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(SMMT) Completes Targeted Enrolment for SMT19969 Phase 2 Trial for C. diff
OXFORD, United Kingdom, Sept. 10, 2015 — Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection (‘CDI’), today announced the completion of patient enrolment into the CoDIFy Phase 2 proof of concept trial of SMT19969 for the treatment of CDI. Patient dosing and follow-up is continuing and top-line results are expected in the fourth quarter of 2015. SMT19969 is a novel, oral antibiotic designed to selectively target C. difficile bacteria while not harming the gut microbiome that is essential in protecting against disease recurrence.
“CDI is now widely accepted to be a major healthcare issue, and with current antibiotics used to treat CDI having high rates of disease recurrence, there is an urgent need to develop new therapies,” said Glyn Edwards, Chief Executive Officer of Summit. “We believe SMT19969 represents an important advance as its potency in killing C. difficile bacteria is complemented by selective targeting that leaves the healthy gut microbiome unharmed. The timely completion of enrolment into our CoDIFy proof of concept trial achieves an important milestone and means we remain on-track to report top-line results in the fourth quarter of this year.”
C. difficile is one of three pathogens that pose an immediate public health threat according to the US Center for Disease Control and Prevention (‘CDC’). CDI has a high economic impact with annual acute care costs estimated at $4.8 billion in the United States alone. The key clinical issue is disease recurrence with approximately 25% of patients suffering recurrence of CDI, a risk that rises to 40% after a first recurrence and over 65% after a second recurrence.
SMT19969 has received Qualified Infectious Disease Product designation (‘QIDP’) and Fast Track status from the US Food and Drug Administration. The development of SMT19969 is being supported by a Wellcome Trust Translational Award.
About CoDIFy Phase 2 Clinical Trial
CoDIFy, is a double-blind, randomized, active control Phase 2 trial evaluating the efficacy of SMT19969 against the current standard of care, vancomycin. CoDIFy is being conducted in the United States and Canada. The trial has enrolled a total of 100 patients, with half receiving ten days of dosing with SMT19969, and half receiving ten days of dosing with vancomycin. The primary endpoint of the trial is sustained clinical response, a composite endpoint which is defined as clinical cure at the test of cure visit with no recurrence of CDI within 30 days after the end of treatment. The trial is also examining a number of secondary endpoints, including the safety and tolerability of SMT19969 and its impact on patients’ gut microbiome.
About SMT19969
SMT19969 is a novel, oral small molecule antibiotic that is being developed specifically for the treatment of CDI. Results from non-clinical efficacy studies show that SMT19969 combines potent bactericidal activity against C. difficile with high levels of antibacterial selectivity. A Phase 1 trial conducted in healthy volunteers showed SMT19969 to be well tolerated at all doses tested. In addition, a significant reduction in total clostridia but not in other bacterial groups was reported, demonstrating that SMT19969 was highly sparing of the gut microbiome.
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).
For more information, please contact:
| Summit Therapeutics | |
| Glyn Edwards / Richard Pye (UK office) | Tel: +44 (0)1235 443 951 |
| Erik Ostrowski (US office) | +1 617 294 6607 |
| Cairn Financial Advisers LLP | |
| (Nominated Adviser) | |
| Liam Murray / Tony Rawlinson | Tel: +44 (0)20 7148 7900 |
| N+1 Singer | |
| (Broker) | |
| Aubrey Powell / Jen Boorer | Tel: +44 (0)20 7496 3000 |
| MacDougall Biomedical Communications | |
| (US media contact) | Tel: +1 781 235 3060 |
| Michelle Avery | mavery@macbiocom.com |
| Peckwater PR | |
| (Financial public relations, UK) | Tel: +44 (0)7879 458 364 |
| Tarquin Edwards | tarquin.edwards@peckwaterpr.co.uk |
Forward Looking Statements
Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, the timing of initiation, completion and availability of data from clinical trials and expectations regarding the sufficiency of Summit’s cash balance to fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.
(LIFE) Doses First Patient In Long-Term Safety Extension Study Of Resolaris™
Physiocrine-Based Therapy Harnesses Natural Immunomodulation Pathway to Address Rare Genetic Muscular Dystrophy
SAN DIEGO, Sept. 10, 2015 — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe rare diseases, today announced that the first patient has been dosed in a newly initiated long term-safety extension study of Resolaris™ for adult patients with facioscapulohumeral muscular dystrophy (FSHD), a rare and severe genetic myopathy for which there are currently no approved treatments.
The open label study is designed to assess the long-term safety, tolerability and biological activity of Resolaris™ and will include adult patients who are currently enrolled in an ongoing, double-blind, placebo-controlled, multiple ascending dose Phase 1b/2 trial of Resolaris™ in adult patients with FSHD. Data from the Phase 1b/2 study are expected in the fourth quarter of 2015 or first quarter of 2016. The extension study is expected to continue through mid-2016.
“Our Resolaris extension study takes the next step in developing a new class of Physiocrine-based medicines for patients who currently have few options. The trial will also expand our growing safety and tolerability database over a longer treatment period,” said John Mendlein, Ph.D., CEO and executive chairman of aTyr Pharma. “When given in therapeutic doses, we believe Physiocrine-based therapies may productively modulate immune processes by rebalancing the immune systems in chronic rare muscle diseases to provide new options for these severely affected patients.”
Resolaris™ is the first Physiocrine-based therapeutic under investigation for any disease and is based on a naturally occurring protein identified by aTyr Pharma. The Company is also planning trials in additional indications, including early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B, and both are expected to initiate later this year.
For additional information on this study, please visit www.clinicaltrials.gov.
About Physiocrines
Physiocrines comprise naturally occurring proteins that aTyr believes promote homeostasis, a fundamental process of restoring stressed or diseased tissue to a healthier state. Physiocrines are extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis. aTyr is currently focused on Physiocrines that act as endogenous modulators of the immune system. Physiocrines offer the opportunity for modulating biological pathways through newly discovered, naturally occurring mechanisms, many of which may provide advantages over engineered immuno-modulatory therapeutics, including the potential for improved patient outcomes and reduced side effect profiles.
About Resolaris™
aTyr Pharma is developing Resolaris™ as a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris™ is derived from a naturally occurring protein released in vitro by human skeletal muscle cells. aTyr believes Resolaris™ has the potential to provide therapeutic benefit to patients with rare myopathies with an immune component characterized by excessive immune cell involvement.
About FSHD
Facioscapulohumeral muscular dystrophy (FSHD) is a rare genetic myopathy affecting approximately 19,000 people in the United States for which there are no approved treatments. The primary clinical phenotype of FSHD is debilitating skeletal muscle deterioration and weakness. The symptoms of FSHD develop in a descending pattern, starting with the face and upper body to the lower body and progressing in a “muscle by muscle” fashion. In addition to muscle weakness, FSHD patients often experience debilitating fatigue and chronic pain. The disease is typically diagnosed by the presence of a characteristic pattern of muscle weakness and other clinical symptoms, as well as through genetic testing.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological modulators. The Company’s lead candidate, Resolaris™, is a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. Resolaris™ is currently in a Phase 1b/2 clinical trial in adult patients with facioscapulohumeral muscular dystrophy (FSHD). Trials are planned in additional indications, including early onset FSHD and limb-girdle muscular dystrophy (LGMD) 2B. Trials are also planned for indications in interstitial lung disease (ILD). To protect this pipeline, aTyr built an intellectual property estate comprising 45 issued or allowed patents and over 240 pending patent applications that are solely owned or exclusively licensed by aTyr. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. For more information, please visit http://www.atyrpharma.com.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential of Resolaris, the ability of the Company to undertake certain development activities (such as clinical trial enrollment and the conduct of clinical trials) and accomplish certain development goals, and the timing of initiation of additional clinical trials reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our Physiocrine-based product candidates, as well as those set forth in the prospectus for our recent offering of common stock and our most recent Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
(SGMO) Unanimous Recombinant DNA Advisory Committee Approval Of ZFP Phase 1 Protocol
First Application of Sangamo’s In Vivo Protein Replacement Platform (IVPRP) for Potential Cure of Hemophilia B
RICHMOND, Calif., Sept. 10, 2015 — Sangamo BioSciences, Inc. (Nasdaq: SGMO), a leader in therapeutic genome editing, announced unanimous approval by the National Institutes of Health’s Recombinant DNA Advisory Committee (RAC) of a Phase 1 study protocol for a ZFP Therapeutic as a potential curative therapy for hemophilia B. The Factor IX program will be the first clinical study of in vivo genome editing and the first therapeutic application of Sangamo’s In Vivo Protein Replacement Platform (IVPRP).
Sangamo expects to file an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) by the end of 2015 and, pending FDA clearance, plans to initiate a Phase 1 clinical trial in 2016. The Company recently reacquired all of its hemophilia assets from Shire plc as a result of the amendment to the companies’ 2012 collaboration and license agreement.
“Hemophilia B is the first clinical application of our IVPRP which can be applied to many other diseases that are currently treated by protein replacement including hemophilia A and lysosomal storage disorders,” said Geoff Nichol, M.B., Ch.B., Sangamo’s executive vice president of research and development. “Successful review, by the NIH RAC, of the first human in vivo genome editing clinical protocol is a major milestone for Sangamo. We appreciate this careful consideration and unanimous approval of our proposed clinical trial and look forward to the commencement of our Phase 1 study in the near future.”
“We are pleased with the outcome from this thorough review, by the NIH RAC, of our first IVPRP clinical protocol,” said Edward Lanphier, Sangamo’s president and chief executive officer. “We will continue to leverage the potential of this strategy for development of ZFP Therapeutics for other monogenic diseases, and remain on track to file IND applications for the hemophilia B program and the first of our lysosomal storage disorder programs by the end of 2015.”
Sangamo’s IVPRP
The IVPRP approach makes use of the albumin gene locus, a highly expressing and liver-specific genomic “safe-harbor site”, that can be edited with zinc finger nucleases (ZFNs) to accept and express any therapeutic gene. The platform enables the patient’s liver to permanently produce therapeutic levels of a corrective protein product such as factor VIII or IX to treat hemophilia, or replacement enzymes to treat lysosomal storage disorders. With such a large capacity for protein production (approximately 15g/day of albumin), which is in excess of the body’s requirements, targeting and co-opting only a very small percentage of the albumin gene’s capacity is sufficient to produce the needed replacement protein at therapeutically relevant levels with no significant effect on albumin production.
Sangamo
Sangamo BioSciences, Inc. is focused on Engineering Genetic CuresTM for monogenic and infectious diseases by deploying its novel DNA-binding protein technology platform in therapeutic gene regulation and genome editing. The Company has a Phase 2 clinical program to evaluate the safety and efficacy of novel ZFP Therapeutics® for the treatment of HIV/AIDS (SB-728). Sangamo’s other therapeutic programs are focused on monogenic and rare diseases. The Company has formed a strategic collaboration with Shire International GmbH to develop therapeutics for Huntington’s disease, and with Biogen Inc. for hemoglobinopathies, such as sickle cell disease and beta-thalassemia. It has also established strategic partnerships with companies in non-therapeutic applications of its technology, including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website at www.sangamo.com.
ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.
This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFNs, potential therapeutic applications of its ZFP technology for the treatment of hemophilia A and B, lysosomal storage disorders and other monogenic diseases, the potential therapeutic applications of the IVPRP, the expected timing for filing of IND applications and commencement of clinical trials. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties and risks relating to clinical trials, compliance with regulatory and other requirements, the ability of Sangamo to develop commercially viable products and technological developments by our competitors. See the SEC filings, and in particular, the risk factors described in Sangamo’s Annual Reports on Form 10-K and most recent Quarterly Reports on Form 10-Q. Sangamo does not assume any obligation to update the forward-looking information contained in this press release.
(FARM) to Present at the Inaugural B. Riley & Great American Group Consumer Conference
TORRANCE, Calif., Sept. 10, 2015 — Farmer Bros. Co. (“Farmer Brothers”, or the “Company”), a coffee roaster and distributor with a history of more than 100 years, has been invited to present at the Inaugural B. Riley & Great American Group Consumer Conference being held September 16, 2015 at the New York Athletic Club, New York.
Mike H. Keown, President & Chief Executive Officer and Mark J. Nelson, Treasurer and Chief Financial Officer are scheduled to present the corporate overview and strategy, and discuss the Company’s financial results and corporate relocation on Wednesday, September 16 in one‑on‑one meetings held throughout that day from 8:00 a.m. Eastern time.
A copy of the presentation will also be available on the Investor Relations section of the Company’s website at www.farmerbros.com at the time of the presentation.
For more information about the conference or to schedule a one-on-one meeting with Farmer Brothers management, please email conference@brileyco.com.
About Farmer Bros. Co.
Founded in 1912, Farmer Bros. Co. is a manufacturer, wholesaler and distributor of coffee, tea and culinary products. The Company’s customers include restaurants, hotels, casinos, offices, quick service restaurants (“QSRs”), convenience stores, healthcare facilities and other foodservice providers, as well as private brand retailers in the QSR, grocery, drugstore, restaurant, convenience store, and independent coffee house channels. The Company’s product line includes roasted coffee, liquid coffee, coffee-related products such as coffee filters, sugar and creamers, assorted iced and hot teas, cappuccino, cocoa, spices, gelatins and puddings, soup bases, dressings, gravy and sauce mixes, pancake and biscuit mixes, and jellies and preserves. Currently headquartered in Torrance, Calif., Farmer Bros. Co. generated net sales of over $500 million in fiscal 2015 and has approximately 1,800 employees nationwide. The Company’s primary brands include Farmer Brothers™, Artisan Collection by Farmer Brothers™, Superior®, Metropolitan™ , Cain’s™ and McGarvey®. For more information, visit: www.farmerbros.com.
Contact: Farmer Bros. Co. Mark Nelson (310) 787-5241
(ENVI) Ericsson Announces Agreement to Acquire Envivio
Shareholders to Receive $4.10 Per Share in Cash in Transaction Valued at Approximately $125 Million
SAN FRANCISCO, Sept. 10, 2015 — Envivio, Inc. (Nasdaq:ENVI), a leading provider of software-based video processing and delivery solutions, today announced that it has entered into a definitive agreement to be acquired by Ericsson, a provider of communications technology and services.
“The uniting of Envivio’s pioneering software solutions and Ericsson’s strength in the marketplace is a great combination for our customers and stockholders,” said Julien Signès, founder and CEO of Envivio. “Ericsson shares a similar vision for the future of video processing and shift to software defined and virtualized encoding solutions. Ericsson brings tremendous resources, a broad product and solutions portfolio and reach that will accelerate the adoption of Envivio’s software-based video solutions.”
As part of Ericsson’s TV and Media business, Envivio will continue to work with its customers and partners to develop its current software based video solutions for video processing, delivery and monetization. Envivio’s customers will be able to rely on the global stability and scale and the strong commitment of Ericsson in the TV and Media business with access to Ericsson’s full portfolio of products, solutions, and global services expertise.
“Our consumer research clearly shows that viewers are demanding TV on their terms on any device, and expecting experiences that continually evolve,” said Per Borgklint, Senior Vice President and Head of Business Unit Support Solutions at Ericsson. “We are committed to offering our customers a clear path towards fully agile cloud agnostic platforms that delight TV consumers. I look forward to welcoming the market leader in pure software-defined video encoding, processing, and packaging into Ericsson. The combination will strengthen our encoding position with both custom silicon and pure software encoding, delivering performance and flexibility.”
Under the terms of the definitive agreement, Ericsson will commence a cash tender offer to purchase all of Envivio’s outstanding shares, with a merger following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $4.10 per share. Certain of Envivio’s major stockholders, collectively owning approximately 34 percent of Envivio’s outstanding common stock, have entered into a tender and support agreement with Ericsson committing to tender all of their Envivio shares in the tender offer and to vote in favor of the merger. The acquisition is expected to close in the fourth quarter of 2015, subject to customary closing conditions.
The board of directors of Envivio has unanimously agreed to recommend that Envivio’s stockholders tender their shares to Ericsson in the tender offer.
For further information regarding all terms and conditions contained in the definitive merger agreement, please see Envivio’s Current Report on Form 8-K, which will be filed in connection with this transaction.
About Envivio
Envivio (NASDAQ:ENVI) is a global market leader and innovator of video software solutions that are trusted by video service providers and content companies worldwide to power stunning video quality and captivating, personalized experiences to our millions of viewers on any device, over any network. Leveraging our pioneering and technically superior virtualized video delivery solutions, we enable video operators of any size to increase revenues and reduce costs while uniquely providing the best-in-class quality, reliability, efficiency, and scalability to support the new age of video anywhere. Envivio is headquartered in San Francisco, California with offices worldwide in France, China and Singapore. Visit www.envivio.com for more information, or connect with us on LinkedIn.
About Ericsson
Ericsson (NASDAQ:ERIC) is the driving force behind the Networked Society – a world leader in communications technology and services. Our long-term relationships with every major telecom operator in the world allow people, business and society to fulfill their potential and create a more sustainable future.
Our services, software and infrastructure – especially in mobility, broadband and the cloud – are enabling the telecom industry and other sectors to do better business, increase efficiency, improve the user experience and capture new opportunities.
With approximately 115,000 professionals and customers in 180 countries, we combine global scale with technology and services leadership. We support networks that connect more than 2.5 billion subscribers. Forty percent of the world’s mobile traffic is carried over Ericsson networks. And our investments in research and development ensure that our solutions – and our customers – stay in front.
Founded in 1876, Ericsson has its headquarters in Stockholm, Sweden. Net sales in 2014 were SEK 228.0 billion (USD 33.1 billion). Ericsson is listed on NASDAQ OMX stock exchange in Stockholm and the NASDAQ in New York.
Important Additional Information
The tender offer for the outstanding common stock of Envivio has not yet commenced. This communication is for informational purposes only and it is neither an offer to purchase nor a solicitation of an offer to sell shares of Envivio common stock. At the time the tender offer is commenced, Ericsson will file a tender offer statement, containing an offer to purchase, a form of letter of transmittal and other related tender offer documents with the Securities and Exchange Commission (the “SEC”), and Envivio will file a Solicitation/Recommendation Statement on Schedule 14D-9 relating to the tender offer with the SEC. Envivio’s stockholders are strongly advised to read these tender offer materials, as well as any other documents relating to the tender offer and the associated transactions that are filed with the SEC, carefully and in their entirety when they become available, and as they may be amended from time to time, because they will contain important information about the tender offer that Envivio’s stockholders should consider prior to making any decisions with respect to the tender offer. Once filed, stockholders of Envivio will be able to obtain a free copy of these documents at the website maintained by the SEC at www.sec.gov or by directing a request to Ericsson, Investor Relations, +46 10 719 00 00 or e-mail: investor.relations@ericsson.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the anticipated benefits of the proposed acquisition of Envivio by Ericsson, the potential impact to Envivio’s customers of the proposed acquisition of Envivio and other statements relating to the combined entity following the proposed acquisition. Although we attempt to be accurate in making forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Important factors that could cause results to differ materially from the statements herein include the following, general economic risks; execution risks with acquisitions; closing conditions; risks associated with sales not materializing based on a change in circumstances; disruption to sales following acquisitions; increasing competitiveness in the video processing and delivery market; ability to retain key personnel from the acquisition, unexpected changes in Envivio’s business, the loss of significant customers, changes in capital spending in the markets Envivio serves, the failure of Envivio’s target markets to develop as anticipated, disruption with existing channel partners, unpredictable sales cycles, fluctuations in operating results, failure to develop new and enhanced products in a timely manner, the loss of a key customer or customers, the loss of a key supplier or suppliers, claims of technology infringement, general economic conditions and other risks detailed from time to time in Envivio’s Quarterly Report on Form 10-Q for the three months ended April 30, 2015 and other SEC reports, which can be found at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements herein reflect our opinions only as of the date of this release, and we undertake no obligation, and expressly disclaim any obligation, to update forward-looking statements herein in light of new information or future events.
CONTACT: NMN Advisors
Investor Relations
Avelina Kauffman
ir@envivio.com
+1.510.344.2664
(TNDM) Announces FDA Approval of t:slim G4 Insulin Pump with CGM Integration
The First and Only CGM-enabled Touch-Screen Pump
SAN DIEGO, Sept. 9, 2015 — Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced U.S. Food and Drug Administration approval of the t:slim G4™ Insulin Pump, the first and only touch-screen pump with continuous glucose monitoring (CGM) integration, for use by people 12 years of age or older who use insulin. It combines features of the t:slim® Insulin Pump and Dexcom G4® PLATINUM CGM System, devices that have consistently ranked #1 in independent surveys1, into a single device that is simple to use. The t:slim G4 Pump is the only pump that conveniently displays CGM graphs and trend information with current insulin delivery activity together on the home screen to help make informed treatment decisions. Orders for the t:slim G4 Insulin Pump can be placed now with shipments expected to begin in October 2015.
“The t:slim G4 Pump combines our intuitive touch-screen interface and bright color display with Dexcom’s CGM technology, giving the diabetes community a powerful new tool to help simplify therapy management,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “CGM integration has been one of the most requested features since the launch of the t:slim Pump. The addition of t:slim G4 to our product family allows us to address a wider variety of diabetes management needs through the broadest range of insulin pump options available from one company.”
“The integration of Tandem’s touch-screen interface and Dexcom’s G4 PLATINUM CGM product could prove to be a powerful combination for people with diabetes,” said Kupper Wintergerst, MD, pediatric endocrinologist at the University of Louisville and director of the Wendy L. Novak Diabetes Care Center in Louisville, KY. “It’s great to have another integrated option for my patients, particularly one with an age indication for people as young as 12 years old.”
“We believe the t:slim G4 Pump’s touch screen technology and simple user interface are a great combination for Dexcom G4 PLATINUM CGM integration,” said Steve Pacelli, EVP, Strategy and Corporate Development at Dexcom. “CGM-integration is key to future automated insulin delivery technology, and we are pleased to be working with a company like Tandem who is continuously innovating to make diabetes technology simpler to use for people with diabetes.”
The t:slim G4 Pump is the newest addition to the Company’s family of products, which includes the t:slim® and t:flex™ Insulin Pumps. Each pump in the portfolio features a touch-screen with a streamlined, user-friendly interface. This provides people rapid access to frequently used features while eliminating the need for excessive scrolling and button pressing, making these features simple to learn and simple to use. Each Tandem product utilizes modern technology, such as a built-in rechargeable battery and micro-USB port for convenient charging and fast data transfers. They also feature the Company’s Micro-Delivery® technology that allows for basal delivery every 5 minutes in increments as small as 0.001 unit. The t:slim G4 and t:slim Pumps are the slimmest and smallest durable insulin pumps on the market, yet still hold up to 300 units of insulin, and the t:flex offers similar size benefits while holding up to 480 units of insulin.
The t:slim G4 Pump can operate as a stand-alone insulin pump without CGM, or be paired with a Dexcom G4 PLATINUM sensor. When paired with a sensor, the CGM component of the pump closely mimics the interface of the Dexcom system, tracking glucose continuously and displaying color-coded graphs and arrows directly on the Pump’s home screen2. The system also allows users to program personalized information, such as glucose targets and alerts, and has an alarm feature to notify the user if glucose levels rise or fall to dangerous levels.
For additional product and safety information, or to begin the order process, visit www.tandemdiabetes.com/tslimG4
or call (877) 801-6901, Monday – Friday between 6am and 5pm Pacific Time
Download Tandem’s free t:simulator™ App to experience the t:slim G4 Pump’s touch screen interface directly on your mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans. Tandem estimates that more than 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 425,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 125,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.
Conference Call Details:
The Company will hold a conference call and simultaneous webcast on September 9, 2015 at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss FDA approval of the t:slim G4 Insulin Pump with CGM Integration. To listen to the conference call, please dial (855) 427-4396 (US/Canada) or (484) 756-4261 (International) and use the participant code “37158883”. A link to the webcast will be available on Tandem Diabetes Care’s Investor Center website located at http://investor.tandemdiabetes.com in the “Investor Events” section. An archive of the webcast will be available for 30 days following the event.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim® Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, the t:flex™ Insulin Pump, the first pump designed for people with greater insulin requirements, and the t:slim G4™ Insulin Pump, the first CGM-enabled pump with touch-screen simplicity. Tandem is based in San Diego, California.
Forward Looking Statement
This press release includes forward-looking statements relating to the anticipated timing of the commercial launch of the t:slim G4 Pump, the anticipated benefits associated with use of the t:slim G4 Pump and the potential advantages of the t:slim G4 Pump over existing insulin pumps. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including: Tandem’s ability to begin commercial scale manufacturing of the t:slim G4 Pump and associated cartridges; the potential that newer products that compete with the t:slim G4 Pump, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, including potential new products offered by Dexcom, may render the t:slim G4 Pump obsolete or less desirable; the potential that customers may not perceive the anticipated benefits associated with the use of the t:slim G4 Pump when paired with a Dexcom G4 sensor; the potential that customers may not be willing to concurrently use a G4 sensor and the t:slim G4 Pump; and other risks identified in Tandem’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update any forward-looking statement in this press release.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim, #tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at http://www.linkedin.com/company/tandemdiabetes
t:slim, Micro-Delivery and Tandem Diabetes Care are registered trademarks, and t:slim G4, t:flex, and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G4 PLATINUM are registered trademarks of Dexcom, Inc.
1 dQ&A USA Diabetes Connections Surveys. t:slim Pump: 2013-2014. Dexcom G4 PLATINUM CGM: 2009-2014.
2 A minimum of two finger sticks a day is required for calibration. System may require more.
(CRNT) Large Mobile Operators Expand 4G Services Throughout North America
LITTLE FALLS, New Jersey, September 9, 2015 —
Ceragon Networks Ltd. (NASDAQ: CRNT), the #1 wireless backhaul specialist today announced that three large North American mobile operators, all existing Ceragon customers, are deploying its IP-20 platform for their separate 4G network expansion and modernization projects.
The growing demand for Ceragon’s IP-20 platform in North America is attributed to its high capacity, high availability, high reliability and backwards compatibility capabilities, providing exceptional performance. These mobile operators chose Ceragon’s IP-20 wireless backhaul solution as it enables them to quickly and efficiently modernize the existing networks to 4G and rapidly expand coverage and capacity. The IP-20 platform allows them to meet increasing network traffic demands with its ability to deliver the highest possible capacity under any condition, while ensuring maximal spectral efficiency. By providing uncompromised reliability and redundancy, Ceragon’s IP-20 platform ensures consistent and reliable network performance, hence enabling all three operators to deliver an excellent, uninterrupted mobile experience to their end users.
The Ceragon offering allows these three long standing Ceragon customers to save significant CAPEX and OPEX as they are able to leverage their legacy Ceragon antennas and radios while performing minimal upgrades to sites. The operators additionally enjoy the IP-20 platform’s backwards compatibility capabilities with legacy Ceragon products installed at remote sites, which significantly reduce implementation times and required site visits, ultimately allowing their network to be up and running quickly with minimal service interruptions. With its compact radios, the IP-20 platform also saves operators site and tower real estate costs. The Ceragon high power IP-20 platform delivers operators a complete wireless backhaul solution that enables them to meet their operational efficiency targets.
“We are extremely pleased to see our North American customers embracing the IP-20 platform in their 4G expansion projects,” said Ira Palti, president and CEO of Ceragon. “We appreciate the long term partnerships we have with our customers, and are to continuously providing them with a truly best of breed portfolio of products that meets their current and future needs.”
About Ceragon Networks Ltd.
Ceragon Networks Ltd. (NASDAQ: CRNT) is the #1 wireless backhaul specialist. We provide innovative, flexible and cost-effective wireless backhaul solutions that enable mobile operators and other service providers to deliver 4G/LTE, 3G/2G, and other wireless broadband services to their subscribers with high quality of experience. Our solutions are deployed by public utilities, government and defense organizations for delivering mission critical multimedia and other applications at high reliability and speed. Ceragon’s high-capacity solutions use microwave technology to transfer multimedia, voice and data traffic while maximizing bandwidth efficiency, to deliver more capacity over longer distances under any deployment scenario. Based on our extensive global experience, Ceragon delivers turnkey solutions that support service provider profitability at every stage of the network lifecycle enabling faster time to revenue, cost-effective operation and simple modernization to all-IP networks. As the demand for multimedia services pushes the need for ever-increasing capacity, Ceragon is committed to serve the market with unmatched technology and innovation, ensuring effective solutions for the evolving needs of the marketplace. Our solutions are deployed by more than 430 service providers in over 130 countries.
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Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.
Safe Harbor
This press release contains statements concerning Ceragon‘s future prospects that are “forward-looking statements“ under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,“ “plans,“ “anticipates,“ “believes,“ “estimates,“ “predicts,“ “expects,“ “intends,“ “potential“ or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon‘s expectations regarding future revenues and profitability will not materialize; the risk that Ceragon will not comply with the financial or other covenants in its agreements with its lenders; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera‘s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon‘s Annual Report on Form 20-F and Ceragon‘s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
Media Contact:
Matthew Krieger
GK Public Relations
Tel: +1-914-768-4219
matthew@gkpr.com
Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163
tanyas@ceragon.com
Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080
claudiag@ceragon.com
(CFRXW) Announces Poster Presentation at the ICAAC/ICC 2015 Meeting for CF-301
First Lysin Allowed by the FDA to Enter Human Clinical Trials
YONKERS, NY–(Sep 9, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that it will present new preclinical data for its lead compound CF-301 in a poster presentation at the ICAAC/ICC 2015 conference September 17-21, 2015 in San Diego, CA.
The company will present preclinical findings on CF-301, which is currently in Phase I development for the treatment of Staph aureus bloodstream infections, including MRSA. The abstract summarizing the data is published on the ICAAC/ICC website and is available to conference registrants at: http://www.abstractsonline.com/plan/start.aspx
Details of the poster presentation are as below:
Presentation Title: Lysin CF-301 Activates Daptomycin in Pulmonary Surfactant in vitro and Rescues Mice from Lethal Staphylococcal Pneumonia
Session Day & Time: Friday, September 18, 2015 12:00 PM – 2:00 PM PT
Location: Exhibit Hall F/San Diego Convention Center
Poster Number: F-290b
Session Title: New Agents and Approaches Addressing Gram-Positive Pathogens, including Mycobacteria
About CF-301:
CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.
About ContraFect:
ContraFect is a clinical-stage biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. ContraFect intends to address drug-resistant infections using its therapeutic product candidates from its lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (drug-resistant staphylococcus bacteria) and influenza.
About the ICAAC/ICC 2015
ICAAC/ICC 2015 is a joint meeting of American Society for Microbiology (ASM)’s Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Society of Chemotherapy (ISC)’s International Congress of Chemotherapy and Infection (ICC). ICAAC, the premier conference on antimicrobial agents and infectious diseases, showcases the latest-breaking science and lectures from top researchers from around the world. With over 60% of its attendees living outside of the United States, ICAAC provides a rare opportunity to bring together the field’s foremost leaders to discuss the state of infection control and prevention on a global scale. Through oral and poster presentations, 10,000 physicians, clinical microbiologists, researchers, and pharmacists will come together to share their research, discover the latest breakthroughs, and work towards fostering global solutions to the problems of infectious diseases and antimicrobial agents.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “potential” or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include statements regarding our preclinical data that will be presented at ICAAC/ICC and our ability to address drug-resistant infections using our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses, all of which are subject to certain assumptions, risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contact:
Paul Boni
ContraFect Corporation
Tel: 914-207-2300
Email: Email Contact
Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact
(WGBS) to Present New Single-Cell System Results at the Single Cell Genomics Meeting
Data Generated From Early Access Program Also to be Presented
FREMONT, Calif., Sept. 9, 2015 — WaferGen Bio-systems, Inc. (Nasdaq:WGBS) will present results from the Company’s single-cell analysis system at the Single Cell Genomics (SCG) Conference on September 16th, 2015, in Utrecht, The Netherlands. The presentation will highlight throughput and performance levels not previously achieved prior to the development of WaferGen’s single-cell research platform (poster abstract code P036). In addition, data generated by the Company’s single-cell early access partners utilizing WaferGen’s technology will also be presented at the conference.
Both the in-house generated results and the data produced by WaferGen’s partners will demonstrate that thousands of individual cells can be isolated and analyzed from heterogeneous cell populations which, when coupled with partitioning the chip into multiple sections, allows for powerful screening of cells for applications including therapeutic dose determination and gene insertion/deletion efficacy studies. WaferGen’s presentation, which will be given by Dr. Maithreyan Srinivasan, the Company’s Chief Technology Officer, will also include a demonstration of a first of its kind software designed specifically for selecting isolated cells for subsequent processing for RNA-Sequencing applications.
“The development of our single-cell analysis platform is progressing extremely well. The system is producing compelling data both in-house and with our world-class early access partners at Genentech, Karolinska Institutet, National Jewish Health, and MD Anderson Cancer Center. We are pleased to present late-breaking results of our program at SCG 2015, and look forward to providing additional details surrounding these results shortly,” said Rollie Carlson, President and CEO of WaferGen.
About WaferGen
WaferGen Bio-systems, Inc. is a biotechnology company that offers innovative genomic technology solutions for single-cell analysis and clinical research. The single cell analysis platform is a revolutionary system which can isolate thousands of single cells and processes specific cells for analysis, including Next Generation Sequencing (NGS). The SmartChip platform can be used for profiling and validating molecular biomarkers, and can perform massively-parallel single-plex PCR for one-step target enrichment and library preparation for clinical NGS. These technologies offer a powerful set of tools for biological analysis at the molecular and single-cell level in the life sciences, pharmaceutical, and clinical laboratory industries.
About SCG 2015
Building on the success of the single cell genomics meeting at the Karolinska Institutet in September 2014 and at the Weizmann Institute in 2013, the third Single Cell Genomics meeting will be held September 16-18, 2015, at the Hubrecht Institute in Utrecht, The Netherlands. Single cell genomics is rapidly emerging as a revolutionary technology transforming many fields of biological research. Through its many applications (single cell genome sequencing, single cell transcriptomics, various single cell epigenetic profiling approaches), researchers can characterize the genetic and functional properties of individual cells in their native conditions, leading to numerous experimental and clinical opportunities.
The conference will bring together many of the pioneers and leading experts in the field for three days of extensive, interdisciplinary and informal discussion. The meeting will include presentations from thirty invited leaders and several selected abstracts, a poster session and many opportunities for interaction. (www.weizmann.ac.il/conferences/SCG2015)
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
CONTACT: INVESTOR CONTACTS:
LifeSci Advisors, LLC
Brian Ritchie
BRitchie@LifeSciAdvisors.com
WaferGen Bio-systems, Inc.
Rollie Carlson
Rollie.Carlson@wafergen.com
(LATX) NFL Week One Contests Now Available on 360 Fantasy Live.com
360 Fantasy Live Offers $5 in Matching Funds With Promo Code “360LIVE”; Users Have the Chance to Win Big Money
NEW YORK, NY–(Sep 9, 2015) – Latitude 360, Inc. (OTCQB: LATX) (www.latitude360.com), the “ultimate upscale multi-dimensional entertainment eatery,” has kicked-off its highly anticipated daily fantasy football contests for the first week of the 2015 National Football League (NFL) season on 360 Fantasy Live (www.360fantasylive.com).
Based on finalized rosters of NFL teams, 360 Fantasy Live will provide its wide range of daily and weekly NFL contests throughout the entire 2015 season. 360 Fantasy Live players can make their own game plan, choosing from free entry games and wagered games contests as they line up against other players and have the chance to win big money every day. Weekly NFL contests include week long contests as well as daily contests specific to Sunday and Monday night games.
The 360 Fantasy Live platform also includes other exciting sports competitions, including daily Major League Baseball contests, which are also currently available for play.
To celebrate the launch of 360 Fantasy Live, new users are being offered $5 in matching funds for a limited time when they join 360 Fantasy Live and deposit at least $5 within 30 days. New users need to use the promo code “360LIVE” when signing up at www.360fantasylive.com to receive the funds.
In addition to appealing to national fantasy sports enthusiasts, 360 Fantasy Live will be activated within all of Latitude 360’s cutting-edge dining and entertainment venues. Now, in addition to enjoying top-quality entertainment, food and drinks, guests can participate in daily fantasy contests while watching their players perform on huge HD screens.
“We’re excited to enhance our current line of offerings with the launch of 360 Fantasy Live, building on the months-long excitement and competitiveness of the NFL season. Our mission is to continually evolve the Latitude 360 brand to reach more consumers and build customer loyalty once they step into our venues — all part of an overarching vision to empower our brand and exponentially grow shareholder value,” said Brent Brown, CEO of Latitude 360. “By strengthening the entertainment value for sports fanatics, we believe we’re on track to achieve this goal.”
ABOUT LATITUDE 360
Latitude 360 (OTCQB: LATX) is an award-winning pioneer of combining premier upscale casual dining with state-of-the-art entertainment creating a “360 Experience” in its unique venues. The Company develops, constructs and operates cutting-edge Latitude 360 locations (from 50,000-70,000 sq. ft.) that appeal to a broad base of consumers and corporate clients. Current locations can be found in Jacksonville, Pittsburgh, and Indianapolis. Management plans to open three new venues per year for the next four years. Two new locations in Syracuse, NY and Bethlehem, PA are expected to operate as Latitude 360 locations in the fourth quarter of this year.
Latitude 360’s “360 Experience” provides a dining and entertainment experience unlike any concept in the world. Key offerings at each Latitude 360 location include, but are not limited to:
- Latitude 360 Grille, a full-service, upscale casual restaurant and bar
- Latitude LIVE, a Las Vegas-style live entertainment theatre
- 360 Fantasy LIVE, providing daily fantasy sports contests for guests including the ability to wager and win big money while enjoying top quality sports watching on massive HD screens (and continue playing outside the venue via www.360fantasylive.com)
- Axis Bar & Stage, a lush bar featuring the area’s top musicians and/or DJ’s
- Luxury Bowling, a high end lounge for boutique bowling lanes
- Cinegrille, a full service dine-in movie experience
- HD Sports Theater, a state-of-the art HD viewing area with full service dining
- Arcade, an exciting game arcade featuring the most popular video and redemption games available
- Latitude Lit, a luxury Cigar Lounge
Safe Harbor Statement
This press release contains “forward-looking statements.” Such statements include those related to the company’s expectations about future events or financial performance, including the potential acquisition of the Revolutions venues, the anticipated benefits of the potential acquisition, anticipated growth opportunities, a potential listing of the Company’s stock on a securities exchange and access to capital, and are not historical facts. Forward-looking statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements are not guarantees of future performance, are based on certain assumptions, and are also subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in forward-looking statements. The company does not undertake any obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
5W Public Relations
Latitude360@5wpr.com
+1-212-999-5585
(NVIV) Announces Enrollment of Fifth Patient in Pilot Spinal Cord Injury Study
– Communicates Intent to Incorporate Pilot Study into Pivotal Probable Benefit Study –
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the fifth patient has been enrolled in the company’s ongoing pilot study of its investigational Neuro-Spinal Scaffold™ implant in patients with acute thoracic spinal cord injury at the Keck Hospital of University of Southern California (USC) in Los Angeles.
Patrick Hsieh, M.D., Principal Investigator at this site, performed the fifth-ever Neuro-Spinal Scaffold implantation approximately 69 hours after the injury occurred.
“Enrolling the fifth patient in our first clinical study is a momentous milestone for the company, and we are pleased this accomplishment came ahead of previous guidance,” said Mark Perrin, InVivo’s CEO and Chairman. “We are in productive discussions with the FDA regarding the transition to the pivotal probable benefit study, and our plan is to incorporate the pilot study into the pivotal probable benefit study. We expect to use this single study as the basis for a Humanitarian Device Exemption (HDE) application, which would allow us to dramatically reduce the time to approval and commercialization.”
Mr. Perrin continued, “While we are discussing plans with the FDA for the pivotal probable benefit study and the incorporation of the pilot study, we intend to request expanding the number of patients in the current pilot study beyond five to further compress clinical timelines. We anticipate that we will receive formal approval of this expansion within the next two months. During this interim period, additional eligible patients at participating clinical sites may receive the Neuro-Spinal Scaffold under the Emergency Use Expanded Access Mechanism on a case-by-case basis, and the safety and outcomes data from these patients will be included in the HDE application. We have fostered a collaborative relationship with the FDA, and we are optimistic that we will finalize the pivotal probable benefit study design in the coming months.”
For more information, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110
About the Neuro-Spinal Scaffold™
Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011 the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the FDA’s approval of a new pivotal study and/or an expansion of the company’s pilot study and the timing of such approvals and the nature of the company’s negotiations with the FDA and the timeline for commercialization of the Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the volatility of the trading price of the company’s common stock; the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to modify its pilot trial protocol or to conduct a future study; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
(IPXL) Announces Resolution of FDA Warning Letter Related to its Hayward Manufacturing Facility
– Impax to Host Conference Call Today at 8:30 AM ET –
HAYWARD, Calif., Sept. 8, 2015 — Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it received written notice from the United States Food and Drug Administration (FDA) verifying that the Company has successfully addressed all items raised by the FDA in the May 2011 Warning Letter relating to its Hayward, California manufacturing facility.
The FDA notice follows a re-inspection in 2015 by the FDA of the Hayward facility. Receipt of the FDA notice means that pursuant to the Agency’s regulatory practice, the Company’s remediation activities at the Company’s Hayward facility and its quality management and compliance systems of the facility are deemed to be acceptable.
“Resolving the FDA Warning Letter is a testament to the progress we have made toward improving our quality and compliance systems in Hayward, with such initiatives being fully instituted across the Company,” said Fred Wilkinson, President and Chief Executive Officer of Impax. “We want to thank the FDA for working cooperatively with us to resolve the items previously raised by the Agency. We will remain committed to investing in our Quality Improvement Program and maintaining a culture that is focused on continuously improving these key systems.”
“With the resolution of the Warning Letter, we are excited about the potential for approvals and launches of new products from this facility. While we cannot predict the timing of approvals, we are planning to accelerate certain spending initiatives during the remainder of 2015 in order to prepare for these potential events. Despite the increase in costs associated with these activities, we continue to expect that we will remain within the ranges of our previously issued guidance for full year 2015.”
Conference Call Information
The Company will host a conference call with financial analysts at 8:30 a.m. ET today. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 35430606. A replay of the conference call will be available shortly after the call for a period of seven days. To access the replay, dial (855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers).
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. For more information, please visit the Company’s Web site at: www.impaxlabs.com.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in revenues and operating income; the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner; reductions or loss of business with any significant customer; the substantial portion of the Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the impact of competition; the Company’s ability to sustain profitability and positive cash flows; any delays or unanticipated expenses in connection with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal, and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies; product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements ; the Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the Company’s lack of a license partner for commercialization of IPX066 outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply chain; the Company’s policies regarding returns, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property; exposure to product liability claims; risks relating to goodwill and intangibles; changes in tax regulations; the Company’s ability to manage growth, including through potential acquisitions and investments; the integration of the acquired business of Tower Holdings, Inc. and Lineage Therapeutics Inc. by the Company being more difficult, time-consuming or costly than expected, operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) being greater than expected following the acquisition, the retention of certain key employees of the acquired business being difficult, the Company’s and the acquired business’s expected or targeted future financial and operating performance and results, the combined company’s capacity to bring new products to market, and the possibility that the Company may be unable to achieve expected synergies and operating efficiencies in connection with the acquisition within the expected time-frames or at all, the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of indebtedness and liabilities and the potential impact on cash flow available for operations; uncertainties involved in the preparation of the Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Company Contacts:
Mark Donohue
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com
(CAPN) Acquires Neonatal Pulmonary Resuscitation Solutions From NeoForce Group
Acquisition Strengthens Capnia’s Presence in Neonatology
NeoForce President and Chief Executive Officer to Join Capnia as General Manager of Neonatology
REDWOOD CITY, Calif., Sept. 8, 2015 — Capnia, Inc. (NASDAQ:CAPN), focused on the development and commercialization of novel products based on its proprietary technologies for precision metering of gas flow, today announced that it has acquired substantially all assets from privately-held NeoForce Group, Inc., a developer of innovative pulmonary resuscitation solutions for the inpatient and ambulatory neonatal markets.
Under the terms of the agreement, Capnia will pay to NeoForce a $1.0 million upfront payment, which represents less than one times of NeoForce’s 12-month forward looking revenue, plus a low single-digit royalty on sales of NeoForce products for a period of 36 months. NeoForce’s currently marketed products include the NeoPIP™ Infant T-Piece Resuscitator and the CPRNome Resuscitation Timer. Additionally, NeoForce President and Chief Executive Officer, Otho Boone, will join the Company as General Manager of Neonatology. Mr. Boone, who founded NeoForce in 2005, brings to Capnia over 25 years of medical device sales, operations and product development experience at neonatology focused companies such as Drager, Hill-Rom Air Shields and Ohmeda. Prior to founding NeoForce, Mr. Boone was Vice President of Global Marketing at Drager.
“The acquisition of NeoForce further underscores our commitment to leveraging technology to address unmet medical needs in Neonatology, which is one of the most attractive segments in the healthcare business today,” said Anish Bhatnagar, MD, Chief Executive Officer of Capnia. “As General Manager of Neonatology, Otho brings a depth of expertise and broad relationships with top tier hospitals across the United States which we can leverage to accelerate the adoption of our CoSense® ETCO monitor. Neonatology is a high-growth area, and we believe that the addition of Otho and the NeoForce product line, together with the ongoing commercial rollout of CoSense®, significantly strengthen our presence in this area.”
“I am excited to be joining the Capnia team and advancing the Company’s commercial efforts,” said Otho Boone, President and CEO of NeoForce. “NeoForce is a revenue generating, profitable entity that will benefit greatly from additional commercial manpower to further scale its operations. We also have a number of new products that we would like to bring to the market. Capnia’s expertise is highly complementary, and I look forward to calling on new and existing hospital customers to maximize the potential of our combined platform of products, as well as bring more innovation to the market.”
For additional information on NeoForce, please visit www.neoforcegroup.com.
About Capnia
Capnia, Inc. develops and commercializes novel products based on its proprietary technologies for precision metering of gas flow. Capnia’s lead product CoSense® is based on the Sensalyze™ Technology Platform. It is a portable, non-invasive device that rapidly and accurately measures carbon monoxide (CO) in exhaled breath. CoSense has 510(k) clearance for sale in the U.S. and has received CE Mark certification for sale in the European Union. CoSense is used for the monitoring of CO from internal sources (such as hemolysis, a dangerous condition in which red blood cells degrade rapidly), as well as external sources (such as CO poisoning and smoke inhalation). The initial target market is newborns with jaundice that are at risk for hemolysis, comprising approximately three million births in the U.S. and European Union. Capnia’s proprietary therapeutic technology uses nasal, non-inhaled CO2 and is being evaluated to treat the symptoms of allergies, as well as the trigeminally-mediated pain conditions such as cluster headache, trigeminal neuralgia and migraine.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials, that neonatology is a high-growth area, that this acquisition will strengthen our presence in this area and the amount of revenue to be generated from this acquisition in the next 12 months.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Capnia’s Form 10-K filed with the Securities and Exchange Commission on March 13, 2015, including under the caption titled “Risk Factors.” Capnia expressly disclaims any intent or obligation to update these forward looking statements, except as required by law.
CONTACT: Investor Relations Contact:
Michelle Carroll/Susie Kim
Argot Partners
(212) 600-1902
michelle@argotpartners.com
susan@argotpartners.com
(VTAE) Positive Top-Line Results, Initial Phase 1 Study of RORyt Inhibitor VTP-43742
- Single ascending doses of VTP-43742 safe and generally well-tolerated, demonstrated once-daily pharmacokinetics
- Robust ex vivo biomarker response, suppressing pro-inflammatory IL-17A by more than 90 percent
FORT WASHINGTON, Pa., Sept. 8, 2015 — Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced positive top-line results from its Phase 1 single ascending dose clinical study of VTP-43742 in autoimmune disorders. VTP-43742 is Vitae’s first-in-class, wholly owned RORγt inhibitor being developed for the treatment of a range of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and irritable bowel disease (IBD), as well as numerous orphan diseases.
In this double-blind, randomized, placebo-controlled study that evaluated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of single oral doses of VTP-43742 in 53 healthy human volunteers, VTP-43742 was safe and generally well tolerated at all dose levels across a 60-fold dose range. No serious adverse events were reported and there were no drug-related clinical laboratory or electrocardiogram (ECG) abnormalities.
VTP-43742 was also evaluated in an ex vivo assay for its ability to inhibit the production of pro-inflammatory cytokine IL-17A in blood obtained from study subjects. Subjects receiving VTP-43742 showed a dose-dependent suppression of RORγt dependent IL-17A production by more than 90 percent, with the effect largely sustained over the full 24-hour measurement period.
In animal studies, steady inhibition of RORγt was necessary to achieve full therapeutic efficacy, indicating the importance of a relatively long plasma half-life. The plasma half-life of VTP-43742 was observed to be approximately 30 hours in this clinical trial, supporting the potential for effective once-a-day dosing in humans.
“VTP-43742’s robust and sustained lowering of IL-17A production observed in the ex vivo blood assay, paired with its favorable safety, tolerability and PK profile, demonstrate that this first-in-class drug candidate has the potential to safely and effectively treat a range of autoimmune conditions,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We are extremely encouraged by the PK and PD data, and look forward to reporting additional clinical results, including top-line proof-of-concept data in psoriasis patients, by the end of the year.”
Vitae is currently conducting a Phase 1 multiple ascending dose clinical trial of VTP-43742, which was initiated in August 2015. This trial includes both healthy human volunteers and patients with moderate to severe psoriasis. The Company plans to begin dosing psoriatic patients in the second half of 2015, with top-line clinical efficacy results expected by the end of 2015.
About Autoimmune Disorders
Autoimmune disorders, where a patient’s own immune system attacks normal tissue, make up a large number of human disorders. Increased activity of a class of lymphocytes called Th17 cells, and the subsequent excess production of pro-inflammatory cytokines, including IL-17, by those cells are critical parts of the pathophysiology of many human autoimmune disorders. RORγt is a nuclear hormone receptor that is essential for the formation and function of Th17 cells. Vitae believes inhibition of excess RORγt activity in immune cells will be beneficial for the treatment of multiple autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and / or IBD, as well as numerous orphan diseases.
About VTP-43742
VTP-43742 is Vitae’s first-in-class, wholly owned product candidate for the potential treatment of a variety of autoimmune disorders and orphan diseases. In preclinical studies, VTP-43742 inhibited the activity of RORγt and has demonstrated potent inhibition of multiple Th17 cell-dependent pro-inflammatory cytokines, including IL-17. It is highly selective versus other ROR isotypes, and has a plasma half following single oral dosing that is consistent with a once a day dosing schedule. VTP-43742 has demonstrated superior efficacy in an animal model of multiple sclerosis in direct comparison to an IL-17A monoclonal antibody. Vitae initiated Phase 1 testing with VTP-43742 in June of 2015 with this Phase 1 single ascending dose clinical trial in healthy human volunteers. A Phase 1 multiple ascending dose clinical trial in healthy human volunteers was initiated in August 2015.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including programs in autoimmune disorders, atopic dermatitis, Alzheimer’s disease and diabetes. This robust and growing portfolio of novel product candidates is generated internally by Contour®, Vitae’s proprietary structure-based drug discovery platform.
For additional information, please visit the company’s website at www.vitaepharma.com.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the clinical development of VTP-43742. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “impending” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vitae is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vitae’s forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its collaborative partners; the ability to obtain and maintain regulatory approval of Vitae’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitae’s product candidates; the size and growth of the potential markets for Vitae’s product candidates and the ability to serve those markets; Vitae’s expectations regarding Vitae’s expenses and revenue, the sufficiency of Vitae’s cash resources and needs for additional financing; Vitae’s ability to attract or retain key personnel; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 and Vitae’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 which have been filed with the Securities and Exchange Commission (SEC). In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors also could affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vitae undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
CONTACT: INVESTORS:
Vitae Pharmaceuticals, Inc.
Richard S. Morris, CPA
Chief Financial Officer
(215) 461-2000
rmorris@vitaerx.com
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com
MEDIA:
6 Degrees PR
Tony Plohoros
(908) 591-2839
tplohoros@6degreespr.com
(AKBA) Announces Positive Top-Line Results from its Phase 2 Study of Vadadustat
-Treatment with Vadadustat Successfully Maintained Mean Hemoglobin Levels Following Conversion from rESA Therapy-
-Vadadustat Demonstrated a Favorable Safety Profile with Once Daily and Three Times per Week Dosing-
-Conference Call at 5:00 PM Eastern Time Today-
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced positive top-line results from its Phase 2 study of vadadustat (formerly AKB-6548) in dialysis patients with anemia related to chronic kidney disease (CKD). The study achieved its primary objective, indicating that vadadustat maintained stable hemoglobin (HGB) levels throughout the 16-week treatment period following conversion from recombinant erythropoiesis-stimulating agent (rESA) therapy. Vadadustat demonstrated a favorable safety profile with no drug-related serious adverse events and no deaths. The results highlight the potential of vadadustat, dosed either once daily or three times per week, to safely and predictably manage and sustain HGB levels in CKD patients undergoing dialysis.
The open-label, multi-center, 94 patient study was designed to evaluate the ability of vadadustat to maintain hemoglobin levels in patients undergoing hemodialysis who were previously being treated with rESAs. Patients were assigned to one of three dose cohorts: once daily vadadustat at a starting dose of 300mg, once daily vadadustat at a starting dose of 450mg, or vadadustat three times per week in conjunction with the patient’s hemodialysis schedule at a starting dose of 450mg. The study achieved its primary endpoints of maintaining stable hemoglobin levels over 16 weeks of treatment in all three cohorts of patients converting from rESAs to vadadustat.
| Mean Hemoglobin Levels (g/dL)* | Baseline | Week 7/8 | Week 15/16 | |||||||||||||
| 300mg Daily Dose | 10.4 | 10.4 | 10.3 | |||||||||||||
| 450mg Daily Dose | 10.6 | 10.3 | 10.5 | |||||||||||||
| 450mg Three Times per Week Dose | 10.5 | 10.2 | 10.4 | |||||||||||||
| * Modified intent-to-treat (MITT) population, n=94 | ||||||||||||||||
Vadadustat was well tolerated among patients in all three dose cohorts. Treatment-emergent adverse events (TEAEs) with vadadustat were balanced across the cohorts. Serious adverse events (SAEs) were reported in 13 subjects (13.8%), well within the expected range for this patient population. There were no drug-related SAEs and no deaths reported in the study.
“This study was a clear success, demonstrating the potential of vadadustat to effectively and safely treat anemia in dialysis patients switching from injectable rESA therapy,” said Brad Maroni, M.D., Chief Medical Officer at Akebia. “We are impressed with the consistency in hemoglobin levels across the duration of the study, which highlights the ability of vadadustat to control and maintain hemoglobin levels in this patient population. Furthermore, the results indicate that daily and three times per week dosing regimens are both viable options for patients on dialysis.”
John P. Butler, President and Chief Executive Officer of Akebia, stated, “These results further confirm vadadustat as a potential best-in-class anemia treatment for CKD patients, and reinforce our confidence in this product candidate as we advance toward our Phase 3 program. Adding these results to the 12 other clinical studies we have completed, we are confident in the potential for vadadustat to treat anemia in a broad array of patients with CKD. We are pleased to have successfully completed this stage of our drug development and look forward to initiating Phase 3 studies.”
Complete efficacy and safety data from this Phase 2 study will be presented at an upcoming medical meeting.
About the Phase 2 Study Design of Vadadustat in Dialysis Patients with Anemia Related to CKD
The Phase 2 multi-center, open-label study evaluated 94 patients over 16 weeks of treatment, at 20 dialysis centers in the United States, including an assessment of HGB response to the starting dose of vadadustat during the first 8 weeks, followed by an assessment of HGB response to algorithm-guided dose adjustments of vadadustat during the subsequent 8 weeks of treatment. The study enrolled three cohorts, each consisting of approximately 30 CKD patients with anemia undergoing dialysis who were switched from injectable rESA therapy to vadadustat. Patients in the first two cohorts received once daily doses of vadadustat, while patients in the third cohort received vadadustat three times per week in conjunction with their hemodialysis schedule.
| Conference Call and Webcast | ||||
| Date: | September 8, 2015 | |||
| Time: | 5:00 PM ET | |||
| Telephone Access: | Domestic callers: dial 877-458-0977 | |||
| International callers: dial 484-653-6724 | ||||
| Please reference the Akebia conference call | ||||
| Passcode: 3379-3912 | ||||
| Online Access: | Go to the Investor Relations section of the Akebia website and follow instructions for accessing the live webcast. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary. | |||
About Vadadustat (Formerly AKB-6548)
Vadadustat is an oral therapy currently in development for the treatment of anemia related to CKD. Vadadustat is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.
As a HIF stabilizer with best-in-class potential, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat has been shown to improve iron mobilization, potentially eliminating the need for intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Approximately 30 million people in the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body’s inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable rESAs, which are associated with inconsistent hemoglobin responses and well-documented safety risks.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through HIF biology. The company has completed Phase 2 development of its lead product candidate, vadadustat, an oral therapy for the treatment of anemia related to CKD in both non-dialysis and dialysis patients.
Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications, dosing and benefits of vadadustat, the development plan for vadadustat, plans for presenting a more detailed analysis of the data from the Phase 2 study, and the initiation of the Phase 3 program. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia’s product candidates and operate the company, and the actual expenses associated therewith; the cost of our Phase 3 studies and the availability of financing to cover such cost; the timing and content of decisions made by the FDA and other regulatory authorities; the acceptance of Akebia’s abstract for presentation at a medical meeting; the actual time it takes to prepare for and initiate Phase 3 clinical studies; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.
Investors:
Akebia Therapeutics, Inc.
Ed Joyce, 617-844-6130
ejoyce@akebia.com
or
Media:
Argot Partners
Eliza Schleifstein, 917-763-8106
Eliza@argotpartners.com
(ISCO) Announces Next Phase of Research Collaboration With Rohto Pharma
CARLSBAD, CA–(September 08, 2015) – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, announced today that it had entered into the second phase of the existing Research Agreement with Rohto Pharmaceutical Co., Ltd. (“Rohto”), a global Japanese pharmaceutical company. After successfully completing preliminary studies of ISCO’s human parthenogenetic neural stem cells (hpNSCs) Rohto acknowledged that ISCO’s proprietary cells demonstrate consistent high quality and are suitable for further use in Rohto’s research. If Rohto successfully demonstrates hpNSCs’ efficacy in rodent models, which could lead to a possible treatment of a variety of degenerative eye disorders, Rohto will enter into negotiations of a definitive license agreement with ISCO in order to license ISCO’s proprietary technology for therapeutic and commercial use.
“Based on hpNSCs known performance in various animal models we expect that in the next four months Rohto will be able to demonstrate the efficacy of these stem cells in treating retinal degenerative disorders,” said Ruslan Semechkin, Ph.D., Chief Scientific Officer of ISCO.
About Rohto Pharmaceutical Company, Ltd.
Founded in 1899, Rohto Pharmaceutical is the second-largest consumer health company in Japan, and is a world leader in the manufacturing and marketing of pharmaceuticals, cosmetics, and skincare and healthcare products. Rohto has global operations and its products are available in more than 110 countries.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Contacts:
International Stem Cell Corporation
Ruslan Semechkin, Ph.D.
Chief Scientific Officer
Phone: 760-940-6383
Email: ir@intlstemcell.com
Media:
Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com
Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com
(GWGH) to Present at the 4th Annual Liolios Gateway Conference on September 9, 2015
MINNEAPOLIS, Sept. 4, 2015 — GWG Holdings (NASDAQ:GWGH) a specialty finance company and a leader in the life insurance secondary market, has been invited to present at the 2015 Liolios Gateway Conference being held on September 9-10, 2015 at the Four Seasons Hotel San Francisco.
GWG CFO William Acheson is scheduled to present on Wednesday, September 9 at 1:30 p.m. Pacific time, with one-on-one meetings held throughout the conference.
Acheson will discuss GWG’s value proposition for consumers and investors:
- GWG, through its subsidiaries, purchases life insurance policies from seniors who no longer want, need or can afford their policies
- GWG offers a fixed income, non-correlated security for income investors seeking attractive yields
- GWG offers high growth equity stock for growth investors
The presentation will be webcast live and available for replay in the Investor Relations section of GWG’s website at www.gwglife.com or on the Gateway Conference website at www.gateway-conference.com/presenters.
To receive additional information, request an invitation or to schedule a one-on-one meeting, please email gateway@liolios.com.
About the Gateway Conference
The 4th Annual Gateway Conference is an invite-only conference presented by Liolios, a comprehensive financial communications firm. Gateway was designed to bring together the most compelling companies with the nation’s top institutional investors and analysts. This year’s event features more than 90 companies from a number of growth industries, including technology, business and financial services, consumer, digital media, clean technology and life sciences. The format has been designed to give attendees direct access to senior management via company presentations, Q&A sessions and one-on-one meetings. For more information, visit www.gateway-conference.com or www.liolios.com.
About GWG Holdings
GWG Holdings, Inc. (NASDAQ:GWGH) is a specialty finance company and a leader in the life insurance secondary market. GWG, through its subsidiaries, purchases life insurance policies from seniors who no longer want, need or can afford their policies. Since 2006, GWG has purchased more than $1.7 billion in life insurance policy benefits and paid seniors over $291 million for their policies – approximately $274 million more than the surrender or lapse value offered by insurance carriers. GWG’s strategy is to originate and manage a diverse portfolio of life insurance policies that generate yields that exceed the costs to finance the policies (in aggregate). GWG finances the purchase and maintenance of a portfolio of policies primarily through a fixed income alternative investment product that is offered through independent broker-dealers and registered investment advisors nationwide. GWG’s goal is to generate financial returns for GWG’s investors and shareholders while providing valuable post-retirement financial solutions to seniors.
CONTACT: Rubenstein Associates
Stefan Prelog
Senior Vice President
Tel: (212) 843-8076
Email: sprelog@rubenstein.com
GWG Holdings, Inc.
Rose Reifsnyder
Director of Communications and Media Relations
Tel: (612) 840-7204
Email: rreifsnyder@gwglife.com
(RLYP) Announces New Employment Inducement Grants
REDWOOD CITY, Calif., Sept. 4, 2015 — Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that on September 1, 2015, the compensation committee of the company’s board of directors granted 14 new employees options to purchase an aggregate of 80,800 shares of the company’s common stock with a per share exercise price of $22.54, the closing trading price on the grant date, and 12,700 restricted stock units. The stock options and restricted stock units were granted pursuant to the Relypsa, Inc. 2014 Employment Commencement Incentive Plan, which was approved by the company’s board of directors in June 2014 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the company.
About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular and metabolic diseases. The company’s lead product candidate is Patiromer for Oral Suspension for the treatment of hyperkalemia, a potentially life-threatening condition defined as abnormally elevated levels of potassium in the blood. A two-part pivotal Phase 3 trial of Patiromer for Oral Suspension has been completed and the primary and secondary endpoints were met. A New Drug Application for Patiromer for Oral Suspension for the treatment of hyperkalemia was accepted by the U.S. Food and Drug Administration and is currently under review. Patiromer for Oral Suspension has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.
CONTACT: Charlotte Arnold
Vice President, Corporate Communications
650.421.9352
IR@relypsa.com
(SKYW) to Present at Upcoming Investor Conferences
Executive leadership scheduled at Cowen and Co., Deutsche Bank and Imperial
SAINT GEORGE, Utah, Sept. 4, 2015 — SkyWest, Inc. (NASDAQ: SKYW) will participate in a number of upcoming investor conferences, including:
- Cowen and Company 8th Annual Global Transportation Conference in Boston on Wednesday, Sept. 9
- Deutsche Bank Airline Day in New York on Thursday, Sept. 10
- Imperial Capital 9th Annual Global Opportunities Conference on Thursday, Sept. 17
Rob Simmons, SkyWest’s Chief Financial Officer, and Eric Woodward, SkyWest’s Chief Accounting Officer, are scheduled to present at Cowen and Deutsche Bank. SkyWest, Inc. President, Chip Childs, will present with Eric Woodward at Imperial Capital. SkyWest has a redesigned, user-friendly website with additional SkyWest information at inc.skywest.com.
About SkyWest, Inc.
SkyWest, Inc. was named one of “America’s Best Employers” by Forbes in 2015 and was Air Transport World’s Regional Airline of the Year in 2014. SkyWest, Inc. is the holding company for two scheduled passenger airline operations and an aircraft leasing company and is headquartered in St. George, Utah. SkyWest’s airline companies provide commercial air service in cities across the United States, Canada, Mexico and the Caribbean with more than 3,200 daily flights and a fleet of 664 aircraft. SkyWest Airlines operates through partnerships with United Airlines, Delta Air Lines, American Airlines and Alaska Airlines. ExpressJet Airlines operates through partnerships with United Airlines, Delta Air Lines and American Airlines. SkyWest is headquartered in St. George, Utah, and continues to set the standard for excellence in the regional industry with unmatched value for customers, shareholders and its nearly 20,000 employees. This press release and more information about SkyWest can be found at inc.skywest.com.
(ICLD) Announces a New Cloud Data Disaster Recovery Services Agreement
InterCloud Continues to Expand on the Over $2.6M in Services With JBFCS
SHREWSBURY, N.J., Sept. 4, 2015 — InterCloud Systems, Inc. (Nasdaq:ICLD) (the “Company” or “InterCloud”), announced today it has been selected by The Jewish Board of Family and Children’s Services (“The Jewish Board”) to provide disaster recovery cloud services. InterCloud will provide key value add elements including geographic data redundancy to guard critical customer data against any colossal failure, natural disaster or human error. In addition, InterCloud will provide a total turnkey implementation including set-up, maintenance and managed services, as they deploy industry-leading next generation network solutions.
Uday Madasu, CIO of The Jewish Board, stated, “We are excited to start this new project with InterCloud Systems. Our goal is to further protect our critical data with a high quality, resilient solution, with a partner that has executed successfully for The Jewish Board in the past. In addition, InterCloud’s unique positioning in the marketplace will allow for a smooth migration as we look to take advantage of the cloud for our business disaster recovery initiatives.”
Joseph Scotti, Vice President of Sales for InterCloud Systems, stated, “We are pleased to report the broadening of our relationship with The Jewish Board. The additional InterCloud cloud disaster recovery services are expected to be provisioned immediately and will safeguard The Jewish Board critical data against any unforeseen events.”
About The Jewish Board of Family and Children’s Services
For 140 years, as the largest health and human services agency in New York City, The Jewish Board of Family and Children’s Services has been helping New Yorkers realize their potential and live as independently as possible. With hope and resilience guiding our work, we promote recovery by addressing all aspects of an individual’s life, including mental and physical health, family, housing, employment and education. Inspired by Jewish values, The Jewish Board brings the ideals of Jewish service to all New Yorkers. Visit us at www.jbfcs.org.
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a leading provider of cloud networking orchestration and automation, for Software Defined Networking (SDN) and Network Function Virtualization (NFV) cloud environments to the communications service provider and corporate enterprise markets, through cloud solutions and professional services. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations
InterCloud Systems, Inc.
561-988-1988
(BTX) Announces Dual Listing on the Tel Aviv Stock Exchange
– Common shares are currently listed on NYSE MKT and will also be listed on the Tel Aviv Stock Exchange (TASE) beginning September 8, 2015 under ticker symbol BTX
– Anticipated inclusion in the TASE: TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed Indexes
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company focused on the development and commercialization of cell-based therapies, announced today that the Tel Aviv Stock Exchange (TASE) has approved the new listing of BioTime’s common shares beginning on Tuesday, September 8, 2015 under the ticker symbol BTX. Based on the current market capitalization, BioTime’s shares are anticipated to be included in five TASE equity indexes: TASE’s TA-75, TA-100, TA-BlueTech, TA-Tech-Elite and TA-Biomed.
“We believe that the dual listing on the TASE will help us to open a new access point for our shares in the Israeli market that is becoming a center for biomed and emerging technology companies,” said Michael D. West, Ph.D., CEO of BioTime. “The new listing also offers an opportunity to expand and diversify our shareholder base by increasing our exposure and improving our accessibility to Israeli investors.”
TASE CEO, Yossi Beinart said, “We welcome BioTime to the Tel Aviv Stock Exchange Dual Listing, and believe that this is a recognition of the Biomed sector’s special position at the Tel Aviv Stock Exchange. BioTime joins a group of 46 cross-listed companies entitling them to significant benefits including, added exposure among Israeli investors, extension of the trading day, investment by Exchange Traded Product vendors, and easy access to institutional and retail investors as well as to global growth companies.”
BioTime considers this listing a natural extension of its long-standing relationship with the Israeli biotechnology industry, including its two Israeli subsidiaries Cell Cure Neurosciences Ltd. (“Cell Cure”) of Jerusalem and LifeMap Sciences Ltd. of Tel Aviv which has benefited from a rewarding relationship with the Weizmann Institute of Science.
In conjunction with the Hadassah Human Embryonic Stem Cell Research Center at Hadassah University Medical Center, BioTime’s Jerusalem-based subsidiary Cell Cure is currently conducting a Phase I/IIa clinical trial of its lead product OpRegen®, the first cell therapy product derived from human embryonic stem cells (ESCs) ever to undergo clinical testing in Israel. Utilizing retinal pigment epithelial (RPE) cells derived from ESCs, the OpRegen® trial is targeting the dry form of age-related macular degeneration (AMD). AMD is the number one cause of blindness in the elderly in the developed world. The clinical trial is being funded in part by a grant from the Office of the Chief Scientist (OCS).
Trading Regulations
BioTime’s shares will continue to be listed on the NYSE MKT, subject to the rules and regulations of the NYSE MKT applicable to listed companies. Under Israel’s Dual Listing Law, U.S.-listed companies may also list on the TASE without any additional regulatory requirements. Investors should note that the trading on the TASE occurs Sunday through Thursday from 8:30 am to 4:30 pm Israel time, except on TASE trading holidays, and trading on the NYSE MKT occurs Monday through Friday, 9:30 am to 4:00 pm Eastern Time, except on NYSE holidays. The TASE Clearing House is electronically linked to the Depository Trust Company, a subsidiary of the Depository Trust & Clearing Corporation, to automate the cross-border settlement of shares listed on both the TASE and a U.S. Exchange.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include OpRegen®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing the completion of initial clinical studies for the detection of lung, bladder, and breast cancers. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include the publicly traded Asterias Biotherapeutics, Inc., developing pluripotent stem cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen®; OncoCyte Corporation, developing cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated online database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP-compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases, and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com
BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimemail.com
or
Investor Contact:
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Media Contact:
Gotham Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com
or
Israel Contact:
Gelbart-Kahana Investor Relations
Zeev Gelbart, +972-3-6074717
zeevg@gk-biz.com
(SLP) Awarded New Cooperative Agreement with FDA
Project to Support Enhancements to Company’s Industry-Leading GastroPlus™ Software
Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it had been notified by the U.S. Food and Drug Administration (FDA) that the company has been awarded a second cooperative agreement for $200,000 per year for up to three years. This award is in addition to the similar project the company was awarded last year, and which was recently renewed for the second year. This new project is for the development of PBPK simulation for long-acting injectable microspheres.
Dr. Viera Lukacova, team leader for simulation technologies and product manager for the company’s flagship GastroPlus™ software, is the principal investigator for the cooperative agreement. Dr. Lukacova said, “We are very pleased to have another opportunity to work with the FDA on an important simulation and modeling project. GastroPlus captures the best current understanding of the complex interplay between drug product attributes and human physiology. This project will contribute substantially to improvements in the program, specifically directed toward the behavior of long-acting injectable microsphere dosage forms which are typically subcutaneous or intramuscular doses that release drugs over long periods, often weeks or months. We expect the developments under this agreement will aid the FDA in developing regulatory science and policies in the area of drug absorption from long-acting injectable microspheres, and it will aid the generic pharmaceutical industry in designing high quality products that meet public expectations for effectiveness.”
Under the cooperative agreement, the FDA’s purpose is to support and stimulate Simulations Plus’ activities in the development of drug absorption and pharmacokinetics models for long-acting injectable microspheres. FDA scientific and program staff will assist and participate in project activities in a partnership role. As principal investigator, Dr. Lukacova will have primary responsibility for the scientific, technical, and programmatic aspects of the award, and for the day-to-day management of the project.
Walt Woltosz, chairman and chief executive officer of Simulations Plus and its wholly owned subsidiary, Cognigen, said, “This award means additional support for our in-house product development and company growth. Although the science behind this model development effort is quite sophisticated, this award demonstrates the FDA’s confidence that GastroPlus provides a sound basis for related drug and formulation characteristics for long-acting injectable microsphere dosage forms. We look forward eagerly to collaborating with the FDA on this important project.”
Funding for this collaboration was made possible by the Food and Drug Administration through grant 1 U01 FD005463-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation software, which is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies worldwide. For more information, visit our Web site at www.simulations-plus.com.
Cognigen Corporation, a wholly owned subsidiary of Simulations Plus, Inc., is a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. For more information, visit Cognigen’s website at www.cognigencorp.com.
The combined company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software products and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.
Simulations Plus Investor Relations
Ms. Renee Bouche, 661-723-7723
renee@simulations-plus.com
or
Hayden IR
Mr. Cameron Donahue, 651-653-1854
cameron@haydenir.com
(CERE) Sells Forage Sorghum in Puerto Rico
– Island dairies plant commercial evaluations of Ceres’ improved forage sorghum hybrids – Subtropical conditions similar to other international markets
THOUSAND OAKS, Calif., Sept. 3, 2015 — Ceres, Inc. (Nasdaq: CERE), an agricultural biotechnology company, today announced that it has expanded commercial evaluations of its improved forage hybrids in Puerto Rico. Growers and dairies on the island territory have planted multiple, commercial-scale evaluations of Ceres’ seed products in order to diversify their supply of feed and forage.
Milk production is the single largest sector of Puerto Rico’s agricultural economy. Due in part to limits on land and resources, the sector includes highly sophisticated dairy businesses, which optimize supply chains and feed rations to maximize production and efficiency, including locally sourced feed and forage crops.
“Success here can be a good indicator for other markets,” said Walter Nelson, Ceres Vice President of Product Development. He noted that the island is a major testing and production location for seed companies, including Ceres. “Our roll-out here has been customer-driven. When local growers and dairies saw our research results, they expressed interest in evaluating our products for their own commercial use. We are optimistic that mainland dairies will follow suit once they become more familiar with our products.”
The company indicated that the growing conditions on the island provide a useful proving ground for its products under subtropical conditions, which include high heat, humidity and disease pressure. Puerto Rico’s subtropical geography is similar to India, Thailand and Africa where sorghum is commonly grown.
In Puerto Rico, Ceres distributes its products through 3rd Millennium Genetics (3MG), a local seed and research services company.
Ed Baumgartner, President of 3MG, said that Puerto Rico’s year-round growing season provides growers with a unique opportunity to continually compare various seed varieties and crops side-by-side. He reported that after initial commercial plantings earlier this year, growers and dairies have increased their orders for Ceres’ improved forage sorghum hybrids. In addition to selling seed, 3MG has worked with Ceres to develop cropping plans, including identifying optimal planting and harvest times. This information is especially important for tropical geographies due to the year-round growing season.
“Dairies on the island are highly interested in developing a reliable, year-round supply of locally produced grasses and forage sorghum promises to be an increasingly important component of the mix,” said Baumgartner. “We have had strong interest in Ceres’ Blade brand hybrids, which have demonstrated excellent performance, especially early in the season, and have compared very favorably with silage corn and other traditional forage crops.”
About Ceres
Ceres, Inc. is an agricultural biotechnology company that develops and markets seeds and traits to produce crops for animal feed, sugar and other markets. The company’s advanced plant breeding and biotechnology technology platforms, which can increase crop productivity, improve quality, reduce crop inputs and improve cultivation on marginal land, have broad application across multiple crops, including food, feed, fiber and fuel crops. Ceres markets its seed products under its Blade brand. The company also licenses its biotech traits and technology, including its Persephone genome visualization software, to other life science companies and organizations.
About 3rd Millennium Genetics
3rd Millennium Genetics, based in Santa Isabel, Puerto Rico, provides research crop services, including winter nurseries, to more than 100 customers in eleven countries. It also distributes seed to agricultural producers. In 2014, the company launched its own line of corn technology called DuraYield, which provides greater tolerance to drought and heat stress as well as insect damage.
Ceres Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, including statements regarding Ceres’ efforts to develop and commercialize its products and technologies, anticipated yields and product performance, status of crop plantings, short-term and long-term business strategies, market and industry expectations, future operating metrics, and future results of operations and financial position, including anticipated cost savings from the company’s restructuring plan and projected cash expenditures, are forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Ceres’ control. Factors that could materially affect actual results can be found in Ceres’ filings with the U.S. Securities and Exchange Commission. Ceres undertakes no obligation to update publicly, except to the extent required by law, any forward-looking statements for any reason after the date the company issues this press release to conform these statements to actual results or to changes in the company’s expectations.
(ISDR) Leading Software Industry Veteran, Andre M Boisvert, Joins K2View Board
TEL AVIV, Israel, September 3, 2015 —
K2View Corporation, a provider of next generation data management products, is delighted to announce that Andre M Boisvert has been elected to the company’s Board of Directors.
Mr. Boisvert has been in the technology field for over 35 years. Boisvert started his career with IBM in 1976 where he spent 13 years. While at IBM, Boisvert held senior management positions in sales, marketing and R&D. After leaving IBM, Boisvert held executive positions in some of the best respected software companies in the software industry, such as Cognos Corporation and Oracle Corporation where he was Senior Vice President of Worldwide Marketing and was a member of Oracle’s Management committee.
In 2000, Boisvert was recruited as the President & COO of SAS Institute Inc., the world’s largest privately held software company with revenues currently exceeding $3B annually, with the mission of bringing the company public. When the plans of an IPO were abandoned in 2001, Boisvert joined one of SAS Institute Inc.’s’ investments as Chairman & CEO of Sagent Technologies Inc. (NASDAQ: SGNT). In April of 2004, Boisvert successfully completed the sale of Sagent Technologies Inc. to Group 1 Software Inc. (NASDAQ:GSOF).
In March 2002, Boisvert became a director of VA Software (NASDAQ:LNUX), the creator and owner of SourceForge, the world’s largest repository of open source projects. During his four year term at VA Software, Boisvert developed a wealth of knowledge about open source projects and their applicability to solving real world problems, which previously had been exclusively addressed through expensive proprietary software.
This experience led Boisvert to co-founding Pentaho Corporation in October of 2004, the world’s most popular commercial open source business intelligence platform. Pentaho was subsequently acquired by Hitachi Data Systems for +$500M in Feb, 2015. Boisvert also serves/served as an advisor/director of several other leading commercial open source companies, Revolution Analytics (acquired by Microsoft in January 2015), Zenoss Inc. (systems management), Infobright (data warehousing) and Zend Technologies Inc. (the PHP company).
Boisvert is also Chairman of Palamida Corporation, a leader in Software Composition Analysis for intellectual property & security risk management, and Vice-Chairman of River Logic Inc., a leader in prescriptive analytics. Additionally, Boisvert is a Director of Clario Analytics Inc., a cloud based analytics solution aimed at companies using multi-channels to market their products & services and London based SmartFocus Corporation, a leader in email & social marketing.
In 2012 Boisvert became a Director of Issuer Direct, a leading provider of regulatory compliance solutions & services for publicly traded companies. In 2013 Boisvert was appointed Chairman of Issuer Direct and in 2014 the company uplifted its public listing to the New York Stock Exchange (NYSE:ISDR).
“We are excited to have an industry luminary like Andre involved with K2View”, said Ayal Shiran, Chairman of the board. “We look forward to benefiting from Andre’s unparalleled experience in the industry as we continue to build upon the success K2View has enjoyed to date across multiple industries and on a global basis.”
K2View’s patent-pending Logical Unit technology is a revolutionary new approach to Big Data Management. K2View allows organizations to manage and manipulate their data using their business entity view – be it a customer, a product or any entity that drives their business.
“I look forward to working closely with the team at K2View”, said Mr. Boisvert. “Having lived through several major technology transformations over the last few decades, I have developed an appreciation for truly transformative solutions. Given that K2View’s products definitely fall into this elite category, I am excited about helping build another game changing , world class software company.”
About K2View
K2View is revolutionizing the data management industry with its revolutionary new product called Fabric. Fabric “wraps around” an enterprises existing data architecture and seamlessly transforms it to a distributed, Big Data architecture. Fabric includes a suite of Big Data solutions that offer unmatched processing performance, seamless and easy integration, unparalleled processing performance and breach-proof security. Learn more at http://www.k2view.com.
For more information please contact
Osnat Segev-Harel
osnat@k2view.com
(DIOD) to Acquire Pericom Semiconductor Corporation
All-Cash Transaction Valued at Approximately $400 Million for Pericom’s $129 Million in TTM Revenue and Approximately $129 Million of Cash Equivalents as of June 27, 2015
Diodes Incorporated (Nasdaq: DIOD), a leading global manufacturer and supplier of high-quality application specific standard products within the broad discrete, logic and analog semiconductor markets and Pericom Semiconductor Corporation (Nasdaq: PSEM), a worldwide supplier of high performance connectivity and timing solutions, today announced that Diodes Incorporated and Pericom have entered into an Agreement and Plan of Merger that provides for the acquisition of Pericom by Diodes.
Highlights of the transaction include:
- Combined trailing twelve months (“TTM”) reported revenue of approximately $1.0 billion and gross profit of approximately $337 million;
- Expected to be immediately accretive to Diodes’ GAAP earnings per share;
- Strengthens Diodes’ analog product offering and adds an extensive mixed-signal connectivity portfolio;
- Provides enhanced platform content for focused and emerging applications;
- Balances revenue contribution across target end markets;
- Enhances market and margin expansion opportunities with greater scale and value-added solutions; and
- Expected to result in operating and administrative efficiencies.
At the effective date of the merger, each share of Pericom will be converted into the right to receive $17.00 in cash, without interest. The aggregate consideration will be approximately $400 million. The purchase price represents a 40 percent premium to the closing price on September 2, 2015. The boards of both companies have approved the transaction, which is still subject to approval by Pericom’s shareholders, as well as other customary closing conditions and regulatory approvals. The transaction is expected to close in the fourth quarter of 2015.
Commenting on the transaction, Dr. Keh-Shew Lu, President and Chief Executive Officer of Diodes, stated, “The proposed acquisition of Pericom accelerates the attainment of Diodes’ goal of a $1 billion annual revenue run rate with 35 percent gross margin, while being immediately accretive to earnings. This transaction broadens Diodes’ analog footprint and adds a strong mixed-signal connectivity offering that will drive expanded product content in target market applications. Also, Pericom’s extensive timing product lines complement Diodes’ standard product portfolio and broaden our analog footprint. We look forward to integrating the Pericom team into Diodes’ family as we work closely with our customers to familiarize them with our new expanded offerings.”
Also commenting on the proposed acquisition, Alex Hui, President and Chief Executive Officer of Pericom said, “Diodes’ size and scale provides an excellent platform for our products to gain access to a broader customer base and drive a higher level of growth than Pericom would be able to achieve as a standalone company. Most importantly, this transaction delivers significant value for our shareholders as well as for our employees and customers by creating the opportunity to be part of a larger organization and enabling even greater future success for Pericom.”
Diodes expects to fund the purchase price of the acquisition mainly by drawing down additional capital following a recent $200 million increase to its existing credit facility. Bank of America Merrill Lynch acted as sole lead arranger for the credit facility increase and financial advisor on the transaction. Sheppard Mullin Richter & Hampton LLP acted as legal counsel to Diodes. Cowen and Company acted as exclusive financial advisor and Latham & Watkins LLP acted as legal counsel to Pericom Semiconductor.
Conference Call and Slide Presentation Information
Diodes will host a conference call today at 12:00 p.m. Central Time (1:00 p.m. Eastern Time). This conference call will be broadcast live over the Internet with a slide presentation and can be accessed by all interested parties on the Investor section of Diodes’ website at http://www.diodes.com. On the call to discuss the proposed acquisition will be Dr. Keh-Shew Lu, Diodes’ President and Chief Executive Officer, Rick White, Diodes’ Chief Financial Officer, Mark King, Diodes’ Senior Vice President of Sales and Marketing, Julie Holland, Diodes’ Vice President of Worldwide Analog Products, Laura Mehrl, Diodes’ Director of Investor Relations and Alex Hui, Pericom’s President and Chief Executive Officer. Investors and analysts are invited to participate on the call. To listen to the live call, please go to the Investor section of Diodes website and click on the Conference Call link at least fifteen minutes prior to the start of the call to register, download, and install any necessary audio software.
When: Thursday, September 3, 2015
Time: 12:00 noon CT / 1:00 p.m. ET
Dial in: 855-232-8957; outside the U.S. +1-315-625-6979
Participant Code: 31123932
Live Webcast: http://investor.diodes.com
For those unable to participate during the live broadcast, a replay will be available shortly after the call and will be available on Diodes’ website for approximately 60 days. The replay number is 855-859-2056 with a pass code of 31123932. International callers should dial +1-404-537-3406 and enter the same pass code at the prompt.
Further details of the transaction and arrangement are set out in Diodes’ Current Report on Form 8-K filed with the Securities and Exchange Commission on September 3, 2015.
About Diodes Incorporated
Diodes Incorporated (Nasdaq: DIOD), a Standard and Poor’s SmallCap 600 and Russell 3000 Index company, is a leading global manufacturer and supplier of high-quality application specific standard products within the broad discrete, logic and analog semiconductor markets. Diodes serves the consumer electronics, computing, communications, industrial, and automotive markets. Diodes’ products include diodes, rectifiers, transistors, MOSFETs, protection devices, functional specific arrays, single gate logic, amplifiers and comparators, Hall-effect and temperature sensors; power management devices, including LED drivers, AC-DC converters and controllers, DC-DC switching and linear voltage regulators, and voltage references along with special function devices, such as USB power switches, load switches, voltage supervisors, and motor controllers. Diodes’ corporate headquarters and Americas’ sales office are located in Plano, Texas. Design, marketing, and engineering centers are located in Plano; San Jose, California; Taipei, Taiwan; Manchester, England; and Neuhaus, Germany. Diodes’ wafer fabrication facilities are located in Kansas City, Missouri and Manchester, with two additional facilities located in Shanghai, China. Diodes has assembly and test facilities located in Shanghai and in Chengdu, China, as well as in Neuhaus and in Taipei. Additional engineering, sales, warehouse, and logistics offices are located in Taipei; Hong Kong; Manchester; Shanghai; Shenzhen, China; Seongnam-si, South Korea; and Munich, Germany, with support offices throughout the world. For further information, including SEC filings, visit Diodes’ website at http://www.diodes.com.
About Pericom Semiconductor
Pericom Semiconductor Corporation (NASDAQ: PSEM) enables serial connectivity with the industry’s most complete solutions for the computing, communications, consumer and embedded market segments. Pericom’s analog, digital and mixed-signal integrated circuits, along with its frequency control products are essential in the timing, switching, bridging and conditioning of high-speed signals required by today’s ever-increasing speed and bandwidth demanding applications. Company headquarters is in Milpitas, California, with design centers and technical sales and support offices globally. Pericom and the Pericom logo are trademarks or registered trademarks of Pericom Semiconductor Corp in the U.S. and/or other countries. For more information, please visit http://www.pericom.com.
Additional Information About the Merger and Where to Find It
Pericom Semiconductor Corporation (“Pericom” or the “Company”) intends to file with the Securities and Exchange Commission (the “SEC”) a proxy statement in connection with its proposed acquisition by Diodes and furnish or file other materials with the SEC in connection with the proposed transaction. The definitive proxy statement will be sent or given to the shareholders of the Company and will contain important information about the proposed transaction and related matters. BEFORE MAKING ANY VOTING DECISION, PERICOM’S SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND THOSE OTHER MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. The proxy statement and other relevant materials (when they become available), and any other documents filed by Pericom with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, security holders will be able to obtain free copies of the proxy statement from Pericom by contacting Pericom’s Investor Relations by telephone at (408) 232-9100, or by mail to Investor Relations Department, Pericom Semiconductor Corporation, 1545 Barber Lane, Milpitas, California 95035 or by going to Pericom’s Investor Relations page on its corporate website at www.pericom.com.
Participants in the Solicitation
Pericom, Diodes and their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Pericom in connection with the proposed transaction. Information regarding the interests of these directors and executive officers in the transaction described herein will be included in the proxy statement described above. Additional information regarding the directors and executive officers of Pericom is included in Pericom’s proxy statement for its 2014 Annual Meeting, which was filed with the SEC on October 16, 2014, and is supplemented by other public filings made, and to be made, with the SEC by Pericom. Additional information regarding the directors and executive officers of Diodes is included in Diode’s proxy statement for its 2015 Annual Meeting, which was filed with the SEC on April 16, 2015, and is supplemented by other public filings made, and to be made, with the SEC by Diodes.
Forward-Looking Statements for Diodes
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Any statements set forth above that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such statements include statements as to: the expected benefits of the acquisition, including the acquisition being immediately accretive; the efficiencies, cost savings, revenues, and enhanced product offerings, market position, and design and manufacturing capabilities of Diodes after the acquisition; and other statements identified by words such as “estimates,” “expects,” “projects,” “plans,” “will” and similar expressions. Potential risks and uncertainties include, but are not limited to, such factors as: the possibility that the transaction may not be consummated, including as a result of any of the conditions precedent; the risk of superior acquisition proposal from other parties; the risk of Diodes being unable to obtain sufficient financing from lenders to complete the acquisition; the risk of global market downturn conditions and volatilities impacting the completion of the acquisition or the funding; the risk that Pericom’s business will not be integrated successfully into Diodes’; the risk that the expected benefits of the acquisition may not be realized, including the realization of the accretive effect of the acquisition; the risk that Pericom’s standards, procedures and controls will not be brought into conformance within Diodes’ operation; difficulties coordinating Diodes’ and Pericom’s new product and process development, hiring additional management and other critical personnel, and increasing the scope, geographic diversity and complexity of Diodes’ operations; difficulties in consolidating facilities and transferring processes and know-how; difficulties in reducing the cost of Pericom’s business; the diversion of our management’s attention from the management of our business; Diodes may not be able to maintain its current growth strategy or continue to maintain its current performance, costs and loadings in its manufacturing facilities; risks of domestic and foreign operations, including excessive operation costs, labor shortages, higher tax rates and Diodes’ joint venture prospects; unfavorable currency exchange rates; and the impact of competition and other risk factors relating to our industry and business as detailed from time to time in Diodes’ filings with the United States Securities and Exchange Commission.
Recent news releases, annual reports and SEC filings are available at Diodes’ website: http://www.diodes.com and Pericom’s website: http://www.pericom.com. Written requests may be sent directly to Diodes or Pericom, or they may be e-mailed to: diodes-fin@diodes.com or ir@pericom.com.
Forward-Looking Statement for Pericom
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially from those indicated in such forward-looking statements, including, but not limited to, the ability of the parties to consummate the proposed transaction; satisfaction of closing conditions to the consummation of the proposed transaction; the impact of the announcement of the proposed transaction on Pericom’s relationships with its employees, existing customers or potential future customers; and such other risks and uncertainties pertaining to the Pericom’s business as detailed in its filings with the SEC on Forms 10-K and 10-Q, which are available on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date thereof. Pericom assumes no obligation to update any forward-looking statement contained in this document.
Diodes Contact:
Diodes Incorporated
Laura Mehrl
Director of Investor Relations
P: 972-987-3959
E: laura_mehrl@diodes.com
or
Investor Relations Contact:
Shelton Group
Leanne Sievers
EVP, Investor Relations
P: 949-224-3874
E: lsievers@sheltongroup.com
or
Pericom Semiconductor Contact:
Kevin Bauer
Chief Financial Officer
Tel: 408-232-9100
(ALTV) Momentum Telecom to Acquire Alteva
BIRMINGHAM, AL and PHILADELPHIA, PA–(Sep 3, 2015) – Momentum Telecom, Inc. (“Momentum Telecom”) and Alteva, Inc. (“Alteva”) (NYSE MKT: ALTV) announced that they have entered into a definitive agreement under which Alteva will be acquired by Momentum Telecom for a total equity purchase price of $28.7 million (the “Merger”).
Upon the closing of the Merger, shareholders of Alteva will receive $4.70 per common share, which represents a premium of 31% based on the closing price of Alteva’s stock on September 2, 2015 and 38% based on Alteva’s 20-day average price.
The combination of Momentum Telecom and Alteva:
- Builds on each company’s expertise in delivering best-in-class unified communications services
- Enhances the reach of the sales and marketing initiatives
- Strengthens the ability to support new and existing customers
- Increases Momentum Telecom’s number of users to over 250,000
Bill Fox, President and Chief Executive Officer of Momentum Telecom, commented, “The combined strengths of these two companies further enhance Momentum Telecom as a market leader in the VoIP and unified communications industry. Alteva shares our dedication to providing top-notch reliability and service to its customers. We are excited about the opportunity to invest in and grow upon Alteva’s success and significantly expand Momentum’s presence in the Northeast. With the merger, customers will continue to experience the high quality products, service and support that they count on from Alteva and Momentum today.”
Brian J. Kelley, Chief Executive Officer of Alteva, commented, “After a comprehensive evaluation of strategic alternatives, which included the payment of a dividend of $2.60 per common share on June 30, 2015, our Board of Directors concluded that combining with Momentum Telecom represents the best opportunity to realize immediate, substantial value for our shareholders. In the past year it has become exceedingly clear that profitability in the VoIP space requires significant scale to achieve maximum efficiency. As the industry grows, so does the competitive landscape. The control of selling expenses and the achievement of operating efficiencies depend on scale. Momentum Telecom and Alteva together constitute the most viable solution toward achieving these goals and benefitting our employees, customers and partners.”
Alteva’s Board of Directors has unanimously approved the Merger, which is expected to close in the fourth quarter of 2015, subject to Alteva shareholder approval, regulatory approvals and other customary closing conditions. Certain officers and directors of Alteva have signed voting agreements committing to support the Merger. Oppenheimer & Co. Inc. is serving as financial advisor to Alteva and DLA Piper LLP is serving as legal counsel to Alteva. Bradley Arant Boult Cummings LLP is serving as legal counsel to Momentum Telecom.
Additional Information and Where to Find It
In connection with the proposed Merger, Alteva will file with the Securities and Exchange Commission (the “SEC”) and furnish to Alteva’s shareholders a proxy statement and other relevant documents. This communication does not constitute a solicitation of any vote or approval. Shareholders are urged to read the proxy statement when it becomes available and any other documents to be filed with the SEC in connection with the proposed Merger or incorporated by reference in the proxy statement because they will contain important information about the proposed Merger. Before making any voting decision, investors and security holders are urged to read the proxy statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed Merger as they become available because they will contain important information about the proposed Merger and related matters. Investors will be able to obtain a free copy of documents filed with the SEC at the SEC’s website at http://www.sec.gov. In addition, investors may obtain a free copy of Alteva’s filings with the SEC from Alteva’s website at www.Alteva.com or by directing a request to: Alteva, Inc., 400 Market Street, Suite 1100, Philadelphia, Pennsylvania 19106, Attn: Investor Relations.
Participants in Solicitation
The directors, executive officers and certain other members of management and employees of Alteva and Momentum Telecom may be deemed “participants” in the solicitation of proxies from shareholders of Alteva in favor of the proposed Merger. Information regarding the persons who may, under the rules of the SEC, be considered participants in the solicitation of the shareholders of Alteva in connection with the proposed Merger will be set forth in the proxy statement and the other relevant documents to be filed with the SEC. You can find information about Alteva’s executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2014 (the “Form 10-K”) as filed with the SEC on March 17, 2015 and Amendment No. 1 to the Form 10-K as filed with the SEC on April 30, 2015.
About Momentum Telecom
Momentum Telecom is a leading VoIP, broadband services and unified communications provider, offering smart, customizable cloud solutions to direct subscribers and more than 400 partners nationwide. Momentum Telecom delivers superior quality products backed by a geo-redundant network with best- in-class uptime and industry leading customer service. Headquartered in Birmingham, AL, Momentum Telecom has regional offices across the United States. To learn more visit momentumtelecom.com or connect with us on Facebook, Google Plus, Twitter, or Linkedin. You can also visit the Momentum blog to keep up with the latest innovations in cloud communications and business productivity.
About Alteva
Alteva (NYSE MKT: ALTV) is a premier provider of hosted Unified Communications as a Service (“UCaaS“) that significantly enhances business productivity and efficiency. Alteva’s UCaaS solution integrates and optimizes best-in-class cloud-based technologies and business applications to deliver a comprehensive voice, video and collaboration service for the office and mobile workforce. Alteva is committed to delivering meaningful value to our customers through a consistent, high quality and unified user experience across multiple devices, platforms and operating systems. These attributes have positioned Alteva as a leading hosted communications provider and the partner of choice for a growing number of business customers nationwide and internationally. To learn more about Alteva, please visit www.alteva.com. You can also follow Alteva on Twitter @AltevaInc or LinkedIn.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which include statements regarding the proposed Merger may be identified by the inclusion of words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “goal” and variations of such words and other similar expressions, and are based on current expectations, estimates, assumptions and projections that are subject to change, and actual results may differ materially from the forward-looking statements. These statements, as they relate to Alteva or Momentum, the management of either such company or the proposed Merger, involves risks and uncertainties that may cause results to differ materially from those set forth in the statements. Alteva intends that such forward-looking statements be subject to the safe-harbor provided by the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Alteva’s actual results, performance or achievements or industry results to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Many factors, including the following, could cause actual results to differ materially from the forward-looking statements: the occurrence of any event, change or other circumstances that could give rise to the termination of the definitive Merger agreement between the parties; the inability to complete the proposed Merger due to the failure to obtain shareholder approval for the proposed Merger or the failure to satisfy other conditions to completion of the proposed Merger, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; risks related to disruption of management’s attention from Alteva’s ongoing business operations due to the proposed Merger; the effect of the announcement of the proposed Merger on Alteva’s relationships with its customers, suppliers, operating results and business generally and other risks and uncertainties described under “Item 1A. Risk Factors” in Alteva’s Annual Report on Form 10-K and in the Alteva’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015 and in other documents filed with the SEC by Alteva. Given these uncertainties, current and prospective investors should be cautioned regarding reliance on such forward-looking statements. Except as required by law, Alteva disclaims any obligation to update any such factors or to publicly announce the results of any revision to any of the forward-looking statements contained herein to reflect future events or developments. A more comprehensive discussion of risks, uncertainties, financial reporting restatements, and forward-looking statements may be seen in Alteva’s Annual Report on Form 10-K and other periodic filings with the U.S. Securities and Exchange Commission.
Media/Investor Contacts:
At Momentum Telecom:
Stuart Roesel
Marketing Director
Stuart.Roesel@momentumtelecom.com
At Alteva:
shareholderrelations@alteva.com
(LATX) Officially Launches “360 Fantasy Live”
Latitude 360 Enters Exploding Daily Fantasy Sports Market
NEW YORK, NY–(Sep 3, 2015) – Latitude 360, Inc. (OTCQB: LATX) (www.latitude360.com), the “ultimate upscale multi-dimensional entertainment eatery,” today announces the highly anticipated launch of its 360 Fantasy Live platform at www.360fantasylive.com, just in time for the official start of the 2015 NFL season.
Users can now register on the 360 Fantasy Live site and participate in exciting and competitive daily fantasy contests ranging from free competitions to wagered events with chances to win big money every day.
Other exciting competitions include daily Major League Baseball contests, which are immediately available, and NFL season contests that will start shortly thereafter on Monday, September 7.
360 Fantasy Live dramatically elevates the sports watching experience while intensifying the overall dynamic Latitude 360 entertainment concept. In addition to appealing to national daily fantasy sports enthusiasts, 360 Fantasy Live will be activated within Latitude 360’s dining and entertainment venues, providing a substantial enhancement to guests who can participate in a daily fantasy contest while watching their players perform on huge HD screens.
“We are excited about bringing 360 Fantasy Live to patrons as well as those who never heard about our venues. This platform is special and our expectations are very high because it allows everyone to continue the Latitude 360 experience after leaving one of our locations,” said Brent Brown, CEO of Latitude 360.
ABOUT LATITUDE 360
Latitude 360 (OTCQB: LATX), is an award-winning pioneer of combining premier upscale casual dining with state-of-the-art entertainment creating a “360 Experience” in its unique venues. The Company develops, constructs and operates cutting-edge Latitude 360 locations (from 50,000-70,000 sq. ft.) that appeal to a broad base of consumers and corporate clients. Current locations can be found in Jacksonville, Pittsburgh, and Indianapolis. Management plans to open three new venues per year for the next four years. Two new locations in Syracuse, NY and Bethlehem, PA are expected to operate as Latitude 360 locations in the fourth quarter of this year.
Latitude 360’s “360 Experience” provides a dining and entertainment experience unlike any concept in the world. Key offerings at each Latitude 360 location include, but are not limited to:
- Latitude 360 Grille, a full-service, upscale casual restaurant and bar
- Latitude LIVE, a Las Vegas-style live entertainment theatre
- 360 Fantasy LIVE, providing daily fantasy sports contests for guests including the ability to wager and win big money while enjoying top quality sports watching on massive HD screens (and continue playing outside the venue via www.360fantasylive.com)
- Axis Bar & Stage, a lush bar featuring the area’s top musicians and/or DJ’s
- Luxury Bowling, a high end lounge for boutique bowling lanes
- Cinegrille, a full service dine-in movie experience
- HD Sports Theater, a state-of-the art HD viewing area with full service dining
- Arcade, an exciting game arcade featuring the most popular video and redemption games available
- Latitude Lit, a luxury Cigar Lounge
Safe Harbor Statement
This press release contains “forward-looking statements.” Such statements include those related to the company’s expectations about future events or financial performance, including the potential acquisition of the Revolutions venues, the anticipated benefits of the potential acquisition, anticipated growth opportunities, a potential listing of the Company’s stock on a securities exchange and access to capital, and are not historical facts. Forward-looking statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Such statements are not guarantees of future performance, are based on certain assumptions, and are also subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in forward-looking statements. The company does not undertake any obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
5W Public Relations
Latitude360@5wpr.com
+1-212-999-5585
(DTSI) to Acquire iBiquity Digital Corporation
- Combines businesses with similar and compelling IP licensing models driving diverse recurring revenue streams and high gross margins
- Expands DTS’ leading suite of high definition audio solutions with iBiquity’s extensive patent portfolio and strong customer relationships in automotive and radio broadcast
- DTS’ global licensing platform combined with iBiquity’s HD Radio™ technology provides geographic and market expansion opportunities in automotive, home and mobile
- Expected to drive strategic and financial synergies and be accretive beginning in 2016
CALABASAS, Calif., Sept. 2, 2015 — DTS, Inc. (Nasdaq:DTSI), a leader in high-definition audio solutions and audio enhancement technologies, today announced it has entered into a definitive agreement to acquire iBiquity Digital Corporation, the developer of digital HD Radio technology for AM/FM audio and data broadcasting for approximately $172 million. DTS expects to finance the transaction through a combination of cash on hand and debt.
iBiquity is the exclusive developer and licensor of HD Radio technology, the sole FCC-approved method for upgrading AM/FM broadcasting from analog to digital. HD Radio technology provides compelling benefits, including improved audio quality, expanded content choices and new digital data services such as album cover art and real-time traffic updates. iBiquity’s partners include leading automakers, consumer electronics and broadcast equipment manufacturers, radio broadcasters, semiconductor and electronic component manufacturers and retailers.
In particular, iBiquity has very successfully driven penetration of HD Radio technology in the North American automotive OEM market. Every one of the 36 major auto brands serving the U.S. market offers HD Radio technology on some of their vehicles, many as standard equipment. The Company’s technology was built into approximately 35% of cars sold in the U.S. in 2014, and DTS expects the majority of North American vehicles to come equipped with HD Radio technology over time. The combination is also expected to provide opportunities for additional geographic, service and technology expansion.
“DTS has long been at the forefront of the highest quality audio technology, and we saw a similar spirit at iBiquity, which identified an opportunity to revolutionize traditional AM/FM broadcasting and is now strongly positioned to capitalize on broadcast radio’s ongoing digital upgrade,” said Jon Kirchner, chairman and CEO of DTS. “This transaction extends our strategy of delivering a personalized, immersive and compelling experience across the network-connected entertainment value chain, and complements our existing suite of technology and content delivery solutions while enabling us to strengthen our position in the large automotive OEM market. Consumers have come to expect a higher quality sound experience in their car, and we believe there is a tremendous opportunity for DTS to capitalize on the upgrade to HD Radio technology as cars are increasingly equipped with screens and advanced entertainment systems. We are thrilled to welcome the talented iBiquity team to the DTS family.”
“We are excited to join forces with DTS, a true pioneer in high definition audio,” said Bob Struble, president and CEO of iBiquity. “In DTS, we have found a like-minded partner and we look forward to bringing our breakthrough HD Radio technology to the DTS portfolio of solutions. Today’s announcement is an exciting step forward for our employees and customers, who will benefit from the additional scale and enhanced resources of a larger collective company.”
The transaction is expected to close later in 2015 and is subject to customary closing conditions. The transaction is expected to be accretive beginning in 2016.
iBiquity Digital Corporation is a privately held company based in Columbia, Maryland with approximately 120 employees. After closing, Bob Struble will continue to lead the HD Radio business for DTS.
Advisors
Centerview Partners LLC acted as financial advisor and DLA Piper LLP acted as legal advisor to DTS, Inc. Moelis & Company LLC acted as financial advisor and Jones Day acted as legal advisor to iBiquity Digital Corporation.
Conference Call Information for September 2, 2015
DTS will host a conference call and live webcast at 8:00 AM Eastern Time to discuss additional details of the transaction. To access the conference call, dial 1-888-539-3678 or 1-719-325-2315 (outside the U.S. and Canada). A live webcast of the call and accompanying presentation will be available from the Investor Relations section of the Company’s corporate website at www.dts.com and via replay beginning two hours after the completion of the call. An audio replay of the call will also be available to investors beginning at 11:00 AM Eastern Time, September 2, 2015 through 11:00 AM Eastern Time, September 9, 2015, by dialing 1-888-203-1112 or 1-719-457-0820 (outside the U.S. and Canada) and entering pass code 6768572.
About DTS, Inc.
Since 1993, DTS, Inc. (Nasdaq:DTSI) has been dedicated to making the world sound better. Through its pioneering audio solutions for mobile devices, home theater systems, cinema and beyond, DTS provides incredibly high-quality, immersive and engaging audio experiences to listeners everywhere. DTS technology is integrated in more than two billion devices globally, and the world’s leading video and music streaming services are increasingly choosing DTS to deliver premium sound to their listeners’ network-connected devices. For more information, please visit www.dts.com.
About iBiquity Digital Corporation
iBiquity Digital Corporation is the developer of HD Radio technology, which is fueling the digital radio revolution in the United States and around the world. The digital technology enables broadcasters to offer new and unique FM content via HD2/HD3 channels, crystal-clear sound and data services on both the AM and FM bands – all free, with no subscription fee. Leading broadcasters, consumer electronics manufacturers, automakers and retailers are committed to HD Radio technology. iBiquity Digital is a privately held company with operations in Columbia, MD, Auburn Hills, MI, and Piscataway, NJ. For more information, please visit hdradio.com and www.ibiquity.com.
Media Contact
Sard Verbinnen & Co for DTS, Inc.
John Christiansen/Jenny Gore/Alyssa Linn
(415) 618-8750
Investor Contact
DTS, Inc.
Geri Weinfeld
Director, Investor Relations
geri.weinfeld@dts.com
(818) 436-1231
Forward-Looking Statements
This document contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These forward-looking statements, which are based on current expectations, estimates and projections about the industry and markets in which DTS and iBiquity operate and beliefs of and assumptions made by DTS, iBiquity and their respective management teams, involve uncertainties that could significantly affect the financial results of DTS or iBiquity or the combined company. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements, which generally are not historical in nature. Such forward-looking statements include, but are not limited to, statements about the benefits of the transaction involving DTS and iBiquity, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future — including statements relating to the increasing availability of HD Radio receivers in new vehicles, opportunities for additional geographic, service and technology expansion, integrating our companies, and the expected timetable for completing the proposed transaction — are forward-looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Although we believe the expectations reflected in any forward-looking statements are based on reasonable assumptions, we can give no assurance that our expectations will be attained and therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. For example, these forward-looking statements could be affected by factors including, without limitation:
- the possibility that iBiquity or DTS may be adversely affected by economic, business and/or competitive factors before or after closing of the transaction;
- the availability of HD Radio receivers in new vehicles;
- the ability to successfully complete the integration of the business being acquired from iBiquity by, among other things, realizing revenue, expense and other synergies, renewing contracts on competitive terms, successfully leveraging the information technology platform of the acquired business, and retaining key personnel; and
- any adverse effect to DTS’ business or the business being acquired from iBiquity due to uncertainty relating to the transaction.
This list of important factors is not intended to be exhaustive. Additional risks and factors are discussed in reports filed with the Securities and Exchange Commission (“SEC”) by DTS from time to time, including those discussed under the heading “Risk Factors” in its most recently filed reports on Form 10-K and 10-Q. DTS assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
(UNIS) Announces Review of Strategic Alternatives
Morgan Stanley Appointed as Strategic Advisor in Response to Expressions of Interest from Third Parties
YORK, Pa., Sept. 2, 2015 — Unilife Corporation (“Unilife” or the “Company”) (NASDAQ: UNIS and ASX: UNS), a developer, manufacturer and supplier of injectable drug delivery systems, today announced that in response to third-party initiated expressions of interest, the Company’s Board of Directors has engaged Morgan Stanley & Co. LLC to conduct a review of strategic alternatives to maximize shareholder value.
Potential strategic alternatives to be explored and evaluated during the review process may include a possible sale of the Company, a strategic partnership with one or more parties or the licensing of some of the Company’s proprietary technologies. The Unilife Board of Directors will not provide any commitment regarding when or if this strategic review process will result in any type of transaction, and no assurance can be given that the Company will determine to pursue a potential sale, strategic partnership or licensing arrangement.
Mr. Alan Shortall, Chairman and CEO of Unilife, said: “In keeping with the Board’s commitment to act in the best interests of all shareholders, we have determined at this time that it is prudent to explore strategic alternatives to determine the best opportunities for enhancing shareholder value. Unilife management will continue to operate the business as normal during this review process to serve the needs of existing and prospective pharmaceutical customers.”
About Unilife Corporation
Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife’s portfolio of innovative, differentiated products includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto injectors, wearable injectors, insulin patch pumps, ocular delivery systems and novel systems. Products within each platform are customizable to address specific customer, drug and patient requirements. Unilife’s global headquarters and manufacturing facilities are located in York, PA. For more information, visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.
General: UNIS-G
Forward-Looking Statements
This press release contains forward-looking statements. All statements that address operating performance, or other events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.
(BVXV) to Launch Phase 2 Trial in U.S. in Collaboration with NIH
NESS ZIONA, Israel, September 2, 2015 —
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced the intent of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) within the Department of Health and Human Services (HHS), to launch a new phase 2 trial to be held in the United States in the 2015-16 timeframe. The trial will examine the use of BiondVax’s universal flu vaccine candidate, Multimeric-001 (M-001), as a primer vaccine, which would be administered several weeks before a pandemic vaccine. The trial will be a collaboration between BiondVax and the National Institute of Allergy and Infectious Diseases.
The trial will assess the ability of M-001 in humans to serve as a pandemic primer to the H7N9 avian pandemic vaccine, by enhancing protective immunity to these highly pathogenic avian influenza H7 strains. It will also look to strengthen previous clinical and pre-clinical findings on M-001 priming capacity to other seasonal and pandemic strains.
Typically, a strain-specific flu vaccine for a pandemic outbreak takes 4-6 months to manufacture, a period during which the virus can spread rapidly, causing high levels of illness and mortality. Stockpiling of M-001 as a pandemic primer would enable vaccination schedules to start immediately upon any pandemic declaration.
BiondVax is currently producing the M-001 vaccine batch for this clinical trial.
Ron Babecoff, BiondVax‘s President and CEO, commented, “The recognition of the potential of our technology by a foremost public health authority in the United States, is a significant milestone in our clinical development program. This trial will assess our vaccines’ ability to be used as the stockpiled flu vaccine for pandemic protection. The scenario is that immediately following a flu pandemic outbreak of any strain, our vaccine could be used from day zero, saving multiple lives and limiting the wild spread of a flu pandemic. This collaboration with NIAID brings us a significant step closer to our Phase 3 clinical trial.”
Tamar Ben-Yedidia, BiondVax‘s Chief Scientific Officer, commented, “This important trial is examining the use of M-001 in the event of an H7 avian influenza outbreak. It is complementary to a previous clinical trial in the elderly that concluded successfully, showing enhanced immunogenicity against the H1N1 swine pandemic virus in participants that received our M-001 vaccine as primer. This study is also complementary to our upcoming European clinical trial in which the M-001 will serve as a primer to the H5N1 avian pandemic vaccine.”
About BiondVax Pharmaceuticals Ltd
BiondVax is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal and pandemic flu strains.
BiondVax’s technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, uncertainty of clinical trial results or regulatory approvals or clearances, final results from subsequent clinical trials, risks inherent in the development and commercialization of potential products, dependence upon collaborators, and adequacy of capital resources for product development and commercialization. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
For further information, please contact:
Company Contact
Limor Chen, Director of BD
limor.c@biondvax.com
Investor Relations Contact
GK Investor Relations
Kenny Green, Partner
+1-646-201-9246
kenny@biondvax.com
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