Uncategorized
$LPCN Wins #Dismissal of #Patent #Infringement Lawsuit Related to #LPCN1021
SALT LAKE CITY, Oct. 07, 2016 — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that U.S. District Court in Delaware granted our motion to dismiss a lawsuit filed by Clarus Therapeutics, Inc. (“Clarus”). Clarus claimed that LPCN 1021 infringed Clarus’ patent (U.S. Patent No. 8,828,428). LPCN 1021 is Lipocine’s oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
“We are pleased that the court has dismissed this lawsuit. Going forward, we will continue to aggressively defend our intellectual property,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “We believe that LPCN 1021 has the potential to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners that exist with topical gels.”
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily oral testosterone replacement therapy product candidate, was well tolerated and met primary efficacy end point in Phase 3 testing which utilized 24-hour pharmacokinetic data for dose adjustments. LPCN 1111, a novel prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing. LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA was recently completed. For more information, please visit www.lipocine.com.
Forward-Looking Statements
This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to our intention to defend our intellectual property, the potential uses and benefits of LPCN 1021 and the potential uses and benefits of our other product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, our available resources, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
CONTACT: Morgan Brown Executive Vice President & Chief Financial Officer Phone: (801) 994-7383 mb@lipocine.com Investors: John Woolford Phone: (443) 213-0500 john.woolford@westwicke.com
$CPST & $SKYS $50 Million Strategic #Financing Agreement
CHATSWORTH, Calif. and HONG KONG, Oct. 06, 2016 — Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST), the world’s leading clean technology manufacturer of microturbine energy systems, announced today that it has entered into a strategic financing relationship agreement with Sky Solar Holdings, Ltd. (”Sky Solar”) (www.skysolargroup.com) (Nasdaq:SKYS) and Sky Capital America, Inc., a Sky Solar subsidiary (together, “Sky Group”) to provide funding to Capstone Turbine’s Capstone Energy Finance (“CEF”) joint venture.
Pursuant to the strategic financing agreement, Capstone and CEF granted a right of first refusal (“ROFR”) to Sky Group to provide funding of up to $50 million, which may be extended by an additional $100 million (the “Project Fund”) at Sky Group’s sole discretion for various CEF projects on a global basis after Capstone and CEF have exhausted their internal funding sources of up to $25 million. The ROFR also includes an option for Sky Group to jointly fund power purchase agreement (“PPA”) backed opportunities with Capstone, CEF, end use customers, and/or any authorized Capstone distributors under certain mutually agreeable conditions. The agreement will expire at the earlier of the end of three years following the effective date or upon the exhaustion of Sky Group’s Project Fund.
“Capstone’s new finance subsidiary has developed a twenty million dollar pipeline of well-qualified projects since its launch last December, and we expect to quickly surpass our ability to fund projects with our internal resources,” said Darren Jamison, Capstone’s President and Chief Executive Officer. “We have looked at several potential partners and, after months of due diligence and discussions with several companies, we have selected Sky Solar because we believe they have the right skill set, ability, experience and global reach to help us successfully grow our Capstone Energy Finance business over the next three years,” added Mr. Jamison.
“As we have highlighted in the past, we remain focused on expanding our power market portfolio by selectively pursuing non-solar renewable asset classes that can generate returns higher than typical solar projects, and we expect this new strategic partnership with Capstone will provide an attractive avenue for additional growth,” said Sanjay Shrestha, Sky Solar Chief Investment Officer and President of Sky Capital America.
About Sky Solar
Sky Solar is a global independent power producer (“IPP”) that develops, owns and operates solar parks around the world with broad geographic reach and an established presence across several key solar markets. Sky Solar has developed and completed more than 250 MW of solar parks in various countries and has over 150 MW of IPP assets in operation globally.
This press release contains forward-looking statements. These statements constitute “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, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to the following: the reduction, modification or elimination of government subsidies and economic incentives; global and local risks related to economic, regulatory, social and political uncertainties; resources Sky Solar may need to familiarize itself with the regulatory regimes, business practices, governmental requirements and industry conditions as Sky Solar enter into new markets; Sky Solar’s ability to successfully implement its on-going strategic review to unlock shareholder value; global liquidity and the availability of additional funding options; the delay between making significant upfront investments in Sky Solar’s solar parks and receiving revenue; potential expansion of Sky Solar’s business into China; risk associated with the Sky Solar’s limited operating history, especially with large-scale IPP solar parks; risk associated with development or acquisition of additional attractive IPP solar parks to grow Sky Solar’s project portfolio; and competition. Further information regarding these and other risks is included in Sky Solar’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, Sky Solar does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
About Capstone Turbine Corporation
Capstone Turbine Corporation (www.capstoneturbine.com) (Nasdaq:CPST) is the world’s leading producer of low-emission microturbine systems and was the first to market commercially viable microturbine energy products. Capstone has shipped approximately 8,800 Capstone Microturbine systems to customers worldwide. These award-winning systems have logged millions of documented runtime operating hours. Capstone is a member of the U.S. Environmental Protection Agency’s Combined Heat and Power Partnership, which is committed to improving the efficiency of the nation’s energy infrastructure and reducing emissions of pollutants and greenhouse gases. A UL-Certified ISO 9001:2008 and ISO 14001:2004 certified company, Capstone is headquartered in the Los Angeles area with sales and/or service centers in the United States, Latin America, Europe, Middle East, China and Singapore.
This press release contains “forward-looking statements,” as that term is used in the federal securities laws, about the growth of our Capstone Energy Finance business and the success of our relationship with Sky Solar. Forward-looking statements may be identified by words such as “expects,” “objective,” “intend,” “targeted,” “plan” and similar phrases. These forward-looking statements are subject to numerous assumptions, risks and uncertainties described in Capstone’s filings with the Securities and Exchange Commission that may cause Capstone’s actual results to be materially different from any future results expressed or implied in such statements. Capstone cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Capstone undertakes no obligation, and specifically disclaims any obligation, to release any revisions to any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
“Capstone” and “Capstone Microturbine” are registered trademarks of Capstone Turbine Corporation. All other trademarks mentioned are the property of their respective owners.
For Capstone Turbine Corporation: Investor and investment media inquiries: 818-407-3628 ir@capstoneturbine.com INVESTORS: Dian Griesel Int’l Cheryl Schneider 212-825-3210 For SKYS: Investor Relations ICR, LLC Vera Tang 646-277-1215 ir@skysolarholding.com
$MESO Phase 2 Results #Mesoblast #CellTherapy in #Diabetic #KidneyDisease
NEW YORK and MELBOURNE, Australia, Oct. 06, 2016 — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that results from the randomized, placebo-controlled Phase 2 trial of its proprietary allogeneic Mesenchymal Precursor Cell (MPC) product candidate, MPC-300-IV, in patients with diabetic kidney disease have been published in the current issue of the peer-reviewed journal EBioMedicine.
The paper, entitled ‘Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo Controlled, Dose Escalation Study’, concluded that a single intravenous infusion of MPC-300-IV was well tolerated and had positive effects on renal function at the 12-week primary endpoint in a Phase 2 trial in adult patients with type 2 diabetic nephropathy. The study was conducted by researchers at the University of Melbourne, Epworth Medical Centre and Monash Medical Centre in Australia.
The Phase 2, double-blind, randomized, placebo-controlled, dose-escalating trial evaluated MPC-300-IV in patients with type 2 diabetes and moderate to severe renal impairment, stage 3b-4 chronic kidney disease (CKD), who were already on a stable regimen of the standard of care therapy for diabetic nephropathy (renin-angiotensin system inhibition with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers). A total of 30 patients were randomized to receive a single infusion of 150 million MPCs, 300 million MPCs, or saline control on top of maximal therapy.
The objectives of the trial were to evaluate safety and to explore potential efficacy signals of MPC-300-IV treatment on renal function. The primary efficacy endpoint of decline or change in glomerular filtration rate (GFR) was in line with the 2012 joint workshop held by the United States Food and Drug Administration and the National Kidney Foundation, which recommended that time to 30%-40% decline in GFR is an acceptable primary endpoint for evaluating potential benefits of new therapies for this patient population.
Key trial results were:
- Safety profile for MPC-300-IV treatment was similar to placebo, with no treatment-related adverse events.
- Efficacy testing showed that patients receiving a single MPC infusion at either dose had improved renal function relative to placebo, as defined by preservation or improvement in GFR at 12 weeks.
- The rate of decline in estimated GFR at 12 weeks was significantly reduced in the group receiving a single dose of 150 million MPCs relative to the placebo group (p=0.05).
- There was a trend toward more pronounced treatment effects relative to placebo in the pre-specified subgroup of patients with GFR>30 ml/min/1.73m2 at baseline (p=0.07).
Dr David Packham, Associate Professor in the Department of Medicine at the University of Melbourne, Director of the Melbourne Renal Research Group, and lead author on the publication said: “The efficacy signal observed with respect to preservation or improvement in GFR is exciting, especially given that this trial was not powered to show statistical significance. Patients receiving a single infusion of MPC-300-IV showed no evidence of developing an immune response to the administered cells, suggesting that repeat administration is feasible and may in the longer term be able to halt or even reverse progressive chronic kidney disease. I hope that this very promising investigational therapy will be advanced to rigorous Phase 3 clinical trials to test this hypothesis as soon as possible.”
About Diabetic Nephropathy
Diabetic nephropathy is the single leading cause of end-stage kidney disease, accounting for nearly half of all end-stage kidney disease cases in the United States and over 40% of new patients entering dialysis treatment. There were almost 2 million cases of moderate to severe diabetic nephropathy in 2013.
Diabetic nephropathy occurs even when glucose levels are well controlled, and is thought to be due to chronic infiltration of the kidneys by inflammatory monocytes which secrete pro-inflammatory cytokines resulting in endothelial dysfunction and fibrosis.
Staging of CKD is based on absolute levels of GFR, and GFR decline is on the path of progression to kidney failure (stage 5, GFR<15ml/min/1.73m2). The current standard of care (renin-angiotensin system inhibition with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) only slows the rate of progression to kidney failure by 16-25%, leaving a large residual risk for end-stage kidney disease. For patients with end-stage kidney disease, the only treatment option is renal replacement (dialysis or kidney transplantation), which incurs high medical costs and substantial disruptions to a normal lifestyle. Due to a severe shortage of kidneys, in 2012 approximately 92,000 persons in the United States died while on the transplant list. For those on dialysis, the mortality rate is high with an approximately 40% fatality rate within two years.
About Mesoblast’s Product Candidate MPC-300-IV and Potential Mechanisms of Action
Mesoblast is developing MPC-300-IV for the treatment of specific conditions caused by excessive inflammation and endothelial dysfunction, including biologic-refractory rheumatoid arthritis and diabetic nephropathy.
MPCs produce immunomodulatory biomolecules such as prostaglandin E2 (PGE2) and indoleamine2, 3-dioxygenase (IDO), in response to activation by pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-alpha), interleukin-1, -6, or -17 (IL-1, IL-6 or IL-17). This results in modulation of multiple immune pathways, including polarizing pro-inflammatory M1 monocytes to anti-inflammatory M2 monocytes, and switching activated Th1 and Th17 T cells to anti-inflammatory Th2 cells and FOXP3 T regulatory cells.
About Mesoblast
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular diseases, immune-mediated and inflammatory disorders, orthopedic disorders, and oncologic/hematologic conditions.
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
For further information, please contact: Schond Greenway Investor Relations, Mesoblast T: +1 212 880 2060 E: schond.greenway@mesoblast.com Julie Meldrum Corporate Communications, Mesoblast T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com
$ICUI to #Acquire #HospiraInfusionSystems Business $PFE
The addition of Hospira’s IV pumps, solutions, and devices business to ICU Medical’s existing portfolio will create a leading pure-play infusion therapy company
- Creates an integrated pure-play infusion therapy company with focus and scale
- Combined business to compete in the US market with a unified organization and a complementary portfolio
- Extends global reach for the combined company with direct operations in over 20 countries
- Value-creating and risk mitigated deal structure
- ICU Medical Inc. management conference call today at 8:30 am EDT, details below
SAN CLEMENTE, Calif. and NEW YORK, Oct. 06, 2016 — ICU Medical Inc. (NASDAQ:ICUI) and Pfizer Inc. (NYSE:PFE) today announced that they have entered into a definitive agreement under which ICU Medical will acquire all of Pfizer’s global infusion therapy business, Hospira Infusion Systems (HIS), for $1 billion in cash and stock. The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with ICU Medical’s existing businesses, will create a leading pure-play infusion therapy company, with estimated pro forma combined revenues of approximately $1.45 billion based on trailing twelve month results as of June 2016.
Under the terms of the agreement, Pfizer will receive approximately $400 million in newly issued shares of ICU Medical common stock and $600 million in cash from ICU Medical subject to customary adjustment for net working capital. Upon completion of the transaction, which the companies expect to occur in the first quarter of 2017 subject to customary closing conditions including required regulatory approvals, Pfizer will own approximately 16.6 percent of ICU Medical. In addition, so long as Pfizer continues to hold 10% or more of ICU Medical’s common equity, it will have the right to nominate one director to the company’s board of directors in ICU Medical’s proxy materials, and Pfizer has agreed to certain restrictions on transfer of its shares for at least 18 months.
John Young, Group President of Pfizer Essential Health commented, “We are pleased that Hospira Infusion Systems is combining with ICU Medical, and we believe the combined company will be well positioned in the marketplace to deliver value to customers through its strong product portfolio and the expertise of colleagues from both companies. I’m proud of the Hospira Infusion Systems team and their positive impact on patients around the world.”
The acquisition complements ICU Medical’s existing business by creating a company that has a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets, and gives the company a significantly enhanced global footprint and a platform for continued competitiveness and growth. With an integrated product offering, ICU Medical will hold industry-leading positions in key segments and have access to the full US infusion marketplace with a compelling product portfolio.
“The combination of these two businesses is the natural evolution of a productive relationship that began more than 20 years ago when Hospira began integrating ICU Medical’s needlefree technology into their infusion offering globally,” explained Vivek Jain, ICU Medical’s Chief Executive Officer. “By acquiring the Hospira Infusion Systems business, currently our largest single customer, we create a pure-play infusion business with the focus and scale to compete globally, eliminate our single customer concentration issue, and have a significant value creation opportunity as a much larger company. We look forward to serving more customers as we continue to bring clinical and economic value to the marketplace.”
ICU Medical’s financial advisors for the transaction were Barclays and Wells Fargo Securities, LLC, and Latham & Watkins acted as its legal advisor. Goldman, Sachs & Co. and Guggenheim Securities served as Pfizer’s financial advisors for the transaction, while Skadden, Arps, Slate, Meagher & Flom LLP and Ropes & Gray LLP served as its legal advisors.
ICU Medical Q3 Preliminary Results and Fiscal Year 2016 Guidance Update
For the third quarter of 2016, ICU Medical expects to report quarterly revenue of approximately $96 million and adjusted EBITDA of approximately $33.5 million, and $1.20 adjusted earnings per share. For the year, ICU Medical expects to report results slightly above the high-end of its previously announced guidance of $370 million revenue, $131 million adjusted EBITDA, and $4.60 adjusted diluted earnings per share. See reconciliation of GAAP to non-GAAP financial measures (unaudited) below.
ICU Medical Conference Call and Investor Meetings
ICU Medical, Inc. invites you to review the presentation here.
ICU Medical will host a conference call to discuss the Hospira Infusion Systems acquisition this morning, October 6, 2016 at 8:30 a.m. EDT (5:30 am PDT). The call can be accessed at (800) 936-9761, international (408) 774-4587, conference ID 94524232. The conference call will be simultaneously available by webcast, which can be accessed by going to ICU Medical’s website at www.icumed.com, clicking on the Investors tab, clicking on the Webcast icon and following the prompts. The webcast will also be available by replay.
Members of the ICU Management team will be holding an open investor group meeting in Boston, today October 6 at 12:00 pm at the Boston Hilton, 89 Broad Street, Boston, MA in the Kilby Room and available for one-on-one meetings in Boston on October 6th and New York on October 7th. Please email John Mills at John.Mills@icrinc.com to schedule a meeting or confirm participation in the group meeting.
ICU Medical Cautionary Statements Regarding Forward-Looking Information
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and may often be identified by the use of words such as ”will”, “may”, ”could”, “should”, ‘‘would,’’ “project”, ”believe”, “anticipate”, ”expect”, “plan”, “estimate”, “forecast”, “potential”, “intend”, ”continue”, “target”, ”build”, ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding ICU Medical expectations, goals or intentions regarding the future, including, but not limited to, its full year 2016 guidance, the transaction, the expected timetable for completing the transaction, benefits and synergies of the combined business or the transaction, future opportunities for ICU Medical and products and any other statements regarding ICU Medical and the combined business’s future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition, and other expectations and targets for future periods.
These forward-looking statements are based on Management’s current expectations, estimates, forecasts and projections about ICU Medical and assumptions Management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for ICU Medical ‘s products; decreased free cash flow; the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all; changes in product mix; increased competition from competitors; lack of continued growth or improving efficiencies; unexpected changes in ICU Medical’s arrangements with its largest customers; the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the transaction; changes in relevant tax and other laws; the parties’ ability to consummate the transaction; the conditions to the completion of the transaction; the regulatory approvals required for the transaction not being obtained on the terms expected or on the anticipated schedule; inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with GAAP and related standards or on an adjusted basis; the integration of the acquired business by ICU Medical being more difficult, time-consuming or costly than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the transaction; the retention of certain key employees of the business being difficult; ICU Medical’s and the business’s expected or targeted future financial and operating performance and results; the scope, timing and outcome of any ongoing legal proceedings and the impact of any such proceedings on ICU Medical’s and the business’s consolidated financial condition, results of operations or cash flows; ICU Medical’s and the business’s ability to protect their intellectual property and preserve their intellectual property rights; the effect of any changes in customer and supplier relationships and customer purchasing patterns; the ability to attract and retain key personnel; changes in third-party relationships; the impacts of competition; changes in economic and financial conditions of ICU Medical’s business or the business; uncertainties and matters beyond the control of management; and the possibility that ICU Medical may be unable to achieve expected synergies and operating efficiencies in connection with the Transaction within the expected time-frames or at all and to successfully integrate the business.
For more detailed information on the risks and uncertainties, associated with ICU Medical’s business activities, see the risks described in ICU Medical’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission (the “SEC”). You can access ICU Medical’s Form 10-K through the SEC website at www.sec.gov, and ICU Medical strongly encourages you to do so. ICU Medical undertakes no obligation to update any statements herein for revisions or changes after the date of this communication.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of October 6, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information related to, among other things, an agreement by Pfizer to sell its Hospira Infusion Systems business to ICU Medical, including the potential benefits of the transaction and the anticipated timing of the completion of the transaction, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to satisfaction of the conditions to closing the transaction (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including the possibility that the transaction does not close; risks related to the ability to realize the anticipated benefits of the transaction; potential decreases in the market value of the stock component of the consideration package; potential dilution to Pfizer’s ownership position; other business effects, including the effects of industry, market, economic, political or regulatory conditions; and risks related to the ICU Medical common stock that Pfizer will receive in the transaction.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About ICU Medical, Inc.: ICU Medical, Inc. develops, manufactures and sells innovative medical devices used in vascular therapy, oncology and critical care applications. ICU Medical’s products improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers from exposure to infectious diseases or hazardous drugs. The company’s complete product line includes custom IV systems, closed delivery systems for hazardous drugs, needlefree IV connectors, catheters and cardiac monitoring systems. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com.
About Pfizer: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at http://www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Use of Non-GAAP Financial Information
This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies. Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods. We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation. The non-GAAP financial measures included in this press release are adjusted EBITDA and adjusted diluted earnings per share (“Adjusted Diluted EPS”).
Adjusted EBITDA excludes the following items:
Intangible asset amortization expense: We do not acquire businesses or capitalize certain patent costs on a predictable cycle. The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition. Capitalized patent costs can vary significantly based on our current level of development activities. We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods.
Depreciation expense: We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation expense among companies.
Stock compensation expense: Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years. The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control. The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period. Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved. Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance.
Restructuring and strategic transaction: We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business. Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods.
Adjusted Diluted EPS excludes, net of tax, intangible asset amortization expense, stock compensation expense, restructuring and strategic transaction, legal settlement and bargain purchase gain, which was tax free. We apply our GAAP consolidated effective tax rate to our non-GAAP financial measures, other than when the underlying item has a materially different tax treatment.
From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management.
The following tables reconcile our expected GAAP and non-GAAP financial measures:
| ICU MEDICAL, INC. AND SUBSIDIARIES | |||||
| Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) | |||||
| (In thousands, except per share data) | |||||
| “Expected” | |||||
| Adjusted EBITDA | |||||
| Three months ended September 30, 2016 |
|||||
| GAAP net income | $ | 17,501 | |||
| Non-GAAP adjustments: | |||||
| Stock compensation expense | 3,824 | ||||
| Depreciation and amortization expense | 4,863 | ||||
| Restructuring and strategic transaction expense | 520 | ||||
| Provision for income taxes | 6,793 | ||||
| Total non-GAAP adjustments | 16,000 | ||||
| Adjusted EBITDA | $ | 33,500 | |||
| Adjusted diluted earnings per share |
|||||
| Three months ended September 30, 2016 |
|||||
| GAAP diluted earnings per share | $ | 1.01 | |||
| Non-GAAP adjustments: | |||||
| Stock compensation expense | $ | 0.22 | |||
| Amortization expense | $ | 0.04 | |||
| Restructuring and strategic transaction expense | $ | 0.03 | |||
| Estimated income tax impact from adjustments | $ | (0.11 | ) | ||
| Adjusted diluted earnings per share | $ | 1.20 | |||
ICU Medical Investor Contacts: Scott Lamb, ICU Medical, Inc. 949-366-2183 slamb@icumed.com John Mills, ICR, Inc 646-277-1254 John.Mills@icrinc.com Media Contact: Tom McCall, ICU Medical, Inc. 949-366-4368 tmccall@icumed.com Pfizer Inc. Investor Contact Chuck Triano 212-733-3901 Media Contact: Joan Campion 212-733-2798
$GTWN to Be #Acquired by #SalemFiveBancorp
Salem Five Bancorp, parent of Salem Five Cents Savings Bank (“Salem Five Bank”) and Georgetown Bancorp, Inc. (NASDAQ: GTWN) (“Georgetown Bancorp”) parent of Georgetown Bank, today jointly announced that they have signed a definitive agreement whereby Salem Five Bancorp has agreed to acquire Georgetown Bancorp, Inc. and its subsidiary Georgetown Bank, in an all cash transaction valued at approximately $49.2 million.
Under the terms of the agreement, shareholders of Georgetown Bancorp, Inc. will receive $26.00 in cash in exchange for each share of Georgetown Bancorp common stock. The consideration represents approximately 148% of Georgetown Bancorp tangible book value at June 30, 2016.
“Salem Five and Georgetown Bank both have longstanding histories as community banks with high standards of integrity, as well as a strong sense of responsibility for the economic vitality of our region. Their foot print is an area of the North Shore, Merrimack Valley and Southern New Hampshire where we are excited to expand our existing branch franchise and complement Salem Five’s existing retail network. Salem Five looks forward to serving the families, businesses, and communities that have relied on Georgetown Bank’s high quality banking with our own trademark commitment to exceptional service and technology,” said Ping Yin Chai, Salem Five Bancorp President and Chief Executive Officer.
At June 30, 2016, Salem Five Bancorp’s consolidated assets were approximately $4.0 billion and Georgetown Bancorp, Inc. had assets of approximately $300 million. Georgetown Bancorp and Salem Five Bancorp are both considered well-capitalized under applicable regulatory capital guidelines, and Salem Five expects to be well-capitalized under such standards upon completion of the transaction. After the completion of the merger, which is expected to close during the first quarter of 2017, the combined entity is expected to have approximately $4.3 billion in assets.
“Georgetown Bank is very excited to partner with Salem Five, one of the most respected community banking organizations in Massachusetts. Our values, culture, management style, and approach to business are very much the same. Additionally, with 30 branches, $4.0 billion in assets, and varied business units, Salem Five can offer career opportunities for our employees, financial services, and community support far greater than we can at our current size and scope. We couldn’t be more confident that this partnership is in the best interests of all of our constituents; shareholders, employees, customers, and community and we look forward to a vibrant and successful future together,” stated Robert E. Balletto, President and Chief Executive Officer of Georgetown Bancorp.
The respective boards of each parent company have unanimously approved the transaction. The transaction is subject to receipt of state and federal regulatory approvals and approval by shareholders of Georgetown Bancorp.
Sandler O’Neill & Partners, L.P. acted as financial advisor to Salem Five Bancorp, and Keefe, Bruyette & Woods, Inc. acted as financial advisor to Georgetown Bancorp, Inc. K&L Gates LLP served as legal counsel to Salem Five Bancorp and Luse Gorman, PC served as legal counsel to Georgetown Bancorp.
About Salem Five Bancorp
Salem Five Bancorp is the parent company of Salem Five Bank (www.salemfive.com), a mutual institution founded in 1855 which designs and delivers sophisticated consumer and commercial banking products and services utilizing smart technology. Salem Five’s products and services are designed from its core belief that, with the right tools and expert service, it is possible to make money less complicated and thereby make customers’ lives simpler and easier. Among the first banks in the country to offer online banking, Salem Five continues to innovate, providing banking access wherever its customers need it: online, mobile, ATMs, offices, phone, email and more. Salem Five is one of the largest Massachusetts-headquartered mutual savings banks with approximately $4.0 billion in assets and 30 retail branches in Essex, Middlesex, Suffolk and Norfolk counties. Deposits are insured through the FDIC and DIF. Salem Five Mortgage Company finances more homes statewide than any other Massachusetts bank, and is one of the largest servicers of mortgages in New England. Salem Five Financial offers financial and retirement planning, portfolio review and money management with a focus on retirement income. Salem Five Insurance provides personal and commercial insurance. Investment and Insurance products sold through Salem Five Financial or Salem Five Insurance are not FDIC insured, not bank guaranteed, may lose value, are not a deposit and not insured by any federal government agency.
About Georgetown Bancorp, Inc.
Georgetown Bancorp, Inc. is the holding company for Georgetown Bank. Georgetown Bank, with branch offices in Georgetown, North Andover and Rowley, Massachusetts, as well as Stratham, New Hampshire, is committed to making a positive difference in the markets it serves. Georgetown Bank’s highest priority is to provide exceptional personal service, act with high ethical standards and in the best interest of its customers, employees, shareholders and business partners. Georgetown Bank strives to help each of its customers achieve their unique financial goals through a competitive array of financial products and services.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Forward-looking statements include statements regarding the anticipated closing date of the transaction and anticipated future results. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. They often include words like “believe,” “expect,” “anticipate,” “estimate,” and “intend” or future or conditional verbs such as “will,” “would,” “should,” “could,” or “may.” Certain factors that could cause actual results to differ materially from expected results include delays in completing the merger, including delays in obtaining regulatory or shareholder approval, difficulties in achieving cost savings from the merger or in achieving such cost savings from the merger or in achieving such cost savings within the expected time frame, difficulties in integrating Georgetown Bancorp, Inc. and Salem Five Bancorp, increased competitive pressures, changes in the interest rate environment, changes in general economic conditions, legislative and regulatory changes that adversely affect the business in which Georgetown Bancorp, Inc. and Salem Five Bancorp are engaged, changes in the securities markets and other risks and uncertainties.
This press release does not constitute a solicitation of proxies.
Georgetown Bancorp, Inc. will provide its shareholders with a proxy statement and other relevant documents concerning the proposed transaction. Shareholders of Georgetown Bancorp are urged to read the proxy statement and any amendments or supplements to those documents, because they will contain important information which should be considered before making any decision regarding the transaction. Shareholders of Georgetown Bancorp will also be able to obtain a copy of the proxy statement, without charge, when it becomes available, by directing a request to:
Robert E. Balletto
President and Chief Executive Officer
Georgetown Bancorp, Inc.
2 East Main Street
Georgetown, MA 01833
Georgetown Bancorp, Inc. and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Georgetown Bancorp in connection with the merger. Information about the directors and executive officers of Georgetown Bancorp, their ownership of Georgetown Bancorp common stock along with additional information regarding the interests of such participants in the transaction and any agreements with such persons to vote shares of Georgetown Bancorp for approval of this merger with Salem Five will be contained in the proxy statement when it becomes available.
Persons seeking additional information regarding Georgetown Bancorp, Salem Five Bancorp or the transaction may wish to visit the websites of each institution:
Georgetown Bancorp, Inc. – http://www.georgetownbank.com/
Salem Five Bancorp – https://www.salemfive.com/
Salem Five Bank
Martha R. Acworth, 978-720-5340
Senior Vice President/CMO
martha.acworth@salemfive.com
or
Georgetown Bancorp, Inc.
Robert Balletto, 978-352-8600 ext. 1201
President/CEO
rballetto@georgetownbank.com
$AUPH Releases Strong Open-Label #AURION Data on #Voclosporin in #Lupus
-Patients in remission at eight weeks remained in remission at 24 weeks
-Data presented at the 10th Annual European Lupus Meeting
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) a clinical stage biopharmaceutical company focused on the global immunology market, today announced 24-week data in all 10 patients from the AURION study, an open-label exploratory study to assess the short-term predictors of response using voclosporin (23.7mg BID) in combination with mycophenolate mofetil (MMF) and oral corticosteroids in patients with active lupus nephritis (LN). The data are being presented by Robert Huizinga, Vice President of Clinical Affairs at Aurinia at the 10th Annual European Lupus Meeting in Venice, Italy.
The primary objective of the study is to examine biomarkers of disease activity at eight weeks and their ability to predict response at 24 and 48 weeks.
In this study, 70% (7/10) patients achieved complete remission (CR) at 24 weeks as measured by a urinary protein creatinine ratio (UPCR) of ≤ 0.5mg/mg, eGFR within 20% of baseline and concomitant steroid dose of <5mg/day. Of the 10 patients that achieved a reduction of UPCR of ≥ 25% at 8 weeks, 80% were responders (≥ 50% reduction in UPCR over baseline) at 24 weeks and 70% were in CR at 24 weeks. In addition, inflammatory markers such as C3, C4 and anti-dsDNA all continued to normalize to 24 weeks. Voclosporin was well-tolerated with no unexpected safety signals observed.
“The results of AURION provide further proof of concept data to support voclosporin’s use in the treatment of active LN and continue to indicate that 23.7mg BID is the optimal dose to advance into our phase III program,” said Neil Solomons, MD, Chief Medical Officer of Aurinia. “We are encouraged by our ability to quickly predict responses and remission rates in these patients, which can help clinicians optimize patient care and long-term outcomes.”
Details of the results are below:
| Patient # | Attained ≥25% reduction in UPCR at 8 weeks |
Attained Partial Remission* at 8 weeks |
Attained Partial Remission* at 24 weeks |
Attained Complete Remission at 8 weeks |
Attained Complete Remission at 24 weeks |
|||||
| 1 | Y | Y | Y | Y | Y | |||||
| 2 | Y | Y | Y | Y | Y | |||||
| 3 | Y | Y | Y | N | N | |||||
| 4 | Y | N | N | N | N | |||||
| 5 | Y | Y | Y | Y | Y | |||||
| 6 | Y | Y | Y | Y | Y | |||||
| 7 | Y | N | N | N | N | |||||
| 8 | Y | Y | Y | Y | Y | |||||
| 9 | Y | N | Y | N | Y | |||||
| 10 | Y | Y | Y | N | Y | |||||
| TOTALS: | 100% (10/10) | 70%(7/10) | 80% (8/10) | 50% (5/10) | 70% (7/10) |
*Retrospectively defined by ≥50% reduction in UPCR
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 (23.7mg) in combination with mycophenolate mofetil and oral corticosteroids 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.
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients in other indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.
About Lupus Nephritis (LN)
Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.
About Aurinia
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN). The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com
Forward Looking Statements
This press release contains forward-looking statements, including statements related to Aurinia’s regulatory strategy (including plans to meet with the U.S. Food and Drug Administration to discuss these data and the voclosporin’s subsequent clinical development and path to registration in LN), Aurinia’s analysis, assessment and conclusions of the results of the AURION clinical study, and the efficacy and commercial potential of voclosporin. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of the AURION clinical study set forth in this release may change based on further analyses of such data, and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2015 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Investor & Media Contact:
Aurinia Pharmaceuticals Inc.
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com
$EXPI and Commissions Inc. Announce Enterprise #LeadGeneration #CRM Platform
BELLINGHAM, WA–(October 06, 2016) – eXp Realty, the Agent-Owned Cloud Brokerage® (eXp World Holdings, Inc.) (OTCQB: EXPI) today announced a new strategic relationship with Commissions Inc. (CINC), the leading provider of web-based real estate marketing and CRM software for elite agents and teams across North America. Under this new relationship, CINC will become eXp’s primary enterprise lead generation and CRM platform for eXp’s 1800 agents in the U.S and Canada.
To date, CINC has been heralded by high performing teams as the most effective online lead generation and CRM platform on the market. When the system goes live in early 2017, eXp will be the only large brokerage firm where all eXp agents will have access to the CINC tools and resources at no additional cost. Every eXp agent will receive a consumer website that integrates with local MLS data, a comprehensive CRM platform through which agents can manage clients from lead to close, and three mobile apps (CINC Agent App, Houses.net, and Open Houses by CINC).
“eXp Realty puts our agents and brokers first in every decision we make and we are continually looking for valuable partnerships which will deliver long term sustainable value to them,” stated eXp Realty CEO Jason Gesing. “While there are plenty of lead-gen and CRM choices in the marketplace, there are only a handful of companies that provide best in class tools and systems and CINC is at the top of that list. As third party portals continue to proliferate, we believe that providing a fully integrated CRM and IDX-based consumer search experience, the ability for agents to easily feature their own listings on their websites and the ability to promote themselves as part of a custom ‘portal strategy’ is an essential part of our vision as a leading technology-based brokerage. We are honored to be selected by a company with the stellar reputation like CINC as their first Enterprise client and look forward to a long and mutually beneficial relationship.”
“We have been searching for a company that shares both our dedication to make agents successful and our belief that having the best technology is a critical part of the agents growth,” said Alvaro Erize, COO of Commissions Inc. “eXp, with its extremely rapid growth and agent focused values, is the perfect opportunity to get CINC in the hands of the right agents, knowing they are already part of a family geared for success.”
The announcement came at eXp’s international convention, eXp Con, in San Antonio, Texas where more than 600 broker and agent owners from the U.S. and Canada gathered to learn, share and motivate and celebrate eXp as the brokerage model that is quickly gaining national attention.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 89.4% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, Virginia and New Mexico. First Cloud Mortgage has positioned itself as a Planet Friendly Mortgage Company via the purchase of carbon offsets for homeowners offsetting the first year of the Carbon Footprint of the typical home on each mortgage originated through First Cloud Mortgage, Inc.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com and for First Cloud Mortgage, Inc. check out FirstCloudMortgage.com.
About CINC
Founded in Marietta, Georgia in 2011, CINC (Commissions Inc.) is the leading provider of web-based real estate marketing and CRM software for elite agents and teams across North America. The solution includes a consumer website that integrates with local MLS data, a complete CRM platform that allows real estate agents to nurture clients and monitor their business, and access to three mobile apps (CINC Agent App, Houses.net, and Open Houses by CINC). Built with the support and input of some of North America’s top brokers, CINC powers the business for thousands of agents and connects them with millions of consumers every month.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
CEO
eXp Realty
jason.gesing@exprealty.com
617-970-8518
$REED #ReedsGingerBrews now available in more than 1,300 $TGT Target Stores Nationwide
LOS ANGELES, Oct. 05, 2016 — Reed’s, Inc. (NYSE:REED), maker of the top selling craft sodas nationwide today announced that Reed’s Ginger Brews are now authorized and available in 1,335 Target stores throughout the country. Target is headquartered in Minneapolis, Minnesota and is the second largest discount retailer in the U.S., operating 1,792 locations. Reed’s Extra Ginger Brew and Reed’s Original Ginger Brew launched in stores last week and will be featured in Target’s craft soda specialty set.
Neal Cohane, SVP Sales & Marketing commented, “This launch in Target is a great opportunity to expand our brand presence in the mainstream mass merchandise channel and meet the growing consumer demand for the Reed’s brand. There is an evolution in the mindset of retailers across the country as consumers are drinking less of the typical artificial sodas and are seeking out healthier alternatives like Reed’s, the leader in the premium craft soda category. Target has not only recognized this shift in consumer demand, but has embraced it.”
About Target
Minneapolis-based Target Corporation (NYSE:TGT) serves guests at 1,792 stores and at Target.com. Since 1946, Target has given 5 percent of its profit to communities, which today equals more than $4 million a week. For more information, visit Target.com/Pressroom. For a behind-the-scenes look at Target, visit Target.com/abullseyeview or follow @TargetNews on Twitter.
About Reed’s, Inc.
Reed’s, Inc. makes the top-selling sodas in the natural and specialty foods industry and are sold in over 15,000 natural and mainstream supermarkets nationwide. Reed’s products are sold through an additional estimated 40,000 accounts that include specialty gourmet, natural food stores, retail stores, convenience stores and restaurants nationwide and in select international markets. Reed’s has sold over 500 million bottles since inception in June 1989 and is considered the leader of the fast growing craft soda category. Its seven award-winning non-alcoholic Ginger Brews are unique in the beverage industry, being brewed, not manufactured and using fresh ginger, spices and fruits in a brewing process that predates commercial soft drinks. The Company owns the top-selling root beer line in natural foods, the Virgil’s Root Beer product line, and a top-selling cola line in natural foods, the China Cola product line. In 2012, the Company launched its Reed’s Culture Club Kombucha line of organic live beverages. Other product lines include Reed’s Ginger Candies and Reed’s Ginger Ice Creams.
For more information about Reed’s, please visit the Company’s website at: http://www.reedsinc.com or call 800-99-REEDS.
Follow Reed’s on Twitter at http://twitter.com/reedsgingerbrew; Reed’s Facebook Fan Page at https://www.facebook.com/ReedsGingerBrew
SAFE HARBOR STATEMENT
Some portions of this press release, particularly those describing Reed’s goals and strategies, contain “forward-looking statements.” These forward-looking statements can generally be identified as such because the context of the statement will include words, such as “expects,” “should,” “believes,” “anticipates” or words of similar import. Similarly, statements that describe future plans, objectives or goals are also forward-looking statements. While Reed’s is working to achieve those goals and strategies, actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These risks and uncertainties include difficulty in marketing its products and services, maintaining and protecting brand recognition, the need for significant capital, dependence on third party distributors, dependence on third party brewers, increasing costs of fuel and freight, protection of intellectual property, competition and other factors, any of which could have an adverse effect on the business plans of Reed’s, its reputation in the industry or its expected financial return from operations and results of operations. In light of significant risks and uncertainties inherent in forward-looking statements included herein, the inclusion of such statements should not be regarded as a representation by Reed’s that they will achieve such forward-looking statements. For further details and a discussion of these and other risks and uncertainties, please see our most recent reports on Form 10-K and Form 10-Q, as filed with the Securities and Exchange Commission, as they may be amended from time to time. Reed’s undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CONTACT: Reed's, Inc. Investor Relations - Email: ir@reedsinc.com
$PHMD #DefinitiveAgreement to #Acquire $ICTV #HairRemoval Brand
ICTV to Acquire Consumer Brands no!no!, Kyrobak, and ClearTouch From PhotoMedex, Inc. Purchase Price of $9.5 Million Includes $6 Million of GAAP Inventory Acquired Assets Have Generated Approximately $50 Million in Net Sales Over the Prior Twelve Months $5 Million of Acquisition Financing Secured Subject to Customary Closing Contingencies
WAYNE, PA–(Oct 5, 2016) – ICTV Brands, Inc. (OTCQX: ICTV), (CSE: ITV), a digitally focused, direct response marketing and branding company specializing in the health, wellness and beauty sector, today announced the signing of a definitive agreement to acquire the consumer products business of PhotoMedex, Inc. (NASDAQ: PHMD) for a total consideration of $9.5 million.
The agreement calls for ICTV to acquire the assets of PhotoMedex’s flagship product no!no!, along with the Kyrobak and Cleartouch brands. The purchase price of $9.5 million consists of a $3 million cash payment on closing, $2 million cash payment due on the 90th day following the closing, and a $4.5 million capped royalty based on future net sales of the acquired product lines. This asset purchase will include the respective product trademarks, patents, and other intellectual property, along with manufacturing tooling, and PhotoMedex’s Hong Kong and Brazilian subsidiaries. ICTV will also receive a minimum of $6 million of GAAP inventory.
In addition to the tangible assets, ICTV will acquire highly experienced research and development, logistics, sales and marketing personnel. The R&D and logistics group, based in Israel, have a long history of developing unique and successful at-home health and beauty devices. The sales and marketing team, based in the US and UK, will provide seamless integration of the acquired brands into ICTV’s platform.
The Board of Directors of both ICTV and PhotoMedex have unanimously approved this agreement. In addition, ICTV’s Board has approved a financing of up to $7 million in a private placement of common shares priced at $0.34. To date, $3 million of this raise has been placed in escrow, led by a group of existing shareholders. The additional $2 million that has been secured is in the form of an irrevocable letter of credit. Assuming the closing of both the acquisition and the $7 million equity financing, the Company expects to have over $3 million in cash, no debt, and approximately 51 million shares outstanding. The closing of the acquisition and the financing are subject to customary closing conditions.
Richard Ransom, President of ICTV Brands, stated, “The acquisition of the no!no! brand will be transformative to our organization and accretive to our shareholders. By combining these great brands under one platform, ICTV should gain the operating leverage and cost savings to generate significant EBITDA and cash flow going forward. We believe this transaction will firmly establish ICTV Brands as a worldwide leader in the health and beauty device industry.”
no!no!, launched in 2006, is the first professional hair removal device for in-home use with patented Thermicon technology. The product line has grown from its original version, now known as the no!no! Classic, to include seven more hair removal products, including no!no! LITE, no!no! PLUS, no!no! MICRO, no!no! Hair, no!no! Hair for MEN, no!no! PRO and no!no! ULTRA, all with different features and technologies. In addition to the hair removal line, no!no! expanded to include no!no! Skin for pimple treatments, and no!no! Smooth, a full skincare line formulated with hair growth inhibitors. With over 6 million units sold and over $1 billion dollars in sales since inception, no!no! has established itself as a leader in the hair removal category.
ICTV Brands’ Chairman and CEO Kelvin Claney added, “Over the last two years, we have repositioned ICTV to take full advantage of the rapid expansion of the digital marketplace. Our team has built and continues to refine a multi-channel sales platform to deliver profitable sales of health and beauty products across all methods of distribution, including e-commerce, traditional brick and mortar, direct to consumer, live home shopping, and international distributorships. The timing of the acquisition of no!no! and the associated brands is perfect, as it will allow ICTV to accelerate growth through the Company’s new multi-channel sales platform. Through operational efficiencies, I believe the synergies created by these two great brands, no!no! and DermaWand, will generate significant growth and earnings both now and in future years.”
The transaction is expected to close in the 4th quarter of 2016.
For more information on ICTV Brands product, DermaWand, or the no!no, Kyrobak, and ClearTouch brands, please visit each products respective consumer websites:
ICTV Brands, Inc.
ICTV Brands, Inc. sells various health, wellness and beauty products through a multi-channel distribution strategy. ICTV utilizes a distinctive marketing strategy and multi-channel distribution model to develop, market and sell products through direct response television (DRTV), Internet/digital, e-commerce, international third party distributors, live television shopping and retail. Its products are sold in the North America and are available in over 65 countries. Its products include DermaWand, a skin care device that reduces the appearance of fine lines and wrinkles, and helps improve skin tone and texture, DermaVital, a professional quality skin care line that effects superior hydration, the CoralActives brand of acne treatment and skin cleansing products, and Derma Brilliance, a sonic exfoliation skin care system which helps reduce visible signs of aging, Jidue, a facial massager device which helps alleviate stress, and Good Planet Super Solution, a multi-use cleaning agent. ICTV Brands, Inc. was founded in 1998 and is headquartered in Wayne, Pennsylvania. For more information on our current initiatives, please visit www.ictvbrands.com.
PhotoMedex, Inc.
PhotoMedex is a global skin health company providing aesthetic solutions to dermatologists, professional aestheticians and consumers. The company provides proprietary products and services that address skin diseases and conditions including acne and photo damage. Its long-held experience in the physician market provides the platform to expand its skin health solutions to spa markets, as well as traditional retail, online and direct to consumer outlets for home-use products. PhotoMedex sells home-use devices under the no!no! brand for various indications including hair removal, acne treatment and skin rejuvenation. The company also offers a professional product line for acne clearance, skin tightening, psoriasis care and hair removal sold to physician clinics and spas.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by, or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could” are generally forward-looking in nature and not historical facts. Among these forward-looking statements are any statements regarding the expected completion of the acquisition of PHMD’s assets, the closing of the proposed common stock financing, the ability of ICTV and PHMD to successfully satisfy all of the closing conditions to the PHMD asset acquisition and the related common stock financing, and any other statements regarding ICTV’s plans or objectives with respect to the assets to be acquired from PHMD. Although ICTV believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release. These include risks that may affect the proposed acquisition and financing, including the satisfaction of the conditions contained in PHMD asset purchase agreement, any delay or inability to obtain necessary approvals or consents from third parties, the ability of ICTV to complete the proposed common stock financing and satisfy the conditions to such financing, and the ability of ICTV to realize the anticipated benefits from the acquisition. For additional risks and uncertainties that could impact ICTV’s forward-looking statements, please see ICTV’s Annual Report on Form 10-K for the year ended December 31, 2015, including but not limited to the discussion under “Risk Factors” therein, which ICTV has filed with the SEC and similar disclosure, if any, contained in Quarterly Reports filed by ICTV on Form 10-Q after the filing of such Annual Report on Form 10-K, which may be viewed at http://www.sec.gov. ICTV disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise.
Contact Information
Rich Ransom
Ransom@ictvbrands.com
484-598-2313
Kelvin Claney
Claney@ictvbrands.com
484-598-2314
$ABEO #ABO102 Dose Escalation Approved, #SanfilippoSyndrome Type A
NEW YORK, NY and CLEVELAND, OH–(October 05, 2016) – Abeona Therapeutics Inc. (NASDAQ: ABEO)
- ABO-102 (AAV-SGSH) delivers first-in-man AAV-based gene therapy administered by single intravenous injection to treat CNS and peripheral manifestations of Sanfilippo syndrome type A
- Data Safety Monitoring Board (DSMB) approves ABO-102 dose escalation for the high-dose cohort
Abeona Therapeutics Inc. (NASDAQ: ABEO), a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the clinical trial, has reviewed the initial safety data from the low dose cohort (n=3) in the Phase 1/2 clinical trial of ABO-102 (AAV-SGSH) enrolling at Nationwide Children’s Hospital in Columbus, Ohio. Following review of the safety data, the DSMB authorized that the clinical trial proceed with enrollment and dose escalation for the second cohort. The high-dose cohort will enroll up to six additional patients dosed at 1.0 X 1013 vg/kg, which is twice the amount of ABO-102 received by patients in the low-dose cohort.
“These early results support Abeona’s unique approach to treating patients with Sanfilippo syndrome, where there are both profound CNS and whole body manifestations of the disease,” stated Timothy J. Miller, Ph.D., President and CEO of Abeona Therapeutics. “We look forward to reporting on future progress and potential for ABO-102 as we begin to enroll patients at the high dose and open additional clinical sites internationally.”
Abeona’s ABO-102 program has been granted both Orphan Product Designation and Rare Pediatric Disease Designation in the USA and plans to open two additional clinical sites, one in Spain and one in Australia, to test ABO-102. A Phase 1/2 clinical study of ABO-102 in Spain was recently approved by the Agencia Espanola de Medicamentos y Productos Sanitarios, and the Company is preparing to conduct this clinical study at Cruces University Hospital in Bilbao, Spain.
Sanfilippo Syndrome Type A, or MPS IIIA, is a rare lysosomal storage disease caused by genetic mutations that result in a deficiency of SGSH enzyme activity, leading to abnormal accumulation of certain sugars (specifically, the glycosaminoglycan (GAG) heparan sulfate) in the central nervous system (CNS) and systemic tissues and organs. The accumulation of heparan sulfate results in neurocognitive decline, speech loss, loss of mobility, and premature death.
About ABO-102 (AAV-SGSH): ABO-102 is an adeno-associated viral (AAV)-based gene therapy for patients with MPS IIIA (Sanfilippo syndrome), that is delivered as a one-time intravenous injection. ABO-102 delivers a functioning, corrective copy of the SGSH gene to cells of the central nervous system (CNS) and other organs with the goal of correcting the underlying deficits caused by the inborn genetic errors that are the cause the disease. ABO-102 has been well tolerated through 30 day post-injection in subjects injected with the low-dose (n=3). Encouraging signs of early biopotency have been observed in urinary and CSF GAG (glycosaminoglycan, specifically, heparan sulfate) measurements, as well as potential disease-modifying effects in the liver and spleen of the initial subjects enrolled and treated in the trial. The clinical study is supported by neurocognitive evaluations, biochemical assessments and MRI data generated in a 25-subject MPS III Natural History Study, also conducted at Nationwide Children’s Hospital, where patients continued through one-year of follow up assessments.
About Sanfilippo syndromes (or mucopolysaccharidosis (MPS) type III): a group of four inherited genetic diseases each caused by a single gene defect, described as type A, B, C or D, which cause enzyme deficiencies that result in the abnormal accumulation of glycosaminoglycans (GAGs, or sugars) in body tissues. MPS III is a lysosomal storage disease, a group of rare inborn errors of metabolism resulting from deficiency in normal lysosomal function. The incidence of MPS III (all four types combined) is estimated to be 1 in 70,000 births. Mucopolysaccharides are long chains of sugar molecule used in the building of connective tissues in the body. There is a continuous process in the body of replacing used materials and breaking them down for disposal. Children with MPS III are missing an enzyme, which is essential in breaking down the used mucopolysaccharides called heparan sulfate. The partially broken down mucopolysaccharides remain stored in cells in the body causing progressive damage. In MPS III, the predominant symptoms occur due to accumulation within the central nervous system (CNS), including the brain and spinal cord, resulting in cognitive decline, motor dysfunction, and eventual death. Importantly, there is no cure for MPS III and treatments are largely supportive care.
About Abeona: Abeona Therapeutics Inc. is a clinical stage company developing gene and plasma-based therapies for life-threatening rare genetic diseases. Abeona’s lead programs are ABO-102 (AAV-SGSH) and ABO-101 (AAV-NAGLU), adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome (MPS IIIA and IIIB), respectively. Abeona is also developing EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten disease (JNCL); ABO-202 (AAV-CLN1) gene therapy for treatment of infantile Batten disease (INCL), and ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases. In addition, Abeona has a plasma-based protein therapy pipeline, including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD, using our proprietary SDF™ (Salt Diafiltration) ethanol-free process. For more information, visit www.abeonatherapeutics.com.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, our plans for continued development and internationalization of our clinical programs in Spain and Australia; that early results support our unique approach to treating patients with Sanfilippo syndrome; that encouraging signs of early biopotency have been observed as well as potential disease-modifying effects in the liver and spleen of the initial subjects enrolled and treated in the trial; and that ABO-102 is well-tolerated through 30 day post-injection in subjects injected with the low dose; These statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the ability to successfully continue our clinical trials; the impact of competition; the ability to develop our products and technologies; the ability to achieve or obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.
Investor Contact:
Christine Silverstein
Vice President, Investor Relations
Abeona Therapeutics Inc.
+1 (212)-786-6212
csilverstein@abeonatherapeutics.com
Media Contact:
Andre’a Lucca
Vice President, Communications & Operations
Abeona Therapeutics Inc.
+1 (212)-786-6208
alucca@abeonatherapeutics.com
$UEPS Announces #Acquisition of a Strategic Stake in Blue Label #Telecoms
JOHANNESBURG, SOUTH AFRICA–(October 05, 2016) – Net 1 UEPS Technologies, Inc. (“Net1” or the “Company”) (NASDAQ: UEPS) (JSE: NT1) today announced that it has entered into a share subscription agreement with Blue Label Telecoms Limited (“Blue Label”) (JSE: BLU) to subscribe for approximately 117.9 million shares in Blue Label, at a subscription price of ZAR16.96 per share, representing a 10% discount to ZAR18.84, being the 30-day volume weighted average price of a Blue Label share traded on the Johannesburg Stock Exchange (“JSE”) to September 29, 2016. The aggregate subscription consideration payable by Net1 is ZAR2.0 billion ($144.0 million). Following implementation of the subscription, Net1 will own approximately 15% of the issued ordinary shares in Blue Label. Net1 expects to settle the subscription consideration through a combination of cash resources, debt instruments and an equity issuance of five million shares of common stock, at an issue price of $9.00 per share. Following implementation of the subscription, which is subject to the finalization of the financing package and the approval of Blue Label shareholders, Net1 will be entitled to nominate a director to Blue Label’s board.
Blue Label, which operates in South Africa, Mexico and India, is listed in the Telcoms – Mobile Telcoms sector of the Main Board of the JSE, and is a market leading virtual and physical distributor of secure electronic tokens of value as well as a provider of transactional and value added services. Blue Label also announced today that it intends to acquire a 45% interest in Cell C, one of South Africa’s three major licensed mobile network operators. For the fiscal year ended May 31, 2016, Blue Label reported revenue of ZAR26.2 billion ($1.9 billion), EBITDA of ZAR1.24 billion ($90.0 million) and earnings per share of ZAR1.04 ($0.07).
“This investment cements the start of a multi-layered strategic alliance between our two groups that will greatly enhance shareholder value on both sides through cooperation between our combined local and international operations,” said Serge Belamant, Chairman and CEO of Net1. “Blue Label has announced that it intends to acquire 45% of Cell C, the third largest telecom operator in South Africa and this new alliance will assist Net1, Blue Label and Cell C to accelerate the growth of their combined customer bases, and facilitate cross selling opportunities between themselves. Our aim is to provide customers a truly bespoke, affordable and comprehensive package that will go much further than basic telephony. The combination of the Net1 and Blue Label infrastructures is expected to envelop all areas of South Africa through our combined physical and mobile branches, associations with merchant stores and virtual distribution services via USSD, voice, internet and social media linked with traditional payment systems including EFTs, debit and credit cards and our Virtual Card solution. We believe that our coalition will be a global first that provides customers with an offering that includes banking, transacting, debit and credit cards, micro-finance, insurance, distribution of both airtime and electricity, web services, voice and data as well as access to low cost handsets offering the most advanced functionality. In addition, the new alliance ensures that all required support services are provided in-house using our own combined technologies, software and hardware products. As a result, our technology platform can address and service the entire LSM1 to 8 categories in South Africa in a broad and meaningful way.
In India, Net1 and Blue Label are shareholders in MobiKwik and Oxigen respectively, and we believe that there are compelling opportunities for us to extend our collaboration through the provision of innovative payment solutions, enabling universal acceptance and value to customers of two of India’s leading digital wallet providers who also have unparalleled online and offline infrastructure and capabilities. Our alliance with Blue Label is expected to further enhance the marketing of our international remittances, virtual cards and merchant financing strategies. In addition, the POS infrastructure that Blue Label has deployed in Mexico opens up new and real potential to participate in, acquiring, bill payments and remittances when combined with our technology and relationships in North America,” he concluded.
Brett and Mark Levy, the joint CEOs of Blue Label, stated: “The strategic cooperation between Blue Label and Net1 will touch multi-million consumers per day through our combined points of presence as a result of the respective parties’ combining Product, Distribution Footprint and Customers, from formal and informal retail right through to the extensive rural market. This will create a highly robust business model that will be resilient to disintermediation and fluctuations in economic conditions.”
Conference Call
The Company will host a conference call to discuss this transaction on October 5, 2016, at 8:30 a.m. Eastern Time. To participate in the call, dial 1-855-481-5362 (US and Canada), 0808-162-4061 (U.K. only) or 0-800-200-648 (South Africa only) ten minutes prior to the start of the call. Callers should request “Net1 call” upon dial-in. The call will also be webcast on the Net1 homepage, www.net1.com. Please click on the webcast link at least ten minutes prior to the call. A webcast of the call will be available for replay on the Net1 website through October 26, 2016.
About Net1 (www.net1.com)
Net1 is a leading provider of alternative payment systems that leverage its Universal Electronic Payment System (“UEPS”) or utilize its proprietary mobile technologies. The Company operates market-leading payment processors in South Africa and the Republic of Korea. Through Transact24, Net1 offers debit, credit and prepaid processing and issuing services for Visa, MasterCard and ChinaUnionPay in China and other territories across Asia-Pacific, Europe and Africa, and the United States. Through Masterpayment, Net1 provides payment processing and enables working capital financing in Europe.
UEPS permits the Company to facilitate biometrically secure, real-time electronic transaction processing to unbanked and under-banked populations of developing economies around the world in an online or offline environment. Net1’s UEPS/EMV solution is interoperable with global EMV standards that seamlessly enable access to all the UEPS functionality in a traditional EMV environment. In addition to payments, UEPS can be used for banking, healthcare management, payroll, remittances, voting and identification.
Net1’s mobile technologies include its proprietary mobile payments solution — MVC, which offers secure mobile-based payments, as well as mobile banking and prepaid value-added services in developed and emerging countries. The Company intends to deploy its varied mobile solutions through its ZAZOO business unit, which is an aggregation of innovative technology companies and is based in the United Kingdom.
Net1 has a primary listing on the NASDAQ and a secondary listing on the Johannesburg Stock Exchange.
About Blue Label (www.bluelabeltelecoms.co.za)
Blue Label is a significant virtual distributor of secure electronic tokens of value across a global footprint of touch points, including distribution of prepaid airtime, starter packs, data and electricity tokens, as well as transactional services such as ticketing and financial services. If a product can be digitised, it can be distributed by Blue Label.
Blue Label’s stated strategy is to extend its global footprint of touch points, both organically and acquisitively, in fulfilling the significant demand for the delivery of multiple prepaid products and services through a single distributor, across various delivery mechanisms and via numerous merchants or vendors. As distribution plays an important role in any economy, Blue Label’s leverage of the last mile of the distribution channel is critical. Whoever manages the last mile of the channel actually owns the whole distribution channel. Since the POS terminal is always located in the last mile, the person managing it decides what products and services may be sold from it.
Blue Label is headquartered in Johannesburg, South Africa and employs approximately 2,200 employees across its operations in South Africa, India and Mexico. The group processes approximately 5 billion transactions per annum and reported revenue of ZAR26.2 billion ($1.9 billion) for fiscal 2016. Blue Label maintains a primary listing on the Johannesburg Stock Exchange and has a Level 1 ADR (American Depositary Receipt) program in the United States.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this press release regarding strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that the Company makes. Factors that might cause such differences include, but are not limited to: the possibility that the expected synergies from the investment will not be realized, or will not be realized within the expected time period; disruption from the investment making it more difficult to maintain business and operational relationships; and other factors, many of which are beyond the Company’s control; and other important factors included in the Company’s reports filed with the Securities and Exchange Commission, particularly in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016, as such Risk Factors may be updated from time to time in subsequent reports. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Financial Adviser and Transaction Sponsor:
Rand Merchant Bank, a division of FirstRand Bank Limited
Investor Relations Contact:
Dhruv Chopra
Head of Investor Relations
Phone: +1-917-767-6722
Email: dchopra@net1.com
$SCYX Complete Results, Phase 2 #Oral #SCY078 in #VVC
Study Results Confirm Overall Antifungal Activity of Oral SCY-078 in Patients with Candida Infections
Well-Tolerated and Active Oral Dose of SCY-078 Identified for Invasive Candidiasis Patients
Evidence of Efficacy and Lower Relapse Rates versus Standard of Care in VVC Patients
Strong Cash Position to Accelerate and Expand Development of SCY-078 in Multiple Indications
JERSEY CITY, N.J., Oct. 05, 2016 — Drug development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced the complete results of its two recently completed Phase 2 studies as well as the closing of a $15 million term loan with Solar Capital Ltd. (Nasdaq:SLRC).
In the first study, treatment with oral SCY-078 in patients with vulvovaginal candidiasis (VVC), resulted in significantly better clinical cure rates and fewer recurrences of VVC at the four-month follow-up when compared to the standard of care (oral fluconazole). In the second study, which evaluated oral SCY-078 as a step down therapy in patients with invasive candidiasis, oral SCY-078 achieved the target exposure for efficacy and was well-tolerated.
“We are delighted with these positive results that support the concept that a fungicidal product with high tissue penetration like SCY-078 could yield superior clinical outcomes,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “We identified a well-tolerated oral dose that achieves our target exposure in invasive candidiasis patients, and further confirmed the antifungal activity of oral SCY-078 in two independent human models of Candida infections. These results support our planned development of SCY-078 as the first drug in a novel antifungal class for the treatment of a broad range of fungal infections with growing unmet medical needs.”
Phase 2 Proof-of-Concept Study of Oral SCY-078 in Patients with VVC
The first study evaluated the effect of two dose regimens of SCY-078 in patients with moderate to severe VVC as a proof-of-concept study to support the development of SCY-078 in invasive candidiasis and other Candida infections. Clinical cure rate, defined as a resolution of signs and symptoms of infection without further antifungal treatment, is now the recommended primary endpoint per the latest FDA guidelines for VVC. As previously reported, clinical cure rate was higher for patients receiving oral SCY-078 compared to oral fluconazole at the test of cure visit (Day 24). Additionally, follow-up data now available showed a high clinical cure rate at the four-month visit (end of observation period) of 88% in patients who received SCY-078 compared to 65% in patients who received fluconazole (p=0.04). Moreover, during the four-month observation period, patients who received SCY-078 had a lower recurrence rate (4%) versus fluconazole (15%).
Phase 2 Study of Oral SCY-078 in Patients with Invasive Candidiasis
The second study evaluated the pharmacokinetics (PK), safety, and tolerability of SCY-078 as an oral step-down treatment in patients initially treated with intravenous (IV) echinocandin therapy for invasive Candida infections. Twenty-two patients were randomized to receive study drug or standard of care (one of the patients randomized to standard of care could not receive oral fluconazole due to a Candida glabrata with decreased fluconazole-susceptibility and received micafungin for the entire duration of antifungal therapy). As previously reported, the study met its primary objective by confirming the once daily oral dose of SCY-078 750mg as a dose that is both overall safe and tolerated and achieves the target exposure in these patients. During the study period, there were no reports of mycological failures in the SCY-078 750mg group (n=7) versus two infection-related failures (one fungemia and one abdominal sepsis) in the fluconazole group (n=7). No relapses were observed in these two groups during the six-week follow-up period.
As previously reported, SCY-078 was overall safe and tolerated in both studies. There were no discontinuations due to adverse events (AEs) and no related serious AEs. Consistent with previous findings, the most common AEs were mild to moderate gastrointestinal (GI) events such as diarrhea nausea, vomiting, abdominal pain or discomfort. In patients with invasive candidiasis, the number of GI events were comparable in both the SCY-078 and fluconazole treatment arms.
“We achieved our stated goals and further de-risked the development of our lead product candidate, SCY-078,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “With these positive Phase 2 data in hand, we believe SCY-078 is now the most advanced novel agent in a new antifungal class that can address the growing issue of resistance. We are also pleased to announce the infusion of additional funds from Solar Capital, providing us with the financial strength and flexibility to accelerate and expand the development of SCY-078 and to leverage our internal antifungal platform.”
Additional Capital Raised
SCYNEXIS closed a $15 million term loan with Solar Capital, fully funded at close. This transaction complements the company’s recent equity raise, and results in minimal dilution to shareholders. Please refer to the Form 8-K filing with the Securities and Exchange Commission for additional information about the facility.
“Solar Capital is pleased to start a financing partnership with SCYNEXIS that should enable the company to expand its pipeline of indications for SCY-078, as well as accelerate its other development programs,” said Anthony Storino, head of life science lending at Solar Capital. “We believe SCYNEXIS offers a unique value proposition in an area with significant unmet medical needs, and we are excited to contribute to the company’s growth and future successes.”
As of September 30, 2016, SCYNEXIS’ preliminary estimate of its cash, cash equivalents and marketable securities totaled $58.4 million, including the $15 million from the loan facility.
Armentum Partners acted as financial advisor to SCYNEXIS on the loan facility.
About the Studies
Phase 2 Proof-of-Concept Study of Oral SCY-078 in Patients with Vulvovaginal Candidiasis (VVC)
Multicenter, randomized, active controlled, evaluator-blinded study (clinicaltrials.gov identifier: NCT02679456) of oral SCY-078 compared to oral fluconazole in adult female patients with acute vulvovaginal candidiasis (VVC). A total of 96 patients with an acute moderate to severe, symptomatic episode of VVC were randomized in a 1:1:1 ratio to receive either three daily doses or five daily doses of oral SCY-078 750mg QD with a 1,250mg loading dose or oral fluconazole, at the labeled approved dose regimen of 150mg single dose. This was a pilot investigation and not powered to demonstrate a statistical significant difference in the parameters tested (p values for the comparisons mentioned were >0.05 unless otherwise indicated). Efficacy was evaluated based on the proportion of patients achieving clinical cure, mycological eradication and therapeutic cure (combination of both clinical cure and mycological eradication) at day 24 (+/-3) after initiation of treatment. The 3-day and the 5-day SCY-078 regimens performed similarly, allowing a pooled analysis. Intent-to-treat (ITT) population is defined as all subjects randomized (n=96 subjects). Per-Protocol (PP) population is defined as subjects with culture confirmed Candida infection at baseline (n=70 subjects). Subjects in the PP population were followed for four months. Recurrence was defined as a symptomatic VVC episode requiring additional antifungal therapy, per investigators’ decision.
Phase 2 Study of Oral SCY-078 in Patients with Invasive Candidiasis
Multicenter, multinational, randomized, open-label study (clinicaltrials.gov identifier: NCT02244606) following three to ten days of IV echinocandin therapy. A total of 27 patients with invasive candidiasis were enrolled and 22 were randomized to receive either SCY-078 500mg QD with a 1,000mg loading dose (7 patients), SCY-078 750mg QD with a 1,250mg loading dose (7 patients) or standard of care (7 patients receiving fluconazole 400mg QD with a 800mg loading dose and 1 patient receiving micafungin IV 100mg QD due to a Candida glabrata with decreased fluconazole-susceptibility for up to 28 days). Efficacy was assessed based on achievement of favorable global response defined as the resolution of signs and symptoms attributable to the Candida infection and mycological eradication without the use of any other antifungal agent. Patients were followed for six weeks after the end of treatment.
About SCY-078
SCY-078 is an oral and IV glucan synthase inhibitor in Phase 2 clinical development for the treatment for fungal infections caused by Candida and Aspergillus species. SCY-078 is a semi-synthetic triterpene derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitor. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the flexibility of having intravenous (IV) and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole and echinocandin resistant strains. Positive results from two recently reported Phase 2 studies provided evidence of the antifungal activity of orally administered SCY-078 in patients with Candida infections. The U.S. Food and Drug Administration (FDA) granted Fast Track, Qualified Infectious Disease Product (QIDP) and orphan drug designations (ODD) for the oral and IV formulations of SCY-078 for the indications of invasive Candida infections (including candidemia) and invasive Aspergillus infections.
About Invasive Candidiasis
Invasive candidiasis is a serious, often life-threatening infection caused by Candida species that typically affects a highly vulnerable population such as immunocompromised patients or patients under intensive care in hospital settings. We estimate that the U.S. annual incidence is approximately 98,000 cases with high mortality rates (i.e., 20-40%) despite currently available antifungal agents. Furthermore, the limited number of antifungal drug classes, consisting of azoles, echinocandins and polyenes, and their widespread use, has led to increased numbers of candida infections with drug-resistant strains. The Centers for Disease Control and Prevention (CDC) has listed fluconazole-resistant Candida as a serious public health threat requiring prompt and sustained action.
About Vulvovaginal Candidiasis
VVC, commonly known as a “yeast infection,” is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%-45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC.
About SCYNEXIS, Inc.
SCYNEXIS is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug for the treatment of serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
About Solar Capital
Solar Capital Partners, the investment advisor to Solar Capital Ltd., Solar Senior Capital Ltd. and other affiliated funds, primarily invests in leveraged, middle market companies in the form of senior secured loans, unitranche loans, mezzanine loans, and equity securities. As of June 30, 2016, Solar Capital Partners has invested approximately $5.6 billion in more than 250 different portfolio companies since it was founded in 2006 and has completed transactions with more than 145 different financial sponsors and venture capital firms.
Solar Capital’s life science lending segment provides financing solutions for bio-pharma, medical device, healthcare IT and healthcare services companies, both venture-backed private and public, and from pre-revenue clinical to early commercial stage.
Forward Looking Statement
Statements contained in this press release regarding the expected benefits from the loan agreement, including SCYNEXIS’s belief that it provides the company with the financial strength and flexibility to accelerate and expand the ongoing development of SCY-078 and to leverage its internal antifungal platform, and the expected benefits of SCY-078, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to a number of factors, including: regulatory risks; the risk that results in prior trials may not be repeated in subsequent trials; the risk that unexpected events may occur that may delay the reporting of results from clinical trials; and the risk that unexpected costs will be incurred in the clinical trials or otherwise. These risks and other risks are described more fully in SCYNEXIS’ filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: Media Relations Blair Atkinson MacDougall Biomedical Communications Tel: 781.235.3060 batkinson@macbiocom.com Investor Relations Susan Kim Argot Partners Tel: 212.203.4433 susan@argotpartners.com
$ARLZ to #Acquire From $AZN #US #Rights to #BetaBlocker #ToprolXL
-On an Adjusted EBITDA Basis, Transaction Expected to be EBITDA Accretive and to Move Profitability Forward to 2017-
-Company to Host Conference Call on October 4, 2016 at 8:30 a.m. ET-
MISSISSAUGA, Ontario, Oct. 4, 2016 — Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ), a global specialty pharmaceutical company, today announced it will acquire the U.S. rights to Toprol-XL® (metoprolol succinate) and its Authorized Generic (AG) pursuant to an agreement entered into between AstraZeneca and Aralez Pharmaceuticals Trading DAC, a subsidiary of Aralez. Toprol-XL is a cardioselective beta-blocker indicated for the treatment of hypertension, alone or in combination with other antihypertensives; the long term treatment of angina pectoris and treatment of stable, symptomatic (NYHA class II or III) heart failure of specific origins. It was first approved in the U.S. in 1992. AstraZeneca recorded U.S. net revenues from Toprol-XL and its AG of $89 million and $53 million in 2015 and year-to-date June 2016, respectively. The transaction is expected to be immediately EBITDA accretive and to move profitability forward to 2017, in each case on an adjusted EBITDA basis. The transaction is expected to be completed in the fourth quarter of 2016, subject to customary closing conditions.
The agreement includes an initial upfront payment of $175 million, which will be financed through a previously committed senior secured debt facility with Deerfield Management. At closing, Aralez will also borrow funds under this credit facility to replenish $25 million that was paid from cash on hand in connection with the recently announced ZONTIVITY® acquisition. In addition, Deerfield has agreed to provide Aralez access to up to an additional $250 million in capital to fund future mutually agreeable acquisitions. The transaction with AstraZeneca also includes mid-teen percentage royalties and up to $48 million of potential contingent milestone payments. In connection with the Asset Purchase Agreement, at closing the parties will enter into a Supply Agreement pursuant to which AstraZeneca will continue to manufacture and supply Toprol-XL and the AG to Aralez for at least ten years, a License Agreement with respect to certain trademarks and copyrights and a Transition Services Agreement. Under the terms of the Transition Services Agreement, AstraZeneca will continue to distribute the product on behalf of Aralez for up to nine months until the product is transferred to Aralez Pharmaceuticals Trading DAC.
“We are delighted to enter into an agreement with AstraZeneca for the U.S. rights to Toprol-XL and its AG, a beta blocker that further broadens our cardiovascular portfolio and, importantly, strengthens our financial profile by generating meaningful cash, which should accelerate our profitability to 2017 on an adjusted basis in addition to offsetting launch costs for YOSPRALA™ and ZONTIVITY,” said Adrian Adams, Chief Executive Officer of Aralez. “This transaction further reflects our ability to deliver against the expectations that we set upon the formation of Aralez that included promoting FIBRICOR®, approval and commercialization of YOSPRALA, and seizing opportunities to expand through aggressive business development and licensing as evidenced by our recent acquisition of ZONTIVITY and now Toprol-XL.”
Toprol-XL is an extended-release tablet that belongs to a family of high blood pressure medications known as beta-blockers. Extended-release tablets need to be taken only once a day. After swallowing Toprol-XL, the coating of the tablet dissolves, releasing a multitude of controlled release pellets filled with metoprolol succinate. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval of 24 hours.
Greenhill & Co. served as Financing Advisor and Willkie Farr & Gallagher LLP served as Legal Advisor in connection with the transaction.
Conference Call and Webcast
Aralez will host a conference call today at 8:30 a.m. ET, to discuss details of the transaction. The webcast can be accessed live and will be available for replay at www.aralez.com.
Conference Call Details
Date: Tuesday, October 4, 2016
Time: 8:30 a.m. ET
Dial-in (U.S.): 877-407-8037
Dial-in (International): 201-689-8037
About Hypertension
Hypertension, or high blood pressure, is dangerous because it makes the heart work too hard and contributes to atherosclerosis (hardening of the arteries). It increases the risk of heart disease and stroke, which are the first and third leading causes of death among Americans. High blood pressure can also result in other conditions, such as congestive heart failure, kidney disease, and blindness.
About Toprol-XL
Toprol-XL® is approved for the treatment of high blood pressure. By lowering blood pressure, Toprol-XL may lower the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Toprol-XL is also indicated for the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance and for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, Toprol-XL decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals.
Toprol-XL is supplied as 25mg, 50mg, 100mg and 200mg tablets designed for oral administration. For full prescribing information and additional important safety information, please visit: www.TOPOL-XL.com.
Important Safety Information
Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking Toprol-XL suddenly. If your doctor decides you should stop taking Toprol-XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.
Toprol-XL may not be right for everyone, especially people who have the following health conditions:
- Extreme slowing of the heart rate.
- Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally.
- Uncontrolled heart failure.
- Slowdown of the heart’s electrical signal causing a slower heart rate.
- Damage to the heart’s natural pacemaker that affects the heart’s rhythm unless one has a pacemaker device.
- Any allergies to Toprol-XL or its ingredients.
It is important to take your medications every day as directed by your doctor.
Patients who have asthma or asthma-like lung disease should, in general, not take Toprol-XL.
Your doctor may not want you to take Toprol-XL if you are currently taking certain types of high blood pressure medicine, or have adrenal gland tumors, diabetes, low blood sugar, liver damage, overactive thyroid disease, or hardening of the arteries in the arms or legs.
Your doctor may not want you to start taking Toprol-XL if you are about to have any type of surgery.
If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking Toprol-XL.
Until you know how you will react to Toprol-XL, avoid activities that require alertness.
Contact your doctor if you have any difficulty in breathing.
In patients with high blood pressure, the most common side effects were tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, and slow heart rate. If you experience any of these or other side effects, contact your doctor.
About Aralez Pharmaceuticals Inc.
Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ and TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients’ lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular, pain and other specialty areas. Aralez’s Global Headquarters is in Mississauga, Ontario, Canada, its U.S. Headquarters is planned to be in Princeton, NJ and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com.
Cautionary Language Concerning Forward-Looking Statements
This press release includes certain statements that constitute “forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements regarding transition matters and our ability to successfully integrate the acquisition of the U.S. rights to Toprol-XL and its AG, the closing of the acquisition of the U.S. rights to Toprol-XL and its AG, including the expected completion in the fourth quarter of 2016, financing the upfront payment of the acquisition of the U.S. rights to Toprol-XL and its AG under the debt facility with Deerfield Management and borrowing under such facility to replenish cash paid in connection with the recently announced ZONTIVITY acquisition, access to up to an additional $250 million in capital from Deerfield Management to fund future mutually agreeable acquisitions, payments of royalties and potential contingent milestones with respect to Toprol-XL and its AG, the distribution of the product by AstraZeneca on behalf of Aralez for up to nine months, the manufacture and supply of Toprol-XL and the AG by AstraZeneca, the benefits of Toprol-XL and its AG, the expected benefits to us of the acquisition of the U.S. rights to Toprol-XL and its AG, including that the transaction is expected to be immediately EBITDA accretive and to move profitability forward to 2017, in each case on an adjusted EBITDA basis, Toprol-XL and its AG as further broadening our cardiovascular portfolio and the acquisition as strengthening our financial profile by generating meaningful cash, offsetting launch costs for YOSPRALA and ZONTIVITY, the acquisition of the U.S. rights to Toprol-XL and its AG reflecting our ability to deliver against the expectations that we set upon our formation, that included promoting FIBRICOR, approval and commercialization of YOSPRALA, and seizing opportunities to expand through aggressive business development and licensing, and other statements that are not historical facts, and such statements are typically identified by use of terms such as “may,” “will,” “would,” “should,” “could,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “likely,” “potential,” “continue” or the negative or similar words, variations of these words or other comparable words or phrases, although some forward-looking statements are expressed differently.
You should be aware that the forward-looking statements included herein represent management’s current judgment and expectations, and are based on current estimates and assumptions made by management in light of its experience and perception of historical trends, current conditions and expected future developments, as well as other factors that it believes are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct and, as a result, the forward-looking statements based on those assumptions could prove to be incorrect. Accordingly, actual results, level of activity, performance or achievements or future events or developments could differ materially from those expressed or implied in the forward-looking statements. Our operations involve risks and uncertainties, many of which are outside of our control, and any one or any combination of these risks and uncertainties could also affect whether the forward-looking statements ultimately prove to be correct and could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, without limitation, our inability to build, acquire or contract with a sales force of sufficient scale for the commercialization of YOSPRALA, ZONTIVITY and FIBRICOR in a timely and cost-effective manner; our failure to successfully commercialize our products and product candidates; increased generic competition; costs and delays in the development and/or approval of our product candidates, including as a result of the need to conduct additional studies or due to issues with third-party API or finished product manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; the inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca AB and Horizon Pharma USA, Inc. for the sales and marketing of VIMOVO, our dependence on Patheon Pharmaceuticals Inc. for the manufacture of YOSPRALA, our dependence on Schering-Plough (Ireland) Company for the supply of ZONTIVITY and (following the closing of the acquisition of the U.S. rights thereto) our dependence on AstraZeneca AB for the manufacture and supply of Toprol-XL and its AG; our ability to protect our intellectual property and defend our patents; regulatory obligations and oversight; failure to successfully identify, execute, integrate and maintain new acquisitions, such as the integration of ZONTIVITY and (following the closing of the acquisition of the U.S. rights thereto) Toprol-XL and its AG; fluctuations in the value of certain foreign currencies, including the Canadian dollar, in relation to the U.S. dollar, and other world currencies; changes in government regulations, including tax laws and unanticipated tax liabilities; general adverse economic, market and business conditions; and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in the Company’s Securities and Exchange Commission (“SEC”) filings and reports and Canadian securities law filings, including in our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, which are available on EDGAR at www.sec.gov, on SEDAR at www.sedar.com, and on the Company’s website at www.aralez.com, and those described from time to time in our future reports filed with the SEC and applicable securities regulatory authorities in Canada. You should not place undue importance on forward-looking statements and should not rely upon this information as of any other date. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Contact Information:
Aralez Pharmaceuticals US Inc.
Nichol Ochsner
Executive Director,
Investor Relations & Corporate Communications
732.754.2545
nochsner@aralez.com
$PRTK to Ring @NASDAQ #ClosingBell Recognizing 20th Anniversary
BOSTON, Oct. 04, 2016 — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) will today ring the closing bell at Nasdaq to mark the company’s 20th anniversary of working to develop new antibiotics. Paratek Chairman and Chief Executive Officer Michael Bigham will be joined by his colleagues for the Closing Bell ceremony at 3:45 pm ET.
“We are honored to have been invited to participate in the Nasdaq Closing Bell ceremony and to celebrate Paratek’s 20th anniversary,” said Michael Bigham, Chairman and Chief Executive Officer, Paratek. “Through the steadfast devotion and hard work of our team our lead drug candidate omadacycline is in late phase 3 development, with one successful phase 3 study announced in June of this year, and with two additional phase 3 studies actively enrolling. Omadacycline is a broad spectrum, well-tolerated, once-daily oral and intravenous antibiotic being developed for the treatment of serious community-acquired bacterial infections, particularly where resistance is of concern.”
A live stream of the Nasdaq Closing Bell ceremony will be available at https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos of the ceremony will be available at http://business.nasdaq.com/discover/market-bell-ceremonies
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek’s lead product candidate, omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. In June 2016 Paratek announced positive efficacy data in a Phase 3 registration study in ABSSSI demonstrating the efficacy and safety of omadacycline compared to linezolid. A Phase 3 registration study for community acquired bacterial pneumonia (CABP) comparing IV-to-oral omadacycline to IV-to-oral moxifloxacin was initiated in November 2015. Enrollment continues on track to report top line data as early as the third quarter of 2017. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. Top line data are expected as early as the second quarter of 2017. A phase 1b study in uncomplicated urinary tract infections (UTI) was initiated in May 2016. Enrollment is nearly complete with top line data expected as early as the fourth quarter of 2016. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration.
Omadacycline is a new once-daily oral and IV, well-tolerated broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community acquired bacterial pneumonia, urinary tract infections and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians.
Paratek’s second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily, oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan initiated two identical Phase 3 registration studies in December 2014 for sarecycline for the treatment of moderate to severe acne vulgaris. Top line data are expected in the first half of 2017.
For more information, visit www.paratekpharma.com.
Forward Looking Statement
Certain statements in this press release are forward-looking statements. These forward-looking statements are based upon Paratek’s current expectations and involve substantial risks and uncertainties. These risks and uncertainties include, but are not limited to: (i) unexpected results may cause the designs of the clinical trials to change, or the projected timelines of the trials to be extended, (ii) unexpected decline in the rates of patient enrollment in the clinical trials, (iii) unforeseen adverse effects experienced by patients resulting in a clinical hold, (iv) failure of patients to complete clinical trials, (v) risks related to regulatory oversight of the trials, (vi) the need for substantial additional funding to complete the development and commercialization of product candidates and (vii) risks that data to date and trends may not be predictive of future results. These and other risk factors are discussed under “Risk Factors” and elsewhere in Paratek’s Annual Report on Form 10-K for the year ended December 31, 2015 and Paratek’s other filings with the Securities and Exchange Commission. Paratek expressly disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein.
CONTACTS: Media Relations: Michael Lampe (484) 575-5040 michael@scientpr.com Investor Relations: Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568
$ACIA .Announces. Launch of Proposed #PublicOffering
MAYNARD, Mass., Oct. 04, 2016 — Acacia Communications, Inc. (NASDAQ:ACIA), a leading provider of high-speed coherent optical interconnect products, today announced that it has commenced a follow-on public offering of 4,500,000 shares of its common stock pursuant to a registration statement on Form S-1 filed with the Securities and Exchange Commission. Acacia is proposing to sell 1,210,302 shares of Acacia common stock, and certain selling stockholders are proposing to sell 3,289,698 shares of Acacia common stock. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 675,000 shares of Acacia common stock from certain of the selling stockholders.
Acacia intends to use proceeds from the offering for working capital and general corporate purposes. Acacia will not receive any of the proceeds from any sale of shares by the selling stockholders.
Goldman, Sachs & Co., BofA Merrill Lynch, Deutsche Bank Securities Inc. and Morgan Stanley & Co. LLC are acting as joint bookrunners for the offering, and Needham & Company, LLC, Cowen and Company, LLC, William Blair & Company, L.L.C. and Northland Securities, Inc. are acting as co-managers.
The offering of these securities will be made only by means of a written prospectus. A copy of the prospectus related to the offering may be obtained from Goldman, Sachs & Co., Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: (866) 471-2526, or email: prospectus-ny@ny.email.gs.com; BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or email: dg.prospectus_requests@baml.com; Deutsche Bank Securities Inc., 60 Wall Street, New York, NY 10005, Attn: Prospectus Group, telephone: (800) 503-4611, or email: prospectus.cpdg@db.com; or Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, telephone: (866) 718-1649, or email: prospectus@morganstanley.com.
A registration statement relating to these securities was filed with the Securities and Exchange Commission but has not yet become effective. These 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 sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Acacia Communications
Acacia Communications develops, manufactures and sells high-speed coherent optical interconnect products that are designed to transform communications networks through improvements in performance, capacity and cost. By converting optical interconnect technology to a silicon-based technology, a process Acacia refers to as the “siliconization of optical interconnect,” Acacia is able to offer products that meet the needs of cloud and service provider customers in a simple, open, high-performance form factor that can be easily integrated in a cost-effective manner with existing network equipment.
For further information: Investor Relations Contact: Monica Gould Office: (212) 871-3927 Email: IR@acacia-inc.com Public Relations Contact: Jason Ouellette Office: (617) 399-4908 Email: Jason.ouellette@text100.com
$FTEO Drops #LitiView 2.0 #BusinessIntelligence Tool #AI Engine, #BigData
Improved features include simplified usage and multi-criteria analysis, enhancing FRONTEO’s AI to meet today’s growing speed of business
TOKYO, Oct. 04, 2016 — FRONTEO, Inc. (“FRONTEO” or “the Company”) (Nasdaq:FTEO) (TSE:2158), which provides big-data analytics services using its proprietary Artificial Intelligence (“AI”) engine, today announced that it has released a new version of “Lit i View AI Sukedachi Samurai”. The original version of the software, was put into service in October of last year, in order to assist companies mainly in the area of business intelligence; specifically, the software has been used for automatic extraction of relevant news both domestically and internationally, and automated classification of customer feedback in customer service centers.
With this new version, the Company has enhanced the usability of the software, enabling users to analyze data in a simpler and faster manner. The Company expects that this enhancement will move its AI use a step forward to meet today’s ever growing demands for speedy processing. “Lit i View AI Sukedachi Samurai” Version 2.0 implements the following features:
1. Improved workflow and User Interface
The workflow, from data importing to scoring, has been thoroughly overhauled, enabling the software to perform more straightforward and intuitive analyses.
2. Analysis capability from multiple perspectives
This new version can simultaneously analyze data from multiple perspectives. For example, wine may often be analyzed from multiple angles, such as “taste” and “value”. Adopting these different perspectives on the same data produces more sophisticated results, leading to a more accurate overall analysis.
“Lit i View AI Sukedachi Samurai” was developed as a system to support the Company’s clients through their decision-making process. FRONTEO has achieved the milestone of “supporting clients’ decision-making” by developing its proprietary artificial intelligence (AI) engine, “KIBIT” which learns senses and feelings — such as tacit knowledge or intuitive determination — specific to individual corporations. This ability to resolve problems with less effort has advanced the FRONTEO’s concept of a “practical AI”. Version 2.0 provides users with a more streamlined and nimble experience.
About FRONTEO, Inc.
FRONTEO, Inc. (“FRONTEO”) (Nasdaq:FTEO) (TSE:2158) supports the analysis of big data based on behavior informatics by utilizing its technology, “KIBIT”. FRONTEO’s KIBIT technology is driven by FRONTEO AI based on knowledge acquired through its litigation support services. KIBIT incorporates experts’ tacit knowledge, including their experiences and intuitions, and utilizes that knowledge for big data analysis. FRONTEO continues to expand its business operations by applying KIBIT to new fields such as healthcare and marketing. FRONTEO was founded in 2003 as a provider of e-discovery and international litigation support services. These services include the preservation, investigation and analysis of evidence materials contained in electronic data, and computer forensic investigation. FRONTEO provides e-discovery and litigation support by making full use of its data analysis platform, “Lit i View®“, and its Predictive Coding technology adapted to Asian languages. The company name was changed from FRONTEO, Inc. to FRONTEO, Inc. as of July 1, 2016.
For more information about FRONTEO, contact usinfo@fronteo.com or visit
http://www.fronteo.com/global/.
Safe Harbor Statement
This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the amount of data that FRONTEO expects to manage this year and the potential uses for FRONTEO’s new service in intellectual property-related litigation, contain forward-looking statements. FRONTEO may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about FRONTEO’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: FRONTEO’s goals and strategies; FRONTEO’s expansion plans; the expected growth of the data center services market; expectations regarding demand for, and market acceptance of, FRONTEO’s services; FRONTEO’s expectations regarding keeping and strengthening its relationships with customers; FRONTEO’s plans to invest in research and development to enhance its solution and service offerings; and general economic and business conditions in the regions where FRONTEO provides solutions and services. Further information regarding these and other risks is included in FRONTEO’s reports filed with, or furnished to the Securities and Exchange Commission. FRONTEO does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release and in the attachments is as of the date of this press release, and FRONTEO undertakes no duty to update such information, except as required under applicable law.
CONTACT: FRONTEO Global PR FRONTEO USA, Inc. Tel: (212) 924-8242 global_pr@fronteo.com
$SMMT & $SRPT #License & #Collaboration Agreement #European Rights to #Utrophin in #MS
- Sarepta and Summit collaborate to advance the development of novel therapies for patients with Duchenne muscular dystrophy
- Summit receives $40 million upfront, with potential future ezutromid-related milestone payments totalling up to $522 million plus royalties
- Sarepta and Summit to share research and development costs
- Sarepta also receives option for Latin American rights
CAMBRIDGE, Mass. and OXFORD, United Kingdom, Oct. 04, 2016 — Sarepta Therapeutics (NASDAQ:SRPT) and Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) today announced that they have entered into an exclusive license and collaboration agreement granting Sarepta rights in Europe, as well as in Turkey and the Commonwealth of Independent States (‘the licensed territory’), to Summit’s utrophin modulator pipeline, including its lead clinical candidate, ezutromid, for the treatment of Duchenne muscular dystrophy (‘DMD’). As part of the agreement, Sarepta also obtains an option to license Latin American rights to Summit’s utrophin modulator pipeline. Summit retains commercialization rights in all other countries.
Utrophin modulation is a potential disease-modifying treatment for all patients with the fatal muscle wasting disease DMD, regardless of their underlying dystrophin gene mutation. Ezutromid is currently in a Phase 2 proof of concept trial called PhaseOut DMD.
“This partnership with Summit Therapeutics furthers our commitment to invest in innovative approaches to treating Duchenne and supports our common goal of improving the lives of patients with DMD,” said Edward Kaye, M.D., Sarepta’s Chief Executive Officer. “Summit’s utrophin modulation technology represents a potentially promising approach to treat DMD, which may complement our current approach of exon skipping therapy.”
“Sarepta Therapeutics has paved the way in the development of disease-modifying therapies for DMD with the first FDA-approved drug in this disease area, making them a strong strategic partner to support our utrophin modulator pipeline,” commented Glyn Edwards, Chief Executive Officer of Summit. “This agreement provides us with access to Sarepta’s development, regulatory and commercialisation expertise for the continued advancement of our promising utrophin modulator pipeline. We look forward to this partnership and working together to bring great advances to patients and families living with DMD.”
Under the terms of the agreement, Summit will receive an upfront fee of $40 million. In addition, Summit will be eligible for future ezutromid related development, regulatory and sales milestone payments totalling up to $522 million, including a $22 million milestone upon the first dosing of the last patient in Summit’s PhaseOut DMD trial, and escalating royalties ranging from a low to high teens percentage of net sales in the licensed territory. Summit will also be eligible to receive development and regulatory milestones related to its next-generation utrophin modulators. Sarepta and Summit will share specified utrophin modulator-related research and development costs at a 45%/55% split, respectively, beginning in 2018. If Sarepta elects to exercise its option for Latin American rights, Summit would be entitled to additional fees, milestones and royalties.
Sarepta and Summit will host an update call for the Duchenne community on Monday, October 10 at 12:00pm EDT. Details of the call can be accessed by visiting http://www.parentprojectmd.org/communitycall.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to treat all patients with DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company’s lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration (‘FDA’) and the European Medicines Agency have granted orphan drug status to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation and Rare Pediatric Disease designation by the FDA.
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 programmes 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).
About Sarepta
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.
Contacts
For Sarepta Therapeutics:
| Sarepta Ian Estepan |
Tel: 617-274-4052 iestepan@sarepta.com |
| W2O Group Brian Reid |
Tel: 212-257-6725 breid@w2ogroup.com |
For Summit:
| Summit Glyn Edwards / Richard Pye (UK office) Erik Ostrowski / Michelle Avery (US office) |
Tel: +44 (0)1235 443 951 +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 |
| MacDougall Biomedical Communications (US media contact) Chris Erdman / Karen Sharma |
Tel: +1 781 235 3060 cerdman@macbiocom.com ksharma@macbiocom.com |
| Consilium Strategic Communications (Financial public relations, UK) Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Lindsey Neville |
Tel: +44 (0)20 3709 5700 Summit@consilium-comms.com |
Sarepta Forward-looking Statements
This press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the terms of the license and collaboration agreement Sarepta has entered into with Summit (Oxford) LTD, including the rights, obligations and benefits of each party under the agreement such as Sarepta’s commercialization rights for certain product candidates in specified territories and Sarepta’s payments associated with those rights to Summit; the potential of ezutromid and utrophin modulation as a disease-modifying treatment for all patients with DMD regardless of their dystrophin gene mutation; the potential benefits to the parties and the DMD community resulting from the agreement; the partnership between the parties furthering their common goal of improving the lives of patients with DMD; the potential of utrophin modulation technology to complement Sarepta’s current approach of exon skipping therapy; Summit’s plans to access Sarepta’s expertise for the continued advancement of their promising utrophin modulator pipeline and working together to bring great advances to patients and families living with DMD.
These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: the expected benefits and opportunities related to the license and collaboration and agreement may not be realized or may take longer to realize than expected due to challenges and uncertainties inherent in product research and development; the partnership between Sarepta and Summit may not result in any viable treatments suitable for clinical research or commercialization due to a variety of reasons including the results of future research may not be consistent with past positive results or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates or may never become commercialized products due to other various reasons including any potential future inability of the parties to fulfill their commitments and obligations under the agreement, including any inability by Sarepta to fulfill its financial commitments to Summit; and even if the agreement results in commercialized products the parties may not achieve any significant revenues from the sale of such products.
Any of the foregoing risks could adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta’s 2015 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Summit 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 potential benefits and future operation of the collaboration with Sarepta Therapeutics, including any potential future payments thereunder, 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 ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials 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, 2016. 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.
$OPCO @OurPetsBrand #KathleenHomyock Talks #SmartTechnology Trends In #Pet Industry
FAIRPORT HARBOR, OH–(Oct 4, 2016) – OurPet’s Company (OTCQX: OPCO), a leading proprietary pet supply company, continues to show innovation leadership, as demonstrated by the Company’s recent presentation by Kathleen Homyock, Vice President of Sales and Business Development, at last month’s National Pet Industry Trade Show hosted by the Pet Industry Joint Advisory Council (PIJAC) Canada.
Homyock’s presentation, titled “Technology Translated to Pet Fitness, Food and Fun,” showcases how intelligent technology accessories enable pet owners to effectively monitor optimum health and wellbeing of their pets.
“It is always interesting to speak with industry professionals about how smart technology is changing pet products. I was excited to have the opportunity to speak at the show in September and I am even more excited to work for a company that values this technology and continuously works to bring intelligent health and fitness monitoring products into the marketplace,” says Homyock.
OurPet’s Company recently launched its OurPets® Intelligent Pet Care™ line of products that utilize smart technology to monitor pet health with the IntelligentPetLink™ smartphone app. The product line includes the SmartScoop – Intelligent Litter Box, the SmartLink Feeder – Intelligent Pet Bowl, and the SmartLink Waterer – Intelligent Water Fountain.
You can find Homyock’s presentation, as well as more information about OurPet’s and its products, on the company’s website at www.ourpets.com.
About the OurPet’s Company
The OurPet’s Company (OTCQX: OPCO) designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets® and Pet Zone® brands domestically and internationally. OurPets® and Pet Zone® products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. Since its founding in 1995, the OurPet’s Company has been building an extensive intellectual property portfolio with more than 170 patents in either issued or pending status all devoted to solving problems related to the human/pet bond. OurPet’s was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, the OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.
Media Contact:
Peter Ostapowicz
Marketing Communications Specialist
Email Contact
Investor Relations:
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
Email Contact
$CATM to #Acquire #DirectCashPayments
Highlights
- DirectCash Payments is a leading operator of approximately 25,000 ATMs across Australia, Canada, the United Kingdom, New Zealand and Mexico
- Acquisition includes DCPayments’ acquisition of 3,500 ATMs in Australia from First Data Corporation, completed on September 30, 2016
- Establishes Australia and New Zealand as new markets for Cardtronics
- Significantly scales presence in Canada and the United Kingdom
- Addition of new marquis financial institution and retail customers in multiple markets
- Expected to be accretive to Cardtronics adjusted net income per share after closing
- Expected to close in the first quarter of 2017
HOUSTON and CALGARY, Alberta, Oct. 03, 2016 — Cardtronics plc (Nasdaq:CATM) and DirectCash Payments Inc. (“DCPayments”) today announced a definitive agreement under which Cardtronics would acquire DCPayments. The purchase price of CAD$19.00 per share includes the assets of First Data Corporation’s Australian retail ATM and managed services ATM portfolio (“First Data ATM portfolio”), which was acquired by DCPayments on September 30. DCPayments is a leading global ATM services provider with approximately 25,000 ATMs (inclusive of its First Data ATM portfolio acquisition) with primary operations in Australia, Canada and the United Kingdom. The combination will leverage Cardtronics’ existing infrastructure and relationships, and drive substantial operating synergies. The combined companies would serve approximately 225,000 ATMs in North America, Europe and Asia-Pacific.
Cardtronics Chief Executive Officer Steve Rathgaber commented:
“Our proposed combination with DCPayments will enhance our global presence by adding Australia as an anchor market in Asia-Pacific, in addition to New Zealand. It also would grow Cardtronics’ existing ATM estates in Canada, the United Kingdom and Mexico. The combination will further position us to be the preferred global provider of ATM solutions to retailers and financial institutions. This acquisition would broaden our exposure to helping financial institutions reevaluate their physical presence as part of the bank transformation trends we are seeing worldwide.”
Expansion into Asia-Pacific
The acquisition of DCPayments would establish Australia as a new platform for growth, alongside Cardtronics’ existing presence in North America and Europe. DCPayments is a leading independent ATM operator in Australia, with approximately 11,000 ATMs owned or managed, inclusive of its recent First Data ATM portfolio acquisition.
Enhanced Scale and Capabilities in Canada
This combination would result in Cardtronics managing more than 11,000 ATMs in Canada, a leadership position in the independent ATM market that would also create opportunities to service additional Canadian financial institutions to add convenient points of presence to their ATM networks.
United Kingdom Expansion
DCPayments would add more than 5,700 ATMs to the company’s existing footprint in the United Kingdom, providing an opportunity to deliver Cardtronics’ service level excellence and cost efficiency to these additional ATMs.
DCPayments President & Chief Executive Officer Jeffrey J. Smith commented:
“The combination of DCPayments and Cardtronics creates a unique platform that is ideally suited to maximize customer value for both organizations. There is a tremendous fit between our two organizations, and I am confident that the combined businesses will perform at even higher levels for customers and employees.”
Cardtronics Chief Executive Officer Steve Rathgaber added:
“The acquisition of DCPayments marks a significant milestone for Cardtronics, taking us into Asia-Pacific and growing our presence in existing geographies. Combining these two strong businesses will offer exceptional opportunities for everyone that we serve – customers, employees, partners and shareholders. I am particularly excited about the implications for our customers, who will benefit from our expanded global footprint as well as our combined expertise, talent and capabilities.”
Transaction Details
Under the terms of the agreement, Cardtronics will acquire all of the outstanding equity of DCPayments for CAD$19.00 per share in cash, representing a transaction value of approximately $460 million in U.S. dollars, including approximately $53 million of debt incurred by DCPayments to finance its purchase of the First Data Australian ATM portfolio on September 30, 2016. The First Data Australian ATM portfolio acquisition is expected to contribute more than $10 million of annual Adjusted EBITDA. Cardtronics intends to fund the DCPayments acquisition with cash on hand as well as fully committed debt financing. Cardtronics has received commitments from banks to expand the size of its credit facility upon the completion of the transaction. Subject to satisfaction of certain closing conditions, including the approval of DCPayments’ shareholders and court approval as required by applicable law, the transaction is expected to close early in the first quarter of 2017. After closing, we expect the acquisition to be accretive to non-GAAP adjusted net income per share. After completion of the transaction, the financial impact will be reflected in our fiscal 2017 guidance, expected to be issued in the first quarter of 2017.
RBC Capital Markets, LLC is serving as financial advisor and Baker & McKenzie is serving as legal counsel to Cardtronics. BMO Capital Markets is serving as financial advisor to DCPayments, and Bennett Jones is serving as legal counsel.
Conference Call
Cardtronics will host a conference call today, October 3, at 9:00 a.m. EDT to discuss this transaction.
To access the call, please call the conference call operator at:
Conference line: (877) 303-9205
Alternate dial-in: (760) 536-5226
Please call in 15 minutes prior to the scheduled start time and request to be connected to the “Cardtronics Conference Call.” Additionally, a live audio webcast of the conference call will be available online through the investor relations section of Cardtronics’ website at www.cardtronics.com.
A digital replay of the conference call will be available through October 17, 2016 and can be accessed by calling (855) 859-2056 or (404) 537-3406 and entering 93209837 for the conference ID. A replay of the conference call will also be available online through Cardtronics’ website subsequent to the call through October 15, 2016.
About DirectCash Payments
Established in 1997 and based in Calgary, Alberta, Canada, DCPayments is one of the leading ATM services providers in Canada, Australia and the United Kingdom, plus established footprints in New Zealand and Mexico. DCPayments is also one of the leading providers of credit union and other financial institution processing and outsourcing services, branded non-financial institution debit terminals and prepaid card products in Canada. DCPayments has proven itself as a global leader in delivering a wide array of best-in-class payments and ATM solutions. DCPayments’ end-to-end payment solutions business includes long-term contracts with a diversified base of premium retail and banking entities across its global footprint.
Additional information about DCPayments is available on SEDAR (www.sedar.com) and on the DCPayments website (www.directcash.net).
About Cardtronics (Nasdaq:CATM)
Making ATM cash access convenient where people shop, work and live, Cardtronics is at the convergence of retailers, financial institutions, prepaid card programs and the customers they share. Cardtronics provides services to approximately 200,000 ATMs in North America and Europe. Whether Cardtronics is driving foot traffic for North America and Europe’s top retailers, enhancing ATM brand presence for card issuers or expanding card holders’ surcharge-free cash access, Cardtronics is convenient access to cash, when and where consumers need it. Cardtronics is where cash meets commerce.
Non-GAAP Information
This press release refers to non-GAAP financial measures utilized by Cardtronics as complements to U.S. GAAP measures. Please see Cardtronics’ filings with the U.S. Securities and Exchange Commission for definitions of Adjusted EBITDA and Adjusted Net Income per share, along with management’s view of the usefulness of such measures.
Contact Information – Cardtronics:
Media Relations
Nick Pappathopoulos
Director – Public Relations
832-308-4396
npappathopoulos@cardtronics.com
Investor Relations
Phillip Chin
EVP Corporate Development & Investor Relations
832-308-4975
ir@cardtronics.com
Contact Information – DCPayments:
Jeffrey J. Smith
President & Chief Executive Officer
(403) 387-2101
jeff@directcash.net
Cardtronics is a registered trademark of Cardtronics plc and its subsidiaries
All other trademarks are the property of their respective owners.
$AQXP Dr. #BarbaraTroupin as #CMO (Chief Medical Officer)
VANCOUVER, British Columbia, Oct. 03, 2016 — Aquinox Pharmaceuticals, Inc. (“Aquinox”) (NASDAQ:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, is pleased to announce the appointment of Dr. Barbara Troupin, M.D. as Chief Medical Officer and Vice President, Clinical Development. Dr. Troupin will lead overall clinical and medical affairs strategies for Aquinox’s ongoing programs as well as future development and potential commercialization plans.
Over more than 18 years Dr. Troupin has led clinical development and strategy at multiple, leading clinical research institutions and within the therapeutic drug development sector. Dr. Troupin most recently served as Senior Vice President and Chief Medical Officer at Apricus Bioscience, Inc. where she led the development and execution of clinical strategy for three drug development programs ranging from proof-of-concept to NDA filing, including Vitaros for the treatment of erectile dysfunction. Prior to Apricus, Dr. Troupin held the role of Vice President in Medical Affairs at VIVUS, Inc. where she led risk evaluation and mitigation strategy for Qsymia to treat weight loss, while also building relationships with thought leaders and key opinion leaders (KOLs). Dr. Troupin received her Doctorate in Medicine in 1995 from the University of Pennsylvania School of Medicine where she also completed her Master’s in Business Administration, with an emphasis in health care management, from the Wharton School of Business.
“Barbara brings a proven track record of building KOL and patient advocacy relationships, defending regulatory submissions, and overall success in clinical strategy,” said David Main, President & CEO of Aquinox. “Barbara joins at an ideal time for contributing medical and clinical leadership to our recently initiated Leadership 301 phase 3 clinical trial with AQX-1125 in Interstitial Cystitis/Bladder Pain syndrome (IC/BPS) as well as for guiding our clinical expansion and supporting our potential partnering and commercial preparations.”
About Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
IC/BPS is a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency. For many sufferers, these symptoms are severe and adversely affect all major aspects of their lives, including overall physical and emotional health, employment, social and intimate relationships, and leisure activities. While the cause of the disease remains largely unknown, erosion of the bladder lining is thought to be a significant contributor. IC/BPS is estimated to affect millions of people in the United States and around the world. Most IC/BPS patients continue to suffer this debilitating condition, despite treatment with existing therapies. Most current therapies and those in development are focused solely on symptomatic relief of IC/BPS. Aquinox believes new and innovative therapies that target the underlying disease in order to reduce the chronic pain and urinary symptoms are needed.
About AQX-1125
AQX-1125, Aquinox’s lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. By increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration to sites of inflammation. AQX-1125 has demonstrated preliminary safety and favorable drug properties for once daily oral administration in multiple preclinical studies and seven completed clinical trials.
About Aquinox Pharmaceuticals, Inc.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Aquinox’s lead drug candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. With a successful Phase 2 clinical trial completed in 2015, Aquinox initiated a Phase 3 trial in 2016 (LEADERSHIP 301) with AQX-1125 for treatment of IC/BPS in August of 2016. Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1. For more information, please visit www.aqxpharma.com.
Cautionary Note on Forward-looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to potential commercialization of, and market opportunities for, AQX-1125. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; as an organization, we have never conducted a pivotal clinical trial before; the size and growth of the potential markets for AQX-1125 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of AQX-1125 or any future product candidates; reaching agreement on design of pivotal trials with regulatory authorities and our expectations regarding the potential safety, efficacy or clinical utility of AQX-1125 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Aquinox is contained in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 filed with the Securities and Exchange Commission. Aquinox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact Info:
Brendan Payne
Senior Manager, Investor Relations
Aquinox Pharmaceuticals, Inc.
604.901.3019
ir@aqxpharma.com
Gitanjali Ogawa
Vice President
The Trout Group
646-378-2949
Gogawa@troutgroup.com
$CCIH to Participate in Jefferies 6th #AnnualGreaterChinaSummit
BEIJING, Oct. 03, 2016 — ChinaCache International Holdings Ltd. (“ChinaCache” or the “Company”) (NASDAQ:CCIH), the leading total solutions provider of Internet content and application delivery services in China, today announced its participation in the Jefferies 6th Annual Greater China Summit on October 26-27 at the Island Shangri-La hotel in Hong Kong.
Management will meet with institutional investors throughout the event. For additional information, please contact the respective institutional sales representative at the sponsoring bank.
About ChinaCache International Holdings Ltd.
ChinaCache International Holdings Ltd. (Nasdaq:CCIH) is the leading total solutions provider of Internet content and application delivery services in China. As a carrier-neutral service provider, ChinaCache’s network in China is interconnected with networks operated by all telecom carriers, major non-carriers and local Internet service providers. With more than a decade of experience in developing solutions tailored to China’s complex Internet infrastructure, ChinaCache is a partner of choice for businesses, government agencies and other enterprises to enhance the reliability and scalability of online services and applications and improve end-user experience. For more information on ChinaCache, please visit ir.chinacache.com.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. ChinaCache may also make written or oral forward-looking statements in its reports filed or furnished to the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statements, including but not limited to the following: the Company’s goals and strategies, expansion plans, the expected growth of the content and application delivery services market, the Company’s expectations regarding keeping and strengthening its relationships with its customers, and the general economic and business conditions in the regions where the Company provides its solutions and services. Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of this press release, and ChinaCache undertakes no duty to update such information, except as required under applicable law.
For investor and media inquiries please contact: Investor Relations Department ChinaCache International Holdings Tel: +86 (10) 6408 5307 Email: ir@chinacache.com Mr. Ross Warner The Piacente Group | Investor Relations Tel: +86 (10) 6535-0149 Email: chinacache@tpg-ir.com Mr. Alan Wang The Piacente Group | Investor Relations Tel: +1 212-481-2050 Email: chinacache@tpg-ir.com
$CXRX Exercises Option to Defer Portion of #EarnOut
OAKVILLE, ON, Oct. 3, 2016 – Concordia International Corp. (the “Company”) (NASDAQ: CXRX) (TSX: CXR) – together with its subsidiaries (“Concordia”) – an international pharmaceutical company focused on legacy pharmaceutical products and orphan drugs, today announced that it has exercised an option to defer half of the anticipated £144 million earn-out obligation due to Cinven1 and the other sellers of Concordia’s International segment, to February 1, 2017.
“Our decision to defer £72 million of the earn-out reflects Cinven’s continued support for Concordia and provides the Company with greater flexibility to manage its obligations,” said Mark Thompson, Chairman and Chief Executive Officer of Concordia.
Concordia expects the first payment of £72 million will be paid to Cinven and the other sellers of Concordia’s International segment on or about December 19, 2016, followed by a payment of approximately £73.4 million (which includes a financing charge of up to £1.4 million) on or before February 1, 2017. Concordia intends to use cash on hand generated by its International segment to make the first payment of £72 million.
Update on review of strategic alternatives
The Company continues to evaluate its strategic alternatives including, but not limited to, various capital markets financing options. There can be no assurance that any transaction will occur. Concordia does not intend to make any additional comments at this time regarding various strategic alternatives potentially available to the Company.
About Concordia
Concordia is a diverse, international pharmaceutical company focused on legacy pharmaceutical products and orphan drugs. The Company has an international footprint with sales in more than 100 countries, and has a diversified portfolio of more than 200 established, off-patent molecules that make up more than 1,300 SKUs. Concordia also markets orphan drugs through its Orphan Drugs Division, consisting of Photofrin® for the treatment of certain rare forms of cancer, which is currently undergoing testing for potential new indications.
Concordia operates out of facilities in Oakville, Ontario, Bridgetown, Barbados; London, England and Mumbai, India.
Notice regarding forward-looking statements:
This press release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding Concordia and its business, which may include, but are not limited to, statements with respect to the estimated cost to Concordia to defer the earn-out, the intention to pay the earn-out due in December 2016 with cash on hand, the expected date on which the first half of the earnout obligation will be paid and the flexibility that the deferred earnout payment provides Concordia to manage its obligations, any strategic alternatives potentially available to the Company (including, any financing options) and other factors. Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of Concordia’s management, and are based on assumptions and subject to risks and uncertainties. Although Concordia’s management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this press release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the inability to complete a transaction, risks associated with any financing, Concordia’s securities, risks associated with developing new product indications, increased indebtedness and leverage, the inability to generate cash flows, revenues and/or stable margins, the inability to grow organically, the inability to repay debt and/or satisfy future obligations (including, without limitation, earn out obligations), risks associated with Concordia’s outstanding debt, risks associated with the geographic markets in which Concordia operates and/or distributes its products, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), risks associated with the use of Concordia’s products to treat certain diseases, the pharmaceutical industry and the regulation thereof, regulatory investigations, the failure to comply with applicable laws, risks relating to distribution arrangements, possible failure to realize the anticipated benefits of acquisitions and/or product launches, risks associated with the integration of assets and businesses into Concordia’s business, product launches, the inability to launch products, the fact that historical and projected financial information may not be representative of Concordia’s future results, the failure to obtain regulatory approvals, economic factors, market conditions, acquisition opportunities, risks associated with the acquisition and/or launch of pharmaceutical products, risks regarding clinical trials and/or patient enrollment into clinical trials, the equity and debt markets generally, risks associated with growth and competition (including, without limitation, with respect to Concordia’s niche, hard-to-make products), general economic and stock market conditions, risks associated with the United Kingdom’s exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross-border tariff and cost structures and the loss of access to the European Union global trade markets), risks related to patent infringement actions, the loss of intellectual property rights, risks and uncertainties detailed from time to time in Concordia’s filings with the Securities and Exchange Commission and the Canadian Securities Administrators and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and forward-looking information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or forward-looking information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and forward-looking information speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement or forward-looking information, whether as a result of new information, future events, or otherwise.
1In this press release ‘Cinven’ means, depending on the context, any of or collectively, Cinven Group Limited, Cinven Partners LLP, Cinven (LuxCo1) S.A., Cinven Capital Management (V) General Partner Limited and their respective Associates (as defined in the Companies Act 2006) and/or funds managed or advised by the group.
SOURCE Concordia International Corp.
$ITUS #Cchek Early #CancerDetection Platform With #Liver #Cancer
LOS ANGELES, CA–(October 03, 2016) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS) today announced that it has successfully utilized its Cchek™ early cancer detection platform to identify the presence of Liver Cancer. Although somewhat rare in the United States, Liver Cancer is the 6th most diagnosed cancer worldwide, and 5th leading cause of cancer deaths.
Cchek™ is ITUS’s early cancer detection technology which measures a patient’s immunological response to a malignancy by detecting the presence, absence, and quantity of certain unique immune system cells that exist in and around a tumor and that enter the blood stream. As part of the ongoing development of ITUS’s Cchek diagnostic platform, the company has successfully used Cchek to detect the presence of Liver Cancer in patients that have been diagnosed via conventional means such as invasive procedures like surgical biopsies.
Approximately 782,000 new cases of Liver Cancer are diagnosed each year worldwide and Liver Cancer accounts for approximately 554,000 annual deaths.
The 5-year relative survival rate for patients with Liver Cancer is 17%. Forty-three percent of patients are diagnosed with a localized stage of disease, for which 5-year survival is 31%. The company previously announced success with Cchek detecting Breast Cancer, Lung Cancer, Colorectal Cancer, Ovarian Cancer, and Melanoma.
ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies in areas such as biotechnology. The Company is developing a platform called Cchek™, a series of non-invasive, blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2015 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com
$VHC Wins Again Over $AAPL $302M #Texas #Patent #Infringement Verdict
Caldwell Cassady & Curry law firm notches fifth trial victory against tech giant
TYLER, Texas, Oct. 3, 2016 — Attorneys from Dallas’ Caldwell Cassady & Curry have won another multimillion-dollar patent infringement award for Nevada-based VirnetX Holding Corp. (NYSE MKT: VHC) against technology giant Apple Inc. (NASDAQ: AAPL) based on an East Texas jury’s finding that Apple owes more than $302 million in royalties for infringing internet security patents owned by VirnetX.
Jurors in the Tyler, Texas, courtroom of Judge Robert W. Schroeder III delivered the verdict in favor of VirnetX on Sept. 30 after one week of trial. The case is VirnetX Inc., et al. v. Apple Inc., No. 6:10-CV-417, in the U.S. District Court for the Eastern District of Texas.
Caldwell Cassady & Curry name principals Bradley W. Caldwell, Jason D. Cassady and J. Austin Curry led the team representing VirnetX. The company also called on Johnny Ward from Ward, Smith & Hill, PLLC, in Longview and attorneys from Parker, Bunt & Ainsworth, P.C., of Tyler. Also representing VirnetX from Caldwell Cassady & Curry were firm principal Justin T. Nemunaitis and firm attorneys Hamad M. Hamad, Warren J. McCarty, Jason S. McManis, Daniel R. Pearson, Christopher S. Stewart, and John F. Summers.
VirnetX previously won two significant jury awards against Apple with Caldwell Cassady & Curry as lead counsel, including a 2012 patent infringement verdict of $368 million involving four VirnetX network patents used in iPhones, iPads and other Apple products. Two years later, the U.S. Court of Appeals for the Federal Circuit upheld the jury’s infringement finding on two of the contested patents and confirmed a finding of no invalidity on all four patents before vacating the damages award. That ruling allowed Apple to stop paying royalties and cleared the way for a retrial on damages.
In the retrial decided earlier this year before Judge Schroeder, the attorneys from Caldwell Cassady & Curry won a $625 million verdict for VirnetX when jurors determined that Apple infringed the same four patents from the original trial. That award, which stands as the fourth-largest jury verdict in the U.S. this year, was then vacated by the trial court. The case was then severed into two trials, the first of which VirnetX won on Friday.
“This verdict is the third time in a row that a jury has told Apple that it must pay for infringing VirnetX’s patents,” says Mr. Cassady. “It is clear that Apple used our client’s intellectual property without permission in order to sell hundreds of millions of devices, which is why the jury ruled the way it did.”
In addition to the three trial wins on behalf of VirnetX, Caldwell Cassady & Curry helped a different client win a $22 million patent infringement verdict against Apple two weeks ago before another Eastern District jury. In a separate patent dispute decided last year, the firm won the nation’s third-largest verdict when another Eastern District jury awarded $532.9 million against Apple.
Dallas-based Caldwell Cassady & Curry represents clients in intellectual property disputes and commercial litigation claims. The firm is home to trial lawyers who have tried and won some of the biggest verdicts of the past decade against some of the largest companies in the world. Visit http://www.caldwellcc.com.
For more information, contact Bruce Vincent at bruce@androvett.com or 800-559-4534.
$FVE Grants Certain Ownership Limitation Exemptions to #ABPAcquisition $RMR
On October 1, 2016, the Board of Directors of Five Star Quality Care, Inc. (Nasdaq:FVE), acting by a special committee, granted ABP Acquisition LLC a conditional exemption from certain Five Star bylaw and charter restrictions applicable to certain ownership limitations of not more than 5% and 9.8% of Five Star’s shares of common stock, respectively. Five Star understands that ABP Acquisition LLC intends to make a tender offer for up to 10,000,000 shares at $3.00 per share. ABP Acquisition LLC is affiliated with Mr. Barry Portnoy, a Managing Director of Five Star, and with the controlling shareholders of The RMR Group Inc. (Nasdaq: RMR) and its subsidiary The RMR Group LLC, Five Star’s business manager.
A Special Committee of Five Star’s Board of Directors composed of all of Five Star’s Independent Directors negotiated and approved a Consent, Standstill, Registration Rights and Lock-Up Agreement with ABP Acquisition LLC, pursuant to which the Five Star shares ABP Acquisition LLC may acquire in the tender offer will be subject to standstill and lockup restrictions for extended periods. The Board acting by this Special Committee intends to express no opinion to the Company’s shareholders with respect to the tender offer as it believes the decision as to whether to tender Five Star shares is a personal decision which should be made by shareholders based upon their personal circumstances. Five Star’s Board suggests that each shareholder should review the tender offer and all related information, when available, consult with such holder’s financial and tax advisors and make an independent determination.
Five Star Quality Care, Inc. is a senior living and healthcare services company. As of June 30, 2016, Five Star operated 276 senior living communities (excluding one senior living community classified as a discontinued operation) with 31,191 living units located in 32 states, including 214 communities (22,952 living units) that it owned or leased and 62 communities (8,239 living units) that it managed. These communities include independent living, assisted living, continuing care retirement communities and skilled nursing communities. Five Star is headquartered in Newton, Massachusetts.
IMPORTANT NOTICE
This press release does not constitute an offer to sell or purchase, or the solicitation of tenders with respect to Five Star’s shares. ABP Acquisition LLC has not yet commenced the tender offer described herein. If ABP Acquisition LLC commences a tender offer for shares of Five Star common stock, it will file with the Securities and Exchange Commission a tender offer statement on Schedule TO and Five Star will file a solicitation/recommendation statement on Schedule 14D-9. Shareholders of Five Star are encouraged to read each of the tender offer statement of ABP Acquisition LLC and Five Star’s solicitation/recommendation statement on Schedule 14D-9 when each becomes available because they will contain important information about the tender offer. Shareholders may obtain the tender offer statement and the solicitation/recommendation statement and other filed documents at no charge by requesting them when they are available on the Securities and Exchange Commission’s website (www.sec.gov) and at no charge from Five Star or ABP Acquisition LLC. Five Star shareholders are urged to read these materials, if and when they become available, carefully before making any decision with respect to the tender offer.
WARNING REGARDING FORWARD LOOKING STATEMENTS
THIS PRESS RELEASE CONTAINS STATEMENTS THAT CONSTITUTE FORWARD LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 AND OTHER SECURITIES LAWS. ALSO, WHENEVER FIVE STAR USES WORDS SUCH AS “BELIEVE”, “EXPECT”, “ANTICIPATE”, “INTEND”, “PLAN”, “ESTIMATE”, “MAY” OR SIMILAR EXPRESSIONS, FIVE STAR IS MAKING FORWARD LOOKING STATEMENTS. THESE FORWARD LOOKING STATEMENTS ARE BASED UPON FIVE STAR’S PRESENT INTENT, BELIEFS OR EXPECTATIONS, BUT FORWARD LOOKING STATEMENTS ARE NOT GUARANTEED TO OCCUR AND MAY NOT OCCUR. ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE CONTAINED IN OR IMPLIED BY FIVE STAR’S FORWARD LOOKING STATEMENTS AS A RESULT OF VARIOUS FACTORS. FOR EXAMPLE: THE FIVE STAR BOARD UNDERSTANDS THAT ABP ACQUISITION LLC INTENDS TO MAKE A TENDER OFFER FOR 10,000,000 SHARES AT $3.00 PER SHARE. IN FACT THE NUMBER OF SHARES AND THE PRICE PER SHARE THAT IS OFFERED IS AT THE DISCRETION OF ABP ACQUISITION LLC AND MAY CHANGE AND ABP ACQUISITION LLC MAY NOT COMMENCE THE TENDER OFFER.
THE INFORMATION CONTAINED IN FIVE STAR’S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION, OR SEC, INCLUDING UNDER “RISK FACTORS” IN FIVE STAR’S PERIODIC REPORTS, OR INCORPORATED THEREIN, IDENTIFIES OTHER IMPORTANT FACTORS THAT COULD CAUSE FIVE STAR’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE STATED IN OR IMPLIED BY FIVE STAR’S FORWARD LOOKING STATEMENTS. FIVE STAR’S FILINGS WITH THE SEC ARE AVAILABLE ON THE SEC’S WEBSITE AT WWW.SEC.GOV.
YOU SHOULD NOT PLACE UNDUE RELIANCE UPON FORWARD LOOKING STATEMENTS.
EXCEPT AS REQUIRED BY LAW, FIVE STAR DOES NOT INTEND TO UPDATE OR CHANGE ANY FORWARD LOOKING STATEMENTS AS A RESULT OF NEW INFORMATION, FUTURE EVENTS OR OTHERWISE.
Five Star Quality Care, Inc.
Brad Shepherd, (617) 796-8245
Director, Investor Relations
$GWRS Declares Monthly #Dividend
PHOENIX, Ariz., Sept. 30, 2016 — Global Water Resources, Inc. (NASDAQ:GWRS), (TSX:GWR), a pure-play water resource management company, has declared, under its dividend policy, a monthly cash dividend in the amount of $0.022 per common share (an annualized amount of $0.264 per share), which will be payable on October 31, 2016, to holders of record at the close of business on October 17, 2016.
About Global Water Resources, Inc.
Global Water Resources, Inc. is a comprehensive water resource management company based in Phoenix, Arizona. It manages the entire water cycle by owning and operating water, wastewater and recycled water utilities. For more information about Global Water Resources, visit www.gwresources.com.
Company Contact for Global Water Resources Michael J. Liebman Chief Financial Officer and Corporate Secretary (480) 999-5104 mike.liebman@gwresources.com Investor Relations for Global Water Resources: Ronald A. Both Liolios Investor Relations (949) 574-3860 gwrs@liolios.com
$CQH #Buyout Offer by $LNG
HOUSTON, Sept. 30, 2016 — Cheniere Energy Partners LP Holdings, LLC (“Cheniere Partners Holdings”) (NYSE MKT: CQH) announced today that its board of directors has received a proposal from Cheniere Energy, Inc. (“Cheniere”) (NYSE MKT: LNG) pursuant to which Cheniere would acquire the publicly held shares of Cheniere Partners Holdings not already owned by Cheniere in a stock for stock exchange. Subject to negotiation and execution of a definitive agreement, Cheniere is proposing consideration of 0.5049 Cheniere shares for each issued and outstanding publicly-held share of Cheniere Partners Holdings as part of a transaction that would be structured as a merger of Cheniere Partners Holdings with a wholly-owned subsidiary of Cheniere. The proposed consideration represents a value of $21.90 per common share of Cheniere Partners Holdings, or a premium of approximately 3.0% over the closing price of Cheniere Partners Holdings’ shares, based on the closing prices of Cheniere Partners Holdings’ shares and of Cheniere’s shares as of September 29, 2016, or a premium of approximately 7.0% over the 30-trading day average CQH / LNG exchange ratio as of September 29, 2016.
Cheniere owns 80.1% of the issued and outstanding shares of Cheniere Partners Holdings.
The proposed transaction is subject to the negotiation and execution of a definitive agreement and approval of such definitive agreement and transactions contemplated thereunder by the board of directors of Cheniere, the board of directors of Cheniere Partners Holdings and a conflicts committee established by the board of directors of Cheniere Partners Holdings, and the consummation of the proposed transaction would be subject to customary closing conditions. There can be no assurance that any such approvals will be forthcoming, that a definitive agreement will be executed or that any transaction will be consummated.
About Cheniere Partners Holdings
Cheniere Partners Holdings owns a 55.9% limited partner interest in Cheniere Energy Partners, L.P. (NYSE MKT: CQP) (“Cheniere Partners”), a publicly traded limited partnership. Cheniere Partners Holdings’ only business consists of owning Cheniere Partners units and, accordingly, its results of operations and financial condition are dependent on the performance of Cheniere Partners. Cheniere Partners owns and operates liquefied natural gas (“LNG”) regasification facilities and, adjacent to these facilities, plans to construct over time up to six natural gas liquefaction trains (“Trains”) with an expected aggregate nominal production capacity of approximately 27 mtpa. Trains 1 and 2 have achieved substantial completion. Train 3 is undergoing commissioning, Trains 4 and 5 are under construction, and Train 6 is fully permitted.
For additional information, please refer to the Cheniere Partners Holdings website at www.cheniere.com and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the Securities and Exchange Commission.
Forward-Looking Statements
This press release includes “forward-looking statements”. In particular, statements using words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “project,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “pursue,” “target,” “continue,” the negative of such terms or other comparable terminology generally involve forward-looking statements. The forward-looking statements contained herein (including statements regarding the proposed transaction and its effects, benefits and costs, savings, opinions, forecasts, projections, expected timetable for completion, expected distribution, and any other statements regarding Cheniere Partners Holdings’ and Cheniere’s future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance that are not statements of historical fact) are largely based on our expectations, which reflect estimates and assumptions made by our management. These estimates and assumptions reflect our best judgment based on currently known market conditions and other factors. Although we believe that such estimates are reasonable, they are inherently uncertain and involve a number of risks and uncertainties beyond our control. In addition, assumptions may prove to be inaccurate. We caution that the forward-looking statements contained herein are not guarantees of future performance and that such statements may not be realized or the forward-looking statements or events may not occur. Actual results may differ materially from those anticipated or implied in forward-looking statements as a result of numerous factors, including, but not limited to, the negotiation and execution, and the terms and conditions, of a definitive agreement relating to the proposed transaction and the ability of Cheniere or Cheniere Partners Holdings to enter into or consummate such an agreement; the risk that the proposed merger does not occur; negative effects from the pendency of the proposed merger; the ability to realize expected cost savings and benefits; failure to obtain the required vote of Cheniere Partners Holdings’ shareholders; the timing to consummate the proposed transaction; the impact of regulatory changes; and other factors affecting future results disclosed in Cheniere’s and Cheniere Partners Holdings’ respective filings with the SEC (available at the SEC’s website at www.sec.gov), including but not limited to those discussed under Item 1A, “Risk Factors”, in Cheniere’s Annual Report on Form 10-K for the year ended December 31, 2015 and Cheniere Partners Holdings’ Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date made, and other than as required by law, we undertake no obligation to update or revise any forward-looking statement or provide reasons why actual results may differ, whether as a result of new information, future events or otherwise.
Additional Information and Where to Find It
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of a proxy or of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed transaction between Cheniere and Cheniere Partners Holdings. In the event that the parties enter into a definitive agreement with respect to the proposed transaction, the parties intend to file a registration statement on Form S-4, containing a proxy statement/prospectus (the “S-4”) with the SEC. This communication is not a substitute for the registration statement, definitive proxy statement/prospectus or any other documents that Cheniere or Cheniere Partners Holdings may file with the SEC or send to shareholders in connection with the proposed transaction. INVESTORS AND SHAREHOLDERS OF CHENIERE PARTNERS HOLDINGS ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE PROXY STATEMENT/PROSPECTUS IF AND WHEN FILED, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.
When available, investors and security holders will be able to obtain copies of the S-4, including the proxy statement/prospectus and any other documents that may be filed with the SEC in the event that the parties enter into a definitive agreement with respect to the proposed transaction free of charge at the SEC’s website at http://www.sec.gov. Copies of documents filed with the SEC by Cheniere will also be made available free of charge on Cheniere’s website at www.cheniere.com. Copies of documents filed with the SEC by Cheniere Partners Holdings will also be made available free of charge on Cheniere Partners Holdings’ website at www.cheniere.com.
Participants in the Solicitation
Cheniere, Cheniere Partners Holdings and their respective directors and executive officers may be deemed to be participants in any solicitation of proxies from Cheniere Partners Holdings’ shareholders with respect to the proposed transaction. Information about Cheniere Partners Holdings’ directors and executive officers is set forth in Cheniere Partners Holdings’ 2015 annual report on Form 10-K, which was filed with the SEC on February 19, 2016, and in Cheniere Partners’ Holdings current reports on Form 8-K, which were filed with the SEC on May 12, 2016, June 6, 2016, and September 19, 2016. Information about Cheniere’s directors and executive officers is set forth in Cheniere’s proxy statement for its 2016 Annual Meeting of Shareholders, which was filed with the SEC on April 21, 2016, and in Cheniere’s current reports on Form 8-K, which were filed with the SEC on May 12, 2016, June 6, 2016, and September 19, 2016. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction if and when they become available. Investors should read the proxy statement/prospectus carefully if and when it becomes available before making any voting or investment decisions.
CONTACTS:
Investors: Randy Bhatia: 713-375-5479
Media: Faith Parker: 713-375-5663
$ASCMA Monitronics Rebrands as #MONI Begins New Era Of Smart #HomeSecurity
New Name Reflects the Company’s Evolution as a Smart Home Security Solutions Organization with Faster, More Personalized Offerings
DALLAS, Sept. 30, 2016 — Monitronics, a subsidiary of Ascent Capital Group, Inc. (Nasdaq: ASCMA) today unveiled its new name: “MONI,” beginning a new era of smart home security that brings increased speed and personalization to the market.
The Company has been the “secret sauce” behind more than 600 independent alarm companies’ successes for the past two decades, with a cutting-edge monitoring solution that secures more than one million residential customers and commercial client accounts in the US. However, “Monitronics” was intentionally unbranded in the eyes of the consumer, allowing independent dealer brands to take center stage. The new MONI brand will be marketed directly to consumers and supported by direct-to-consumer sales and customer support. This will not only enable MONI’s expert custom solutions to flow directly into the home, but is designed to nurture MONI’s trusted dealer network by showing consumers the strength behind the individual dealer brands. The new branding will also provide dealers with the national marketing, sales and customer service support that they need to compete more effectively in their regional markets.
“As a leader in home security solutions for more than 20 years, professionally installed and monitored smart home security has always remained at the core of our business,” said Jeff Gardner, president and CEO of MONI. “Home and business security needs are as unique and individualized as each customer. Solution offerings and customer service throughout the industry must change as we enter a new era of smart home security that emphasizes a customized approach to comprehensive safety and protection.”
MONI sees the new era of smart home security as one where personal safety takes priority in the connected home. This is enabled by:
- Simplified “Smart” Homes
- Delivering leading products that integrate with existing systems and packages, enabling mainstream home automation features that emphasize complete security and control
- Customer-Centric Personalization
- Personalized solutions that are truly tailored to the needs of each individual consumer, allowing them to customize not only equipment and services, but the entire customer experience for greater control, confidence and security
- Faster Response
- Faster response times to alarm events – managing the personal and home security concerns that matter most in seconds for true peace of mind
“Whether it is a routine situation or lives are on the line, MONI knows that every moment matters,” continued Gardner. “Over the last two decades we have built our business on the ability to listen and respond. Customers have spoken, and they are calling for a new approach to smart home security, a new era of customer-centric personalization with solutions designed to meet the needs of each individual, and MONI is poised to deliver.”
To learn more about MONI and the full suite of personalized security solutions available, visit www.mymoni.com.
About MONI
MONI, the new Monitronics, is a subsidiary of Ascent Capital Group, Inc. (NASDAQ: ASCMA) and is one of the largest home security alarm monitoring companies in the U.S. Headquartered in the Dallas Fort-Worth area, MONI secures more than one million residential customers and commercial client accounts with monitored home and business security system services. The company is supported by the nation’s largest network of independent Authorized Dealers, providing products and support to customers in the U.S., Canada and Puerto Rico.
Contact: Lindsay Lougee
MONI Smart Security
Tel: 972-243-7443, ext. 73121
E-mail: llougee@mymoni.com
$SVVC Portfolio Company #Nutanix Goes Public
SAN JOSE, Calif., Sept. 30, 2016 — Firsthand Technology Value Fund, Inc. (NASDAQ:SVVC) (the “Fund”), a publicly traded venture capital fund that invests in technology and cleantech companies, announced today that Nutanix, a Fund holding since May 2015, went public today through an initial public offering (“IPO”). The IPO was priced last evening at $16.00 per share, resulting in proceeds to the company of approximately $238 million. The shares, which now trade on the NASDAQ under the ticker symbol “NTNX”, opened their first day of trading at $26.50.
“In what has been a challenging environment for tech IPOs, we are excited about the successful public debut for Nutanix,” stated Kevin Landis, Firsthand’s CEO. “This marks the 7th IPO for our fund since its inception in 2011 and follows the successful exits of Mattson and Tapad earlier this year.”
The Fund holds 459,772 shares of Nutanix common stock as of September 30, 2016, at an approximate average cost of $16.04 per share. The Fund’s shares are subject to a customary 180-day lockup provision.
Nutanix is a provider of so-called “hyperconverged” data center equipment that merges computing, storage, and networking capabilities in a single piece of equipment. The company’s products offer corporate customers access to technologies similar to those used by Google, Amazon, and Facebook in their own data centers.
About Firsthand Technology Value Fund
Firsthand Technology Value Fund, Inc. is a publicly traded venture capital fund that invests in technology and cleantech companies. More information about the Fund and its holdings can be found online at www.firsthandtvf.com.
The Fund is a non-diversified, closed-end investment company that elected to be treated as a business development company under the Investment Company Act of 1940. The Fund’s investment objective is to seek long-term growth of capital. Under normal circumstances, the Fund will invest at least 80% of its total assets for investment purposes in technology and cleantech companies. An investment in the Fund involves substantial risks, some of which are highlighted below. Please see the Fund’s public filings for more information about fees, expenses and risk. Past investment results do not provide any assurances about future results.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release contains “forward-looking statements” as defined under the U.S. federal securities laws. Generally, the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “project,” “will,” and similar expressions identify forward-looking statements, which generally are not historical in nature. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to materially differ from the Fund’s historical experience and its present expectations or projections indicated in any forward-looking statement. These risks include, but are not limited to, changes in economic and political conditions, regulatory and legal changes, technology and cleantech industry risk, valuation risk, non-diversification risk, interest rate risk, tax risk, and other risks discussed in the Fund’s filings with the SEC. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Fund undertakes no obligation to publicly update or revise any forward-looking statements made herein. There is no assurance that the Fund’s investment objectives will be attained. We acknowledge that, notwithstanding the foregoing, the safe harbor for forward-looking statements under the Private Securities Litigation Reform Act of 1995 does not apply to investment companies such as us.
Contact: Heather Hohlowski Firsthand Capital Management, Inc. (408) 624-9525 vc@firsthandtvf.com
$ITUS Demonstrates Efficacy of #Cchek in #Ovarian #Cancer
LOS ANGELES, CA–(September 30, 2016) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS), today announced that it has successfully utilized its Cchek™ early cancer detection platform to identify the presence of Ovarian Cancer. There is currently no sufficiently accurate test for the early detection of Ovarian Cancer, which has a 5-year survival rate of only 46%.
Cchek™ is ITUS’s early cancer detection technology which measures a patient’s immunological response to a malignancy by detecting the presence, absence, and quantity of certain unique immune system cells that exist in and around a tumor and that enter the blood stream. As part of the ongoing development of ITUS’s Cchek diagnostic platform, the company has successfully used Cchek to detect the presence of Ovarian Cancer in patients that have been diagnosed via conventional means such as invasive procedures like surgical biopsies.
Approximately 250,000 new cases of Ovarian Cancer are diagnosed each year worldwide, and Ovarian Cancer causes approximately 140,000 deaths. Overall, only 15% of Ovarian Cancer cases are diagnosed at a local stage, for which the 5-year survival rate is 92%. The company previously announced success with Cchek detecting Breast Cancer, Lung Cancer, Colorectal Cancer and Melanoma.
ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies in areas such as biotechnology. The Company is developing a platform called Cchek™, a series of non-invasive, blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2015 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com
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- August 2009
- July 2009
- June 2009



