Archive for February, 2015
(ROVI) Announces Pricing of $300 Million in Convertible Senior Notes
Rovi Corporation (NASDAQ:ROVI) announced today the pricing of $300 million principal amount of 0.500% Convertible Senior Notes due 2020 (the “Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). In addition, Rovi has also granted the initial purchasers for the offering an option to purchase up to an additional $45 million principal amount of Notes from Rovi solely to cover over-allotments. The sale of the Notes is expected to close on March 4, 2015, subject to customary closing conditions.
The Notes will be general unsecured obligations of Rovi, and interest will be payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2015, at a rate of 0.500% per year. The Notes will mature on March 1, 2020, unless earlier repurchased or converted in accordance with their terms. The initial conversion rate will be 34.5968 shares of Rovi’s common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $28.90 per share of Rovi’s common stock). The initial conversion price represents a premium of approximately 26% to the $22.94 per share closing price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. Prior to the close of business on the business day immediately preceding December 1, 2019, the Notes will be convertible at the option of the holders only upon the satisfaction of certain conditions. Thereafter, the Notes will be convertible at the option of the holders at any time until the close of business on the second scheduled trading day immediately preceding maturity on March 1, 2020. The Notes will be convertible into cash up to the aggregate principal amount of the Notes to be converted and shares of Rovi’s common stock in respect of the remainder, if any, of Rovi’s conversion obligation in excess of the aggregate principal amount of the Notes being converted.
In connection with the pricing of the Notes, Rovi has entered into privately negotiated convertible note hedge transactions with one or more affiliates of certain of the initial purchasers (the “Option Counterparties”). The convertible note hedge transactions are expected generally to reduce the potential dilution to Rovi’s common stock upon any conversion of Notes. Rovi has also entered into privately negotiated warrant transactions with the Option Counterparties. The strike price for the warrant transactions will initially be $40.1450 per share, which represents a 75% premium to the closing sale price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. The warrant transactions will separately have a dilutive effect to the extent that the market price per share of Rovi’s common stock exceeds the applicable strike price of the warrants. If the initial purchasers exercise their option to purchase additional Notes, Rovi expects to enter into additional convertible note hedge transactions and additional warrant transactions with the Option Counterparties.
Rovi expects that in connection with establishing their initial hedge of the convertible note hedge transactions and warrant transactions, the Option Counterparties or their respective affiliates will enter into various derivative transactions with respect to Rovi’s common stock and/or purchase Rovi’s common stock prior to, concurrently with or shortly after the pricing of the Notes. This activity could increase (or reduce the size of any decrease in) the market price of Rovi’s common stock or the Notes at that time, and could result in a higher effective conversion price for the Notes.
In addition, Rovi expects that the Option Counterparties or their respective affiliates will modify their hedge positions by entering into or unwinding various derivatives with respect to Rovi’s common stock and/or by purchasing or selling Rovi’s common stock or other securities of Rovi in secondary market transactions following the pricing of the Notes and prior to the maturity of the Notes (and are likely to do so during any observation period relating to a conversion of the Notes or in connection with any repurchase of Notes by Rovi). This activity could also cause or avoid an increase or a decrease in the market price of Rovi’s common stock or the Notes, which could affect the ability of noteholders to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of the Notes, it could affect the amount of cash and number of shares, if any, that noteholders will receive upon conversion of the Notes.
Rovi estimates that the proceeds from this offering will be approximately $291.3 million, or $335.2 million if the initial purchasers exercise their over-allotment option in full, after deducting initial purchasers’ discounts and estimated offering expenses.
Rovi intends to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described above (after such cost is partially offset by the proceeds to Rovi from the warrant transactions described above). Rovi expects to use approximately $100.1 million of the net proceeds from the offering to repay certain borrowings and accrued interest under its revolving credit facility, which were incurred to finance in part the repurchase on February 20, 2015 of approximately $287.4 million principal amount of its 2.625% Convertible Senior Notes due 2040. In addition, Rovi expects to use approximately $25.0 million of the net proceeds from the offering to repurchase shares of its common stock in privately negotiated transactions effected through Morgan Stanley & Co. LLC or one of its affiliates as Rovi’s agent. Rovi expects to repurchase such shares from purchasers of the Notes in the offering at a purchase price per share equal to $22.94 per share, the closing price of Rovi’s common stock on The NASDAQ Global Select Market on February 26, 2015. Rovi intends to use the remainder of the net proceeds from the offering for general corporate purposes.
Rovi has agreed not to sell or issue other equity securities during the 60-day period beginning February 26, 2015, subject to certain exceptions, including an exception that Rovi may issue up to $125.0 million aggregate principal amount of additional convertible notes during the lock-up period to a commercial customer. Any such additional notes would contain substantially the same terms as the Notes, with the net proceeds from any such issuance to be applied to reduce outstanding indebtedness and pay the cost of any additional convertible note hedge transactions Rovi may enter into in connection with such additional notes. Rovi has not entered into any agreement to issue any such additional notes, and there can be no assurance that Rovi will issue any such additional notes.
Morgan Stanley, J.P. Morgan and BofA Merrill Lynch are acting as book-running managers for the offering, and Barclays is acting as a co-manager for the offering.
The Notes, the convertible note hedge transactions, the warrants and any shares of Rovi’s common stock underlying these securities (including any shares of Rovi’s common stock issuable upon conversion of the Notes) have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements.
This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
Forward-Looking Statements
This press release contains forward-looking statements including, among other things, statements relating to the expected closing of the offering and the expected use of proceeds from the offering. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Rovi will consummate the offering, the expected use of the proceeds of the offering and the impact of general economic, industry or political conditions in the United States or internationally as well as other risks and uncertainties described in Rovi’s filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2014. Rovi assumes no obligation to update any such forward-looking statements after the date of this release.
About Rovi Corporation
Rovi is leading the way to a more personalized entertainment experience. Rovi’s pioneering guides, data and recommendations continue to drive program search and navigation on millions of devices across the globe. With a new generation of cloud-based discovery capabilities and emerging solutions for interactive advertising and audience analytics, Rovi is enabling premier brands worldwide to increase their reach, drive consumer satisfaction and create a better entertainment experience across multiple screens. Rovi holds over 5,000 issued or pending patents worldwide and is headquartered in Santa Clara, California.
Rovi Corporation
Peter Halt, +1 818-295-6800
Peter Ausnit, +1 818-565-5200
(NATH) Announces Proposed Offering of Senior Secured Notes due 2020
JERICHO, N.Y., Feb. 27, 2015 — Nathan’s Famous, Inc. (NASDAQ: NATH) (“Nathan’s”) announced today that it intends to offer, subject to market and other conditions, $125.0 million aggregate principal amount of Senior Secured Notes due 2020 (the “Notes”) in a private offering. The Notes are being offered only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States in reliance on Regulation S under the Securities Act. The interest rate and other terms of the Notes will be determined based on prevailing market conditions.
Nathan’s intends to use the net proceeds of the Notes offering to pay a special dividend of up to approximately $116.0 million to Nathan’s stockholders of record and the remaining net proceeds for general corporate purposes, including working capital. If the Notes offering is consummated, the Nathan’s board of directors will set the record date and the payment date of the dividend following closing.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any sale of the Notes in any state or jurisdiction in which such offer, solicitation or sale would be unlawful. Any offers of the Notes will be made only by means of a private offering memorandum. The Notes have not been registered under the Securities Act or the securities laws of any state or other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the Securities Act and applicable state securities laws.
About Nathan’s Famous, Inc.
Nathan’s is a Russell 2000 Company that currently distributes its products in 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, the Cayman Islands and ten foreign countries through its restaurant system, foodservice sales programs and product licensing activities. Last year, over 480 million Nathan’s Famous hot dogs were sold. Nathan’s was ranked #22 on the Forbes 2014 list of the Best Small Companies in America and was listed as the Best Small Company in New York State in October 2013. For additional information about Nathan’s please visit our website at www.nathansfamous.com. The contents of our website have not been incorporated into and do not form a part of this press release.
Forward-Looking Statements
Except for historical information contained in this news release, the matters discussed are forward looking statements that involve risks and uncertainties. Words such as “anticipate”, “believe”, “estimate”, “expect”, “intend”, and similar expressions identify forward-looking statements, which are based on the current belief of Nathan’s management, as well as assumptions made by and information currently available to Nathan’s management. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, statements regarding Nathan’s ability to complete the offer of the Notes and other risks and factors identified from time to time in Nathan’s filings with the SEC. You are cautioned not to place undue reliance on any forward-looking statements contained in this press release. Nathan’s does not undertake any obligation to update such forward-looking statements.
Contact information:
Investors: Ronald DeVos, Chief Financial Officer, (516) 338-8500
(UPLD) to Present at the 27th Annual ROTH Conference
AUSTIN, Texas, Feb. 27, 2015 — Upland Software, Inc. (Nasdaq: UPLD), a leader in cloud-based Enterprise Work Management applications, today announced that Jack McDonald, Upland’s Chairman and CEO, is scheduled to present at the 27th Annual ROTH Conference on Tuesday, March 10th at 8:30 a.m. Pacific Time. The conference is being held at The Ritz-Carlton Laguna Niguel in Dana Point, California.
The presentation will be webcast live and accessible on Upland’s website at investor.uplandsoftware.com. In addition to the live webcast, a recorded replay will be available on Upland’s website for 30 days following the event.
About Upland Software
Upland (Nasdaq: UPLD) is a leading provider of cloud-based Enterprise Work Management software. Our family of applications connects people through technology, automates the flow of work and brings visibility to all aspects of the organization. With more than 1,200 enterprise customers around the globe, and over 200,000 users, Upland helps teams in IT, marketing, finance, professional services and process excellence run their operations smoothly, adapt to change quickly and achieve better results every day. To learn more, visit www.uplandsoftware.com.
(LPCN) Announces Presentation of LPCN 1021 Clinical Data at ENDO 2015
SALT LAKE CITY, Feb. 27, 2015 — Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced that data from its ongoing Study of Oral Androgen Replacement (“SOAR”) pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone (“Low T”) will be presented at ENDO 2015 in San Diego, CA. As previously announced, overall, the study demonstrated positive results with respect to the trial’s primary efficacy endpoint with no drug related serious adverse events to date.
Presentation details are as follows:
Session: | Testosterone Replacement Therapy: Risks and Benefits |
Title: | Efficacy and Pharmacokinetics of LPCN 1021, a Novel Oral Testosterone Replacement |
Therapy (TRT) in Hypogonadal Men: Study of Androgen Replacement (SOAR) | |
Date/Time: | Saturday, March 7, 2015, 11:30 am – 1:00 pm PT |
Oral Session Number: | OR34-5 |
Presenter: | Christina Wang, MD |
Associate Director | |
UCLA Clinical and Translational Science Institute | |
Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute | |
Professor of Medicine | |
David Geffen School of Medicine at UCLA |
About LPCN 1021
The current testosterone market is dominated by topical products that are associated with poor patient compliance and FDA “black box” warnings related to inadvertent transfer of testosterone. LPCN 1021 is a twice-a-day, oral product candidate with three simple oral dosing options that we expect will overcome the major shortcomings of existing products.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, demonstrated positive top-line efficacy results in Phase 3 testing and is targeted for testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, and is currently in Phase 1 testing.
Forward-Looking Statements
This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to expectations regarding clinical trials, the potential uses and benefits of Lipocine’s product candidates, and product development and commercialization efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the Company’s website at www.lipocine.com or on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
CONTACT: Morgan Brown Executive Vice President & Chief Financial Officer Phone: (801) 994-7383 Email: mb@lipocine.com John Woolford Phone: (443) 213-0500 john.woolford@westwicke.com
(CVM) Key Milestone with Clearance to Conduct Phase III Trial in 21 Countries
CEL-SCI Corporation (NYSE MKT: CVM) today announced the Ministry of Health of the Republic of Belarus has cleared the Company to commence patient enrollment for its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Belarus is the 21th country to approve CEL-SCI’s Phase III trial.
“This means that CEL-SCI has now reached a key milestone in this pivotal Phase III clinical trial, receiving clearance in the planned 20 countries in addition to the United States. Well over 10 countries have been added to the study since we dismissed the prior clinical research organization (CRO). With the very large increase in enrollment in the study under the new CRO, we now also see strong interest from doctors and clinical centers in other countries too. Therefore, we are working on further expanding this global trial beyond the 21 countries in which we are already cleared to conduct the study. We expect that expanding the geography of the trial will yet further accelerate patient recruitment,” stated CEL-SCI Chief Executive Officer Geert Kersten.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
About Multikine
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The Phase I trial started enrolling patients in September 2014. CEL-SCI also entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.
About CEL-SCI Corporation
CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. CEL-SCI believes that the best way may be to activate the immune system of patients before they have received surgery, radiation and/or chemotherapy. Its lead investigational therapy Multikine (Leukocyte Interleukin, Injection) is currently being studied in a pivotal Phase III clinical trial against head and neck cancer. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care only is satisfied, the study results will be used to support applications which will be submitted to regulatory agencies in order to receive from these agencies commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine which are being investigated include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the U.S. Navy under a CRADA.
CEL-SCI is also developing its LEAPS technology for the treatment of pandemic influenza and as a potential therapeutic vaccine against rheumatoid arthritis. CEL-SCI received a Phase I SBIR Grant from the National Institutes of Health to develop LEAPS as a potential treatment for rheumatoid arthritis with researchers from Rush University Medical Center in Chicago, Illinois. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, the words “intends,” “believes,” “anticipated”, “plans” and “expects” and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation’s SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2014. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CEL-SCI Corporation
Gavin de Windt, 703-506-9460
(AVEO) Conference Call Final Results P2 Biomarker Analysis Of Tivozanib In Colorectal Cancer
AVEO Oncology (NASDAQ:AVEO) today announced that management will host a conference call and webcast on Friday, March 6, 2015, at 8:00 a.m. Eastern Time to discuss the presentation of final results and a predefined biomarker analysis of its BATON-CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer. The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” will be presented in a poster session on March 6 at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference in Orlando, FL.
The call can be accessed by dialing 1-877-280-4954 (domestic) or 1-857-244-7311 (international) five minutes prior to the start of the call and providing the passcode 38640881. A replay of the call will be available two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 54500453. The replay will be available for two weeks from the date of the live call.
The live webcast of the conference call can be accessed by visiting the investors section of the AVEO website at www.aveooncology.com. A replay of the webcast will be archived on the AVEO website for two weeks following the call.
A copy of the poster presentation will be made available on AVEO’s website at www.aveooncology.com.
About AVEO
AVEO Oncology (NASDAQ:AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that are being leveraged in the clinical development strategy of its therapeutic candidates. For more information, please visit the company’s website at www.aveooncology.com.
Company, Media and Investor Contact:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com
(SPLK) Introduces Pricing for Enterprise-wide Deployments
New License Model Accelerates Adoption and Value of Splunk Enterprise Across the Organization
Splunk Inc. (NASDAQ:SPLK), provider of the leading software platform for real-time Operational Intelligence, today announced that customers of any size can now purchase unlimited licenses of Splunk® Enterprise and benefit from fixed, predictable costs as they expand their use of Splunk software. By offering unlimited enterprise adoption agreements (EAAs), Splunk is providing customers with an additional, new licensing option that is independent of data volumes and use cases, providing pricing predictability as organizations drive broad-based adoption across all of their machine data use cases. Unlimited EAAs increase the value organizations can gain from Splunk software by collecting, analyzing and acting on machine data generated across a wide variety of use cases – without license limits on the amount of data they are ingesting.
“Our customer base is experiencing explosive data growth and needs Splunk to help them tap into the value of all of their machine data,” said Godfrey Sullivan, Chairman and CEO, Splunk. “Splunk has always embraced simple pricing to help fuel our customers’ success, and we have been focused on continually driving down the cost of collecting, indexing and analyzing data in Splunk software. This new licensing model further removes barriers and encourages organizations to gain insights from all of their machine-generated big data by standardizing on Splunk Enterprise.”
An unlimited EAA enables organizations to deliver the most value from their machine data by utilizing Splunk Enterprise as a platform for machine data for the entire business and across diverse, high-value use cases such as IT operations, application delivery, security, business analytics and the Internet of Things. The unlimited EAAs also include support, education and professional services to help customers realize the maximum value from their Splunk investment. The unlimited EAA is Splunk’s latest move to make it easier for organizations to take advantage of their machine data. Last year, Splunk doubled license capacity at entry levels of Splunk Enterprise and also reduced the cost of Splunk Cloud by 33 percent.
Contact Splunk Sales to inquire about an unlimited EAA, or visit the pricing page on the Splunk website for other pricing options. Splunk does not charge for data sources, data types, number of users, number of searches or alerts, total data stored or other charges often added on to software licenses.
About Splunk Inc.
Splunk Inc. (NASDAQ:SPLK) provides the leading software platform for real-time Operational Intelligence. Splunk® software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. More than 8,400 enterprises, government agencies, universities and service providers in more than 100 countries use Splunk software to deepen business and customer understanding, mitigate cybersecurity risk, prevent fraud, improve service performance and reduce cost. Splunk products include Splunk® Enterprise, Splunk Cloud™, Hunk®, Splunk MINT Express™ and premium Splunk Apps. To learn more, please visit http://www.splunk.com/company.
Social Media: Twitter | LinkedIn | YouTube | Facebook
Splunk, Splunk>, Listen to Your Data, The Engine for Machine Data, Hunk, Splunk Cloud, Splunk Storm, SPL, Splunk MINT Express and Splunk MINT Enterprise are trademarks and registered trademarks of Splunk Inc. in the United States and other countries. All other brand names, product names, or trademarks belong to their respective owners. © 2015 Splunk Inc. All rights reserved.
Splunk Inc.
Tom Stilwell, 415-852-5561
tstilwell@splunk.com
Investor Contact
Ken Tinsley, 415-848-8476
ktinsley@splunk.com
(CYBX) & Sorin Group To Merge, Creating Premier Global Medical Technology Company
Diverse product portfolio and scale across geographies to drive shareholder value Focused innovation platform to exploit market opportunities and accelerate product development in heart failure, sleep apnea and percutaneous mitral valve to improve patient outcomes All-stock transaction resulting in pro forma combined equity value of $2.7 billion Transaction expected to enhance revenue growth, drive cash flow generation and be accretive to cash EPS for all shareholders from 2016
MILAN and HOUSTON, Feb. 26, 2015 — Sorin S.p.A. (“Sorin”), (MTA; Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, and Cyberonics Inc. (NASDAQ: CYBX), a medical device company with core expertise in neuromodulation, today announced their merger plan to create a new global leader in medical technologies with a combined equity value of approximately $2.7 billion (€2.4 billion1) based on the closing price of Sorin and Cyberonics shares on 25 February.
The proposed transaction has been unanimously approved by the boards of directors of both companies. Under the terms of the transaction, Sorin and Cyberonics will combine under a newly formed holding company, “NewCo”, which the parties will name prior to closing. Each Cyberonics stockholder will receive one ordinary share of NewCo for every share of Cyberonics owned. Each Sorin shareholder will receive a fixed ratio of 0.0472 ordinary shares of NewCo for every Sorin share owned. Following completion of the transaction, assuming no withdrawal rights under Italian law are exercised by Sorin shareholders with respect to the merger, Sorin shareholders will own approximately 46 percent of NewCo, and Cyberonics shareholders will own approximately 54 percent, on a fully diluted basis.
The proposed transaction will bring together global leaders in cardiac surgery and neuromodulation, and the combined company will also be a major player in cardiac rhythm management, especially in Europe and Japan. NewCo will have several promising opportunities focused on multi-billion dollar markets, including complementary research programs addressing heart failure, with an initial commercial launch in Europe anticipated in the coming weeks. Both companies bring minority equity investments that are complementary in different forms of sleep apnea. Sorin, in addition, has opportunities that address mitral valve regurgitation.
Andre-Michel Ballester, Chief Executive Officer of Sorin, will serve as Chief Executive Officer of NewCo and Dan Moore, Chief Executive Officer of Cyberonics, will become non-executive Chairman.
Commenting on the announcement, Andre-Michel Ballester said:
“I am delighted to announce this transformational merger between Sorin and Cyberonics, which we expect to create significant value for shareholders. As one company we will be able to leverage our combined strengths, capture new opportunities and create new solutions to benefit patients and healthcare professionals alike. This is particularly exciting for our employees, who will be able to share technical expertise and innovate faster, ensuring that we serve our customers by remaining at the forefront of new product development which continues to be the foundation of our success.”
Dan Moore said:
“This transformational transaction maximizes both companies’ strengths and leadership positions for the benefit of patients and our shareholders. Sorin is an ideal partner, given its heart failure programs and the ability to combine Vagus Nerve Stimulation with cardiac rhythm management technology. Sorin’s well-established international operations are expected to accelerate our epilepsy growth strategy by enabling us to reach a larger number of potential new patients in the underpenetrated markets outside the U.S. while integrating Sorin’s technology expertise into future neuromodulation products. While each company has a strong track record of execution on its own, the geographic diversification, benefits of scale and strong financial profile of the combined company will create tremendous new opportunities to drive growth and build significant shareholder value.”
Strategic rationale
The proposed transaction will create a global leader in the large and growing markets for cardiac surgery and neuromodulation and a leading innovator in cardiac rhythm management with a diversified product portfolio, leveraging product technologies and complementary marketing capabilities. The potential combination of product development, clinical and regulatory expertise will accelerate time to market across worldwide geographies and will leverage the combined group’s extensive relationships with healthcare professionals globally, as well as patient education and awareness initiatives.
In particular NewCo will have several exciting opportunities focused on three multi-billion dollar product categories: heart failure, sleep apnea and percutaneous mitral valve. In heart failure, NewCo will have promising products with European market entry starting as early as 2015. Cyberonics recently received CE Mark approval of its VITARIA™ device delivering autonomic regulation therapy for the treatment of chronic heart failure and will commence a limited market launch in Europe in the coming weeks. Recently, Sorin announced the first successful implants of its Equilia™ Vagus Nerve Stimulation system for heart failure patients. NewCo is expected to benefit from the developing market for active implantable treatments for sleep apnea with investments aimed at the under-addressed obstructive sleep apnea (OSA) market, and also in central sleep apnea (CSA), recently launched in selected European countries. In addition, NewCo is expected to have new percutaneous mitral valve replacement/repair products with estimated initial market entry in 2017.
Financial highlights
The combined company will have pro-forma revenues of approximately $1.3 billion2, and the merger is expected to drive significant cash flow generation. The proposed transaction is expected to be cash EPS3 accretive to all shareholders from 2016.
The merger presents the opportunity to achieve significant revenue and cost synergies. Approximately $80 million of annual pre-tax synergies are expected to be delivered by the end of calendar year 2018 as the combined company leverages an efficient corporate structure and a global operational platform with the commercial, regulatory, supply chain, R&D and manufacturing capabilities to drive growth and efficiencies.
NewCo’s strong cash flow generation and robust balance sheet with essentially no net debt will enable investment in new medical technology solutions for patients and customers and provide the ability to fund future growth opportunities. NewCo will have a sound financial profile with a larger market capitalization and the opportunity to attract a wider, global investor base.
Cyberonics and Sorin currently have different fiscal year ends and report under different accounting standards and currencies. After the closing of the transaction, NewCo is expected to report on a calendar year basis, with reporting in US$ and on US Generally Accepted Accounting Principles (GAAP).
Governance and organizational structure
Upon closing of the transaction, the Board of Directors of NewCo will be equally balanced between Sorin and Cyberonics, with four directors designated by Sorin and four by Cyberonics. One additional Board member will be jointly selected.
NewCo will operate as three business units: Cardiac Surgery, Cardiac Rhythm Management and Neuromodulation, with operating headquarters in Mirandola (Italy), Clamart (France) and Houston (U.S.) respectively. The combined company will have a strategic presence in over 100 countries on five continents around the world with approximately 4,500 employees.
Additional transaction details
Under the terms of the proposed transaction, Cyberonics and Sorin will combine under NewCo, which will be domiciled in the UK and will apply for dual-listing on NASDAQ and the London Stock Exchange (LSE). The all-stock transaction will be implemented through two mergers, which will occur in immediate succession: first, Sorin will be merged with and into NewCo by means of an EU cross-border merger, with NewCo as the surviving company in the merger, and immediately thereafter, a wholly owned subsidiary of NewCo will be merged with and into Cyberonics, with Cyberonics surviving the merger as a wholly owned subsidiary of NewCo. At the closing of the transaction, Cyberonics shares will cease trading on NASDAQ and Sorin shares will cease trading on the Borsa Italiana (MTA).
For Sorin shareholders, the exchange ratio implies a per share valuation of Sorin that represents approximately 14.2 percent premium to Sorin’s closing share price on 25 February, 2015, the last trading day prior to the parties announcing the agreement.
The merger will trigger the withdrawal right, which can be exercised by any Sorin shareholder who does not attend the shareholders’ meeting called to approve the merger of Sorin into Newco, or abstains or votes against the merger. There is no cap linked to the exercise of withdrawal rights.
The transaction is currently expected to be completed by the end of the third calendar quarter of 2015 and is subject to approval by both Sorin and Cyberonics’ shareholders, the receipt of required antitrust and regulatory clearances, and other customary closing conditions. Where required by local law, including in France, Sorin will initiate a consultation on the proposed transaction with its relevant works councils, trade unions and other employee organizations. Once the works council consultation process in France is completed, the parties anticipate entering into a definitive agreement.
Mittel S.p.A. and Equinox Two S.C.A., which control Bios S.p.A. and Tower 6 Bis S.a.r.l., holding in total 25.6 percent of Sorin’s outstanding shares, have entered into a support agreement with Cyberonics pursuant to which they have agreed to vote in favor of the transaction and not to sell their shares until the closing of the transaction. Mittel S.p.A. and Equinox Two S.c.a. are expected to hold approximately 11.5 percent of NewCo’s ordinary shares following the closing of the proposed transaction. In addition, the Chairman and CEO of each of Sorin and Cyberonics have also entered into support agreements in favor of the proposed transaction.
The above undertakings will be disclosed to the public pursuant to article 122 of Legislative Decree no. 58 of 24 February, 1998 and its implementing regulations.
In connection with this transaction, Rothschild is serving as financial advisor to Sorin, and Latham & Watkins is serving as its primary legal advisor. Piper Jaffray is serving as financial advisor to Cyberonics, and Sullivan & Cromwell is serving as its legal advisor, with Legance advising Cyberonics on Italian law matters.
Investor Call
Sorin and Cyberonics will hold a joint investor conference call to discuss the combination today at 2:00PM Central European Time, 7:00AM U.S. Central Time, 8:00AM U.S. Eastern Time. To access the call, please use one of the following dial-in numbers: 877-638-4557 (toll-free U.S. and Canada), and 001-914-495-8522 (International), and enter the Conference ID number 61678386.
Prior to the conference call, an Investor Presentation will be available on the Investor Relations sections of Sorin’s and Cyberonics’ websites and on the authorized storage mechanism 1Info (www.1Info.it). A telephone replay of the call will be available within 24 hours on each company’s Investor Relations sections.
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With approximately 3,900 employees worldwide, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). Every year, over one million patients are treated with Sorin Group devices in more than 100 countries.
About Cyberonics
Cyberonics Inc., (NASDAQ: CYBX) is a medical device company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy system, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy system uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy system in selected markets worldwide. Cyberonics also has CE Mark for VITARIA™, providing autonomic regulation therapy for chronic heart failure.
Important Information for Investors and Shareholders
This press release is for informational purposes only and is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and applicable European regulations. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction. This press release does not represent an investment solicitation in Italy, pursuant to Section 1, letter (t) of Legislative Decree no. 58 of February 24, 1998, as amended.
NewCo will file with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which will include a proxy statement of Cyberonics that also constitutes a prospectus of NewCo (the “proxy statement/prospectus”). INVESTORS AND SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT SORIN GROUP, CYBERONICS, NEWCO, THE PROPOSED TRANSACTIONS AND RELATED MATTERS.
Investors and shareholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed with the SEC by the parties through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders will be able to obtain free copies of the proxy statement/prospectus and other documents filed with the SEC on Cyberonics’s website at www.cyberonics.com or within the “Investor Relations” section or by contacting Cyberonics’s Investor Relations (for documents filed with the SEC by Cyberonics) or on Sorin Group’s website at www.sorin.com (for documents filed with the SEC by NewCo).
The release, publication or distribution of this press release in certain jurisdictions may be restricted by law, and therefore persons in such jurisdictions into which this press release is released, published or distributed should inform themselves about and observe such restrictions.
Italian CONSOB Regulation No. 11971 of May 14, 1999
Prior to the meeting of Sorin Group shareholders, Sorin will voluntarily make available an information document pursuant to Article 70, paragraph 6, of the CONSOB Regulation on Issuers (CONSOB Regulation no. 11971 of May 14, 1999, as amended), in accordance with applicable terms.
Italian CONSOB Regulation No. 17221 of March 10, 2010
Pursuant to Article 6 of the CONSOB Regulation no. 17221 of March 12, 2010 (as amended, the “CONSOB Regulation”), NewCo is a related party of Sorin, being a wholly owned subsidiary of Sorin Group. The merger agreement providing for the terms and conditions of the transaction, which exceeds the thresholds for “significant transactions” pursuant to the Regulation, was approved unanimously by the board of directors of Sorin Group. The merger of Sorin into NewCo is subject to the exemption set forth in Article 14 of the CONSOB Regulation and Article 13.1.(v) of the “Procedura per operazioni con parti correlate” (“Procedures for transactions with related parties”) adopted by Sorin on October 26, 2010 and published on its website (www.sorin.com). Pursuant to this exemption, Sorin will not publish an information document (documento informativo) for related party transactions as provided by Article 5 of the CONSOB Regulation. Prior to the meeting of Sorin shareholders, Sorin will make available an information document pursuant to Article 70, Pararaph 6, of the CONSOB Regulation on Issuers (CONSOB Regulation no. 11971 of May 24, 1999, as amended), in accordance with applicable terms.
Participants in the Distribution
Sorin, Cyberonics and NewCo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Cyberonics with respect to the proposed transactions contemplated by the proxy statement/prospectus. Information regarding the persons who are, under the rules of the SEC, participants in the solicitation of proxies from the shareholders of Cyberonics in connection with the proposed transactions, including a description of their direct or indirect interests, on account of security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information regarding Cyberonics’ directors and executive officers is contained in Cyberonics’s Annual Report on Form 10-K for the year ended on April 25, 2014 and its Proxy Statement on Schedule 14A, dated July 30, 2014, which are filed with the SEC and can be obtained free of charge from the sources indicated above.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”)) concerning Cyberonics, Sorin Group, NewCo, the proposed transactions and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise. They are based on current beliefs of the management of Cyberonics and Sorin Group as well as assumptions made by, and information currently available to, such management, and therefore, you are cautioned not to place undue reliance on them. These forward-looking statements are subject to various risks and uncertainties, many of which are outside the parties’ control. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. None of Cyberonics, Sorin Group or NewCo undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the medical device industry, and other legal, regulatory and economic developments. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe harbor provisions of the PSLRA. Factors that could cause actual results to differ materially from those in the forward-looking statements include the failure to obtain applicable regulatory or shareholder approvals in a timely manner or otherwise, or the requirement to accept conditions that could reduce the anticipated benefits of the proposed transactions as a condition to obtaining regulatory approvals; the failure to satisfy other closing conditions to the proposed transactions; the length of time necessary to consummate the proposed transactions, which may be longer than anticipated for various reasons; risks that the new businesses will not be integrated successfully or that the combined companies will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected; the inability of Cyberonics and Sorin Group to meet expectations regarding the timing, completion and accounting and tax treatments with respect to the proposed transactions; risks relating to unanticipated costs of integration, including operating costs, customer loss or business disruption being greater than expected; reductions in customer spending, a slowdown in customer payments and changes in customer demand for products and services; unanticipated changes relating to competitive factors in the industries in which the companies operate; the ability to hire and retain key personnel; the potential impact of announcement or consummation of the proposed transactions on relationships with third parties, including customers, employees and competitors; the ability to attract new customers and retain existing customers in the manner anticipated; reliance on and integration of information technology systems; changes in legislation or governmental regulations affecting the companies; international, national or local economic, social or political conditions that could adversely affect the companies or their customers; conditions in the credit markets; risks to the industries in which Cyberonics and Sorin Group operate that are described in the “Risk Factors” section of the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC by Cyberonics and NewCo and the analogous section from Sorin Group’s annual reports and other documents filed from time to time with the Italian financial market regulator (CONSOB); risks associated with assumptions the parties make in connection with the parties’ critical accounting estimates and legal proceedings; the parties’ international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; and the potential of international unrest, economic downturn or effects of currencies, tax assessments, tax adjustments, anticipated tax rates, raw material costs or availability, benefit or retirement plan costs, or other regulatory compliance costs. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the parties’ businesses, including those described in Cyberonics’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the SEC and those described in Sorin Group’s annual reports, registration documents and other documents filed from time to time with CONSOB. Nothing in this press release is intended, or is to be construed, as a profit forecast or to be interpreted to mean that earnings per Sorin share or Cyberonics share for the current or any future financial years or those of the combined group, will necessarily match or exceed the historical published earnings per Sorin share or Cyberonics share, as applicable. Neither Cyberonics nor Sorin gives any assurance (1) that either Cyberonics, Sorin or Newco will achieve its expectations, or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results.
Contacts:
For Sorin Group | |
InvestorsDemetrio Mauro
CFO Sorin Group Tel: +39 02 69969 512 e-mail: investor.relations@sorin.com
Media Gabriele Mazzoletti Director, Corporate Communications Sorin Group Tel: +39 02 69 96 97 85 Mobile: +39 348 979 22 01 e-mail: corporate.communications@sorin.com
|
Francesca RambaudiDirector, Investor Relations
Sorin Group Tel: +39 02 69969716 e-mail: investor.relations@sorin.com
|
Edward SimpkinsFinsbury (London)
Tel: +44 7958 421 519 e-mail: edward.simpkins@finsbury.com
|
Kal GoldbergFinsbury (New York)
Tel: +(1) 646-805-2000 e-mail: Kal.Goldberg@finsbury.com
|
For Cyberonics Inc: | |
Investors | Media |
Greg BrowneChief Financial Officer
Cyberonics, Inc. Tel: +(1) 281-228-7262 e-mail: ir@cyberonics.com |
Andrew Cole/Chris KittredgeSard Verbinnen & Co (New York)
Tel: +(1) 212-687-8080 London: Conrad Harrington Tel: +44 (0)20 3178 8914
|
1 Translated at €/$ exchange rate as of 25 February, 2015.
2 Based on the last four quarters reported ended January 23, 2015 for Cyberonics and preliminary financial results presented by Sorin as of December 31, 2014 at an average exchange rate of €1/$1.33
3 Cash EPS is based on US GAAP, excluding transaction related expenses, purchase accounting and stock based compensation expenses. Calculated on a fully-diluted basis
(MNDO) Reports Record Revenue of $25 Million in 2014, Board Declares Cash Dividend
YOQNEAM, ISRAEL–(February 26, 2015) – MIND C.T.I. LTD. – (NASDAQ: MNDO), a leading provider of convergent end-to-end prepaid/postpaid billing and customer care product based solutions for service providers as well as unified communications analytics and call accounting solutions for enterprises, today announced results for the fourth quarter and year ended December 31, 2014.
The following will summarize our business in the fourth quarter of 2014 and provide a more detailed review of the financial results for the quarter. The financial results can be found in the Investors section www.mindcti.com/investor/PressReleases.asp and in our Form 6-K.
Financial Highlights of Q4 2014
- Revenues of close to $6.5 million, same as the third quarter of 2014, and up 28% from $5.1 million in the fourth quarter of 2013.
- Operating income was $2.5 million, up 15% sequentially from the third quarter of 2014 and compared to $1.0 million in the fourth quarter of 2013.
- Net income of $1.9 million or $0.10 per share, compared to $1.0 million or $0.05 per share in the fourth quarter of 2013.
- One modest win and multiple upgrades.
As of December 31, 2014 we had 352 employees, the same as of December 31, 2013.
Year 2014 Financial Highlights
- Revenues of $25 million, up 35% from $18.5 million in 2013.
- Operating income was $7.5 million, or 29.8% of revenue, compared to $2.2 million, or 11.7% of revenue, in 2013.
- Net income of $5.5 million, or $0.29 per share, compared to $2.2 million or $0.12 per share in 2013.
- Cash flow from operating activities was $3.8 million, compared to $5.2 million in 2013.
- Cash position of approximately $19.3 million as of December 31, 2014.
Monica Iancu, CEO, commented: “We are pleased that in 2014 we succeeded to translate the large deals we signed in 2013 into revenues through successful execution of the implementation of our projects milestones. While in 2014 we reached exceptional revenues and operating margins, some new deals that we expected to close in 2014 were delayed, thus our booking is lower than a year ago.”
Revenue Distribution for Q4 2014
Revenues in the Americas represented 54.5% of total revenues, revenues in Europe represented 34.2% and revenues in Israel represented 6.6% of total revenues.
Revenues from our customer care and billing software totaled $5.5 million, or 85% of total revenues, while revenues from our enterprise call accounting software were $1.0 million, or 15% of total revenues.
Revenues from licenses were $1.2 million, or 18% of total revenues, while revenues from maintenance and additional services were $5.3 million, or 82% of total revenues.
Revenue Distribution for Full Year 2014
Revenues in the Americas represented 57.6%, revenues in Europe represented 28.6% and revenues in Israel represented 9.0% of total revenue.
Revenues from our customer care and billing software totaled $21.0 million, or 84% of total revenues, compared with $14.2 million, or 77% of total revenues in 2013, while revenues from our enterprise call accounting software were $4.0 million, or 16% of total revenue, compared with $4.3 million or 23% of total revenues in 2013.
Revenues from licenses were $5.4 million, or 21.6% of total revenues, compared with $4.6 million, or 25% of total revenues in 2013 while revenues from maintenance and additional services were $19.6 million, or 78.4%, compared with $13.9 million or 75% of total revenues in 2013.
New Wins & Follow-on Orders in Q4 2014
In the fourth quarter we had one modest new win as well as some major upgrades from existing customers, the upgrades mainly for service enhancements and additional functionalities.
The new win is with a leading European global financial services company. PhonEX-ONE has been chosen for its advanced telecom business analysis and cost control management solution for global organizations.
One major upgrade includes enhancement of the MIND system to distinguish between data services (Internet, MMS, VoLTE), and to authorize and rate these differently. MIND will provide different configurable authorization amounts for “capping” the data services that will be offered by this customer.
Dividend Distribution
Since July 2003, when we first adopted a dividend policy, according to which we declare, subject to specific Board approval and applicable law, a dividend distribution once per year, we have distributed 11 yearly dividends with an average of 21 cents per share.
We continue to believe that our annual dividends enhance shareholders value and we plan to continue with yearly distributions.
Taking into consideration our dividend policy and the remaining cash after the distribution, our Board declared on February 26, 2015 a gross dividend of $0.30 per share. The record date for the dividend will be March 12, 2015 and the payment date will be March 26, 2015. Tax will be withheld at a rate of about 24%.
Investing in R&D
In order to maintain a state-of-the-art technology, each year we invest in R&D, sometimes adding new modules, sometimes in order to be compliant with new standards and many times to keep up with the new tools and new platforms that we use to build upon.
In 2014, along with supporting the additional needs defined by our customers, we invested significantly in a massive upgrade of the MINDBill infrastructure that includes technology updates of the entire spectrum, including application infrastructure, application server and database upgrades and improved monitoring.
New Office in Romania
Lately we started to analyze the option to open a new MIND office location in East Europe in order to enlarge and diversify our teams, mainly in the Professional Services department.
We checked the availability of qualified resources and office space in several locations, and we decided that Suceava, Romania is the preferred location. Our second location in Romania started to operate on February 16, 2015.
Monica concluded: “We are pleased as always with the growing recurring revenues and the follow-on orders that reconfirm our customer satisfaction. We operate in a very active market that shows continuous demand for our products and services and we expect that in 2015 we will be able to close new deals and significant follow-on orders. The valuable customer base, well supported by our devoted professional team and the ongoing investment in development of enhanced functionality and state-of-the-art technology are the basis for our expected long-term continuous performance.”
About MIND
MIND CTI Ltd. is a leading provider of convergent end-to-end billing and customer care product based solutions for service providers as well as unified communications analytics and call accounting solutions for enterprises. MIND provides a complete range of billing applications for any business model (license, managed service or complete outsourced billing service) for Wireless, Wireline, Cable, IP Services and Quad-play carriers in more than 40 countries around the world. A global company, with over thirteen years of experience in providing solutions to carriers and enterprises, MIND operates from offices in the United States, Romania and Israel.
Cautionary Statement for Purposes of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995: All statements other than historical facts included in the foregoing press release regarding the Company’s business strategy are “forward-looking statements.” These statements are based on management’s beliefs and assumptions and on information currently available to management. Forward-looking statements are not guarantees of future performance, and actual results may materially differ. The forward-looking statements involve risks, uncertainties, and assumptions, including the risks discussed in the Company’s filings with the United States Securities Exchange Commission. The Company does not undertake to update any forward-looking information.
For more information please contact:
Andrea Dray
MIND CTI Ltd.
Tel: +972-4-993-6666
investor@mindcti.com
(OHRP) Appoints Avner Ingerman, M.D. as Chief Clinical Officer
NEW YORK, Feb. 26, 2015 — Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an Ophthalmology research and development company, today announced the appointment of Avner Ingerman, MD, to the newly created position of Chief Clinical Officer. Dr. Ingerman is an ophthalmologist, with more than 15 years of pharmaceutical industry product development experience. He will be responsible for the management and operation of Ohr’s clinical development programs, including the upcoming Phase III trials of OHR-102 in wet-AMD and additional studies evaluating OHR-102 in other retinal indications.
Dr. Ingerman’s previous roles included serving as Vice President of Ophthalmology at Regeneron Pharmaceuticals, where he was responsible for the Eylea® development program, which was conducted in collaboration with Bayer Healthcare. At Johnson & Johnson, he was research and development director in Israel and the UK, and clinical leader for the Lastacaft® development program in the U.S. Dr. Ingerman additionally served as an ophthalmology development consultant to numerous companies. Dr. Ingerman received his MD degree from the Tel-Aviv University Sackler School of Medicine and completed his ophthalmology residency at the Rabin Medical Center in Israel.
Dr. Irach Taraporewala, Chief Executive Officer of Ohr Pharmaceutical, stated, “We are extremely pleased to have Dr. Ingerman join the management team at Ohr. Dr. Ingerman brings with him a wealth of experience in ophthalmic product development, including clinical development design and execution, global regulatory and operational management, and development program management. He has a thorough understanding of patient and clinician needs, and will apply his experience to the continued growth of Ohr’s pipeline development programs. We expect Dr. Ingerman’s expertise to prove invaluable for our upcoming Phase III registration trials with OHR-102 in the treatment of wet-AMD.”
Commenting on his appointment, Dr. Ingerman stated, “I recognize the tremendous opportunity that Ohr Pharmaceutical’s pipeline presents, and I am delighted to be joining the Company at this exciting time. I look forward to contributing my expertise to the advancement of Ohr’s clinical programs that seek to find treatments for back-of-the eye diseases.”
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. is an ophthalmology research and development company whose lead product, Squalamine, is being studied as an eye drop formulation (OHR-102) in several company-sponsored and investigator sponsored Phase II clinical trials for various back-of-the-eye diseases. These diseases include the wet form of age-related macular degeneration, retinal vein occlusion, diabetic macular edema, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. The company also has a research agreement with Alcon on a sustained release program. Additional information on the company may be found at www.ohrpharmaceutical.com.
Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
Lastacaft® is a registered trademark of Allergan Inc.
CONTACT: Ohr Pharmaceutical Inc. Investor Relations 888-388-2327 ir@ohrpharmaceutical.com LifeSci Advisors, LLC Michael Wood 646-597-6983 mwood@lifesciadvisors.com
(ATOS) Henry Schein Medical to Offer Atossa Genetics’ FullCYTE Breast Aspirator
SEATTLE, WA–(Feb 26, 2015) – Atossa Genetics Inc. (NASDAQ: ATOS), the Breast Care Company, announced today that Henry Schein Medical, the U.S. Medical business of Henry Schein, Inc. (NASDAQ: HSIC), will offer its customers the FullCYTE Breast Aspirator. The Atossa FullCYTE Breast Aspirator is used by OB/GYNs, primary care physicians and women’s clinics to collect fluid from breasts for subsequent cytological evaluation.
Dr. Steven C. Quay, Chairman, President & CEO of Atossa Genetics, commented, “Working with Henry Schein is an important step forward in making the FullCYTE Breast Aspirator available nationwide. Henry Schein is an industry leader and its multi-channel sales organization allows for expanded reach into multiple market segments within health care for our device. We are thrilled to work with a company such as Henry Schein and believe our arrangement will contribute positively to our upcoming nationwide launch.”
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services and the Company’s medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For more information, please visit www.atossagenetics.com.
About Henry Schein, Inc.
Henry Schein, Inc. is the world’s largest provider of health care products and services to office-based dental, animal health and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites. A Fortune 500® Company and a member of the NASDAQ 100® Index, Henry Schein employs more than 17,500 Team Schein Members and serves more than 1 million customers.
The Company offers a comprehensive selection of products and services, including value-added solutions for operating efficient practices and delivering high-quality care. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 96,000 branded products and Henry Schein private-brand products in stock, as well as more than 110,000 additional products available as special-order items. The Company also offers its customers exclusive, innovative technology solutions, including practice management software and e-commerce solutions, as well as a broad range of financial services.
Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 28 countries. The Company’s sales reached a record $10.4 billion in 2014, and have grown at a compound annual rate of approximately 16% since Henry Schein became a public company in 1995. For more information, visit the Henry Schein website at www.henryschein.com.
Forward-Looking Statements
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory approvals needed by Atossa to sell its products, responses to regulatory matters, Atossa’s ability to continue to manufacture and sell its products, recalls of products, the safety and efficacy of Atossa’s products and services, performance of distributors, whether Atossa can launch in the United States and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
(CYTX) FDA Approves Expansion of Pivotal Scleroderma STAR Trial to 20 Clinical Sites
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January 2015 to study the effects of Cytori’s lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
“Increasing the number of trial sites to 20 institutions should make the STAR trial more accessible to physicians and patients with scleroderma,” said Dr. Steven Kesten, Chief Medical Officer of Cytori Therapeutics. “There are only about 35 specialized scleroderma centers in the U.S. and this decision to expand the trial sites by FDA allows us to substantially broaden the geographic coverage of the trial, increase the number of centers trained in the use of this therapeutic and ultimately facilitate trial enrollment.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cytori Therapeutics, Inc.
Shawn Richardson, 1-858-875-5279
ir@cytori.com
(CRIS) Prices Public Offering of Common Stock
LEXINGTON, Mass., Feb. 25, 2015 — Curis, Inc. (Nasdaq:CRIS), announced today the pricing of an underwritten registered public offering of 21,818,181 shares of its common stock at a public offering price of $2.75 per share resulting in aggregate proceeds of $60.0 million, before underwriting discounts, commissions and estimated expenses. All of the shares to be sold in the offering are to be sold by Curis. The offering is expected to close on or about March 2, 2015, subject to the satisfaction of customary closing conditions. The joint book-running managers for the offering are Cowen and Company, LLC and RBC Capital Markets and Robert W. Baird & Co. Incorporated and Roth Capital Partners, LLC are acting as co-lead managers for the offering.
Curis has granted the underwriters a 30-day option to purchase up to an additional 3,272,727 shares of its common stock at the public offering price. The expected gross proceeds to Curis referenced above do not include any proceeds that Curis would receive if the underwriters exercise such option.
Curis anticipates using the net proceeds from the offering to conduct further preclinical testing and clinical studies of its product candidates, particularly CUDC-907 and any product candidates for which it may exercise its option to exclusively in-license from Aurigene Discovery Technologies Limited, to fund potential acquisitions of new business, technologies or products that it believes complement or expand its business, and for general working capital and capital expenditures. The shares will be issued by Curis pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission (“SEC”). A preliminary prospectus supplement related to the offering has been filed with the SEC and can be accessed on the SEC’s website located at www.sec.gov. A final prospectus supplement will be filed with the SEC. Copies of the prospectus supplements and accompanying prospectus relating to this offering may be obtained from:
Cowen and Company, LLC | RBC Capital Markets |
c/o Broadridge Financial Solutions | 200 Vesey Street |
1155 Long Island Avenue | 8th Floor |
Edgewood, NY 11717 | New York, NY 10281-8098 |
Attn: Prospectus Department | Attention: Equity Syndicate |
Phone: (631) 274-2806 | Phone: (877) 822-4089 |
Fax: (631) 254-7140 | Email: equityprospectus@rbccm.com |
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities, in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
Curis, Inc.
Curis is a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers.
Forward-Looking Statements: Statements contained in this press release about Curis that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements involve known and unknown risks and uncertainties that may cause Curis’ actual results, performance or achievements to be materially different than those expressed or implied by the forward-looking statements Curis makes.Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, whether or not Curis will be able to raise capital through the sale of shares of common stock, the satisfaction of customary closing conditions related to the proposed public offering, Curis’ business and financial condition, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the proposed offering, Curis and its business can be found under the caption “Risk Factors” included in Curis’ annual report on Form 10-K for the year ended December 31, 2014 filed with the SEC on February 24, 2015, Curis’ preliminary prospectus supplement filed with the SEC on February 24, 2015, and in other filings that Curis periodically makes with the SEC.
Any forward-looking statements contained in this press release speak only as of the date hereof. While Curis may elect to update these forward-looking statements at some point in the future, Curis expressly disclaims any obligation to update any forward-looking statements, except as required by law.
CONTACT: For More Information: Mani Mohindru, Ph.D. Vice President, Corporate Strategy and Investor Relations Curis, Inc. 617-503-6605 mmohindru@curis.com Michael P. Gray Chief Financial and Chief Business Officer Curis, Inc. 617-503-6632 mgray@curis.com
(RMGN) to Present at the 27th Annual ROTH Conference
CEO Robert Michelson and COO Loren Buck to Present on March 9, 2015
DALLAS, TX–(Feb 25, 2015) – RMG Networks Holding Corporation (NASDAQ: RMGN), or RMG Networks, a leading provider of technology-driven visual communications solutions, today announced that Robert Michelson, Chief Executive Officer, and Loren Buck, Chief Operating Officer, will present at the 27th Annual ROTH Conference at 11:30 a.m. PT, on Monday, March 9, 2015. The conference will be held March 8-11, 2015 at The Ritz Carlton in Dana Point, California. RMG Networks management will be available during the day on March 9 for one-on-one meetings. Please contact your ROTH representative to schedule a meeting.
The company’s group presentation will be available for the public to access at http://wsw.com/webcast/roth29/rmgn. This webcast will be archived for 90 days following the live presentation.
About RMG Networks
RMG Networks (NASDAQ: RMGN) helps brands and organizations communicate more effectively using location-based video networks. The company builds enterprise video networks that empower organizations to visualize critical data to better run their business. The company also connects brands with target audiences using video advertising networks comprised of over 200,000 display screens, reaching over 100 million consumers each month. RMG Networks works with over 70% of the Fortune 100. The company is headquartered in Dallas, Texas, with offices in the United States, United Kingdom, Singapore and the UAE. For more information, visit http://www.rmgnetworks.com.
Contact:
For RMG Networks Holding Corporation
Investor
Brett Maas
646-536-7331
Email Contact
or
Media
Julie Rasco
800-827-9666
Email Contact
(WGBS) Positive Results Single Cell Study Utilizing Its SmartChip(TM) Technology
Results to be Presented at Upcoming 2015 Advances in Genome Biology & Technology (AGBT) Meeting
FREMONT, Calif., Feb. 25, 2015 — WaferGen Bio-systems, (Nasdaq:WGBS) announced today that it has produced positive results in a study aimed at validating the utility of its SmartChipTM technology for isolating and studying single cells via Next-Generation Sequencing (NGS). The study was conducted in collaboration with the Broad Institute, and the findings will be presented at the 2015 Advances in Genome Biology & Technology (AGBT) meeting to be held February 25-28 in Marco Island, Florida.
In a proof of concept study, WaferGen has engineered a solution for depositing single cells into the individual SmartChipTM wells in a directed fashion, to achieve far greater chip utilization. At this level of efficiency, each chip could produce more than 4,000 single cells for analysis. The cell’s genetic composition was then successfully analyzed with the NGS method by adapting the Single Cell RNA Barcoding and Sequencing (SCRB-Seq) technology pioneered by the Broad Institute. SCRB-Seq measurements have already resulted in critical discoveries of novel cell types that play an important role in disease mechanisms.
“We are pleased with the single cell transcriptome analysis results obtained with the SmartChip™ platform in this initial study,” said Dr. Chad Nusbaum, Scientific Director, Broad Technology Labs, and Co-Director, Genome Sequencing and Analysis at Broad Institute.
“Single cell analysis has the potential to play a significant role in the development of precision medicine, which is transforming healthcare,” said Ivan Trifunovich, President and Chief Executive Officer of WaferGen. “We expect our SmartChipTM technology will be able to yield a 50-fold increase in the production of single cells per chip at a fraction of the current per cell cost. We continue to expect to launch an Early Access Program for this technology during the second quarter of 2015.”
About WaferGen
WaferGen Bio-systems, Inc. is a life science company that offers innovative genomic solutions for clinical testing and research. The SmartChip MyDesignTM Real-Time PCR System is a high-throughput genetic analysis platform for profiling and validating molecular biomarkers via microRNA and mRNA gene expression profiling, as well as single nucleotide polymorphism (SNP) genotyping. The SmartChip TETM System is a novel product offering for target enrichment geared towards clinical Next-Gen sequencing (NGS). The Seq-ReadyTM TE System powered by SmartChipTM massively-parallel singleplex PCR technology, is an innovative one-step target enrichment and library preparation solution. The Company now also offers the Apollo 324TM product line used in library preparation for NGS. These three complementary technologies offer a powerful set of tools enabling more accurate, faster and cheaper genetic analysis based on Next-Gen Sequencing and Real-Time PCR.
For additional information, please see http://www.wafergen.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities 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. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage and our expectations concerning our competitive position and business strategy. 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 recently filed Annual Report on Form 10-K and our subsequently filed 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.
CONTACT: INVESTOR CONTACTS: WaferGen Bio-systems, Inc. Ivan Trifunovich ivan.trifunovich@wafergen.com (510) 651-4450 LifeSci Advisors, LLC Brian Stollar bstollar@lifesciadvisors.com
(SFXE) Robert F.X. Sillerman, CEO Proposes Going-Private Transaction
Robert F.X. Sillerman, Chief Executive Officer and Executive Chairman of the Board of Directors of SFX Entertainment Inc. (NASDAQ:SFXE) (SFX), today announced that he has proposed to the company’s Board of Directors a transaction through which Mr. Sillerman would acquire all of the outstanding shares of common stock of the company not already owned by him for $4.75 per share in cash. The proposed cash consideration represents an approximately 44% premium to the closing price of the Company’s common stock on February 23, 2015, the day before Mr. Sillerman submitted his proposal.
Under Mr. Sillerman’s proposal, any stockholders who wish to retain their equity interests in the company would have the opportunity to do so and remain as investors — alongside Mr. Sillerman — in the company.
“I have put forward a proposal that offers substantial value and flexibility to all shareholders,” said Mr. Sillerman. “Given the inherent risks in our business, my offer guarantees a substantial premium to current price. Those shareholders who are interested in remaining as investors in the company alongside me will have the ability to elect to keep all or part of their shares.”
Mr. Sillerman has requested that the Board appoint a special committee of independent directors to consider his proposal and make a recommendation to the full Board. Mr. Sillerman emphasized that he would not proceed with the proposed transaction unless it was approved by the special committee. In addition, the transaction would be subject to a non-waivable condition requiring approval by holders of a majority of the shares of the Company’s common stock not owned by Mr. Sillerman or his affiliates.
Mr. Sillerman recognizes the Board’s fiduciary duties in the context of his proposal and understands that the Board or the special committee may decide to explore alternative transactions involving a sale of the company. Mr. Sillerman has indicated that, if the Board or the special committee decides to explore alternative transactions, he would be prepared to assist in those efforts and, as a stockholder, would be prepared to support an alternative sale transaction that provides compelling value to the Company’s stockholders.
Mr. Sillerman’s proposal is not binding. Any transaction would be subject to the execution of definitive transaction documents acceptable to Mr. Sillerman and the special committee. Under Mr. Sillerman’s proposal, his proposed transaction would not be subject to any financing condition.
Mr. Sillerman has served as CEO and Executive Chairman of the Board of the company since its inception. Moreover, his history with the business pre-dates the company’s formal creation: he served as Executive Chairman, a Member of the Office of the Chairman, and a director of the original SFX, SFX Entertainment Inc., a company that owned and operated live entertainment venues, from its formation in December 1997 through its sale to Clear Channel in August 2000. That company is now known as Live Nation (NYSE: LYV).
Mr. Sillerman will file today with the Securities and Exchange Commission a beneficial ownership report on Schedule 13D to which a copy of the proposal letter he submitted to the Board will be attached as an exhibit.
Additional Information
An agreement in respect of the transaction described in this release has not yet been executed, and this release is neither a solicitation of a proxy nor an offer to purchase nor a solicitation of an offer to sell shares of the Company’s common stock nor a substitute for any filings that may be made with the Securities and Exchange Commission (SEC) should the proposed transaction go forward. Any solicitation will only be made through materials filed with the SEC. The Company’s stockholders are strongly advised to read such materials when they become available because they will contain important information about the transaction and the Company. Once filed, these documents will be available at no charge on the SEC’s website at www.sec.gov.
Cautionary Statement
Statements in this document represent the intentions, plans, expectations and beliefs of Mr. Sillerman and involve risks and uncertainties that could cause actual events to differ materially from the events described in this release, including risks or uncertainties related to whether the proposed transaction will be completed, as well as changes in general economic conditions, stock market trading conditions, government regulation, and changes in the business or prospects of the Company. These factors, as well as factors described in Mr. Sillerman’s and the Company’s SEC filings are among the factors that could cause actual events or results to differ materially from Mr. Sillerman’s current expectations described in this release.
The Marino Organization
Lee Silberstein, 212-889-0808
lee@themarino.org
or
Steve Vitoff, 212-889-0808
steve@themarino.org
(BIOC) Schedules Webcast and Conference Call for Fourth Quarter 2014 Financial Results
SAN DIEGO, Feb. 25, 2015 — Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced that the Company will issue its financial results for the fourth quarter of 2014 on Monday, March 9, 2015, after the close of the market, and will hold a conference call on this day at 4:30 p.m. ET to discuss the financial results and provide a company update.
The conference call will be hosted by Michael Nall, President and Chief Executive Officer, and Bill Kachioff, Chief Financial Officer. The conference call can be accessed by dialing 1-877-407-4018 for domestic callers and 1-201-689-8471 for international callers. The conference ID number for both is 13602297. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at, ir.biocept.com.
After the live webcast, the event will remain archived on Biocept’s website for one year. In addition, a telephonic replay of the call will be available until March 16, 2015. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers. Please use event passcode 13602297.
About Biocept, Inc.
Biocept, Inc., headquartered in San Diego, California, is a commercial-stage oncology diagnostics company focused on providing information on patients’ tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA or ctDNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers its OncoCEE-BRTM test for breast cancer and OncoCEE-LUTM for non-small cell lung cancer and OncoCEE- GATM for Gastric Cancer and plans to introduce additional CLIA validated tests for breast, lung, colorectal, melanoma, prostate and other solid tumors based on its proprietary technology platforms over the coming months.
CONTACT: Investor Contact: The Ruth Group David Burke Tel: 646-536-7009 dburke@theruthgroup.com
(BNFT) to Present at the Raymond James 36th Annual Institutional Investors Conference
CHARLESTON, S.C., Feb. 25, 2015 — Benefitfocus, Inc. (Nasdaq:BNFT), a leading provider of cloud-based benefits software solutions, today announced that Chief Financial Officer, Milt Alpern, will present at the Raymond James 36th Annual Institutional Investors Conference in Orlando.
The Benefitfocus presentation is scheduled for Tuesday, March 3, 2015 at 11:00 a.m. Eastern Time. The presentation will be available via live webcast and available under the “Events & Presentations” section on the Benefitfocus investor relations website at http://investor.benefitfocus.com/.
About Benefitfocus
Benefitfocus, Inc. (Nasdaq:BNFT) is a leading provider of cloud-based benefits software solutions for consumers, employers, insurance carriers and brokers. Benefitfocus has served more than 23 million consumers on its platform that consists of an integrated portfolio of products and services enabling clients to more efficiently shop, enroll, manage and exchange benefits information. With a user-friendly interface and consumer-centric design, the Benefitfocus Platform provides one place for consumers to access all their benefits. Benefitfocus solutions support the administration of all types of benefits including core medical, dental and other voluntary benefits plans as well as wellness programs. For more information, visit www.benefitfocus.com.
CONTACT: Benefitfocus, Inc. 843-284-1052 ext. 3546 pr@benefitfocus.com Investor Relations: ICR for Benefitfocus, Inc. Brian Denyeau 646-277-1251 brian.denyeau@icrinc.com
(PETX) Regains Rights to AT-004
Product is the first approved monoclonal antibody to aid in the treatment of canine B-cell lymphoma
KANSAS CITY, Kan., Feb. 24, 2015 — Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, announced today it has regained manufacturing and commercial rights for AT-004, a monoclonal antibody that received a full product license from the U.S. Department of Agriculture (USDA) on January 2, 2015 as an aid in the treatment of canine B-cell lymphoma.
With the termination of its exclusive license agreement with Novartis Animal Health US, Inc., an affiliate of Elanco Animal Health (“Elanco”), Aratana has regained commercial rights to the product in the US and Canada. Elanco retains a right of first negotiation if Aratana licenses, assigns or otherwise transfers the patent rights or conveys rights to commercialize the canine specific monoclonal antibody to treat canine B-cell lymphoma. The parties also agreed to periodically review collaboration opportunities in oncology.
Aratana will pay Elanco an upfront fee of $2.5 million and will pay an additional $0.5 million on first commercial sale of the product.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, commented, “Aratana is committed to veterinary oncology, and AT-004 fits very well with our AT-005 product, a monoclonal antibody conditionally approved as an aid in the treatment of canine T-cell lymphoma. Given our expertise in this space, we look forward to future collaborative efforts with Elanco.”
Aratana had historically manufactured AT-004 for clinical and regulatory studies. The company will now assume manufacturing the product for commercial use. However, commercial availability will be expanded only after Aratana has worked with several leading veterinary oncologists to better define and evaluate the products in the context of concomitant use of chemotherapy.
Conference Call and Webcast
Aratana will host a conference call today, Tuesday, February 24, 2015, beginning at 6:00 p.m. Eastern Time. Please see below for details.
Conference call numbers: | |
Domestic: | 1 (866) 364-3820 |
Canada: | 1 (855) 669-9657 |
International: | 1 (412) 902-4210 |
Webcast:
Accessible via the Investor Relations section of the Company’s website at aratana.investorroom.com.
A replay of the conference call and webcast will be available beginning approximately one hour after the completion of the call. Access numbers for this replay are 1 (877) 344-7529 (U.S.), 1 (855) 669-9658 (Canada) and 1 (412) 317-0088 (international); conference ID: 10061350.
About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative biopharmaceutical products for companion animals. Aratana believes that it can leverage the investment in the human biopharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The company’s pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious medical conditions. Aratana believes the development and commercialization of these therapeutics will permit veterinarians and pet owners to manage pets’ medical needs safely and effectively, resulting in longer and improved quality of life for pets. For more information, please visit www.aratana.com.
About Elanco Animal Health
Elanco is a global innovation-driven company that develops and markets products to improve animal health, food animal production and companion animal care in nearly 70 countries. Elanco, a division of leading pharmaceutical company Eli Lilly and Company, employs approximately 7,000 people worldwide, with offices in more than 40 countries. Additional information about Elanco is available at www.elanco.com.
Novartis Animal Health US, Inc. is now a part of Elanco, a division of Eli Lilly and Company.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements with respect to expectations regarding licensure of products; expectations regarding development programs, trials, studies and commercialization; expectations regarding in-licensing initiatives and collaborations; and expectations regarding the Company’s plans and opportunities.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; our lack of commercial sales; our failure to obtain any necessary additional financing; market conditions and our ability to raise capital under the shelf registration statement from the sale of our securities; our substantial dependence on the success of certain of our lead product candidates, our inability to identify, license, develop and commercialize additional product candidates; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; uncertainties regarding the outcomes of studies regarding our products; our inability to realize all of the anticipated benefits of our acquisitions of Vet Therapeutics and Okapi Sciences; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, partners and other third parties which conduct our target animal studies and certain other development efforts; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing; our lack of a sales organization; our significant costs of operating as a public company; our current exemption from the requirement to maintain internal control over financial reporting, and any failure to achieve or maintain effective internal control over financial reporting in the future; changes in distribution channels for pet therapeutics; consolidation of our customers; impacts of generic products; limitations on our ability to use our net operating carryforwards; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; our failure to comply with regulatory requirements; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an “emerging growth company,” as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the significant control over our business by our principal stockholders and management; the potential that a significant portion of our total outstanding shares could be sold into the market in the near future; effects of anti-takeover provisions in our charter documents and under Delaware law; and our intention not to pay dividends. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 26, 2014, and the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 12, 2014, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contacts:
For Aratana investor inquires:
Aratana Therapeutics, Inc.
Craig Tooman
ctooman@aratana.com; (913) 353-1026
For Aratana media inquiries:
Tiberend Strategic Advisors, Inc.
Andrew Mielach
amielach@tiberend.com; (212) 375-2694
For Elanco media inquiries:
Elanco Animal Health
Julie Lawless
lawlessj@elanco.com; (615) 585-5861
(SIGM) Designs to Present at the 27th Annual ROTH Conference on March 9, 2015
MILPITAS, CA–(Feb 24, 2015) – Sigma Designs® (NASDAQ: SIGM), a leading provider of system-on-chip (SoC) solutions for Smart TV, Internet of Things for Smart home, media connectivity and set-top-boxes (STBs), announced that management is scheduled to present at the 27th Annual ROTH Conference on March 9, 2015, at 10:30 a.m. Pacific Time.
Event: 27th Annual ROTH Conference
Date: Monday, March 9, 2015
Time: 10:30 a.m. Pacific Time
Location: The Ritz-Carlton – Dana Point, Calif.
A webcast of the ROTH conference presentation will be available in the investor relations section of the Company’s website at www.sigmadesigns.com.
About Sigma Designs
Sigma Designs, Inc. (NASDAQ: SIGM) is a world leader in enabling smart home convergence. The company designs and builds the essential semiconductor technologies that serve as the foundation for the world’s leading IPTV set-top boxes, Smart TV, connected media players, Internet of Things (IoT) for smart home devices and residential gateways and whole home media connectivity. For more information about Sigma Designs, please visit www.sigmadesigns.com.
Investor Contact:
Darrow Associates, Inc.
Jim Fanucchi
+1-408-404-5400
ir@sigmadesigns.com
Press Contact:
Mary Miller
Sigma Designs
+1-408-957-9885
Mary_Miller@sigmadesigns.com
(CTP) Board of Directors Forms Special Committee
CTPartners Executive Search, Inc. announced that its Board of Directors has formed a Special Committee, composed solely of independent directors, to review strategic alternatives for the Company, including a previously announced unsolicited, non-binding proposal from DHR International, Inc. to acquire all of the outstanding shares of the Company for $7.00 a share and a range of other alternatives. The Special Committee has engaged Robert W. Baird & Co. to serve as its financial adviser.
The Company does not currently plan to provide interim updates on the Special Committee’s work, and does not expect to report on the strategic review process until the Special Committee has completed the process and made its recommendation to the full Board of Directors for its consideration and action, if any. The Special Committee has not established a timetable and there is no assurance that the review process will result in any transaction being announced or completed.
About CTPartners
CTPartners is a leading global executive search firm that is designed to deliver in-depth expertise, creative strategies, and outstanding results to clients worldwide. Committed to a philosophy of partnering with its clients, CTPartners offers a proven track record in C-Suite, top executive, and board searches, as well as extensive experience in serving private equity and venture capital firms.
From its 44 offices in 24 countries, CTPartners serves clients with a global organization of more than 500 professionals and employees, offering expertise in board advisory services, key leadership functions, and executive recruiting services in the financial services, life sciences, industrial, professional services, retail and consumer, and technology, media and telecom industries.
Press Inquiries:
CTPartners
Derek Creevey, 212-209-5708
dcreevey@ctnet.com
(FLKS) Nobel Laureate, Rod MacKinnon, M.D., Joins Board of Directors
Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions, today announced that Nobel Laureate and Scientific Co-Founder, Rod MacKinnon, M.D., has joined its Board of Directors. In addition, Scientific Co-Founder, Bruce Bean, Ph.D., will join the Board as an observer based upon his significant contributions and ongoing involvement with the Company’s development efforts.
Dr. MacKinnon was awarded the Nobel Prize in Chemistry in 2003 for his work determining the structure of ion channels and showing the mechanism by which they select for particular ions (Doyle, et al., The Structure of the Potassium Channel: Molecular Basis of K+ Conduction and Selectivity, April 1998, Science). His work serves as the foundation of Flex Pharma’s approach to preventing muscle cramping. Dr. MacKinnon is Investigator at Howard Hughes Medical Institute and the John D. Rockefeller Jr. Professor, Laboratory of Molecular Neurobiology and Biophysics at the Rockefeller University, and a member of the National Academy of Sciences.
Dr. Bean, Flex Pharma Scientific Co-Founder and Co-Chair of the Company’s Scientific Advisory Board, is a member of the National Academy of Sciences and the Robert Winthrop Professor of Neurobiology at Harvard Medical School, where he oversees a leading research laboratory studying the biophysics of sodium, calcium and potassium ion signaling in relation to pain processing.
“As a Scientific Co-Founder, I am thrilled to join the Board of Flex Pharma and look forward to further advancing the translation of our novel insights into treatments that can help the many individuals suffering from cramps and spasms associated with a broad range of neuromuscular disorders,” commented Rod MacKinnon, M.D., Nobel Laureate and Flex Pharma Co-Founder and Co-Chair of the Company’s Scientific Advisory Board.
“The Board of Flex Pharma is privileged to work with world class physicians and scientists, such as Dr. MacKinnon and Dr. Bean, whose amazing scientific insights appear to have solved a long-standing medical mystery, unraveling the cause of muscle cramping, thereby providing a potential solution for athletes and patients who suffer from muscle cramps,” said Flex Pharma Board member and investor, John Sculley, former CEO of Pepsi and Apple.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions. In three randomized, blinded, placebo-controlled, cross-over studies, Flex Pharma’s proprietary treatment has shown a statistically significant reduction in the intensity of muscle cramps in healthy normal volunteers.
Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chairman and Chief Executive Officer Christoph Westphal, M.D., Ph.D.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success and timing of ongoing and anticipated clinical studies for our current product candidates; our expectations regarding the effectiveness and safety of our product candidates; and the timing of and our expectations for the launch of our consumer product. Various factors may cause differences between our expectations and actual results as discussed in greater detail under the heading “Risk Factors” in the registration statement on Form S-1 (commission file number 333-201276), which was declared effective by the Securities and Exchange Commission (SEC) on January 28, 2015. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
VP, Investor Relations & Corporate Communications
irdept@flex-pharma.com
(NDRM) CEO to Present at Upcoming Investor Conferences
REHOVOT, Israel, Feb. 24, 2015 — NeuroDerm Ltd. (Nasdaq:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that CEO Oded S. Lieberman, PhD will present at the following investor conferences in March:
- Cowen and Company 35th Annual Health Care Conference taking place in Boston, Massachusetts from March 2 – 4, 2015. Dr. Lieberman’s presentation will take place on Monday, March 2, at 2:50pm ET.
- 27th Annual ROTH Conference taking place in Laguna Niguel, California from March 8 – 11, 2015. Dr. Lieberman’s presentation will take place on Monday, March 9 at 3:00pm PT, 6:00pm ET.
To access the live webcasts of these presentations, please visit ir.neuroderm.com/. Replays will be available for one month following each presentation.
About NeuroDerm
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. NeuroDerm is headquartered in the Rabin Science Park, Rehovot, Israel.
CONTACT: NeuroDerm Contact: Oded S. Lieberman, PhD MBA, CEO oded@neuroderm.com Tel.: +972-8-946 2729 Cell: +1-617-517-6077 U.S. Investor Contact: David Carey Lazar Partners Ltd. dcarey@lazarpartners.com +212-867-1762 U.S. Media Contact: Hollister Hovey Lazar Partners Ltd. hhovey@lazarpartners.com +212-867-1762
(EYES) Announces First Commercial Implants of the Argus® II Retinal Prosthesis
Second Sight Medical Products, Inc. (Nasdaq:EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics to provide functional vision to blind patients, today announced that all three of the centers approved to implant the Argus II Retinal Prosthesis System (“Argus II”) under the French Government national healthcare reimbursement program entitled ‘Forfait Innovation’ have successfully completed their first implants in patients with retinitis pigmentosa (RP). Current French implant centers are located in Paris, Bordeaux, and Strasbourg.
In 2014, the Argus II became the first-ever medical device to be named as the recipient of Forfait Innovation, allowing select hospitals in France to offer this “early access” and innovative treatment to patients with advanced RP. Forfait Innovation provides dedicated support to patients implanted with Argus II, funding the costs of implantation and patients’ hospital fees. 36 RP patients in France now stand to benefit from this life-changing technology with this first step in national reimbursement.
“We are pleased to see RP patients, who previously had no treatment option, gain access to this revolutionary device through Forfait Innovation,” stated Dr. Robert Greenberg, Chief Executive Officer of Second Sight. “There is great potential for patients in France, as the French government has taken a progressive step in supporting a sometimes overlooked patient population.”
RP, an inherited disease that often results in nearly complete blindness, affects roughly 24,000 French persons and 167,000 persons across Europe in total.
To date, the Argus II has been implanted in more than 100 individuals worldwide, and is the first approved retinal prosthesis in the world. Currently, the treatment is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, United Kingdom and the United States. The system induces visual perception in blind individuals by providing electrical pulses to stimulate the retina’s remaining cells, resulting in a perception of light patterns in the brain. The Argus II has the potential to offer life changing visual capabilities to those with little or no remaining functional vision. The Argus II implant can positively impact a blind person’s ability to conduct routine daily activities, such as recognizing shapes or large objects, locating people, identifying the location of doorways, and following lines or edges. Ultimately, this is meant to allow Argus II users to live their daily lives with more confidence.
About Retinitis Pigmentosa (RP)
RP is a rare, hereditary disease that causes a progressive degeneration of the light-sensitive cells of the retina, leading to significant visual impairment, and ultimately, blindness. There are an estimated 1.2 million people worldwide with RP. Second Sight’s Argus II System employs electrical stimulation to bypass the defunct cells and stimulate remaining viable retinal cells inducing visual perception in blind individuals. The Argus II is the first artificial retina to receive approval in the United States and worldwide.
About the Argus® II Retinal Prosthesis System
Second Sight’s Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound retinitis pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient’s glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells, resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. The Argus II is the first artificial retina to receive widespread approval, and is offered at approved centers in Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, United Kingdom and the United States. The system is controlled by software and is upgradeable, which may provide improved performance as new algorithms are developed and tested.
About Second Sight
Second Sight Medical Products, Inc. was founded in 1998 to create a retinal prosthesis to provide sight to patients blinded from outer retinal degenerations such as RP. Second Sight’s mission is to develop, manufacture, and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. The company’s Argus II retinal prosthesis is approved in the U.S., Canada, Europe and Saudi Arabia, and trials are currently underway to test the safety and efficacy of the Argus II in patients with Dry AMD. Clinical trials are planned to test improved software, which is currently under development. Second Sight is also developing the OrionTM cortical prosthesis to restore functional vision to individuals who are blind due to causes other than preventable or treatable conditions. The population of legally blind people potentially eligible for the future Orion cortical prosthesis in France is about 40,000 and 6 million worldwide. The company’s headquarters are in Sylmar, California, and its European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com.
Safe Harbor
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements”. 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 contained within our final prospectus filed with the United States Securities and Exchange Commission on November 20, 2014. 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.
For Patient Inquiries:
Argus II hotline:
France: 0 805 080 596
International: 1 (818) 833-5027
US (toll free): 1 (855) 756-3703
patients@secondsight.com
or
Media Relations:
Pascale Communications, LLC
Allison Potter
+1-412-228-1678
allison@pascalecommunications.com
or
Investor Relations:
Retail Investors
MZ North America
Matt Hayden, Chairman
+1-949-259-4896
matt.hayden@mzgroup.us
or
Institutional Investors
In-Site Communications, Inc.
Lisa Wilson, President
+1-212-452-2793
lwilson@insitecony.com
(DGLY) Awarded GSA Schedule 84 Contract
LENEXA, KS–(Feb 23, 2015) – Digital Ally, Inc. (NASDAQ: DGLY), which develops, manufactures and markets advanced video surveillance products for law enforcement, homeland security and commercial applications, today announced that it has been awarded GSA Status by the U.S. General Services Administration (“GSA”), the procurement arm of the federal government.
The Schedule 84 award encompasses federal, state and local government agencies that are purchasing total video solutions for law enforcement, security, facilities management, fire and rescue, clothing, marine craft, and emergency/disaster response requirements. The five-year contract allows federal, state and local governmental customers to efficiently purchase a wide range of Digital Ally video evidence collection and management products and services.
The GSA establishes long-term, government-wide contracts with commercial vendors in order to streamline and standardize the process of procuring products and services for the entire federal government. The GSA is the most widely used government contract vehicle, representing more than $32 billion in total contract volume in Fiscal 2014. Digital Ally’s inclusion as a GSA Schedule 84 vendor enables all government agencies to obtain hardware and software products, support, training, and warranty services at approved pricing and with authorized license terms from a trusted vendor. In Fiscal 2014, more than $1.5 billion in total vendor contract volume with the federal government involved the Schedule 84 contracting process.
Digital Ally has been pursuing this GSA designation for almost two years. The GSA Schedule 84 award represents the culmination of a rigorous process during which the GSA carefully evaluates prospective vendors to determine their proficiency and suitability for providing products and/or services to the federal government. This assessment covers an array of the vendor’s capabilities, including organizational structure, performance history, customer satisfaction and other criteria. In awarding Digital Ally a GSA Schedule 84 contract, the federal government has determined that the Company is recognized as a preferred vendor and is fully authorized to conduct business directly with federal government agencies.
“We are very pleased that our state-of-the-art video surveillance products and data storage services will now be available for purchase by all federal agencies under the Schedule 84 contract,” stated Stanton E. Ross, Chief Executive Officer of Digital Ally, Inc. “By reducing procurement issues, the GSA contract allows Digital Ally and prospective government clients to focus on what matters most — assessing and resolving critical evidence collection and IT challenges. We believe our GSA status will expedite the ability of government agencies to acquire our evidence gathering solutions and services, including body-worn cameras, in-car video systems, and cloud storage solutions, in a more efficient and timely manner.”
Federal, state and local government agencies can obtain information about Digital Ally, Inc.’s GSA Schedule 84 contract services on the GSA Advantage website at www.gsaadvantage.gov (search for Contract Number GS-07F095CA) or by contacting Digital Ally, Inc. directly at (800) 440-4947. Digital Ally’s services are offered under the Special Item Number (“SIN”) 426-4S, Surveillance Systems. The Schedule 84 award is effective February 19, 2015 to February 19, 2020, with three 5-year extension options.
About Digital Ally, Inc.
Digital Ally, Inc. develops, manufactures and markets advanced technology products for law enforcement, homeland security and commercial applications. The Company’s primary focus is digital video imaging and storage. For additional information, visit www.digitalallyinc.com.
The Company is headquartered in Lenexa, Kansas, and its shares are traded on The NASDAQ Capital Market under the symbol “DGLY”.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. A wide variety of factors that may cause actual results to differ from the forward-looking statements include, but are not limited to, the following: whether the Company’s status as a GSA Schedule 84 vendor will result in sales of its products to federal, state and local government agencies and, if so, the volume, price and terms of such sales; whether the new GSA status will expedite sales to government agencies; whether the interest shown in the Company’s newer products will translate into sales; competition from larger, more established companies with far greater economic and human resources; its ability to attract and retain customers and quality employees; the effect of changing economic conditions; and changes in government regulations, tax rates and similar matters. These cautionary statements should not be construed as exhaustive or as any admission as to the adequacy of the Company’s disclosures. The Company cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”, “should”, or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. The Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Additional information respecting factors that could materially affect the Company and its operations are contained in its quarterly report on Form 10-Q for the three and nine months ended September 30, 2014, as filed with the Securities and Exchange Commission.
For Additional Information, Please Contact:
Stanton E. Ross
Digital Ally
CEO
(913) 814-7774
Investor Relations Counsel
RJ Falkner & Company, Inc.
(800) 377-9893
info@rjfalkner.com
(CLDX) Rindopepimut (Rintega) Receives FDA Breakthrough Therapy Designation In Glioblastoma
HAMPTON, N.J., Feb. 23, 2015 — Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega®) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).
This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in December of 2014.
“The FDA’s decision to grant Breakthrough Designation underscores rindopepimut’s therapeutic potential for patients with glioblastoma,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “These patients have extremely limited treatment options, with only three new drugs approved in more than twenty years. Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients. With continued positive data, we look forward to working closely with the FDA to support potential approval of rindopepimut as expeditiously as possible.”
According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII. Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival.
About Rindopepimut
Rindopepimut (Rintega®) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII (v3), a functional and permanently activated variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues.
Three Phase 2 trials of rindopepimut—ACTIVATE, ACT II, and ACT III—have been completed in newly diagnosed EGFRvIII-positive GBM and have shown consistent improvements in both overall survival and median progression-free survival. The most common adverse events for rindopepimut include injection site reactions, fatigue, rash, nausea and pruritus. Rindopepimut is currently being studied in two clinical trials in EGFRvIII-positive GBM—an international Phase 3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT in recurrent GBM.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.
Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the future development and commercialization (by Celldex and others) of Rintega® (“rindopepimut”; “rindo”; CDX-110). Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of rindopepimut; our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and derive benefit from the Breakthrough Therapy Designation for rindopepimut, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact: Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 scavanaugh@celldex.com Media Inquiries: Dan Budwick Pure Communications, Inc. (973) 271-6085 dan@purecommunicationsinc.com
(APRI) Taglich Brothers Initiates Coverage on Apricus Biosciences
NEW YORK, NY–(Feb 23, 2015) – Taglich Brothers, Inc. announces it initiated coverage of Apricus Biosciences, Inc.
Apricus Biosciences, Inc., (NASDAQ: APRI) headquartered in San Diego, California, manufactures a treatment for erectile dysfunction and is developing pharmaceuticals to treat urological and rheumatoid disorders, and women’s sexual disorders. The company’s lead product, Vitaros, is a topical treatment for erectile dysfunction (ED), delivery of which is based on a proprietary permeation enhancer technology (NexACT®) which facilitates the delivery of the drug into the blood stream.
Vitaros is aimed at patients who have not responded satisfactorily to oral ED medications and prefer a treatment that is less invasive or easier to use than other alternatives. Vitaros is cleared for marketing in a number of European countries and in Canada.
Vitaros was launched in the UK, Germany, Sweden, and Belgium in 2014. Revenue to date consists largely of upfront license fees. All product marketing is done by partners currently under exclusive licenses to sell Vitaros in Canada, Europe, most of Southeast Asia, the Mideast, Australia and New Zealand, and certain countries in Africa.
Revenue potential for Vitaros alone is substantial. Erectile dysfunction is a largely age-related ailment due in large measure to the incidence of such conditions as diabetes, hypertension, high cholesterol and heart disease in older patient populations. While the majority of cases are successfully treated with oral phosphodiesterase-5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil, commonly known, respectively, as Viagra, Cialis and Levitra, many ED patients are unresponsive to PDE5 inhibitors.
APRI has three more products in its pipeline. RayVa™, a rheumatology product, is now in a Phase 2a trial for the treatment of Raynaud’s Phenomenon, a symptom of rheumatic disease that causes numbness in the digits in response to cold temperatures or stress. RayVa also uses Apricus’ proprietary permeation enhancer. Apricus plans a 2015 Phase 2b clinical study of fispemifene, an in-licensed tissue-specific selective estrogen receptor modulator designed to treat secondary testosterone deficiency (hypogonadism), chronic prostatitis and lower urinary tract symptoms in men. Apricus is seeking one or more licensees to further develop and commercialize Femprox®, a potential treatment for female sexual interest/arousal disorder (FSIAD) that has been evaluated in earlier human studies.
The complete 17-page report is available at www.taglichbrothers.com.
We do not undertake to advise you as to changes in figures or our views. This is not a solicitation of any order to buy or sell. Taglich Brothers, Inc. is fully disclosed with its clearing firm, Pershing, LLC, is not a market maker and does not sell to or buy from customers on a principal basis. The above statement is the opinion of Taglich Brothers, Inc. and is not a guarantee that the target price for the stock will be met or that predicted business results for the company will occur. There may be instances when fundamental, technical and quantitative opinions contained in this report are not in concert. We, our affiliates, any officer, director or stockholder or any member of their families may from time to time purchase or sell any of the above-mentioned or related securities. Analysts and members of the Research Department are prohibited from buying or selling securities issued by the companies that Taglich Brothers, Inc. has a research relationship with, except if ownership of such securities was prior to the start of such relationship, then an Analyst or member of the Research Department may sell such securities after obtaining expressed written permission from Compliance. As of the date of this report no Taglich Brothers, Inc. employees had a position in the stock of the company mentioned in this report.
All research issued by Taglich Brothers, Inc. is based on public information. All research issued by Taglich Brothers, Inc. is based on public information. In Decemberr 2014 the company paid an initial monetary engagement fee of US$4,500 to Taglich Brothers, Inc. representing payment for the first three months of the creation and dissemination of research reports, after which the company will pay Taglich Brothers, Inc. a monetary fee of US$1,500 per month for another sixmonths of such services.
For further information and Taglich Brothers, Inc. ownership data please refer to each individual report.
Contact:
Richard Oh
Taglich Brothers, Inc.
631-757-1500
(RIGL) & (BMY) R&D Collab. Immuno-Oncology TGF Beta Receptor Kinase Inhibitors
Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s extensive portfolio of small molecule TGF beta receptor kinase inhibitors. TGF beta can promote tumor growth, broadly suppress the immune system and increase the ability of tumors to spread in the body. The collaboration will focus on developing a new class of therapeutics aimed at increasing the immune system’s activity against various cancers either as monotherapy or in combination with immune checkpoint inhibitors, including Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab).
Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel’s TGF beta library, including, but not limited to, those approved to treat cancer. Bristol-Myers Squibb will pay $30 million upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309 million for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
“As a company dedicated to leading scientific advances in immuno-oncology, we are committed to exploring the utility of TGF beta inhibition as a potential therapeutic to fight certain cancers,” said Carl Decicco, Ph.D., Head of Discovery, R&D, Bristol-Myers Squibb. “Working with Rigel and having access to their TGF beta receptor kinase inhibitors extends our existing portfolio of immunotherapeutic approaches to include this key mediator of immunosuppression in the tumor microenvironment.”
“This collaboration places our TGF beta receptor kinase inhibitor program into the hands of Bristol-Myers Squibb, a premier immuno-oncology company. Together, we believe TGF beta inhibition may offer novel therapeutic opportunities in oncology treatments,” said Raul Rodriguez, president and chief executive officer of Rigel. “Rigel has focused on immunology, and oncology via numerous partnerships. This collaboration is Rigel’s first in immuno-oncology and is one of the Company’s several programs in this area.”
TGF beta Inhibition
Within the immune system, TGF beta often plays an immunosuppressive role by potently suppressing effector cell proliferation and function while simultaneously promoting differentiation of certain suppressive T-cells. This master regulator is often present within tumor microenvironments and can significantly dampen anti-tumor host immune responses. Current evidence suggests that TGF beta can arise from many sources, including the cancer itself, surrounding cells and infiltrating macrophages.
Developing a drug that inhibits TGF beta signaling in cancer patients has the potential to counteract an important mechanism used by cancers to escape immuno-surveillance, thereby making this signaling pathway an appealing therapeutic target for immuno-oncology related applications.
Rigel has identified a large number of orally bioavailable, potent and selective small molecule inhibitors of TGF beta receptor kinases that have demonstrated in vivo efficacy, in preclinical animal models of cancer, consistent with an immune-mediated mechanism of action.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory and autoimmune diseases, immuno-oncology related diseases, and muscle disorders. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. Rigel currently has the following product candidates in development: fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, which is in Phase 3 clinical trials for immune thrombocytopenic purpura (ITP) and initiating a Phase 2 clinical trial for IgA nephropathy (IgAN); R348, a topical JAK/SYK inhibitor, in a Phase 2 clinical trial for dry eye in ocular graft-versus-host disease (GvHD); two oncology product candidates in Phase 1 development with partners BerGenBio AG and Daiichi Sankyo; and two preclinical programs with AstraZeneca for R256 in asthma and Bristol-Myers Squibb for TGF beta inhibitors in immuno-oncology.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Rigel Forward-Looking Statements
This release contains forward-looking statements relating to, among other things, the discovery, development and commercialization of cancer immunotherapies and the collaboration with Bristol-Myers Squibb, potential payments and royalties to Rigel, Rigel’s product development programs, and the timing of expected results in its clinical programs. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “planned,” “will,” “may,” “expect,” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigel’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, the availability of resources to develop Rigel’s product candidates, Rigel’s need for additional capital in the future to sufficiently fund Rigel’s operations and research, the uncertain timing of completion of and the success of clinical trials, market competition, risks associated with and Rigel’s dependence on Rigel’s corporate partnerships, as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the discovery, development and commercialization of cancer immunotherapies. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that we will be able to successfully develop a TGF Beta Receptor Kinase Inhibitor. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145
sarah.koenig@bms.com
or
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Rigel
Media:
Susan C. Rogers, 650-430-3777
Rivily, Inc.,
susan@rivily.com
or
Investors:
Raul Rodriguez, 650-624-1302
invrel@rigel.com
(BIOC) Study Highlights Value of Blood-Based Breast Cancer Diagnostic
SAN DIEGO, Feb. 23, 2015 — Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), today announced that its blood-based diagnostic, OncoCEE-BR™, was used to determine hormonal status of metastatic breast cancer patients in a prospective study performed at the Columbia University College of Physicians and Surgeons in New York City. Findings from the Columbia study were recently published in the peer-reviewed journal Clinical and Translational Oncology.
Breast cancer remains one of the most lethal forms of cancer despite advances in early detection and treatment. A patient’s hormone receptor (HR) status, which includes estrogen receptor (ER) and progesterone receptor (PR) status, conveys both prognostic and predictive implications for patients with breast cancer. Up to 75 percent of breast tumors rely on ER signaling to grow. Targeting this pathway with anti-estrogen therapy has been shown in trials to have a clear clinical benefit in the treatment of this subset of breast cancer patients. Understanding HR status at the time of diagnosis, occurrence of metastasis and throughout the course of therapy can help inform patient treatment and, ultimately, has the potential to influence patient outcome.
The Columbia study used Biocept’s proprietary CTC isolation platform to prospectively define hormonal status (ER/PR) using a simple blood sample in women with metastatic breast cancer. These blood samples were compared to the hormonal status results from their corresponding tumor biopsy tissue. The study reports a high concordance of results between testing of a patient’s CTCs and testing of primary and metastatic tissue – results that indicate Biocept’s blood-based diagnostic may be as effective in determining a patient’s HR status as traditional tissue biopsy.
“We are encouraged that the results of this study further support the validity of Biocept’s liquid biopsy in the continuous monitoring and treatment of breast cancer, and we are proud that an academic entity as prestigious as Columbia University Medical Center appreciates the utility of our diagnostic offering,” said Veena Singh, M.D., Biocept Senior Vice President and Senior Medical Director.
“These findings could ultimately have significant implications in how we treat advanced stage breast cancer patients,” said Kevin Kalinsky, M.D., Assistant Professor of Medicine at Columbia University Medical Center and first author of the paper. “Since it is not always feasible to obtain metastatic tissue from breast cancer patients, CTCs are an attractive alternative source of tumor material. CTCs provide real-time information about the HR status of a tumor that can be monitored more readily on an ongoing basis.”
The ultimate goal of CTC evaluation is to assist physicians with making treatment decisions, such as the role of anti-estrogen therapy. The Columbia study shows that CTCs afford diagnostic results that are comparable to tumor tissue.
About Biocept, Inc.
Biocept, Inc., headquartered in San Diego, Calif., is a commercial-stage oncology diagnostics company focused on providing information on patients’ tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers CLIA validated tests for breast, lung and gastric cancer and plans to offer additional assays for colorectal, prostate and other solid tumors based on its proprietary technology platforms in the future.
About Kevin Kalinsky, M.D., M.S.
Dr. Kalinsky received his undergraduate B.A. from Emory University. He received his M.D. from the Medical University of South Carolina and completed his Internal Medicine internship and residency at Tufts Medical Center. During his Hematology/Oncology fellowship at Tufts Medical Center, he received the Abby Shevitz Award for Young Physician’s in Hematology/Oncology. In Boston, he also trained as a breast cancer clinical research fellow at Massachusetts General Hospital. In addition, he completed an advanced oncology fellowship in breast cancer at Memorial Sloan-Kettering Cancer Center.
Dr. Kalinsky cares for patients diagnosed with breast cancer and teaches on the Breast Oncology service. His research involves the development of early phase clinical trials to assess novel therapeutic agents in breast cancer. The goal of his research is to translate findings developed at the bench to clinical trials for study at the bedside. His work is funded by a number of sources, including the National Institute of Health and SWOG/The Hope Foundation.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as Biocept’s impact on diagnostic strategies, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our SEC filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov
CONTACT: Corporate Communications Contact: For Media: Melanie Sollid-Penton, The Ruth Group msollid@theruthgroup.com (646) 536-7023 For Investors: David Burke, The Ruth Group dburke@theruthgroup.com (646) 536-7009
(BIND) to Present at Cowen & Co. 35th Annual Healthcare Conference
BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, announced today that Andrew Hirsch, BIND’s chief operating officer and chief financial officer, will present at the Cowen & Co. 35th Annual Healthcare Conference in Boston on Tuesday, March 3, 2015 at 10:40 a.m. ET.
Interested parties may access a live webcast of the presentation by visiting the BIND Therapeutics website at www.bindtherapeutics.com. The webcasts will be archived on the BIND Therapeutics website following the event for one week.
About BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine platform company developing Accurins, its novel targeted therapeutics. BIND is leveraging its Medicinal Nanoengineering® platform to develop a pipeline of Accurins, initially in oncology, as well as Accurins in collaboration with biopharmaceutical companies.
BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck (known as Merck Sharp & Dohme outside the United States and Canada) to develop Accurins based on their proprietary therapeutic payloads and targeting ligands. BIND’s platform originated from the pioneering nanotechnology research at the Massachusetts Institute of Technology and Brigham and Women’s Hospital/Harvard Medical School of BIND’s scientific founders Dr. Robert Langer and Dr. Omid Farokhzad. For more information, please visit the Company’s web site at www.bindtherapeutics.com.
Media:
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