Archive for October, 2016
More than 35 spine surgeons trained on the BoneScalpel
FARMINGDALE, N.Y., Oct. 31, 2016 — Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, recently participated in the North American Spine Society (NASS) 2016 Annual Meeting in Boston, MA from October 26-29.
NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, and evidence-based spine care. The NASS 2016 Annual Meeting represented the largest spine meeting and exhibit in the world. It was attended by thousands of spine surgeons gathered to discuss new innovative options, trends, and outcomes in spine surgery.
While at the Misonix exhibit meeting attendees engaged with leading surgeons, including Dr. Nicholas Renaldo, Medical Director of Spine Surgery at Vassar Brothers Medical Center, Poughkeepsie NY; Dr. Eric Woodard, Chief of the Section of Neurosurgery, New England Baptist Hospital, Boston MA; and Dr. Connor Telles from Sierra Pacific Orthopedics in Fresno, CA, to learn about their surgical experiences with the BoneScalpel.
Misonix also hosted – by invitation only – several leading surgeons in the “Innovation Room” where the invited surgeons met with members of the Misonix engineering group to learn more about future innovations under development. Gaining feedback directly from the surgeons at the event is a critical step in assuring that the next generation technologies under development reflect end-user recommendations.
In addition to the Company’s booth presence, Misonix hosted a BoneScalpel hands-on cadaveric workshop entitled, Ultrasonic BoneScalpel Techniques in Complex Spine facilitated by Isador Lieberman, MD, Director of the Scoliosis and Spine Tumor Center at the Texas Back Institute in Plano, TX. Dr. Lieberman demonstrated his clinical usage of the BoneScalpel with attendees having the opportunity for trialing the BoneScalpel ultrasonic bone-cutting instrument. More than 35 spine surgeons were trained on the use of BoneScalpel at the lab.
Commenting further on the week’s events was Dr. Juan Uribe, University of South Florida, Tampa, FL, who presented his experience with the BoneScalpel at Friday’s NASS Solutions Showcase. “The advantages of less blood loss, precise cuts, savings in operating room time, and less hand fatigue are among the many reasons that BoneScalpel is now a requirement for a high percentage of the cases I currently perform. In fact, BoneScalpel has changed the way I practice spine surgery,” added Dr. Uribe.
Stavros Vizirgianakis, interim chief executive officer of Misonix, said, “We are gratified that these key opinion leaders in the spinal and neurosurgical space have adopted our technology into their practices and enthusiastically share their expertise and experiences with others in their profession. This is a very positive reflection on the efficacy of the BoneScalpel, our ultrasonic technology, and the skill sets of these surgical professionals to produce improved patient outcomes, and to do so, in a very efficient manner. We are pleased to be associated with these leading surgical professionals.”
Dr. Isadore Lieberman, who facilitied the BoneScalpel cadaveric workshop, said, “I was extremely pleased with the turnout for the workshop and the continued high level of interest in the BoneScalpel by my peers and colleagues at this year’s NASS meeting. In my opinion, BoneScalpel continues to be one of the most important innovations in spine surgery in the past several years and given the number of attendees who participated in the workshop this year, clearly people are taking notice of the importance of this technology.”
Misonix Senior Vice President of Global Sales and Marketing, Scott Ludecker, commented, “BoneScalpel’s ability to mitigate the potential for soft tissue collateral damage and minimize blood loss during complex spine surgeries are some of the key benefits which have drawn the spinal surgeon community to BoneScalpel. These attributes are universally understood as being cornerstones for better patient outcomes. Events like this week’s hands-on cadaver workshop are idea forums for surgeons to experience for themselves the benefits of our technology. Having leading surgeons like Dr. Lieberman available to share his personal experience with them is invaluable.”
About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.
Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.
New RedZone Maps Update Uses Powerful Social Listening Capabilities to Put Real Time Crime Data at its Users’ Fingertips
With beta testing behind them, Zone Technologies, Inc., the creator of RedZone Maps, a GPS-driven, real time crime data aggregation and navigation map application, together with big data analytics provider Helios and Matheson Analytics, Inc. (NASDAQ: HMNY), announced today that RedZone Maps broke through the top 5 in Apple’s App Store in the U.S. navigation maps category, right behind Google Maps and Waze, last week during its successful beta test.
Social empowerment at its best! (Photo: Business Wire)
RedZone Maps now provides its users with real time crime data from approximately 1,250 cities in the United States – across all state borders – showing over 500,000 crimes committed during the past 60 days and as recently as the past 24 hours. The availability of this information in a navigation map format, including information about shootings, assaults and thefts, works to keep users aware of their surroundings, whether in their own neighborhoods or traveling. RedZone plans to deploy its propriety technology worldwide, making big data of the same magnitude available to users globally. Currently, the RedZone app is available free in the Apple App store and expected to be accessible to Android users shortly.
“Our goal is to enable the RedZone Maps technology, when combined with the power of HMNY’s big data and predictive analytics capabilities, to help people avoid dangerous crime,” said Ted Farnsworth, founder of RedZone. “We have designed RedZone Maps to show real time crime data through its social listening, big data and artificial intelligence capabilities in a navigation map format. We’re not aware of any other solution that does that for its users and as a result we believe this makes RedZone the leader in this space,” Mr. Farnsworth continued.
“HMNY’s core strengths have been a great strategic fit with Red Zone Maps’ mission. HMNY’s culture has always been focused on helping and guiding its clients. Our motto is that we offer the ‘wisdom of data to see the light’, and now, RedZone Maps has enabled us to reach beyond the companies we typically serve, and help empower individuals to feel more safe and secure,” said Pat Krishnan, HMNY’s CEO.
The RedZone Maps proprietary mapping and navigation system, offering a safe route and risky route, combined with real time crime data aggregation, crowdsourcing and a social interaction component, are obvious benefits to individual users. We believe, with safety becoming an ever-increasing daily concern around the world, the leading online travel, hotels, lodging and on-demand transportation apps and websites would also benefit significantly from the RedZone Maps solution, joining the interests of individual users with their corporate interests.
About Helios and Matheson
Helios & Matheson Analytics, Inc. provides information technology consulting, training services, software products and enhanced suite of services of predictive analytics. With their client roster including Fortune 500 corporations, they focus mainly on the BFSI and Technology verticals. Their solutions cover the entire spectrum of IT needs, including applications, data, and infrastructure. The company is headquartered in New York, NY. Helios and Matheson Analytics, Inc. is listed on the NASDAQ (HMNY). For more information visit us at http://www.heliosmatheson.com.
About RedZone
RedZone (Zone Technologies, Inc.) is a state-of-the-art mapping and spatial analysis company with offices in the U.S. and Israel. Its eye-opening safety map app enhances mobile GPS navigation by providing advanced proprietary technology, to easily and safely guide travelers to their destinations while avoiding risky areas deemed “red zones,” due to high groupings of crime data, with safer routes generally 15% longer. More than that, the app incorporates a social media component allowing for real-time “It’s happening now” crime reporting coupled with up-to-the-minute data from over 1,400 local, state, national and global sources. Currently available to iOS users with an android version launching shortly, RedZone is available free in the App Store. More information is available on the RedZone website and the free app is available for download in the Apple App Store.
Important Information For Investors And Stockholders
This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This communication relates to a proposed business combination between HMNY and Zone Technologies, Inc. (“Zone”). In connection with the pending business combination between Zone and HMNY, HMNY has filed a definitive Information Statement on Schedule 14C with the Securities Exchange Commission (the “SEC”). INVESTORS AND SECURITY HOLDERS OF HMNY ARE URGED TO READ THE DEFINITIVE INFORMATION STATEMENT AND OTHER DOCUMENTS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN IMPORTANT INFORMATION. The definitive Information Statement has been mailed to stockholders of HMNY in accordance with Regulation 14C under the Securities Exchange Act of 1934, as amended. Investors and security holders may obtain free copies of these documents and other documents filed with the SEC by HMNY through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by HMNY will be available free of charge on HMNY’s website at www.hmny.com.
Cautionary Statement on Forward-looking Information
Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this communication are forward-looking statements.
Such forward-looking statements are based on a number of assumptions. Although HMNY’s management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning HMNY are described in its Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2015, and other filings, including current and periodic reports, filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on HMNY’s current expectations and HMNY does not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
Innoviva, Inc. (NASDAQ: INVA) today announced that Michael W. Aguiar, Innoviva’s President and Chief Executive Officer, will be presenting at two conferences in November 2016. The details are as follows:
CreditSuisse 25th Annual Healthcare Conference
Monday, November 7 from 4:30 to 5:00 p.m. (MST)
The Phoenician Hotel, Scottsdale, Arizona
Webcast Link (archived for 90 days): CreditSuisse Innoviva Presentation
Stifel 2016 Healthcare Conference
Wednesday, November 16 from 10:15 to 10:55 a.m. (EST)
Lotte New York Palace Hotel, New York
Webcast Link (archived for 90 days): Stifel Innoviva Presentation
About Innoviva
Innoviva is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva’s portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance BioPharma, Inc. For more information, please visit Innoviva’s website at www.inva.com.
ANORO®, RELVAR®, BREO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
Ophthotech Corporation (Nasdaq:OPHT) today announced that the Phase 2b study results of Fovista® (pegpleranib), the Company’s anti-PDGF agent administered in combination with Lucentis® (ranibizumab) anti-VEGF therapy for the treatment of wet age-related macular degeneration (AMD), have been published online in Ophthalmology®, the journal of the American Academy of Ophthalmology.
The article in Ophthalmology from this prospective, randomized, controlled Phase 2b clinical trial of 449 patients with wet AMD, indicates that Ophthotech’s Fovista® (1.5 mg), administered in combination with Lucentis®, met the pre-specified primary efficacy endpoint of mean change in visual acuity. Patients receiving the combination of Fovista® (1.5 mg) and Lucentis® (0.5 mg) gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis® monotherapy (p=0.019). This represents a 62% additional benefit from baseline. No significant safety issues were observed for either treatment group in the trial.
The published article, “Dual Antagonism of PDGF and VEGF in Neovascular Age-related Macular Degeneration,” can be accessed under “Articles in Press” at: http://www.aaojournal.org/inpress.
“We are honored to have the findings of the Phase 2b Fovista® combination therapy study in wet AMD patients published in Ophthalmology, the journal of the American Academy of Ophthalmology, a highly-respected peer-review publication,” said Samir Patel, M.D., President and Vice-Chairman of the Board of Ophthotech. “The strength of results of this large trial represent the basis for our Fovista® in combination with anti-VEGF therapy Phase 3 registration program for the treatment of wet AMD.”
“We would like to thank all the participating physicians, patients and their staff for their splendid effort in this well conducted trial. We look forward to topline data from the two Phase 3 clinical trials of Fovista® in combination with Lucentis® in the fourth quarter of this year,” said David R. Guyer, M.D., Chief Executive Officer and Chairman of the Board of Ophthotech.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat back of the eye diseases, with a focus on developing innovative therapies for age-related macular degeneration (AMD). Ophthotech’s most advanced product candidate, Fovista® anti-PDGF therapy, is in Phase 3 clinical trials for use in combination with anti-VEGF therapy that represents the current standard of care for the treatment of wet AMD. Ophthotech’s second product candidate, Zimura®, an inhibitor of complement factor C5, is being developed for the treatment of geographic atrophy, a form of dry AMD, and in combination with anti-VEGF therapy in wet AMD patients. For more information, please visit www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotech’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about Ophthotech’s strategy, future operations and future expectations and plans and prospects for Ophthotech, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, Ophthotech’s forward looking statements include statements about the timing and progress of the Fovista® Phase 3 clinical program. Such forward-looking statements involve substantial risks and uncertainties that could cause Ophthotech’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory approvals or other actions and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that Ophthotech files with the Securities and Exchange Commission. Any forward-looking statements represent Ophthotech’s views only as of the date of this press release. Ophthotech anticipates that subsequent events and developments will cause its views to change. While Ophthotech may elect to update these forward-looking statements at some point in the future, Ophthotech specifically disclaims any obligation to do so except as required by law.
OPHT-G
CORAL GABLES, Fla., Oct. 31, 2016 — Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach to be taken in Catalyst’s upcoming Phase 3 study evaluating Firdapse® (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS).
A SPA is a process by which sponsors ask the FDA to evaluate the protocol of a proposed clinical trial to determine whether it adequately addresses scientific and regulatory requirements for the purpose identified by the sponsor. A SPA agreement indicates concurrence with the adequacy and acceptability of specific critical elements of protocol design, endpoints and analysis. Additionally, it provides a binding agreement with FDA’s review division that a pivotal trial design, conduct, and planned analysis adequately addresses the scientific and regulatory objectives in support of a regulatory submission for drug approval. However, final marketing approval depends upon the results of efficacy, the safety profile, and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical trial, among other requirements. For further information regarding the SPA process, please visit the FDA website at www.fda.gov.
“Receipt of this SPA agreement is a major milestone which provides us with a clearly defined development and regulatory pathway for Firdapse in the treatment of LEMS,” said Patrick J. McEnany, Catalyst’s Chief Executive Officer. “We would like to thank the FDA for its engagement and guidance in this process.”
Catalyst intends to conduct its second Phase 3 trial (designated as LMS-003) at two clinical trial sites, one on the east coast of the United States and one on the west coast of the United States. This double-blind, placebo controlled withdrawal trial will include approximately 28 subjects, so that the trial is adequately powered, and will have the same co-primary endpoints as Catalyst’s first Phase 3 trial evaluating Firdapse for the treatment of LEMS. Further, the FDA has agreed to allow Catalyst to enroll patients from its expanded access program as study subjects in this second trial. Finally, after further discussion with the FDA in connection with the SPA request, this second trial will be a parallel design and not a cross-over design.
Final details of the Phase 3 clinical trial will be available at the launch of the study on www.clinicaltrials.gov. As previously reported, Catalyst expects to initiate this trial before the end of this year.
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette’s Disorder. Firdapse for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS, CMS and Myasthenia Gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette’s Disorder. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, the timing of Catalyst’s second clinical trial evaluating Firdapse for the treatment of LEMS and whether the trial will be successful, whether Catalyst’s assumptions in its updated business plan will be accurate and the impact of unanticipated events or delays in projected activities on Catalyst’s cash requirements and on Catalyst’s ability to get to an accepted NDA submission for Firdapse without the need for additional funding, what clinical trials and studies will be required before Catalyst can resubmit an NDA for Firdapse for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether the investigator-sponsored study evaluating Firdapse for the treatment of MuSK-MG will be successful, whether any NDA for Firdapse resubmitted to the FDA will ever be accepted for filing, the timing of any such NDA filing or acceptance, whether, if an NDA for Firdapse is accepted for filing, such NDA will be given a priority review by the FDA, whether Firdapse will ever be approved for commercialization, whether Catalyst will be the first company to receive approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether CPP-115 will be determined to be safe for humans, what additional testing will be required before CPP-115 is “Phase 2 ready”, whether CPP-115 will be determined to be effective for the treatment of infantile spasms, post-traumatic stress disorder, Tourette’s Disorder or any other indications, whether Catalyst can successfully design and complete a bioequivalence study of its version of vigabatrin compared to Sabril that is acceptable to the FDA, whether any such bioequivalence study the design of which is acceptable to the FDA will be successful, whether any ANDA that Catalyst submits for a generic version of Sabril will be accepted for filing, whether any ANDA for Sabril accepted for filing by the FDA will be approved (and the timing of any such approval), whether any of Catalyst’s product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2015 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Investor Contact
Brian Korb
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com
Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 420-3200
pmcenany@catalystpharma.com
Media Contacts
David Schull
Matt Middleman, M.D.
Russo Partners
(212) 845-4271
(212) 845-4272
david.schull@russopartnersllc.com
matt.middleman@russopartnersllc.com
- Total cash consideration for sale of Latin American business (which is 30% of current Oculus revenue) exceeds Oculus’ current market capitalization of $17 million U.S.
- Transaction further includes a 10-year annual payment of 3% on Latin American sales (excluding Mexico) with a minimum of $250,000 year
- Business Update Conference call to be held Tuesday, November 1, 2016 at 9:00 am EDT
PETALUMA, Calif., Oct. 31, 2016 — Oculus Innovative Sciences, Inc. (NASDAQ: OCLS, warrants OCLSW), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced the sale of the company’s Latin American-related assets to Invekra S.A.P.I. de C.V. of Mexico for $19.5 million in cash. Additionally, Invekra will pay Oculus a three percent payment on all Latin American revenues outside of Mexico, with a minimum payment of $250,000 per year for the next ten years, to be paid quarterly in Mexican pesos.
According to the agreement, Oculus will sell all its Latin American assets related to the Microdacyn®-based products sold into Latin America and the Caribbean (except for dermatology products in Brazil). In exchange, Invekra will pay Oculus $19.5 million, with $18 million already paid as of October 28, 2016, and $1.5 million to be placed in escrow until certain equipment is delivered to Invekra, which is expected in February 2017. As part of the agreement, Oculus will maintain its current manufacturing facility in Guadalajara, Mexico for production of its Oculus-branded Microdacyn-based products for all countries outside of the United States and Latin America. Meanwhile, Oculus will provide assistance and equipment in the establishment of Invekra’s own Microdacyn manufacturing facility in Mexico City’s metropolitan area.
Jim Schutz, CEO of Oculus, said, “We genuinely see this as a strategic opportunity to focus on our growing dermatological business. From Invekra’s perspective, they are acquiring guaranteed exclusivity in the Latin American market for our Microdacyn family of products, thus controlling their own destiny and reaping the full rewards from their marketing spend. From Oculus’ perspective, we are selling a slower growing, lower-margin segment of our business in exchange for a significant influx of immediate cash, allowing us to further advance our higher-margin, fast growing U.S. dermatology business. In addition, the proceeds from this deal provide us with more than sufficient capital for us to reach commercial breakeven and achieve operating profitability.”
Business Update Conference Call
Oculus’ management will hold a business update conference call on Tuesday, November 1, 2016 beginning at 9:00 am. EDT to discuss the Invekra agreement. Individuals interested in participating in the conference call may do so by dialing (877) 303-7607 for domestic callers or (973) 638-3203 for international callers.
Those interested in listening to the conference call live via the Internet may do so at http://ir.oculusis.com/events.cfm. Please log on approximately 30 minutes prior to the presentation in order to register and download the appropriate software.
A telephone replay will be available for seven days following the conclusion of the call by dialing (855) 859-2056 for domestic callers, or (404) 537-3406 for international callers, and entering conference code 96131841. A webcast replay will be available on the site at http://ir.oculusis.com/events.cfm for one year following the call.
About Invekra
Invekra S.A.P.I. de C.V. is the holding company of Laboratorios Sanfer, one of Mexico’s leading private market pharmaceutical companies, with sales throughout Latin America and the Caribbean. With over 75 years of experience in the pharmaceutical industry and over 1,000 sales people in Mexico, and 200-plus in other Latin American countries, Invekra’s business model is primarily focused on the development, manufacture and commercialization of patented and off-patent branded specialty pharmaceuticals products. The company’s product portfolio in Mexico consists of 185 brands and 371 SKUs spanning multiple therapeutic areas of human and animal health, such as metabolic, cardiovascular, respiratory, oncology and antibiotics. More information is available at www.sanfer.com.mx.
About Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.oculusis.com.
Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “will pay,” “expected” and “delivered,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s common stock and warrants may be delisted from NASDAQ, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, the Company may not be able to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its annual report on Form 10-K for the fiscal year ended March 31, 2016. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Oculus®, Microdacyn® and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
Media and Investor Contact:
Oculus Innovative Sciences, Inc.
Dan McFadden
VP of Public and Investor Relations
(425) 753-2105
– Increase in CD4+ polyfunctional T cells indicates GEN-003 is stimulating a multi-faceted T cell immune response to genital herpes –
– GEN-003 elicited strong antibody responses at 12 months post-dosing –
CAMBRIDGE, Mass., Oct. 28, 2016 — Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies, today presented new 12 month immunogenicity data from the Phase 2a trial of its genital herpes immunotherapy GEN-003. This analysis shows that GEN-003 immunization results in the development of CD4+ polyfunctional T cells, which indicates that GEN-003 is stimulating a multi-faceted T cell immune response to genital herpes. The presentation also details the strong, antigen-specific antibody responses elicited by GEN-003 for up to 12 months post-dosing, consistent with its sustained effect on viral shedding and clinical disease at the same time point. Data were presented at the Infectious Disease Society of America (IDSA) annual meeting in New Orleans, Louisiana.
“These data provide strong evidence of clear and robust T and B cell immune responses that support the positive 12 month clinical results from the Phase 2a trial, which show that GEN-003 has a significant and durable effect on genital herpes viral shedding and clinical disease for at least 12 months after dosing,” said Jessica Baker Flechtner, Ph.D., chief scientific officer at Genocea. “We are particularly excited about the data showing the development of polyfunctional T cells, which are considered to deliver a more effective immune response than those T cells which secrete only one mediator. This immunological data once again demonstrates that GEN-003 can have a true biological effect against genital herpes and supports our confidence in its potential to become a cornerstone treatment for this serious disease.”
Twelve-month clinical data previously reported from this Phase 2a trial found that, for the 60 μg per protein / 50 μg of adjuvant dose, which has been selected as the best dose for Phase 3 trials, viral shedding was reduced by 66 percent vs. baseline (p<0.0001). Significant clinical efficacy was also demonstrated at this dose with a 65 percent reduction in the genital lesion rate vs. baseline (p=0.003) and 30 percent of patients remaining lesion free for 12 months post dosing. These data show that a single course of injections with GEN-003 can result in similar outcomes to taking a year of daily oral antiviral therapy.
This new analysis found that GEN-003 induced polyfunctional T cells post-immunization that peaked at day 8 and persisted through at least day 50. This data could have important implications for the understanding of how the immune system controls genital herpes infections given that polyfunctional T cells have been linked to the control of HIV and other persistent viral infections. Furthermore, mean IgG titers increased up to 21-fold to ICP4.2 and 8-fold to gD2DTMR and persisted 7- and 3-fold above baseline, respectively, at one year. Mean neutralizing antibody titers increased more than 5-fold and remained more than 2-fold over baseline at one year. These increases in antigen-specific immune response was accompanied by reductions in both viral shedding and genital lesion rates. (Poster #1343, Functional Antibody Responses to GEN-003, a Herpes Simplex Virus Immunotherapy that Durably Reduces Viral Shedding up to 12 Months Post Dosing, Friday, October 28, 2016 between 12:30pm and 2:00pm ET).
About the GEN-003 Phase 2a Clinical Trial
This Phase 2a study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, twelve months following dosing. No booster doses were given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over across the 6 active combinations of GEN-003 and Matrix-M2 under a separate protocol.
For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
About GEN-003
We believe that inducing a T cell response against genital herpes is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licensed from Novavax, Inc. For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.
About Genital Herpes
Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.
About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus (development suspended; actively seeking partnership opportunities to conduct a Phase 2 infant and toddler study), and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.
Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising oncology vaccine and immunotherapy product candidates; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.
For media:
Liz Bryan
Spectrum Science Communications
O: 202-587-2526
lbryan@spectrumscience.com
For investors:
Jonathan Poole
Genocea Biosciences
O: 617-876-8191
jonathan.poole@genocea.com
PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Oct. 28, 2016 — Ocera Therapeutics, Inc. (NASDAQ:OCRX), today announced that Willard Dere, M.D., Professor of Internal Medicine at the University of Utah Health Sciences Center and former Senior Vice President in Research and Development at Amgen, has been appointed to the Company’s Board of Directors.
“We are delighted to welcome Will to our Board of Directors,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “His 25 years of seasoned industry expertise in drug development and regulatory matters, as well as his deep understanding of patient care, will bring important perspective to Ocera at a pivotal time.”
“We are thrilled to have Will join the Ocera Board,” said Eckard Weber, M.D., Chairman. “With the depth of his experience in clinical development, I am confident he will add significantly to Ocera’s future success.”
“I am honored to join the board of a company pursuing novel therapeutics for liver diseases and excited to help Ocera pursue its goals,” said Dr. Dere. “I look forward to working with such an esteemed team.”
Dr. Dere will be joining Chairman, Eckard Weber, M.D., Partner, Domain Associates; President and Chief Executive Officer of Ocera, Linda Grais, M.D., Lead Independent Director, Steven James, former President and Chief Executive Officer, Labrys Biologics, Inc.; Nina Kjellson, General Partner, Canaan Partners; Michael Powell, Ph.D., General Partner, Sofinnova Ventures, Anne M. VanLent, President of AMV Advisors; and Wendell Wierenga, Ph.D., former Executive Vice President, Research and Development at Santarus, Inc.
About Willard Dere, M.D.
Dr. Dere serves as the Professor of Internal Medicine; B. Lue and Hope S. Bettilyon Presidential Endowed Chair in Internal Medicine for Diabetes Research, Executive Director of Personalized Health, and Co-Principal Investigator of the Center for Clinical and Translational Science at the University of Utah Health Sciences Center. Prior to re-joining academia in November 2014, Dr. Dere was in the biopharmaceutical industry for 25 years. He joined Amgen in 2003 where he held multiple roles including head of global development, international research and development, and both corporate and international chief medical officer. He led the development program for Prolia and several other programs, and retired from Amgen in October 2014. He began his career at Eli Lilly in 1989, and held a number of different global roles in clinical pharmacology, regulatory affairs, and both early-stage translational, and late-stage clinical research. While at Eli Lilly, he led the development of Evista and Forteo. Since 2014, he has been a member of the Board of Directors of Radius Health and serves on the scientific advisory board of the California Institute of Regenerative Medicine. In addition, he joined the Board of Directors of BioMarin in July 2016.
Dr. Dere attended undergraduate and medical school at the University of California, Davis. He trained in internal medicine at the University of Utah and endocrinology/ metabolism at the University of California at San Francisco, and was on the Internal Medicine faculty at the University of Utah for 4 years during which time he was recognized annually with teaching awards. He has published numerous articles; wrote and co-edited a primary care textbook; was awarded the 2008 transformational leadership award from his alma mater; and is a fellow in the American College of Physicians.
About Ocera
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure and acute-on-chronic liver disease.
Forward-Looking Statements
This press release contains “forward-looking” statements, including, without limitation, all statements related to the addition of a new company director. 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 “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.
OCRX-G
Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109
Updated 2016 Guidance
HOUSTON, TX–(Oct 28, 2016) – Nobilis Health Corp. (NYSE MKT: HLTH) (TSX: NHC) (“Nobilis” or the “Company”) today announced that it has entered into a new $82.5 million five-year credit facility with BBVA Compass Bank consisting of a $52.5 million term loan and a $30.0 million revolving credit facility. The new facility is led by Compass Bank as administrative agent with BBVA Compass as sole lead arranger and book runner, and Legacy Texas Bank as documentation agent. Four other banks participated in the facility. Legacy Texas Bank, who participated in the previous credit facility at $10.0 million, increased their participation in the new credit facility to $21.0 million.
Proceeds from the credit facility will be used to refinance all previously held debt and lines of credit currently under Healthcare Financial Solutions, LLC (formerly known as GE Capital Corporation) and fund the previously announced acquisition of Arizona Vein and Vascular Center (“AVVC”) and its affiliated surgery centers. The new facility bears interest at a rate of 3.00% to 3.75%, plus LIBOR, based on the Company’s consolidated leverage ratio, versus 4.00% plus LIBOR under the previous facility.
“The expansion of our borrowing capacity and refinancing of existing debt enhances our ability to continue to implement our long-term growth strategy, lowers our overall borrowing costs and further increases our liquidity position,” said Harry Fleming, Chief Executive Officer of Nobilis. “The support of our new bank syndicate led by BBVA Compass enables us to utilize this new source of credit to continue our ongoing execution of fundamental organic growth, while funding acquisitions in new and existing markets.”
Additional details regarding the Company’s credit facility agreement will be included in a Current Report on Form 8-K that will be filed with the Securities and Exchange Commission.
Nobilis is also pleased to announce that it has closed its previously announced acquisition of AVVC and its four affiliated surgery centers operating as “The Arizona Center for Minimally Invasive Surgery” (“ACMIS”). The purchase price for the acquisition was $22.0 million, comprised of $17.5 million of cash, $2.25 million in the form of a convertible note (payable in three years in cash or stock, at the then current stock price, at the option of the Company) and $2.25 million of restricted stock, plus a performance-based earn-out based on growth in EBITDA1. AVVC’s 2015 audited financial statements disclosed $20.0 million in revenue, $7.9 million in EBITDA1 and $7.1 million in net income.
The acquisition expands Nobilis’ presence in two high-growth geographic markets, Phoenix and Tucson, and increases its multi-specialty offering with a new vascular surgical division. Dr. L. Philipp Wall, an award-winning, board-certified vascular surgeon, and founder of AVVC and ACMIS, will join Nobilis as President of the newly created Nobilis Vascular Division.
“We are pleased with the successful completion of this acquisition and are looking forward to further expanding our new Clarity brand to Houston and Dallas, while driving additional volume to the AVVC facilities,” said Harry Fleming, Chief Executive Officer of Nobilis.
Nobilis’ new vascular division offers specialized procedures to treat a variety of vein conditions. Nobilis will market vein and vascular procedures under the existing, highly-respected AVVC brand within the Arizona market, and under a new brand, Clarity, which has already commenced in the Houston and Dallas markets.
“The addition of 5 clinical locations and 4 surgical facilities in the Arizona market will enhance our existing marketing efforts, increase conversion rates and lower the acquisition costs of current Direct to Consumer Marketing brands while allowing a broader sales offering to area physicians,” said Kenneth Efird, President of Nobilis.
Updated Full Year 2016 Guidance
The Company raised its full year 2016 guidance for total revenues and adjusted EBITDA1 to reflect the closing of the acquisition of AVVC and ACMIS. Full year 2016 total revenues are now expected to be $281 million, up from $275 million. Full year Adjusted EBITDA1 is now expected to be $53 million, up from $51 million.
About Nobilis Health Corp.
Nobilis (www.NobilisHealth.com) is a full-service healthcare development and management company which currently owns or manages fourteen surgical facilities and six clinics, partners with thirty-six additional facilities throughout the country, and markets seven independent brands. Deploying a unique patient acquisition strategy driven by direct-to-consumer marketing, Nobilis is focused on a specified set of procedures that are performed at our centers by local physicians.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of Canadian and United States securities laws, including the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and may be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan” or “continue.” These forward-looking statements are based on current plans and expectations and are subject to a number of risks, uncertainties and other factors which could significantly affect current plans and expectations and our future financial condition and results. These factors, which could cause actual results, performance and achievements to differ materially from those anticipated, include, but are not limited to our ability to successfully maintain effective internal controls over financial reporting; our ability to implement our business strategy, manage the growth in our business, and integrate acquired businesses; the risk of litigation and investigations, and liability claims for damages and other expenses not covered by insurance; the risk that payments from third-party payers, including government healthcare programs, may decrease or not increase as costs increase; adverse developments affecting the medical practices of our physician limited partners; our ability to maintain favorable relations with our physician limited partners; our ability to grow revenues by increasing case and procedure volume while maintaining profitability at the Nobilis Facilities; failure to timely or accurately bill for services; our ability to compete for physician partners, patients and strategic relationships; the risk of changes in patient volume and patient mix; the risk that laws and regulations that regulate payments for medical services made by government healthcare programs could cause our revenues to decrease; the risk that contracts are cancelled or not renewed or that we are not able to enter into additional contracts under terms that are acceptable to us; and the risk of potential decreases in our reimbursement rates. The foregoing are significant factors we think could cause our actual results to differ materially from expected results. However, there could be additional factors besides those listed herein that also could affect us in an adverse manner.
We have not undertaken any obligation to publicly update or revise any forward-looking statements. All of our forward-looking statements speak only as of the date of the document in which they are made or, if a date is specified, as of such date. Subject to a mandatory requirements of applicable law, we disclaim any obligation or undertaking to provide any updates or revisions to any forward-looking statement to reflect any change in our expectations or any changes in events, conditions, circumstances or information on which the forward-looking statement is based. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing factors and in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed on March 15, 2016, as updated by other filings with the Securities and Exchange Commission.
1Use of Non-GAAP Financial Measures
EBITDA and Adjusted EBITDA (“Adjusted EBITDA”) are defined as earnings before interest, income taxes, depreciation and amortization, non-cash compensation expenses, change in fair value of warrant and stock option derivative liabilities, acquisition expenses and non-recurring expenses. Adjusted EBITDA should not be considered a measure of financial performance required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). Items excluded from Adjusted EBITDA are significant components in understanding and assessing financial performance. Adjusted EBITDA is an analytical indicator used by management and the health care industry to evaluate company performance, allocate resources and measure leverage and debt service capacity. Adjusted EBITDA should not be considered in isolation or as an alternative to net income, cash flows generated by operations, investing or financing activities, or other financial statement data presented in the consolidated financial statements as indicators of financial performance or liquidity. Because Adjusted EBITDA is not a measurement determined in accordance with U.S. GAAP and is thus susceptible to varying calculations, Adjusted EBITDA as presented may not be comparable to other similarly titled measures of other companies. Net income attributable to Nobilis Health Corp. common shareholders is the financial measure calculated and presented in accordance with U.S. GAAP that is most comparable to Adjusted EBITDA as defined.
CHANTILLY, Va., Oct. 28, 2016 — Intersections Inc. (Nasdaq: INTX) (“Intersections, Inc. or the “Company”) announced today that its Board of Directors has received a non-binding proposal from Loeb Holding Corporation (“LHC”), the Company’s largest stockholder, to acquire the Company’s Pet Health Monitoring Segment. LHC’s proposal is set forth in an amendment to its Schedule 13D filed today with the SEC.
The process of evaluating the proposal and negotiation of any transaction will be overseen by a Special Committee of three independent directors: Thomas G. Amato, Steve Bartlett and John H. Lewis. The Special Committee has selected Baker Botts LLP to serve as its independent legal advisor and expects to retain an independent financial advisor to assist the Special Committee in evaluating the proposal.
The Board of Directors cautions the Company’s stockholders and others considering trading in its securities that the Board of Directors and the Special Committee have just received the proposal and no decisions have been made by the Board of Directors or the Special Committee with respect to the Company’s response to the proposal. There can be no assurance that any definitive offer will be made or accepted, that any agreement will be executed or that any transaction will be completed. The Company does not intend to comment further regarding the evaluation of LHC’s proposal, unless and until definitive agreements for a transaction are entered into or the Special Committee determines to conclude the process, or as otherwise required by law.
About Intersections Inc.
Intersections Inc. (Nasdaq: INTX) provides innovative, information-based solutions that help consumers manage risks and make better-informed life decisions. Under its IDENTITY GUARD® brand and other brands, the company helps consumers monitor, manage and protect against the risks associated with their identities and personal information. The company’s subsidiary Habits at Work provides insurance and other services that help consumers manage risks and achieve personal goals. The company’s i4C Innovations subsidiary provides VOYCE™, a groundbreaking pet wellness monitoring system for pet owners and veterinarians. Headquartered in Chantilly, Virginia, the company was founded in 1996. To learn more, visit www.intersections.com.
Forward-Looking Statements:
Statements in this release relating to future plans, results, performance, expectations, achievements and the like are considered “forward-looking statements.” You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “should,” “can have,” “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Those forward-looking statements involve known and unknown risks and uncertainties and are subject to change based on various factors and uncertainties that may cause actual results to differ materially from those expressed or implied by those statements, including the timing and success of new product launches, including our Identity Guard®, Voyce® and Voyce Pro™ platforms, and other growth initiatives; the continuing impact of the regulatory environment on our business; the continued dependence on a small number of financial institutions for a majority of our revenue and to service our U.S. financial institution customer base; our ability to execute our strategy and previously announced transformation plan; our incurring additional restructuring charges; our incurring impairment charges on goodwill and/or assets, including assets related to our Voyce® products; our ability to control costs; and our needs for additional capital to grow our business, including our ability to maintain compliance with the covenants under our new term loan or seek additional sources of debt and/or equity financing. Factors and uncertainties that may cause actual results to differ include but are not limited to the risks disclosed under “Forward-Looking Statements,” “Item 1. Business—Government Regulation” and “Item 1A. Risk Factors” in the Company’s most recent Annual Report on Form 10-K, and in its other filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to revise or update any forward-looking statements unless required by applicable law.
Number 2 Agent Team in Arkansas Joins the Agent-Owned Cloud Brokerage
BELLINGHAM, WA–( October 28, 2016) – eXpWorld Holdings, Inc. (OTCQB: EXPI) announced today that Eric Burch, principal of the independent brokerage Burch & Co. Real Estate has transitioned his team of 17 agents and brokers over to eXp Realty, the Agent-Owned Cloud Brokerage®. The announcement marks the second time this week and third in the last two weeks that eXp Realty has added one of the leading real estate teams in the United States.
“Burch & Co. is our heart, our baby,” said Burch whose team closed 325 transactions in 2015 and was ranked number 1 in Northeast Arkansas and number 2 statewide. “We wouldn’t be making the transition if we didn’t firmly believe that eXp represents the very best option for us as a team and as individual real estate professionals. With eXp, we can provide better service to our clients and, importantly, the opportunity for true ownership to our agents.”
Burch will be introduced to the nationwide eXp Realty community members during the Company’s weekly leadership meeting this morning at 11am ET/8am PT which can be viewed on the Company’s Youtube channel: youtube.com/exprealty.
“eXp provides top teams and brokerage owners with the opportunity to expand into new markets without additional capital requirements and an agent experience for their members that is collaborative, interpersonal and enriching,” said eXp Realty President, Vikki Bartholomae. “We welcome Eric and his team to Agent Ownership and look forward to extending that same opportunity to other entrepreneurial brokerage owners, agents, and teams of agents in all markets.”
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
— Multinational Trials to Evaluate ALXN1210 Administered Every Eight Weeks in Patients with PNH and aHUS; Enrollment to Begin in Q4 –
— ALXN1210 Subcutaneous Clinical Program Commenced with Dosing Underway in Healthy Volunteers in Phase I Study —
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the initiation of two Phase 3 trials of ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement. The first trial is a Phase 3 open-label, multinational, active-controlled study of ALXN1210 compared to eculizumab (Soliris®) in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). Alexion has also accelerated the initiation of a registration trial of ALXN1210 in patients with atypical hemolytic uremic syndrome (aHUS). This second trial is a Phase 3, open-label, single arm, multinational trial to evaluate the safety and efficacy of ALXN1210 in complement inhibitor treatment-naïve adolescent and adult patients with aHUS. Both studies will evaluate ALXN1210 administered intravenously every eight weeks. Alexion expects to begin enrolling patients into these trials later this year, and plans to initiate a Phase 3 trial of ALXN1210 in pediatric patients with aHUS in 2017.
Alexion has also commenced dosing of a new formulation of ALXN1210 administered subcutaneously in healthy volunteers in a Phase I study.
PNH is a debilitating, ultra-rare and life-threatening blood disorder characterized by complement-mediated hemolysis (destruction of red blood cells).1 aHUS is a genetic, chronic, ultra-rare disease associated with vital organ failure and premature death.2,3,4 Both PNH and aHUS are caused by chronic uncontrolled complement activation.
“With more than 20 years of expertise in the discovery and development of complement inhibitors, our ongoing commitment is to bring even higher levels of innovation to patients with devastating ultra-rare diseases,” said Martin Mackay, Ph.D., Executive Vice President and Global Head of R&D at Alexion. “We are very pleased with our agreement with global regulators to progress ALXN1210 into Phase 3 studies in patients with PNH and aHUS and are now working with investigators to enroll patients into the registration studies with urgency.”
About the ALXN1210 PNH Study
The PNH trial is a Phase 3, randomized, open-label, active-controlled, multicenter 26-week study to evaluate the safety and efficacy of ALXN1210 compared to eculizumab in complement inhibitor treatment-naïve patients with PNH. The co-primary endpoints are the normalization of lactate dehydrogenase (LDH) levels and the percentage of patients who achieve transfusion avoidance (TA). Secondary endpoints include percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and percentage of patients with stabilized hemoglobin. The study is designed to evaluate the non-inferiority of ALXN1210 compared to eculizumab.
Patients in the ALXN1210 arm will receive a single loading dose of ALXN1210, followed by regular maintenance dosing every 8 weeks based on 3 weight cohorts. Patients in the eculizumab arm will receive 4 weekly induction doses, followed by regular maintenance dosing every 2 weeks. The multinational study will enroll approximately 214 adults (≥ 18 years of age) with a diagnosis of PNH who have never been treated with a complement inhibitor.
About the ALXN1210 aHUS Study
The aHUS trial is a Phase 3, open-label, single arm, multicenter 26-week study to evaluate the safety and efficacy of ALXN1210 in complement inhibitor treatment-naïve adolescent and adult patients with aHUS. The primary endpoint is complete thrombotic microangiopathy (TMA) response at 26 weeks. Secondary endpoints include dialysis requirement status, complete TMA response over time, observed value and change from baseline in estimated glomerular filtration rate, and change from baseline in chronic kidney disease stage, all evaluated at 26 weeks; time to complete TMA response; and additional efficacy measures. Patients will receive a single loading dose of ALXN1210, followed by regular maintenance dosing every 8 weeks based on 3 weight cohorts.
The multinational study will enroll approximately 55 adolescent (12 to < 18 years of age) and adult (≥ 18 years of age) patients with aHUS who have never been treated with a complement inhibitor.
About Paroxysmal Nocturnal Hemoglobinuria (PNH)
PNH is an ultra-rare blood disorder in which chronic, uncontrolled activation of complement, a component of the normal immune system, results in hemolysis (destruction of the patient’s red blood cells). PNH strikes people of all ages, with an average age of onset in the early 30s.1 Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger.5 PNH develops without warning and can occur in men and women of all races, backgrounds and ages. PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years.6 In the period of time before Soliris® (eculizumab) was available, it had been estimated that approximately one-third of patients with PNH did not survive more than five years from the time of diagnosis.7 PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS).8,9,10 In patients with thrombosis of unknown origin, PNH may be an underlying cause.11
About aHUS
aHUS is a chronic, ultra-rare, and life-threatening disease in which a life-long and permanent genetic deficiency in one or more complement regulatory genes causes chronic uncontrolled complement activation, resulting in complement-mediated thrombotic microangiopathy (TMA), the formation of blood clots in small blood vessels throughout the body.2,3 Permanent, uncontrolled complement activation in aHUS causes a life-long risk for TMA, which leads to sudden, catastrophic, and life-threatening damage to the kidney, brain, heart, and other vital organs, and premature death.2,4 Prior to the availability of Soliris, seventy-nine percent of all patients with aHUS died, required kidney dialysis or had permanent kidney damage within three years after diagnosis despite plasma exchange or plasma infusion (PE/PI).12 Moreover, 33 to 40 percent of patients died or progressed to end-stage renal disease with the first clinical manifestation of aHUS despite PE/PI.12,13 Prior to the availability of Soliris, the majority of patients with aHUS who received a kidney transplant commonly experienced subsequent systemic TMA, resulting in a 90 percent transplant failure rate in these TMA patients.14
aHUS affects both children and adults. Complement-mediated TMA also causes reduction in platelet count (thrombocytopenia) and red blood cell destruction (hemolysis). While mutations have been identified in at least ten different complement regulatory genes, mutations are not identified in 30-50 percent of patients with a confirmed diagnosis of aHUS.12,14,15
About ALXN1210
ALXN1210 is a highly innovative, longer-acting anti-C5 antibody discovered and developed by Alexion that inhibits terminal complement. In early studies, ALXN1210 demonstrated rapid, complete, and sustained reduction of free C5 activity.16 Alexion has completed enrollment in two ongoing clinical studies of ALXN1210 in patients with PNH—a Phase 1/2 dose-escalating study and an open-label, multi-dose Phase 2 study that is also evaluating longer dosing intervals beyond 8 weeks.
ALXN1210 is currently in Phase 3 trials in patients with PNH and aHUS. In addition, Alexion is conducting a Phase 1 study to evaluate a new formulation of ALXN1210 administered subcutaneously in healthy volunteers.
In June 2016, the European Commission granted Orphan Drug Designation (ODD) to ALXN1210 for the treatment of patients with PNH.
About Soliris® (eculizumab)
Soliris is a first-in-class terminal complement inhibitor developed from the laboratory through regulatory approval and commercialization by Alexion. Soliris is approved in the U.S. (2007), European Union (2007), Japan (2010) and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. PNH is a debilitating, ultra-rare and life-threatening blood disorder, characterized by complement-mediated hemolysis (destruction of red blood cells). Soliris is also approved in the U.S. (2011), European Union (2011), Japan (2013) and other countries as the first and only treatment for patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, or TMA (blood clots in small vessels). aHUS is a debilitating, ultra-rare and life-threatening genetic disorder characterized by complement-mediated TMA. Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). For the breakthrough medical innovation in complement inhibition, Alexion and Soliris have received some of the pharmaceutical industry’s highest honors: the Prix Galien USA (2008, Best Biotechnology Product) and France (2009, Rare Disease Treatment).
More information, including the full U.S. prescribing information, on Soliris is available at www.soliris.net.
Important Safety Information
The U.S. product label for Soliris includes a boxed warning: “Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early [see Warnings and Precautions (5.1)]. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Immunize patients with a meningococcal vaccine at least two weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. [See Warnings and Precautions (5.1) for additional guidance on the management of the risk of meningococcal infection]. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program [see Warnings and Precautions (5.2)]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747).”
In patients with PNH, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, nasopharyngitis (runny nose), back pain and nausea. Soliris treatment of patients with PNH should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. In patients with aHUS, the most frequently reported adverse events observed with Soliris treatment in clinical studies were headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia. Soliris is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Please see full prescribing information for Soliris, including BOXED WARNING regarding risk of serious meningococcal infection.
About Alexion
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. In addition, Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing the most robust rare disease pipeline in the biotech industry with highly innovative product candidates in multiple therapeutic areas. This press release and further information about Alexion can be found at: www.alexion.com.
[ALXN-G]
Forward-Looking Statement
This press release contains forward-looking statements, including statements related to Alexion’s development plans for ALXN1210, the medical benefits of ALXN1210 for the treatment of PNH and aHUS, medical and commercial potential of ALXN1210, and plans for regulatory filings for ALXN1210. Forward-looking statements are subject to factors that may cause Alexion’s results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of our products, delays, interruptions or failures in the manufacture and supply of our products and our product candidates, progress in establishing and developing commercial infrastructure, failure to satisfactorily address matters raised by the FDA and other regulatory agencies, the possibility that results of clinical trials are not predictive of safety and efficacy results of our products in broader patient populations in the disease studied or other diseases, the risk that strategic transactions will not result in short-term or long-term benefits, the possibility that current results of commercialization are not predictive of future rates of adoption of Soliris in PNH, aHUS or other diseases, the possibility that clinical trials of our product candidates could be delayed or that additional research and testing is required by regulatory agencies, including for ALXN1210, the adequacy of our pharmacovigilance and drug safety reporting processes, the risk that third party payors (including governmental agencies) will not reimburse or continue to reimburse for the use of our products at acceptable rates or at all, risks regarding government investigations, including investigations of Alexion by the SEC and DOJ, the risk that anticipated regulatory filings are delayed, including for ALXN1210, the risk that estimates regarding the number of patients with PNH, aHUS, HPP and LAL-D are inaccurate, the risks of shifting foreign exchange rates, and a variety of other risks set forth from time to time in Alexion’s filings with the U.S. Securities and Exchange Commission, including but not limited to the risks discussed in Alexion’s Quarterly Report on Form 10-Q for the period ended June 30, 2016 and in our other filings with the U.S. Securities and Exchange Commission. Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.
References |
|
|
|
|
|
1. |
|
Socié G, Mary JY, de Gramont A, et al. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Lancet. 1996: 348:573-577. |
|
2. |
|
Benz K, Amann K. Thrombotic microangiopathy: new insights. Curr Opin Nephrol Hypertens. 2010;19(3):242-7. |
|
3. |
|
Ariceta G, Besbas N, Johnson S, et al. Guideline for the investigation and initial therapy of diarrhea-negative hemolytic uremic syndrome. Pediatr Nephrol. 2009;24:687-96. |
|
4. |
|
Tsai HM. The molecular biology of thrombotic microangiopathy. Kidney Int. 2006;70(1):16-23. |
|
5. |
|
Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106(12):3699-3709. |
|
6. |
|
Dacie JV, Lewis SM. Paroxysmal nocturnal haemoglobinuria: clinical manifestations, haematology, and nature of the disease. Ser Haemat. 1972;5:3-23. |
|
7. |
|
Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Natural history of paroxysmal nocturnal hemoglobinuria. N Engl J Med. 1995;333(19):1253-1258. |
|
8. |
|
Wang H, Chuhjo T, Yasue S, Omine M, Naka S. Clinical Significance of a minor population of paroxysmal nocturnal hemoglobinuria-type cells in bone marrow failure syndrome. Blood. 2002;100(12):3897-3902. |
|
9. |
|
Iwanga M, Furukawa K, Amenomori T, et al. Paroxysmal nocturnal hemoglobinuria clones in patients with myelodysplastic syndromes. Br J Haematol. 1998;102(2):465-474. |
|
10. |
|
Maciejewski JP, Rivera C, Kook H, Dunn D, Young NS. Relationship between bone marrow failure syndromes and the presence of glycophosphatidyl inositol-anchored protein-deficient clones. Br J Haematol. 2001;115:1015-1022. |
|
11. |
|
Hill A, Kelly RJ, Hillmen P. Thrombosis in paroxysmal nocturnal hemoglobinuria. Blood. 2013;121:4985-4996. |
|
12. |
|
Noris M, Caprioli J, Bresin E, et al. Relative Role of genetic complement abnormalities in sporadic and familial aHUS and their impact on clinical phenotype. Clin J Am Soc Nephrol. 2010;5:1844-59. |
|
13. |
|
Caprioli J, Noris M, Brioschi S, et al; for the International Registry of Recurrent and Familial HUS/TTP. Genetics of HUS: the impact of MCP, CFH, and IF mutations on clinical presentation, response to treatment, and outcome. Blood. 2006;108:1267-1279. |
|
14. |
|
Bresin E, et al. Combined Complement Gene Mutations in Atypical Hemolytic Uremic Syndrome Influence Clinical Phenotype. J Am Soc Nephrol. 2013;24: 475-486. |
|
15. |
|
Fremeaux-Bacchi, et al. Genetics and Outcome of Atypical Hemolytic Uremic Syndrome: A Nationwide French Series Comparing Children and Adults. Clin J Am Soc Nephrol. 2013 Apr 5; 8(4): 554–562. |
|
16. |
|
Sahelijo L, Mujeebuddin A, Mitchell D, et al. First in human single-ascending dose study: safety, biomarker, pharmacokinetics and exposure-response relationships of ALXN1210, a humanized monoclonal antibody to C5, with marked half-life extension and potential for significantly longer dosing intervals. Blood. 2015;126 (23):4777. |
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Alexion
Media
Stephanie Fagan, 475-230-3777
Senior Vice President, Corporate Communications
or
Kim Diamond, 475-230-3775
Executive Director, Corporate Communications
or
Investors
Elena Ridloff, CFA, 475-230-3601
Vice President, Investor Relations
Software-focused company veteran to lead F5’s application delivery, security, and cloud technology teams
F5 Networks (NASDAQ: FFIV) today announced that Ryan Kearny has been appointed to the company’s executive leadership team as Executive Vice President of Product Development and Chief Technology Officer, reporting to the CEO. In this role, Kearny will oversee the company’s product development and innovation strategy for all F5 solutions.
“Ryan’s experience, perspective, and technical acumen make him an ideal fit to take F5 further into emerging areas—particularly around software and cloud technologies,” said John McAdam, President and CEO of F5 Networks. “Building on the company’s market leadership position, we see opportunities to enhance F5’s application services offerings with sophisticated orchestration, analytics, and security capabilities in the cloud and on-premises. As Application Delivery Controllers become increasingly software-centric, Ryan and his teams will be instrumental in delivering programmable, scalable solutions that can support all types of data center, cloud, and app-focused environments.”
Kearny joined F5 in 1998, previously serving as Senior Vice President of Product Development, among other technology leadership positions. Kearny has been a key contributor to the success of the company’s flagship BIG-IP® product line, including its expansion into virtual editions, and the development of the TMOS® architecture. He now takes on an expanded role that includes the planning and execution of F5’s technology roadmap, along with the leadership of all product engineering personnel.
“In my career, I’ve had the chance to discuss the evolution of IT with many of our customers first-hand, in addition to countless hours spent with our architects, software developers, and platform engineers,” said Kearny. “I’m excited to apply what I’ve learned at the executive level, with a sincere nod of gratitude to the technology leaders that have made F5 the company it is today.”
Kearny is based in Seattle at F5’s corporate headquarters. He holds a B.S. in Electrical Engineering from the University of Washington.
About F5
F5 (NASDAQ: FFIV) provides solutions for an application world. F5 helps organizations seamlessly scale cloud, data center, telecommunications, and software defined networking (SDN) deployments to successfully deliver applications and services to anyone, anywhere, at any time. F5 solutions broaden the reach of IT through an open, extensible framework and a rich partner ecosystem of leading technology and orchestration vendors. This approach lets customers pursue the infrastructure model that best fits their needs over time. The world’s largest businesses, service providers, government entities, and consumer brands rely on F5 to stay ahead of cloud, security, and mobility trends. For more information, go to f5.com.
You can also follow @f5networks on Twitter or visit us on LinkedIn and Facebook for more information about F5, its partners, and technologies.
F5, BIG-IP, and TMOS are trademarks or service marks of F5 Networks, Inc., in the U.S. and other countries. All other product and company names herein may be trademarks of their respective owners.
This press release may contain forward looking statements relating to future events or future financial performance that involve risks and uncertainties. Such statements can be identified by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of such terms or comparable terms. These statements are only predictions and actual results could differ materially from those anticipated in these statements based upon a number of factors including those identified in the company’s filings with the SEC.
F5 Networks
Nathan Misner, 206-272-7494
n.misner@f5.com
or
WE Communications
Holly Lancaster, 415-547-7054
hluka@we-worldwide.com
Tested marketing leader, Mathieu Stevenson, with experience at McKinsey & Company, HomeAway Inc. and Capital One, joins leading provider of technology-enabled financial solutions to consumers, small businesses and tax professionals
BELLEVUE, Wash., Oct. 27, 2016 — Blucora, Inc. (NASDAQ:BCOR), a leading provider of technology-enabled financial solutions to consumers, small businesses and tax professionals, today announced that it has hired Mathieu Stevenson as Chief Marketing Officer. Stevenson will report directly to Blucora President and Chief Executive Officer, John Clendening.
A tested marketing leader who previously served in various roles at McKinsey & Company, HomeAway Inc. and Capital One, Stevenson comes to Blucora after having served most recently as Chief Strategy Officer for Catalina Marketing Corporation, where he led corporate strategy and developed personalized digital media campaigns to drive lift and loyalty for the world’s leading CPG retailers and brands. With nearly 15 years’ experience in corporate marketing, he has worked in multiple industries and driven both business-to-business and business-to-consumer strategies, with much of that experience coming in the financial services industry.
“Mathieu is a key strategic hire for us,” said John Clendening, president and chief executive officer of Blucora. “Mathieu brings to Blucora very deep experience in data and analytics and performance marketing through digital channels and new-media platforms, which are crucial for Blucora as we continue to execute on our transformation and growth plans,” Clendening explained. “Mathieu is incredibly smart with an entrepreneurial and growth orientation that will serve the company well.”
Blucora also announced that the independent compensation committee of Blucora’s Board of Directors granted equity awards to Stevenson as an inducement to Stevenson entering into employment with Blucora. The awards were granted under Blucora’s 2016 Equity Inducement Plan, as amended, which Blucora’s board of directors adopted to facilitate the granting of equity awards to new employees in accordance with NASDAQ Listing Rule 5635(c)(4).
The inducement awards consist of restricted stock units, or RSUs, for an aggregate of 27,848 shares of Blucora common stock and stock options to purchase an aggregate of 201,434 shares of Blucora common stock. Subject to continued employment with Blucora, the RSUs will vest over a three-year period, with 33 1/3rd of the RSUs vesting on the first anniversary of the vesting commencement date, which is October 24, 2016, and the remainder vesting in equal six-month installments over the two years thereafter. The stock options have an exercise price of $11.85 per share, the closing price per share of Blucora common stock as reported by NASDAQ on October 24, 2016, the date of grant. The options have a seven-year term and, subject to continued employment with Blucora, will vest over a three-year period, with 33 1/3rd of the options vesting on the first anniversary of the vesting commencement date, which is October 24, 2016, and the remainder vesting in equal six-month installments over the two years thereafter.
About Blucora®
Blucora, Inc. (NASDAQ:BCOR) is a leading provider of technology-enabled financial solutions to consumers, small businesses and tax professionals. Our products and services in tax preparation and wealth management, through TaxAct and HD Vest, help consumers manage their financial lives. TaxAct is an affordable digital tax preparation solution for individuals, business owners and tax professionals. HD Vest Financial Services ® supports an independent network of tax professionals who provide comprehensive financial planning solutions. For more information on Blucora or its businesses, please visit www.blucora.com.
Contact
Stacy Ybarra, 425-709-8127
Blucora, Inc.
stacy.ybarra@blucora.com
ADVISORY, Oct. 27, 2016 —
What:
Ra Pharmaceuticals Inc. (Nasdaq:RARX), a clinical stage biopharmaceutical company focusing on the development of next-generation therapeutics for diseases of complement dysregulation, will visit the Nasdaq MarketSite in Times Square in celebration of its initial public offering (IPO).
In honor of the occasion, Douglas Treco, Ph.D., Chief Executive Officer and Co-Founder, will ring the Opening Bell.
Where:
Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio
When:
Thursday, October 27, 2016 – 9:15 a.m. to 9:30 a.m. ET
Ra Pharmaceuticals Media Contact:
Eliza Schleifstein
(917) 763-8106
eliza@argotpartners.com
Nasdaq MarketSite:
Emily Pan
(646) 441-5120
emily.pan@nasdaq.com
Feed Information:
Fiber Line (Encompass Waterfront): 4463
Gal 3C/06C 95.05 degrees West
18 mhz Lower
DL 3811 Vertical
FEC 3/4
SR 13.235
DR 18.295411
MOD 4:2:0
DVBS QPSK
Social Media:
For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies, please visit our Facebook page:
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Webcast:
A live stream of the Nasdaq Opening Bell will be available at:
https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx
Photos:
To obtain a hi-resolution photograph of the Market Open, please go to http://business.nasdaq.com/discover/market-bell-ceremonies and click on the market open of your choice.
About Ra Pharmaceuticals
Ra Pharmaceuticals is a clinical stage biopharmaceutical company focusing on the development of nextgeneration therapeutics for diseases of complement dysregulation and for orphan indications. The Company utilizes small molecules and peptide approaches to address pathological targets in the complement cascade. Derived from its proprietary Extreme Diversity™ peptide chemistry platform, RA101495 is a macrocyclic peptide inhibitor of complement C5, and is currently in Phase 1 development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). For more information, please visit: www.rapharma.com.
About Nasdaq
Nasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets. As the creator of the world’s first electronic stock market, its technology powers more than 70 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to more than 3,700 listed companies with a market value of approximately $9.3 trillion and nearly 18,000 corporate clients. To learn more, visit: nasdaq.com/ambition or business.nasdaq.com.
CorPath® GRX enhances procedural control and improves workflow, bringing added benefits to robotic-assisted coronary interventions
Corindus Vascular Robotics, Inc. (NYSE MKT:CVRS), a leading developer of precision vascular robotics, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CorPath GRX, the second generation of its CorPath Vascular Robotic System. Corindus expects to commence commercialization of CorPath GRX in the first quarter of 2017.
“CorPath GRX is a critical advancement in our core technology and a meaningful step toward realizing our vision of fundamentally changing how PCI procedures are performed,” said Mark Toland, President and CEO of Corindus. “GRX will enable us to build more robust and sustainable cardiovascular robotic programs with our hospital partners as we remain focused on providing the highest level of care to patients while protecting the health and wellness of the cath lab staff. We are excited to debut the GRX at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference later this week where we will be holding clinician demonstrations.”
CorPath GRX significantly builds upon the CorPath platform, adding a significant number of key upgrades that increase precision, improve workflow, and extend the capabilities and range of procedures that can be performed robotically. These features include Active Guide Management which enables control of the guide catheter along with robotic control of the guidewire and balloon or stent catheter, with one-millimeter advancement, from the control console. This precise positioning will enable physicians to adjust guide catheter position during PCI procedures, and may expand use of CorPath to more complex cases. CorPath GRX also features a completely redesigned Bedside Unit featuring an Extended Reach Arm and a touchscreen display to streamline workflow.
“The new features of the next generation CorPath System, particularly the addition of active guide catheter management, will allow physicians to increase the complexity of procedures performed robotically,” said J. Aaron Grantham, M.D., Chief Medical Officer of Corindus. “This is a tremendous advancement in the technology platform that will greatly extend the clinical capability of the system.”
Corindus’ CorPath System is the first and only FDA-cleared medical device to bring robotic precision to Percutaneous Coronary Interventions (PCI) and protects medical professionals from radiation exposure occurring in hospital cath labs.
CorPath GRX will be on display for the first time at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) 2016 conference where Corindus will sponsor a breakfast symposium entitled “Robotic Therapy – Current Applications & Future Vision” on Monday, October 31 at 7:00 a.m. Register here to visit Corindus at Booth #1322 for an opportunity to use CorPath GRX with an advanced simulator.
About Corindus Vascular Robotics
Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company’s CorPath® System is the first FDA-cleared medical device to bring robotic precision to interventional procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance guide catheters, stents, and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. With the CorPath System, Corindus Vascular Robotics brings robotic precision to interventional procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual procedures.* Corindus stands behind its product with its unique $1,000 hospital credit “One Stent Program.” For additional information, visit www.corindus.com, and follow @CorindusInc.
* Clinical trials conducted using the CorPath 200 System
Forward-Looking Statements
Statements made in this release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Corindus to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward looking statements. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements in the conditional or future tenses or that includes terms such as “believes,” “belief,” “expects,” “estimates,” “intends,” “anticipates” or “plans” to be uncertain and forward-looking. Forward-looking statements may include comments as to Corindus’ beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside Corindus’ control.
Examples of such statements include statements regarding:
- the expectation that Corindus will commence commercialization of CorPath GRX in the first quarter of 2017,
- that CorPath GRX is a critical advancement in Corindus’ core technology that fulfills the Company’s vision to fundamentally change how PCI procedures are performed, and
- that the new features of CorPath GRX will enable physicians to extend the volume and complexity of procedures performed robotically.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, including, but not limited to the following: the rate of adoption of our CorPath System and the rate of use of our cassettes; risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; our need for additional funds to support our operations; our ability to manage expenses and cash flow; factors relating to engineering, regulatory, manufacturing, sales and customer service challenges; potential safety and regulatory issues that could slow or suspend our sales; and the effect of credit, financial and economic conditions on capital spending by our potential customers. Forward looking statements speak only as of the date they are made. Corindus undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date. More information is available on Corindus’ website at http://www.corindus.com.
PayOnline to lead panel at Russian Interactive Week 2016 to discuss the future of online payments in Russia
MIAMI, FL–(Oct 27, 2016) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that its wholly owned PayOnline subsidiary will lead the futuristic section of the Russian Interactive Week (“RIW”) 2016 with a session entitled, “How we will pay in 2020: projections and fantasies.”
RIW is the biggest annual event of Russian Internet, combining a multi-threaded conference, media communication forum and many extracurricular activities, awards, presentations and promotions. This year’s event is scheduled to be attended by more than 20,000 visitors. RIW 2016 is organized by RUNET Group and will be held at Moscow’s Expo Center from November 1-3, 2016, http://riw.moscow.
As an official payment partner of RIW since 2012, PayOnline will open the second day of the conference highlighting expected changes in Russian Internet payments to take place over the next five years. The company will be joined by representatives from MasterCard, MTS, VTB24 Bank and Mail Group who will forecast what’s in store for Russia’s online payment marketplace and brainstorm about future innovations. Experts will share their views on the development of different areas of the payments ecosystem and together with participating visitors will try to create a common vision on how payments will work in the Russian Internet by the year 2020.
“Payment service providers reside at the intersection of information technology and electronic payments directly interacting with payment systems, banks, IT companies and mobile operators. Taking stock of the payments landscape, we noticed that based on their individual challenges, each of our partners have their own vision of the ‘future payments’ of Russia; thus was born the idea of bringing together key industry players in the payment sector and try to create a shared vision of our future,” says lead panelist and CEO of PayOnline Marat Abasaliev. “This conference unites all relevant representatives of the industry. I am confident the visitors of our session will take an active part in the discussion of the controversial issues to form the basis for further fruitful discussions in the community and find the payment scope of a single development strategy in Russian Internet.”
RIW 2016 will be produced by the collection of expert assessments on a number of key issues related to the electronic and physical payments in Russia in a five-year term. The most visionary expert will be awarded by the organizers at RIW 2020. Follow the news of RIW on the official Facebook page of PayOnline.
About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US, we are growing transactional revenue with innovative services including our cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.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 Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
Incoming specialists to focus on Quality Control and Quality Assurance Aspects of Supply Chain
NEW YORK, Oct. 26, 2016 — Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today the appointment of Maria Gomes Nunes, Dr. PH, to the position of Manager of QC/QA (Quality Control/Quality Assurance) and Laura Chen to the position of Senior Quality Assurance Specialist. These new hires will report to J.C. Simeon, Actinium’s recently hired Executive Director of Quality Assurance, as part of an ongoing expansion of the Company’s Supply Chain Team.
“We are excited to welcome Dr. Nunes and Ms. Chen to the Actinium team,” said Kaushik J. Dave, Actinium’s Chief Executive Officer. “The hiring of such high quality individuals shortly after onboarding J.C. Simeon gives me great confidence in our ability to attract the talent we require as we build out strong pre-commercialization capabilities for our phase 2 and phase 3 programs and also prepare for pipeline expansion.”
Dr. Nunes will be responsible for providing quality assurance/control oversight related to clinical products release activities at Actinium’s external contract manufacturing organizations and contract testing labs. Dr. Nunes has over twenty years of experience encompassing management of quality control groups, systems and processes, laboratory and analytical method development and compliance, oncology drug discovery and development of small molecules and biologics at companies such as Wyeth, Pfizer, ImClone Systems/Eli Lilly and Mesoblast. Dr. Nunes holds a Doctorate in Public Health from Columbia University and a B.S. in Biology from University of Lisbon, Portugal. Ms. Laura Chen joins Actinium from Pfizer, where she worked for 11 years in several quality assurance positions, culminating as Senior Associate QA, Biotech Quality Operations. Laura holds a Bachelor of Arts degree from Rutgers University and is currently pursuing a Certificate in Quality Assurance/Regulatory Affairs from Temple University.
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radioimmunotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting Actinium-225 and Bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory or relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company’s second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for patients newly diagnosed with AML over the age of 60 in a single-arm multicenter trial.
Forward-Looking Statements for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact:
Steve O'Loughlin
Vice President, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
soloughlin@actiniumpharma.com
Jinhua, China–(October 26, 2016) – Kandi Technologies Group, Inc. (NASDAQ GS: KNDI) (the “Company” or “Kandi”) today announced that Kandi Electric Vehicles Group Co., Ltd. (the “JV Company,” a 50/50 joint venture between Kandi and Geely Automobile Holdings Ltd.) has received an initial payment of RMB 27,408,000 (or approximately USD $4 million) from Shanxi Coal Asset Management Group (“Shanxi Coal”), as provided for under their previously-announced strategic cooperation agreement to produce and sell more than 50,000 electric vehicles (“EVs”) during a five-year period.
Mr. Hu Xiaoming, Chairman and Chief Executive Officer of Kandi, commented, “Receiving the initial multi-million dollar payment from Shanxi Coal is a strong indicator that both parties have made substantial progress under our strategic cooperation agreement, and we look forward to continued successful cooperation between Kandi and Shanxi Coal in the future.”
“Although the national government will begin reducing the amount of renewable energy subsidies to all EV manufacturers in 2017, the subsidy program itself will continue through 2020. Under the Government’s current subsidy policy, the EVs produced and sold by the JV Company meet national renewable energy subsidy requirements and are eligible to receive subsidy payments. Kandi is currently developing EV market growth strategies that do not rely solely on subsidy payments and is identifying key areas of focus in which to improve Kandi’s earnings capabilities,” Mr. Hu concluded.
About Kandi Technologies Group, Inc.
Kandi Technologies Group, Inc. (KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicle products. Kandi has established itself as one of China’s leading manufacturers of pure electric vehicle (“EV”) products (through its joint venture), EV parts and off-road vehicles. More information can be viewed at the Company’s corporate website at http://www.kandivehicle.com. The Company routinely posts important information on its website.
Safe Harbor Statement
This press release contains certain statements that may include “forward-looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on the SEC’s website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Follow us on Twitter: @Kandi_Group
Company Contact:
Ms. Kewa Luo
Kandi Technologies Group, Inc.
Phone: 1-212-551-3610
Email: IR@kandigroup.com
Animators can utilize Microsoft’s new Surface Dial and Moho 2D animation software for faster, easier animation with the turn of a dial.
ALISO VIEJO, California, Oct. 27, 2016 — Today at the launch event for Microsoft’s new Surface Studio, Smith Micro Software, Inc. (NASDAQ: SMSI) showcased enhancements to its award-winning tool for 2D animation, Moho™ 12 (formerly Anime Studio®). The latest release includes new features optimized to work with Microsoft’s groundbreaking new Surface Dial, making it faster and easier to create complex animations with the turn of a dial.
“We were flattered to be invited by Microsoft to demo our unique Moho animation software in their product showcase as part of this important launch event,” said William W. Smith, Jr., President and CEO of Smith Micro Software. “The combination of Moho running on the new Surface Studio will allow digital artists and animators to truly turn their desktops into highly productive design studios.”
“Moho 12 is already the most complete drawing and animation solution on the market. Now with the power of the new Microsoft Surface Studio, and the ease and creativity afforded by the new Surface Dial, Moho turns the tedious work of traditional animation into a faster, more streamlined digital experience,” said Fahim Niaz, Director of Product Management at Smith Micro Software.
“We are excited to see how the Moho animation software comes alive on the Surface Studio and takes advantage of Surface Dial to allow people to more quickly and easily create complex animations,” said John Richards, General Manager of Surface at Microsoft. “The Smith Micro experience on Surface Studio is a fantastic example of how Surface Dial can deliver real value and open new possibilities and efficiencies to creative professionals.”
Moho Features Enabled for Microsoft’s Surface Studio and Surface Dial:
- New Overlay Timeline: When the Surface Dial is on the screen, a new overlay timeline appears following its position, hiding other windows and allowing the artist to intuitively navigate in time, and animate using the entire screen.
- Rigged Characters: The Surface Dial allows artists to easily select frames within the timeline where new animation can be added to rigged characters using Moho’s SmartBones feature. As movements are added via pen or cursor, the animator can use the Surface Dial to scroll back and forth through the new animation sequence to easily see if the movement is correct.
- Rotating Canvas: After selecting Rotation Mode in the Surface Dial, artists can easily rotate the canvas by turning the dial left or right, making free-hand drawing easier by changing the canvas orientation up to 360 degrees.
- Frame-by-Frame Animation: Using the Surface Dial to quickly add new frames with a double-click, artists can draw on a sequence of still frames, and then rotate the dial left or right to simulate flip-book animation.
Customers can purchase Moho 12 ahead of Surface Studio availability by visiting Smith Micro’s online store, or from the Microsoft Windows online store. The new Moho 12 off-screen features created for the new Surface Dial will work on all Microsoft Surface devices.
For more information, about Moho 12 running on the Microsoft Surface Studio, click here.
For information about other Smith Micro graphics and animation solutions, click here.
About Smith Micro Software, Inc.:
Smith Micro develops software to simplify and enhance the mobile experience, providing solutions to some of the leading wireless service providers, device manufacturers, and enterprise businesses around the world. From optimizing wireless networks to uncovering customer experience insights, and from streamlining Wi-Fi access to ensuring family safety, our solutions enrich today’s connected lifestyles while creating new opportunities to engage consumers via smartphones. Our portfolio also includes a wide range of products for creating, sharing, and monetizing rich content, such as visual messaging, video streaming, and 2D/3D graphics applications. For more information, visit smithmicro.com (NASDAQ: SMSI)
Safe Harbor Statement:
This release contains forward-looking statements that involve risks and uncertainties, including without limitation, forward-looking statements relating to the company’s financial prospects and other projections of its performance, the existence of new sales opportunities and interest in the company’s products and solutions, the company’s ability to increase its revenue by capitalizing on new opportunities, and customer concentration given that the majority of our sales depend on a few large client relationships, including Sprint. Among the important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements are changes in demand for the company’s products from its customers and their end-users, new and changing technologies, customer acceptance and timing of deployment of those technologies, and the company’s ability to compete effectively with other software and technology companies. These and other factors discussed in the company’s filings with the Securities and Exchange Commission, including our filings on Forms 10-K and 10-Q, could cause actual results to differ materially from those expressed or implied in any forward-looking statements. The forward-looking statements contained in this release are made on the basis of the views and assumptions of management regarding future events and business performance as of the date of this release, and the company does not undertake any obligation to update these statements to reflect events or circumstances occurring after the date of this release.
Smith Micro and the Smith Micro logo are registered trademarks or trademarks of Smith Micro Software, Inc. Third-party trademarks mentioned are the property of their respective owners. The use of the word partner does not imply a partnership relationship between Smith Micro and any other company.
Positive Data Leads to Acceleration of Preclinical Toxicology Testing
HOUSTON, TX–(October 26, 2016) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced promising initial results of the preclinical toxicology work that has begun for WP1122, a unique inhibitor of glucose metabolism, which is an important driver of glycolytic brain tumor progression and survival.
The Company indicated that preliminary escalating single dose toxicity testing in mice (oral administration) was successfully completed and even at the highest possible dose, no toxic death was observed. In multiple therapeutic doses, WP1122 was well tolerated during intense twice-daily oral dosing. The Company plans to move forward with completing the preclinical toxicology package in order to generate proof of concept in humans.
Moleculin’s Chairman and CEO, Walter Klemp, commented, “As the newest of our technologies, we are pleased to see development work move to the next level. WP1122 has received significant attention from the scientific community as a promising new approach to treating brain tumors. Part of the excitement relates to the unusual nature of WP1122 and its design allowing for high brain uptake and retention. The design uses an alteration similar to that which turns morphine into heroine and enables rapid brain uptake. A similar alteration to our drug allows it to successfully enter the brain in high quantities and increases its circulation time.”
Prior to this announcement, the Company had previously announced the presentation of promising preclinical data in July of this year (Moleculin Announces Data on WP1122 Presented at the 28th Annual International Carbohydrate Symposium), supporting the potential for using WP1122 as a treatment for glioblastoma.
No curative therapy exists for patients with high-grade brain tumors and new approaches to the treatment of this disease are urgently needed. One new approach to tackling this problem has been to focus on shutting down the metabolism of tumor cells, which can be highly dependent on glucose for continued survival and proliferation. WP1122 has been shown both in vitro and in vivo to induce a destruction of glioma cells, the most aggressive form of brain tumor, by essentially “starving” them. Its translational potential as a drug for brain tumors in general and glioma in particular is promising due to its improved circulation time as well as its increased brain uptake.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.
For more information about Moleculin, please visit http://www.moleculin.com
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability to successfully generate a proof of concept in humans for WP1122. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com
FARMINGDALE, N.Y., Oct. 25, 2016 — Misonix, Inc. (NASDAQ: MSON), an international surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery, neurosurgery, wound debridement, skull based surgery, laparoscopic surgery and other surgical applications, has announced its plans to participate in the North American Spine Society (NASS) 2016 Annual Meeting to be held in Boston on October 26 – 29, 2016.
NASS is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value and evidence-based spine care for patients. The NASS 2016 Annual Meeting represents the world’s largest spine meeting and exhibition. Approximately 3,500 spine care professionals are expected to attend this year’s meeting.
During exhibit hours there will be scheduled Meet The Experts sessions at the Misonix booth. Guest surgeons will include Dr. Nicholas Renaldo, Medical Director of Spine Surgery at Vassar Brothers Medical Center, Poughkeepsie NY; Dr. Eric Woodard, Chief of the Section of Neurosurgery, New England Baptist Hospital, Boston MA; and Dr. Connor Telles from Sierra Pacific Orthopedics in Fresno, CA. NASS attendees will be able to engage these surgeon BoneScalpel users at the Misonix booth to learn first-hand about their positive experiences with BoneScalpel use in adolescent and adult spine surgery.
Misonix will also be hosting a BoneScalpel hands-on cadaveric workshop on October 26. The workshop entitled, Ultrasonic BoneScalpel Techniques in Complex Spine will be facilitated by Isador Lieberman, MD, Director of the Scoliosis and Spine Tumor Center at the Texas Back Institute in Plano, TX. Dr. Lieberman will demonstrate and speak to his clinical usage of the BoneScalpel and surgeon attendees will have the opportunity for hands-on experience with the BoneScalpel system. It is anticipated that there will be more than 35 spine surgeons trained on the use of BoneScalpel.
Scott Ludecker, senior vice president of global sales and marketing for Misonix, said, “The BoneScalpel Hands-On Workshops that we are hosting at NASS this year will allow participants to not only trial the BoneScalpel on cadaveric specimens, but benefit from the instruction and actual experience of key opinion leading surgeons who have adopted the BoneScalpel into their clinical practices. Learning how to use BoneScalpel in a formal lab setting such as this workshop is an important step for surgeons to gain confidence with the device and to see for themselves why so many of their colleagues around the world have made BoneScalpel an important part of their surgical armamentarium. We look forward to a great event this year.”
“BoneScalpel is increasingly becoming adopted by the spinal surgeon community for the purpose of making precise and safe bone cuts during challenging spine surgeries,” said Stavros Vizirgianakis, Interim Misonix CEO. “Misonix is very pleased to participate in NASS this year as we value the opportunity to engage some of the most prominent spine surgeons in the world. We are looking forward to providing platforms for the attendees to be able to trial first-hand the technologically advanced BoneScalpel system. Our commitment to medical education and for training surgeons on advanced surgical techniques with our advanced technology remains central to our mission at Misonix.”
About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.
Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.
MIDLAND, Texas, Oct. 25, 2016 — Legacy Reserves LP (“Legacy”) (NASDAQ:LGCY) today announced that it has executed a second lien term loan credit agreement (the “Second Lien”) with GSO Capital Partners LP (“GSO”) to provide loans in an aggregate amount up to $300 million. Advances under the Second Lien will be issued with an upfront fee of 2%, bear interest of 12.0% per annum and mature, subject to certain conditions, on August 31, 2021. Legacy intends to use the initial $60 million of gross loan proceeds to repay outstanding indebtedness and pay associated transaction expenses.
In connection with the foregoing transaction, Legacy entered into an amendment (the “Amendment”) to its revolving credit facility agreement to permit the Second Lien and included a reduction of the borrowing base from $630 million to $600 million. In addition, the Second Lien and the Amendment added a secured debt asset coverage covenant of 1.00 times starting with the fiscal quarter ended June 30, 2017 and a Secured Debt / EBITDA covenant starting with the fiscal quarter ended December 31, 2018, increased the mortgage requirement to 95% of the value of oil and natural gas properties, required 75% of projected oil and natural gas production from proved developed producing reserves to be hedged through 2018, and amended the interest coverage ratio to 2.00 times.
Also, D. Dwight Scott, Senior Managing Director of Blackstone Group L.P. and Head of GSO’s Energy business, will be added to the Board of Directors of Legacy Reserves GP, LLC, the general partner of Legacy, pursuant to the terms of a Director Nominating Agreement.
Paul T. Horne, the Chairman, President and CEO of Legacy’s general partner said, “As previously communicated, our management and Board have been working diligently in this prolonged period of depressed commodity prices to position Legacy for increased chances of success. After considerable evaluation of numerous alternatives, we are pleased to announce this second lien term loan agreement with GSO that reduces our outstanding bank debt and provides a source of future capital for the business. GSO’s investment expertise in the oil and gas industry makes them an ideal capital provider for Legacy. We are eager to pursue additional opportunities and have provided GSO the ability to participate in up to 50% of our future debt or equity financings. Additionally, we are pleased to welcome Dwight Scott to our Board of Directors. Dwight’s extensive experience and industry knowledge will be a valued asset in Legacy’s boardroom. We look forward to continuing to work with GSO as we navigate these tough and uncertain times in the industry.”
Dwight Scott added, “We have watched the progress made on many fronts by the Legacy team over the last year, and are excited to be a part of the Company’s continued focus on strengthening its balance sheet and in the ultimate growth of the business as the industry recovery continues.”
Jefferies LLC acted as sole financial advisor and Kirkland & Ellis LLP acted as legal advisor to Legacy in this transaction. Latham & Watkins LLP acted as legal advisor to GSO.
Conference Call to Report Third Quarter 2016 Results
Legacy will provide details of its third quarter 2016 operating and financial performance with its earnings report which is scheduled to be released on Wednesday, November 2, 2016, following the close of NASDAQ trading. A teleconference and webcast will be held on Thursday, November 3, 2016, beginning at 9:00 a.m. Central Time. Those wishing to participate in the conference call should dial 877-266-0479. A replay of the call will be available through Thursday, November 10, 2016, by dialing 855-859-2056 or 404-537-3406 and entering replay code 98590760. Those wishing to listen to the live or archived webcast via the Internet should go to the Investor Relations tab of our website at www.LegacyLP.com.
Additional Information for Holders of Legacy Units
Although Legacy has suspended distributions to both the 8% Series A and Series B Fixed-to-Floating Rate Cumulative Redeemable Perpetual Preferred Units (the “Preferred Units”), such distributions continue to accrue. Pursuant to the terms of Legacy’s partnership agreement, Legacy is required to pay or set aside for payment all accrued but unpaid distributions with respect to the Preferred Units prior to or contemporaneously with making any distribution with respect to Legacy’s units. Accruals of distributions on the Preferred Units are treated for tax purposes as guaranteed payments and will generally be taxable to the holders of such Preferred Units as ordinary income even in the absence of contemporaneous distributions.
In addition, as partners in a partnership for federal income tax purposes, Legacy unitholders, just like unitholders of other master limited partnerships, are allocated taxable income irrespective of the amount of cash, if any, distributed to the unitholders. The tax allocation of taxable income may require the payment of United States federal income taxes and, in some cases, state and local income taxes by our unitholders. As of January 21, 2016, Legacy has suspended all cash distributions to unitholders and holders of the Preferred Units. Legacy may engage in transactions to de-lever the Partnership and manage its liquidity that may result in income and gain to unitholders without a corresponding cash distribution. For example, unitholders may be allocated taxable income and gain resulting from asset sales. Further, if Legacy engages in debt exchanges, debt repurchases, or modifications of our existing debt, these or similar transactions could result in “cancellation of indebtedness income” (also referred to as “COD income”) being allocated to unitholders as taxable income. Unitholders may be allocated gain and income from asset sales and COD income and may owe income tax as a result of such allocations notwithstanding the fact that we have currently suspended cash distributions to unitholders. The ultimate effect of any such allocations will depend on the unitholder’s individual tax position with respect to its units. Unitholders are encouraged to consult their tax advisors with respect to the consequences of potential partnership or unitholder transactions that may result in income and gain to unitholders.
Additionally, if Legacy’s unitholders, just like unitholders of other master limited partnerships, sell any of their units, they will recognize gain or loss equal to the difference between the amount realized and their tax basis in those units. Prior distributions to Legacy’s unitholders that were in the aggregate in excess of the cumulative net taxable income they were allocated for a unit, and therefore decreased their adjusted tax basis in that unit, will, in effect, become taxable income to Legacy’s unitholders if the unit is sold at a price greater than their tax basis in that unit, even if the price Legacy’s unitholders receive is less than their original cost. A substantial portion of the amount realized, whether or not representing gain, may be ordinary income to Legacy’s unitholders due to the potential recapture items, including depreciation, depletion and intangible drilling costs.
About Legacy Reserves LP
Legacy Reserves LP is a master limited partnership headquartered in Midland, Texas, focused on the acquisition and development of oil and natural gas properties primarily located in the Permian Basin, East Texas, Rocky Mountain and Mid-Continent regions of the United States. Additional information is available at www.LegacyLP.com.
Cautionary Statement Relevant to Forward-Looking Information
This press release contains forward-looking statements relating to our operations that are based on management’s current expectations, estimates and projections about its operations. Words such as “anticipates,” “expects,” “intends,” “plans,” “targets,” “projects,” “believes,” “seeks,” “schedules,” “estimated,” and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors, some of which are beyond our control and are difficult to predict. Among the important factors that could cause actual results to differ materially from those in the forward-looking statements are: realized oil and natural gas prices; production volumes, lease operating expenses, general and administrative costs and finding and development costs; future operating results and the factors set forth under the heading “Risk Factors” in our annual and quarterly reports filed with the SEC. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The reader should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Unless legally required, Legacy undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
Legacy Reserves LP
Dan Westcott
Executive Vice President and Chief Financial Officer
432-689-5200
Company expects accretive M&A transactions will complement organic growth
MIDDLETOWN, R.I., Oct. 25, 2016 — Towerstream Corporation (Nasdaq:TWER) (the “Company”), a leading fixed-wireless fiber alternative company, announced today that it expects to add 100 new buildings to its On-Net footprint in Q4 to 437 total buildings. This is more than double the 265 that were in the On-Net footprint at the end of H1.
- Expected to add 100 new buildings to On-Net footprint in Q4
- 437 total buildings projected by H2 is more than double the 265 at end of 2015
- Management considering strategic M&A transactions in 2017 to complement organic growth
- Company’s competitive advantages, including cost, driving growing adoption
In addition to this expansion, management is considering select M&A transactions that would complement its organic growth. The company seeks fixed wireless companies that are similar to it and would be accretive.
Management Comment
“With our ability to provide fiber-like speed and fiber-like stability at a fraction of fiber’s CapEx cost, more companies are recognizing the benefits of our network,” stated Philip Urso, interim chief executive officer. “By sharing CapEx cost among many customers located in our On-Net buildings, we can offer market-setting prices and provide leading-edge service.”
“There is momentum in our business now,” stated Arthur Giftakis, chief operating officer. “We accelerated our On-Net platform in Q1 of this year and already 48 percent of our buildings have multiple customers and several have more in this early stage of our expansion initiative.”
About Towerstream Corporation
Towerstream Corporation (Nasdaq:TWER) is a leading Fixed-Wireless Fiber Alternative company delivering high-speed Internet access to businesses. The company offers broadband services in 12 urban markets, including New York City, Boston, Los Angeles, Chicago, Philadelphia, the San Francisco Bay area, Miami, Seattle, Dallas-Fort Worth, Houston, Las Vegas-Reno, and the greater Providence area.
Safe Harbor
Certain statements contained in this press release are “forward-looking statements” within the meaning of applicable federal securities laws, including, without limitation, anything relating or referring to future financial results and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by the company with the Securities and Exchange Commission. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements contained herein. The company undertakes no obligation to correct or update any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Contact:
Robert Haag
Managing Director
IRTH Communications
twer@irthcommunications.com
1-866-976-4784
SYLMAR, California, October 25, 2016 —
Provides Proof of Concept for the Ongoing Development of the Orion™ I Visual Cortical Prosthesis
Second Sight Medical Products, Inc. (Nasdaq: EYES) (Second Sight or the Company), a developer, manufacturer and marketer of implantable visual prosthetics to restore functional vision to blind patients, today announced the first successful implantation and activation of a wireless visual cortical stimulator in a human subject, providing the initial human proof of concept for the ongoing development of the Company’s Orion™ I Visual Cortical Prosthesis (Orion I). In the UCLA study supported by Second Sight, a 30 year old patient was implanted with a wireless multichannel neurostimulation system on the visual cortex and was able to perceive and localize individual phosphenes or spots of light with no significant adverse side effects.
Dr. Robert Greenberg, Chairman of the Board of Second Sight, said, “It is rare that technological development offers such stirring possibilities. This first human test confirms that we are on the right track with our Orion I program to treat blind patients who cannot benefit from the Argus® II Retinal Prosthesis (Argus II). This initial success in a patient is an exciting and important milestone even though it does not yet include a camera. By bypassing the optic nerve and directly stimulating the visual cortex, the Orion I has the potential to restore useful vision to patients completely blinded due to virtually any reason, including glaucoma, cancer, diabetic retinopathy, or trauma. Today these individuals have no available therapy and the Orion I offers hope, increasing independence and improving their quality of life.”
“While we still have much work ahead, this successful human proof of concept study gives us renewed energy to move our Orion I development efforts forward,” said Will McGuire, President and CEO at Second Sight. “We believe this technology will ultimately provide a useful form of vision for the nearly six million people worldwide who are blind but not a candidate for an Argus II retinal prosthesis. We also remain focused on further developing our Argus II technology for patients with Retinitis Pigmentosa, making it more widely available, and exploring its potential to improve the vision of nearly two million patients blinded by Age-Related Macular Degeneration worldwide.”
Dr. Nader Pouratian, the UCLA neurosurgeon who performed the surgery, added, “Based on these results, stimulation of the visual cortex has the potential to restore useful vision to the blind, which is important for independence and improving quality of life.”
This implant was performed as part of a proof of concept clinical trial whose purpose is to demonstrate initial safety and feasibility of human visual cortex stimulation. The initial success of this study, coupled with the significant additional pre-clinical work gathered to-date readies Second Sight to submit an application to the FDA in early 2017 to gain approval for conducting an initial clinical trial of the complete Orion I system, including the camera and glasses. Assuming positive initial results in patients and discussions with regulators, an expanded pivotal clinical trial for global market approvals is then planned.
About Second Sight
Second Sight’s mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed and now manufactures and markets the Argus® II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ I Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. U.S. Headquarters are in Sylmar, California, and European Headquarters are in Lausanne, Switzerland. For more information, visit http://www.secondsight.com.
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 outer retinal degeneration such as retinitis pigmentosa (RP). 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 useful vision. The system is controlled by software and is upgradeable, which may provide improved performance as new algorithms are developed and tested. Therefore current and future Argus II users may benefit from the continuously improving technology. The Argus II is the first artificial retina to receive widespread approval, and is offered at approved centers in Austria, Canada, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland, Turkey, United Kingdom and the United States.
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 and Exchange Act of 1934, as amended, which 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.” These statements may be identified by words such as “estimates,” “anticipates,” “projects,” “plans,” or “planned,” “seeks,” “may,” “will,” “expects,” “intends,” “believes,” “should,” “potentially,” “objectives,” and similar expressions or the negative versions thereof and which also may be identified by their context. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s Annual Report on Form 10-K as filed on March 11, 2016 and the Company’s other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating the Company’s 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 the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Top Producing REALTOR(R) in Baton Rouge Joins Agent-Owned Cloud Brokerage(R)
BELLINGHAM, WA–(October 25, 2016) – eXpWorld Holdings, Inc. (OTCQB: EXPI) announced today that Darren James, principal of the Baton Rouge brokerage Darren James Real Estate Experts has transitioned his team of agents and brokers over to eXp Realty, the Agent-Owned Cloud Brokerage®.
“The eXp Realty business model is more progressive and agent-centric than any I’ve seen in my 15 years in this business,” said James. “This is a tremendous opportunity, not just for me and for my family, but for all of the agents who have been great and loyal contributors to my success.”
Among James’ accomplishments:
- 456 transactions closed in 2015;
- Team ranked #51 among top teams (measured by transaction sides) in the United States by the Wall Street Journal Real Trends report of top REALTORS® in 2015;
- Recognized in Forbes magazine on the Inc. 5000 fastest growing companies (across all industries) in the United States in both 2015 and 2016;
- Number 1 REALTOR® in the gulf states region for total production individually in both 2014 and 2015.
“Increasingly, eXp Realty is the destination for top producing teams and for brokerage owners looking to increase profitability, achieve scalable growth across markets, and deliver the opportunity of ownership to their valued agents and team members,” said eXp Realty CEO, Jason Gesing. “As a company, we are committed to offering a value proposition that is so strong that it would professionally irresponsible for an agent affiliate with any other brokerage.”
James will be introduced to eXp Realty community members during the Company’s weekly leadership meeting on Friday at 11am ET/8am PT which can be viewed on the Company’s Youtube channel: youtube.com/exprealty.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Record Q3 Net Revenue of $7.26 million — Net Income Increases to $495,669
OurPet’s Company (OTCQX: OPCO) (www.ourpets.com), a leading proprietary pet supply company, today reports record third-quarter revenue of $7.26 million, an increase of 21% compared to revenues of $5.99 million reported in the same period of 2015. Net income for the third quarter ended September 30, 2016, increased 21% to $495,669, or $0.025 per share, compared to $410,450, or $0.020 per share, for the same period of 2015. Third quarter 2015 results included a one-time U.S. Custom exam refund of $94,000. Discounting the $94,000 refund, the adjusted net income between third quarters 2015 and 2016 grew 57%.
“With the resumption of shipments to our major specialty pet retail customer, we were firing on all cylinders this past quarter. The double-digit growth in sales was also driven by a 19% growth in the Food Drug & Mass market segment, as well as initial shipments of our new electronic cat toy, Intelligent Pet Care, and Switchgrass BC cat litter products. With the strong third-quarter sales, we are up almost 10% for the nine months of 2016, more than double the pet industry average,” states Dr. Steven Tsengas, president and CEO of OurPet’s.
Based on initial October sales bookings and the strong acceptance of product innovations, OurPet’s is guardedly optimistic of a strong fourth quarter and fiscal year 2016, with growth thereafter supported by new products and key partnerships.
“Beyond 2016, our strategy is to achieve double-digit growth in sales and net income with an emphasis on developing and launching proprietary, innovative products and entering appropriate new market segments,” says Dr. Tsengas. “We recently announced our new partnership with Paulee Cleantec, Inc. whereby we plan to commercialize its patented technology to develop portable and fixed-base product solutions to safely and conveniently eliminate pet waste.
“In addition, we recently completed contracts with a leading direct TV (DRTV) marketing company to test market several of our new electronic interactive cat toys for a possible DRTV campaign to launch sometime in the second quarter of 2017. The contracts will allow both parties to move forward with what we believe will be the first of several DRTV programs to raise customer awareness for our entire electronic interactive pet toy category. We have many ‘irons in the fire’ and are very excited about the future.”
2016 Third-Quarter Results
Net revenue increased 21% to $7,259,904 versus revenues of $5,986,645 for the same period last year. The approximate $1.3 million increase was due to strong sales in the Pet Specialty and Food, Drug and Mass channels.
Net income increased 20.76% to $495,669 compared to $410,450 for the third quarter of 2015. Net income per diluted share increased to $0.025 compared to $0.021 a year ago and would have been higher if not for an additional 265,573 shares added to the weighted average of common and basic shares used in calculating diluted earnings per share.
As previously mentioned, third quarter 2015 results included a one-time U.S. Custom exam refund of $94,000. Discounting the $94,000 refund, the adjusted net income between third quarters 2015 and 2016 grew 57%.
Gross profit for third quarter 2016 was $2,443,470 compared to $2,012,177 the prior year. Gross profit margin stayed about the same year-over-year at 33.66%.
As of September 30, 2016, OurPet’s reduced total long-term liabilities by $672,008 (-15%), maintained strong liquidity and achieved a Current Ratio of 5.04, and grew stockholder’s equity by $964,773 (+11%).
2016 First Nine Months Results
Net revenue for the first nine months of 2016 increased 10% to $18,872,791 versus revenues of $17,170,795 reported for the same period last year. The year-over-year increase was due to strong Food, Drug, and Mass sales.
Net income for the 2016 period increased 3.4% to $916,882 compared to $886,319 for the same period of 2015. Net income per share increased to $0.045 for the first nine months of 2015 from $0.044 last year.
Gross profit increased 8% to $5,847,171 for the first nine months of 2016 versus the prior year.
About OurPet’s Company
OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investors and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.
Forward-Looking Statements
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.
OurPet’s Company
Dr. Steven Tsengas, CEO, 440-343-6500, x111
or
DreamTeamNetwork
512-758-8877 Office
www.DreamTeamNetwork.com
Editor@DreamTeamNetwork.com
Santa Fe, New Mexico Police Department Continues Full-Fleet Deployment of the Total Integrated Solution Including DVM-800 In-Car Video Systems, FirstVu HD Body Cameras and VuLink(TM) Automatic Activation Technology
LENEXA, KS–(Oct 24, 2016) – Digital Ally, Inc. (NASDAQ: DGLY) (“Digital” or the “Company”), which develops, manufactures and markets advanced video surveillance products for law enforcement, homeland security and commercial applications, today announced the receipt of notable orders from the Santa Fe, New Mexico Police Department (“Santa Fe”) for its FirstVu HD body-worn camera, DVM-800 in-car digital audio/video system, DVM-440 Motorcycle system and patented VuLink® automatic activation system.
The Santa Fe Police Department has been a Digital Ally customer since 2008 and currently deploys the DVM-500 Plus Legacy in-car digital audio/video system in addition to its new DVM-800 in-car system. The latest order involves three DVM-440 Ultra motorcycle cameras and 27 additional DVM-800 in-car digital audio/video system as part of the Department’s plan to complete a full-fleet upgrade to Digital Ally’s integrated solution utilizing the Company’s FirstVu HD body-worn camera, DVM-800 in-car digital audio/video system, DVM-440 Ultra motorcycle camera system and patented VuLink® automatic activation system. The Santa Fe Police Department has previously completed orders in its planned upgrade including over 120 FirstVu HD body cameras and docking stations, 85 DVM-800 in-car digital video systems and approximately 40 patented VuLink® connectivity systems, which provide “hands-free activation” of the body-worn cameras and the in-car video systems in a fully integrated manner. Over 100 DVM-500 Plus legacy systems are expected to be upgraded in continuation of the planned full-fleet upgrade.
“This order illustrates an industry-wide trend in which we believe a growing number of law enforcement agencies will choose Digital Ally as their total video solution,” stated Stanton E. Ross, Chief Executive Officer of Digital Ally, Inc. “Our superior products and comprehensive back office software are fully integrated, thereby truly setting us apart from our competitors. The Santa Fe Police Department is just one of many agencies that have selected Digital Ally as their ‘one-stop’ video solution provider. An important factor in obtaining these orders is the ability to offer our patented VuLink® auto activation system, which allows our digital audio/video cameras (such as the DVM-800) and our body-worn cameras to automatically and simultaneously start recording once either of the devices is activated. This allows multiple recordings of the same event from different perspectives in order to provide a more comprehensive recording of incidents in the field. The automatic activation technology included in our patented VuLink® has quickly become a standard requirement in many requests for proposals and has drawn attention from our competitors, who have attempted to introduce their own automatic activation technology that we believe infringes on our patent. In that regard, the Company has initiated patent infringement lawsuits against two competitors: Taser International, Inc. and Enforcement Video, LLC d/b/a WatchGuard Video.”
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. The Company is headquartered in Lenexa, Kansas, and its shares are traded on The Nasdaq Capital Market under the symbol “DGLY.” For additional news and information please visit www.digitalallyinc.com or follow us on Twitter @digitalallyinc and Facebook www.facebook.com/DigitalAllyInc
Follow additional Digital Ally Inc. social media channels here:
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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 a growing number of law enforcement agencies will choose Digital Ally as their total video solution; the ultimate outcome of the Company’s litigation against Taser International, Inc. and Enforcement Video, LLC; competition from larger, more established companies with far greater economic and human resources; 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 annual report on Form 10-K for the year ended December 31, 2015 and quarterly report on Form 10-Q for the three and six months ended June 30, 2016, as filed with the Securities and Exchange Commission.
For Additional Information, Please Contact:
Stanton E. Ross
CEO
(913) 814-7774
or
Thomas J. Heckman
CFO
(913) 814-7774
Study Provides Further Validation of Company’s Proprietary Aerosol Delivery Technology Management to Discuss Results on a Conference Call, Tuesday, October 25, 2016 at 8:00 a.m.
WARRINGTON, Pa., Oct. 24, 2016 — Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today released data from a lung deposition study conducted in non-human primates (NHPs) that demonstrates the Company’s proprietary aerosol delivery system (ADS) is capable of delivering aerosolized KL4 surfactant throughout all regions of the lung. The study consisted of a series of experiments in NHPs designed to assess the distribution and deposition of aerosolized KL4 surfactant in the lung when administered using the ADS. The Company is developing the ADS as part of its lead development program, AEROSURF® (lucinactant for inhalation). AEROSURF is currently being studied in a phase 2b clinical trial as a potential noninvasive treatment for respiratory distress syndrome (RDS) in premature infants. The Company will host a conference call and live webcast on Tuesday, October 25, 2016 at 8:00 a.m. EDT to provide additional details of the study results as well as provide an update on the AEROSURF phase 2 program.
“These study results confirm the ability of our aerosol delivery technology to overcome the barriers of successfully aerosolizing and delivering a surfactant with particle sizes appropriate for deep lung delivery with uniform distribution across all regions of the lung,” commented Craig Fraser, President and Chief Executive Officer. “These results not only support the premise of our AEROSURF RDS program, but also complement the clinical evidence seen in our phase 2a trial in premature infants 29 to 34 week gestational age and provide further insight into other potential applications of this novel technology in the future.”
Data from this study were generated from an in vivo distribution study using three NHPs, cynomolgus macaques, which received three-to-ten minute exposures of technetium-labeled KL4 surfactant that was aerosolized using the same model ADS currently being used in the AEROSURF phase 2b clinical program. After administration, researchers immediately acquired 2-D planar images followed by 3-D SPECT images and then a second 2-D planar image to assess overall pulmonary distribution. Additionally, the 3-D SPECT lung data were analyzed using a quantitative methodology whereby regional distribution was assessed across ten equally sized shells (or layers) of the lung, from the innermost shell through the outermost shell.
Results from the analysis of the 2-D planar and 3-D SPECT images show that aerosolized KL4 surfactant, delivered using the ADS via constant flow nasal continuous positive airway pressure (nCPAP), was generally uniformly deposited in all regions of the NHPs lungs (Image 1 – right).
Results from a quantitative analysis further demonstrated that there was generally uniform distribution in all regions of the lung, with an average total lung distribution of 52 percent in the five inner shells and 48 percent in the five outer shells (Chart 1 – right).
“We are extremely pleased with the results of this study because, along with other work we have done, it serves as yet another validation of the potentially transformational capabilities of our ADS device, which aerosolizes our KL4 surfactant in a consistent and controlled flow and delivers it throughout the lungs to the areas where a surfactant needs to reach to produce its beneficial effects,” commented Steve Simonson, M.D, Senior Vice President and Chief Development Officer.
Conference Call and Webcast Details
The Company will host a conference call and webcast (including a slide presentation) at 8:00 a.m. EDT on Tuesday, October 25, 2016 to provide updates on the AEROSURF® phase 2 clinical program and the lung deposition study in non-human primates.
To participate in the live call and take part in the question and answer session, dial (844) 802-2436 (domestic) or (412) 317-5129 (international). The live webcast, including a slide presentation, can be accessed at http://windtreetx.investorroom.com/events.
A replay of the conference call will be accessible one hour after completion through November 1, 2016 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing conference number 10095419. An archive of the webcast can be accessed on the Company’s website at http://windtreetx.investorroom.com/events.
About AEROSURF®
Windtree’s lead product candidate is AEROSURF (lucinactant for inhalation), a novel, investigational combination drug/device product that combines the Company’s proprietary KL4 surfactant and aerosolization technologies. AEROSURF is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). Enrollment is ongoing in a phase 2b clinical trial to study AEROSURF administered to premature infants receiving nasal continuous positive airway pressure (nCPAP) for RDS, compared to infants receiving nCPAP alone. The phase 2b trial is a global trial with clinical sites in North America, Europe and Latin America.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree’s proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.
For more information, please visit the Company’s website at www.windtreetx.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties include those risks related to Windtree’s aerosolized KL4 surfactant development programs, including for AEROSURF, which may involve time-consuming and expensive clinical trials that may be subject to potentially significant delays or regulatory holds, or fail; risks related to the development of aerosol delivery systems (ADS) and related components; risks related to the manufacture by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree’s products; and other risks and uncertainties described in Windtree’s filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
HOUSTON, Oct. 24, 2016 — SAExploration Holdings, Inc. (NASDAQ:SAEX), or SAE, today announced that it has received approximately $24.4 million of tax credit certificates from the state of Alaska’s Department of Revenue. SAE further announced that as a result of receiving these tax credit certificates, and having substantially satisfied the conditional requirements under its senior term loan facility (the “Senior Loan Facility”), it has been granted access to the remaining $15.0 million of funding available under its Senior Loan Facility.
Jeff Hastings, Chairman and CEO of SAE, commented, “We are very pleased that we have begun to receive tax credit certificates from the State of Alaska sooner than expected and access to the remaining $15.0 million under our Senior Loan Facility ensures our ability to progress through the receipt and monetization of the remaining tax credits. We believe the value that can ultimately be derived from these tax credit certificates, and those yet to be issued, will be highly accretive to the company and to our stockholders.”
While some applications for tax credit certificates are still being processed by the State of Alaska, and certain remaining applications cannot be filed until after January 1, 2017, SAE currently expects to receive an additional $60.5 million of tax credit certificates from the State of Alaska over the next twelve months. While the method, terms and conditions are not certain, the company remains optimistic that it will be able to ultimately monetize a significant portion of its tax credit certificates absent material changes in Alaskan laws and further believes this process could begin before the end of this year. Any amounts received for the tax credit certificates will be applied towards the company’s outstanding accounts receivable. Consistent with the company’s past disclosure practices, however, SAE does not intend to disclose the monetization of any of its tax credit certificates, outside of its customary disclosures made in its periodic filings with the SEC.
Under the terms of SAE’s recently completed comprehensive restructuring, receipt of certificates evidencing Alaskan tax credits in excess of $25.0 million was a condition precedent to the advance of the remaining $15.0 million available under the Senior Loan Facility. Having substantially satisfied this requirement by receiving $24.4 million, or approximately 98%, of the required $25.0 million in face value of tax credit certificates, on October 24, 2016, a majority of the lenders under the Senior Loan Facility entered into Amendment No.1 to the Senior Loan Facility agreement, which waived the $25.0 million requirement, thereby granting SAE access to the remaining $15.0 million.
About SAExploration Holdings, Inc.
SAE is an internationally-focused oilfield services company offering a full range of vertically-integrated seismic data acquisition and logistical support services in remote and complex environments throughout Alaska, Canada, South America and Southeast Asia. In addition to the acquisition of 2D, 3D, time-lapse 4D and multi-component seismic data on land, in transition zones and offshore in depths reaching 3,000 meters, SAE offers a full suite of logistical support and in-field data processing services, such as program design, planning and permitting, camp services and infrastructure, surveying, drilling, environmental assessment and reclamation and community relations. SAE operates crews around the world, performing major projects for its blue-chip customer base, which includes major integrated oil companies, national oil companies and large independent oil and gas exploration companies. Operations are supported through a multi-national presence in Houston, Alaska, Canada, Peru, Colombia, Bolivia, Brazil, New Zealand and Malaysia. For more information, please visit SAE’s website at www.saexploration.com.
The information in SAE’s website is not, and shall not be deemed to be, a part of this notice or incorporated in filings SAE makes with the Securities and Exchange Commission.
Forward Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws with respect to SAE. These statements can be identified by the use of words or phrases such as “expects,” “estimates,” “projects,” “budgets,” “forecasts,” “anticipates,” “intends,” “plans,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions. These forward-looking statements include statements regarding SAE’s financial condition, results of operations and business and SAE’s expectations or beliefs concerning future periods and possible future events. These statements are subject to significant known and unknown risks and uncertainties that could cause actual results to differ materially from those stated in, and implied by, this press release. Risks and uncertainties that could cause actual results to vary materially from SAE’s expectations are described under “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in SAE’s Form 10-Q filed on August 12, 2016, for the period ended June 30, 2016. Except as required by applicable law, SAE is not under any obligation to, and expressly disclaims any obligation to, update or alter its forward looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.
Contact
SAExploration Holdings, Inc.
Ryan Abney
Vice President, Capital Markets & Investor Relations
(281) 258-4409
rabney@saexploration.com