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Leader in Global Product Safety Testing Confirms Award-Winning Wireless Charging Technology Meets Power Delivery and Transmission Expectations
SAN JOSE, CA–(November 09, 2015) – Energous Corporation (“Energous®” or “the Company”) (NASDAQ: WATT), the developer of WattUp™, a revolutionary wire-free charging technology for mobile and IoT devices that provides “over-the-air” power at a distance, today announced the results of an industry-first, independent performance evaluation completed by Underwriters Laboratories, Inc. (UL). The UL testing, which was conducted at their labs, evaluated the performance of the award-winning WattUp technology and validated receive power at various distances, simultaneous multiple device receive capability as well as mobility.
“We are pleased to have the leading independent testing facility confirm that WattUp exceeded performance expectations for delivering power within various charging ranges,” said Stephen R. Rizzone, CEO of Energous. “As the leader in the emerging Uncoupled Power market, we have set the bar and validated the performance of Energous’ award-winning WattUp wireless charging solution. These results independently document the rapid progress of our product development efforts that are expected to enable us to release products to the consumer through our licensing partnerships in late 2016, early 2017.”
TARGETED PERFORMANCE
- 4W delivered within 0-5 feet
- 2W delivered within 5-10 feet
- 1W delivered within 10-15 feet
UL TESTING RESULTS
The UL testing conducted in their lab measured the amount of actual power delivered to a device at varying distances from a single WattUp transmitter. The test noted below measures actual power received by a device.
DISTANCE:
| Distance |
Power Received at the Receiver |
| 0-5 feet |
5.55W |
| 5-10 feet |
3.74W |
| 10-15 feet |
1.06W |
RECEPTION OF POWER SIMULTANEOUSLY BY MULTIPLE DEVICES:
UL tested a single transmitter sending power simultaneously to multiple receivers at a distance of five feet yielding the following results:
| Device |
Power |
| Receiver 1 |
5.44W |
| Receiver 2 |
6.66W |
MOBILITY:
UL testing facilities did not have a robotic arm capable of simulating motion. To validate mobility, a single WattUp transmitter located, acquired and transmitted power sequentially in near-real-time to four WattUp receivers spread 30 degrees apart, equidistant at 8.5 feet. Actual power delivered in sequence is as follows:
| Device |
Power |
| Receiver 1 |
2.36W |
| Receiver 2 |
2.02W |
| Receiver 3 |
2.08W |
| Receiver 4 |
2.04W |
UL (www.UL.com) is a global independent safety science company with more than a century of expertise in testing and innovating safety solutions. For more information on the results and to view the full downloadable report, please see www.energous.com/report.
About Energous Corporation
Energous Corporation (NASDAQ: WATT) is developing WattUp, an award-winning wire-free charging technology that will transform the way people and industries charge and power their electronic devices at home, in the office, in the car and beyond. WattUp is a revolutionary, patent-pending solution that delivers intelligent, scalable power via the same radio bands as a Wi-Fi router. WattUp differs from current wireless charging systems in that it will deliver meaningful, usable power, at a distance, to multiple devices, resulting in a wire-free experience that saves users from having to remember to plug in their devices or place them on a mat. For more information, please visit Energous.com, or follow Energous on Twitter and Facebook.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements in this release that are not based on historical fact are “forward looking statements”. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Receives $1.4 Million Order for Advanced Signal Generator Products
SAN RAMON, Calif., Nov. 09, 2015 — Giga-tronics Incorporated announced today that it has received a $1.4 million order from a major prime contractor for its new Advanced Signal Generator. The Company anticipates fulfilling the order in the current fiscal year, under the expectation the Company gains an ISO9001 certification of its Supplier Quality Management System which the order requires.
John Regazzi, President and CEO of Giga-tronics, said, “Having received a multiple unit order from a second top tier defense prime contractor is a further proof point from the electronic warfare community of the unique performance and cost effectiveness of our new Advanced Signal Generator product, and validates our focus and commitment to this market space as a strategic company direction. We are working on our ISO9001 certification and plan to have it in place when the initial units under this order are ready to ship.”
Giga-tronics is a publicly held company, traded on the NASDAQ Capital Market under the symbol “GIGA”. Giga-tronics produces instruments, subsystems and sophisticated microwave components that have broad applications in defense electronics, aeronautics and wireless telecommunications.
This press release contains forward-looking statements concerning operating results, future orders, and sales of new products, long term growth, shipments, quality control certification and customer acceptance of new products. Actual results may differ significantly due to risks and uncertainties, such as: delays in customer orders for the new Advanced Signal Generation System and our ability to manufacture it, receipt or timing of future orders, cancellations or deferrals of existing or future orders, our need for additional financing, probable delisting from trading on the NASDAQ Capital Market and moving to the OTCQB marketplace; the volatility in the market price of our common stock; the ability to regain AS9100C or substantially equivalent certification; and general market conditions. For further discussion, see Giga-tronics’ most recent annual report on Form 10-K for the fiscal year ended March 28, 2015 Part I, under the heading “Risk Factors” and Part II, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations”.

Contact: Steven D. Lance
Vice President of Finance/Chief Financial Officer
slance@gigatronics.com
(925) 302-1056
Littelfuse, Inc. (NASDAQ:LFUS) today announced it has entered into a definitive agreement to acquire the circuit protection business of TE Connectivity Ltd. (NYSE:TEL) for $350 million in cash. This business has a leading position in polymer-based resettable circuit protection devices with a strong global presence in the automotive, battery, industrial, communications and mobile computing markets. The business is headquartered in Menlo Park, California with manufacturing facilities in Shanghai and Kunshan, China and Tsukuba, Japan.
“This business is an excellent strategic fit with Littelfuse,” said Gordon Hunter, CEO of Littelfuse. “It will expand our global circuit protection product portfolio as well as our presence in the automotive electronics and battery end markets. This business has a long history of technology innovation and new product development, and its synergies with our existing circuit protection business will drive deeper engagement with our customers and channel partners. The business will also significantly increase our presence in Japan and serve as a platform for future growth.”
Transaction Highlights
The TE circuit protection business had estimated revenue of $190 million in fiscal 2015 with an EBITDA margin of approximately 20%. The company expects the transaction to be immediately accretive to earnings excluding acquisition and integration related costs. The company expects cost synergies of at least $10 million annually starting in 2017.
The transaction, which was approved by the Littelfuse Board of Directors, is subject to customary closing conditions and regulatory approvals. The acquisition is expected to close in the first quarter of 2016 and will be financed through a combination of cash on hand and bank debt. Wachtell, Lipton, Rosen and Katz is acting as legal advisor to Littelfuse.
Conference Call and Webcast Information
Littelfuse will hold a conference call for investors on Monday, November 9, at 9:00 a.m. CST to discuss this announcement. The call will be broadcast live over the Internet and be accessed through the company’s website: www.littelfuse.com, including presentation materials. Listeners should go to the website at least 15 minutes prior to the call to download and install any necessary audio software. An audio replay of the call will be available on the company’s website beginning November 9.
About Littelfuse
Founded in 1927, Littelfuse is the world leader in protection with growing global platforms in power controls and sensing. The company serves global customers in the electronics, automotive and industrial markets with technologies including fuses, semiconductors, polymers, ceramics, relays and sensors. Littelfuse has over 8,000 employees in more than 35 locations throughout the Americas, Europe and Asia.
For more information, please visit the Littelfuse website: littelfuse.com.
Safe Harbor Statement
The statements in this press release that are not historical facts are intended to constitute “forward-looking statements” entitled to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties, including, but not limited to, risks relating to product demand and market acceptance, economic conditions, the impact of competitive products and pricing, product quality problems or product recalls, capacity and supply difficulties or constraints, coal mining exposures reserves, failure of an indemnification for environmental liability, exchange rate fluctuations, commodity price fluctuations, the effect of the company’s accounting policies, labor disputes, restructuring costs in excess of expectations, pension plan asset returns less than assumed, integration of the acquired business or other acquisitions, the ability to consummate the proposed transaction on the anticipated timeline or at all, the ability to realize the anticipated benefits of the proposed transaction, and other risks which may be detailed in the company’s other Securities and Exchange Commission filings. Should one or more of these risks or uncertainties materialize or should the underlying assumptions prove incorrect, actual results and outcomes may differ materially from those indicated or implied in the forward-looking statements. This press release should be read in conjunction with information provided in the financial statements appearing in the company’s Annual Report on Form 10-K for the year ended December 27, 2014. For a further discussion of the risk factors of the company, please see Item 1A. “Risk Factors” to the company’s Annual Report on Form 10-K for the year ended December 27, 2014.
Use of Non-GAAP Financial Measures
The information provided in this press release includes the non-GAAP financial measure EBITDA margin. This non-GAAP financial measure should not be considered in isolation or a substitute for the comparable GAAP measure. Management uses this non-GAAP measure to compare operating results to other industry participants. A reconciliation of EBITDA margin to the most directly comparable GAAP measure is not accessible without unreasonable effort due to the nature of the acquisition, particularly the acquisition of certain, but not all, assets of the seller.
LFUS-A
Littelfuse, Inc.
Phil Franklin, 773-628-0810
Executive Vice President and CFO
Sterling Construction Company, Inc. (NasdaqGS:STRL) (“Sterling” or “the Company”) today announced that Ronald A. Ballschmiede has been named Executive Vice President & Chief Financial Officer effective November 9, 2015 and that Kevan Blair will resume his role as Senior Vice President, Corporate Finance.
Mr. Ballschmiede brings nearly 40 years of accounting and financial management experience to Sterling, most recently with Chicago Bridge & Iron (NYSE: CBI) (“CB&I”), where he served as Executive Vice President and Chief Financial Officer from June 2006 to March 2015. Based in The Haag, Netherland, with its administrative office in The Woodlands, Texas, CB&I is a leading engineering, procurement and construction contractor with approximately $13 billion in sales and 54,000 employees.
Prior to joining CB&I, Ron was a Partner with Deloitte & Touche LLP, joining the firm in 2002. Previously, he had been with Arthur Andersen since 1977, becoming a Partner in 1989. While with Andersen, Ballschmiede was the Lead Client Service Partner for CB&I from 1989 to 2002. In addition, he led the manufacturing and industrial products audit practice and served a number of major manufacturing and construction companies. He holds a B.S. in Accounting from Northern Illinois University and is a Certified Public Accountant.
“We feel very fortunate to have Ron join our organization,” stated Paul J. Varello, Sterling’s Chief Executive Officer. “We are confident that Ron’s experience in managing a highly sophisticated global finance operation will translate into the adoption and implementation of best practices for Sterling. CB&I is a very large, world class construction company with an outstanding track record of executing complex construction projects, particularly for energy infrastructure markets. The Board and I want to thank Kevan Blair for stepping in as Interim CFO on short notice in July. Kevan’s efforts over the last several months have been critical to supporting the turnaround that is now underway at Sterling. We are pleased that we will continue to benefit from his hard work and expertise as he returns to the role of our Senior Vice President, Corporate Finance.”
Sterling is a leading heavy civil construction company that specializes in the building and reconstruction of transportation and water infrastructure projects in Texas, Utah, Nevada, Arizona, California, Hawaii, and other states where there are profitable construction opportunities. Its transportation infrastructure projects include highways, roads, bridges and light rail. Its water infrastructure projects include water, wastewater and storm drainage systems.
This press release includes certain statements that fall within the definition of “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Any such statements are subject to risks and uncertainties, including overall economic and market conditions, federal, state and local government funding, competitors’ and customers’ actions, and weather conditions, which could cause actual results to differ materially from those anticipated, including those risks identified in the Company’s filings with the Securities and Exchange Commission. Accordingly, such statements should be considered in light of these risks. Any prediction by the Company is only a statement of management’s belief at the time the prediction is made. There can be no assurance that any prediction once made will continue thereafter to reflect management’s belief, and the Company does not undertake to update publicly its predictions or to make voluntary additional disclosures of nonpublic information, whether as a result of new information, future events or otherwise.
Sterling Construction Company, Inc.
Jennifer Maxwell, 281-951-3560
Director of Investor Relations
or
Investor Relations Counsel:
The Equity Group, Inc.
Fred Buonocore, 212-836-9607
or
Linda Latman, 212-836-9609
First Chronic Dosing Trial of Oral Omecamtiv Mecarbil Showed Statistically Significant Improvements in Several Pre-Specified Measures of Cardiac Function and Volumes
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Nov. 8, 2015 — Amgen (NASDAQ: AMGN) and Cytokinetics Incorporated (NASDAQ: CYTK) today announced the presentation of data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, in a Late-Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando, Fla. The trial met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.1,2
The expansion phase of COSMIC-HF was designed to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or a dose titration group where 25 mg twice daily dosing could be increased to 50 mg twice daily depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment with the 25 mg dose. Data from the expansion phase showed that dose titration controlled patient exposure to omecamtiv mecarbil. Approximately 60 percent of patients in the dose titration group escalated dosing to 50 mg twice daily.
Following 20 weeks of treatment, statistically significant improvements were observed in pre-specified secondary endpoint measures of cardiac function in the dose titration group, compared to placebo. Systolic ejection time increased by 25.0 msec (p<0.001), stroke volume increased by 3.63 mL (p=0.022) and heart rate decreased by 2.97 beats per min (p=0.007). Left ventricular end-systolic and end-diastolic dimensions decreased by 1.79 mm (p=0.003) and 1.29 mm (p=0.013), respectively, and were associated with statistically significant reductions in left ventricular end-systolic and end-diastolic volumes. N-terminal pro-brain natriuretic peptide (NT-proBNP) decreased by 970 pg/mL (p=0.007). Additionally, in the 25 mg twice daily group, there were statistically significant increases in systolic ejection time and stroke volume and a decrease in NT-proBNP. All changes are from baseline compared to placebo. The pharmacodynamic effects of omecamtiv mecarbil were generally dose dependent and larger in patients that received oral dosing with 50 mg twice daily.
Adverse events (AEs), including serious AEs, in patients on omecamtiv mecarbil were comparable to placebo. The incidence of adjudicated deaths (2.7 percent died on placebo, 1.4 percent died on omecamtiv mecarbil), myocardial infarction (1.34 percent on placebo, 0.34 percent on omecamtiv mecarbil) and unstable angina (0 percent on placebo, 0.34 percent on omecamtiv mecarbil) was similar. Other cardiac AEs were generally balanced between placebo and active treatment groups. In the omecamtiv mecarbil groups, compared to placebo, cardiac troponin increased by 0.001 ng/mL and 0.006 ng/mL (median change from baseline at week 20) in the 25 mg twice daily group and dose titration group, respectively. Events of increased troponin (n=278 across all treatment groups) were independently adjudicated and none were determined to be myocardial ischemia or infarction.
“Heart failure remains a large and growing problem for the global health care community. The results from COSMIC-HF suggest chronic dosing of omecamtiv mecarbil may have a favorable and meaningful impact on cardiac function and remodeling,” said John Teerlink, M.D., professor of Clinical Medicine at the University of California San Francisco and director of Heart Failure at the San Francisco Veterans Affairs Medical Center. “The magnitude of cardiac effects observed in this trial are impressive and could potentially translate into improvements in clinical outcomes.”
“The improvements observed in cardiac function with omecamtiv mecarbil in the COSMIC-HF trial are promising,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Omecamtiv mecarbil is a unique investigational therapy for heart failure patients, and we continue to review the data with Cytokinetics and leading heart failure experts to better understand the potential role of this novel medicine.”
“Data from COSMIC-HF highlight the potential of cardiac myosin activation for the treatment of heart failure patients,” said Robert I. Blum, president and CEO at Cytokinetics. “It’s particularly gratifying to see the consistency of effect with chronic omecamtiv mecarbil therapy across important echocardiographic measures of cardiac function.”
Heart failure is a common condition that affects more than 23 million people worldwide,3,4 about half of whom have reduced left ventricular function.5 It is the leading cause of hospitalization and readmission in people age 65 and older.6,7 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.8 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.9,10
COSMIC-HF Trial Design
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure) is a double-blind, randomized, placebo-controlled, multicenter, Phase 2 trial designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. The trial consisted of two parts, a dose escalation phase and a larger and longer expansion phase. The dose escalation phase, which completed in 2013, assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil and was used to select one formulation for further evaluation in the expansion phase. In the dose escalation phase, 96 patients were randomized 1:1:1:1 to placebo or one of three omecamtiv mecarbil oral modified-release formulations in two cohorts (25 mg twice daily or 50 mg twice daily). Each patient cohort was followed for 35 days.
The expansion phase evaluated 448 chronic heart failure patients with reduced ejection fraction who were dosed with the selected oral formulation of omecamtiv mecarbil for 20 weeks and followed for a total of 24 weeks. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil 25 mg twice daily or 25 mg with dose escalation to 50 mg twice daily depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment. The primary endpoints for the expansion phase were to assess the maximum and pre-dose plasma concentration of omecamtiv mecarbil. The secondary endpoints were to assess changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) at week 20, as well as the safety and tolerability of omecamtiv mecarbil including incidence of adverse events from baseline to week 24.
COSMIC-HF was not designed to assess the impact of omecamtiv mecarbil on cardiovascular outcomes in heart failure patients.
COSMIC-HF was conducted by Amgen in collaboration with Cytokinetics.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes.1,2,11
Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization rights. Additionally, Les Laboratoires Servier obtained an exclusive option to commercialize omecamtiv mecarbil in Europe.
About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.12 Amgen’s research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today’s important unmet patient needs, such as high cholesterol and heart failure.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics’ specified development and commercialization participation rights. For additional information about Cytokinetics, visit www.cytokinetics.com.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen or us) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Nov. 8, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we and our partners routinely obtain patents for products and technology, the protection of our products offered by patents and patent applications may be challenged, invalidated or circumvented by our or our partners’ competitors and there can be no guarantee of our or our partners’ ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase common stock.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
Cytokinetics Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities, including the significance and utility of COSMIC-HF clinical trial results and the potential progression of omecamtiv mecarbil to Phase 3 development; and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Amgen’s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)
CONTACT: Cytokinetics, South San Francisco
Diane Weiser, 415-290-7757 (investors and media)
References
- Malik FI, Hartman JJ, Elias KA, et al. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011;331(6023):1439-1443.
- Shen YT, Malik FI, Zhao X, et al. Improvement of Cardiac Function by a Cardiac Myosin Activator in Conscious Dogs With Systolic Heart Failure. Circ Heart Fail. 2010;3(4):522-527.
- Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011;8:30-41.
- McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J. 1998;19 (Suppl P):P9–P16.
- Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327.
- Centers for Disease Control and Prevention. National Health Statistics Report: 2006 National Hospital Discharge Survey. http://www.cdc.gov/nchs/data/nhsr/nhsr005.pdf. Accessed November 2015.
- Jencks SF, Williams MV, Coleman EA. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. NEJM. 2009;360:1418-1428.
- Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in First Hospitalization for Heart Failure and Subsequent Survival Between 1986 and 2003. Circulation. 2009;119:515-523.
- Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics—2015 Update: A Report From the American Heart Association. Circulation. 2015;131:e1-e294.
- Rogers VL, Weston SA, Redfield MM, et al. Trends in Heart Failure Incidence and Survival in a Community-Based Population. JAMA. 2004;292:344-350.
- Malik FI, Morgan BP. Cardiac myosin activation part 1: From concept to clinic. J Mol Cell Cardiol. 2011;51:454-461.
- World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed November 2015.
– Company to Provide Updated Conference Call Scheduling Later This Week –
NEW YORK, Nov. 9, 2015 — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that it will be rescheduling its 2015 third quarter financial results conference call originally scheduled for November 10, 2015 at 11 a.m. ET to a future date to be determined later this week.
About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.
About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.
Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com
Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net
– Goal is to Utilize ATLASTM to Discover Biologically Relevant Neoantigens for Vaccine Development –
– Company to Discuss Collaboration and Oncology Strategy on Third Quarter 2015 Earnings Call at 9am ET Today –
Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced a collaboration with Memorial Sloan Kettering Cancer Center to screen the T cell responses of melanoma and non-small cell lung cancer patients treated with checkpoint inhibitors (CPI) against the complete repertoire of patient-specific putative cancer neoantigens.
The goals of the collaboration are to identify signatures of T cell response in cancer patients associated with response or non-response to CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS will be used in conjunction with Memorial Sloan Kettering’s patient-specific cancer neoantigen sequences and blood samples from the same cancer patients. This new collaborative work will be led by investigators Timothy A. Chan, M.D., Ph.D., Vice Chair, Department of Radiation Oncology, and Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center.
“ATLAS is unique in that it makes no assumptions about which cancer antigens are meaningful and which are not. It instead takes a panoramic view of all the mutations that may yield novel targets and reveals clinically relevant T cell antigens that associate with protective immunity,” said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. “We believe that ATLAS is a powerful platform that enables the identification of T cell responses that must be present to see an effective response to therapy. This can ultimately lead to the discovery of T cell antigens that may drive cancer vaccine development.”
About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.
About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.
Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising product candidates in oncology; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.
For media:
Spectrum Science Communications
Megan Lustig, 202-955-6222
mlustig@spectrumscience.com
or
For investors:
Genocea Biosciences
Jonathan Poole, 617-876-8191
jonathan.poole@genocea.com
CSG Systems International, Inc. (NASDAQ: CSGS), a global provider of interactive transaction-driven solutions and services, announced today that the company’s Chief Executive Officer, Peter Kalan, President and Chief Operating Officer, Bret Griess and Senior Vice President of Investor Relations and Strategic Communications, Liz Bauer, will participate in the 2015 RBC Capital Markets’ Technology, Internet, Media & Telecommunications Conference.
The conference will be held November 10 – 11, 2015 in New York City, New York. CSG International’s fireside chat is scheduled for Wednesday, November 11th at 4:30 p.m. ET and can be accessed via the following URL: http://www.veracast.com/webcasts/rbc/technology2015/52215339518.cfm.
About CSG International
CSG Systems International, Inc. (NASDAQ:CSGS) is a market-leading business support solutions and services company serving the majority of the top 100 global communications service providers, including leaders in fixed, mobile and next-generation networks such as AT&T, Charter Communications, Comcast, DISH Network, Orange, T-Mobile, Telefonica, Time Warner Cable, Vodafone, Vivo and Verizon. With over 30 years of experience and expertise in voice, video, data and content services, CSG International offers a broad portfolio of licensed and Software-as-a-Service (SaaS)-based products and solutions that help clients compete more effectively, improve business operations and deliver a more impactful customer experience across a variety of touch points. For more information, please visit www.csgi.com.
CSG International
Liz Bauer, +1 303-804-4065
Investor Relations
Liz.bauer@csgi.com
EDGEWOOD, NY–(Nov 5, 2015) – CPI Aerostructures, Inc. (“CPI Aero®“) (NYSE MKT: CVU) today announced that it has won Penton’s Aviation Week Program Excellence Award in the Sub-System Production Category. As the Aerospace & Defense industry’s preeminent honor for strong program performers with innovative ideas, technologies and process improvements, the awards were announced at a gala dinner on November 4, during Aviation Week’s Aerospace & Defense Programs Conference in Litchfield Park, AZ.
CPI Aero was recognized for the Phenom 300 engine inlet program it performs for Embraer, the manufacturer of the Phenom 300 executive jet. According to a report by the General Aviation Manufacturers Association (GAMA), the Phenom 300 was the most delivered business jet in the world for the past two years. Embraer, S.A., headquartered in São José dos Campos, Brazil, is the world’s largest manufacturer of aircraft up to 130 seats.
“Aviation Week provides the industry’s most extensive intelligence and analysis available about programs, so it is a great honor to celebrate the best of the best programs — programs that are delivering results but also finding entirely new ways to be more innovative, more efficient, and better at delivering value to customers, the companies involved, and to the people who make it happen,” said Carole Rickard Hedden, Aviation Week’s editorial director for Executive Intelligence and the Program Excellence initiative.
Douglas McCrosson, President and CEO of CPI Aero commented, “The Aviation Week Program Excellence Award is one of our industry’s most prestigious awards and we are honored to have been recognized by our customers and peers. I want to congratulate Nazz Palmerini, Director of Program Management, Derick Martin, Program Manager, and the talented men and women that work on the Embraer program for this amazing accomplishment. This award recognizes the years of investment CPI Aero has made in creating world class manufacturing, program management and supply chain management capabilities, and it is especially gratifying to be considered the best of the best in this regard. This award would not have been possible without Embraer’s commitment to its supply chain partners, so I’d like to thank Embraer for fostering a culture of cooperation and teamwork that put CPI Aero in the best position to succeed on this assembly program.”
About Penton’s Aviation Week Network
Penton’s Aviation Week Network is the largest multimedia information and services provider for the global aviation, aerospace and defense industries that has a database of 1.2 million professionals around the world. Industry professionals rely on Aviation Week for analysis, marketing and intelligence. Customers include the world’s leading manufacturers, suppliers, airlines, business aviation operators, militaries, governments and other organizations that serve this global market. The product portfolio includes Aviation Week & Space Technology, Air Transport World, AviationWeek.com, Aviation Week Intelligence Network, and SpeedNews, among others.
About CPI Aero
CPI Aero is a U.S. manufacturer of structural assemblies for fixed wing aircraft, helicopters and airborne Intelligence Surveillance and Reconnaissance (ISR) pod systems in both the commercial aerospace and national security markets. Within the global aerostructure supply chain, CPI Aero is either a Tier 1 supplier to aircraft original equipment manufacturers or a Tier 2 subcontractor to major Tier 1 manufacturers. CPI also is a prime contractor to the U.S. Department of Defense, primarily the Air Force. In conjunction with its assembly operations, CPI Aero provides engineering, program management, supply chain management, and MRO services. Among the key national security programs that CPI Aero supplies are the E-2D Advanced Hawkeye surveillance aircraft, the UH-60 BLACK HAWK® helicopter, the F-16 Falcon fighter, the T-38C Talon trainer, the MH-53/CH-53 variant helicopters, the MH-60S mine countermeasure helicopter, the AH-1Z ZULU attack helicopter, the DB-110 reconnaissance pod, the ALMDS mine detecting pod, and the A-10 Thunderbolt attack jet. In the commercial aviation market CPI Aero manufactures products for the Gulfstream G650 ultra-large cabin business jet, the HondaJet advanced light jet, the Embraer Phenom 300 business jet, the new Cessna Citation X+, and the S-92® helicopter. CPI Aero is included in the Russell Microcap® Index.
The above statements include forward looking statements that involve risks and uncertainties, which are described from time to time in CPI Aero’s SEC reports, including CPI Aero’s Form 10-K for the year ended December 31, 2014 and Form 10-Q for the quarters ended March 31, 2015 and June 30, 2015.
CPI Aero® is a registered trademark of CPI Aerostructures, Inc.
— Based on Positive Safety Data and Preliminary Signs of Efficacy, Study Expected to Advance to Phase 2 Portion in Early 2016 —
SOUTH SAN FRANCISCO, Calif., Nov. 5, 2015 — OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced initial data from a Phase 1b/2 study of the company’s lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient™ (pazopanib) in patients with advanced recurrent ovarian cancer. The data are from the ongoing “PAZOFOS” study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.
“The initial results we’ve seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016,” said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. “We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer.”
Dr. Rustin reported that 12 patients have been enrolled in the phase 1b portion of the study. Nine of the patients were evaluated for objective response using RECIST criteria, showing two partial responses, five stable diseases and two progressive diseases. Eight of the ten patients with evaluable data demonstrated decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria. Dr. Rustin also noted that four patients were still on treatment, and that the efficacy data are currently preliminary and unverified. Safety data showed that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). The most commonly reported AEs were hypertension, fatigue, and pain. The Development Safety Update Report #1 submitted to the regulatory body stated that no definitive conclusions can be made regarding the benefit of treatment in the small subset of patients treated so far.
“The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors,” said William D. Schwieterman, MD, OXiGENE’s President and CEO. “We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin® in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016.”
PAZOFOS is a randomized, controlled clinical study consisting of a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone. The study is designed to enroll up to 128 patients at up to ten sites in the United Kingdom. The primary endpoint for the phase 2 portion is progression-free survival; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.
PAZOFOS is sponsored by The Christie NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by OXiGENE and GlaxoSmithKline/Novartis, respectively.
About CA4P
CA4P (also known as fosbretabulin) is a vascular disrupting agent and is OXiGENE’s lead investigational drug. CA4P exerts its anti-tumor effects by targeting an established tumor’s immature endothelial cells within the tumor’s blood vessels, compromising the tumor vasculature and leading to widespread ischemia and necrosis of the cells within the central core of the tumor. OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which prevent the growth of new tumor blood vessels. Following an extensive clinical review, OXiGENE recently announced its plans to focus on initiation of two late-stage clinical programs for CA4P in 2016. These planned programs combine CA4P with standard-of-care in platinum-resistant ovarian cancer and in glioblastoma multiforme. In addition to PAZOFOS, CA4P is also being evaluated in an ongoing study in neuroendocrine tumors.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company’s investigational drugs include CA4P, which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE’s reports to the Securities and Exchange Commission, including OXiGENE’s reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.
CONTACT: Investor and Media Contact:
ir@oxigene.com
650-635-7000
WALTHAM, Mass., Nov. 5, 2015 — Eyegate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced interim data on the effects of iontophoretic delivery of their EGP-437 ophthalmic solution on Macular Edema patients.
“Overall, the interim data from this pilot trial suggests that iontophoresis can non-invasively deliver EGP-437 to the back of the eye. The non-invasive delivery of EGP-437 has demonstrated a positive response in some patients with macular edema. We believe that this data is encouraging, and warrants an extension to the trial to continue to work on the ideal dose and dosing regimen for the iontophoretic delivery of EGP-437,” said Dr. Jeffrey Heier, M.D., Director of Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston and the principal investigator of the trial.
The ongoing Phase 1b / 2a clinical trial is a multi-center, open-label trial. To date, the trial has enrolled 19 patients with macular edema associated with Retinal Vein Occlusion, Diabetic Retinopathy or Post-Surgical (cystoid) Macular Edema. The primary objective of this trial was to evaluate the safety and efficacy of iontophoretic EGP-437 in patients suffering from Macular Edema. Three treatments at 14.0 mA-min (3.5mA) were administered on day 0, day 4 and day 9. Primary outcome of the trial measured reduction in mean central subfield thickness on day 4, day, 9 and day 14. Ozurdex® was administered as control to patients that did not respond to the investigational therapy at day 14 and were re-evaluated at day 28.
A positive response was observed in some of the patients, with pseudophakic eyes (an eye implanted with an intraocular lens) responding better than phakic eyes (an eye with a natural lens). Additionally, the investigational therapy showed no serious treatment emergent adverse effects including no increase in ocular pressure even at three times the iontophoretic dose that was used for the Company’s Phase 3 non-infectious anterior uveitis trial.
“The interim results of the trial are highly promising and suggest the ability of the EyeGate® II Delivery System to deliver drug to the posterior segment of the eye, which could present important new opportunities for our iontophoretic technology and drug formulations in additional disease indications. We look forward to additional data from the extension of this trial, which we expect in mid-2016,” said Stephen From, President and Chief Executive Officer of EyeGate.
The extension stage of the trial will recruit an additional 15 patients with a modified dosing regimen, 3 consecutive days at the same iontophoretic dosage. It was observed that the edema returns when drug has cleared from the tissues. Thus the new dosing regimen may help to overcome this issue by providing a cumulative effect. The extension of the trial will also evaluate the efficacy of iontophoretic EGP-437 in phakic versus pseudophakic eyes to collect additional data on the differences in the responses of both types of eyes. This data may be interesting from a physiological standpoint and will be helpful in designing further clinical trials. The extension of the trial is expected to begin by the end of 2015.
About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. EGP-437, the Company’s first and only product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate® II Delivery System. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EGP-437, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on March 31, 2015, or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
CONTACT: Lee Roth / Joseph Green
The Ruth Group for Eyegate Pharmaceuticals
646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
MISSION VIEJO, Calif., Nov. 04, 2015 — The Ensign Group, Inc. (NASDAQ:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that its board of directors approved a new stock repurchase program, which allows Ensign to repurchase up to $15 million of its common stock over the next 12 months.
“This program reflects our strong commitment to enhancing shareholder value and our confidence in the Company’s short- and long-term operating and financial performance,” said Christopher Christensen, Ensign’s President and Chief Executive Officer. Mr. Christensen reaffirmed that the Company expects to continue paying quarterly dividends and growing and diversifying its business, noting, “We are pleased that Ensign is in a position to simultaneously return value to shareholders through our quarterly dividends and share repurchases. Management and the Board of Directors believe that repurchasing Company common stock is an important piece of our multipronged capital allocation strategy.”
Mr. Christensen noted that the Company’s strong balance sheet, robust cash flow and existing credit facility provide the flexibility to opportunistically repurchase Ensign shares while continuing to acquire well-performing and struggling long-term care skilled nursing operations, assisted living operations, urgent care centers and start-up or early-stage hospice and home health agencies.
Under the stock repurchase program, the Company is authorized to repurchase its issued and outstanding common shares from time to time in open-market and privately negotiated transactions and block trades in accordance with federal securities laws, including Rule 10b-18 promulgated under the Securities Exchange Act of 1934 as amended. The Company has no obligation to repurchase any dollar amount or number of shares under this repurchase program authorization, and the program may be suspended, discontinued or modified at any time, in the discretion of the board of directors and in accordance with legal and regulatory requirements.
The number of shares repurchased by the company will depend entirely upon the levels of cash available, the attractiveness of alternate investment and business opportunities either at hand or on the horizon, and management’s determination of value relative to market price, as well as other legal, regulatory and contractual requirements.
Safe Harbor Statement
This press release may include forward-looking statements, including, but not limited to, statements as to our plans, objectives, expectations and business strategy. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words. These forward-looking statements include, but are not limited to, statements regarding growth prospects, future operating and financial performance. They are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to materially and adversely differ from those expressed in any forward-looking statement. Important factors which could cause actual results to differ materially from those in the forward-looking statements are detailed in filings made by Ensign with the Securities and Exchange Commission. Ensign undertakes no obligation to update or revise any such forward-looking statements to reflect subsequent events or circumstances.
About Ensign(TM)
The Ensign Group, Inc.’s independent operating subsidiaries provide a broad spectrum of skilled nursing and assisted living services, physical, occupational and speech therapies, home health and hospice services, urgent care services and other rehabilitative and healthcare services at 182 facilities, thirteen hospice agencies, fifteen home health agencies, three home care businesses and seventeen urgent care clinics in California, Arizona, Texas, Washington, Utah, Idaho, Colorado, Nevada, Iowa, Nebraska, Oregon, Wisconsin, Kansas and South Carolina. More information about Ensign is available at http://www.ensigngroup.net.
CONTACT: The Ensign Group, Inc., (949) 487-9500, ir@ensigngroup.net
Largest Order to Date from an Existing Customer
AUSTIN, TX–(Nov 4, 2015) – Ideal Power Inc. (NASDAQ: IPWR), a developer of innovative power conversion technologies, announced today that it has received an order for 14.5 MW of its power conversion products for use in Battery Energy Storage Systems predominately for California and Hawaii. The order comes from an existing customer and includes a mixture of the Company’s 30kW Battery Converter, Grid-Resilient 30kW Multi-Port Power Conversion System, and the newly released Grid-Resilient 125kW Power Conversion System. The products are expected to be delivered throughout 2016 with initial deliveries expected to begin in January.
“This represents the largest order in Ideal Power’s history and positions us to enter 2016 with a robust backlog and enhanced visibility,” said Dan Brdar, CEO of Ideal Power. “This commitment validates that our channel partners are closing business, further establishing our market leadership in providing power conversion systems for behind-the-meter energy storage solutions.”
About Ideal Power Inc.
Ideal Power Inc. (NASDAQ: IPWR) has developed a novel, patented power conversion technology called Power Packet Switching Architecture™ (PPSA). PPSA improves the size, cost, efficiency, flexibility and reliability of electronic power converters. PPSA can scale across several large and growing markets, including commercial grid storage, combined solar and storage, microgrids, and electrified vehicle charging. Ideal Power also has a capital-efficient business model that can enable it to address these markets simultaneously. Ideal Power has won multiple grants for its PPSA technology, including a $2.5 million grant from the Department of Energy’s Advanced Research Projects Agency – Energy (ARPA-E) program, and market-leading customers are incorporating PPSA as a key component of their systems. For more information, visit www.IdealPower.com.
Safe Harbor Statement
All statements in this release that are not based on historical fact are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. These forward looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not limited to, whether the patents for our technology provide adequate protection and whether we can be successful in maintaining, enforcing and defending our patents, whether a demand for energy storage products will grow, whether demand for our products, which we believe are disruptive, will develop and whether we can compete successfully with other manufacturers and suppliers of energy conversion products, both now and in the future, as new products are developed and marketed. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. The order described in this release is subject to commercial terms that enable the customer to delay or reschedule delivery of product, thereby impacting the timing of our recognition of associated revenue. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.
SOUTH SAN FRANCISCO, Calif., Nov. 4, 2015 — Veracyte, Inc. (NASDAQ: VCYT) announced that company and external researchers will present four abstracts at the PFF Summit 2015: From Bench to Bedside that reveal current diagnostic challenges associated with interstitial lung disease (ILD), as well as the potential for improvement using new genomic-based testing approaches. The biennial international Summit is being held November 12-14 at the JW Marriott Hotel in Washington, DC.
Each year in the United States and Europe, up to 200,000 patients are suspected of having an ILD, including idiopathic pulmonary fibrosis (IPF), which is among the most common and most deadly, and is notoriously difficult to diagnose.
“The recent availability of therapies that slow progression of IPF makes improved, timely diagnosis of this disease even more imperative,” said Bonnie Anderson, president and chief executive officer of Veracyte. “We are proud that the new research findings that we and others are sharing at this year’s Summit help to elucidate the specific challenges associated with ILD and IPF diagnosis, as well as promising, potential solutions.”
All four abstracts are part of a poster session taking place Thursday, November 12 from 5:00-8:00 p.m. EST in the Penn Avenue Terrace of the JW Marriott Hotel. During this session, researchers will share updated findings from a study evaluating the ability of a Veracyte molecular classifier to help distinguish IPF from other ILDs among patient samples obtained through bronchoscopy. This ability may potentially enable improved IPF diagnosis without the need for invasive surgery.
| Abstract Title: |
Diagnosis of idiopathic pulmonary fibrosis: Classifying the usual interstitial pneumonia pattern in transbronchial biopsies using machine learning |
| Presenter: |
Jing Huang, Ph.D., Veracyte |
Three additional presentations will quantify the significant challenges that physicians and patients face in confirming an ILD diagnosis. These presentations include results from a national physician survey exploring the potential clinical utility of Veracyte’s in-development molecular classifier to reduce the need for invasive diagnostic procedures, as well as assessing the degree to which non-specialist pulmonologists differ from ILD specialists in their use of invasive diagnostic procedures. Additionally, data from a national survey exploring the diagnostic experiences of 600 ILD and IPF patients will be presented. The latter survey was commissioned by the Pulmonary Fibrosis Foundation (PFF) with sponsorship from Veracyte.
| Abstract Title: |
The clinical utility of a molecular diagnostic in differentiating idiopathic pulmonary fibrosis from other interstitial lung diseases |
| Presenter: |
Xiaoping Wu, M.D., Weill Cornell Medical College |
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| Abstract Title: |
Current diagnostic approaches in ILD: ILD versus non-specialty clinics |
| Presenter: |
Elizabeth Belloli, M.D., University of Michigan |
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| Abstract Title: |
Interstitial lung disease patient diagnostic journey (INTENSITY) survey |
| Presenters: |
David J. Lederer, M.D., Pulmonary Fibrosis Foundation |
All abstracts and results are embargoed until 5:00 p.m. EST, Thursday, November 12.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for approximately 150 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.
BELLEVUE, Wash. and AUSTIN, Texas, Nov. 4, 2015 — Expedia, Inc., (NASDAQ: EXPE) and HomeAway, Inc., (NASDAQ: AWAY) announced today that they have entered into a definitive agreement under which Expedia has agreed to acquire HomeAway, including all of its brands, for an equity value of approximately $3.9 billion in cash and Expedia common stock, representing a per share price for HomeAway shares of $38.31, based on Expedia’s closing price on November 3, 2015. Under the terms of the transaction, Expedia will offer to acquire each outstanding share of common stock of HomeAway in exchange for $10.15 in cash and 0.2065 of a share of Expedia common stock.
The Boards of Directors of both companies unanimously approved the transaction, which remains subject to customary closing conditions, including regulatory approvals and the tender of a majority of the outstanding shares of HomeAway common stock. The companies expect the transaction to close in the first quarter of 2016.
“We have long had our eyes on the fast growing ~$100 billion alternative accommodations space and have been building on our partnership with HomeAway, a global leader in vacation rentals, for two years. Bringing HomeAway into the Expedia, Inc. family and adding its leading brands to our portfolio of the most trusted brands in travel is a logical next step,” said Dara Khosrowshahi, Chief Executive Officer, Expedia, Inc. “We have tremendous respect for the HomeAway team and the business they have built. With our expertise in powering global transactional platforms and our industry-leading technology capabilities, we look forward to partnering with them to accelerate their shift from a classified marketplace to an online, transactional model to create even better experiences for HomeAway’s global traveler audience and the owners and managers of its 1.2 million properties around the world.”
“We could not be more excited about joining the Expedia family of leading travel brands and what this move means for our very bright future,” said Brian Sharples, Chief Executive Officer of HomeAway, Inc., noting that the company has been moving toward a fully online bookable marketplace and closer to the type of transactional business model with which Expedia has tremendous experience. “We’re eager to benefit from Expedia’s distribution, technology and expertise, which will allow us to provide an even better product and service experience for our owners, property managers and travelers. In this way, I believe our combination with Expedia will turbocharge our growth and industry leadership for many years to come.”
Conference Call to Discuss Transaction
Expedia, Inc., and HomeAway, Inc., will host a conference call to discuss the transaction on Wednesday, November 4, 2015 at 1:45 p.m. Pacific Time / 3:45 p.m. Central Time. Callers in the U.S. and Canada may dial 877-741-4244 and use passcode 4111332. All other international callers may dial 719-325-4784 and use passcode 4111332. A live webcast of the conference call will be available to the public at http://ir.expediainc.com and http://investors.homeaway.com. A replay of the call is expected to be available for at least three months.
About Expedia, Inc.
Expedia, Inc. (NASDAQ: EXPE) is one of the world’s leading travel companies, with an extensive brand portfolio that includes leading online travel brands, such as:
- Expedia.com®, a leading full service online travel agency with localized sites in 32 countries
- Hotels.com®, the hotel specialist that offers Hotels.com® Rewards and Secret Prices through its mobile booking apps and localized websites in more than 65 countries
- Hotwire®, a leading discount travel site that offers Hot Rate® Hotels, Hot Rate® Cars and Hot Rate® Airfares, as well as vacation packages
- Orbitz Worldwide, a global travel portfolio including Orbitz, ebookers, HotelClub and CheapTickets, brands and business-to-business offerings, including Orbitz Partner Network and Orbitz for Business
- Travelocity®, a pioneer in online travel and a leading online travel agency in the US and Canada
- Egencia®, a leading corporate travel management company
- Venere.com™, an online hotel reservation specialist in Europe
- trivago®, a leading online hotel search with sites in 52 countries worldwide
- Wotif Group, a leading portfolio of travel brands operating in the Australia/New Zealand region, including Wotif.com®, Wotif.co.nz, lastminute.com.au®, lastminute.com.nz and travel.com.au®
- Expedia Local Expert®, a provider of online and in-market concierge services, activities, experiences and ground transportation in hundreds of destinations worldwide
- Classic Vacations®, a top luxury travel specialist
- Expedia® CruiseShipCenters®, a provider of exceptional value and expert advice for travelers booking cruises and vacations through its network of 200 retail travel agency franchises across North America
- CarRentals.com™, the premier car rental booking company on the web
The company delivers consumers value in leisure and business travel, drives incremental demand and direct bookings to travel suppliers and provides advertisers the opportunity to reach a highly valuable audience of in-market consumers through Expedia® Media Solutions. Expedia also powers bookings for thousands of affiliates, including some of the world’s leading airlines, top consumer brands and high traffic websites through Expedia® Affiliate Network. For corporate and industry news and views, visit us at www.expediainc.com or follow us on Twitter @expediainc.
Trademarks and logos are the property of their respective owners. © 2015 Expedia, Inc. All rights reserved. CST: 2029030-50
About Homeaway, Inc.
HomeAway, Inc. based in Austin, Texas, is the world leader in vacation rentals, with sites representing over one million paid listings of vacation rental homes in 190 countries. Through HomeAway, owners and property managers offer an extensive selection of vacation homes that provide travelers with memorable experiences and benefits, including more room to relax and added privacy, for less than the cost of traditional hotel accommodations. The company also makes it easy for vacation rental owners and property managers to advertise their properties and manage bookings online. The HomeAway portfolio includes the leading vacation rental websites HomeAway.com, VRBO.com and VacationRentals.com in the United States; HomeAway.co.uk and OwnersDirect.co.uk in the United Kingdom; HomeAway.de in Germany; Abritel.fr and Homelidays.com in France; HomeAway.es and Toprural.es in Spain; AlugueTemporada.com.br in Brazil; HomeAway.com.au and Stayz.com.au in Australia; Bookabach.co.nz in New Zealand, and Asia Pacific short-term rental site, travelmob.com.
HomeAway also operates BedandBreakfast.com, the most comprehensive global site for finding bed-and-breakfast properties, providing travelers with another source for unique lodging alternatives to chain hotels. For more information about HomeAway, please visit www.HomeAway.com.
Additional Information and Where to Find It
The exchange offer referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for any offer materials that Expedia, Inc. (“Expedia”) and its acquisition subsidiary will file with the U.S. Securities and Exchange Commission (“SEC”). At the time the exchange offer is commenced, Expedia and its acquisition subsidiary will file a tender offer statement on Schedule TO, Expedia will file a registration statement on Form S-4, and HomeAway will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the exchange offer. THE EXCHANGE OFFER MATERIALS (INCLUDING AN OFFER TO EXCHANGE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER EXCHANGE OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION. HOMEAWAY STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF HOMEAWAY SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING EXCHANGING THEIR SECURITIES. The Offer to Exchange, the related Letter of Transmittal and certain other exchange offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of HomeAway stock at no expense to them. The exchange offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Expedia’s Investor Relations department at (425) 679-3759.
In addition to the Offer to Exchange, the related Letter of Transmittal and certain other exchange offer documents, as well as the Solicitation/Recommendation Statement, Expedia and HomeAway file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Expedia and HomeAway at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Expedia and HomeAway’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally can be identified by phrases such as “will,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. Similarly, statements herein that describe the proposed transaction, including its financial and operational impact, and other statements of management’s beliefs, intentions or goals also are forward-looking statements. It is uncertain whether any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what impact they will have on the results of operations and financial condition of the combined companies or the price of Expedia or HomeAway stock. These forward-looking statements involve certain risks and uncertainties, many of which are beyond the parties’ control, that could cause actual results to differ materially from those indicated in such forward-looking statements, including but not limited to the ability of the parties to consummate the proposed transaction on a timely basis or at all and the satisfaction of the conditions precedent to consummation of the proposed transaction, including majority of HomeAway’s shares being validly tendered into the exchange offer, the ability to secure regulatory approvals on the terms expected, at all or in a timely manner; the ability of Expedia to successfully integrate HomeAway’s operations; the ability of Expedia to implement its plans, forecasts and other expectations with respect to HomeAway’s business after the completion of the transaction and realize expected synergies; business disruption following the merger; the proposed transaction may not be completed on the timeframe expected or at all; and the other risks and important factors contained and identified in Expedia’s and HomeAway’s filings with the Securities and Exchange Commission (the “SEC”), such as their respective Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, any of which could cause actual results to differ materially from the forward-looking statements, the Tender Offer Statement on Schedule TO (including the offer to purchase, the letter of transmittal and other documents relating to the tender offer) to be filed by Expedia and its acquisition subsidiary, the registration statement on Form S-4 to be filed by Expedia, and the Solicitation/Recommendation Statement on Schedule 14D-9 to be filed by HomeAway. As a result of these and other risks, the proposed transaction may not be completed on the timeframe expected or at all. The forward-looking statements included in this press release are made only as of the date hereof. Neither Expedia nor HomeAway undertakes any obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by law.
NEW YORK, Nov. 4, 2015 — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that the Company will host its 2015 third quarter financial results conference call on Tuesday, November 10, 2015 at 11:00 a.m. EST.
All interested participants should dial in approximately 5 to 10 minutes prior to the 11:00 a.m. EST conference call and ask for the Elephant Talk third quarter conference call.
About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK), is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.
About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.
Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com
Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net
SAN FRANCISCO, Nov. 03, 2015 — FibroGen, Inc. (NASDAQ:FGEN) (“FibroGen”), today announced that analyses of clinical data from Phase 2 clinical trials of roxadustat (FG‑4592), a potential first-in-class oral compound in late-stage development for the treatment of anemia associated with chronic kidney disease (CKD), will be presented at the American Society of Nephrology (ASN) Kidney Week on November 5, 2015.
Roxadustat is currently in Phase 3 development as a potential therapy for anemia of chronic kidney disease both in patients on dialysis and in patients not on dialysis. The global development program is being conducted by FibroGen and its development partners, AstraZeneca and Astellas.
The schedule and details for the presentations are as follows:
- Anemia Correction with Roxadustat Lowers Hepcidin in Chronic Kidney Disease (both CKD and ESRD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO646 (Szczech, et al.)
- Anemia Correction with Roxadustat Increases Soluble Transferrin Receptor in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO647 (Szczech, et al.)
- Anemia Correction with Roxadustat Lowers Cholesterol in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: CKD: Clinical Trials
Thursday, November 5, 2015 10:00 AM – 12:00 PM PT
Abstract Session # TH-PO648 (Szczech, et al.)
- Anemia Correction with Roxadustat Improves Health Related Quality of Life (HRQOL) in Chronic Kidney Disease (CKD) Patients in Phase 2 Studies
Session: Clinical Trials in CKD: Pursuing a New Horizon
Thursday, November 5, 2015, 6:06 PM PT
Oral Program # TH-OR039 (Szczech, et al.)
About Chronic Kidney Disease
CKD affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although it can occur at any age, it becomes more common in aging populations and its prevalence is increasing. Kidney disease can have multiple causes such as diabetes mellitus and hypertension. While there are treatments for many causes of kidney disease, there are currently no treatments that are curative or that can completely halt the loss of kidney function in CKD, creating a significant unmet medical need.
About Roxadustat
Roxadustat (FG-4592) is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in development for the treatment of anemia of chronic kidney disease both in patients on dialysis and in patients not on dialysis. Hypoxia-inducible factor is a transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced) and other protective pathways.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate multiple programs targeting various therapeutic areas. Our most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD). Our second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. For more information about FibroGen, please visit www.fibrogen.com.

Contact
Greg Mann
FibroGen, Inc.
(415) 978-1433
gmann@fibrogen.com
LISHUI, China, Nov. 3, 2015 — Tantech Holdings Ltd. (NASDAQ: TANH) (“Tantech” or the “Company”), a leading manufacturer of bamboo-based charcoal products, announced today that it has established a wholly-owned subsidiary, Zhejiang Babiku Charcoal Co., Ltd. (“Babiku”), a PRC company with registered capital of RMB10 million, to manage its BBQ products business.
The Company is in the process of transferring its self-produced BBQ products business, currently managed by Zhejiang Tantech Energy Technology Co., Ltd. (“Energy Tech”), a wholly owned subsidiary, to Babiku. The Company currently sells two categories of BBQ products, 1) OEM BBQ Charcoal – non-bamboo based charcoal briquettes produced by third parties, and 2) self-produced BBQ Charcoal – bamboo based charcoal briquettes produced in the Company’s Lishui facility and primarily sold in the international market.
As a result of today’s announcement, the Company will have three wholly-owned manufacturing subsidiaries managing the three key product categories separately and independently, with Babiku for self-produced BBQ products, Energy Tech for EDLC carbon products, and Zhejiang Tantech Bamboo Charcoal Co., Ltd. (“Tantech Charcoal”) for branded Charcoal Doctor products. The new corporate structure, with improved focus and accountability, is expected to allow the Company to manage its businesses more effectively.
About Tantech Holdings Ltd.
Established in 2001 and headquartered in Lishui City, Zhejiang Province, China, Tantech Holdings Ltd., together with its subsidiaries, develops and manufactures bamboo-based charcoal products in China and internationally. It operates through three segments: Consumer Products, Trading, and Biofuel Energy. The company produces pressed and formed charcoal briquettes for use in grills, incense burners, and other applications under the Algold brand. It also offers Charcoal Doctor branded products, such as air purifiers and humidifiers, automotive accessories for air purification, underfloor humidity control, pillows and mattresses, wardrobe deodorizers, mouse pads and wrist mats, refrigerator deodorants, charcoal toilet cleaner disks, liquid charcoal cleaners, shoe insoles, and decorative charcoal gifts. In addition, the Company provides liquid byproduct consists of bamboo vinegar that is used in disinfectants, detergents, lotions, specialized soaps, toilet cleaners, and fertilizers, as well as in various agricultural applications. Further, it engages in providing bamboo carbon for use in EDLCs; the production of electric double-layer capacitor carbon products; and the industrial purchase and sale of rubber. The Company provides its products for industrial energy applications, as well as household cooking, heating, purification, agricultural, and cleaning uses. The company also exports its bamboo vinegar, bamboo charcoal purification, and EDLC carbon products. For more information about Tantech Holdings Ltd., please visit: http://www.tantech.cn/en/index.asp
Forward-Looking Statements
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, changes in technology, economic conditions, the impact of competition and pricing, government regulations, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the Company, are expressly qualified by this cautionary statement and any other cautionary statements which may accompany the forward-looking statements. In addition, the Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.
For more information please contact:
Tantech Holdings Ltd.
Ms. Ye Ren
IR Manager
+86-578-261-2869
ir@tantech.cn
Weitian Investor Relations
Ms. Tina Xiao
+1-917-609-0333
TANH@weitian-ir.com
Demonstrates Potential of “Prime-Pull” Immunotherapy Approach
SEATTLE and SOUTH SAN FRANCISCO, Calif., Nov. 3, 2015 — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced new preclinical data showing that a dendritic-cell targeting lentiviral vector from its ZVex™ immunotherapy platform administered with G100, which contains a potent synthetic TLR4 agonist, synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models. These data are being presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) Conference, National Harbor, Maryland, November 4-8, 2015.
“These findings further illustrate the potential of ZVex-based product candidates and G100 to play an important role in the emerging field of cancer immunotherapy, especially in potential combination therapies with immune checkpoint inhibitors,” said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. “Mechanistically, it is generally believed that the generation of tumor-specific CD8 T-cells can improve the clinical efficacy of checkpoint inhibitors, especially in patients with insufficient T-cell responses. These preclinical data provide a strong rationale for our ongoing and planned clinical trials which combine LV305, CMB305 and G100, agents from our ZVex and GLAAS discovery platforms, with KEYTRUDA and Atezolizumab.”
In the presentations, Immune Design scientists present data showing that in the murine B16 melanoma model, intratumoral injection of G100 improves the trafficking of ZVex-induced antigen-specific CD8 T-cells into tumors and induces systemic anti-tumor immunity mediated by antigen spreading. This discovery that Immune Design’s two platforms appear to “pull” T cells (G100) that were “primed” (ZVex agent) into the tumor potentially opens up new possibilities of enhancing the immunotherapy of solid tumors by changing the tumor microenvironment. In addition, combining G100 or a ZVex agent with both anti-PD1 and anti-PDL1 antibodies demonstrated increased efficacy in this experiment. The presentations are entitled “Intratumoral Injections of G100 (synthetic TLR4 agonist) Increases Trafficking of Lentiviral Vector-induced Antigen-specific CD8 T Cells to the Tumor Microenvironment” and “Checkpoint Inhibitors Synergize with Therapeutic Platforms, ZVex™ and GLAAS™ by Enhancing Lentiviral Vector-induced Tumor-specific Immunity and Adjuvant-mediated Anti-tumor Efficacy.”
These abstracts will be published in the Journal for ImmunoTherapy for Cancer on November 4, 2015, and the posters will be posted on the publications page of the Immune Design website following presentation at the conference.
About G100
G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. A Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. In the first eight patients in MCC study, G100 had an acceptable safety profile and the combined therapy of G100 followed by radiation and/or surgery resulted in an objective response rate (ORR) of 50%. A second Phase 1 trial is planned to examine intratumoral administration of G100 with intravenous administration of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with follicular non-Hodgkin’s lymphoma receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions.
About ZVex™
ZVex is Immune Design’s discovery platform designed to activate and expand the immune system’s natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo.
The ZVex delivery system uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells (DCs) in the skin. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen.
About Immune Design
Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the primary focus of Immune Design’s ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVexTM and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.
Forward Looking Statement:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design’s product candidates and the reporting of clinical data regarding Immune Design’s product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Immune Design’s collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Immune Design’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
CONTACT: Contact for Immune Design:
Media Contact
Julie Rathbun
Rathbun Communications
julie@rathbuncomm.com
206.769.9219
Investor Contact
Shari Annes
Annes Associates
sannes@annesassociates.com
650-888-0902
SOUTH SAN FRANCISCO, Calif., Nov. 3, 2015 — CytomX Therapeutics (Nasdaq: CTMX), a biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today announced that Matthew Young has joined the company’s board of directors. Mr. Young currently serves as chief financial officer of Jazz Pharmaceuticals, and brings more than two decades of experience in finance.
“Matt’s broad financial expertise and long-standing relationships with the investment community enrich our growing board of directors,” said Sean McCarthy, D. Phil, chief executive officer of CytomX. “His extensive corporate development experience and financial acumen will help guide us as we advance our innovative Probody pipeline and build CytomX for the long term.”
Mr. Young was appointed executive vice president and chief financial officer of Jazz Pharmaceuticals in February 2015. He previously held numerous positions within Jazz, including senior vice president, corporate development. Prior to joining the company, Mr. Young worked in investment banking for approximately 20 years. From 2009 to 2013, he served as a managing director in global healthcare of Barclays Capital, including acting as the co-head of life sciences. From 2007 to 2008, Mr. Young served as a managing director of Citigroup Global Markets, and from 2003 to 2007 as a managing director of Lehman Brothers. From 1992 to 2003, Mr. Young served in various capacities at other investment banking firms. In 2015, he joined the board of directors of PRA Health Sciences, a contract research company. Mr. Young received a bachelor’s degree in economics and a master’s in business from the Wharton School of the University of Pennsylvania.
About CytomX Therapeutics
CytomX is an oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform. The company uses the platform to create development-stage proprietary cancer immunotherapies against clinically-validated targets, as well as to develop first-in-class investigational cancer therapeutics against novel targets. CytomX believes that its Probody platform has the potential to improve the combined efficacy and safety profile of monoclonal antibody modalities, including cancer immunotherapies, antibody drug conjugates and T-cell-recruiting bispecific antibodies. Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. Investigational Probody therapeutics are being developed that address clinically-validated cancer targets in immuno-oncology, such as PD-L1 against which our clinical candidate CX-072 is directed, as well as novel targets, such as CD-166, that are difficult to drug without causing damage to healthy tissues, or toxicities. In addition to its proprietary programs, CytomX is collaborating with strategic partners including Bristol-Myers Squibb Company, Pfizer Inc. and ImmunoGen, Inc. For more information, visit www.cytomx.com.
Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements. Our Probody platform is in preclinical development, and the process by which a preclinical technology could potentially lead to an approved product is long and subject to significant risks and uncertainties. Applicable risks and uncertainties include those relating to our preclinical research and development and other risks identified under the heading “Risk Factors” included in our filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Media Contacts:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388
Investor Contacts:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973
BOSTON, Nov. 03, 2015 — Keryx Biopharmaceuticals, Inc, (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for people with renal disease, today announced that corporate presentations would be delivered at the following upcoming investor conferences.
Credit Suisse 24th Annual Healthcare Conference
Presenter: Greg Madison, Chief Executive Officer
Presentation Date: Tuesday, November 10, 2015
Presentation Time: 10:00 a.m. MST (12:00 p.m. EST)
Stifel 2015 Healthcare Conference
Presenter: Greg Madison, Chief Executive Officer
Presentation Date: Tuesday, November 17, 2015
Presentation Time: 11:00 a.m. EST
Live audio webcasts of these presentations will be accessible from Keryx’s website at http://investors.keryx.com within the Investor Relations section under the “webcasts and presentations” page. Archived versions of these webcasts will be available for at least 15 days following the conclusion of the live presentation.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices in New York and Boston, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the company launched its first FDA-approved product, Auryxia™ (ferric citrate) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis, in the United States. In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex) for the control of hyperphosphatemia in adults with non-dialysis and dialysis-dependent chronic kidney disease. For more information about Keryx, please visit www.keryx.com.

KERYX CONTACT:
Lora Pike
Senior Director, Investor Relations
T: 617-466-3511
lora.pike@keryx.com
CARLSBAD, CA–(November 03, 2015) – International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that after a recent meeting with Australian Therapeutics Goods Administration (TGA) the Company’s wholly owned subsidiary Cyto Therapeutics signed a Letter of Intent (LOI) with Royal Melbourne Hospital (Australia) to conduct phase I/IIa clinical trials of ISCO’s proprietary human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson’s Disease. Under this process, a full agreement will be signed after TGA and the HREC approve the clinical protocol for the phase I/IIa trials.
“We had a productive meeting with TGA where we discussed the clinical protocol and potentially came to an agreement on all remaining items. We look forward to receiving TGA approval for clinical trials in November and enrolling patients soon thereafter,” said Russell A. Kern, Ph.D., chief scientific officer of ISCO.
ISCO’s Parkinson’s disease program uses human parthenogenetic neural stem cells (hPNSC) which are a novel therapeutic cellular product derived from the Company’s proprietary human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system offers a potential new opportunity for the treatment of Parkinson’s disease.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and results of both the studies and regulatory approvals), progress of research and development initiatives, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Madison-Based Manufacturer of Cologuard Focuses on a Scalable Environment that Expands Existing Footprint
Exact Sciences Corp. (NASDAQ: EXAS) announced today that it will continue collaborating with the City of Madison in an attempt to establish a headquarters in Madison and is in discussions with the University of Wisconsin to develop a biotech campus that expands the company’s existing operations and research and development facilities.
“This is an opportunity to work with the city, build on our current footprint in Madison and partner with the University to continue grooming its aspiring talent,” said Exact Sciences Chairman and CEO Kevin Conroy. “We’re grateful for the Mayor and the City Council’s efforts to help efficiently bring our teams together. While the chance to build a headquarters downtown was incredibly appealing, an opportunity to develop a campus allows us to bring our team together and make a prudent investment that benefits the company and community for the long term.”
Exact Sciences and its more than 425 Madison-based employees are currently stretched across three buildings in the University Research Park and the 35,000 square foot Exact Sciences Laboratories. More than sixty percent of Exact Sciences research and development staff are graduates of the UW-System.
“The City understands and respects the reasons that Exact Sciences will not be moving its corporate headquarters to the downtown. I am encouraged that the company plans to focus its future facility planning in the City of Madison at University Research Park. We will now proceed to review other development plans for parking, a new hotel and other commercial development on the downtown site,” said Madison Mayor Paul Soglin. “City staff as well as those from Exact Sciences and the Hammes Corporation have invested hundreds of hours of work into this project and I am grateful for the commitment.”
“I’m pleased that through University Research Park, UW-Madison is able to help the city and Exact Sciences find a solution that keeps the company in Madison. We look forward to continuing to partner with Exact Sciences on workforce development and lifesaving research,” said University of Wisconsin-Madison Chancellor Rebecca Blank.
“University Research Park is one of the most concentrated communities of life sciences companies in the Midwest,” said University Research Park Managing Director Aaron Olver. “We’re proud to be called home by Exact Sciences and look forward to the opportunity to support their continued growth.”
Established in 1984, University Research Park is an internationally recognized research and technology park that supports early-stage and growth-oriented businesses in a range of sectors, including engineering, computer and life sciences. The park is home to more than 125 companies employing more than 3,800 workers. University Research Park is a non-profit 501(c)(3) affiliated with the University of Wisconsin-Madison.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
ZP-Triptan Patch is Well-Tolerated and Achieves Rapid Absorption With Potential for Fast Relief Alternative for Migraine Patients
FREMONT, Calif., Nov. 02, 2015 — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 1 clinical trial of its proprietary ZP-Triptan patch treatment for migraine.
ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. The objective of the Phase 1 clinical study was to evaluate the tolerability and pharmacokinetics of the ZP-Triptan patch in healthy volunteers. The crossover study among 20 healthy volunteers tested five doses of ZP-Triptan compared to an oral administration of zolmitriptan and additionally a subcutaneous injection of sumatriptan. ZP-Triptan demonstrated rapid absorption compared to the zolmitriptan tablet. All treatments were well tolerated and no safety issues were identified. The results for the sumatriptan injection were similar to those reported in the literature.
|
|
Cmax (SD)
ng/ml |
|
Tmax (range)
minutes |
|
AUC0-2hr (SD)
ng/ml hour |
|
AUC0-last (SD)
ng/ml hour |
|
|
|
|
|
|
|
|
|
| ZP-Triptan 0.48 mg |
|
1.8 (0.53) |
|
20 (2-30) |
|
2.1 (0.73) |
|
2.8 (1.36) |
|
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 0.48 mg |
|
3.7 (1.05) |
|
20 (2-30) |
|
4.2 (0.95) |
|
6.5 (1.97) |
|
|
|
|
|
|
|
|
|
| ZP-Triptan 1.9 mg |
|
6.8 (2.75) |
|
20 (2-30) |
|
7.4 (2.53) |
|
12.3 (4.31) |
|
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 1.9 mg |
|
14.6 (4.46) |
|
17.5 (2-30) |
|
16.4 (5.34) |
|
27.8 (9.93) |
|
|
|
|
|
|
|
|
|
| ZP-Triptan 3.8 mg |
|
22.6 (14.00) |
|
15 (2-30) |
|
19.3 (5.37) |
|
31.7 (8.35) |
|
|
|
|
|
|
|
|
|
| Zolmitriptan Oral Tablet |
|
3.8 (1.51) |
|
60 (30-240) |
|
4.7 (2.24) |
|
22.2 (10.79) |
|
|
|
|
|
|
|
|
|
Note: Mean values (median for Tmax) for the various zolmitriptan treatments are shown in the table above
“We are extremely pleased with the tolerability and pharmacokinetic results from our ZP-Triptan Phase 1 study,” said Thorsten von Stein, MD, PhD, Zosano Chief Medical Officer. “We expect that the demonstrated fast absorption will translate into fast pain relief. If so, ZP-Triptan’s fast absorption and simple injection-free administration may represent a strong product option for patients suffering from migraines. We look forward to discussing the program with the U.S. Food and Drug Administration (FDA) and to advancing clinical development.”
The company, which holds exclusive global rights to develop and commercialize the ZP-Triptan patch, intends to discuss further development plans with FDA and expects to initiate a Phase 2 clinical trial in 2016.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of clinical trial data and other expectations, beliefs and future events. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in Zosano Pharma Corporation’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with Securities and Exchange Commission on March 26, 2015. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano Pharma and Zosano Pharma assumes no obligation to update any such forward-looking statements.

Zosano Contact:
Vikram Lamba
Chief Executive Officer
510-745-1200
Investor Contact:
Patti Bank
Westwicke Partners
415-513-1284
patti.bank@westwicke.com
Media Contact:
Jamie Lacey-Moreira
PressComm PR, LLC
410-299-3310
jamielacey@presscommpr.com
Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies, today announced that Tom Farrell, President and CEO, will present a corporate overview at two healthcare investor conferences in November.
24th Annual Credit Suisse Healthcare Conference
- Location: The Phoenician, Scottsdale, AZ
- Presentation Date: Tuesday, November 10, 2015
- Presentation Time: 11:00 a.m. MST (1 p.m. EST)
Jefferies 2015 Global Healthcare Conference
- Location: The May Fair Hotel, London, UK
- Presentation Date: Thursday, November 19, 2015
- Presentation Time: 2:00 p.m. GMT (9:00 a.m. EST)
The presentations will be webcast live and may be accessed from the News & Events section of the Bellicum website. Archived versions of the webcasts will be available for replay for at least two weeks following the events.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including hematological cancers and solid tumors, as well as orphan inherited blood disorders. The Company is using its proprietary Chemical Induction of Dimerization, or CID, technology platform to engineer and control components of the immune system in real time. Bellicum is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.
Conn’s, Inc. (NASDAQ:CONN) (the “Company”), a specialty retailer of furniture and mattresses, home appliances, consumer electronics and home office products, and provider of consumer credit announced today that it has amended and restated its asset-based revolving credit facility (the “Amended Credit Facility”) that, among other things:
- Provides total commitments of $810 million;
- Extends the maturity date from November 25, 2017 to October 30, 2018;
- Increases the total leverage ratio covenant from 2.0x to 4.0x;
- Eliminates the fixed charge coverage ratio covenant and replaces it with an interest coverage covenant; and
- Adds a new minimum liquidity requirement for repurchases of the Company’s common stock, notes and other debt pre-payment, which, combined with the new total leverage ratio covenant, is expected to provide the Company greater flexibility for repurchases.
Concurrently with execution of the Amended Credit Facility, the Company executed a Second Supplemental Indenture (the “Supplemental Indenture”) to the Indenture (as supplemented or amended, the “Indenture”) that governs the Company’s 7.250% Senior Notes due 2022 (the “Notes”). The Supplemental Indenture changes the restricted payments provisions under the Indenture by:
- Amending, from May 1, 2014 to November 1, 2015, the beginning of the accounting period from which consolidated net income is calculated for purposes of determining the size of the “restricted payment basket” exception to the restricted payments limitation; and
- Increasing, from $75.0 million to $375.0 million, the dollar threshold exception to the restricted payments limitation (together with the first point, the “Indenture Amendments”).
The Indenture Amendments were approved by the holders of a majority in principal amount of the Notes through the Company’s consent solicitation that was completed on October 29, 2015.
Norm Miller, Conn’s President and Chief Executive Officer commented, “We are pleased with the successful completion of these amendments and believe they reflect the confidence of our lenders and bond holders in our company. The credit facility, combined with expected future securitizations and use of high-yield notes provides us with ample liquidity to pursue our growth initiatives supported by a diversified capital structure.”
“With the completion of the amendments to our bank facility and senior notes indenture, we are also pleased to announce an additional $100 million share repurchase program which supports our goal of returning value to our shareholders while investing in our business and improving our capital structure. We intend to complete the repurchases under this authorization during our fiscal quarter ending January 31, 2016, as long as market conditions and other factors continue to support such use of our capital. The amendments to our bank facility and senior note indenture give us the ability to consider additional repurchase programs over time, dependent on market conditions, capital availability and other factors.”
The Company utilized substantially all of its authorization available under the previously approved $75 million repurchase program. During the quarter ended October 31, 2015, the Company purchased 1.9 million shares, using $51.6 million of its $75 million stock and bond repurchase authorization. Additionally, the Company utilized $22.9 million of the repurchase authorization to acquire $23.0 million of face of value of its senior notes. As a result of the bond repurchases, the Company incurred a loss during the quarter of approximately $0.5 million, related primarily to the write-off of deferred costs related to the bonds acquired. Additionally, the Company will write off approximately $0.9 million of deferred costs related to the amendment of its bank facility.
About Conn’s, Inc.
The Company is a specialty retailer currently operating approximately 100 retail locations in Arizona, Colorado, Georgia, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee and Texas. The Company’s primary product categories include:
- Furniture and mattress, including furniture and related accessories for the living room, dining room and bedroom, as well as both traditional and specialty mattresses;
- Home appliance, including refrigerators, freezers, washers, dryers, dishwashers and ranges;
- Consumer electronics, including LCD, LED, 3-D and Ultra HD televisions, Blu-ray players, home theater and portable audio equipment; and
- Home office, including computers, printers and accessories.
Additionally, the Company offers a variety of products on a seasonal basis. Unlike many of its competitors, the Company provides flexible in-house credit options for its customers in addition to third-party financing programs and third-party rent-to-own payment plans.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include information concerning the Company’s future financial performance, business strategy, plans, goals and objectives. Statements containing the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” or the negative of such terms or other similar expressions are generally forward-looking in nature and not historical facts. Although we believe that the expectations, opinions, projections, and comments reflected in these forward-looking statements are reasonable, we can give no assurance that such statements will prove to be correct, and actual results may differ materially. A wide variety of potential risks, uncertainties, and other factors could materially affect the Company’s ability to achieve the results either expressed or implied by the Company’s forward-looking statements including, but not limited to: general economic conditions impacting the Company’s customers or potential customers; the Company’s ability to execute periodic securitizations of future originated loans including the sale of any remaining residual equity on favorable terms; the Company’s ability to continue existing customer financing programs or to offer new customer financing programs; changes in the delinquency status of the Company’s credit portfolio; unfavorable developments in ongoing litigation; increased regulatory oversight; higher than anticipated net charge-offs in the credit portfolio; the success of the Company’s planned opening of new stores; technological and market developments and sales trends for the Company’s major product offerings; the Company’s ability to protect against cyber-attacks or data security breaches and to protect the integrity and security of individually identifiable data of the Company’s customers and employees; the Company’s ability to fund its operations, capital expenditures, debt repayment and expansion from cash flows from operations, borrowings from the Company’s revolving credit facility, and proceeds from accessing debt or equity markets; the ability to continue the Company’s stock repurchase program; and the other risks detailed in the Company’s most recent SEC reports, including but not limited to, the Company’s Annual Report on Form 10-K and the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. If one or more of these or other risks or uncertainties materialize (or the consequences of such a development changes), or should our underlying assumptions prove incorrect, actual outcomes may vary materially from those reflected in our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We disclaim any intention or obligation to update publicly or revise such statements, whether as a result of new information, future events or otherwise. All forward-looking statements attributable to us, or to persons acting on our behalf, are expressly qualified in their entirety by these cautionary statements.
S.M. Berger & Company
Andrew Berger, 216-464-6400
STONY BROOK, NY–(November 02, 2015) – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced that it has shipped its first orders of DNA used as a diagnostic reagent to reagent suppliers and two international diagnostics customers. The total value of these shipments, which were made in its fiscal 2015 fourth quarter and the current fiscal first quarter, is over $400,000.
On September 11, 2015, APDN announce the acquisition of Vandalia Research, Inc., whose core technology and intellectual property portfolio allows for the large-scale production of specific DNA sequences using polymerase chain reaction (PCR). As part of the acquisition, Applied DNA assumed Vandalia’s backlog of orders.
Dr. James Hayward, CEO of Applied DNA Sciences, stated: “With the fulfillment of these orders, we are already beginning to reap the benefits of the acquisition. Whereas Vandalia’s PCR technology enhances our in-house DNA manufacturing capacity as demand drivers strengthen across key business verticals, it simultaneously provides us entrée into biotechnology, pharmaceutical and diagnostic markets. As we continue to provide contract production of DNA to clients in these markets, we plan to also introduce them to our DNA-based security solutions to protect their products against theft of their IP and the invasion of counterfeits into their supply chains.”
DNA production by PCR is not a broadly available commercial service, especially at large scale. The advantage of PCR-based production is the purity of product compared to the DNA produced by the more commonly available fermentation methods. DNA-based diagnostic reagents may be used in the early detection of cancer, or the diagnosis of genetic, metabolic or infectious diseases. DNA-based therapeutics may be used in gene therapies, DNA vaccines, and other therapies that are generally in the early stage of development. By providing the production of DNA for diagnostics and therapeutics, APDN expects to gain access to pharmaceutic customers who will likely have supply chain concerns, and need to protect themselves against the potential of counterfeit infiltration and comply with FDA efforts to eliminate counterfeits.
“Double-stranded DNA is fundamental to the biotechnology, pharmaceutical and diagnostics markets and we believe our capacity to manufacture it by PCR is unsurpassed in the world,” concluded Dr. Hayward. “Unlike “synthetic DNA,” which is single-stranded, double-stranded DNA provides more informational content and is less subject to degradation, which can lead to an inability to authenticate when the need is critical. Much of our patent portfolio addresses the stability of our double-stranded DNA markers, which, when supplemented by Vandalia’s enhancements to our manufacturing capabilities, delivers cutting-edge value, purity of product and capacity to manufacture to the demanding specifications these markets require. With leadership positions in double-stranded DNA and its manufacture, we believe we are well positioned to succeed in these markets.”
About Applied DNA Sciences
Applied DNA Sciences makes life real and safe by providing biotechnology-driven solutions to help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. Patented botanical DNA solutions can be used to identify, tag, track, and trace products, to help assure authenticity, traceability and quality of products. SigNature DNA is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators.
Go to adnas.com for more information, events and to learn more about how Applied DNA Sciences makes life real and safe. Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.
Forward Looking Statements
The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, as amended on March 6, 2015, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2015, May 11,2015 and August 10, 2015, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.
FAIRPORT HARBOR, OH–(November 02, 2015) – OurPet’s Company (OTCQX: OPCO) (www.ourpets.com), a leading proprietary pet supply company, today reported record third-quarter revenue of $5.99 million, an increase of 7% from $5.60 million in revenues for the comparable three months of 2014. Net income for the third quarter ended September 30, 2015, increased 428% to $410,450, or $0.02 diluted earnings per share, compared to $77,751, or $0.00, for the year prior.
Dr. Steven Tsengas, President and CEO, commented, “We are pleased with our results for the third quarter in which we achieved record net revenue, gross margins improving to 34%, and net income from operations of almost 11% of sales. We continue to see strong sales growth in the Pet Specialty channel driven by our cat toys and bowls/feeder lines. E-commerce sales rebounded and grew 7% while the Food, Drug, Mass channel slightly decreased; however, we anticipate improved sales as the conversion to the PetZone brand is completed by year end. Unfortunately, with the strengthening of the U.S. dollar, international sales have been negatively impacted particularly in Canada and the United Kingdom.”
Dr. Tsengas continued, “We have expanded and strengthened our relationship with several domestic and international independent sales representative organizations, and have added another experienced salesperson to our staff. With the recent and anticipated introduction of a significant number of new innovative products in all our product categories, we are experiencing robust sales activity. Our Catty Whack™, winner of the SuperZoo ‘Best New Cat Product’ award, is beginning to ship and is receiving strong consumer reaction. We expect to release more information on other major, trend-setting products over the next six months.
“As we have previously communicated, the last five years have been challenging for OurPet’s as we have transitioned from a small- to a medium-sized company poised for accelerated future growth in both revenue and net income. This required large investments in management/operating informational systems; strengthening and, where appropriate, adding management and professional/technical talent; improving warehousing and inventory management efficiencies; strengthening relationships of strategic domestic and overseas suppliers; and strengthening our relationship with our banking resources. We sincerely believe that these improvements will positively impact revenue and profit results going into the fourth quarter of 2015 and beyond.”
2015 Third Quarter Results
Net revenue increased 7% to $5,986,645 for the 2015 third quarter versus the same period last year. The $386,000 increase was attributable to strong sales in the Pet Specialty and Value channels, partially offset by a decrease in the Food, Drug and Mass channel.
Gross Profit was $2,012,177 for the 2015 third quarter compared to $1,640,751 the prior year. Gross profit margin increased 4.3 percentage points to 33.6% for the 2015 third quarter from 29.3% for the same period a year ago due to continuous improvement initiatives, price increases, and product mix.
Income from operations increased to $649,023 for the 2015 third quarter from $152,768 a year ago. This increase was primarily due to higher gross profit and also benefited from lower selling, general, and administrative expenses.
Other income for the 2015 third quarter increased to $14,582 from $6,051 a year ago due to a higher amount of patent infringement settlements.
Income before taxes was almost five times greater at $627,686 for the 2015 third quarter compared to $127,666 a year ago.
Income tax expense for the 2015 third quarter increased to $217,236 from $49,915 a year ago due to the higher income.
Net income increased to $410,450 for the 2015 third quarter from $77,751 last year. Net income per diluted share increased to $0.02 for the third quarter of 2015 from $0.00 a year ago.
EBITDA was $825,696 for the 2015 third quarter versus $323,140 a year ago. A reconciliation of EBITDA to GAAP net income is provided in an attachment to the summary financial statements.
2015 First Nine Months Results
Net revenue increased 6% to $17,170,795 for the first nine months of 2015. The year-over-year increase was due to strong Pet Specialty sales, especially in the bowls and feeders category.
Gross profit increased 15% to $5,424,591 for the first nine months of 2015 versus the prior year. Gross profit margin increased 2.5 percentage points to 31.6% for the first nine months of 2015 from 29.1% the prior year due to the same factors that benefited the 2015 third quarter results.
Income from operations increased 143% to $1,427,797 for the first nine months of 2015, which was attributable to higher gross profit and lower selling, general, and administrative expenses.
Other income decreased to $40,582 for the first nine months of 2015 from $77,713 for the same period last year due to a greater amount of patent infringement settlements in 2014.
Income before taxes increased to $1,383,158 for the first nine months of 2015 compared to $566,658 for the same period a year ago.
Income tax expense was $496,839 for the first nine months of 2015 compared to $206,723 the prior year.
Net income for the first nine months of 2015 increased 146% to $886,319 from $359,935 for the same period in 2014. Net income per share increased to $0.04 for the first nine months of 2015 from $0.02 last year.
EBITDA increased 72% to $1,984,688 the first nine months of 2015 compared to $1,153,656 the prior year. A reconciliation of EBITDA to GAAP Net Income is provided in an attachment to the summary financial statements.
The Current Ratio improved to 5.61, reflecting or strong liquidity, while Stockholders’ Equity improved by $904,319 or 12.1% over the comparable date last year.
About OurPet’s Company
OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investors and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.
Forward-Looking Statements
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.
|
| OURPET’S COMPANY AND SUBSIDIARIES |
| CONSOLIDATED OPERATING RESULTS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net revenue |
|
$ |
5,986,645 |
|
|
$ |
5,601,011 |
|
|
$ |
17,170,795 |
|
|
$ |
16,175,692 |
|
| Cost of goods sold |
|
|
3,974,468 |
|
|
|
3,960,260 |
|
|
|
11,746,204 |
|
|
|
11,462,593 |
|
|
|
Gross profit on sales |
|
|
2,012,177 |
|
|
|
1,640,751 |
|
|
|
5,424,591 |
|
|
|
4,713,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Selling, general and administrative expenses |
|
|
1,363,154 |
|
|
|
1,487,983 |
|
|
|
3,996,794 |
|
|
|
4,126,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
649,023 |
|
|
|
152,768 |
|
|
|
1,427,797 |
|
|
|
586,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other (income) and expense, net |
|
|
(14,582 |
) |
|
|
(6,051 |
) |
|
|
(40,582 |
) |
|
|
(77,713 |
) |
| Interest expense |
|
|
35,919 |
|
|
|
31,153 |
|
|
|
85,221 |
|
|
|
97,519 |
|
| Income before taxes |
|
|
627,686 |
|
|
|
127,666 |
|
|
|
1,383,158 |
|
|
|
566,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Income Tax expense |
|
|
217,236 |
|
|
|
49,915 |
|
|
|
496,839 |
|
|
|
206,723 |
|
| Net Income |
|
$ |
410,450 |
|
|
$ |
77,751 |
|
|
$ |
886,319 |
|
|
$ |
359,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Income Per Common Share After Dividend Requirements For Preferred Stock |
|
$ |
0.02 |
|
|
$ |
0.00 |
|
|
$ |
0.04 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common shares outstanding used to calculate basic earnings per share |
|
|
17,562,239 |
|
|
|
17,056,910 |
|
|
|
17,558,085 |
|
|
|
16,884,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common and equivalent shares outstanding used to calculate diluted earnings per share |
|
|
19,824,793 |
|
|
|
18,037,565 |
|
|
|
19,220,115 |
|
|
|
18,160,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OURPET’S COMPANY AND SUBSIDIARIES |
| CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2015 |
|
2014 |
| ASSETS |
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
101,775 |
|
$ |
192,448 |
|
Receivables, net |
|
|
4,048,759 |
|
|
3,116,448 |
|
Inventories, net |
|
|
7,802,675 |
|
|
6,894,115 |
|
Prepaid expenses |
|
|
467,126 |
|
|
478,593 |
|
|
Total current assets |
|
|
12,420,335 |
|
|
10,681,604 |
|
|
|
|
|
|
|
| LONG TERM ASSETS |
|
|
|
|
|
|
|
Property and equipment, net |
|
|
1,867,252 |
|
|
1,769,548 |
|
Amortizable intangible assets, net |
|
|
361,259 |
|
|
384,063 |
|
Non amortizable Intangible Assets |
|
|
461,000 |
|
|
461,000 |
|
Goodwill |
|
|
67,511 |
|
|
67,511 |
|
Deposits and Other assets |
|
|
18,003 |
|
|
18,003 |
|
|
Total long term assets |
|
|
2,775,025 |
|
|
2,700,125 |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
15,195,360 |
|
$ |
13,381,729 |
|
|
|
|
|
|
|
| LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current maturities of long-term debt |
|
|
311,470 |
|
|
601,632 |
|
Accounts payable |
|
|
1,244,885 |
|
|
1,489,982 |
|
Accrued expenses |
|
|
656,652 |
|
|
565,491 |
|
|
Total current liabilities |
|
|
2,213,007 |
|
|
2,657,105 |
|
|
|
|
|
|
|
| LONG TERM LIABILITIES |
|
|
|
|
|
|
|
Long-term debt – less current portion above |
|
|
938,894 |
|
|
119,780 |
|
Revolving line of credit |
|
|
3,473,032 |
|
|
2,862,032 |
|
Deferred income taxes |
|
|
204,947 |
|
|
281,651 |
|
|
Total long term liabilities |
|
|
4,616,873 |
|
|
3,263,463 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
6,829,880 |
|
|
5,920,568 |
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
8,365,480 |
|
|
7,461,161 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
15,195,360 |
|
$ |
13,381,729 |
|
|
|
|
|
|
|
|
|
| OURPET’S COMPANY AND SUBSIDIARIES |
| CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
September 30, |
|
December 31, |
|
|
2015 |
|
2014 |
|
|
Unaudited |
|
|
| ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
| CURRENT ASSETS |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
101,775 |
|
$ |
192,448 |
|
Accounts receivable – trade, less allowance for doubtful accounts of $37,824 and $39,539 |
|
|
4,048,759 |
|
|
3,116,448 |
|
Inventories net of reserve |
|
|
7,802,675 |
|
|
6,894,115 |
|
Prepaid expenses |
|
|
467,126 |
|
|
478,593 |
|
|
Total current assets |
|
|
12,420,335 |
|
|
10,681,604 |
|
|
|
|
|
|
|
| PROPERTY AND EQUIPMENT |
|
|
|
|
|
|
|
Computers and office equipment |
|
|
1,020,239 |
|
|
883,163 |
|
Warehouse equipment |
|
|
585,815 |
|
|
567,816 |
|
Leasehold improvements |
|
|
289,217 |
|
|
276,952 |
|
Tooling |
|
|
4,207,203 |
|
|
3,885,401 |
|
Construction in progress |
|
|
222,573 |
|
|
157,031 |
|
|
Total |
|
|
6,325,047 |
|
|
5,770,363 |
|
Less accumulated depreciation |
|
|
4,457,795 |
|
|
4,000,815 |
|
|
Net property and equipment |
|
|
1,867,252 |
|
|
1,769,548 |
|
|
|
|
|
|
|
| OTHER ASSETS |
|
|
|
|
|
|
|
Amortizable Intangible Assets, less amortization of $476,677 and $417,349 |
|
|
361,259 |
|
|
384,063 |
|
Intangible Assets |
|
|
461,000 |
|
|
461,000 |
|
Goodwill |
|
|
67,511 |
|
|
67,511 |
|
Deposits and other assets |
|
|
18,003 |
|
|
18,003 |
|
|
Total other assets |
|
|
907,773 |
|
|
930,577 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
15,195,360 |
|
$ |
13,381,729 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
|
| OURPET’S COMPANY AND SUBSIDIARIES |
| CONDENSED CONSOLIDATED BALANCE SHEETS (CONTINUED) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2015 |
|
2014 |
|
|
Unaudited |
|
|
| LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
| CURRENT LIABILITIES |
|
|
|
|
|
|
|
Current maturities of long-term debt |
|
|
311,470 |
|
|
601,632 |
|
Accounts payable – trade |
|
|
1,244,885 |
|
|
1,489,982 |
|
Other accrued expenses |
|
|
656,652 |
|
|
565,491 |
|
|
Total current liabilities |
|
|
2,213,007 |
|
|
2,657,105 |
|
|
|
|
|
|
|
| LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
Long-term debt – less current portion above |
|
|
938,894 |
|
|
119,780 |
|
Revolving Line of Credit |
|
|
3,473,032 |
|
|
2,862,032 |
|
Deferred Income Taxes |
|
|
204,947 |
|
|
281,651 |
|
|
Total long term liabilities |
|
|
4,616,873 |
|
|
3,263,463 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
6,829,880 |
|
|
5,920,568 |
|
|
|
|
|
|
|
| STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
| COMMON STOCK, |
|
|
|
|
|
|
|
no par value; 50,000,000 shares authorized, 17,562,239 and 16,657,660 shares issued and outstanding at September 30, 2015 and December 31, 2014 respectively |
|
|
5,031,766 |
|
|
5,031,766 |
|
|
|
|
|
|
|
| CONVERTIBLE PREFERRED STOCK, |
|
|
|
|
|
|
|
no par value; convertible into Common Stock at the rate of 10 common shares for each preferred share; 4,825,000 shares authorized, 63,500 shares issued and outstanding at September 30, 2015 and December 31, 2014 |
|
|
579,850 |
|
|
579,850 |
|
|
|
|
|
|
|
|
Series 2009 no par value; convertible into Common Stock at the rate of 10 common shares for each preferred share; 175,000 shares authorized, 123,616 shares issued and outstanding at September 30, 2015 and December 31, 2014 |
|
|
865,312 |
|
|
865,312 |
|
|
|
|
|
|
|
| PAID-IN CAPITAL |
|
|
71,307 |
|
|
53,307 |
|
|
|
|
|
|
|
| ACCUMULATED EARNINGS |
|
|
1,817,245 |
|
|
930,926 |
|
|
Total stockholders’ equity |
|
|
8,365,480 |
|
|
7,461,161 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
15,195,360 |
|
$ |
13,381,729 |
|
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
|
| OURPETS COMPANY AND SUBSIDIARIES |
| CONSOLIDATED STATEMENTS OF OPERATIONS |
| (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net revenue |
|
$ |
5,986,645 |
|
|
$ |
5,601,011 |
|
|
$ |
17,170,795 |
|
|
$ |
16,175,692 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Cost of goods sold |
|
|
3,974,468 |
|
|
|
3,960,260 |
|
|
|
11,746,204 |
|
|
|
11,462,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Gross profit on sales |
|
|
2,012,177 |
|
|
|
1,640,751 |
|
|
|
5,424,591 |
|
|
|
4,713,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Selling, general and administrative expenses |
|
|
1,363,154 |
|
|
|
1,487,983 |
|
|
|
3,996,794 |
|
|
|
4,126,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Income from operations |
|
|
649,023 |
|
|
|
152,768 |
|
|
|
1,427,797 |
|
|
|
586,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other income |
|
|
(14,582 |
) |
|
|
(6,051 |
) |
|
|
(40,582 |
) |
|
|
(77,713 |
) |
| Interest expense |
|
|
35,919 |
|
|
|
31,153 |
|
|
|
85,221 |
|
|
|
97,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Income before income taxes |
|
|
627,686 |
|
|
|
127,666 |
|
|
|
1,383,158 |
|
|
|
566,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Income tax expense |
|
|
217,236 |
|
|
|
49,915 |
|
|
|
496,839 |
|
|
|
206,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net income |
|
$ |
410,450 |
|
|
$ |
77,751 |
|
|
$ |
886,319 |
|
|
$ |
359,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and Diluted Earnings Per Common Share After Dividend Requirements For Preferred Stock: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
0.02 |
|
|
$ |
0.00 |
|
|
$ |
0.04 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common shares outstanding used to calculate basic earnings per share |
|
|
17,562,239 |
|
|
|
17,056,910 |
|
|
|
17,558,085 |
|
|
|
16,884,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average number of common and equivalent shares outstanding used to calculate diluted earnings per share |
|
|
19,824,793 |
|
|
|
18,037,565 |
|
|
|
19,220,115 |
|
|
|
18,160,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
|
| OURPET’S COMPANY AND SUBSIDIARIES |
|
| CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (Unaudited) |
|
| FOR THE NINE MONTHS ENDED September 30, 2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
Series 2009 Preferred Stock |
|
Common Stock |
|
|
|
|
|
|
|
|
Number of
Shares |
|
Amount |
|
Number of
Shares |
|
Amount |
|
Number of
Shares |
|
Amount |
|
Paid-In
Capital |
|
Accumulated
Earnings |
|
Total
Stockholders’
Equity |
| Balance at December 31, 2014 |
|
63,500 |
|
$ |
579,850 |
|
123,616 |
|
$ |
865,312 |
|
17,553,007 |
|
$ |
5,031,766 |
|
$ |
53,307 |
|
$ |
930,926 |
|
$ |
7,461,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Common Stock issued upon exercise of stock options |
|
– |
|
|
– |
|
– |
|
|
– |
|
9,232 |
|
|
– |
|
|
– |
|
|
– |
|
|
– |
| Net income |
|
– |
|
|
– |
|
– |
|
|
– |
|
– |
|
|
– |
|
|
– |
|
|
886,319 |
|
|
886,319 |
| Stock-Based compensation expense |
|
– |
|
|
– |
|
– |
|
|
– |
|
– |
|
|
– |
|
|
18,000 |
|
|
– |
|
|
18,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at September 30, 2015 (unaudited) |
|
63,500 |
|
$ |
579,850 |
|
123,616 |
|
$ |
865,312 |
|
17,562,239 |
|
$ |
5,031,766 |
|
$ |
71,307 |
|
$ |
1,817,245 |
|
$ |
8,365,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the condensed consolidated financial statements.
|
| OURPET’S COMPANY AND SUBSIDIARIES |
|
| CONSOLIDATED STATEMENTS OF CASH FLOWS |
|
| (Unaudited) |
|
|
|
|
|
|
|
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
|
2015 |
|
|
2014 |
|
| CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
886,319 |
|
|
$ |
359,935 |
|
|
Adjustments to reconcile net income to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
Loss on Disposal of Fixed Assets |
|
|
20,657 |
|
|
|
12,323 |
|
|
|
Depreciation expense |
|
|
456,981 |
|
|
|
430,988 |
|
|
|
Amortization expense |
|
|
59,328 |
|
|
|
58,491 |
|
|
|
Stock option expense |
|
|
18,000 |
|
|
|
9,000 |
|
|
|
(Increase) decrease in assets: |
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable – trade |
|
|
(932,311 |
) |
|
|
(417,090 |
) |
|
|
|
Inventories |
|
|
(908,560 |
) |
|
|
(1,848,425 |
) |
|
|
|
Prepaid expenses |
|
|
11,467 |
|
|
|
33,901 |
|
|
|
Amortizable Intangible Asset Additions |
|
|
(36,524 |
) |
|
|
(67,154 |
) |
|
|
Increase (decrease) in liabilities: |
|
|
|
|
|
|
|
|
|
|
|
Accounts payable – trade |
|
|
(245,097 |
) |
|
|
933,303 |
|
|
|
|
Accrued expenses |
|
|
91,161 |
|
|
|
(415,195 |
) |
|
|
|
Deferred tax liabilities |
|
|
(76,704 |
) |
|
|
(58,234 |
) |
|
|
|
|
Net cash used in operating activities |
|
|
(655,284 |
) |
|
|
(968,157 |
) |
|
|
|
|
|
|
|
|
|
| CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment |
|
|
(490,341 |
) |
|
|
(398,816 |
) |
|
|
|
|
Net cash used in investing activities |
|
|
(490,341 |
) |
|
|
(398,816 |
) |
|
|
|
|
|
|
|
|
|
| CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
|
Principal borrowings of long-term debt |
|
|
1,000,000 |
|
|
|
– |
|
|
Principal payments on long-term debt |
|
|
(556,048 |
) |
|
|
(335,289 |
) |
|
Borrowings on bank line of credit |
|
|
611,000 |
|
|
|
1,649,000 |
|
|
Issuances of Common Stock |
|
|
– |
|
|
|
72,500 |
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,054,952 |
|
|
|
1,386,211 |
|
|
|
|
|
Net increase (decrease) in cash |
|
|
(90,673 |
) |
|
|
19,238 |
|
|
|
|
|
|
|
|
|
|
| CASH AT BEGINNING OF PERIOD |
|
|
192,448 |
|
|
|
57,975 |
|
| CASH AT END OF PERIOD |
|
$ |
101,775 |
|
|
$ |
77,213 |
|
|
|
|
|
|
|
|
|
|
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION |
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
126,552 |
|
|
$ |
81,856 |
|
|
Income taxes paid |
|
$ |
472,150 |
|
|
$ |
425,466 |
|
|
|
|
|
|
|
|
|
|
| SUPPLEMENTAL DISCLOSURE OF NON CASH TRANSACTIONS |
|
|
|
|
|
|
|
|
|
Non cash exercise of stock options/ warrants |
|
$ |
6,933 |
|
|
$ |
539,128 |
|
|
Tooling Obtained through Asset Purchase |
|
$ |
85,000 |
|
|
$ |
– |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the consolidated financial statements.
|
|
| OURPET’S COMPANY AND SUBSIDIARIES |
|
| STATEMENT OF COMPUTATION OF NET INCOME PER SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2015 |
|
2014 |
|
|
2015 |
|
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net income (loss) |
|
$ |
410,450 |
|
$ |
77,751 |
|
|
$ |
886,319 |
|
|
$ |
359,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Preferred Stock dividend requirements |
|
|
– |
|
|
(24,610 |
) |
|
|
(35,621 |
) |
|
|
(73,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net income (loss) attributable to common stockholders |
|
$ |
410,450 |
|
$ |
53,141 |
|
|
$ |
850,698 |
|
|
$ |
286,907 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic weighted average number of common shares outstanding |
|
|
17,562,239 |
|
|
17,056,910 |
|
|
|
17,558,085 |
|
|
|
16,884,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Preferred Stock Common Share Equivalents |
|
|
1,871,160 |
|
|
– |
|
|
|
1,236,160 |
|
|
|
– |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dilutive Stock Options outstanding for the Period |
|
|
97,973 |
|
|
380,077 |
|
|
|
111,733 |
|
|
|
594,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dilutive Warrants outstanding for the Period |
|
|
293,420 |
|
|
600,578 |
|
|
|
314,137 |
|
|
|
682,372 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Diluted weighted average number of common and equivalent shares outstanding |
|
|
19,824,793 |
|
|
18,037,565 |
|
|
|
19,220,115 |
|
|
|
18,160,978 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and Diluted Net income (loss) per common share |
|
$ |
0.02 |
|
$ |
0.00 |
|
|
$ |
0.04 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| EBITDA Q3’15 |
|
|
|
|
|
|
|
|
|
| EBITDA |
|
Q3’15 |
|
Q3’14 |
|
1st nine
months
2015 |
|
1st nine
months
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net Income |
|
$ |
410,450 |
|
$ |
77,751 |
|
$ |
886,319 |
|
$ |
359,935 |
| Interest |
|
|
35,919 |
|
|
31,153 |
|
|
85,221 |
|
|
97,519 |
| Tax Expense |
|
|
217,236 |
|
|
49,915 |
|
|
496,839 |
|
|
206,723 |
| Depreciation |
|
|
143,135 |
|
|
143,977 |
|
|
456,981 |
|
|
430,988 |
| Amortization |
|
|
18,956 |
|
|
20,344 |
|
|
59,328 |
|
|
58,491 |
|
Total EBITDA |
|
$ |
825,696 |
|
$ |
323,140 |
|
$ |
1,984,688 |
|
$ |
1,153,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The above table reconciles the Company’s disclosure of Net Income per GAAP with the non GAAP financial measure EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization). As the investment community has often requested the EBITDA calculation to help them evaluate performance, Management has chosen to provide this disclosure. Although EBITDA is widely used in the investment community as a benchmark to reflect operating performance, financing capability and liquidity, it is not regarded as a measure of operating performance and liquidity under generally accepted accounting principles (“GAAP”). It also does not represent cash flows from operating activities. In addition, the Company’s EBITDA may not be comparable to similar indicators provided by other companies. The Presentation of this additional information is not meant to be considered in isolation or as a substitute for net income (loss), or any component thereof, in accordance with GAAP.
CAMBRIDGE, Mass. and VANCOUVER, British Columbia, Oct. 30, 2015 — VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”) and SciVac Therapeutics Inc. (TSX:VAC) (OTCQX:SVACF) (“SciVac”) will host a joint conference call for their respective shareholders at 3:00 P.M. Eastern Time on Thursday, November 5, 2015. The call will be hosted by Jeff Baxter, President & CEO of VBI, and Dr. Curtis Lockshin, CEO of SciVac, who will together discuss the previously announced entry into a merger agreement whereby, subject to the satisfaction of certain conditions, a wholly owned subsidiary of SciVac will merge with and into VBI, with VBI surviving as a wholly owned subsidiary of SciVac. The conference call will provide shareholders of VBI and SciVac with an opportunity to ask questions regarding the proposed merger.
The conference call registration information is listed below:
CONFERENCE CALL INFORMATION:
WHEN: Thursday, November 5, 2015, 3:00 P.M. Eastern Time
TO REGISTER: Please visit: http://dpregister.com/10075803 to receive dial-in instructions for the conference call
For those shareholders unable to participate in the conference call, a transcript will be available on VBI’s website at www.vbivaccines.com and will be filed with the U.S Securities and Exchange Commission and available at www.sec.gov.
About SciVac Therapeutics Inc.
SciVac Therapeutics Inc., headquartered in Rehovot Israel, is in the business of developing, producing and marketing biological products for human healthcare. SciVac’s flagship product, Sci-B-Vac™, is a recombinant third-generation hepatitis B vaccine. SciVac also offers contract development and manufacturing services to the life sciences and biotechnology markets.
Website Home: http://www.scivactherapeutics.com
Investors: http://ir.scivactherapeutics.com/
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company developing novel technologies that seek to expand vaccine protection in large underserved markets. VBI’s eVLP vaccine platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus. VBI’s lead eVLP asset is a prophylactic Cytomegalovirus (“CMV”) vaccine; VBI has initiated work for GMP manufacturing of its CMV candidate for use in formal preclinical and Phase I trials. VBI’s second platform is a thermostable technology that enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating temperatures. VBI has completed proof of concept thermostability studies on a number of vaccine and biologic targets. VBI is headquartered in Cambridge, MA with research facilities in Ottawa, Canada.
Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
Investors: http://ir.vbivaccines.com/
Important Information For Investors And Stockholders
This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed business combination between VBI Vaccines Inc. (“VBI”) and SciVac Therapeutics Inc. (“SciVac”). In connection with this proposed business combination, VBI and/or SciVac will file relevant materials with the Securities Exchange Commission (the “SEC”) and applicable Canadian securities regulatory authorities (“Canadian Securities Commissions”), including a SciVac registration statement on Form F-4 or S-4 that will include a proxy statement of VBI and constitute a prospectus of SciVac. INVESTORS AND SECURITY HOLDERS OF VBI AND SCIVAC ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC AND THE CANADIAN SECURITIES COMMISSIONS CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Any definitive proxy statement (if and when available) will be mailed to stockholders of VBI. Investors and security holders will be able to obtain free copies of these documents (if and when available) and other documents filed with the SEC by VBI and/or SciVac through the website maintained by the SEC at www.sec.gov and, in the case of documents of SciVac filed with the Canadian Securities Commissions, on SciVac’s SEDAR profile on www.sedar.com. Copies of the documents filed with the SEC by VBI will be available free of charge on VBI’s website at http://www.vbivaccines.com or by contacting VBI’s Investor Relations Department by email at ir@vbivaccines.com or by phone at (617) 830-3031 x128. Copies of the documents filed with the SEC and the Canadian Securities Commissions by SciVac will be available free of charge on SciVac’s website at www.scivactherapeutics.com or by contacting SciVac’s Investor Relations Department by email at jmartin@scivactherapeutics.com or by phone at (305) 575-4207.
Participants in Solicitation
VBI, SciVac, their respective directors and certain of their respective executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of VBI is set forth in the proxy statement for VBI’s 2015 Annual Meeting of Stockholders, which was filed with the SEC on April 15, 2015 and available for review at www.sec.gov. Information about the directors and executive officers of SciVac is set forth in its Management Information Circular, furnished as Exhibit 99.1 to SciVac’s Form 6-K, furnished to the SEC on September 2, 2015 and available for review at www.sec.gov.
These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitations 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 and with the Canadian Securities Commissions when they become available.
Cautionary Statement on Forward-looking Information
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: the ability of SciVac and VBI to consummate the transactions contemplated by the merger agreement, whereby, subject to the satisfaction of certain conditions, a wholly owned subsidiary of SciVac will merge with and into VBI, with VBI surviving as a wholly owned subsidiary of SciVac (the “Agreement); the anticipated benefits of the merger contemplated by the Agreement; and statements regarding the operation of each of VBI and SciVac’s businesses, including the expected development and/or commercialization of each of VBI and SciVac’s products.
Such forward-looking statements are based on a number of assumptions, including assumptions regarding the ability of the parties to satisfy, in a timely manner, the conditions contained in the Agreement; the successful development and/or commercialization of VBI and SciVac’s respective products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties’ respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in laws, rules and regulations applicable to VBI and SciVac.
Although management of VBI and SciVac believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: non-completion of the transactions contemplated by the Agreement, including due to the parties failing to receive the necessary shareholder, stock exchange and regulatory approvals or the inability of the parties to satisfy in a timely manner and on satisfactory terms the necessary conditions; the failure to successfully develop or commercialize the parties’ respective products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in each of VBI and SciVac’s periodic disclosure.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the parties’ current expectations and neither party undertakes an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange), accepts responsibility for the adequacy or accuracy of this news release.
CONTACT: SciVac Contact
Curtis Lockshin, Chief Executive Officer
Phone: +972-8-948-0625
Email: lockshin@scivactherapeutics.com
SciVac Investor Contact
James Martin, Chief Financial Officer
Phone: (305) 575-4207
Email: jmartin@scivactherapeutics.com
VBI Contact
Perri Maduri, Communications Executive
Phone: (617) 830-3031 x124
Email: ir@vbivaccines.com
VBI Investor Contact
Nell Beattie
Director, Corporate Development and Investor Relations
Tel. (617) 830-3031 x128
Email: nbeattie@vbivaccines.com
Powered by the MediaCentral Platform, the Portable and Affordable Ergonomic Surface Provides Intelligent, Versatile Studio Control
NEW YORK CITY, Oct. 30, 2015 — AES (Booth #718) — Avid® (Nasdaq:AVID) today introduced Pro Tools® | Dock, a portable, affordable surface that gives audio and music professionals intelligent studio control. Delivering on Avid Everywhere™, Pro Tools | Dock gives users the power and control to create better sounding mixes more efficiently. Working together with an iPad running the free Pro Tools | Control app, it gives users the access, integration, and precision they need to edit and mix projects faster.
Powered by the Avid MediaCentral™ Platform, Pro Tools | Dock is based on the advanced touchscreen workflows of the award-winning Pro Tools | S6 and the hybrid touchscreen/hardware control of the bestselling Avid Artist | Control surface. Users can navigate large projects quickly and access any track instantly on the iPad touchscreen.
With Pro Tools | Dock, users can work with their favorite EUCON-enabled DAWs and video editing tools, including Pro Tools, Media Composer®, Logic Pro X, Cubase, and Premiere Pro. When paired with Pro Tools | S3, users gain new timesaving touch workflows and custom control making it ideal for mixing music and post projects in smaller spaces—and on smaller budgets.
“With Avid Everywhere we strive to deliver innovative solutions to help our customers bring their creative ideas to life,” said Kyle Kim-Hays, senior vice president and chief marketing officer, Avid. “Pro Tools | Dock gives audio professionals the tactile precision they need to focus on their mix with their ears instead of their eyes, enabling them to create better sounding mixes faster.”
Availability
Pro Tools | Dock will be available in Q1 2016.
Notes to editors
Pro Tools | Dock enhances the free Pro Tools | Control iOS app and the Pro Tools | S3 control surface, allowing music and audio professionals and aspiring pros to:
- Get extensive touchscreen control – Pro Tools | Dock will quickly connect with a user’s iPad and the free Pro Tools | Control iOS app, providing intelligent control of audio and video projects. The app offers a host of touch controls and visual feedback to improve efficiency, allowing users to navigate huge sessions with ease and bring the channels they’re looking for to the surface quickly.
- Enhance existing workflows with EUCON – Pro Tools | Dock features EUCON™, a high-speed Ethernet-based technology that enables the hardware to communicate directly with EUCON-enabled applications. This lets users work on a Pro Tools project, then switch to Logic Pro X, Cubase, Media Composer, Premiere Pro, and any other EUCON-compatible audio and video software—in sequence or in parallel—in seconds.
- Get deep Pro Tools integration – when paired with Pro Tools or Pro Tools | HD, Pro Tools | Dock becomes an extension of the software. Users can access hundreds of key commands, shortcuts, functions, and UI elements without clicking a mouse. Users can even create custom soft keys to perform practically any Pro Tools function and recall Layouts to the surface with a single button press.
- Bring enhanced touch workflows to Pro Tools | S3 – pairing Pro Tools | Dock with a Pro Tools | S3 control surface delivers even more timesaving workflows. Users can also view additional visual feedback to enhance their mixing experience.
- Adjust parameters with a twist – Pro Tools | Dock provides eight touch-sensitive Soft Knobs that extend the functionality of Pro Tools | Control. These push-top rotary controls enable users to interact with whatever knob set they’ve selected in the app. By making adjustments with physical controls, users don’t have to focus on the screen, enabling them to really listen to how their adjustments affect their mix.
- Speed up tasks with Soft Keys – users can click through frequently performed editing and mixing tasks or adapt the Dock to their unique workflow by programming macros to perform more complex tasks.
- Navigate the project their way – users can quickly access any channel with the color-coded Track Tiles and Universe view—no matter how big the session.
- Get their hands on important channels – users can work with multiple tracks in Pro Tools | Control, but when they need to focus on a specific track—or want more tactile precision—they can use a single “attention” channel. Users simply select any track from the touchscreen and the channel maps directly to the Dock’s surface controls.
- Automate tracks with ease – with 12 dedicated automation switches, users can toggle modes and write automation directly from the surface.
For a full list if features visit: http://connect.avid.com/ProToolsDocksignup.html
About Avid
Through Avid Everywhere™, Avid delivers the industry’s most open, innovative and comprehensive media platform connecting content creation with collaboration, asset protection, distribution and consumption. Media organizations and creative professionals use Avid solutions to create the most listened to, most watched and most loved media in the world—from the most prestigious and award-winning feature films, to the most popular television shows, news programs and televised sporting events, as well as a majority of today’s most celebrated music recordings and live concerts. Industry leading solutions include Pro Tools®, Media Composer®, ISIS®, Interplay®, ProSet and RealSet, Maestro, PlayMaker, and Sibelius®. For more information about Avid solutions and services, visit www.avid.com, connect with Avid on Facebook, Instagram, Twitter, YouTube, LinkedIn, or subscribe to Avid Blogs.
© 2015 Avid Technology, Inc. All rights reserved. Avid, the Avid logo, Avid Everywhere, EUCON, iNEWS, Interplay, ISIS, AirSpeed, Media Composer, Pro Tools, and Sibelius are trademarks or registered trademarks of Avid Technology, Inc. or its subsidiaries in the United States and/or other countries. The Interplay name is used with the permission of the Interplay Entertainment Corp. which bears no responsibility for Avid products. All other trademarks are the property of their respective owners. Product features, specifications, system requirements and availability are subject to change without notice.

PRESS CONTACT:
Sara Griggs
Avid
sara.griggs@avid.com
310-907-6909