties in Benitec’s plans to develop and commercialise its product candidates, the timing of the initiation and completion of preclinical and clinical trials, the timing of patient enrolment and dosing in clinical trials, the timing of expected regulatory filings, the clinical utility and potential attributes and benefits of ddRNAi and Benitec’s product candidates, potential future out-licenses and collaborations, the intellectual property position and the ability to procure additional sources of financing. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

$NAKD Launches #ComfortablyYou

Comfortably You, LLC, a wholly owned subsidiary of Naked Brand Group Inc. (NASDAQ:NAKD) (“Naked”), today announced that the launch of its exclusive sleepwear, loungewear, and intimates lifestyle collection, Comfortably You™, will be airing on The Home Shopping Network (“HSN”) today, Thursday, February 2^nd at 9:00 pm and 10:00 pm ET and Friday, February 3^rd at 8:00 am and 5:00 pm ET. The four hour-long shows will be hosted by Sara Allard, daughter of Naked Brand Group CEO & Chief Creative Officer Carole Hochman. Ms. Allard served as Creative Director of the Carole Hochman Group for over 15 years and developed the marketing and branding for both Comfortably You™ and Naked.

Created for the modern woman looking for comfortable and fashionable styles that can be worn both in the bedroom and around the home, the debut Comfortably You™ collection will feature eight sleepwear and casual wear styles including a robe set, night gown and t-shirt, and separates including a bralette, yoga pants and jacket. All styles will be available exclusively on HSN in an assortment of solid colors and prints in sizes ranging from XS – 3XL, all priced under $60. Designed and manufactured by Carole Hochman and her team at Naked, the collection will feature a proprietary “caressa” fabric to provide the ultimate soft feeling with easy garment care that drapes beautifully around any silhouette.

About Comfortably You, LLC:

Comfortably You, LLC is a wholly owned subsidiary of Naked Brand Group Inc. (NASDAQ:NAKD), an innovative inner fashion and lifestyle brand, and an extension of the core Naked brand philosophy of being free to be yourself and feel comfortable in your own skin. Our brand ideal is about shedding the layers of the day and letting go of the pressures and stresses of our daily lives. Our brand promise is about providing the optimal fit, feel, and function in the essential, most intimate garments we all wear closest to our skin, under our clothes, or at home where we relax and sleep. As a brand, Comfortably You sets out to bring modern, affordable sleep, lounge, and inner wear that is elegantly simple and extraordinarily comfortable.

About Naked Brand Group Inc.:

Naked was founded on one basic desire–to create a new standard for how products worn close to the skin fit, feel, and function. Naked’s women’s and men’s collections are available at www.wearnaked.com, and Naked has a growing retail footprint for its innovative and luxurious innerwear products in some of the leading online and department stores in North America including Nordstrom, Bloomingdale’s, Dillard’s, Soma, Saks Fifth Avenue, Amazon.com, BareNecessities.com, and more. In 2014, renowned designer and sleepwear pioneer Carole Hochman joined Naked as Chief Executive Officer, Chief Creative Officer, and Chairwoman with the goal of growing Naked into a global lifestyle brand. In June 2015, Naked announced a strategic partnership with NBA Miami HEAT (now Chicago Bulls) star Dwyane Wade. The 3-time NBA Champion, 11-time All Star, and Olympic Gold Medalist joined the Company’s Advisory Board, and is the Creative Director for a signature collection of men’s innerwear launching 2016. Naked is headquartered in New York City and plans to expand in the future into other apparel and product categories that can exemplify the mission of the brand, such as activewear, swimwear, sportswear and more. http://www.nakedbrands.com/

Forward Looking Statements:

This press release contains forward-looking statements, which reflect the expectations of management of Naked with respect to potential future events. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, but are not limited to, statements regarding Naked’s expansion into new apparel and product categories. These forward-looking statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of such risks and uncertainties, which include, without limitation: an economic downturn or economic uncertainty in Naked’s key markets; Naked’s inability to effectively manage the growth and the increased complexity of its business; Naked’s highly competitive market and increasing competition in the market; Naked’s inability to deliver its products to the market and to meet customer expectations due to problems with its distribution system; Naked’s failure to maintain the value and reputation of its brand; Naked’s failure to raise the capital necessary to carry out its business plan and operations; and other risk factors detailed in Naked’s reports filed with the Securities and Exchange Commission and available at www.sec.gov. These forward-looking statements are made as of the date of this press release, and Naked disclaims any intent or obligation to update the forward-looking statements, or to update the reasons why actual results, performance or developments could differ from those anticipated in the forward-looking statements, except as required by applicable law, including the securities laws of the United States. Although Naked believes that any beliefs, plans, expectations and intentions contained in this news release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate.

Media:
Comfortably You/Naked Brand Group
ICR
Alecia Pulman/Brittany Fraser, 203-682-8200
NakedBrandsPR@icrinc.com

$SMMT post #FDA #EMA Meetings, Outlines #Phase3 for #CDI #Antibiotic #Ridinilazole

OXFORD, United Kingdom, Feb. 01, 2017  — Summit Therapeutics plc (AIM:SUMM) (NASDAQ:SMMT), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’), today outlines its Phase 3 programme for its novel antibiotic, ridinilazole, following recent regulatory meetings with the US Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’). With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of CDI. A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.

Mr Glyn Edwards, Chief Executive Officer of Summit commented: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care. This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”

Summit discussed its Phase 3 development programme with the FDA at an End of Phase 2 meeting and through a scientific advice process with EMA. With input from both agencies, the Phase 3 programme is expected to include two trials evaluating ridinilazole as compared to the standard of care, vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response (‘SCR’). Other planned endpoints will include health economic outcome measures. The Phase 3 trial designs are consistent with the successful proof of concept Phase 2 trial, CoDIFy, in which ridinilazole achieved statistical superiority over vancomycin in SCR. SCR is a combined endpoint that measures cure at the end of treatment and a lack of recurrence in the 30 days after treatment. FDA also confirmed that ridinilazole would be eligible for Priority Review based on its QIDP designation.

Mr Edwards continued: “As we continue to evaluate our options to maximise the value of ridinilazole, our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc. means Summit has more time to fully explore all options. These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organisations. In parallel, activities to prepare ridinilazole for Phase 3 trials continue with these anticipated to start in the first half of 2018.”

About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with over one million estimated cases of CDI each year in the United States and Europe. It is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation and severe diarrhoea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the US.

About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

For more information, please contact:

Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about development and potential commercialisation of our product candidates, the therapeutic potential of our product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential benefits and future operation of the collaboration with Sarepta Therapeutics Inc., including any potential future payments thereunder, any other potential third-party collaborations and expectations regarding the sufficiency of our cash balance to fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that we make with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended 31 January 2016. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).

$GSM Announces #Offering of $350,000,000 #SeniorNotes Due 2022

LONDON, Feb. 01, 2017 — Ferroglobe PLC (NASDAQ:GSM) (“Ferroglobe”) announced today that it has launched an offering of $350,000,000 aggregate principal amount of Senior Notes due 2022 (the “Notes”).

The Notes will be co-issued with Ferroglobe’s wholly owned subsidiary, Globe Specialty Metals, Inc., (“GSM”) and guaranteed by certain of Ferroglobe’s other subsidiaries (the “Guarantees” and, together with the Notes, the “Securities”). An amendment to GSM’s existing revolving credit facility is also expected to be entered into. Under the amendment, it is expected that borrowings up to an aggregate principal amount of $200,000,000 will be made available to Ferroglobe and GSM as co-borrowers.

The proceeds from the offering of the Notes will be used to (i) repay certain existing indebtedness, (ii) pay certain compensation expenses owed to Ferroglobe’s former Executive Chairman and (iii) pay certain fees and expenses incurred in connection with the foregoing.

About Ferroglobe

Ferroglobe PLC is one of the world’s leading suppliers of silicon metal, silicon-based specialty alloys, and ferroalloys serving a customer base across the globe in dynamic and fast-growing end markets, such as solar, automotive, consumer products, construction and energy.  The company is based in London.

Cautionary Statement

It may be unlawful to distribute this press release in certain jurisdictions. The information in this press release does not constitute an offer of securities for sale or a solicitation of an offer to buy securities in Canada, Japan, Australia or the United States or in any other jurisdiction in which such offer, solicitation or sale is not permitted.

The Securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), and the Securities may not be sold in the United States unless they are registered or are exempt from registration. The Company does not intend to register any portion of this offering in the United States or to conduct a public offering in the United States. Any public offering of securities to be made in the United States will be made by means of a prospectus that will contain detailed information about the Company and its management, as well as financial statements. The Securities are being offered only to qualified institutional buyers in accordance with Rule 144A under the U.S. Securities Act and outside the United States in accordance with Regulation S under the U.S. Securities Act. Copies of this press release are not being, and should not be, distributed in or sent into the United States.

This communication is for distribution only to persons who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended the “Financial Promotion Order”), (ii) are persons falling within Article 49(2)(a) to (d) (“high net worth companies, unincorporated associations etc.”) of the Financial Promotion Order, (iii) are outside the United Kingdom or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons together being referred to as “relevant persons”). This communication is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons.

This announcement has been prepared on the basis that any offer of the Securities will be made pursuant to an exemption under Article 3 of Directive 2003/71/EC (the “Prospectus Directive”), as implemented in member states of the European Economic Area (the “EEA”), from the requirement to publish a prospectus for offers of Securities. Accordingly any person making or intending to make any offer within the EEA of the Securities, which are the subject of the placement contemplated in this announcement may only do so in circumstances in which no obligation arises for the issuer or any of the initial purchasers of such Securities to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive, or otherwise, in each case, in relation to such offer. Neither the issuer nor the initial purchasers of such Securities have authorized, nor do they authorize, the making of any offer of Securities in circumstances in which an obligation arises for the issuer or any initial purchasers of such Securities to publish or supplement a prospectus for such offer.

Neither the content of Ferroglobe’s website nor any website accessible by hyperlinks on Ferroglobe’s website is incorporated in, or forms part of, this announcement. The distribution of this announcement into certain jurisdictions may be restricted by law. Persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

Forward-Looking Statements

This release contains ‘‘forward-looking statements’’ within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended.  Forward-looking statements are not historical facts but are based on certain assumptions of management and describe the company’s future plans, strategies and expectations.  Forward-looking statements generally can be identified by the use of forward-looking terminology, including, but not limited to, “may,” “could,” “seek,” “guidance,” “predicts,” “potential,” “likely,” “believe,” “will,” “expect,” “anticipate,” “estimate,” “plan,” “intends,” “forecast” or variations of these terms and similar expressions, or the negative of these terms or similar expressions.

Forward-looking statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain.  As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control.

You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the legacy businesses of Globe and FerroAtlántica will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected.  Important factors that may cause actual results to differ include, but are limited to: (i) risks relating to unanticipated costs of integration, including operating costs, customer loss and business disruption being greater than expected; (ii) our organizational and governance structure; (iii) the ability to hire and retain key personnel; (iv) regional, national or global political, economic, business, competitive, market and regulatory conditions including, among others, changes in metals prices; (v) availability and increases in the cost of raw materials, (vi) cost of energy; (vii) competition in the metals and foundry industries; (viii) environmental and regulatory risks; (ix) ability to identify liabilities associated with acquired properties prior to their acquisition; (x) ability to manage price and operational risks including industrial accidents and natural disasters; (xi) ability to manage foreign operations; (xii) changes in technology; (xiii) ability to acquire or renew permits and approvals; (xiv) changes in legislation or governmental regulations affecting Ferroglobe; (xv) conditions in the credit markets; (xvi) risks associated with assumptions made in connection with critical accounting estimates and legal proceedings; (xvii) Ferroglobe’s international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; (xviii) the potential of international unrest; and (xix) the effect of tax assessments, tax adjustments, anticipated tax rates, or other regulatory compliance costs.  The foregoing list is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the “Risk Factors” section of our Annual Reports on Form 20-F, Current Reports on Form 6-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results.

All information in this press release is as of the date of its release. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this press release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this press release.

$XGTI Launches #DragonFly Ultra-Miniature #Wireless #Video System

MPEG-4 COFDM Transmitter/Camera Delivers Unprecedented Perspective and Points of View for Drone/UAV, Body Cam, Sports Broadcast and Reality-Based Production Applications

HACKETTSTOWN, N.J., Feb. 1, 2017  — Integrated Microwave Technologies (“IMT”), a business unit of xG Technology, Inc. (“xG”) (Nasdaq: XGTI, XGTIW), and a leader in advanced digital microwave systems serving the law enforcement, broadcast, sports and entertainment markets, announces the DragonFly, an ultra-miniature wireless video system, has begun shipping to customers.

The Dragonfly sets the standard in compact wireless video technology by delivering completely new and expanded points of view and perspective. It is available in a range of kits to fit various applications, including drones, sports and broadcast. Each offering caters to the specific needs of the application. The DragonFly has a compact and lightweight form factor and features minimized power requirements, making it ideal for drone and mobile use.

“We realize the broad range of possibilities the DragonFly offers, which is why we designed multiple variations of the product to fit many applications,” says John Payne IV, president of IMT. “With the DragonFly achieving ultra-low latency, users can utilize it for remote control applications, making it the most reliable transmitter on the market.”

The DragonFly features HD/SD-SDI or optional HDMI inputs and delivers up to 50mW of power in a package measuring in at 1.85 in. x 1.38 in. x .51 in. (50 mm x 35 mm x 13 mm) that weighs less than 1.2 oz. (34 g), providing long range, reliable HD video transmission. IMT’s COFDM technology ensures the transmission of uninterrupted, live TV pictures over two miles Line-of-Sight (LOS), despite the effects of foliage, challenging terrain, buildings and other common non-line-of-sight limitations. The DragonFly also features internal ISM and GPS anti-jam filters and is available in licensed and unlicensed frequency bands.

Each DragonFly kit comes with various accessories needed to plug and play the system with ease, including mounting accessories, a microdrone ultra-small omni antenna, an HDMI or SDI extension cable and a DC integration power cable. Addition optional accessories include an ultra-small HD-SDI camera with various lens, and RS-485 and S-Bus cables.

The DragonFly is easily managed through a WiFi webpage. An Android^™ or iOS device can detect the encrypted WiFi signal and automatically opens a browser window. Additionally, the DragonFly supports RS485 control channels and S-Bus controls through a 900MHz transceiver. The transceiver provides bi-direction controls of the transmitter, accessory camera, gimbal controls and more.

The DragonFly is compatible with IMT’s full line of receivers, including the IMT Direct VU HD handheld receiver, DR3 and CRx. Additional information and technical specifications for the DragonFly can be found at https://imt-solutions.com/product/dragonfly/.

About Integrated Microwave Technologies
Integrated Microwave Technologies (IMT), a business unit of xG Technology, Inc., is a leader in advanced digital microwave systems and a provider of engineering, integration, installation and commissioning services serving the broadcast, sports, entertainment and law enforcement markets. The company comprises the leading microwave brands Nucomm, RF Central and IMT, offering customers worldwide complete video solutions. Nucomm is a premium brand of digital broadcast microwave video systems. RF Central is an innovative brand of compact microwave video equipment for licensed and license-free sports and entertainment applications. IMT is a trusted provider of mission-critical wireless video solutions to state, local and federal police departments.

More information can be found at www.imt-solutions.com and www.xgtechnology.com.

Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute 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. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

FOR MORE INFORMATION

xG Technology:
Daniel Carpini
941-953-9035
daniel.carpini@xgtechnology.com
www.xgtechnology.com

$NWMH Expands Market Reach in #NewYork, #Acquires #NortheastDataDestructionandRecycling