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(NVGN) Taps Leading CRO for Cantrixil Phase 1 Clinical
SYDNEY, Nov. 24, 2015 —
- Novogen engages Novotech as CRO for upcoming Phase 1 clinical study
- Cantrixil Phase 1 clinical trial to be conducted in patients with refractory/recurrent peritoneal malignancies with malignant ascites, including ovarian cancer
US-Australian drug discovery company, Novogen Limited (ASX:NRT: NASDAQ: NVGN), announced today that it has engaged Novotech as the Contract Research Organisation (CRO) to conduct its Phase 1 clinical study for the drug candidate, Cantrixil, which will commence in 2016.
This first-in-human study will investigate the safety and feasibility of Cantrixil administered via the intraperitoneal route for patients with refractory /recurrent peritoneal malignancies with malignant ascites.
According to Novogen’s Clinical and Regulatory Affairs Manager, Kimberley Lilischkis, PhD, the Cantrixil Phase 1 study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site.
“However, patients with other cancer types will also be eligible to enrol in this first study since early preclinical data suggests the drug candidate may benefit patients with a range of cancer types,” Dr Lilischkis said.
“Patients with malignant ascites have been chosen because ethically this patient group stands to receive the most benefit and face the least risk from the insertion of a peritoneal port or catheter, which can be used for drug administration but also for the on-going drainage of malignant ascites.”
Dr Lilischkis said Novogen was continuing to progress Cantrixil through the necessary preclinical regulatory requirements and safety evaluations and was on track to complete the ‘in-life’ phase of the toxicity studies by the end of 2015. The Company expected to receive the final report in early 2016 once a comprehensive pathology review was completed.
Acting CEO, Iain Ross said the appointment of Novotech was a key milestone in progressing Novogen’s first oncology drug candidate, Cantrixil, to the clinic. “Novogen is confident that Novotech will add significant value to the clinical trial program bringing their standard of excellence to the development of this promising drug candidate,” Mr Ross said.
Novotech is a prominent Australian-based CRO with extensive background in oncology drug development and a broad range of clinical trial outsourcing services. Novotech has well-established working relationships with the Australian sites and KOLs working with Novogen on this study. This CRO has world-class electronic data and trial management systems that will support the data management, monitoring and safety reporting activities for this study. Novotech is the only Australian-based CRO that has a Quality Assurance system with ISO9001:2008 accreditation and has a superb track record in managing early phase oncology studies.
“We’re delighted to be working with Novogen on this important study. The development of Cantrixil has the potential to add an important new tool in the fight against cancer, and we are looking forward to leveraging our previous experience in all phases of oncology drug development to the management of this program,” CEO of Novotech, Alek Safarian, said.
About the Cantrixil drug candidate
The candidate Cantrixil drug product is cyclodextrin-based containing the active ingredient, TRXE-002-1. The Company anticipates that if approved the drug product would be used as an intra-cavity chemotherapy to be injected directly into the peritoneal cavity. The aim of intraperitoneal administration is to achieve high localized drug levels within the peritoneal cavity and attenuate the spread of resident tumor initiator cells. The target indication sought for Cantrixil is early-stage cancers of the abdominal cavity (eg. ovarian, uterine, colorectal and gastric carcinomas) with Cantrixil being used as an adjuvant first-line therapy. On completion of the requisite safety studies, Cantrixil will enter the clinic in late-stage patients with abdominal cancers including ovarian cancer. The active pharmaceutical ingredient, TRXE-002, has pan anti-cancer activity resulting in caspase-dependent apoptosis via c-Jun activation and pERK downregulation. The actual drug target remains unidentified.
About Novogen Limited
Novogen is a public, Australian-US drug development company whose shares trade on both The Australian Securities Exchange (NRT) and NASDAQ (NVGN). The Novogen Group includes US-based, CanTx Inc., a joint venture company with Yale University. Novogen has two drug technology platforms [the superbenzopyrans (SBPs) and anti-tropomyosins (ATMs)] yielding drug candidates that are first-in-class with potential application across a range of degenerative diseases. Given the encouraging data from in vitro and in vivo preclinical proof-of-concept studies in the field of oncology, the Company’s immediate focus is to undertake the respective toxicology programs. The target indication for Cantrixil is ovarian cancer, and Diffuse Intrinsic Pontine Glioma (DIPG) for Trilexium. While the initial target pediatric indication for Anisina has been identified as neuroblastoma, Novogen is yet to identify the adult indication and is intending to open an all-comers Phase 1 trial initially based on its preclinical studies. For more information, please visit www.novogen.com
Forward Looking Statement
This press 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. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,” “may,” “target,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Cantrixil, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, Cantrixil, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Cantrixil, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Cantrixil, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
(AUPH) Phase 2b Study in Lupus to Continue as Planned
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH-TSX:AUP) (“Aurinia” or the “Company”) has announced today that the independent Data and Safety Monitoring Board (“DSMB”) for the Company’s Phase 2b lupus nephritis study, known as AURA-LV, has completed its third pre-planned safety review of patients enrolled in the study and recommended continuation of the trial without any modifications. The AURA-LV DSMB has been established according to the FDA Guidance for Clinical Trial Sponsors and is guided by its charter. Aurinia remains blinded to the actual safety and efficacy results.
The DSMB reviewed all the safety data from more than 200 patients that had been enrolled and randomized at the time the data was requested. This included adverse events, laboratory results and compliance with the study protocol.
“We are encouraged by the recommendations of the DSMB,” said Stephen W. Zaruby, President and CEO of Aurinia. “The safety profile of voclosporin has been well characterized in the clinic with over 2,000 patients having received voclosporin in other clinical trials to date, outside of lupus nephritis. It is important that having assessed the data emerging from this study, the DSMB’s view on the safety profile remains unchanged.”
Aurinia anticipates completion of patient enrollment in the AURA-LV study around the end of 2015. Additionally, the Company continues to recruit patients into its AURION study and expects to review data early in 2016.
About Aurinia
Aurinia is a clinical stage pharmaceutical company focused on the global nephrology market. It is currently enrolling patients in its Phase 2b clinical trial to evaluate the efficacy of its drug, voclosporin, as a treatment for LN. LN is an inflammation of the kidneys, that if inadequately treated can lead to end-stage renal disease, making LN a serious and potentially life-threatening condition.
Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with extensive clinical data in over 2,000 patients in other indications. Voclosporin is made by a modification of a single amino acid of the cyclosporine molecule (a CNI approved for use in transplant patients since 1983). This modification results in a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency vs. cyclosporine, an altered metabolic profile, and potential for flat dosing.
About AURA-LV:
The AURA–LV study or “Aurinia Urine Protein Reduction in Active Lupus Nephritis Study” is an adequate and well controlled clinical trial that is being conducted in 20 countries worldwide and is expected to enroll approximately 258 patients which will compare the efficacy of voclosporin against placebo in achieving remission in patients with active lupus nephritis. The AURA-LV study is designed to demonstrate that voclosporin can induce a rapid and sustained reduction of proteinuria in the presence of extremely low steroid exposure and to fulfill specific regulatory requests. It will compare two dosage groups of voclosporin (23.7mg and 39.5mg) administered with mycophenolate mofetil (MMF) vs. MMF alone. All patients will also receive oral corticosteroids as background therapy. There will be a primary analysis to determine complete remission at week 24 and various secondary analyses at week 48 which include biomarkers and markers of non-renal SLE.
About AURION:
The AURION study or “Aurinia Early Urinary Protein Reduction Predicts Response Study” is an open label, exploratory study being conducted in multiple sites in Malaysia to assess the short term predictors of response using voclosporin in combination with mycophenolate mofetil in patients with active lupus nephritis. This study will examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks.
We seek Safe Harbor.
Aurinia Pharmaceuticals Inc.
Mr. Michael Martin, 250-708-4272
Chief Operating Officer
Fax: 250-744-2498
mmartin@auriniapharma.com
or
Mr. Stephen W. Zaruby, 250-708-4293
Chief Executive Officer
Fax: 250-744-2498
szaruby@auriniapharma.com
or
Renmark Financial Communications Inc.
Barry Mire
bmire@renmarkfinancial.com
or
Laura Welsh
lwelsh@renmarkfinancial.com
Tel: 416-644-2020 or 514-939-3989
(CDZI) Announces Agreements to Extend Maturities of Existing Debt
Agreements Extend Maturity of Existing Convertible Debt to March 2020 and Grants Right to Extend First Mortgage to June 2017
LOS ANGELES, Nov. 24, 2015 — Cadiz Inc. (NASDAQ:CDZI) (“Cadiz”, “the Company”) is pleased to announce today that it has entered into an agreement with its senior lenders, including MSD Credit Opportunity Master Fund, L.P., (“Senior Lenders”), which grants the Company the right to extend the maturity date of the $40 million first tranche of its mortgage debt (“First Mortgage”) from March 2016 to June 2017. Additionally, the Company has also entered into agreements with a majority of its convertible note holders to exchange a minimum of $40 million in outstanding convertible notes presently due in March 2018 for substantially similar convertible notes due in March 2020 (“Convertible Notes” or “Notes”). These agreements allow the Company enhanced flexibility to progress implementation of the Cadiz Valley Water Conservation, Recovery and Storage Project (the “Water Project”) at its primary landholding in the eastern Mojave Desert.
Under the agreement with the Senior Lenders, if the Company elects to extend the First Mortgage, it must make a $9 million payment to the lenders prior to March 5, 2016, which will also reduce the Company’s outstanding mortgage balance. The Company may fund this $9 million payment with the proceeds of a possible future equity offering or, alternatively, the Company may replace or extinguish the mortgage debt prior to the March 2016 due date in connection with a potential expansion of the Cadiz Valley agricultural operations. Negotiations with third parties related to such an agricultural expansion are ongoing.
Further, in addition to the agreement with the Senior Lenders, the Company also entered into agreements with a majority of its Convertible Note holders, pursuant to which those holders will exchange their Convertible Notes for new convertible notes with substantially similar terms but with a maturity date in March 2020. In exchange for this maturity extension, the conversion rate on the new convertible notes will be reduced from $8.05 to $6.75 per share. Interest will continue to accrue at 7% with no payment due until maturity.
The implementation of the Cadiz Water Project, a public-private partnership that will make available a new water supply for 400,000 people in California, continues to be the Company’s primary objective. The Water Project has been reviewed and approved under California’s stringent environmental laws and upheld against six separate challenges in California Superior Court. In October 2015, the US Bureau of Land Management’s (“BLM”) California office issued guidance that may require the Water Project to seek a new permit to construct its water conveyance pipeline within an active railroad right-of-way – a route that will avoid environmental impacts and provide numerous benefits to the host railroad.
The use of an active railroad right-of-way continues to be the safest, most sustainable and preferred pipeline route for the Water Project and, with these agreements successfully completed, the Company will continue to seek the reconsideration, overturning or invalidation of this decision over the next few months. If these efforts do not result in the issuance of new guidance by the BLM, then the Company will aggressively pursue all administrative and legal remedies available to firmly establish the railroad’s right to grant access to the Company for a water conveyance pipeline that will also further numerous railroad purposes.
The Company paid its Senior Lenders an amendment fee of $2.25 million in additional debt for the right to extend the maturity date of the First Mortgage to June 2017, which is concurrent with the existing due date of the remaining $12 million second tranche of its mortgage debt. Should the Company opt to extend the First Mortgage maturity date, then it will incur an additional fee of $2.25 million payable in either additional term debt or shares of common stock at the Lenders’ option. Interest will continue to accrue on the First Mortgage at 8%.
About Cadiz
Founded in 1983, Cadiz Inc. is a publicly-held renewable resources company that owns 70 square miles of property with significant water resources in Southern California. The Company operates an organic agricultural development in the Cadiz Valley of eastern San Bernardino County, California and is partnering with public water agencies to implement the Cadiz Water Project, which over two phases will create a new water supply for approximately 100,000 Southern California families and make available up to 1 million acre-feet of new groundwater storage capacity. The Company abides by a wide-ranging “Green Compact” focused on environmental conservation and sustainable practices to manage its land, water and agricultural resources. For more information about Cadiz, visit http://www.cadizinc.com/.
FORWARD LOOKING STATEMENT: This release contains forward-looking statements that are subject to significant risks and uncertainties, including statements related to the future operating and financial performance of the Company and the financing activities of the Company. Although the Company believes that the expectations reflected in our forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Factors that could cause actual results or events to differ materially from those reflected in the Company’s forward-looking statements include the Company’s ability to maximize value for Cadiz land and water resources, the Company’s ability to obtain new financing as needed, the receipt of additional permits for the water project and other factors and considerations detailed in the Company’s Securities and Exchange Commission filings.
CONTACT: Courtney Degener 213.271.1603 cdegener@cadizinc.com
(ADRO) Receives EU Orphan Drug Designation for CRS-207 in Mesothelioma
BERKELEY, Calif., Nov. 23, 2015 — Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to CRS-207 for the treatment of malignant pleural mesothelioma (MPM).
“The receipt of Orphan Drug Designation in the European Union (EU) for CRS-207 for the treatment of MPM marks a significant regulatory milestone for Aduro, as we expand our operations in Europe and advance our therapies closer to the commercial marketplace,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We look forward to working with the EMA to expeditiously advance CRS-207 through development with the goal of bringing this potential therapy to patients throughout Europe suffering from mesothelioma.”
To receive Orphan Drug Designation from the EMA, a therapy must be intended for the treatment of a life-threatening or chronically debilitating rare condition with a prevalence of less than five in 10,000 in the European Union. Orphan Drug Designation provides incentives designed to facilitate development, including protocol assistance and scientific advice and importantly, may provide up to ten years of market exclusivity in the EU following product approval.
Aduro is conducting a Phase 1b study of CRS-207 in combination with standard of care chemotherapy in patients with unresectable malignant pleural mesothelioma. The company plans to advance directly to a Phase 3 clinical trial with CRS-207 in combination with standard-of-care chemotherapy in patients with unresectable MPM in the first half of 2016. In addition to the newly granted Orphan Drug Designation from the EMA, CRS-207 received Orphan Status for the treatment of mesothelioma from the U.S. Food and Drug Administration in March 2015.
About CRS-207
CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induces a potent innate and T cell-mediated adaptive immune response. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.
About Aduro
Aduro Biotech, Inc. is a clinical-stage immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro’s technology platforms, which are designed to harness the body’s natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro’s LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro’s cyclic dinucleotide (CDN) platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for CRS-207, the potential benefits of Orphan Drug Designation, and the potential for eventual regulatory approval, commercialization and launch of our product candidates. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in the most recent Form 10-Q which is on file with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Contact: Sylvia Wheeler SVP, Corporate Affairs 510 809 9264 Media Contact: Angela Bitting 925 202 6211 press@aduro.com
(BNSO) Reports Sale of a Residential Unit
HONG KONG, Nov. 23, 2015 — Bonso Electronics International, Inc. (NASDAQ:BNSO) today announced that it has entered into an agreement to sell a residential unit owned by the Company in Shenzhen to a third party.
In October 2015, the Company entered into an agreement with a third party to sell a residential unit located in Shenzhen, People’s Republic of China, for approximately $832,000. The property was acquired by the company in year 2000, and was leased out to tenants for residential use. The resulting gain before tax is expected to be approximately $744,000 (or $0.14 per share).
The final sale is subject to the buyer obtaining financing from a bank, and the final payment and transfer of the property are expected to be completed by January 31, 2016. The gain from this transaction is expected to be reflected in the financial results of the fiscal year ended March 31, 2016.
About Bonso Electronics
Bonso Electronics designs, develops, manufactures, assembles and markets a comprehensive line of electronic scales, weighing instruments, health care products and pet electronics products. Bonso products are manufactured in the People’s Republic of China for customers primarily located in North America and Europe. Company services include product design and prototyping, production tooling, procurement of components, total quality management, and just-in-time delivery. Bonso also independently designs and develops electronic products for private label markets. Bonso is also beginning the process to redevelop the land upon which its Shenzhen factory was previously located. For further information, visit the company’s web site at http://www.bonso.com.
This news release includes forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward looking statements may be identified by such words or phrases as “should,” “intends,” “is subject to,” “expects,” “will,” “continue,” “anticipate,” “estimated,” “projected,” “may,” “I or we believe,” “future prospects,” “our strategy” or similar expressions. Forward-looking statements made in this press release, which relate to the positive impact resulting from the sale of certain land use rights involve known and unknown risks and uncertainties that may cause the actual results to differ materially from those expected and stated in this announcement. We undertake no obligation to update “forward-looking” statements.
For more information please contact: Albert So Chief Financial Officer and Secretary Tel: 852 2605 5822 Fax: 852 2691 1724
(SMMT) Novel Antibiotic Ridinilazole Achieves Statistical Superiority Over Vancomycin
- Sustained Clinical Response Rates of 66.7% with Ridinilazole vs. 42.4% with Vancomycin
- Ridinilazole to Advance into Phase 3 Clinical Development
- Conference Call Scheduled for 1:00pm GMT / 8:00am EST
OXFORD, United Kingdom, Nov. 23, 2015 — Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces the success of CoDIFy, a Phase 2 proof of concept clinical trial that evaluated the novel, oral antibiotic, ridinilazole (SMT19969) against the current standard of care, vancomycin, for the treatment of CDI.
The Phase 2 trial exceeded its primary endpoint with ridinilazole achieving statistical superiority over vancomycin in sustained clinical response (‘SCR’) using the pre-specified 90% confidence interval, with SCR rates of 66.7% for ridinilazole compared to 42.4% for vancomycin. SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of treatment. The statistical superiority in SCR with ridinilazole in this trial was driven by a large numerical reduction in recurrent disease compared with vancomycin.
“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic with the potential to both treat the initial infection and substantially reduce recurrent disease,” commented Glyn Edwards, Chief Executive Officer of Summit. “There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest. Based on the positive top-line results from the CoDIFy trial, we will now evaluate the optimal path to advance ridinilazole into Phase 3 clinical trials. In addition, Summit sincerely thanks the Wellcome Trust for their support in the development of ridinilazole that has helped to achieve this clinical proof of concept milestone.”
“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Professor Mark Wilcox, Consultant Microbiologist & Head of Microbiology at the Leeds Teaching Hospitals NHS Trust, Professor of Medical Microbiology at the University of Leeds, and Public Health England’s Lead on C. difficile in England. “These clinical data suggest that ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge. I, and many other healthcare practitioners, look forward to the continued clinical development of this compound.”
Design and Top-Line Results from CoDIFy Clinical Trial
CoDIFy was a double blind, randomized, active controlled, multicenter, Phase 2 clinical trial that evaluated the efficacy of ridinilazole against vancomycin in a total of 100 patients. Half of the patients received ridinilazole for ten days (200 mg, twice a day), and the remaining half received vancomycin for ten days (125 mg, four times a day). The trial was conducted in the United States and Canada. The primary endpoint was non-inferiority of ridinilazole compared to vancomycin in SCR. The trial met its primary endpoint with ridinilazole achieving an SCR rate of 66.7% compared to 42.4% for vancomycin (non-inferiority margin of 15%, p=0.0004). This also represents statistical superiority of ridinilazole over vancomycin using the pre-specified 90% confidence interval. The primary analysis was conducted on the modified intent-to-treat (‘mITT’) population that comprised subjects with CDI confirmed by the presence of free toxin. Ridinilazole was generally well tolerated and the overall adverse event profiles of ridinilazole and vancomycin were comparable. More detailed findings from the trial will be reported at relevant conferences and in peer-reviewed journals.
The development of ridinilazole was financially supported through to completion of this Phase 2 clinical trial by Seeding Drug Discovery and Translational Awards from the Wellcome Trust. Ridinilazole has received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration.
Conference Call Details
Summit will host a conference call and webcast to discuss the results of the Phase 2 clinical trial today, 23 November 2015, at 1:00pm GMT / 8:00am EST. To participate in the conference call please dial +44 (0)20 3427 1910 (UK and international participants) or +1 646 254 3364 (US local number) and use the conference confirmation code 8280846. Investors may also access a live audio webcast of the call via the investors section of Summit’s website www.summitplc.com. A replay of the webcast will be available shortly after the conference call finishes.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with between 450,000 and 700,000 cases of CDI in the US annually. It is caused by an infection of the colon by the bacteria C. difficile, which produces toxins that cause inflammation, 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 (SMT19969)
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.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation 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:
| Summit | |
| Glyn Edwards / Richard Pye (UK office) | Tel: +44 (0)1235 443 951 |
| Erik Ostrowski / Michelle Avery (US office) | +1 617 225 4455 |
| Cairn Financial Advisers LLP | |
| (Nominated Adviser) | |
| Liam Murray / Tony Rawlinson | Tel: +44 (0)20 77148 7900 |
| N+1 Singer | |
| (Broker) | |
| Aubrey Powell / Jen Boorer | Tel: +44 (0)20 7496 3000 |
| Peckwater PR | |
| (Financial public relations, UK) | Tel: +44 (0)7879 458 364 |
| Tarquin Edwards | tarquin.edwards@peckwaterpr.co.uk |
| MacDougall Biomedical Communications | |
| (US media contact) | Tel: +1 781 235 3060 |
| Chris Erdman | cerdman@macbiocom.com |
Forward-looking Statements
Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, 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 on-going 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 or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.
(MOC) U. S. Postal Services Reaffirmation to Award $250M Contract
HERNDON, Va., Nov. 23, 2015 — Command Security Corporation (NYSE MKT:MOC) announced today the notification by the U. S. Postal Service (the “USPS”) of its decision to confirm the award of the USPS contract under Solicitation No. 2B-14-A-0078 (the “USPS Contract”) valued at approximately $250 million over a ten year term of service. The USPS and Command Security Corporation (the “Company”) will begin to develop the transition process for the Company to formally assume the responsibilities under the USPS Contract.
The Company initially received notification on December 31, 2014 of the award of the USPS Contract, which provides for security services at 50 USPS locations in 18 states, Puerto Rico and the District of Columbia, valued at approximately $20 million per year, as well as the operation of the two USPS National Law Enforcement Communication Centers (NLECC) at Dulles International Airport, Virginia and in Ft. Worth, Texas, valued at approximately $5 million per year. The award includes a four year base contract and three two-year options.
On January 29, 2015, the Company announced that the USPS had issued a stay of the transition of the USPS Contract awarded to the Company pending the resolution of a dispute over the award of such contract. On January 27, 2015, the Company was notified by the USPS that ABM Security Services (“ABM”) had lodged a protest with the USPS seeking to overturn the contract that was awarded to the Company.
In a decision dated June 15, 2015, the USPS Supplier Disagreement Resolution Officer found that the USPS Contract awarded to the Company represented the best value for the USPS. Accordingly, the Supplier Disagreement Resolution Officer denied the disagreement filed by ABM, and lifted the stay on the performance of the USPS Contract with the Company.
On June 17, 2015, the Company was notified by the United States Department of Justice that ABM had expressed intent to file a protest with the Court of Federal Claims challenging the award of the USPS Contract to the Company, and seeking an injunction to stop the transition of the USPS Contract to the Company. On June 23, 2015, ABM filed a protest with the Court of Federal Claims challenging the award of the USPS Contract to the Company, and the USPS expressed an intent to stay the transition of the USPS Contract awarded the Company pending resolution of the Court of Federal Claims protest filed by ABM. The Court of Federal Claims dismissed the protest filed by ABM on July 7, 2015 to allow for the USPS to take corrective action.
“We have waited a long time for this affirmation and hope there will be no further delays or roadblocks imposed to disrupt this important work. Again, we are extremely gratified and energized to learn of the U. S. Postal Service decision which recognizes the best value proposition our team will provide,” said Craig P. Coy, Chief Executive Officer.
About Command Security Corporation
Command Security Corporation and its Aviation Safeguards subsidiary provides uniformed security officers, aviation security services and support security services to commercial, financial, industrial, aviation and governmental customers throughout the United States. We safeguard against theft, fraud, fire, intrusion, vandalism and the many other threats that our customers are facing today. By partnering with each customer, we design programs customized to meet their specific security needs and address their particular concerns. We bring years of expertise, including sophisticated systems for hiring, training, supervision and oversight, backed by cutting-edge technology, to every situation that our customers face involving security. Our mission is to enable our customers to operate their businesses without disruption or loss, and to create safe environments for their employees. For more information concerning our company, please refer to our website at www.commandsecurity.com.
Forward-Looking Statements
This announcement by Command Security Corporation (referred to herein as the “Company”) 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 within the meaning of the Private Securities Litigation Reform Act of 1995 about the Company that are based on management’s assumptions, expectations and projections about the Company. Such forward-looking statements by their nature involve a degree of risk and uncertainty. The Company cautions that actual results of the Company could differ materially from those projected in the forward-looking statements as a result of various factors, including but not limited to the factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2015, filed with the Securities and Exchange Commission, and such other risks disclosed from time to time in the Company’s periodic and other reports filed with the Securities and Exchange Commission. You should consider the areas of risk described above in connection with any forward-looking statements that may be made by the Company. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures the Company makes in proxy statements, quarterly reports on Form 10-Q, annual reports on Form 10-K and current reports on Form 8-K filed with the Securities and Exchange Commission, which are publicly available at the Securities and Exchange Commission’s website at www.sec.gov/edgar.shtml.
COMPANY CONTACT: N. Paul Brost Command Security Corporation 703-464-4735
(CNCK) Nutritionist Lends Expertise in ValuePenguin Publication
LOS ANGELES, CA–(Nov 23, 2015) – ContentChecked Holdings, Inc. (OTCQB: CNCK) prides itself on a roster of employees well-familiar and highly experienced in their respective roles to the company. Among the company’s staff of degreed nutritionists is Tara Zamani, who offered a bit of industry insight in a recent ValuePenguin article on employment as a dietician/nutritionist.
“Los Angeles is full of food gurus, raw foodies, vegans, vegetarians and nutrition-savvy individuals. I love working in L.A. as a nutritionist because many of my clients already have a good understanding of nutrition and are very open-minded when it comes to holistic health. L.A. is a hub for holistic nutrition, alternative medicine and many people here prefer to use natural remedies for healing, rather than traditional methods,” Zamani says in the article. “Nutritionists are in demand, which makes it a great city for a new nutritionist to start a career. L.A. also offers many healthy restaurants, farmers’ markets, co-ops, health food stores and wellness centers, and guiding clients to choose healthier eating places is easy.”
The article (http://www.valuepenguin.com/getting-job-as-dietitian) links back to ContentChecked’s website, potentially exposing the company to ValuePenguin’s audience of approximately 350,000 monthly viewers.
Complementary to ContentChecked’s efforts to raise awareness of its family of health apps, the company is pleased to contribute its expertise where needed and help Americans better manage their food allergies, migraines and overall health.
“Each ContentChecked employee is highly valued for their strong contributions and hard work that firmly roots our company in the marketplace,” says Kris Finstad, CEO of ContentChecked, the developer of MigraineChecked, SugarChecked and ContentChecked, a family of health apps for people with dietary restrictions and/or food preferences. “It’s always a pleasure to see the expertise of one of our team members being sought after and published in a well-recognized and read publication like ValuePenguin.”
About ContentChecked Holdings, Inc.
ContentChecked has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications to the market. ContentChecked and MigraineChecked applications are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for most U.S. food products. SugarChecked gives consumers the ability to scan the barcodes of grocery store products and determine what kind of sugars are contained within. This enables the applications to meet the needs of millions of people in the United States. As a result, ContentChecked has created a pivotal way for food producers to, at the point of purchase, be able to showcase their products to consumers who are actively seeking them.
Designed for use by those who suffer from food allergies, dietary intolerances, migraines and chronic headaches, ContentChecked and MigraineChecked applications have reached wide adoption levels. In the U.S. alone there are 15 million people who suffer from food allergies and 38 million from migraine and chronic headaches. The food allergy market currently has an estimated value of $6 billion USD. Both applications give the ability to scan a product’s bar code and determine if it is safe for consumption, and if not the apps will recommend a suitable alternative per the user’s specific dietary profile.
SugarChecked identifies four main types of sugars that consumers can avoid, including added sugars, artificial sweeteners, natural low-calorie sweeteners and sugar alcohols. This application is an easy shopping tool for consumers to decipher often-misleading food labels, and receive recommendations for healthier alternative products as they shop in real time.
ContentChecked has created a robust database of allergens, migraine triggers, and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database that is updated regularly. ContentChecked’s applications are highly scalable and can expand into new geographic areas and product categories with limited modifications and investment.
For more information on ContentChecked, please visit its social media channels via Facebook (http://www.facebook.com/contentchecked) Instagram (http://www.instagram.com/contentchecked), or YouTube (http://www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ). You may also visit the social media channels of MigraineChecked on Facebook (http://www.facebook.com/migrainechecked) or Instagram (http://www.instagram.com/migrainechecked/).
Forward-Looking Statements:
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of the Company’s mobile applications, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including, the Company’s Annual Report on Form 10-K filed with the SEC on July 13, 2015. The Company does not undertake to update these forward-looking statements.
Contact:
Investor Relations
Mike Bowdoin
Bowdoin Group
407-590-6995
Mike@BowdoinGrp.com
(MOXC) MissionIR Exclusive Audio Interview With Moxian Creative & Marketing VP Edmund Ooi
ATLANTA, GA–(Nov 23, 2015) – MissionIR today announces the online availability of its interview with Mr. Edmund Ooi, Vice President and Director of Creative & Marketing for Moxian, Inc. (OTCQB: MOXC). The full audio interview is available at http://MOXC.MissionIR.com/interview.html.
Moxian is a social multi-media company building an application platform and merchant rewards system that enable small- and medium-sized businesses to better engage their customers and enhancing their marketing initiatives.
After providing a brief overview of the company, Mr. Ooi describes his own experience creating national marketing projects in Singapore, China, the Middle East and Los Angeles, which he currently applies in helping Moxian create product improvements and applications to a larger audience.
He then offers considerable information on other key members of the company’s management team and how their previous endeavors in international markets contribute to Moxian’s growth. Together, this roster of executives has positioned the company to achieve several milestones in 2015, including rapid market acceptance and strategic personnel additions.
“I think we have seen a great leap in our skillset and our ability to [offer] much stronger and more robust software,” Mr. Ooi says.
Moving forward, Mr. Ooi explains Moxian’s near and longer-term outlook, which includes expanding its merchant base; increasing advertising, transaction and sponsorships revenues; uplisting the company’s common stock; and increasing shareholder value.
Mr. Ooi concludes the interview with a recap of recent company news, including an $8.9 million private placement to facilitate Moxian’s continued corporate growth.
About Moxian, Inc.
Moxian, Inc. engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. The company’s products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. Moxian designs its products and services to allow merchant clients to run advertising campaigns and promotions targeting their customers. Moxian’s platform is also designed and built to entice users to return frequently and to encourage new consumer users to subscribe its website.
For additional information, please visit the Company’s corporate website: www.Moxian.com/indexen.html
This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(AFOP) Announces Increase to the Size of Stock Repurchase Program
SUNNYVALE, Calif., Nov. 20, 2015 — Alliance Fiber Optic Products, Inc. (Nasdaq:AFOP) today announced that its board of directors has approved an increase to the size of the current stock repurchase program, which was announced previously on August 24, 2015 with the amount of twenty five million dollars. The revised stock repurchase program will continue purchasing up to thirty five million dollars of its outstanding shares of Common Stock. The duration of the repurchase program is open-ended.
Under the program, AFOP could purchase shares of Common Stock from time to time through open market and privately negotiated transactions at prices depending on prevailing market conditions and other factors. The program does not obligate AFOP to repurchase any particular amount of common stock during any period and the program may be modified or suspended at any time at the Company’s discretion. The repurchase will be funded by cash on hand.
About AFOP
Founded in 1995, Alliance Fiber Optic Products, Inc. designs, manufactures and markets a broad range of high performance fiber optic components and integrated modules. AFOP’s products are used by leading and emerging communications equipment manufacturers to deliver optical networking systems to the long-haul, enterprise, metropolitan and last mile access segments of the communications network. AFOP offers a broad product line of passive optical components including interconnect systems, couplers and splitters, thin film CWDM and DWDM components and modules, optical attenuators, and micro-optics devices. AFOP is headquartered in Sunnyvale, California, with manufacturing and product development capabilities in the United States, Taiwan and China. AFOP’s website is located at http://www.afop.com.
CONTACT: Keting Lin, IR Associate
Alliance Fiber Optic Products, Inc.
408-736-6900 x188
Email: klin@afop.com
(HABT) Postpones Proposed Follow-On Offering of Common Stock
IRVINE, Calif., Nov. 20, 2015 — The Habit Restaurants, Inc. (Nasdaq:HABT) (“The Habit” or the “Company”) today announced that, in light of current capital market conditions, its previously announced secondary offering of shares of common stock to be sold by certain of the Company’s stockholders has been postponed. The Company’s registration statement on Form S-1, as filed with the Securities and Exchange Commission (“SEC”) and pursuant to which the Company would receive no proceeds, has not been withdrawn and the Company and certain of the Company’s stockholders expect to continue to evaluate the potential for and timing of such secondary offering by certain of the Company’s stockholders.
Piper Jaffray & Co., Robert W. Baird & Co. Incorporated and Wells Fargo Securities, LLC are acting as lead book-runners for the offering. Raymond James & Associates, Inc. is also acting as a book-runner for the offering and Stifel and Stephens Inc. are acting as co-managers for the offering.
A registration statement relating to this offering was filed with the SEC, but has not yet become effective. The securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor may there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.
About The Habit Restaurants, Inc.
The Habit Burger Grill is a fast casual restaurant concept that specializes in preparing fresh, made-to-order char-grilled burgers and sandwiches featuring USDA choice tri-tip steak, grilled chicken and sushi-grade albacore tuna cooked over an open flame. The first Habit opened in Santa Barbara, California in 1969. The Habit has since grown to over 125 restaurants in 12 markets throughout California, Arizona, Utah, New Jersey, Florida and Nevada.
CONTACT: Investors:
(949) 943-8692
HabitIR@habitburger.com
Media:
(949) 943-8691
Media@habitburger.com
(MRNS) Ganaxolone to be Featured at American Epilepsy Society Annual Meeting
Scientific Exhibit to Showcase Posters on Ganaxolone on Sunday, December 6th
RADNOR, Pa., Nov. 19, 2015 — Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, announced today that two abstracts featuring Marinus’s CNS-selective GABAA modulator, ganaxolone have been selected for poster presentation at the 69th Annual Meeting of the American Epilepsy Society, which will be held December 4-8, 2015, at the Pennsylvania Convention Center in Philadelphia, PA.
The posters, which will be presented on Sunday, December 6th, in Hall A of the Convention Center, include:
Title: Additional responder analysis on a phase 2 study of ganaxolone in patients with partial onset seizures
Poster Session #: 2.260
Presenting Author: Albena Patroneva, M.D.Title: Clinical development of an intravenous formulation of ganaxolone for acute care patients supported by non-clinical toxicity studies conducted in rats and rabbits
Poster Session #: 2.238
Presenting Author: Julia Tsai, Ph.D.
Also on Sunday, December 6th, from 2:00 – 5:00 pm in Room 201A, Marinus will be hosting a scientific exhibit, featuring several scientific posters on ganaxolone, including new preclinical data for the recently developed intravenous (IV) formulation.
About Marinus Pharmaceuticals, Inc.
Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone IV is planned to enter clinical trials in 2016 and is being developed to treat status epilepticus. Ganaxolone IV is complemented by its oral dose forms, providing the potential for IV-to-oral continuation therapy for patients transitioning from acute care to outpatient settings. Ganaxolone capsule is being evaluated in a Phase 3 multi-national clinical trial as adjunctive treatment of focal onset seizures in adults. Ganaxolone capsule and liquid are being studied in orphan pediatric indications with comorbidities in seizures and behavior disorders – PCDH19 epilepsy and Fragile X Syndrome. For more information visit www.marinuspharma.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward looking statements contained in this press release include, among others, statements regarding our interpretation of preclinical studies, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release 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 conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters, including the development of formulations of ganaxolone, that could affect the availability or commercial potential of our drug candidates. Marinus 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 filings Marinus has made with the Securities and Exchange Commission.
CONTACTS: Company: Lisa M. Caperelli Senior Director, Investor Relations & Corporate Communications Marinus Pharmaceuticals, Inc. 484-801-4674 lcaperelli@marinuspharma.com Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler 646-362-5750 awheeler@tiberend.com
(FRAN) Resignation of CFO, Appointment of Interim CFO
francesca’s® Announces Preliminary Fiscal Third Quarter Results
Expects Net Sales of Approximately $103.4 million, Comparable Sales Increase of 4%,
and Diluted Earnings Per Share of $0.15 to $0.16
HOUSTON, Nov. 20, 2015 — Francesca’s Holdings Corporation (the “Company”) (Nasdaq:FRAN) today announced that its Chief Financial Officer, Mark Vendetti, has resigned from the Company effective December 4th, 2015 to accept a CFO position at another publicly traded company. Cindy Thomassee, francesca’s® current VP of Accounting, has been appointed to the role of Interim CFO and will report directly to CEO Michael W. Barnes while the Company conducts a search for a CFO.
Michael W. Barnes, Chairman, President, and CEO stated, “I would like to thank Mark for all of his efforts as our Chief Financial Officer over the last two and a half years. I am grateful for Mark’s time at francesca’s® and I wish him continued success in his new role. We appreciate Cindy stepping into the role of Interim CFO as we conduct a search for a permanent replacement.”
In addition, francesca’s® announced preliminary sales results and updated earnings per share guidance for the third quarter ending October 31, 2015. Net sales increased 19% to $103.4 million as compared to the third quarter last year with comparable sales up 4% for the period. The Company now expects diluted earnings per share to be in the range of $0.15 to $0.16 per diluted share compared to the Company’s previous guidance of $0.12 to $0.15 per diluted share. francesca’s® will report its third quarter results and provide its outlook for the fourth quarter on December 9, 2015, at 8:30 a.m. ET.
Michael W. Barnes, Chairman, President, and CEO stated, “We are pleased with our better than expected sales and comps in the third quarter, driven by a terrific product assortment across categories. During the quarter, we saw strong and broad consumer response to our assortments which is driving improved conversion and higher units per transaction; leading to increased average transaction values and the overall comparable sales increase. I look forward to discussing the details of our third quarter results, as well as fourth quarter and full fiscal year 2015 guidance during our third quarter conference call next month.”
Forward-Looking Statements
Certain statements in this release are “forward-looking statements” made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements reflect our current expectations or beliefs concerning future events and are subject to various risks and uncertainties that may cause actual results to differ materially from those that we expected. These risks and uncertainties include, but are not limited to, the following: the risk that we cannot anticipate, identify and respond quickly to changing fashion trends and customer preferences; our ability to attract a sufficient number of customers to our boutiques or sell sufficient quantities of our merchandise through our direct-to-consumer business; our ability to successfully open and operate new boutiques each year; our ability to efficiently source and distribute additional merchandise quantities necessary to support our growth; and our ability to attract and integrate a new Chief Financial Officer. For additional information regarding these and other risks and uncertainties that could cause actual results to differ materially from those contained in our forward-looking statements, please refer to “Risk Factors” in our Annual Report on Form 10-K for the year ended January 31, 2015 filed with the Securities and Exchange Commission on March 27, 2015 and any risk factors contained in subsequent quarterly and annual reports we file with the SEC. We undertake no obligation to publicly update or revise any forward-looking statement.
Preliminary Results
The Company’s announced preliminary results for its fiscal third quarter ended October 31, 2015 are preliminary and may change. The Company and its auditors have not completed their normal quarterly closing and review procedures for the quarter ended October 31, 2015, and there can be no assurance that final results for the quarter will not differ from the preliminary results, including as a result of quarter-end closing procedures or review adjustments. In addition, these preliminary results should not be viewed as a substitute for full interim financial statements prepared in accordance with GAAP that have been reviewed by the Company’s auditors.
About Francesca’s Holdings Corporation
francesca’s® is a growing specialty retailer with retail locations designed and merchandised to feel like unique, upscale boutiques providing customers a fun and differentiated shopping experience. The merchandise assortment is a diverse and balanced mix of apparel, jewelry, accessories and gifts. Today francesca’s® operates 620 boutiques in 47 states and the District of Columbia and also serves its customers through francescas.com. For additional information on francesca’s®, please visit www.francescas.com.
CONTACT: ICR, Inc.
Jean Fontana
646-277-1214
Company
Kate Venturina
832-494-2233
Kate.Venturina@francescas.com
IR@francescas.com
(CLDX) Long-term Survival Benefit Demonstrated in Phase 2 ReACT Study of RINTEGA(R)
— At 2 years, 25% RINTEGA survival rate versus 0% for control —
— Hazard ratio of 0.53 (p=0.0137) indicates a significant overall survival advantage for recurrent GBM patients —
— Clinical benefit continues to be observed across multiple endpoints, including PFS, OS, ORR and steroid requirement with all OS subgroup analyses favoring RINTEGA treatment —
HAMPTON, N.J., Nov. 20, 2015 — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented mature survival data from the Company’s randomized, double-blind Phase 2 study of RINTEGA® (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma (GBM) at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO). The data were presented in a podium presentation by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School; and President of the Society for Neuro-Oncology, as well as the lead investigator of the ReACT study. RINTEGA is an investigational EGFRvIII specific therapeutic vaccine and was granted Breakthrough Therapy Designation in February 2014. Patients with recurrent glioblastoma that express the EGFRvIII mutation typically have a worse prognosis than the overall glioblastoma population, including poor long-term survival (median time from recurrence to death for EGFRvIII-positive patients is 8.7 months1). As previously reported, the primary endpoint of the study, progression-free survival at six months (PFS6) has been met.
- Mature overall survival (OS) data continue to show a marked benefit [hazard ratio = 0.53 (0.32, 0.88); p=0.0137] with a long-term survival benefit clearly seen in the RINTEGA arm. In May, the Company reported a hazard ratio of 0.57 (0.33, 0.98) (p=0.0386) for OS in the study.
- Nine of 10 patients (one patient lost to follow up) on the RINTEGA arm remain alive since the Company last presented data in May compared to only two out of five patients on the control arm.
- At two years, the survival rate for RINTEGA patients is 25% versus 0% for control patients in the intent to treat (ITT) population, with five patients extending beyond two years.
- Five patients in the RINTEGA arm continue survival follow-up without progression per central review, compared to only one patient on the control arm.
- A clear advantage continues to be demonstrated across multiple, clinically important endpoints including overall survival (OS), long-term progression-free survival (PFS), objective response rate (ORR) and need for steroids.
- 33% of patients on the RINTEGA arm who were receiving steroids at baseline were able to stop steroids for six months or longer compared to none on the control arm.
“The results of the ReACT study change the way we think about glioblastoma—offering patients and their families new hope in the face of one of the most difficult to treat cancers and upending the notion that the brain, masked behind the blood brain barrier, is beyond the reach of the promise of immunotherapy,” said David A. Reardon, M.D. “The long-term survival benefit observed in this study is unprecedented as it is exceedingly rare for patients with highly aggressive, EGFRvIII-positive glioblastoma—even in the newly diagnosed setting—to live beyond two years. Most striking perhaps is that not only are patients living considerably longer, they are also living better, with minimal side effects and a reduced need for steroids. The ReACT data also build considerable anticipation for the ACT IV study in newly-diagnosed glioblastoma as these patients typically present with much stronger immune systems and stand to derive an even greater benefit.”
“Patients with glioblastoma—especially those who are EGFRvIII-positive—face a staggering diagnosis, and in the face of this news, making the decision to participate in a clinical trial—especially a randomized study—is never an easy decision,” said Thomas Davis, M.D., Executive Vice President and Chief Medical Officer of Celldex. “To this end, we are extremely gratified on behalf of our ReACT patients, their families and physicians that RINTEGA continues to tell a very consistent, impressive story across multiple, clinically relevant endpoints including, most importantly, long-term survival. These results replicate what we have seen in earlier RINTEGA studies conducted in newly-diagnosed patients, supporting our belief that RINTEGA will be an important treatment option for all patients with EGFRvIII-positive glioblastoma.”
Presentation Details
ReACT is a randomized, controlled Phase 2 exploratory study designed to determine if adding RINTEGA to standard of care bevacizumab (BV; Avastin®) improves outcomes for patients with EGFRvIII-positive, recurrent glioblastoma across multiple measures. Patients [n=73, intent to treat (ITT)] were bevacizumab-naïve at study entry. Tumor responses were evaluated in accordance with RANO criteria by an independent expert review committee blinded to treatment group assignment. Data for this long-term update included study results through September 1, 2015.
- PFS6: As previously reported, the primary endpoint of PFS6 was met. 10 out of 36 (28%) patients were alive at six months without progression on the RINTEGA arm compared to 6 out of 37 (16%) on the control arm (p=0.1163). Given the exploratory nature and size of the trial, the ReACT study required a PFS6 1-sided p-value of 0.2 (powered at 80%) for positivity.
- SURVIVAL: RINTEGA+BV demonstrated a statistically significant, clinically meaningful overall survival benefit compared to BV alone. Consistent with previous studies of RINTEGA and the published data observed for immune-mediated therapeutics, this survival benefit includes a “tail” on the RINTEGA survival curve with multiple patients exceeding what is customary survival for EGFRvIII-positive glioblastoma. Nine patients on the RINTEGA arm continue to be followed for survival, including five without disease progression per central review. Two patients on the control arm continue to be followed for survival, including one without disease progression per central review. At two years, the survival rate for RINTEGA patients in the ITT population is 25% versus 0% for control patients.
| Overall Survival (OS), Intent to Treat (ITT) Population | ||||
| Hazard Ratio (HR) | HR = 0.53 (0.32, 0.88); p=0.0137 | |||
| Median (95% CI) | OS 12 months | OS 18 months | OS 24 months | |
| RINTEGA + BV | 11.3 (9.9, 16.2) | 44% | 32% | 25% |
| Control + BV | 9.3 (7.1, 11.4) | 32% | 13% | 0% |
- OBJECTIVE RESPONSE RATE (ORR): Nine out of 30 evaluable ITT patients (30%) on the RINTEGA arm experienced a confirmed objective response versus six out of 34 evaluable patients (18%) on the control arm. Five patients on the RINTEGA arm experienced durable responses greater than six months, and three of these patients experienced durable responses greater than 18 months (range of 18.6+ to 22.2 months). In contrast, only two patients on the control arm experienced a durable response greater than six months, and none experienced a response greater than 7.4 months.
- STEROID USE: Further emphasizing the level of disease control, 50% of the 18 patients on the RINTEGA arm who were on steroids at the start of treatment were able to stop steroids for at least two months during treatment versus only 26% of the 19 patients on the control arm who were on steroids at the start of treatment. 33% of patients on the RINTEGA arm were able to stop steroids for more than six months, and, of these, three were able to stop for more than one year versus none on the control arm for either time point.
- IMMUNE RESPONSE: Prolonged survival was associated with high anti-EGFRvIII humoral responses that were predominantly of the cell killing IgG1 isotype, and recent in vivo experiments have shown those immune responses had tumor killing function through antibody dependent cellular cytotoxicity (ADCC) of EGFRvIII-expressing tumor cells. This biologic effector function is rarely proven for immune therapies. Importantly, rapid generation of anti-EGFRvIII humoral response correlated with longer survival; however, even those with slower development of immune responses benefitted. No patient in the control arm had detectable EGFRvIII specific antibody response. This effect is consistent with RINTEGA’s proposed mechanism of action as a targeted immunotherapeutic vaccine.
- OTHER: Multiple subgroup and adjusted analyses have concluded that the consistent survival benefit observed in the study was not influenced by potential imbalances in patient demographics.
- SAFETY: RINTEGA was very well tolerated without unexpected additive toxicity to bevacizumab.
RINTEGA® is a registered trademark of Celldex Therapeutics. Avastin® is a registered trademark of Genentech, Inc.
1Data provided the Radiation Therapy Oncology Group (RTOG).
About RINTEGA®
RINTEGA® is an investigational therapeutic vaccine that targets the tumor specific oncogene EGFRvIII, a functional and permanently activated variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long-term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues.
Three Phase 2 trials of RINTEGA—ACTIVATE, ACT II, and ACT III—have been conducted in newly diagnosed EGFRvIII-positive GBM and have shown consistent improvements in both overall survival and progression-free survival compared to matched historical controls. The most common adverse events for RINTEGA include injection site reactions, fatigue, rash, nausea and pruritus. RINTEGA is currently being studied in two clinical trials in EGFRvIII-positive GBM—an international Phase 3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT in recurrent GBM. In February 2014, the U.S. Food and Drug Administration (FDA) granted RINTEGA Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma. The first interim analysis for ACT IV occurred in June 2015, and the study’s Data Safety and Monitoring Board recommended continuation of the study as planned. The Company anticipates that ACT IV will reach the required 75% of events (deaths) to perform the second interim analysis in late 2015 and that the analysis will occur in early 2016.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.
Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company’s strategic focus and the future development and commercialization (by Celldex and others) of RINTEGA® (“rindopepimut”; “rindo”; CDX-110), glembatumumab vedotin (“glemba”; CDX-011), varlilumab (“varli”; CDX-1127), CDX-1401, CDX-301 and other products and our goals for 2015. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of RINTEGA, glembatumumab vedotin and other drug candidates; our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and derive benefit from the Breakthrough Therapy Designation for RINTEGA, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact
Sarah Cavanaugh, Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Media Inquiries
Dan Budwick, Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
(NVCR) New Phase 3 Data Illustrates Optune Plus 2nd Line Chemo Superiority
Glioblastoma patients who received Optune in combination with bevacizumab at first recurrence lived significantly longer than patients who received bevacizumab alone
Novocure (NASDAQ: NVCR) announced today new Phase 3 data showing that glioblastoma patients who received TTFields in combination with chemotherapy at first recurrence lived significantly longer than patients who received chemotherapy alone. The data will be presented at the 20th Annual Society for Neuro-Oncology Meeting in San Antonio.
The post-hoc analysis of the EF-14 Phase 3 clinical trial shows that patients treated with TTFields in combination with physician’s best choice second line chemotherapy reduced their risk of death by 31 percent compared to patients treated with physician’s best choice second line chemotherapy alone (HR= 0.695, p= 0.0489). Patients treated with TTFields in combination with bevacizumab (Avastin®), reduced their risk of death by 39 percent compared to patients treated with bevacizumab alone (HR=0.606, p= 0.0428).
“Our analysis shows that GBM patients continue benefiting from TTFields therapy even after their disease has recurred,” says Santosh Kesari, a trial investigator and Chair of Translational Neuro-Oncology and Neurotherapeutics at John Wayne Cancer Institute and Director of Neuro-Oncology at the Pacific Brain Tumor Center at Providence Saint John’s Health Center in Santa Monica, California. “This survival benefit is maintained across multiple lines of second line therapy, including bevacizumab, and points to the need for physicians to incorporate Optune into the standard-of-care for glioblastoma.”
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Approved Indications
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.
About Novocure
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Germany, Switzerland, and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on October 27, 2015 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com
(SKBI) Announces Receipt of Nasdaq Notification Letter
XI’AN, CHINA–(Nov 19, 2015) – Skystar Bio-Pharmaceutical Company (NASDAQ: SKBI), a China-based manufacturer and distributor of veterinary medicine, vaccines, micro-organisms and feed additives, announced that on November 17, 2015, it received a letter from NASDAQ Stock Market indicating that that Skystar failed to comply with Nasdaq’s filing requirement set forth in Listing Rule 5250(c)(1) (the “Rule”) because it failed to file its Form 10-Q for the fiscal quarter ended September 30, 2015 (the “Quarterly Report”).
The Company previously disclosed a notification from Nasdaq informing the Company that is was subject to delisting because it failed to comply with Nasdaq’s filing requirements set forth in Listing Rule 5250(c)(1) because it failed to file its Form 10-K for the fiscal year ended December 31, 2014, and Forms 10-Q for the periods ended March 31, and June 30, 2015. The failure to file the Quarterly Report constitutes an additional basis for delisting. The Company also previously disclosed that Nasdaq had notified the Company of two additional, and separate, bases for delisting under Listing Rule 5250(b)(1) (failure to disclose material non-public information) and Listing Rule 5101 (public interest concerns).
The Company has a hearing scheduled for December 3, 2015 for the hearing panel to review the delisting determination.
About Skystar Bio-Pharmaceutical Company
Skystar is a China-based developer, manufacturer and distributor of veterinary healthcare and medical care products. Skystar has four product lines: veterinary medicines, probiotics, vaccines and feed additives formulated and packaged in house across several modern manufacturing and distributions facilities. Skystar’s distribution network includes almost 3,000 distribution agents of which 360 are franchised stores with exclusivity agreements covering 29 provinces throughout China. For additional information, please visit http://www.skystarbio-pharmaceutical.com.
Safe Harbor Statements
When used in this release, the words “intends,” “believes,” “anticipated” and “expects” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include, without limitation, the Company’s ability to complete its IgG kit effort as well as other related efforts at the Huxian facilities, the Company’s ability to timely, effectively and accurately assess the efficacy and commercial potential of any technologies that may results from such R&D efforts, the Company’s ability to timely and effectively commercialize any such technologies. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Contact:
Skystar Bio-Pharmaceutical Company
Scott Cramer
Director – Corporate Development & U.S. Representative
(407) 645-4433
(CASM) to Present at LD Micro Main Event
BRANFORD, Conn., Nov. 19, 2015 — CAS Medical Systems, Inc. (NASDAQ:CASM) (CASMED), a leader in medical devices for non-invasive patient monitoring, announces that Thomas M. Patton, President and Chief Executive Officer, will present at the LD Micro Main Event on Wednesday, December 2, 2015, at 9:30 a.m. Pacific time. The conference will be held at the Luxe Sunset Boulevard Hotel in Los Angeles.
Mr. Patton will be available for one-on-one meetings with the investment community on Wednesday, December 2. Please contact LD Micro via the conference website if you would like to arrange a meeting.
Interested parties can access the audio webcast with slide presentation at www.casmed.com or directly at http://wsw.com/webcast/ldmicro9/casm. An archived presentation will be available for 90 days.
About CASMED® – Monitoring What’s Vital
CASMED products are designed to provide unique non-invasive monitoring solutions that are vital to patient care. The Company’s FORE-SIGHT® Cerebral Oximeters provide a highly accurate, non-invasive measurement of tissue oxygenation in the brain. Direct monitoring of tissue oxygenation can provide a superior and powerful tool to alert clinicians to otherwise unrecognized and dangerously low levels of oxygen in the brain and empower them to improve patient care. In addition to FORE-SIGHT Oximeters and accessories, the Company also provides proprietary non-invasive blood pressure monitoring solutions for OEM use and neonatal intensive care supplies. For further information regarding CASMED, visit the Company’s website at www.casmed.com.
| Company Contact CAS Medical Systems, Inc. Jeffery A. Baird Chief Financial Officer (203) 315-6303 ir@casmed.com Investors LHA Bruce Voss / Jody Cain (310) 691-7100 bvoss@lhai.com / jcain@lhai.com @LHA_IR_PR |
(ICLD) Awarded New Contracts Valued at Over $2.3 Million
Revenue Up $13 Million Year Over Year for the First Three Quarters of 2015
NEW YORK, Nov. 19, 2015 — InterCloud Systems, Inc. (the “Company” or “InterCloud”) (NASDAQ:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, today announced that it was recently awarded over $2.3 million in new contracts.
Mark Munro, CEO of InterCloud Systems stated: “Our Company continues to grow in disproportion to our stock price and market cap. InterCloud has reached so many positive milestones thus far in 2015 and below are just a few of the most important for shareholders to review”
Revenue is up 23% to $65 Million through Q-3 2015
Gross Profit percentage has risen to 33% and is up to $21 Million through Q-3 2015
New contracts announced since July 1, 2015 totals over $36.5 Million
Adjusted EBITDA of $1.9 Million through 9 months of 2015 versus a loss of $(3.1M) for 2014
Mr. Munro continues: “Our sales pipeline of new opportunities has been steady in the $140 Million range for almost a year now and gives us the foresight that our growth should continue into 2016. InterCloud has double digit revenue growth in 2015, gross profit margin increases to 33%, adjusted EBITDA growth of over $5 Million since 2014, brand name fortune 100 customers, and operating divisions performing at their highest levels. InterCloud has paid down and extinguished approximately $3.4 Million of senior debt in 2015 and today only has $4.2 Million of senior debt against approximately $18 Million in accounts receivable. Our team has done an extraordinary job in lowering operational expenses through operational synergies and technology integration savings. The Company is a far better business today than it was a year ago and we believe we have created an extremely valuable next-gen IT solutions company with highly valuable services and assets. Our management team continues to execute at the highest levels and has launched new products and solutions to deliver additional future value for our shareholders. We thank you for your support and look forward to finishing strong in Q-4 2015 and on into 2016.
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a leading provider of cloud networking orchestration and automation, for Software Defined Networking (SDN) and Network Function Virtualization (NFV) cloud environments to the telecommunications service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. InterCloud’s cloud solutions offer enterprise and service-provider customers the opportunity to adopt an operational expense model by outsourcing cloud deployment and management to InterCloud rather than the capital expense model that has dominated in recent decades in IT infrastructure management. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
CONTACT: Investor Relations InterCloud Systems, Inc. 561-988-1988
(UNXL) Receives Initial Mass Production Order from Japanese PC Manufacturer
Providing XTouch sensors for new 10 inch tablet
SANTA CLARA, Calif., Nov. 19, 2015 — UniPixel, Inc. (NASDAQ: UNXL), a provider of Performance Engineered Films™ to the touchscreen and flexible electronics markets, announced today the receipt of an initial mass production order from a leading PC manufacturing company based in Japan for a 10-inch tablet product. UniPixel expects the initial delivery of XTouch sensors to this new customer to occur in the current quarter and the first quarter of 2016. The Company expects the lifetime of the product to be in the range of three to four quarters.
Jeff Hawthorne, president and CEO of UniPixel, commented, “This is an important award for UniPixel at this stage in our development as an emerging supplier in the PC touchscreen market. This order validates our belief that we offer leading-edge technology that can help major PC manufacturers create devices that are thinner, lighter, faster, and more cost effective to produce. We are pleased that our ongoing engagement with this customer and their supply chain partners has resulted in one of the world’s leading PC manufacturers choosing UniPixel technology for their new tablet. We look forward to working with them and their supply chain partners on the development of future products.”
Mr. Hawthorne continued, “This order represents the first step in expanding our customer base among the top PC manufacturers. Our products continue to be evaluated by other major OEMs throughout the world and we expect to win more awards in the years to come. Having just completed our second quarter as a focused sales and manufacturing organization, this award exemplifies the significant progress achieved in introducing our highly differentiated products to major PC manufacturers in the U.S. and Asia.”
About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touch screen and flexible electronics markets. The company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.
Forward-looking Statements
All statements in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including the statements regarding expected initial delivery of XTouch sensors and the lifetime for the product, and the ability to win more awards in the future. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014. UniPixel operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and Current Reports on Form 8-K.
Trademarks in this release are the property of their respective owners
Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com
(APDNW) Identifies Suspects in Short Attack
Persons of Interest Reported to State and Federal Authorities
STONY BROOK, NY–(November 19, 2015) – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced that working with former law enforcement officials, it has identified two persons of interest believed to be involved in the short attack on the company that was perpetrated October 29, 2015. The identities of the suspects have been reported to federal authorities and will be reported to states Attorneys General.
APDN believes that the misstatements in the short attack were a deliberate effort to manipulate the stock price coincident with a quadrupling of the short positions.
Furthermore, the forensic IT investigation revealed that one of the suspects has a background in finance and has been previously fined and ordered to cease and desist operation of an unlicensed investment advisory firm. Given the suspects’ backgrounds, the research dedicated to the short attack, and the false and misleading statements and innuendos stated in the short attack, APDN’s management believes the short attack is an example of a coordinated, organized stock manipulation to achieve personal gain by the attackers.
About Applied DNA Sciences
Applied DNA Sciences makes life real and safe by providing biotechnology-driven solutions to help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. Patented botanical DNA solutions can be used to identify, tag, track, and trace products, to help assure authenticity, traceability and quality of products. SigNature DNA is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators.
Go to adnas.com for more information, events and to learn more about how Applied DNA Sciences makes life real and safe. Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
Forward Looking Statements
The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, as amended on March 6, 2015, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2015, May 11,2015 and August 10, 2015, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor contact:
Debbie Bailey
631-240-8817
debbie.bailey@adnas.com
Media contact:
Susan Forman
Dian Griesel Int’l.
212-825-3210
sforman@dgicomm.com
(NLST) Strategic Partnership With Samsung For New Storage Class Memory
Partnership to Deliver NVDIMM-P, the Fastest Non-Volatile Memory-Storage Solution for Cloud Computing, Analytics and Other Data Intensive Applications
IRVINE, Calif., Nov. 19, 2015 — Netlist, Inc. (NASDAQ: NLST), today announced that it has entered into a five year Joint Development and License Agreement (the “Agreement”) with Samsung Electronics Co., Ltd., to produce a new class of NVDIMM-P (NV-P) memory solutions based on Samsung’s industry leading NAND Flash and DRAM, and Netlist’s pioneering work on HyperVault®. The companies will work to create a standardized product interface to facilitate rapid market adoption and bring the compelling benefits of this new technology to a large group of customers in cloud computing, big data, and server and storage markets.
Under the terms of the Agreement, which includes licensing of each company’s respective patent portfolios, Netlist will receive $23 million, consisting of $8 million in cash from Samsung Electronics and $15 million in the form of investment from Samsung Venture Investment Corporation. The Agreement calls for additional exchange of consideration as progress is made toward market introduction of the product. The companies plan to sample NV-P products with select customers in 2016.
NV-P is an emerging industry standard for a new class of NAND-based storage which operates in the memory channel, the fastest data path in a computer. With HyperVault®, Netlist created the industry’s first unified memory-storage architecture where low cost, high density NAND storage can achieve the performance of high cost, high speed DRAM memory. This breakthrough patented architecture will be combined with Samsung’s industry leading DRAM and NAND, to produce NV-P solutions that deliver cost and performance benefits vastly superior to those of traditional storage solutions.
“At Samsung, we are taking the lead in defining the right standards for storage class memory with industry partners, and creating new markets for DRAM and NAND flash memory based on the new standards. By using a standardized hybrid storage solution, our customers will be able to efficiently extract intelligence from large amounts of data in storage systems,” said Dr. Jung-Bae Lee, Senior Vice President of Memory Product Planning and Application Engineering Team, Samsung Electronics. “We are pleased to partner with Netlist, a company with a long-history of innovative memory technology solutions and IP, to productize and drive broad market adoption of this new standard,” he added.
“This is a transformational partnership that validates our unique IP and provides an accelerated path for delivering NV-P to the mainstream market. Samsung is the unparalleled leader in memory and recognizes the value of disruptive technology in this sector,” said C.K. Hong, President and CEO of Netlist. “Samsung’s leadership in memory and Netlist’s expertise in hybrid storage are highly complementary, and together create a powerful platform for driving broad market adoption of this new storage class memory solution.”
“Computer architecture is going through important changes fueled by the advent of a new memory layer based on alternative memory types,” said Jim Handy, General Director of Objective Analysis, a leading independent research firm. “This brings to computing a much faster kind of storage that can harness the raw speed of the memory bus through the NVDIMM-P memory module format. Objective Analysis projects that the market for such modules in servers could grow to $2 billion by 2019.”
NVDIMM-P is nomenclature adopted by the Storage Network Industry Association to describe storage class memory products that combine the functionalities of persistent DRAM and block accessed NAND Flash, and operate in the memory channel. HyperVault®, a “superset” of NVDIMM-P, further expands the capabilities of NAND so that they achieve near-DRAM performance and DDR4 compatibility with no system software modifications. NV-P solutions are expected to be initially targeted at the fastest tiers of storage where data throughput and latency are critical. These applications include big data analytics, virtualization, in-memory database, online transaction processing and high performance database.
Additional details regarding the transaction are available in Netlist’s Current Report on Form 8-K filed concurrently with the issuance of this release.
About Netlist, Inc.
Netlist creates solutions that accelerate turning data into information. We design and manufacture controller and software-based memory solutions for our OEM and Hyperscale customers in the server and storage space. Flagship products NVvault® and EXPRESSvault™ accelerate system performance and provide mission critical fault tolerance. HyperVault®, Netlist’s next-generation architecture, expands the performance and capacity of memory channel storage. The company holds a portfolio of patents, many seminal, in the area of hybrid memory, rank multiplication and load-reduction, among others. To learn more, visit www.netlist.com
Safe Harbor Statement:
This news release contains forward-looking statements regarding future events and the future performance of Netlist. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. These risks and uncertainties include, but are not limited to, risks associated with the joint development efforts with Samsung described above; the launch and commercial success of our products, programs and technologies; the success of product partnerships; continuing development, qualification and volume production of HyperVault™, EXPRESSvault™, NVvault®, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the decrease in sales to our key customer; our ability to leverage our NVvault® and EXPRESSvault™ technology in a more diverse customer base; the rapidly-changing nature of technology; risks associated with intellectual property, including risks associated with the inherent uncertainty of the litigation process, patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined by the United States Patent and Trademark office; volatility in the pricing of DRAM ICs and NAND; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in the Company’s and its customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; the Company’s ability to attract and retain skilled personnel; the Company’s reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; and the political and regulatory environment in the People’s Republic of China. Other risks and uncertainties are described in the Company’s annual report on Form 10-K filed on March 27, 2015, and subsequent filings with the U.S. Securities and Exchange Commission made by the Company from time to time. Except as required by law, Netlist undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
| For more information, please contact: | |
| Investors: | Press: |
| Brainerd Communicators, Inc. | Brainerd Communicators, Inc. |
| Mike Smargiassi/Jenny Perales | Sharon Oh |
| NLST@braincomm.com | NLST@braincomm.com |
| (212) 986-6667 | (212) 986-6667 |
(RITT) Forms Strategic Alliance With Yoga Automation Private Limited
Global Leader in Smart Building Automation to Provide RiT’s Converged Infrastructure Management and Physical Connectivity Solutions
TEL AVIV, Israel, Nov. 18, 2015 — RiT Technologies (NASDAQ:RITT), a leading provider of converged infrastructure management solutions that enable companies to maximize the utilization and security of their network infrastructure announced today that it has entered into a strategic alliance with Yoga Automation Private Limited (Yoga), a leader in smart building automation, to provide RiT’s solutions locally in India, with a several USD millions sales commitment. This collaboration will enable the parties to offer immediate access and availability to RiT’s products, services and support through Yoga’s offices and logistic centers in Mumbai, Bangalore, New Delhi and Ahmedabad. As a result, RiT will be positioned to achieve wider market exposure of enterprise, carrier, and data center customers. According to Gartner, “India’s spending on IT infrastructure is expected to reach $72.3 Billion in 2016, with IT budgets growing at 11.7 percent, compared with the world average of one percent.”
“The significance of RiT’s strategic agreement with Yoga is that it allows us to act as a local company, enabling us to effectively provide sales and support services closer to our customers,” says Assaf Skolnik, VP Regional Sales at RiT. “Yoga’s market and technology leadership, combined with our advanced converged infrastructure management and physical connectivity solutions, will enable India’s enterprises to improve data center agility, optimize capacity, reduce downtime, enforce best-practice policies and reduce operational costs.”
“This strategic alliance is a result of our shared vision of how smart technology can improve efficiency for IT infrastructure to improve productivity and create competitive advantage for Indian enterprises,” said Kamlesh Avasare, Director Sales with Yoga Automations Private Limited. “RiT’s set of wide range of solutions is enabling IoT to the data center.”
RiT’s converged infrastructure management enable users to centrally plan, map and automate communications and IT infrastructure planning to maximize utilization, reliability and security of the network, while minimizing unplanned downtime. These solutions include full visibility of network configurations, work flow management, asset utilization, environment and power IT consumption, and track the exact location of all IP-based equipment automatically. RiT’s high performance, end-to-end structured cabling solutions include high quality cables, outlets, connectors, patch panels and adapters suited for next-generation networks.
Yoga Automations Private Limited solutions include a cloud-based Internet of Things(IoT) platform for smart homes and smart building automation and as Access floors solution for data centers. Already installed at Indiabulls (www.indiabulls.com) and Edelwiess (www.edelweissfin.com), two of India’s leading financial services companies, Yoga boasts 10% market presence in India in Automation and 25% Access Floors.
About Yoga Automation Private Limited
YOGA Automation specializes in Automation of lighting, air conditioning, multimedia, security systems, and access controls via Mobile and Web applications using neural network technologies.
Yoga provides automation and security solutions to Residential and Commercial and brings world class technology and rich experience in this domain including strong access to Data Centers in the Indian market based on our Access Floors product.
About RiT Technologies
RiT Technologies (NASDAQ:RITT) is a leading provider of converged IT infrastructure management and connectivity solutions. RiT offers a platform that provides a unified way to manage converged systems and services to improve network utilization, streamline infrastructure operations, reduce network operation cost, optimize future investments and enhance data security.
RiT’s connectivity solutions includes IIM – Intelligent Infrastructure Management, high performance end-to-end structured cabling solutions.
RiT Technologies’ subsidiary RiT Wireless Ltd. produces a range of optical wireless solutions under the Beamcaster brand, which provide high speed, highly secure data communications across indoor open spaces.
Deployed around the world in data centers, large corporations, government agencies, financial institutions, telecommunications, airport authorities, healthcare organizations and educational facilities. RiT’s shares are traded on the NASDAQ Capital Market under the symbol RITT.
Safe Harbor Statement
In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate”, “forecast”, “target”, “could” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described under the heading “Risk Factors” in our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 20-F, which may be revised or supplemented in subsequent reports filed with the SEC. These factors include, but are not limited to, the following: our ability to raise additional financing, if required; the continued development of market trends in directions that benefit our sales; our ability to maintain and grow our revenues; our dependence upon independent distributors, representatives and strategic partners; our ability to develop new products and enhance our existing products; the availability of third-party components used in our products; the economic condition of our customers; the impact of government regulation; and the economic and political situation in Israel. Except as otherwise required by applicable law, we expressly disclaim any obligation to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.
CONTACT: Kobi Haggay
VP Products and Marketing
M: +972.54.4338382
kobi.haggay@rittech.com
www.rittech.com
Monica Maron
Spicetree Communications
Mobile: +972-54-5429529
monica.maron@spicetreecom.com
(OSIS) Receives Order for RTT Hold Baggage Screening Systems
OSI Systems, Inc. (NASDAQ:OSIS) today announced that HTDS, its French distributor for Rapiscan Systems, has received a multi-year framework contract to provide the RTT® 110 (Real Time Tomography) explosives detection system (EDS) to Charles de Gaulle and Orly international airports located near Paris, France. The company stated that it has received an initial order to deliver four units, and that it has not received any indication of additional orders under this framework agreement at this time.
The RTT employs a proprietary, solid-state approach to create high-resolution, 3-D imaging and its stationary gantry design enables baggage to be screened at higher speeds, allowing the RTT to be installed “in-line” within an airport’s existing baggage handling network without slowing that system down.
About OSI Systems, Inc.
OSI Systems, Inc. is a vertically integrated designer and manufacturer of specialized electronic systems and components for critical applications in the homeland security, healthcare, defense and aerospace industries. It combines more than 30 years of electronics engineering and manufacturing experience with offices and production facilities in more than a dozen countries to implement a strategy of expansion into selective end product markets. For more information on OSI Systems, Inc. or any of its subsidiary companies, visit www.osi-systems.com. News Filter: OSIS-G
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements relate to the Company’s current expectations, beliefs, projections and similar expressions concerning matters that are not historical facts and are not guarantees of future performance. Forward-looking statements involve uncertainties, risks, assumptions and contingencies, many of which are outside the Company’s control that may cause actual results to differ materially from those described in or implied by any forward-looking statements. All forward-looking statements are based on currently available information and speak only as of the date on which they are made. The Company assumes no obligation to update any forward-looking statement made in this press release that becomes untrue because of subsequent events, new information or otherwise, except to the extent it is required to do so in connection with its ongoing requirements under Federal securities laws. For a further discussion of these and other factors that could cause the Company’s future results to differ materially from any forward-looking statements, see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended June 30, 2015 and other risks described in documents filed by the Company from time to time with the Securities and Exchange Commission.
OSI Systems, Inc.
Ajay Vashishat
Vice President, Business Development
310-349-2237
avashishat@osi-systems.com
(VCYT) to Present at Piper Jaffray 27th Annual Healthcare Conference
SOUTH SAN FRANCISCO, Calif., Nov. 18, 2015 — Veracyte, Inc. (NASDAQ: VCYT) today announced that Bonnie H. Anderson, president and chief executive officer, will participate in a fireside chat discussion at the Piper Jaffray 27th Annual Healthcare Conference on Wednesday, December 2, 2015 at 11:00 a.m. ET in New York, NY.
The live audio webcast and subsequent replay may be accessed by visiting Veracyte’s website at http://investor.veracyte.com. The webcast will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 155 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.
(AVXL) Preparation of Regulatory Filings Based on Guidance From the FDA
NEW YORK, Nov. 18, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announces that it is moving forward with the development program for ANAVEX 2-73. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.
“Working with a highly vulnerable patient population, the Company is proceeding in a rational, step-wise process. Armed with the necessary data from the Phase 2a study to optimally design future trials, we look forward to expanding our development program,” said Kristina M. Capiak, Vice President Regulatory Affairs of Anavex.
“The utilization of Adaptive Design and Population Pharmacokinetics/Pharmacodynamics (PK/PD) modeling is a major strength of the Phase 2a study. By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The advantage of having Population PK/PD data is of value for the development of ANAVEX 2-73 in Alzheimer’s disease and also for other potential CNS indications.”
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Shareholder & Media Relations Toll-free: 1-866-505-2895 Outside North America: +1 (416) 489-0092 Email: ir@anavex.com www.anavex.com
(VNRX) Granted Its Second U.S. Patent
NAMUR, Belgium, Nov. 17, 2015 — VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood tests for a broad range of cancer types and other conditions, today announced the grant of U.S. Patent Number 9187780 entitled “Method for Detecting Nucleosome Adducts.”
The new U.S. patent, issued today and expiring in December 2032, relates to VolitionRx’s Nucleosomics® platform for the detection of changes in fragments of chromosomes, called nucleosomes. Scientists at VolitionRx have discovered that cancer-related proteins that form bonds with chromosomes in living cancer cells can also be detected and measured bound to nucleosomes circulating in the blood of cancer patients. The newly issued patent covers the methods for measuring these nucleosome-protein complexes, known as “adducts.”
Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, remarked, “This is a core technology patent for VolitionRx that we believe has an enormous potential application for non-invasive blood testing in cancer — including the measurement of Estrogen Receptor Adducts and Androgen Receptor Adducts, which should be pivotal for the detection breast and prostate cancer disease respectively. The award of this second U.S. patent for the detection of proteins bound to nucleosomes, follows the recent award of our first U.S. patent covering measurement of cancerous changes to the nucleosomes themselves. The new patent is a further milestone in VolitionRx’s progress to build up a world-wide portfolio of intellectual property to protect its Nucleosomics® technology. We continue towards our goal of bringing accurate and affordable detection of early-stage cancer in simple blood tests to market and helping as many patients as possible.”
Cameron Reynolds, Chief Executive Officer of VolitionRx, added, “With the grant of a second patent in the U.S., VolitionRx is making progress toward commercializing our proprietary Nucleosomics® platform. The company is developing a world-wide portfolio of broad-reaching, wholly-owned and royalty-free patents to help protect the company’s intellectual property estate and shareholder value. The VolitionRx-owned patent portfolio currently extends to eight patent families of issued and pending patents in market territories worldwide. Our scientific team is continuing to expand our patent portfolio and we expect further U.S. and other patent grants moving forward. I would also like to congratulate our Chief Scientific Officer, Dr. Micallef, who authored this patent, for his tireless work and vision during the past 6 years — work that is now coming to fruition.”
About VolitionRx
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream — an indication that cancer is present.
VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.
Visit VolitionRx’s website (www.volitionrx.com) or connect with us on Twitter, LinkedIn, Facebook or YouTube.
Media Contacts
Anita Heward, VolitionRx
a.heward@volitionrx.com
Telephone: +44 (0) 7756 034243
Kirsten Thomas, The Ruth Group
kthomas@theruthgroup.com
Telephone: +1 (646) 536-7014
Investor Contacts
Scott Powell, VolitionRx
S.Powell@volitionrx.com
Telephone: +1 (646) 650-1351
Lee Roth, The Ruth Group
lroth@theruthgroup.com
Telephone: +1 (646) 536-7012
Safe Harbor Statement
Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of the Company’s bodily-fluid-based diagnostic tests as well as the Company’s ability to develop and successfully commercialize such test platforms for early detection of cancer. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company’s development pipeline or any other diagnostic products the Company might develop; the Company will face fierce competition and the Company’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
(HDNG) Collaborates on Integrating 3D Printing Technology With Traditional Machining
Developing Hybrid Additive/Subtractive Manufacturing Technology in Partnership With RIT, Hybrid Manufacturing Technologies and IPG Photonics
ELMIRA, N.Y., Nov. 17, 2015 — Hardinge Inc. (NASDAQ:HDNG), a leading international provider of advanced metal-cutting solutions and accessories, announced today that Rochester Institute of Technology (RIT) recently acquired a Bridgeport GX 250 5-axis vertical machining center for use in a collaborative partnership to integrate additive manufacturing functions into the GX 250 traditional machining platform. In addition to RIT and Hardinge, partners on the project include Hybrid Manufacturing Technologies, based in Dallas, Texas, and IPG Photonics, of Oxford, Mass.
Mr. James Langa, Hardinge’s Senior Vice President of Machine Solutions, commented, “Manufacturers are constantly in search of new processes that are flexible, improve part quality and reduce overall cost. We believe that the combination of additive and subtractive technology coupled with precise five-axis machine tool capability has strong potential for real-world industrial applications. Adopting, adapting and advancing cutting edge technologies for the benefit of our customers is vital to our growth strategy.” Hardinge will be providing field service, design and applications engineering for the program.
Ronald Aman, project lead and assistant professor of Industrial and Systems Engineering in RIT’s Kate Gleason College of Engineering, noted, “Today there is no commercial software that can reliably generate the tool paths that are necessary to control both additive and subtractive processes in five-axis equipment. This presents a real challenge for mainstream adoption. We will be addressing this challenge by focusing on improving process planning and tool path generation, developing new materials, advancing overall process development and identifying new applications, as well as fundamental research aimed at radically changing the way we think of materials in a part.”
The GX 250 is a multi-axis machining center that produces precision parts through traditional manufacturing processes. A high precision process, the machine mechanically cuts away material from a block using exacting motion control of rotating tools. RIT researchers will incorporate additive manufacturing, or 3D printing, capabilities to the original machine to take advantage of the geometric freedom afforded by additive manufacturing while meeting aerospace tolerance requirements.
Integration of multiple processes, such as laser additive manufacturing and milling or turning, into a single platform is a new and rapidly growing field referred to as hybrid manufacturing. The hybrid manufacturing process has many advantages such as lower costs and improved accuracy, but also has unique capabilities such as dynamically changing a part’s material composition as it is being built.
As part of the integration process, the researchers will be incorporating multiple powder feeders to blow metal or ceramic powder into the melt-pool, a type of 3D-printing function known as directed energy deposition. Multiple powder feeders will allow the use of more than one material for a product, including a combination of metals and ceramics or two or more metals.
“Imagine the power of smoothly transitioning materials, such as from copper to tool steel, or even ceramics in the future. This eliminates the abrupt material composition change that is nearly always the failure point for materials that have vastly different mechanical or thermal characteristics,” said Professor Aman, who has expertise in the development of direct-metal additive manufacturing processes. He also has background in researching and developing the hybrid additive and subtractive metal manufacturing processes of single and multi-materials systems. “There are not, to my knowledge, any other processes that will have the capabilities of this system,” he added.
Professor Aman and Mr. Langa jointly concluded, “The partnership between RIT and Hardinge is a critical step to advance the hybrid ideas out of the laboratory and make it possible for companies to apply this new technology in production processes.”
The Bridgeport GX 250, which was installed in the Brinkman Machine Tools and Manufacturing Lab located in RIT’s Kate Gleason College of Engineering, will be part of the lab’s extensive series of high-precision machining tools and equipment. It will also be used to support research in the AMPrint Center for Advanced Technology, a new university-corporate partnership focusing on expanding additive manufacturing and multi-functional printing capabilities, considered key economic drivers in New York State.
About Hardinge
Hardinge is a leading global designer and manufacturer of high precision, computer-controlled machine tool solutions developed for critical, hard-to-machine metal parts and of technologically advanced workholding accessories. The Company’s strategy is to leverage its global brand strength to further penetrate global market opportunities where customers will benefit from the technologically advanced, high quality, reliable products Hardinge produces. With approximately two thirds of its sales outside of North America, Hardinge serves the worldwide metal working market. Hardinge’s machine tool and accessory solutions can also be found in a broad base of industries to include aerospace, agricultural, automotive, construction, consumer products, defense, energy, medical, technology and transportation.
Hardinge applies its engineering design and manufacturing expertise in high performance machining centers, high-end cylindrical and jig grinding machines, SUPER-PRECISION® and precision CNC lathes and technologically advanced workholding accessories. Hardinge has manufacturing operations in China, France, Germany, India, Switzerland, Taiwan, the United Kingdom and the United States.
The Company regularly posts information on its website: http://www.hardinge.com.
Safe Harbor Statement
This news release contains forward-looking statements (within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). Such statements are based on management’s current expectations that involve risks and uncertainties. Any statements that are not statements of historical fact or that are about future events may be deemed to be forward-looking statements. For example, words such as “may,” “will,” “should,” “estimates,” “predicts,” “potential,” “continue,” “strategy,” “believes,” “anticipates,” “plans,” “expects,” “intends,” and similar expressions are intended to identify forward-looking statements. The Company’s actual results or outcomes and the timing of certain events may differ significantly from those discussed in any forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CONTACT: For more information, contact:
Company:
Douglas J. Malone
Chief Financial Officer
Phone: (607) 378-4140
Product:
James Langa
Sr. VP, Metal-cutting Machine Solutions &
President, Milling & Turning
Phone: (607) 378-4247
Investor Relations:
Deborah K. Pawlowski, Kei Advisors LLC
Phone: (716) 843-3908
Email: dpawlowski@keiadvisors.com
Rochester Institute of Technology:
Michelle Cometa
Senior Staff Writer
University News Services
Phone: (585) 475-4954
Email: macuns@rit.edu
(WLFC) Modified Dutch Tender Offer to Repurchase $8M in Common Shares
NOVATO, Calif., Nov. 17, 2015 — Willis Lease Finance Corporation (the “Company”) (NASDAQ:WLFC), today announced that it has commenced a modified “Dutch auction” tender offer repurchase for cash up to 516,129 of shares of its common stock at a price not less than $15.50 per share nor greater than $18.00 per share, for an aggregate purchase price not to exceed $8 million (the “Tender Offer”). The Tender Offer is subject to the conditions set forth in the offer to purchase, dated November 17, 2015 (the “Offer to Purchase”), and in the related Letter of Transmittal (which together, may be amended or supplemented from time to time). The Tender Offer, as approved by the Company’s Board of Directors, will expire at 5:00 p.m., New York City time, on December 16, 2015.
Pursuant to the conditions set forth in the Offer to Purchase and in the related Letter of Transmittal, the Company’s stockholders may tender all or a portion of their shares (1) at a price specified by the tendering stockholder of not less than $15.50 per share nor greater than $18.00 per share or (2) without specifying a purchase price, in which case their shares will be purchased at the purchase price determined in accordance with terms of the Tender Offer. When the Tender Offer expires, the Company will determine the lowest price within the range of prices specified above (the “Purchase Price”) that will enable the Company to purchase up to 516,129 shares of its common stock, for an aggregate purchase price not to exceed $8 million. Up to 516,129 shares validly tendered at prices at or below the Purchase Price, and not validly withdrawn, will be eligible for purchase in the Tender Offer. Shares validly tendered will not be purchased if the price specified by the stockholder is greater than the Purchase Price. Stockholders that validly tender their shares will receive the net cash amount of the Purchase Price, subject to applicable withholding tax and without interest, for shares tendered at prices equal to or less than the purchase price, subject to the conditions of the Tender Offer, including the provisions relating to proration, “odd lot” priority and conditional tenders. The Company also reserves the right to purchase up to an additional 2% of its outstanding common shares without extending the Tender Offer.
The Tender Offer will not be conditioned upon any minimum number of shares being tendered; however, the Tender Offer will be subject to a number of other terms and conditions specified in the Offer to Purchase filed with the Securities and Exchange Commission (“SEC”). Stockholders must validly tender their shares prior to the expiration of the Tender Offer, but may withdraw such tender at any time prior to the expiration. In connection with the Tender Offer, Merrill Lynch, Pierce, Fenner & Smith Incorporated is acting as dealer manager, D.F. King & Co., Inc. is serving as information agent and American Stock Transfer & Trust Company, LLC is acting as the depositary.
The Company’s Board of Directors has authorized the Tender Offer. However, none of the Company, the Company’s Board of Directors, the dealer manager, the information agent or the depositary makes any recommendation to stockholders as to whether to tender or refrain from tendering their shares or as to the price or prices at which stockholders may choose to tender their shares. No person is authorized to make any such recommendation. Stockholders must make their own decision as to whether to tender their shares and, if so, how many shares to tender and the price or prices at which their shares should be tendered. In doing so, stockholders should read carefully the information in, or incorporated by reference in, the Offer to Purchase and in the Letter of Transmittal (as they may be amended or supplemented), including the purposes and effects of the Tender Offer. Stockholders are urged to discuss their decisions with their own tax advisors, financial advisors and/or brokers.
News Release for Informational Purposes Only
This news release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any shares of the Company’s common stock. The Tender Offer is being made solely by the Offer to Purchase and the related Letter of Transmittal, which together, may be amended or supplemented from time to time. Stockholders and investors are urged to read the Company’s Tender Offer statement on Schedule TO filed today with the SEC in connection with the Tender Offer, which will include as exhibits the Offer to Purchase, the related Letter of Transmittal and other Tender Offer materials, as well as any amendments or supplements to the Schedule TO when they become available, because they each contain important information. Each of these documents will be filed with the SEC, and investors may obtain them for free from the SEC at its website (www.sec.gov) or from D.F. King & Co., Inc., the information agent for the Tender Offer, by telephone at: (866) 796-7181 (toll-free), or in writing to: infoagent@dfking.com.
About Willis Lease Finance Corporation
Willis Lease Finance Corporation leases large and regional spare commercial aircraft engines, auxiliary power units and aircraft to airlines, aircraft engine manufacturers and maintenance, repair and overhaul providers in 120 countries. These leasing activities are integrated with engine and aircraft trading, engine lease pools supported by cutting edge technology, as well as various end-of-life solutions for aircraft, engines and aviation materials provided through its subsidiary, Willis Aeronautical Services, Inc.
Forward Looking Statements
This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These statements include, but are not limited to, the terms and expiration date of the modified “Dutch auction” Tender Offer. Do not unduly rely on forward-looking statements, which give only expectations about the future and are not guarantees. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them. Our actual results may differ materially from the results discussed in forward-looking statements. Factors that might cause such a difference include, but are not limited to: the effects on the airline industry and the global economy of events such as terrorist activity, changes in oil prices and other disruptions to the world markets; trends in the airline industry and our ability to capitalize on those trends, including growth rates of markets and other economic factors; risks associated with owning and leasing jet engines and aircraft; our ability to successfully negotiate equipment purchases, sales and leases, to collect outstanding amounts due and to control costs and expenses; changes in interest rates and availability of capital, both to us and our customers; our ability to continue to meet the changing customer demands; regulatory changes affecting airline operations, aircraft maintenance, accounting standards and taxes; the market value of engines and other assets in our portfolio; and risks detailed in the Company’s Annual Report on Form 10-K and other continuing reports filed with the SEC.
CONTACT: Charles F. Willis
Chairman & CEO
(415) 408-4700
(OPCO) Named ‘Company of the Month’ in November Issue of The Bowser Report
FAIRPORT HARBOR, OH–(November 17, 2015) – OurPet’s Company (OTCQX: OPCO) was featured in the November issue of The Bowser Report as the Company of the Month. Regular readers of the report are likely already familiar with OPCO, as the company has been recommended multiple times in the publication dating all the way back to May 2007. Recently, the company has caught the attention of researchers by reporting consistent and sustainable growth, and that performance has Bowser recommending OPCO as an addition to portfolios for the third time in less than a decade.
“OurPet’s, now a three-time recommendation, is the model for steady sales growth,” the report stated. “At current values, OPCO is fairly valued from a price-to-earnings perspective, but with the company’s steady growth potential, it could be a long-term winner.”
Taking a look at the markets in which OPCO operates, this growth potential is further illustrated. In 2013, the pet products and services market was valued at $71.3 billion, and additional industry growth is expected in the coming years. OPCO is capitalizing on these market conditions with a two-pronged branding strategy — including OurPets® for the pet specialty channel and PetZone® for the food, drug and mass retail channels. Through these brands, the company has secured roughly 250 distribution customers, including nationwide retailers such as Walmart, PetSmart, Petco and Kroger.
In the past four years, OPCO has leveraged its defined branding strategy and extensive intellectual property portfolio to record a 20.8 percent increase in sales. Likewise, the company’s earnings have grown from $120,674 to $1.1 million since 2011. In recent months, OPCO has attempted to build on this performance by increasing the overall visibility of its stock. The company recently joined the OTCQX, the highest tier of the OTC Markets platform, in an effort to continue pushing toward new 52-week highs.
The Bowser Report has been covering the most intriguing mini-priced stocks for just under 40 years. Utilizing a proprietary rating system and investing game plan, the report highlights the most promising stocks for long-term investment. Since 1976, The Bowser Report‘s effectiveness has attracted tens of thousands of investors to the subscription-only newsletter.
For more information, visit www.ourpets.com
Contact:
Peter Ostapowicz
postapowicz@ourpets.com
(ETAK) Slots Robert H. Turner at Exec. Chairman, ETNA President Tim Payne at Interim CEO
– Robert H. Turner, Former Executive at AT&T and BellSouth Communications, Inc., Brings 40-Years of Global Telecom and Communications Technology Leadership to Company to Drive Growth and Expansion –
NEW YORK CITY, Nov. 17, 2015 — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that the Company has appointed Robert H. Turner (“Hal Turner”) as Executive Chairman and Tim Payne, the current President of Elephant Talk North America (“ETNA”), as interim CEO. Together, both appointees will be responsible for managing and growing Elephant Talk’s global operations. Mr. Steven van der Velden has stepped down as Chairman, CEO and a director of the Company.
Mr. Turner brings over 40 years of international C-level global telecom and communications technology experience to Elephant Talk gained through a career leading and servicing major Tier 1, 2, and 3, incumbent and competitive (MVNO/CLEC/ISP/Cable) wireless and wired operators. Mr. Turner’s expertise includes decades of P&L leadership, M&A, joint ventures, strategic alliances and global partnerships gained through a career including Senior Sales and Marketing roles at AT&T, President and Chief Operating Officer of BellSouth Communications, Inc. (now AT&T) and serving as Chairman, CEO and President of several international voice and data services/networking companies including PTT Telecom Netherlands US, Inc. (now KPN), TeleZone, Inc. (Toronto, Canada) and Davnet Limited (Sydney, Australia).
“On behalf of the Board and the entire management team at Elephant Talk, we are excited to welcome Hal Turner to the Company. We believe he has the ideal mix of business strategy, global management and technology expertise that is needed to advance our industry-leading solutions and add to our growing global customer base that includes Tier 1 customers in the US, Brazil, Europe and the Middle East,” said Mr. Carl Stevens, Member of the Board. “Supported by a dedicated and focused team along with technology that is delivering the highest performance and most reliable services in the industry, Hal will play a vital role in further scaling-up the organization while managing its growth and cost structure ensuring we deliver value for our shareholders.”
“This is an exciting time to be joining a company like Elephant Talk which has created and delivered remarkable technology solutions to MNOs and MVNOs. Elephant Talk’s products are at the leading edge of performance and reliability, leveraging technologies such as SDN, NFV and the cloud to overcome the critical cost and competitive issues now facing mobile operators around the globe,” said Robert H. Turner, newly appointed Executive Chairman of the Board of Elephant Talk Communications Corp. “Thanks to the work done by the Board and the senior team at Elephant Talk, the Company is now well positioned to deliver on the promise of its proprietary technology and it is my goal to ensure that the business capitalizes on this opportunity to supply its best-in-class products and customer support, and do so efficiently and profitably.”
“We would also like to thank Steven van der Velden for his many years of hard work and dedication to Elephant Talk. We look forward to Steven remaining a very large shareholder of the Company and wish him much success in all his future endeavors,” continued Mr. Carl Stevens, on behalf of the Board of Directors.
Recently, Mr. Turner served as Chairman of Pandora Networks, Inc. (now named Panterra Networks), CEO at Pac West Telecomm, Inc. and for the past 28 years, founder at Turner Telecom Holdings Group, LLC, an executive management and board services consultancy and advisory firm focused on serving leading-edge telecom, software and technology companies from start-ups to turnaround, worldwide. Mr. Turner is a featured contributor to key publications in the wireless, networking and technology industries and is also a guest lecturer at The Darla Moore School of Business at The University of South Carolina.
Mr. Payne has been President of Elephant Talk North America since April 2014. Tim has over 20 years of domestic US telecom experience driving sales and distribution programs at top telecommunication companies including serving as Senior National Sales Leader at Verizon Telematics, National Sales Manager at Networkfleet, General Manager at Clearwire and District Manager at Sprint Nextel.
About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.
About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.
Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Elephant Talk’s plans and objectives, projections, expectations and intentions (including, without limitation, Elephant Talk’s plans regard its ValidSoft subsidiary). These forward-looking statements are based on current expectations, estimates and projections about Elephant Talk’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Elephant Talk may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Elephant Talk also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Elephant Talk’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Elephant Talk.
Contacts:
Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com
Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net
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