Archive for May, 2016
(SPPI) Apaziquone Presentation at 2016 Annual AUA, May 6-10
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today presentations of clinical data for apaziquone to be presented at an oral presentation and a moderated poster session at the American Urological Association Education and Research Inc., being held in San Diego, California, from May 6-10, 2016.
For more information about the AUA Meeting and for a complete list of abstracts, please refer to the conference web site at http://www.aua2016.org/abstracts/
Friday, May 6, 2016 1:00 PM-3:00 PM PT (Moderated Poster Session) | ||||||||||||
Abstract # | Type | Title | First Author | Location | ||||||||
MP13-07 | Poster | Improved Efficacy of Adjuvant, Single Dose Intravesical Apaziquone by Timing post-Resection in Two Doubleblind, Randomized, Placebo-Controlled Phase 3 Studies in Non-Muscle Invasive Bladder Cancer | Fred Witjes | Room 28 ABC | ||||||||
Saturday, May 7, 2016, 8:00 AM-10:00 AM PT (Podium Presentation) | ||||||||||||
Abstract # | Type | Title | First Author | Location | ||||||||
PD11-07 | Podium | Integrated Results of Two Multicenter, Randomized, Placebo Controlled, Double Blind, Phase 3 Trials (SPI-611/612) of Single-Dose Intravesical Apaziquone Immediately Following Resection in Patients with Non-Muscle Invasive Bladder Cancer | Lawrence Karsh | Room 23 AB |
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and expects an FDA decision on another drug in the second half of 2016. Additionally, Spectrum’s pipeline includes three drugs in advanced stages of clinical development that have the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved
Spectrum Pharmaceuticals
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
(AVXS) Reports Data from Ongoing Phase 1 Trial of AVXS-101 in Spinal Muscular Atrophy Type 1
— Jerry Mendell, MD, Presented Data as of April 1, 2016 at the American Society of Gene & Cell Therapy 19th Annual Meeting —
— Company to Host Webcast Today at 4:30 p.m. Eastern Daylight Time —
CHICAGO, May 06, 2016 — AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases, today presented an interim analysis of data as of April 1, 2016 from the ongoing Phase 1 trial of AVXS-101 for the treatment of spinal muscular atrophy (SMA) Type 1. Jerry Mendell, MD, director of the Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital, presented the data at the 19th Annual Meeting of the American Society of Gene & Cell Therapy in Washington, D.C.
The data reported at the meeting show that AVXS-101 continues to demonstrate a favorable safety profile in patients studied, with no new treatment-related safety or tolerability concerns identified; all patients in both the low-dose and proposed therapeutic-dose cohorts remain without an “event,” defined as death or until a patient requires at least 16 hours per day of ventilation support for breathing for 14 consecutive days in the absence of an acute reversible illness, or perioperatively; and the mean motor function score continues to increase, with two patients having achieved motor function in a range considered to be normal.
Dr. Mendell said, “Given the rapid and devastating disease course of SMA Type 1, it is very encouraging to see that all patients in both dosing cohorts have remained event free, and all patients have demonstrated sustained improvements above baseline in motor function since receiving AVXS-101. Additionally, new data presented today appear to indicate that AVXS-101 may have a positive impact on both the pulmonary and nutritional support of patients in the trial suffering from SMA Type 1, which may be impacting the overall survival benefit.”
The ongoing Phase 1 study is designed to evaluate safety and preliminary indications of efficacy of AVXS-101 in patients suffering from SMA Type 1. Data as of April 1, 2016 has shown:
- AVXS-101 appears to have a favorable safety profile and to be generally well tolerated in patients studied. There has been a total of 74 adverse events (AEs) reported, 22 of which were determined to be serious adverse events (SAEs). Two of the 22 were deemed treatment-related and, as previously reported, those SAEs were clinically asymptomatic liver enzyme elevations. Of the 52 non-serious AEs, 3 were treatment-related elevations in liver enzymes experienced by two patients. All elevated liver enzyme AEs and SAEs were resolved with prednisolone treatment. Other non-treatment-related AEs were expected and were associated with SMA.
- No patients in either dosing cohort have experienced an “event.” The median event-free age of all 15 patients was 14.9 months, and the median event-free age of patients in Cohort 1 was 25.7 months and in Cohort 2 was 11.7 months. The natural history of the disease indicates that 25 percent of untreated SMA Type 1 patients survive event-free at 13.6 months of age and that 8 percent survive event-free at 20 months of age1.
- Mean increases of 8.7 points and 19.2 points in CHOP-INTEND scores were observed in Cohort 1 and Cohort 2, respectively. Nine out of 12 patients (75 percent) and 7 out of 12 patients (58 percent) in Cohort 2 have achieved CHOP-INTEND scores of at least 40 points or 50 points, respectively. Two patients achieved the maximum score of 64. A score of 60 is considered normal. The Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) is a test developed to measure motor skills of patients with SMA Type 1.
- The natural history of SMA Type 1 indicates that bulbar weakness leads to impaired swallowing, malnutrition and growth failure. The median age to growth failure is 7 months of age2. The median age to nutritional support is 8 months of age (IQR 6-13 months)1. AVXS reported today that 7 of 7 (100%) of AVXS-101 patients that did not require feeding support before treatment continued without feeding support as of April 1, 2016 in the ongoing Phase 1 trial. Five patients had gastric feeding tube placement prior to gene therapy. One patient in Cohort 2 who had gastric feeding tube placement prior to gene transfer is also feeding orally.
- The natural history of SMA Type 1 indicates that bulbar muscle weakness, skeletal muscle weakness in the neck and intercostal muscle weakness lead to respiratory impairment, poor clearance of airway secretions, risk of aspiration and recurrent infections leading to death or permanent ventilation. The median age to permanent ventilation or death is 10.5 months (IQR 8.1-13.6 months), and by 13.6 months only 25 percent of SMA Type 1 patients are alive and free of permanent ventilation1. In the ongoing trial, 8 of 10 (80%) of AVXS-101 patients that did not use biphasic/bi-level ventilation (BiPAP) support before gene transfer continue without any ventilation support as of April 1, 2016 (the 2 exceptions being after severe illness/hospitalizations to assist recovery).
“We are encouraged by these interim results as we work diligently to bring AVXS -101 to patients who suffer from SMA Type 1, a devastating disease for which there are currently no FDA-approved therapies,” said Suku Nagendran, MD, Senior Vice President and Chief Medical Officer, AveXis. “We look forward to reviewing the ongoing data from this study over the coming year as we continue the development of AVXS-101.”
Webcast at 4:30 p.m. EDT
AveXis will host a live audio webcast of a conference call to discuss the interim Phase 1 trial data today at 4:30 p.m. EDT. Analysts and investors can participate in the conference call by dialing (877) 508-0547 for domestic callers and (615) 247-5963 for international callers, using the conference ID 95576133. The webcast can be accessed live on the Events and Presentations page in the Investors and Media section of the AveXis website, www.AveXis.com. The webcast will be archived on the company’s website for 30 days and will be available for telephonic replay for 14 days following the call by dialing (855) 859-2056 (Domestic) or (404) 537-3406 (International), conference ID 95576133.
Phase 1 Trial Design
The Phase 1 open-label, dose-escalation study is designed to evaluate safety and preliminary indications of efficacy of AVXS-101 in patients suffering from SMA Type 1. The primary outcome in the study is safety and tolerability. The secondary outcome measure is efficacy as defined by the time from birth to an “event,” with an event defined as death or until a patient requires at least 16 hours per day of required ventilation support for breathing for 14 consecutive days in the absence of an acute reversible illness or perioperatively. Exploratory outcome measures include motor function testing, measured by the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND), a test developed to measure motor skills of patients with SMA Type 1, and other motor milestone development surveys and tests.
The clinical protocol requires that each patient receive a one-time dosage of AVXS-101, by intravenous injection over a one-hour period. The patient remains at the clinical trial site for 48 hours after dosing for monitoring prior to discharge, and weekly follow-up evaluations are conducted for one month after dosing. After the first month, additional evaluations are conducted monthly for 23 months.
The trial has fully-enrolled with a total of 15 patients who met enrollment criteria of diagnosis of SMA Type 1 before six months of age, with two copies of the SMN2 backup gene, as determined by genetic testing. The trial includes two dosing cohorts:
- Cohort 1 (low dose) includes three patients dosed at (6.7 X1013 vg/kg), aged 5.9 to 7.2 months at time of dosing;
- Cohort 2 (proposed therapeutic dose) includes 12 patients dosed at (2.0 X1014 vg/kg), aged 0.9 to 7.9 months at time of dosing.
About SMA
SMA is a severe neuromuscular disease characterized by the loss of motor neurons leading to progressive muscle weakness and paralysis. SMA is caused by a genetic defect in the SMN1 gene that codes SMN, a protein necessary for survival of motor neurons. The incidence of SMA is approximately one in 10,000 live births.
The most severe form of SMA is Type 1, a lethal genetic disorder characterized by motor neuron loss and associated muscle deterioration, which results in mortality or the need for permanent ventilation support before the age of two for greater than 90 percent of patients. SMA Type 1 is the leading genetic cause of infant mortality.
About AVXS-101
AVXS-101 is a proprietary gene therapy candidate of a one-time, intravenous treatment for SMA Type 1 and is the only clinical-stage gene therapy in development for SMA. AVXS-101 is designed to address the monogenetic root cause of SMA and prevent further muscle degeneration by addressing the defective and/or loss of the primary SMN gene. AVXS-101 also targets motor neurons providing rapid onset of effect, and crosses the blood brain barrier allowing an intravenous (IV) dosing route and effective targeting of both central and systemic features.
About AveXis, Inc.
AveXis is a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. The company’s initial proprietary gene therapy candidate, AVXS-101, is in an ongoing Phase 1 clinical trial for the treatment of SMA Type 1. For additional information, please visit www.avexis.com.
1. Finkel, R. et al. Observational study of spinal muscular atrophy type I and implications for clinical trials. Neurology 83,810–817 (2014).
2. Sproule, D. et al. Age at Disease Onset Predicts Likelihood and Rapidity of Growth Failure Among Infants and Young Children with Spinal Muscular Atrophy Types 1 and 2. J Child Neurol 27, 845-851 (2012).
Forward-Looking Statements:
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, AveXis’ research, development and regulatory plans for AVXS-101, including the expected timing for reporting results from the ongoing Phase 1 clinical trial and the potential for AVXS-101 to positively impact the pulmonary and nutritional support of patients suffering from SMA Type 1. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the scope, progress, expansion, and costs of developing and commercializing AveXis’ product candidates; regulatory developments in the United States and foreign countries, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of AveXis’ Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 18, 2016. In addition to the risks described above and in the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect AveXis’ results. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. AveXis cautions investors not to rely too heavily on the forward-looking statements AveXis makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). AveXis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Media Inquiries: Lauren Barbiero W2O Group 646-564-2156 lbarbiero@w2ogroup.com Investor Inquiries: Jim Goff AveXis, Inc. 650-862-4134 jgoff@avexis.com
(GSV) Completes Strategic Investment in Battle Mountain Gold
VANCOUVER, BRITISH COLUMBIA–(May 6, 2016) – Gold Standard Ventures Corp. (TSX VENTURE:GSV)(NYSE MKT:GSV) (“Gold Standard” or the “Company”) of Suite 610 – 815 West Hastings Street, Vancouver, B.C. V6C 1B4 announces that further to its news release of April 20, 2016, it has acquired ownership of 10,481,435 common shares of Battle Mountain Gold Inc. (“Battle Mountain“) representing 19.9% of Battle Mountain’s issued and outstanding common shares at a price of $0.35 per share for a total subscription price of $3,668,502.25. Gold Standard has also acquired ownership of share purchase warrants entitling the Company to purchase of up to an additional 5,240,717 common shares of Battle Mountain for a period of two years at a price of $0.37 per share, provided that the Company is prohibited from exercising the warrants pending shareholder approval from Battle Mountain for the creation of Gold Standard as a control person. Assuming exercise of the warrants, Gold Standard will own a total of 15,722,152 common shares or approximately 27.15% of Battle Mountain’s issued and outstanding common shares on a post-conversion beneficial ownership basis.
The common shares and warrants were acquired by Gold Standard as principal for investment purposes pursuant to a private placement offering by Battle Mountain (the “Private Placement“) in reliance upon the “minimum investment amount” exemption from the prospectus requirements of applicable securities legislation in National Instrument 45-106 Prospectus Exemptions.
Gold Standard did not own or control any shares of Battle Mountain, either alone or together with any joint actors prior to closing of the Private Placement and, other than the potential exercise of warrants, Gold Standard has no present intention to acquire further securities of Battle Mountain although Gold Standard may in the future and in accordance with applicable securities laws, increase or decrease its investment in Battle Mountain by acquiring or disposing of other securities of Battle Mountain, through the market, privately or otherwise, depending on market conditions or any other relevant factors.
Gold Standard has agreed to vote its shares of Battle Mountain in accordance with the recommendations of Battle Mountain’s board of directors for a period of 18 months and give Battle Mountain prior notice of any sales of shares exceeding 2% of Battle Mountain’s then issued and outstanding shares in any 15 day period for so long as Gold Standard owns not less than 9.9% of Battle Mountain’s issued and outstanding shares.
A report respecting this acquisition will be electronically filed with the applicable securities commission in each jurisdiction where Battle Mountain is reporting and will be available for viewing through the Internet at the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
ABOUT GOLD STANDARD VENTURES – Gold Standard is an advanced stage gold exploration company focused on district scale discoveries on its Railroad-Pinion Gold Project, located within the prolific Carlin Trend. The 2014 Pinion and Dark Star gold deposit acquisitions offer Gold Standard a potential near-term development option and further consolidates the Company’s premier land package on the Carlin Trend. The Pinion deposit now has an NI43-101 compliant resource estimate consisting of an Indicated Mineral Resource of 31.61 million tonnes grading 0.62 grams per tonne (g/t) gold (Au), totaling 630,300 ounces of gold and an Inferred Resource of 61.08 million tonnes grading 0.55 g/t Au, totaling 1,081,300 ounces of gold, using a cut-off grade of 0.14 g/t Au (announced March 15, 2016). The Dark Star deposit, 2.1 km to the east of Pinion, has a NI43-101 compliant resource estimate consisting of an Inferred Resource of 23.11 million tonnes grading 0.51 g/t Au, totaling 375,000 ounces of gold, using a cut-off grade of 0.14 g/t Au (announced March 3, 2015). The 2014 and 2015 definition and expansion of these two shallow, oxide deposits demonstrates their growth potential.
The scientific and technical content and interpretations contained in this news release have been reviewed, verified and approved by Steven R. Koehler, Gold Standard’s Manager of Projects, BSc. Geology and CPG-10216, a Qualified Person as defined by NI 43-101, Standards of Disclosure for Mineral Projects.
Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) nor the NYSE MKT accepts responsibility for the adequacy or accuracy of this news release.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. All statements, other than statements of historical fact, included herein including, without limitation, statements about our proposed financing are forward looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Risk factors affecting the Company include, among others: the results from our exploration programs, global financial conditions and volatility of capital markets, uncertainty regarding the availability of additional capital, fluctuations in commodity prices; title matters; and the additional risks identified in our filings with Canadian securities regulators on SEDAR in Canada (available at www.sedar.com) and with the SEC on EDGAR (available at www.sec.gov/edgar.shtml). These forward-looking statements are made as of the date hereof and, except as required under applicable securities legislation, the Company does not assume any obligation to update or revise them to reflect new events or circumstances.
CAUTIONARY NOTE FOR U.S. INVESTORS REGARDING RESERVE AND RESOURCE ESTIMATES
All resource estimates reported by the Company were calculated in accordance with the Canadian National Instrument 43-101 and the Canadian Institute of Mining and Metallurgy Classification system. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission for descriptions of mineral properties in SEC Industry Guide 7 under Regulation S-K of the U. S. Securities Act of 1933. In particular, under U. S. standards, mineral resources may not be classified as a “reserve” unless the determination has been made that mineralization could be economically and legally produced or extracted at the time the reserve determination is made. Accordingly, information in this press release containing descriptions of the Company’s mineral properties may not be comparable to similar information made public by US public reporting companies.
On behalf of the Board of Directors of Gold Standard,
Jonathan Awde, President and Director
Gold Standard Ventures Corp.
Jonathan Awde
President
604-669-5702
info@goldstandardv.com
www.goldstandardv.com
(EXPI) Real Estate Brokerage Division Appoints CEO and President
BELLINGHAM, WA –(May 06, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI) announced today that it has appointed Jason Gesing Chief Executive Officer of its real estate brokerage division and Vikki Bartholomae as division President.
Bartholomae has over 15 years of real estate industry experience, including more than 6 years as a Team Leader in the Keller Williams organization, during which time she achieved net agent gain of 192% and gains in both agent production (47%) and profit (56%) in the market centers she managed in Southern California and Texas. Bartholomae also has extensive experience in the coaching and training of real estate professionals, which includes the development of mentor programs for new agents. Bartholomae joined eXp Realty in Houston, Texas, where she now resides, in July 2015.
“Becoming part of eXp Realty, was a defining moment for me both personally and professionally,” said Bartholomae. “It is so exciting to be part of the future of the industry I love. eXp’s business model is completely disruptive in real estate by eliminating bricks and mortar and giving the agents true ownership in the company. My role as President gives me the opportunity to serve my agent ownership partners and bring about revolutionary change to our industry at the same time.”
Gesing, who joined eXp Realty in 2010, became EXPI president in October of 2013. Since that time, the Company’s brokerage division has increased its family of real estate professionals from approximately 300 to more than 1,200 and the Company’s revenues have increased from $10.7 million (2013) to $22.87 (2015).
“The eXp Realty business model offers unique and empowering professional development and wealth-building opportunities to real estate professionals because of the Company’s innovative use of technology,” said Gesing. “However, as beneficial and lucrative as the model is, people are joining us because we’ve been able to create an environment and a community that entrepreneurial agents want to be a part of. It’s a community of professionals who work very closely together, who support one another, and whose voices are and will continue to be heard, both as agents and brokers of the company, and as its shareholders.”
“I am very excited about Jason and Vikki working together to steward the real estate division of eXp World Holdings,” said EXPI Founder and CEO, Glenn Sanford. “Jason and I have been working closely together over the last three years and he has really articulated the value proposition in a way that resonates with those who are making meaningful differences in the industry. I have also been very impressed with the way Vikki has selflessly engaged with the Company from the moment she joined, serving to improve and grow the organization even when her role with the company was not well defined. Vikki possesses and has demonstrated great strength and tremendous talent and it quickly became clear that she needed to play a much larger role in the leadership of the company. I believe, based on my observations over the last six months in particular, that Jason and Vikki working together to lead the real estate division will result in even greater differentiation of the agent ownership model relative to the rest of the industry. I fully expect that the culture of the company will continue to strengthen and that the growth of the company will continue to accelerate.”
Vikki Bartholomae can be reached at vikki.bartholomae@exprealty.com or at 714-273-6041.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 90.5% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, New Mexico and Texas.
The corporate name change to “eXp World Holdings, Inc.” has been approved by our Board and stockholders but is not yet effective, pending the mailing of a definitive information statement to our stockholders in accordance with applicable rules and a 20-day notice period thereafter.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit investors.exprealty.com or www.exprealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
President
eXp World Holdings, Inc.
jason@expworldholdings.com
617-970-8518
(FCEL) & (XOM) Pursue Novel Technology in Carbon Capture
- Advancing a novel application of carbonate fuel cells for power plant carbon dioxide capture
- Substantial cost savings relative to commercial technology through unique process that generates power while capturing carbon
Exxon Mobil Corporation (NYSE:XOM) and FuelCell Energy, Inc. (Nasdaq:FCEL) today announced an agreement to pursue novel technology in power plant carbon dioxide capture through a new application of carbonate fuel cells, which could substantially reduce costs and lead to a more economical pathway toward large-scale application globally.
“Advancing economic and sustainable technologies to capture carbon dioxide from large emitters such as power plants is an important part of ExxonMobil’s suite of research into lower-emissions solutions to mitigate the risk of climate change,” said Vijay Swarup, vice president for research and development at ExxonMobil Research & Engineering Company. “Our scientists saw the potential for this exciting technology for use at natural gas power plants to enhance the viability of carbon capture and sequestration while at the same time generating additional electricity. We sought the industry leaders in carbonate fuel-cell technology to test its application in pilot stages to help confirm what our researchers saw in the lab over the last two years.”
Chip Bottone, president and chief executive officer of FuelCell Energy, Inc., said his company is pleased to bring its global leadership in the development of carbonate fuel cells to this project.
“Carbon capture with carbonate fuel cells is a potential game-changer for affordably and efficiently concentrating carbon dioxide for large-scale gas and coal-fired power plants,” Bottone said. “Ultra-clean and efficient power generation is a key attribute of fuel cells and the carbon capture configuration has the added benefit of eliminating approximately 70 percent of the smog-producing nitrogen oxide generated by the combustion process of these large-scale power plants.”
Two years of comprehensive laboratory tests have demonstrated that the unique integration of two existing technologies – carbonate fuel cells and natural gas-fired power generation – captures carbon dioxide more efficiently than existing scrubber conventional capture technology. The potential breakthrough comes from an increase in electrical output using the fuel cells, which generate power, compared to a nearly equivalent decrease in electricity using conventional technology.
The resulting net benefit has the potential to substantially reduce costs associated with carbon capture for natural gas-fired power generation, compared to the expected costs associated with conventional separation technology. A key component of the research will be to validate initial projected savings of up to one-third.
The scope of the agreement between ExxonMobil and FuelCell Energy will initially focus for about one to two years on how to further increase efficiency in separating and concentrating carbon dioxide from the exhaust of natural gas-fueled power turbines. Depending on reaching several milestones, the second phase will more comprehensively test the technology for another one to two years in a small-scale pilot project prior to integration at a larger-scale pilot facility.
ExxonMobil is a leader in carbon capture and sequestration and has extensive experience in all of the component technologies of carbon capture and storage, including participation in several carbon dioxide injection projects over the last three decades. In 2015, ExxonMobil captured 6.9 million metric tons of carbon dioxide for sequestration – the equivalent of eliminating the annual greenhouse gas emissions of more than 1 million passenger vehicles.
“We are continually researching technologies that have an ability to reduce carbon dioxide emissions,” Swarup said. “Most solutions that can make an impact of the scale that is required are not found overnight. Our research with FuelCell Energy will be conducted methodically to ensure that all paths toward viability are explored.”
Using fuel cells to capture carbon dioxide from power plants results in reduced emissions and increased power generation. In the carbon capture context, power plant exhaust is directed to the fuel cell, replacing air that is normally used in combination with natural gas during the fuel cell power generation process. As the fuel cell generates power, the carbon dioxide becomes more concentrated, allowing it to be more easily and affordably captured from the cell’s exhaust and stored.
NOTE TO EDITORS:
Vijay Swarup and Chip Bottone will be available to answer questions from media on a conference call today at 10:30 a.m. CDT. Dial-in details are as follows:
Company Name: | Exxon Mobil Corporation | ||
Date/Time: | May 5, 2016, 10:30 AM CDT | ||
Participant Number: | USA: (877) 311-5896 | ||
Participant Number: | International: (281) 241-6149 | ||
Conference ID Number: | 7316844 | ||
About ExxonMobil
ExxonMobil, the largest publicly traded international oil and gas company, uses technology and innovation to help meet the world’s growing energy needs. ExxonMobil holds an industry-leading inventory of resources, is among the largest refiners and marketers of petroleum products and its chemical company is one of the largest in the world. For more information, visit www.exxonmobil.com or follow us on Twitter www.twitter.com/exxonmobil.
Cautionary Statement: Statements of future events or conditions in this release are forward-looking statements. Actual future results, including project plans and timing and the impact of new technologies, could vary depending on the outcome of further research and testing; the development and competitiveness of alternative technologies; the ability to scale pilot projects on a cost-effective basis; political and regulatory developments; and other factors discussed in this release and under the heading “Factors Affecting Future Results” on the Investors page of ExxonMobil’s website at exxonmobil.com.
About FuelCell Energy, Inc.
Direct FuelCell® power plants are generating ultra-clean, efficient and reliable power at more than 50 locations worldwide. With more than 300 megawatts of power generation capacity installed or in backlog, FuelCell Energy is a global leader in providing ultra-clean baseload distributed generation to utilities, industrial operations, universities, municipal water treatment facilities, government installations and other customers around the world. The company’s power plants have generated over four billion kilowatt hours of ultra-clean power using a variety of fuels including renewable biogas from wastewater treatment and food processing, as well as clean natural gas. For additional information, please visit www.fuelcellenergy.com, follow us on Twitter and view our videos on YouTube.
ExxonMobil
Media Relations, 972-444-1107
or
FuelCell Energy
Investor Relations, 203-830-7494
(SPHS)To Present Topsalysin Phase 3 Data from Positive PLUS-1 Study
SAN DIEGO and VANCOUVER, British Columbia, May 5, 2016 — Sophiris Bio Inc. (NASDAQ: SPHS) (the “Company” or “Sophiris”), a biopharmaceutical company developing topsalysin (PRX302) for the treatment of urological diseases, today announced that positive data from its Phase 3 study of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia will be presented as a late breaking poster on May 7, 2016 from 4:00 p.m. to 5:30 p.m. pacific time in the Science and Technology Hall at the 111th American Urological Association Annual Meeting.
Abstract No. 16-8385 (LB-S&T-04): “Prospective, Randomized, Double Blind, Vehicle Controlled, Multinational, Phase 3 Clinical Trial of the Pore Forming Protein PRX302 for Targeted Treatment of Symptomatic Benign Prostatic Hyperplasia (The PLUS-1 Trial)”
Presenting Author: Dr. Claus Roehrborn, UT Southwestern Medical Center
Poster Session: Late-Breaking Science & Technology Poster
Time: May 7, 2016 from 4:00 p.m. to 5:30 p.m. pacific time
The abstract related to the poster can be accessed through the American Urological Association website at http://www.aua2016.org/abstracts/.
About Sophiris
Sophiris Bio Inc. is a biopharmaceutical company developing topsalysin, a clinical-stage, targeted therapy for the treatment of urological diseases. Topsalysin is in Phase 3 clinical development for the treatment of the symptoms of benign prostatic hyperplasia (BPH) and is designed to be as efficacious as pharmaceuticals, less invasive than the surgical interventions, and without the sexual side effects seen with existing treatments. Topsalysin is also currently in a Phase 2a proof of concept study for the treatment of localized low to intermediate risk prostate cancer. For more information, please visit www.sophirisbio.com.
Company Contact: | |
Peter Slover | |
Chief Financial Officer | |
(858) 777-1760 | |
Corporate Communications and Investor Relations: | |
Jason Spark | Michael Moore |
Canale Communications | NATIONAL Equicom |
Corporate Communications and IR | Investor Relations |
(619) 849-6005 | (858) 886-7813 |
jason@canalecomm.com | mmoore@national.ca |
(CRME) and Allergan Announce XYDALBA™ Licensing Agreement
VANCOUVER, May 5, 2016 – Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) announced that its affiliate has signed an exclusive license agreement with an affiliate of Allergan plc that will result in the Cardiome Group (“Cardiome”) commercializing XYDALBA™ (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada. Cardiome will provide Allergan with a staggered upfront payment totalling US$13 million and will provide Allergan additional milestone payments and royalties based upon commercial achievements and sales of XYDALBA™. Additional terms of the agreement were not disclosed.
XYDALBA™ was approved by the European Medicines Agency (EMA) in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the U.S. Food and Drug Administration (FDA) in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialized under the trade name DALVANCE® in the U.S. and XYDALBA™ in certain countries outside the U.S.
“Our license of XYDALBA™ is a transformational moment for Cardiome,” said William Hunter, M.D., President and CEO of Cardiome. “Over the past three years we have restructured and redirected Cardiome to become a differentiated specialty pharmaceutical company focused on commercializing proprietary growth pharmaceuticals in Europe and Canada. XYDALBA™ will fit perfectly within our current commercial footprint alongside BRINAVESS, AGGRASTAT and ESMOCARD. Licensing a product of this profile is a strong signal of our progress and we look forward to working with Allergan to bring this compelling medicine to patients in need across our territories.”
XYDALBA™ is approved for sale in the following territories licensed by Cardiome: the U.K., Germany, France, Denmark, Iceland, Finland, Malta, Norway, Sweden, Belgium, Netherlands, Luxemburg, and Ireland. XYDALBA™ is not yet approved in other countries for which Cardiome has licensed rights in including Canada and Switzerland. Cardiome expects to initiate commercial sales of XYDALBA™ in its territories as early as 2016.
Conference Call
Cardiome will hold a teleconference and webcast on Friday, May 6, 2016 at 8:00 am Eastern (5:00 am Pacific). To access the conference call, please dial 416-764-8609 or 1-888-390-0605 and use conference ID 47992527. The webcast can be accessed through Cardiome’s website at www.cardiome.com or through the following link:
http://event.on24.com/r.htm?e=1186804&s=1&k=D38CF3F76EA1C201FE12E6E82186C18E
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through June 6, 2016. Please dial 416-764-8677 or 888-390-0541 and enter code 992527# to access the replay.
About XYDALBA
XYDALBA™ is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. XYDALBA™ is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes, and a single dose regimen of 1500 mg also administered over 30 minutes. XYDALBA™ demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
About ABSSSI
There were more than 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, which included patients with cellulitis, erysipelas, wound infection and major cutaneous abscess. In fact, hospital admissions for ABSSSI significantly increased by 17.3 percent during this timeframe. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the U.S. are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESSTM (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner AOP Orphan Pharma in select European markets. Cardiome has also licensed TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension, for Europe, the Middle East and for Canadian markets.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation that may not be based on historical fact, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. Forward- looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for the remainder of 2016 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research and development and product and drug development. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Many such known risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we operate; market demand; technological changes that could impact our existing products or our ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; availability of financial reimbursement coverage from governmental and third-party payers for products and related treatments; adverse results or unexpected delays in pre-clinical and clinical product development processes; adverse findings related to the safety and/or efficacy of our products or products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the requirement for substantial funding to expand commercialization activities; and any other factors that may affect our performance. In addition, our business is subject to certain operating risks that may cause any results expressed or implied by the forward-looking statements in this presentation to differ materially from our actual results. These operating risks include: our ability to attract and retain qualified personnel; our ability to successfully complete pre-clinical and clinical development of our products; changes in our business strategy or development plans; intellectual property matters, including the unenforceability or loss of patent protection resulting from third-party challenges to our patents; market acceptance of our technology and products; our ability to successfully manufacture, market and sell our products; the availability of capital to finance our activities; and any other factors described in detail in our filings with the Securities and Exchange Commission available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on our current expectations and we undertake no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
(AAWW) Announces Agreement with Amazon To Provide Air Transport Service
Service to Include 20 B767-300 Aircraft with a Lease Term of 10 Years
Amazon Granted Rights to Acquire AAWW Equity
PURCHASE, N.Y., May 05, 2016 — Atlas Air Worldwide Holdings, Inc. (Nasdaq:AAWW) announced today that it will provide air cargo services to support Amazon’s (Nasdaq:AMZN) package deliveries to its customers. The new agreements are expected to be meaningfully accretive to Atlas Air Worldwide’s earnings and cash flows over time.
“We are excited to begin a strategic long-term relationship with Amazon to support the continuing expansion of its e-commerce business and to enhance its customer delivery capabilities,” said President and Chief Executive Officer William J. Flynn. “We appreciate Amazon’s confidence in our capabilities, global scale and operating excellence.”
The long-term commercial agreements will include the operation of 20 B767-300 converted freighters for Amazon on a CMI (crew, maintenance and insurance) basis by Atlas Air Worldwide’s airline subsidiary, Atlas Air, Inc., as well as dry leasing by its Titan Aviation leasing unit. The dry leases will have a term of 10 years, while the CMI operations will be for seven years (with extension provisions for a total term of 10 years). Operations under the agreements are expected to begin in the second half of 2016 and ramp up to full service through 2018.
“We are excited to welcome a great provider, Atlas Air, to support package delivery to the rapidly growing number of Prime members who love ultra-fast delivery, great prices and vast selection from Amazon,” said Dave Clark, Amazon’s senior vice president of worldwide operations.
As part of the inherent value creation and to align interests and strengthen the long-term relationship, Atlas Air Worldwide granted Amazon warrants to acquire up to 20 percent (after the issuance) of AAWW’s common shares at a price of $37.50 per share over a period of five years, with vesting tied in part to the commencement of operations of the 20 B767-300 freighter aircraft and other conditions.
The agreements also provide for future growth of the relationship as Amazon may increase its business with Atlas. Atlas Air Worldwide granted Amazon warrants to acquire up to an additional 10 percent (after the issuance) of AAWW’s common shares at the same exercise price, over a period of seven years, with vesting tied to payments made by Amazon in connection with that business.
Morgan Stanley & Co. LLC is serving as financial advisor and Cravath, Swaine & Moore LLP is serving as legal advisor, both to Atlas Air Worldwide, in connection with the transaction.
About Atlas Air Worldwide:
Atlas Air Worldwide is a leading global provider of outsourced aircraft and aviation operating services. It is the parent company of Atlas Air, Inc. (Atlas), Southern Air Holdings, Inc. (Southern Air) and Titan Aviation Holdings, Inc. (Titan), and is the majority shareholder of Polar Air Cargo Worldwide, Inc. (Polar). Atlas Air Worldwide’s companies operate the world’s largest fleet of Boeing 747 freighter aircraft and provide customers the broadest array of 747, 777, 767, 757 and 737 aircraft for domestic, regional and international applications.
Atlas, Southern Air, Titan and Polar offer a range of outsourced aircraft and aviation operating services that include ACMI service – in which customers receive an aircraft, crew, maintenance and insurance on a long-term basis; CMI service – in which customers receive crew, maintenance and insurance but not an aircraft; express network and airport-to-airport cargo service; cargo and passenger charters; and dry leasing of aircraft and engines.
Atlas Air Worldwide’s press releases, SEC filings and other information may be accessed through the Company’s home page, www.atlasair.com.
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect Atlas Air Worldwide’s current views with respect to certain current and future events and financial performance. Such forward-looking statements are and will be, as the case may be, subject to many risks, uncertainties and factors relating to the operations and business environments of Atlas Air Worldwide and its subsidiaries (collectively, the “companies”) that may cause the actual results of the companies to be materially different from any future results, express or implied, in such forward-looking statements.
Factors that could cause actual results to differ materially from these forward-looking statements include, but are not limited to, the following: our ability to effectively operate the network service contemplated by our agreement with Amazon, including the cost and timing of securing any aircraft necessary to fulfill our agreement; our ability to obtain any shareholder approvals that may be required with respect to the equity arrangements expressed in our agreement with Amazon; the ability of the companies to operate pursuant to the terms of their financing facilities; the ability of the companies to obtain and maintain normal terms with vendors and service providers; the companies’ ability to maintain contracts that are critical to their operations; the ability of the companies to fund and execute their business plan; the ability of the companies to attract, motivate and/or retain key executives and associates; the ability of the companies to attract and retain customers; the continued availability of our wide-body aircraft; demand for cargo services in the markets in which the companies operate; economic conditions; the effects of any hostilities or act of war (in the Middle East or elsewhere) or any terrorist attack; labor costs and relations; financing costs; the cost and availability of war risk insurance; our ability to maintain adequate internal controls over financial reporting; aviation fuel costs; security-related costs; competitive pressures on pricing (especially from lower-cost competitors); volatility in the international currency markets; weather conditions; government legislation and regulation; consumer perceptions of the companies’ products and services; anticipated and future litigation; and other risks and uncertainties set forth from time to time in Atlas Air Worldwide’s reports to the United States Securities and Exchange Commission.
For additional information, we refer you to the risk factors set forth under the heading “Risk Factors” in the most recent Annual Report on Form 10-K and subsequent reports on Form 10-Q filed by Atlas Air Worldwide with the Securities and Exchange Commission. Other factors and assumptions not identified above may also affect the forward-looking statements, and these other factors and assumptions may also cause actual results to differ materially from those discussed.
Atlas Air Worldwide assumes no obligation to update such statements contained in this release to reflect actual results, changes in assumptions or changes in other factors affecting such estimates other than as required by law.
Contacts: Dan Loh (Investors) – (914) 701-8200 Bonnie Rodney (Media) – (914) 701-8580
(MOXC) Adopts Oracle Database Solutions for Payment and Transaction Platform
BEIJING, CHINA–(May 5, 2016) – Moxian, Inc. (OTCQB: MOXC) is leveraging Oracle Exadata Database Machine, Oracle Database, Oracle Database Appliance and Oracle ZFS Storage solutions as the foundation for its latest payment and transaction platform, and also big data analytics system. Through Moxian’s big data analytics system, Moxian has a clear-cut picture of its targeted customers, their demands and payment data. Furthermore, the end-user data generated from the platform helps Moxian’s merchant clients achieve precision marketing.
Founded in 2013 in Shenzhen, China, Moxian is a leading offline-to-online (O2O) integrated platform operator. Moxian offers social media platform solutions especially suitable for SMB, integrated entertainment, commerce, shopping and customer loyalty rewards providers. With the fast growth of end-users, the demand for a more stable, powerful and scalable IT system to support the heavy traffic has become more important. Moxian is leveraging Oracle solutions as the foundation for its payment and transaction platform, eliminating the performance bottleneck of massive data management.
“Moxian is committed to providing high quality services to end-users and the company’s merchant clients,” said James Tan, CEO of Moxian. “Oracle’s solutions meet Moxian’s needs with their rich features and best-in-class performance, scalability, stability and reliability. As Moxian continues to expand in domestic and overseas markets, we look forward to furthering our successful relationship with Oracle.”
Moxian not only focuses on the domestic market, but also the global market with Moxian’s data centers in China and Singapore. Moxian is using Oracle Exadata Database Machine in a private cloud environment in its data center in China for more flexible database computing and to maximize database performance on the cloud platform. The implementation also allows Moxian to further save storage space and cost. Moxian’s data center in Singapore leverages the Oracle Database Appliance to improve database performance and reduce overall investment cost with Flash, RAC Heartbeat, memory planning, ASM replication and intelligent data technologies.
The results of high-speed processing tests on Oracle Exadata Database Machine has further demonstrated Oracle’s significant performance advantages. Balanced software and hardware configuration of Oracle Exadata Database Machine has removed a performance bottleneck in terms of virtual currency tracking in Moxian applications with up to 5,000 SQLs processing per second. In addition, Moxian can quickly perform ultra-large table query of billions of records within one minute among massive amounts of data in over 10,000 stores, and the system just went live in the first half of the deployment phase.
Oracle Exadata Database Machine achieves higher application performance and scalability than traditional architecture by dynamically allocating CPU, memory and I/O resources. Its latest information platform provides best-in-class security to ensure business continuity based on isolated security deployment where multiple applications can run independently. Oracle Exadata Database Machine is an integrated software and hardware platform with a consolidated IT architecture, which is able to enhance the cost performance and further optimize ROI.
Apart from product and technology support, Oracle’s professional teams and partners also provided on-site support service to maximize the performance of Oracle’s suite of solutions. Being on-site enabled the new Moxian system to successfully migrate and go live. Ensuring the new system’s operational efficiency, Oracle’s implementation team provided Moxian with comprehensive project planning and training, enabling Moxian to rapidly learn the required systems knowledge, skills and tools.
“Oracle is excited to partner with Moxian to build up its latest payment and transaction platform based on a solid IT architecture,” said Calvin Dang, General Manager, South Region, Oracle China. “The database and infrastructure layer is an important foundation of the IT architecture as it provides powerful support to massive amounts of data. Moxian has demonstrated its full trust in Oracle by adopting a variety of our solutions, and we look forward to our future cooperation with the company.”
Supporting Resources
About Moxian, Inc.
Moxian engages in the business of providing social marketing and promotion platforms to merchants who desire to promote their businesses through online social media. Our products and services aim to enhance the interaction between users and merchant clients by allowing merchant clients to study consumer behavior through data compiled from our database of users’ activities. We design our products and services to allow our merchant clients to run advertising campaigns and promotions targeting their customers. Our platform is also designed to entice users to return frequently and to encourage new consumer users to subscribe our website.
About Oracle
Oracle offers a comprehensive and fully integrated stack of cloud applications and platform services. For more information about Oracle, visit oracle.com.
Trademarks
Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.
Contact Info
Lilian Li
Oracle
+86.10.65356855
Email Contact
Nicolas Lin
Moxian.Inc
+86.0755.66803251
Email Contact
(MGRC) to Present at the Oppenheimer 11th Annual Industrial Growth Conference
LIVERMORE, Calif., May 04, 2016 — McGrath RentCorp (Nasdaq:MGRC), a diversified business to business rental company, today announced that it will participate in the Oppenheimer 11th Annual Industrial Growth Conference at the Westin New York Grand Central in New York, NY on Tuesday, May 10, 2016. McGrath’s President and CEO, Dennis Kakures, and Senior Vice President and CFO, Keith Pratt, will present at 1:45 p.m. ET.
Simultaneous webcast and presentation slides will be available in the Investor Relations section of the Company’s website at http://mgrc.com/Investor/EventsAndArchive. A replay will be available for approximately 90 days on the company’s website shortly after completion of the presentation.
About McGrath RentCorp
Founded in 1979, McGrath RentCorp is a diversified business-to-business rental company. The Company’s Mobile Modular division rents and sells modular buildings to fulfill customers’ temporary and permanent classroom and office space needs in California, Texas, Florida, and the Mid-Atlantic from Washington D.C. to Georgia. The Company’s TRS-RenTelco division rents and sells electronic test equipment and is one of the leading rental providers of general purpose and communications test equipment in the Americas. The Company’s Adler Tank Rentals subsidiary rents and sells containment solutions for hazardous and nonhazardous liquids and solids with operations today serving key markets throughout the United States. In 2008, the Company entered the portable storage container rental business under the trade name Mobile Modular Portable Storage. Today, the business is located in the key markets of California, Texas, Florida, Northern Illinois, New Jersey and most recently entered the North Carolina region. For more information on McGrath RentCorp and its operating units, please visit our websites:
Corporate – www.mgrc.com
Tanks and Boxes – www.adlertankrentals.com
Modular Buildings – www.mobilemodular.com
Portable Storage – www.mobilemodularcontainers.com
Electronic Test Equipment – www.trs-rentelco.com
School Facilities Manufacturing – www.enviroplex.com
FOR INFORMATION CONTACT: Keith E. Pratt Chief Financial Officer 925-606-9200 investor@mgrc.com
(GIGA) Microsource Business Unit Regains AS9100C Quality Certification
SAN RAMON, Calif., May 04, 2016 — Giga-tronics Incorporated (Nasdaq:GIGA) announced today that its Microsource Business Unit regained AS9100C certification of its Supplier Quality Management System. The AS9100C Certification is commonly required in the aircraft manufacturing industry. The Company’s Microsource division sells components used on military aircrafts to two major customers that require such certification. During the lapse in certification the Company worked with one of the major customers to allow continued shipping and orders. The Company was pursuing a similar solution with the second customer, but this is no longer required with the regained certification.
All of Giga-tronics, including the Microsource Business Unit, regained ISO 9001:2008 certification of its Supplier Quality Management System late last year.
John Regazzi, President and CEO of Giga-tronics, said “Regaining these quality certifications was a Company wide effort, and I’d like to congratulate all of our employees. I’d also would like to thank our customers for working with us during the lapse of certification.”
Giga-tronics is a publicly held company, traded on the NASDAQ Capital Market under the symbol “GIGA.” Giga-tronics produces instruments, subsystems and sophisticated microwave components that have broad applications in defense electronics, aeronautics and wireless telecommunications.
This press release contains forward-looking statements concerning operating results, future orders, and sales of new products, shippable backlog within a year, long term growth, shipments, product line sales, and customer acceptance of new products. Actual results may differ significantly due to risks and uncertainties, such as: delays in customer orders for the new Advanced Signal Generation System and our ability to manufacture it; receipt or timing of future orders, cancellations or deferrals of existing or future orders; our need for additional financing; the volatility in the market price of our common stock; and general market conditions. For further discussion, see Giga-tronics’ most recent annual report on Form 10-K for the fiscal year ended March 28, 2015 Part I, under the heading “Risk Factors” and Part II, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Contact: Steven D. Lance Vice President of Finance/Chief Financial Officer slance@gigatronics.com (925) 302-1056
(STXS) to Highlight New Clinical Results and Automation Enhancements at Heart Rhythm 2016
ST. LOUIS, May 04, 2016 — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that it will participate in the 37th Annual Heart Rhythm Society (HRS) Scientific Sessions, May 4-7, 2016 in San Francisco. During its 12th consecutive appearance at HRS, the Company will share results of recently published clinical studies, new technology enhancements, user experiences, and simulations of its computer-controlled mapping and lesion formation capabilities at Booth #1631.
“We are excited to bring together expert users of our remote magnetic navigation platform and physicians searching for treatment options that provide improved outcomes for complex cardiac arrhythmias with a lower risk of adverse events and reduced fluoro exposure to patients and physicians,” said William C. Mills, Stereotaxis Chief Executive Officer. “Inspired by an abundance of clinical data and empirical evidence, hospitals and physicians worldwide are turning to our magnetic navigation and automation solutions to strengthen their leadership in cardiac rhythm management by simplifying and significantly enhancing therapy delivery, especially in the complex clinical setting of ventricular arrhythmias.”
In the HRS Rhythm Theatre on Friday, May 6, Stereotaxis will host a lunch symposium featuring the latest insights and clinical research by experienced users. Chaired by Dr. Mauricio Arruda (University Hospitals Case Medical Center), who has completed more than 1,200 procedures using the Niobe® remote magnetic navigation system, the session will provide impressive clinical results of the Niobe system in the treatment of ischemic and non-ischemic ventricular tachycardia (VT) patients, and a discussion of the Company’s multi-center, randomized, superiority study of VT ablation outcomes. Guest speakers include Dr. Luigi Di Biase (Albert Einstein College of Medicine at Montefiore Hospital), Dr. Hiroshi Nakagawa (Oklahoma University Medical Center), and Dr. Tamas Szili-Torok (Erasmus Medical Center).
Dr. Andrea Natale, Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, recently spoke to EP Lab Digest about the value and potential of remote magnetic navigation in electrophysiology for its May issue, which will be available at HRS. In the article, Dr. Natale said, “The people that have actually invested the time to become proficient with remote magnetic navigation and its learning curve, and addressed the differences between magnetic and manual navigation, love this technology and find it difficult when magnetic navigation cannot be used in a procedure.” Dr. Natale is serving as global principal investigator for the Company’s MAGNETIC-VT multi-center randomized study, which he believes could establish remote magnetic navigation as the “gold standard” for certain VT procedures.
In its exhibit space, Stereotaxis will highlight the latest innovations to its Niobe system including the next generation user interface, which includes new features such as improved catheter tip-to-tissue contact confirmation based on bipolar impedance information. During the HRS Rhythm Theatre on Friday, May 6, Dr. Hiroshi Nakagawa will also share the development progress for the lesion assessment and prediction tool called Magnetic Ablation Index. Each of these software features can provide valuable information to physicians while they are ablating tissue and also furthers the ongoing efforts to fully automate the execution of physician-defined ablation strategies. Finally, the Company will unveil its newly developed, software-based simulation platform for physician training, alongside a modeled beating heart phantom that demonstrates the mechanics of its technologies in effective lesion creation – paramount to acute and long-term success – within the most difficult to reach and navigate regions of the heart.
About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
Company Contact: Martin C. Stammer Chief Financial Officer 314-678-6155 Investor Contact: Todd Kehrli / Jim Byers MKR Group, Inc. 323-468-2300 stxs@mkr-group.com
(EBIO) Genetic Stratification of Drug Response in IL-1 Implicated Eye Diseases
Interleukin Genetics Utilizes Genetic Patterns in Investigational Drug Response Evaluation
WALTHAM, Mass., May 04, 2016 — Interleukin Genetics, Inc. (OTCQB:ILIU), a life sciences company focused on developing and marketing proprietary genetic tests for chronic diseases and health-related conditions, announced today that Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, presented new data from post hoc analyses on the influence of Interleukin’s IL-1 genetic patterns on response to isunakinra (EBI-005) in severe allergic conjunctivitis and severe dry eye study subjects. The data were presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, Washington.
“Working with Eleven Biotherapeutics to evaluate subjects in its Phase 3 study for the two ophthalmic indications was an exciting opportunity to demonstrate our unique ability to utilize IL-1 genetic patterns to help assess clinical response to a novel interleukin-1 receptor inhibitor in allergic conjunctivitis and dry eye,” said Ken Kornman, Chief Scientific Officer of Interleukin Genetics. “The IL-1 genetic pattern data showed that isunakinra treated subjects had a differential clinical response relative to vehicle control. These findings are consistent with previously published results showing that IL-1 genetic patterns identified individuals who were more likely to respond to another IL-1 blocking drug, anakinra, in rheumatoid arthritis.”
The Posters being presented by researchers from Eleven Biotherapeutics are:
“Phase 3 Multi-Center Trial Evaluating the Efficacy, Safety and Tolerability of Isunakinra (EBI-005) in Subjects with Moderate to Severe Allergic Conjunctivitis”
Date and Time: May 1, 2016, 8:30 a.m. to 10:15 a.m. (PT)
Abstract Number: 2307-C0121
Session: Allergic Conjunctivitis / Corneal Immunology and Infection
“A Phase 3 Multi-Center, Randomized Controlled Evaluation of the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Dry Eye”
Date and Time: May 3, 2016, 8:30 a.m. to 10:15 a.m. (PT)
Abstract Number: 2874-A0083
Session: Dry Eye II
The utilization of the IL-1 genetic patterns may facilitate clinical development and commercial deployment of IL-1 inhibitors and drugs operating downstream of IL-1 since the IL-1 genetic patterns have been shown to differentiate individuals at the clinical level in terms of responses to inflammatory challenges or responses to IL-1 blocking drugs.
About Interleukin Genetics
Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic diseases and health-related conditions. The products empower individuals and their healthcare providers to manage existing health and wellness through genetics-based insights and actionable guidance. Interleukin Genetics leverages its research, intellectual property, and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The company markets its tests through healthcare professionals, partnerships with health and wellness companies, and other distribution channels. Interleukin Genetics’ lead products include its proprietary PerioPredict® genetic test for periodontal disease and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvements Amendments (CLIA). For more information, please visit www.ilgenetics.com.
Forward-Looking Statements
Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that utilizing IL-1 genetic patterns to identify individuals who are more likely to respond to drugs that are intended to block IL-1 expression may facilitate the clinical development and commercial deployment of IL-1 inhibitors. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in Interleukin’s annual report on Form 10-K for the year ended December 31, 2015, and other filings with the Securities and Exchange Commission. Interleukin disclaims any obligation or intention to update these forward-looking statements.
Investor Contact: Hans Vitzthum LifeSci Advisors, LLC. (212) 915-2568 hans@lifesciadvisors.com Media Contact: Jennifer Moritz Zer0 to 5ive for Interleukin Genetics (917) 748-4006 jmoritz@0to5.com
(CNAT) Extends Positive Results with Emricasan in Phase 2 Liver Cirrhosis Clinical Trial
– Continued Directional Improvements in Key Measures of Liver Function after Six Months –
– First Drug to Demonstrate Liver Function Benefit in Patients with NASH Cirrhosis –
– Conference Call and Webcast Presentation at 8:00 a.m. ET on Thursday, May 5 –
SAN DIEGO, May 04, 2016 — Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced positive top-line results from the three-month, open-label second stage of the company’s multicenter Phase 2 clinical trial of emricasan, a first-in-class, orally active pan-caspase inhibitor, in patients with liver cirrhosis. Top-line results from the three-month placebo-controlled first stage of the trial were released in January. In the second stage, patients on emricasan in the first stage continued treatment for another three months, and patients on placebo in the first stage switched over to emricasan for three months.
- Key measures of liver function showed continued directional improvements after the second three months of treatment on emricasan in the overall patient population following previously reported favorable trends with emricasan vs. placebo after the first three months.
- Key measures of liver function showed continued directional improvements after the second three months of treatment on emricasan in a subgroup of patients with baseline Model for End-stage Liver Disease (MELD)1 scores ≥15, a prerequisite for a patient receiving a liver transplant, following previously reported statistically significant emricasan treatment effects vs. placebo after the first three months.
- Regardless of baseline MELD score, patients whose cirrhosis was caused by nonalcoholic steatohepatitis (NASH) achieved statistically significant treatment effects vs. placebo on key measures of liver function after the first three months – making emricasan the first drug to demonstrate liver function benefit in patients with NASH cirrhosis. Directional improvements continued after the second three months of treatment.
- A conference call and webcast are scheduled for 8:00 a.m. ET on Thursday, May 5, as detailed below, to discuss both the Liver Cirrhosis clinical trial results and first quarter 2016 financial results to be released before the call.
Continued Directional Improvements in Overall Patient Population
Two clinically relevant measures of liver function and prognosis, MELD score and Child-Pugh-Turcotte (Child-Pugh)2 score, along with other key liver function parameters which demonstrated favorable trends in emricasan treatment effects vs. placebo (improvement in the emricasan group vs. progression in the placebo group) in the overall patient population after three months of treatment showed continued directional improvement after six months of treatment.
Overall Patient Population | Placebo (N=42) | Emricasan (N=44) | Month 3 p-value* |
|||
Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
MELD score | 12.9 | +0.1 | 12.8 | ‒0.1 | ‒0.3 | 0.466 |
Child-Pugh score | 6.9 | +0.1 | 6.9 | ‒0.2 | ‒0.3 | 0.124 |
Total bilirubin (mg/dL) | 2.59 | +0.07 | 2.25 | ‒0.05 | ‒0.05 | 0.209 |
INR | 1.31 | +0.02 | 1.33 | ‒0.02 | ‒0.04 | 0.117 |
Albumin (g/dL) | 3.48 | +0.06 | 3.46 | +0.02 | +0.06 | 0.440 |
*p-values for treatment effect at Month 3, based on adjusted LSMeans from the primary ANCOVA model with baseline value and treatment group; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
Key Exploratory Subgroup Results
Statistically significant emricasan treatment effects vs. placebo (improvement in the emricasan group vs. progression in the placebo group) after the first three months in a subgroup of patients with baseline MELD scores ≥15 showed continued directional improvements after the second three months.
Baseline MELD Score ≥15 Patient Population | Placebo (N=10) | Emricasan (N=9) | Month 3 p-value* |
|||
Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
MELD score | 16.3 | +0.6 | 16.0 | ‒1.6 | ‒2.8 | 0.003 |
Child-Pugh score | 8.2 | +0.6 | 7.8 | ‒0.6 | ‒0.7 | 0.003 |
Total bilirubin (mg/dL) | 4.30 | ‒0.06 | 3.17 | ‒0.55 | ‒0.65 | 0.029 |
INR | 1.45 | +0.06 | 1.54 | ‒0.14 | ‒0.21 | <0.001 |
Albumin (g/dL) | 3.19 | +0.05 | 3.41 | +0.07 | +0.10 | 0.779 |
*p-values for treatment effect at Month 3, based on adjusted LSMeans from the secondary ANCOVA model with baseline value, treatment group, baseline MELD category, etiology, treatment and MELD category interaction, and treatment and etiology interaction; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
In patients whose liver cirrhosis was caused by NASH, statistically significant emricasan treatment effects vs. placebo (slower progression in the emricasan group than in the placebo group) on measures of liver function after the first three months showed continued directional improvement after the second three months.
NASH Patient Population | Placebo (N=9) | Emricasan (N=11) | Month 3 p-value* |
|||
Baseline | Change at Month 3† |
Baseline | Change at Month 3† |
Change at Month 6† |
||
MELD score | 12.8 | +1.0 | 13.0 | +0.3 | +0.1 | 0.029 |
Child-Pugh score | 6.9 | +0.4 | 7.3 | ‒0.3 | ‒0.1 | 0.030 |
Total bilirubin (mg/dL) | 2.26 | +0.39 | 2.68 | +0.09 | ‒0.03 | 0.265 |
INR | 1.27 | +0.07 | 1.25 | +0.01 | 0.00 | 0.017 |
Albumin (g/dL) | 3.60 | +0.11 | 3.39 | +0.05 | +0.03 | 0.645 |
*p-values for treatment effect at Month 3, based on adjusted LSMeans from the secondary ANCOVA model with baseline value, treatment group, baseline MELD category, etiology, treatment and MELD category interaction, and treatment and etiology interaction; not adjusted for multiple testing. †Based on last observation carried forward. |
||||||
Consistent with the company’s previous 15 clinical trials, emricasan was generally well-tolerated in the Liver Cirrhosis clinical trial, and the overall safety profile was similar in the emricasan and placebo groups with regard to both serious and other adverse events.
“We were highly encouraged after the first three months of treatment, in patients with cirrhosis and impaired hepatic function, by the favorable overall trends in two clinically relevant measures of liver function and prognosis – MELD and Child Pugh scores – which clearly were driven by statistically significant improvements in the high baseline MELD score subgroup,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “The continued directional improvements in these measures of liver function after six months of treatment confirm the sustained activity of emricasan and support continued development in patients with cirrhosis. The statistically significant treatment effects in the NASH patient subgroup, which applied regardless of baseline MELD scores, offer a greater range of options for future clinical trials in patients with NASH cirrhosis.”
“We are pleased to confirm and extend the positive results from our Phase 2 Liver Cirrhosis trial,” said Conatus co-founder, President and Chief Executive Officer Steven J. Mento, Ph.D., “with favorable trends in measures of liver function in the overall patient population and significant treatment effects in the high-MELD population after three months, both with continued directional improvements after six months and a reassuring safety and tolerability profile consistent with our prior experience. Our Portal Hypertension trial and Liver Cirrhosis trial have demonstrated emricasan’s rapid and meaningful activity against all three potentially acceptable validated surrogate endpoints identified by the FDA (U.S. Food and Drug Administration) for clinical trials in patients with liver cirrhosis. The subgroup analysis of NASH patients in the Liver Cirrhosis trial provided the first ever demonstration in NASH cirrhosis of liver function benefit in response to drug treatment. We believe this benefit, along with our Fast Track designation by the FDA in NASH cirrhosis, provides strong support to focus on an initial registration of emricasan in NASH cirrhosis. We intend to discuss these results and plans for the ENCORE-LF clinical trial in patients with NASH cirrhosis with regulatory authorities in the coming months as we advance toward trial initiation in early 2017.”
Liver Cirrhosis Trial
The double-blind, placebo-controlled Phase 2 Liver Cirrhosis clinical trial was conducted at 26 U.S. sites and enrolled 86 patients with liver cirrhosis due to different etiologies, mild to moderate liver impairment and baseline MELD scores of 11 to 18. In the double-blind and placebo-controlled stage, patients were randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. The primary endpoint was change from baseline in cCK18 at three months. Secondary endpoints included changes from baseline in MELD and Child-Pugh scores, which include laboratory parameters associated with liver synthetic and excretory function, such as serum albumin levels, international normalized ratio (INR) and total bilirubin levels. In the open-label stage, all patients either on emricasan or placebo received emricasan for an additional three months.
Among the 86 subjects enrolled and dosed, liver cirrhosis etiologies included alcohol (38%), hepatitis C virus, or HCV (29%), NASH (23%), and other causes (9%). Baseline MELD scores were ≤14 in 78% of enrolled subjects and ≥15 in 22% of enrolled subjects. Baseline Child-Pugh status was A (Child-Pugh score of 5-6) in 43% of subjects and B (Child-Pugh score of 7-9) in 56% of subjects.
Conference Call/Webcast/Presentation
Conatus will host a conference call and webcast at 8:00 a.m. Eastern Time on Thursday, May 5, to discuss results from the Liver Cirrhosis trial and first quarter 2016 financial results scheduled to be announced before the call. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 1360910. An associated presentation and live and archived webcast of the call will be available in the Investors section of the company’s website at http://ir.conatuspharma.com/events.cfm.
About Emricasan Clinical Development
To date, emricasan has been studied in over 650 subjects in sixteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing. The company also is evaluating emricasan’s potential longer-term effects on liver structure in its ongoing Phase 2b clinical trial in post-orthotopic liver transplant (POLT) recipients who have reestablished liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection and have successfully achieved a sustained viral response following HCV antiviral therapy (POLT-HCV-SVR). In November 2015, the company announced plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints – the EmricasaN, a Caspase inhibitOR, for Evaluation, or ENCORE trials – as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis. In January 2016, Conatus announced the initiation of ENCORE-NF, the first of the ENCORE trials, a randomized, double-blind, placebo-controlled, Phase 2b clinical trial in patients with biopsy-confirmed NASH and stage 1 to 3 fibrosis using the NASH Clinical Research Network (CRN) Histologic Scoring System.
About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: emricasan as the first drug to demonstrate liver function benefit in patients with NASH cirrhosis; the Liver Cirrhosis trial results as support for continued development of emricasan in patients with liver cirrhosis; the ability of the Liver Cirrhosis trial results to offer a greater range of options for future clinical trials in patients with NASH cirrhosis; the support to focus on an initial registration of emricasan in NASH cirrhosis provided by the subgroup analysis of NASH patients in the Liver Cirrhosis trial; plans to discuss the Liver Cirrhosis trial results and plans for the ENCORE-LF clinical trial in patients with NASH cirrhosis with regulatory authorities and advance toward trial initiation in early 2017; plans to conduct multiple clinical trials covering various liver cirrhosis patient populations for different chronic dosing periods using different endpoints as a strategy for initial registration of emricasan as a potential treatment for patients with liver cirrhosis; and emricasan’s potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including: Conatus’ ability to initiate and successfully complete current and future clinical trials; the potential that further analysis of the data described herein or additional data may yield different results; Conatus’ ability to develop and implement a registration strategy and pathway for emricasan; FDA’s and other regulatory agencies’ interactions and guidance relating to the development of emricasan; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize, emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier clinical trials may not be predictive of future results; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 MELD score is a numerical value ranging from 6 (less ill) to 40 (gravely ill) calculated by a formula using three routine serum biomarkers: total bilirubin, creatinine, and INR, and used to position patients on the liver transplant waiting list. Biomarker values below 1 are rounded to 1 to avoid negative values in the MELD formula. Scores of 15 or greater are required for listing eligibility.
2 Child-Pugh score is a numerical value ranging from 5 (least severe) to 15 (most severe) calculated by totaling the individual scores on a 1-3 scale for three routine serum biomarkers: bilirubin, INR, and albumin; and two clinical factors: encephalopathy and ascites. Scores of 5-6 are classified as Child-Pugh A (mild liver impairment); scores of 7-9 are classified as Child-Pugh B (moderate liver impairment); scores of 10-15 are classified as Child-Pugh C (severe liver impairment).
MEDIA: David Schull Russo Partners, LLC (858) 717-2310 David.Schull@RussoPartnersLLC.com INVESTORS: Alan Engbring Conatus Pharmaceuticals Inc. (858) 376-2637 aengbring@conatuspharma.com
(YOD) to Form Joint Venture with LA-Based Frequency Networks
New JV Frequency Asia will allow YOU On Demand to expand globally beyond China YOD Also Announces Strategic Investment for a 9% equity stake in Frequency Networks
NEW YORK, May 3, 2016 — YOU On Demand Holdings, Inc. (NASDAQ: YOD) (“YOU On Demand” or “YOD” or the “Company”), a premium content Video On Demand service provider in China evolving into a global, mobile-driven, consumer management platform for both enterprises and consumers, announced today that the Company and Frequency Networks, Inc. (“Frequency Networks”), a cloud-based internet video service that aggregates and distributes content from thousands of the world’s top providers, including the leading TV and Multi-Channel Networks, have entered into two agreements: 1. a binding agreement to form a Joint Venture called Frequency Asia (the “Frequency Asia JV”), dated April 13, 2016 (the “JV Agreement)” and 2. a Series A Preferred Stock Purchase Agreement (the “Frequency SPA”) for the purchase by YOD of certain Frequency Series A Preferred Stock.
Frequency Networks, which has global partnerships with leading cable, satellite and mobile operators reaching over 150 million subscribers, builds and operates an intelligent content discovery platform that powers white-labeled video services and applications for TV and mobile devices.
The Frequency Asia JV
The Frequency Asia JV will have two main operational components that will provide YOU On Demand, via the JV, the opportunity to expand both its content offering and distribution footprint.
A. Expanded Distribution: The JV will provide Frequency’s white-labeled platforms exclusively to the Asian region (including, but not limited to China, India, Philippines, Malaysia and Vietnam, etc.). Utilizing a B2B distribution model, the JV will provide customized content services with multi-screen capability to large and established operators in the region. Frequency Asia programming will include more than 70,000 channels, organized into 60+ unique vertical categories. The viewing experience can be further optimized with personal feeds and channels driven by Frequency Networks’ enhanced metadata format and proprietary recommendation and video search engine.
B. Global Content Channels: The JV will develop a stable of made-for-web channels with brand partners that integrates original and licensed content for categories including sports, fitness, music, food, tourism, science and more. These channels will be rolled out globally across the JV’s distribution partners that include major cable, satellite and mobile operators in the US, Europe and Asia, and via direct-to-consumer apps for iOS, Android, Amazon Fire and other platforms. The JV will also integrate and distribute third party e-commerce, social networking & affiliate marketing capabilities into its branded and white-labeled service.
In connection with the JV Agreement, Frequency Networks issued 6-year warrants to the Company exercisable at any time into up to 3,000,000 shares of Frequency Preferred Stock.
Series A Preferred Stock Purchase Agreement
In addition to the JV Agreement, the Company entered into the Frequency SPA for the purchase of $3 million of Series A Preferred Stock (the “Frequency SPA”).
The initial purchase of shares of Frequency Preferred Stock (at a purchase price of $2 million) was closed on April 13, 2016 (as described in YOU On Demand’s current report on Form 8-K, filed on April 19, 2016) and the remaining purchase of shares of Frequency Preferred Stock (at a purchase price of $1 million) closed on April 28, 2016.
YOU On Demand will have an approximate 9% ownership stake in Frequency Networks, Inc. For a more detailed summary of the material provisions of the Frequency SPA and the JV Agreement, see YOU On Demand’s current report on Form 8-K, which has been filed with the U.S. Securities and Exchange Commission (“SEC”) at www.sec.gov.
Bruno Wu, Chairman of YOU On Demand, commented, “Today’s partnership announcement with Frequency is the first of what I hope to be many business development initiatives to come that should begin supporting the framework of our growth plan as well as the pledge to be more regularly and openly communicative. With Frequency and YOD’s now multi-faceted partnership, YOU On Demand is reimagining, sharpening and expanding its fundamentals and original scope in three significant ways: 1. Moving from a pay only model to a pay, free and commerce content model which will be the cornerstone of establishing the world’s premier mobile-based multimedia, social networking & e-commerce-enabled network, 2. Broadening its geographical user base beyond China to become a true global brand and, 3. Moving from the existing user base of several million to an addressable user base of several hundred million users globally by the end of 2016.”
Frequency CEO Blair Harrison stated, “We’re thrilled to be partnering with YOU On Demand. The creation of the Frequency Asia JV is a great opportunity to leverage YOD’s existing distribution and operations to accelerate the expansion of our platform and programming to cable, OTT and mobile operators in region. YOD’s participation in our financing is a strong indicator of the value of Frequency’s platform and business model.”
About YOU On Demand Holdings, Inc. (http://corporate.yod.com)
YOU On Demand (NASDAQ: YOD) is a leading multi-platform entertainment service company delivering premium content, including leading Hollywood movie titles, to customers across China via Subscription Video On Demand and Transactional Video On Demand. The Company has secured alliances with leading global media operators and content developers. YOU On Demand has content distribution agreements in place with many of Hollywood’s top studios including Disney Media Distribution, Paramount Pictures, NBC Universal and Twentieth Century Fox Television Distribution, Miramax, as well as a broad selection of the best content from Chinese filmmakers. The Company has a comprehensive end-to-end secure delivery system, governmental partnerships and approvals and offers additional value-added services. YOU On Demand has strategic partnerships with the largest media entities in China, a highly experienced management team with international background and expertise in Cable, Television, Film, Digital Media, Internet and Telecom. YOU On Demand is headquartered in both New York, NY and Beijing, China.
About Frequency (http://www.frequency.com)
Frequency is a cloud-based internet video service that aggregates and distributes video from thousands of the world’s top providers, including the leading TV and Multi-Channel Networks, and individual creators. TV, mobile and over-the-top operators use Frequency to deliver a complete internet video service to their subscribers. With one simple integration, operators have access to Frequency’s comprehensive portfolio of licensed content, and a fully featured video platform, including real time personalization. Frequency is now powering next-generation consumer video applications for operators on set-top boxes, mobile devices and the web. Frequency was founded by Blair Harrison in Los Angeles in 2010. Harrison previously founded FastTV, an early internet video search site, and was CEO of online video entertainment site IFILM, sold to Viacom in 2005.
Safe Harbor Statement
This press release contains certain statements that may include “forward looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
CONTACT:
Jason Finkelstein
YOU On Demand
212-206-1216
jason.finkelstein@yod.com
@youondemand
corporate.yod.com
(BSTG) to Host Pre-Clinical Research Update, Q1 Call
HOLLISTON, Mass., May 3, 2016 — Biostage, Inc. (NASDAQ: BSTG) a biotechnology company developing bioengineered organ implants for life-threatening conditions of the esophagus, trachea and bronchus, will host a conference call to provide an update on their collaborative large animal pre-clinical research and to review its first quarter results on Thursday, May 12, 2016 at 9:00am ET. The research update and Q1 2016 results will be announced pre-market that day. On the call, management may respond to questions from the audience on any of a number of topics related to the business, including preclinical research, operations, plans and outlook.
Participating in the call will be CEO, Jim McGorry, Chief Medical Officer, Saverio La Francesca, and CFO, Tom McNaughton.
Conference Call Information:
Date/Time: Thursday, May 12th at 9:00 am ET
Call Dial In #: 877-407-8293 U.S. or 201-689-8349 Int’l
Live Webcast/Replay: biostage.com/events-and-presentations
Audio Replay #: 877-660-6853 U.S. or 201-612-7415 Int’l – Access ID #13636819
About Biostage, Inc.: www.biostage.com
Biostage is a biotechnology company developing bioengineered organ implants based on the company’s new CellframeTM technology which combines a proprietary biocompatible scaffold with a patient’s own stem cells to create CellspanTM organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, trachea or bronchus with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.
Cellspan implants are currently being advanced and tested in a collaborative preclinical study. This testing is intended to expand the base of preclinical data in support of Biostage’s goal of filing an Investigational New Drug (IND) application with the U.S. FDA in late 2016. The IND will seek approval to initiate clinical trials for its esophageal implants in humans.
Forward Looking Statements:
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the development expectations and regulatory approval of any of our products, including those utilizing our Cellframe technology, by the FDA, EMA, MHRA or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of our products, including those utilizing ourStonecold3 Cellframe technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, our ability to obtain and maintain regulatory approval for our products; plus other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Twitter: BiostageIR
StockTwits: BiostageIR
Media/Investor Relations Contact: | |
Tom McNaughton | David Collins, Bill Jones |
Chief Financial Officer | Catalyst Global LLC |
774-233-7321 | 212-924-9800 w; 917 734-0339 m |
bstg@catalyst-ir.com |
(ZG) Sellers Temper Expectations as Price Growth Slows in Brooklyn and Manhattan
NEW YORK, May 3, 2016 —
Key facts for Q1 2016:
- Manhattan’s median resale price rose 3.8 percent from last year to $978,765, the lowest annual growth since September 2012.
- The median resale price in Brooklyn grew 7.1 percent from last year to $545,330, the third consecutive month of slowing price growth.
- In Manhattan, sellers received 98.5 percent of their initial asking price, a slight increase from last year; Brooklyn sellers received 98.2 percent.
- The share of Manhattan listings with a price cut decreased from 31.2 percent in Q1 2015 to 27.6 percent in Q1 2016.
- In Brooklyn, the share of all sales inventory with a price cut declined to 22.7 percent, compared to 24.1 percent in the first quarter of 2015.
The Manhattan and Brooklyn sales markets continued to cool in the opening months of 2016. Manhattan’s median resale price grew 3.8 percent year-over-year to $978,765, the lowest annual increase since September 2012, according to the Q1 2016 StreetEasy® Market Reportsi. In Brooklyn, the median resale price increased 7.1 percent from last year to $545,330, with monthly growth slowing since January 2016, as measured by the StreetEasy Price Indicesii.
In Manhattan, sellers may be exhibiting more disciplined pricing strategies to avoid price cuts, aligning their expectations with a market that is seeing slower price growth. The median sale-to-list price ratio in the borough was 98.5 percent in the first quarter, meaning sellers received almost all of their initial asking price, up from 97.7 percent last year. In an additional sign that sellers are exerting more price discipline, the share of all sales inventory that saw a price cut during the first quarter declined from 31.2 percent in 2015 to 27.6 percent. The typical price cut also declined from 6.9 percent in Q1 2015 to 6.7 percent in the first quarter of this year.
Brooklyn mirrored Manhattan, where sellers received 98.2 percent of their initial asking prices in the first quarter, unchanged from last year. Despite this stagnant number, the share of all sales inventory in Brooklyn with a price cut declined to 22.7 percent compared to 24.1 percent in the first quarter of 2015.
“Manhattan and Brooklyn sellers are being more cautious with their pricing and perhaps a little less free-wheeling than they’ve been over the past few years. In order to sell in this market, sellers need to lower their asking prices slightly to see a greater return with fewer price cuts,” said StreetEasy data scientist Alan Lightfeldt. “While price growth is slackening, buyers still face an extremely competitive and expensive market, especially in areas like East Brooklyn and Upper Manhattan where pockets of relatively affordable options are attracting more buyers every day.”
Since October 2014, Upper Manhattan has consistently shown the highest price growth in Manhattan, according to the StreetEasy Price Indices. The median resale price increased 9.7 percent from last year to $629,383 – more than twice as fast as Manhattan overall. Prices in the Upper West Side submarket rose 5.7 percent from last year, followed by Downtown (3.3 percent), Upper East Side (2.7 percent) and Midtown (1.7 percent).
In Brooklyn, price growth in the East Brooklyn submarket surged 23.9 percent from last year to $481,525 in March, the largest annual increase across both boroughs. The resale price in South Brooklyn increased 10.4 percent, followed by Prospect Park (6.1 percent), Northwest Brooklyn (3.4 percent) and North Brooklyn (2.4 percent).
According to StreetEasy Price Forecastsiii, all major submarkets will experience lower growth over the next 12 months, some even experiencing negative growth as we move past the cyclical peak of home shopping season. StreetEasy predicts that Brooklyn will continue to see overall price growth decline, most notably in parts of “Brownstone Brooklyn,” including the Northwest and Prospect Park submarkets. Price growth over the next 12 months across all of Brooklyn is expected to slow to 1.7 percent, considerably lower than the 7.1 percent annual growth of the first quarter. The median resale price in Manhattan is expected to grow by 2.6 percent over the next 12 months.
The complete StreetEasy Market Reports for Manhattan and Brooklyn with additional analysis, neighborhood data and graphics can be viewed at streeteasy.com/blog/market-reports.
Submarket Name | Q1 2016 StreetEasy Price Index | Annual Change |
Manhattan | $978,765 | 3.8% |
Downtown | $1,220,450 | 3.1% |
Midtown | $828,390 | 1.7% |
Upper West Side | $1,094,810 | 2.7% |
Upper East Side | $964,015 | 5.7% |
Upper Manhattan | $629,383 | 9.7% |
Brooklyn | $545,330 | 7.1% |
North Brooklyn | $877,880 | 2.4% |
Northwest Brooklyn | $822,001 | 3.4% |
Prospect Park | $799,105 | 6.1% |
South Brooklyn | $408,677 | 10.4% |
East Brooklyn | $481,525 | 23.9% |
About StreetEasy:
StreetEasy is New York City’s leading local real estate marketplace on mobile and the web, providing accurate and comprehensive for-sale and for-rent listings from hundreds of real estate brokerages throughout New York City and the major NYC metropolitan area. StreetEasy adds layers of proprietary data and useful search tools to help home shoppers and real estate professionals navigate the complex real estate markets within the five boroughs of New York City, as well as Northern New Jersey and the Hamptons.
Launched in 2006, StreetEasy is based in the Flatiron neighborhood of Manhattan. StreetEasy is owned and operated by Zillow Group (NASDAQ: Z and ZG).
StreetEasy is a registered trademark of Zillow, Inc.
i The StreetEasy Market Reports are a monthly overview of the Manhattan and Brooklyn sales and rental markets. Every three months, a quarterly analysis is published. The report data is aggregated from public recorded sales and listings data from real estate brokerages that provide comprehensive coverage of Manhattan and Brooklyn, with most metrics dating back to 1995 in Manhattan and 2005 in Brooklyn. The reports are compiled by the StreetEasy Research team. For more information, visit http://streeteasy.com/blog/market-reports/. StreetEasy tracks data for all five boroughs within New York City, but currently only produces reports for Manhattan and Brooklyn.
ii Median resale prices are measured by the StreetEasy Price Indices. Also referred to as the StreetEasy Manhattan Price Index (MPI) and StreetEasy Brooklyn Price Index (BPI), the metrics are monthly indices that track changes in resale prices of condo, co-op, and townhouse units. Each index uses a repeat-sales method of comparing the sales prices of the same properties since January 1995 in Manhattan and January 2005 in Brooklyn. Given this methodology, each index accurately captures the change in home prices by controlling for the varying composition of homes sold in a given month. Data on sales of homes is sourced from the New York City Department of Finance. Full methodology here: http://streeteasy.com/blog/methodology-streeteasy-price-indices/
iii The Manhattan Price Forecast and the Brooklyn Price Forecast predict the change in resale prices 12 months out from the current reported period. Each forecast incorporates the Price Index for each borough as well as a mix of fundamental market factors including: historical recorded sales price, household income, population, and taxes.
(ECTE) Announces Significant Progress in Key Development Milestones
ISELIN, N.J., May 3, 2016 — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced important advances in its next generation continuous glucose monitoring (CGM) system and its progress toward commercialization in China.
Echo has made significant progress in the development and initial internal clinical testing of key components of its next generation (NextGen) system. Important advancements were made in the NextGen sensor element, hydrogel and other key components of the Company’s highly disruptive technology to the episodic, needle-based glucose monitoring business. Improvements include a higher sensitivity to glucose with increased consistency, a shorter warm-up time, and resistance to acetaminophen interference. Additionally, the new streamlined design, that includes a flexible target base and transmitter housing, is more consumer-friendly and substantially less expensive than the prior version. A working prototype of the next generation CGM system is scheduled for June 2016.
In parallel to the progress made on the next generation system, Echo’s strategic partner Medical Technologies Innovation Asia (MTIA) is finalizing plans for the commencement of the upcoming China Food and Drug Administration (CFDA) clinical trial and the eventual regulatory approval and commercialization of Echo’s CGM in China. As previously announced, MTIA believes that Echo’s locally produced needle-free CGM will be designated as a Class 2 medical device with a review period of 90 working days after filing submission. A formal and final designation from the CFDA is determined only at the time of submission. Approval of Echo’s CGM in China will signify the first non-invasive CGM to address the world’s largest diabetes population. In March, Echo’s team visited China where testing of the Company’s CGM showed linearity between locally manufactured sensors and U.S. produced sensors, marking the successful technology transfer. Echo’s final obligation related to the CFDA clinical trial is the software transfer, scheduled for mid-May, of the application program interface (API) and software application (App). The API allows for the development of third party applications while increasing the security of Echo’s intellectual property.
“Echo has entered a new phase as we have developed and initiated testing of our NextGen system and approach the commencement of the CFDA regulatory trial. We have made tremendous strides toward our goal of delivering life-changing tools to people worldwide with diabetes,” said Scott W. Hollander, Echo’s President and CEO. “We remain on track to deliver our remaining milestones as scheduled and I look forward to providing a more detailed update in our conference call tomorrow.”
As previously announced, Echo will hold a conference call tomorrow, May 4, 2016, at 4:30 p.m. ET to provide an update on the Company’s progress and milestones. Participants can call (855) 327-6837 and reference Echo Therapeutics or pre-register for the call at http://bit.ly/1Wsz21D. The archived audiocast will be available for thirty (30) days following the call by visiting the Events section of Echo’s website at www.echotx.com.
About Echo Therapeutics
Echo Therapeutics is developing its non-invasive, wireless, continuous glucose monitoring (CGM) system. A significant opportunity exists for the Company’s CGM to be used in the outpatient diabetes market and in the fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the hospital settings. Echo developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s clinical studies, the safety and efficacy of Echo’s CGM System, the failure of future development and preliminary marketing efforts related to Echo’s CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell Echo’s CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(732) 201-4189
Connect With Us:
– Visit our website at www.echotx.com
– Follow us on Twitter at www.twitter.com/echotx
– Join us on Facebook at www.facebook.com/echotx
(EXPI) Launches in 4 More States and the District of Columbia
Missouri, Kansas, Minnesota, Idaho and DC Newest Markets for Agent-Owned Brokerage
BELLINGHAM, WA–(May 03, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI) today announced that its real estate brokerage division, eXp Realty, has commenced operations in the states of Kansas, Missouri, Minnesota, and Idaho, as well as in the District of Columbia.
Tameka Bryant, a national trainer for the National Association of REALTORS®, the largest trade association in the United States, and a brokerage owner for more than 10 years, joins eXp as Managing Broker in Missouri and Kansas.
Tara Houston, who has previously held leadership roles in the mid-atlantic region for eXp Realty, becomes Managing Broker for the company in the District of Columbia, a position she also holds in the State of Maryland.
Robert Bass brings more than 28 years of industry management experience (most recently with John L. Scott) to eXp as the company’s Managing Broker in Idaho. Bass received the coveted Realtor of the Year award in 1996 from the Ada County Association of Realtors.
In Minnesota, Jeffrey Hagel becomes Managing Broker for eXp after 10 years in the industry with RE/MAX and Keller Williams Realty.
“Our launch in these new markets reflects our continuing ability to attract and/or develop highly-credible leaders within the industry who understand the impact of Agent-Ownership on culture and collaboration and who see very clearly the opportunities made possible by innovative uses of technology both for industry professionals and for the consumers they serve,” said eXp President, Jason Gesing.
About eXp World Holdings, Inc.
eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage™ as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.
eXp World Holdings, Inc. also owns 90.5% of First Cloud Mortgage, Inc. a Delaware corporation launched in 2015 and now licensed to originate mortgages in Arizona, California, New Mexico and Texas.
The corporate name change to “eXp World Holdings, Inc.” has been approved by our Board and stockholders but is not yet effective, pending the mailing of a definitive information statement to our stockholders in accordance with applicable rules and a 20-day notice period thereafter.
As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.
For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit investors.exprealty.com or www.exprealty.com.
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.
Investor Relations Contact Information:
Glenn Sanford
Chairman & CEO
eXp World Holdings, Inc.
glenn@exprealty.com
360-389-2426
Trade and Media Contact Information:
Jason Gesing
President
eXp Realty World Holdings, Inc.
jason@exprealty.com
617-970-8518
(ENOC) to Present at Needham Emerging Technology Conference
BOSTON, May 02, 2016 — EnerNOC, Inc. (Nasdaq:ENOC), a leading provider of energy intelligence software (EIS) and demand response solutions, today announced that Neil Moses, the Company’s Chief Operating Officer and Chief Financial Officer, is scheduled to participate at the Needham Emerging Technology Conference on Wednesday, May 18, 2016. The Company will webcast its presentation at approximately 5:00pm eastern daylight time (EDT). All interested parties can access the webcast live on the Company’s investor relations website at http://investor.enernoc.com.
About EnerNOC
EnerNOC is a leading provider of energy intelligence software (EIS) and demand response solutions. With capabilities to better address budgets and procurement, utility bill management, facility analysis and optimization, sustainability and reporting, project tracking, and demand management, EnerNOC’s enterprise SaaS platform helps businesses control energy costs, mitigate risk, and streamline compliance and sustainability reporting. EnerNOC also offers access to more demand response programs worldwide than any other provider, offering businesses a valuable payment stream to further enhance bottom line results. EnerNOC’s utility SaaS platform enables energy suppliers to forge deeper customer relationships, address regulatory mandates, and cost-effectively integrate demand-side resources to improve grid reliability through key capabilities, including customer engagement, demand response, energy efficiency, operational effectiveness, and wholesale procurement. For more information, visit www.enernoc.com.
Media Relations: Robin Woodcock 617.692.2601 news@enernoc.com Investor Relations: Christopher Sands 617.692.2569 ir@enernoc.com
(CORI) Announces Streamlined Bioequivalence Development Path for Transdermal Corplex™
Reports Positive PK Results from Clinical Study of Optimized Once-weekly Corplex Donepezil for Alzheimer’s Disease
MENLO PARK, Calif., May 02, 2016 — Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced receiving favorable written feedback from the U.S. Food and Drug Administration (FDA) on the company’s Pre-Investigational New Drug Application submission for once-weekly transdermal Corplex Donepezil.
Following review of Corium’s pre-IND submission, which included summary results from the initial Phase 1 pharmacokinetic (PK) study, the FDA provided clear guidance on the company’s development plans and registration pathway. The agency advised Corium that if the company can adequately demonstrate bioequivalence between Corplex Donepezil Transdermal Delivery System (TDS) and oral Aricept® (donepezil hydrochloride) in its planned PK bioequivalence studies, additional clinical efficacy studies will not be required.
“We are pleased that the FDA has concurred with our clinical development plan, which is intended to demonstrate bioequivalence between transdermal Corplex Donepezil and oral Aricept,” said Peter D. Staple, President and Chief Executive Officer of Corium. “Preparations are underway for a pilot bioequivalence study, which we look forward to starting later this year. Our objective is to use the results from this pilot study to finalize the design of a pivotal bioequivalence study that we expect to commence by mid-2017.”
If the results from the pivotal study supports bioequivalence, Corium expects to be able to submit a 505(b)(2) New Drug Application (NDA) as early as mid-2018.
Positive PK Results for Optimized Once-weekly Corplex Donepezil
Corium also announced positive findings from a new Phase 1 PK study evaluating optimized proprietary formulations of the once-weekly Corplex Donepezil product candidate. Two formulations achieved comparable dosing to oral Aricept with PK profiles that demonstrate the potential for bioequivalence. The company has selected a lead formulation based on these results.
Parminder “Bobby” Singh, Ph.D., Corium’s Chief Technology Officer and Vice President, R&D added, “Our optimized Corplex Donepezil patches achieved the targeted sustained delivery of donepezil and skin tolerability requirements for a once-weekly treatment, while also demonstrating enhanced reproducibility. We look forward to advancing our lead formulation into a pilot bioequivalence study, followed by the pivotal bioequivalence study.”
Bioequivalence clinical studies are designed to assess the biological equivalence of pharmaceutical products based on their PK profiles, and are generally performed in healthy subjects. These studies are relatively short in duration and provide a development path that is substantially less costly and more streamlined than typical clinical development programs, which require studies demonstrating safety and efficacy.
A Section 505(b)(2) NDA is a new drug application in which the applicant may rely on certain investigations of safety and effectiveness that were previously conducted by someone other than the applicant, and typically relates to an active drug substance that has previously been approved in a different form.
About Alzheimer’s Disease and Donepezil
Alzheimer’s disease is a progressive brain disorder in which the brain cells degenerate and die, causing a steady decline in memory and mental function. An estimated 5.1 million Americans suffered from Alzheimer’s disease in 2015, with symptoms typically first appearing in people age 65 and older. By 2025, the number of Americans age 65 and older with Alzheimer’s disease is estimated to reach 7.1 million. Alzheimer’s disease is the most common cause of dementia among older adults. Dementia ranges in severity from mild, when it is just beginning to affect a person’s functioning, to moderate, and severe, when the person must depend on others for the basic activities of day-to-day life.
Donepezil (the active ingredient in Aricept) is the most widely prescribed medication in a class of Alzheimer’s drugs known as cholinesterase inhibitors, and is approved for the treatment of mild, moderate and severe disease. Donepezil is currently only available in tablet or orally disintegrating tablet form, each administered once daily, presenting compliance challenges for family members and caregivers who cannot rely on patients to consistently take their daily tablets, and is known to cause gastrointestinal side effects, including nausea, vomiting and loss of appetite.
About Corplex™
Corium’s Corplex system is a novel commercial-stage platform technology designed to broadly enable the transdermal delivery of small molecules, many of which have not previously been amenable to transdermal delivery. Corplex advanced transdermal and transmucosal systems are broadly adaptable for use in multiple drug categories and indications, and have the potential to reduce quantities of active ingredient utilized in transdermal products. Additionally, Corplex transdermal patches can enable efficient drug delivery, and adhere to either wet or dry surfaces for an extended period of time. Corium’s Corplex technology has been successfully commercialized in Procter & Gamble’s Crest® Whitestrips products, and is being utilized in several proprietary therapeutic products under development.
About Corium
Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company’s broad experience with advanced transdermal and transmucosal delivery systems. Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Teva Pharmaceuticals, Par Pharmaceutical and Procter & Gamble. The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins. The company’s late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics that is currently in Phase 3 trials, and additional transdermal products that are being developed with other partners. Corium has multiple proprietary programs in preclinical and clinical development for the treatment of osteoporosis, and neurodegenerative and neurological disorders. For further information, please visit www.coriumgroup.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding our business strategy, clinical trial and regulatory timing and plans, the achievement of clinical and commercial milestones, and the advancement of our technologies and our products and product candidates. Forward-looking statements are based on management’s current expectations and projections and are subject to risks and uncertainties, which may cause Corium’s actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect Corium’s business and its results are detailed in Corium’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2015, filed with the Securities and Exchange Commission on February 12, 2016, and other reports as filed from time to time with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial or operating performance, which speaks only as of the date they are made. Corium undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.
Corplex™ and MicroCor® are registered trademarks of Corium International, Inc.
Aricept® is a registered trademark of Eisai R&D Management Co., Ltd.
Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.
Investor and Media Contact: BCC Partners Karen L. Bergman kbergman@bccpartners.com (650) 575-1509 Susan Pietropaolo spietropaolo@bccpartners.com (845) 638-6290
(FLML) Receives FDA Approval of Akovaz
LYON, FRANCE–(May 2, 2016) – Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. Flamel obtained NDA approval for Akovaz as scheduled on April 29 and is the first to receive approval from the FDA for ephedrine sulfate. Flamel expects to launch Akovaz during the third quarter 2016 in a strength of 50 mg/mL.
“We are very excited to receive FDA approval for Akovaz, the third product from our Éclat portfolio, and in line with the PDUFA date expectations. Revenue expectations associated with this product were included in our previously issued 2016 revenue guidance of $110 – $130 million. Our Éclat portfolio of products, which includes Bloxiverz® and Vaculep®, has produced significant cash flow for Flamel, allowing us to operate independently of partners, fund strategic acquisitions and continue development of our proprietary pipeline products,” said Mike Anderson, Chief Executive Officer of Flamel.
Currently, there is one “unapproved marketed” formulation of ephedrine sulfate 50 mg/mL injection sold by Akorn Pharmaceuticals, and according to IMS Health, the market size is over five million vials per year.
About Akovaz
Akovaz is the brand name for the Company’s ephedrine sulfate injection, USP, an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Akovaz injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) must be diluted before administration and is injected intravenously as a bolus.
About Flamel Technologies:
Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently markets two previously Unapproved Marketed Drugs (“UMDs”) in the United States, Bloxiverz® (neostigmine methylsulfate injection) and Vazculep® (phenylephrine hydrochloride injection). The Company also develops products utilizing its proprietary drug delivery platforms, Micropump® (oral sustained release microparticles platform), along with its tangent technologies, LiquiTime® (a Micropump-derivative platform for liquid oral products) and Trigger Lock™ (a Micropump-derivative platform for abuse-resistant opioids). Additionally, the Company has developed a long acting injectable platform, Medusa™, a hydrogel depot technology. Current applications of Flamel’s drug delivery products include sodium oxybate (Micropump®), extended-release of liquid medicines such as ibuprofen and guaifenesin (LiquiTime®, through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market) and a current study of the delivery of exenatide utilizing the Medusa™ technology. In February 2016, Flamel acquired FSC Pediatrics, a Charlotte, North Carolina-based company that markets three pediatric pharmaceutical products – Cefaclor for oral suspension, indicated for infection, Karbinal™ ER, indicated for allergic rhinitis and AcipHex® Sprinkle™ (rabeprazole sodium) indicated for the treatment of gastroesophageal disease (GERD). FSC also received 510(k) clearance from the FDA in October 2014 for Flexichamber™, a collapsible holding chamber for used in the administration of aerosolized medication using pressurized Metered Dose Inhalers (pMDIs) for the treatment of asthma. The Company is headquartered in Lyon, France and has operations in Dublin, Ireland and in the USA in both St. Louis, Missouri and Charlotte, North Carolina. Additional information may be found at www.flamel.com.
Safe Harbor: This release may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and the negative of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Flamel’s control and could cause actual results to differ materially from the results contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz® and Vazculep® products, which are not patent protected, could face substantial competition resulting in a loss of market share or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for the two pipeline products we are evaluating for potential application to the FDA pursuant to our “unapproved-to-approved” strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products; our dependence on key personnel to execute our business plan; the amount of additional costs we will incur to comply with U.S. securities laws as a result of our ceasing to qualify as a foreign private issuer; and the other risks, uncertainties and contingencies described in the Company’s filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2015, all of which filings are also available on the Company’s website. Flamel undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
(AST) Announces Oral Presentation at ASGCT 19th Annual Meeting
FREMONT, Calif., May 2, 2016 — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company with three clinical-stage development programs focused on the emerging field of regenerative medicine, today announced that clinical data from its AST-VAC1 (antigen-presenting autologous dendritic cells) immunotherapy clinical program will be presented during an oral session at the upcoming American Society of Gene and Cell Therapy (ASGCT) 19th Annual Meeting, to be held on May 4-7, 2016 in Washington, D.C.
Jane S. Lebkowski, Ph.D., Asterias’ President of R&D and Chief Scientific Officer, will present the data, which is from the Company’s AST-VAC1 Phase 2 clinical trial in acute myelogenous leukemia (AML) and was first presented at the 2015 annual meeting of the American Society for Clinical Oncology (ASCO). The abstract is now available online on the ASGCT Annual Meeting website.
Presentation Details
Title: Long-Term Relapse-Free Survival of Patients with Acute Myeloid Leukemia (AML) Receiving a Telomerase-Engineered Dendritic Cell Immunotherapy
Abstract Number: 276
Session Title: Cancer-Immunotherapy, Cancer Vaccines I
Date: Thursday, May 5, 2016
Time: 5:00 – 5:15 PM
Room: Washington 4
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a leading biotechnology company in the emerging field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of oncology and neurology. AST-VAC1 (antigen-presenting autologous dendritic cells) demonstrated promise in a Phase 2 study in acute myelogenous leukemia (AML) and completed a successful end-of-Phase 2 meeting with the FDA in advance of initiating planning for a single pivotal Phase 3 AML study. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2 clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
(ACRS) to Present at the Bank of America Merrill Lynch 2016 Healthcare Conference
MALVERN, Pa., May 02, 2016 — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage specialty pharmaceutical company, today announced that Dr. Neal Walker, President & Chief Executive Officer, will present at the Bank of America Merrill Lynch 2016 Healthcare Conference on Tuesday, May 10, 2016 at 1:40 p.m. PDT at the Encore at the Wynn Las Vegas, NV.
A live audio webcast of the Aclaris presentation can be accessed by visiting the “Investors” section of the company’s website at www.aclaristx.com. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the presentation date.
About Aclaris
Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company’s website at www.aclaristx.com.
Contact: Aclaris Contact Frank Ruffo Chief Financial Officer 484-324-7933 investors@aclaristx.com Investor Contact Patricia L. Bank Westwicke Partners Managing Director 415-513-1284 patti.bank@westwicke.com Media Contact Mike Beyer Sam Brown, Inc. 312-961-2502 mikebeyer@sambrown.com
(OPCO) Reports Record 2016 First Quarter Results
OurPet’s Company (OTCQX:OPCO) (www.ourpets.com), a leading proprietary pet supply company, today reports record net revenue and record net income for the three months ended March 31, 2016.
First Quarter 2016 net revenue increased 10.3% to $6.17 million compared to $5.59 million for the same period last year. Net income increased 24.7% to a record $266,581 for the 2016 first quarter compared to $213,792 a year ago. Earnings per diluted share were $0.01 for the first quarter of 2016 and 2015.
Dr. Steven Tsengas, Chairman and CEO comments, “These results reflect our continued ability to successfully execute our business strategy. Our E-Commerce and Food, Drug, Mass retail channels led the way this quarter with year over year sales growth of 14% and 8%, respectively. Q1’16 sales in the Pet Specialty market were about the same as Q1’15 sales, though we expect sales growth to improve for the balance of the year. International sales declined about 7.1% due to the strength of the US dollar. We are pleased that all major product categories showed a strong performance with Waste & Odor up 64%, Toys/Accessories up 10% and Bowls/Feeders up 9%.”
Dr. Tsengas continues, “Our profitability exceeded that of Q1’15 by almost 25%, though our gross profit margin of 29.7% was slightly below last year’s 30.3% due to product mix. S, G & A expenses as a percent of sales declined a full percent from 23.9% to 22.9%, a reflection of our maintaining tight cost controls. Income from operations increased 16.5% to $415,269 for the 2016 first quarter versus $356,313 for the 2015 first quarter mainly due to higher sales as S, G & A expenses increased by only $78,556. Our inventory also declined to approximately $7.44 million from approximately $7.91 million at the beginning of the year, the result of an ongoing initiative to reduce our inventory below $7,000,000 by year end without sacrificing any on-time or fill rate metrics.”
Dr. Tsengas concludes, “One of our highlights every first quarter is the Global Pet Expo international trade show held in Orlando, Florida where we present our new, innovative products to the market. This year we presented our new Intelligent Pet Care™ product line that features BlueTooth® and wireless connectivity for three products: our SmartScoop® – Intelligent Litter Box, our SmartLink™ Feeder – Intelligent Pet Bowl and our SmartLink™ Waterer – Intelligent Water Fountain. These products enhance the convenience of pet ownership and the connectivity between pets and pet owners by monitoring various activities that can be interpreted as indicators of pet health such as drinking, feeding and elimination behavior. This information is then transmitted to pet owners through their smartphones. We also introduced our 100% Natural Switchgrass BioChar litter, which produced favorable results when tested against the competition. Needless to say, we are really excited about the balance of 2016.”
About OurPet’s Company
OurPet’s Company designs, produces and markets a broad line of innovative, high-quality accessory and consumable pet products in the U.S. and overseas. Investor and customers may visit www.ourpets.com for more information about our company and its products. OurPet’s websites include www.petzonebrand.com and www.ourpets.com.
Certain of the matters set forth in this press release are forward-looking and involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially are the following: business conditions; growth in the industry; general economic conditions; addition or loss of significant customers; the loss of key personnel; product development; competition; risks of doing business abroad; foreign government regulations; fluctuations in foreign currency rates; rising costs for raw materials and sources of supply that may be limited or unavailable from time to time; the timing of orders booked; and the other risks that are described from time to time in OurPet’s SEC reports.
OURPET’S COMPANY AND SUBSIDIARIES | |||||||||||
CONSOLIDATED OPERATING RESULTS | |||||||||||
For the Three Months Ended | |||||||||||
March 31, | |||||||||||
2016 | 2015 | ||||||||||
Net revenue | $ | 6,175,985 | $ | 5,597,322 | |||||||
Cost of goods sold | 4,344,128 | 3,902,977 | |||||||||
Gross profit on sales | 1,831,857 | 1,694,345 | |||||||||
Selling, general and administrative expenses | 1,416,588 | 1,338,032 | |||||||||
Income from operations | 415,269 | 356,313 | |||||||||
Other (income) and expense, net | (27,006 | ) | (4,723 | ) | |||||||
Interest expense | 32,835 | 24,507 | |||||||||
Income before taxes | 409,440 | 336,529 | |||||||||
Income Tax expense | 142,859 | 122,737 | |||||||||
Net Income | $ | 266,581 | $ | 213,792 | |||||||
Basic and Diluted Earnings Per Common Share | |||||||||||
After Dividend Requirements For Preferred | |||||||||||
Stock: | |||||||||||
Net Income | $ | 0.01 | $ | 0.01 | |||||||
Weighted average number of common shares | |||||||||||
outstanding used to calculate | |||||||||||
basic earnings per share | 17,627,586 | 17,553,077 | |||||||||
Weighted average number of common and | |||||||||||
equivalent shares outstanding used to | |||||||||||
calculate diluted earnings per share | 19,458,840 | 19,267,328 | |||||||||
OURPET’S COMPANY AND SUBSIDIARIES | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
March 31, | December 31, | ||||||||
2016 | 2015 | ||||||||
ASSETS | |||||||||
Cash and cash equivalents | $ | 77,891 | $ | 100,000 | |||||
Receivables, net | 3,928,728 | 4,294,810 | |||||||
Inventories, net | 7,441,353 | 7,914,613 | |||||||
Prepaid expenses | 763,808 | 582,676 | |||||||
Total current assets | 12,211,780 | 12,892,099 | |||||||
LONG TERM ASSETS | |||||||||
Property and equipment, net | 1,929,585 | 1,873,260 | |||||||
Amortizable intangible assets, net | 362,654 | 357,341 | |||||||
Intangible Assets | 461,000 | 461,000 | |||||||
Goodwill | 67,511 | 67,511 | |||||||
Deposits and Other assets | 18,003 | 18,003 | |||||||
Total long term assets | 2,838,753 | 2,777,115 | |||||||
Total assets | $ | 15,050,533 | $ | 15,669,214 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current maturities of long-term debt | 263,128 | 276,890 | |||||||
Accounts payable | 948,614 | 1,582,849 | |||||||
Accrued expenses | 486,090 | 571,858 | |||||||
Total current liabilities | 1,697,832 | 2,431,597 | |||||||
LONG TERM LIABILITIES | |||||||||
Long-term debt – less current portion above | 817,520 | 876,248 | |||||||
Revolving line of credit | 3,180,032 | 3,267,170 | |||||||
Deferred income taxes | 315,203 | 333,834 | |||||||
Total long term liabilities | 4,312,755 | 4,477,252 | |||||||
Total liabilities | 6,010,587 | 6,908,849 | |||||||
Stockholders’ Equity | 9,039,946 | 8,760,365 | |||||||
Total liabilities and stockholders’ equity | $ | 15,050,533 | $ | 15,669,214 | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160502005119/en/
OurPet’s Company
Dr. Steven Tsengas, CEO, 440-354-6500, x111 (Direct)
Fairport Harbor, Ohio
or
Corporate Communications
DreamTeamNetwork (DTN)
Austin, Texas
512-758-8877 (Direct)
www.DreamTeamNetwork.com
Editor@DreamTeamNetwork.com
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