Uncategorized
Leading Gunfire Detection Solution Now Live in Cincinnati, Jacksonville, Louisville, Newburgh, Pittsfield, Syracuse and St. Louis County
NEWARK, Calif., Sept. 19, 2017 — ShotSpotter (Nasdaq:SSTI), the leader in gunshot detection solutions that help law enforcement officials and security personnel identify, locate and deter gun violence, today announced that seven new cities have recently deployed ShotSpotter technology in their communities. The new cities include Cincinnati, OH; Jacksonville, FL; Louisville, KY; Newburgh, NY; Pittsfield, MA; Syracuse, NY and St. Louis County, MO – joining the more than 90 jurisdictions that already rely on ShotSpotter to ensure a fast, accurate response to gunfire incidents. Three existing ShotSpotter cities, New York City, Chicago and Birmingham have also recently expanded their coverage areas.
ShotSpotter provides real-time alerts to law enforcement of detected gunfire so that they can arrive at the precise location of a shooting event safely and quickly. With the speed of response, officers can be on the scene to aid victims, interview witnesses, and collect forensic evidence. This improves the overall effectiveness of an agency in identifying and apprehending shooters, and taking illegal guns off the streets.
“We are excited to be working with police departments in successfully implementing gunshot detection solutions as a critical component of their gun violence prevention efforts,” said Ralph Clark, CEO of ShotSpotter. “Cities are seeing positive outcomes and improved community engagement as a result of their agency’s ShotSpotter adoption and integration with best practices execution. We are thrilled with all of our customer collaborations that are making a real difference in improved public safety for all, especially in those at-risk neighborhoods who also deserve community peace.”
“After just four weeks of using ShotSpotter, we are already seeing a positive impact from the technology,” said Cincinnati Assistant Police Chief Paul Neudigate. “We have three square miles of coverage in one of our most problematic communities for shooting violence and have had over sixty activations in just a month’s time.”
“ShotSpotter is already alerting us to specific addresses that we were not aware were inundated with random gunfire incidents,” Neudigate continued. “In addition, ShotSpotter works well with our established surveillance camera system; we recently caught a running gun battle on video that we would never have known about had we not received the alert. ShotSpotter technology holds great promise for helping to reduce gun violence in the City of Cincinnati as part of an overall gun violence reduction strategy.”
According to Lieutenant Jim Cirillo, Louisville Metro Police Department, “ShotSpotter’s technology product has done exactly what they promised it to do.”
In recent months, three existing ShotSpotter cities – New York City, Chicago and Birmingham – have undergone recent expansions to their coverage areas. New York City began implementing ShotSpotter in 2015 and currently covers 57 square miles, an increase of 17.8 square miles since the beginning of 2017. In Chicago, ShotSpotter was first deployed in the 7th and 11th districts, then in the 15th and 9th. In September 2017, their sixth district also went live with ShotSpotter and the 10th district will go live soon. The city of Birmingham doubled their ShotSpotter coverage from eight to 16 square miles.
In addition, the University of Alabama (UA) Police Department has added ShotSpotter to help make its campus safer. UA becomes one of eight universities in the country to invest in the ShotSpotter gunfire detection technology.
About ShotSpotter, Inc.
ShotSpotter is the leader in gunshot detection solutions that help law enforcement officials and security personnel identify, locate and deter gun violence. ShotSpotter is based in Newark, California and offers its solutions on a SaaS-based subscription model to customers around the world, with current customers located in the United States, Puerto Rico, the U.S. Virgin Islands and South Africa.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the planned expansion and timing of covered miles. These forward-looking statements are made as of the date of this press release and were based on current expectations, estimates, forecasts and projections as well as the beliefs and assumptions of management. Words such as “expect,” “anticipate,” “should,” “believe,” “target,” “project,” “goals,” “estimate,” “potential,” “predict,” “may,” “will,” “plan,” “could,” “intend,” variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the company’s control. The company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: the availability of funding for the company’s customers to purchase the company’s solutions; the complexity, expense and time associated with contracting with government entities; the lengthy sales cycle for the company’s solutions; changes in federal funding available to support local law enforcement; and the company’s ability to deploy and deliver its solutions. Additional factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in the company’s filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, under the caption “Risk Factors.” ShotSpotter assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Media Contact: Liz Einbinder +1 510-794-3147 LEinbinder@ShotSpotter.com
Investor Relations Contact: Matt Glover +1 949-574-3860 matt@liolios.com
SHANGHAI, China, Sept. 19, 2017 — GDS Holdings Limited (“GDS Holdings”, “GDS” or the “Company”) (NASDAQ:GDS), a leading developer and operator of high-performance data centers in China, today announced that it has been awarded a new class of telecom license for the provision of Cloud Connect services in China. The new license allows GDS to provide connectivity services over its own network to Cloud and enterprise customers colocated in all of its data centers. GDS Cloud Connect service is currently being tested by several major customers. Full launch is planned in the next two quarters.
Mr. William Huang, Chairman and Chief Executive Officer of GDS Holdings, stated, “GDS Cloud Connect service will provide unique value proposition and create significant operational benefits for our customers through enhanced connectivity between Cloud service providers and enterprises. By leveraging our data center platform in all Tier 1 markets and the established presence of the key Cloud service providers, we will further advance our strategy to be to the home of the Cloud in China.”
About GDS Holdings Limited
GDS Holdings Limited (Nasdaq:GDS) is a leading developer and operator of high-performance data centers in China. The Company’s facilities are strategically located in China’s primary economic hubs where demand for high-performance data center services is concentrated. The Company’s data centers have large net floor area, high power capacity, density and efficiency, and multiple redundancy across all critical systems. GDS is carrier and cloud neutral, which enables customers to connect to all major PRC telecommunications carriers, and to access a number of the largest PRC cloud service providers, whom GDS hosts in its facilities. The Company offers colocation and managed services, including a unique and innovative managed cloud value proposition. The Company has a 16-year track record of service delivery, successfully fulfilling the requirements of some of the largest and most demanding customers for outsourced data center services in China. The Company’s base of customers consists predominantly of large Internet companies, financial institutions, telecommunications and IT service providers, and large domestic private sector and multinational corporations.
Safe Harbor
This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “estimate,” “expect,” “future,” “guidance,” “intend,” “is/are likely to,” “may,” “ongoing,” “plan,” “potential,” “target,” “will,” and similar statements. Among other things, statements that are not historical facts, including statements about GDS Holdings’ beliefs and expectations regarding the growth of its businesses and its revenue for the full fiscal year, the business outlook and quotations from management in this announcement, as well as GDS Holdings’ strategic and operational plans, are or contain forward-looking statements. GDS Holdings may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”) on Forms 20-F and 6-K, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause GDS Holdings’ actual results or financial performance to differ materially from those contained in any forward-looking statement, including but not limited to the following: GDS Holdings’ goals and strategies; GDS Holdings’ future business development, financial condition and results of operations; the expected growth of the market for high-performance data centers, data center solutions and related services in China; GDS Holdings’ expectations regarding demand for and market acceptance of its high-performance data centers, data center solutions and related services; GDS Holdings’ expectations regarding building, strengthening and maintaining its relationships with new and existing customers; the continued adoption of cloud computing and cloud service providers in China; risks and uncertainties associated with increased investments in GDS Holdings’ business and new data center initiatives; risks and uncertainties associated with strategic acquisitions and investments; GDS Holdings’ ability to maintain or grow its revenue or business; fluctuations in GDS Holdings’ operating results; changes in laws, regulations and regulatory environment that affect GDS Holdings’ business operations; competition in GDS Holdings’ industry in China; security breaches; power outages; and fluctuations in general economic and business conditions in China and globally and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks, uncertainties or factors is included in the GDS Holdings’ filings with the SEC, including its registration statement on Form F-1, as amended. All information provided in this press release is as of the date of this press release and are based on assumptions that GDS Holdings believes to be reasonable as of such date, and GDS Holdings does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
For investor and media inquiries, please contact:
GDS Holdings Limited
Laura Chen
Phone: +86 (21) 5119 6989
Email: ir@gds-services.com
The Piacente Group, Inc.
Ross Warner
Phone: +86 (10) 5730-6200
Email: GDS@tpg-ir.com
Alan Wang
Phone: +1 (212) 481-2050
Email: GDS@tpg-ir.com
New analysis of data shows clinically meaningful reductions in LDL-C and hsCRP across multiple trials and confirms support to advance gemcabene into Phase 3
End of Phase 2 meetings planned for early 2018
ROYAL-1 study accepted for presentation at AHA Scientific Sessions in November 2017
COBALT-1 study to be presented at the FH Foundation’s Summit meeting on Monday, September 25th
Conference call at 4:30 pm ET today
LIVONIA, Mich., Sept. 19, 2017 — Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and NASH, today announced plans to advance its product candidate gemcabene into Phase 3 development in 2018. Gemcabene successfully achieved the primary endpoint in two recently completed Phase 2b studies, COBALT-1 and ROYAL-1, and the Company is now preparing for end of Phase 2 meetings with both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), anticipated to take place in early 2018. The primary focus of these meetings is to reach agreement on the design of the Phase 3 development programs for its hypercholesterolemia indications. Twenty clinical studies have shown gemcabene to be safe and effective as monotherapy or in combination with all current treatments for hypercholesterolemia, including the highest intensity statins, PCSK9 inhibitors and ezetimibe, and thus appears to be beneficial for high-risk patients that have not achieved lipid goals.
Gemphire is developing gemcabene as an add-on therapy to diet and maximally-tolerated statins for the treatment of several hypercholesterolemic populations, including atherosclerotic cardiovascular disease (ASCVD), with an emphasis on the high risk cardiometabolic subset of ASCVD patients, heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). The Company also plans to develop gemcabene as monotherapy or as add-on therapy to diet and other lipid lowering therapies for the treatment of severe hypertriglyceridemia (SHTG). Gemcabene has been shown to be safe and effective in combination with all current treatments for hypercholesterolemia, including the highest intensity statins, PCSK9 inhibitors and ezetimibe.
“I believe we have accumulated a compelling body of clinical data demonstrating the ability of gemcabene to reduce low density lipoprotein cholesterol (LDL-C) in both orphan and broad dyslipidemic conditions,” said Dr. Steven Gullans, Interim CEO of Gemphire. “Gemcabene is a unique late stage clinical asset and the only compound in development across the full spectrum of dyslipidemia that targets the triple threat of LDL-C, inflammation and triglycerides (TG). We look forward to reviewing these data with the FDA and EMA to seek agreement on the design of our comprehensive Phase 3 clinical program to confirm the benefits observed in prior studies and to support regulatory approval for the various indications and commercialization in the major markets.”
“Many high-risk patients are unable to achieve optimal LDL-C reductions and levels with the currently available therapies,” said Evan Stein, MD Director Emeritus of the Metabolic & Atherosclerosis Research Center, in Cincinnati, Ohio. “As such, physicians and patients need additional options that can be combined safely with statin therapy, which is the first therapy utilized for most patients, and can provide additional efficacy across multiple parameters associated with cardiovascular risk. Given the recent data released by Novartis Inc. establishing reduction of inflammation and hsCRP as a novel mechanism to decrease cardiovascular disease (CVD), the combined effect of gemcabene on LDL-C, apolipoprotein B and hsCRP is very promising for patients at high risk for CVD events.”
New Analysis Shows That 600 mg of Gemcabene Reduced LDL-C by 21% in Hypercholesterolemic Patients and by 25% in Mixed Dyslipidemic Patients across Multiple Clinical Trials
The Company has performed an extensive analysis of data on hypercholesterolemic patients across previously completed clinical trials for gemcabene, including the most recently completed COBALT-1 and ROYAL-1 studies. In addition to the LDL-C reduction in the overall cohorts, efficacy was assessed according to baseline LDL-C levels, and other baseline characteristics, such as the degree of obesity, magnitude of HbA1c, mixed dyslipidemia, level of inflammation, a responder analysis and combinations of these factors.
Data for the ROYAL-1 study have been accepted for presentation at the American Heart Association’s (AHA) Scientific Sessions in November 2017. Details of the ROYAL-1 data are embargoed until presentation at AHA; however, the additional analyses of ROYAL-1 showed similar trends as we will outline from the combined analysis below. As such, the announcement today is focusing on the combined analysis of the hypercholesterolemic patients involved in previously completed clinical studies.
Patients were included in the combined analysis if they were hypercholesterolemic and were on stable statin and/or other lipid lowering therapy, which represents the intended use for gemcabene in clinical practice for its hypercholesterolemic indications. The prior clinical trials included 352 hypercholesterolemic patients, composed of placebo (n=110) and gemcabene 150 mg (n=23), 300 mg (n=61), 600 mg (n=94) and 900 mg (n=64) dose groups. Data from the gemcabene 600 mg dose group are presented in the table below since this is the intended target dose for the Phase 3 trials for the reduction of LDL-C across the hypercholesterolemic patient population.
Gemphire believes gemcabene offers a unique value proposition for those patients with a high-risk cardiometabolic profile, specifically those with obesity, pre-diabetes /diabetes, inflammation and/or mixed dyslipidemia. Mixed dyslipidemia refers to a group of patients at high risk for cardiovascular disease that have elevated LDL-C, apolipoprotein B, and TGs. Cardiovascular demographics from the National Health and Nutritional Health Examination Survey (NHANES) data estimate that of the approximately 40 million patients on statins, approximately 6.1 million represent cardiometabolic patients who are not at goal and have LDL levels above 70 mg/dL with approximately 3 million of these patients being above 100 mg/dL. Cardiometabolic patients usually have several lipid abnormalities that can benefit from gemcabene’s ability to lower LDL-C, hsCRP and TGs. The LDL-C reductions for mixed dyslipidemic patients who received 600 mg of gemcabene or placebo are presented separately in the table below.
| Combined results from hypercholesterolemic patients across completed clinical studies |
| All Hypercholesterolemic Subjects |
Gemcabene 600 mg
n= 94 |
Placebo
n=110 |
p value |
| LDL-C reduction |
-21% |
-5% |
p<0.0001 |
Mixed Dyslipidemia Subset (Baseline LDL-C ≥100
and TGs ≥200 and <500 mg/dL) |
Gemcabene 600 mg
(high risk patients)
n= 24 |
Placebo
(high risk patients)
n= 30 |
p value |
| LDL-C reduction |
-25% |
-4% |
p=0.0002 |
Ability of Gemcabene to Reduce hsCRP and Inflammation is Potentially a Key Differentiator
Elevated serum C-Reactive Protein (hsCRP) is a known biomarker for patients at increased risk of a cardiovascular event. As reported previously in the ROYAL-1 study, 600 mg of gemcabene lowered serum hsCRP by 40% (n=51) compared to 6% for placebo (n=51) (p<0.0001). Note that this effect was additive to the reduction of hsCRP provided by statins, as the ROYAL-1 patients were already taking maximally tolerated doses of statins. From the combined analysis in hypercholesterolemic patients the median hsCRP reduction for patients on gemcabene 600 mg was 40% (n=90) compared with 5% in the placebo group (n=108) (p<0.0001).
CRP is a plasma protein biomarker secreted into the blood from the liver in response to inflammation. Reducing this biomarker is associated with a reduction in cardiovascular risk, as confirmed by Novartis Inc.’s Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS) recently presented at the European Society of Cardiology (ESC) congress in Barcelona, Spain, in August of this year. As reported by Novartis Inc. in August 2017, in the CANTOS study, patients with a history of myocardial infarction and elevated hsCRP received treatment with an injectable anti-inflammatory monoclonal antibody to the cytokine IL-1β to determine the direct potential impact of reducing inflammation on cardiovascular events. The results demonstrated that reducing inflammation as measured by hsCRP (with a median hsCRP reduction of 37%) led to a 15% reduction in cardiovascular related MACE (combination of non-fatal myocardial infarction, non-fatal stroke and cardiovascular death). The impact of orally administered gemcabene on hsCRP and inflammation remains a potentially key differentiator from other compounds that are approved or in development as add-on therapy to maximally tolerated statins.
Gemcabene Appears Safe for High Risk Patients in Combination with Maximally Tolerated Statins and Other Approved Treatments
The COBALT-1 and ROYAL-1 trials were designed to determine the safety, tolerability and efficacy of gemcabene as an add-on to the highest doses of statins (e.g., rosuvastatin 20 and 40 mg and atorvastatin 40 and 80 mg doses; moderate intensity therapies were also included), as well as PCSK9 inhibitors, and ezetimibe.
We believe the results from all 20 clinical studies in which 956 patients were exposed to gemcabene have demonstrated that gemcabene is well tolerated and safe. Although in practice, most patients are on low and moderate intensity statins, in our clinical trials gemcabene demonstrated a clean safety profile even when combined with the highest doses of the high intensity statins, simvastatin, atorvastatin and rosuvastatin. To date, there has been no evidence for hepatic or muscle related toxicities and no serious adverse events related to gemcabene treatment. Overall treatment emergent adverse events for gemcabene have been similar to placebo. Most adverse events have been mild to moderate in intensity and the most commonly reported adverse events have been infection and headache (based on occurrence in > 5% of subjects on gemcabene, although the rate for infection was less than placebo).
Gemphire’s Commitment to Cardiometabolic Patients, Physicians and Payors
Cardiovascular disease remains the leading cause of death globally despite the availability of statins and other therapeutics. In addition, the large recent increases in the prevalence of obesity and diabetes will result in a much greater number of individuals at risk for cardiovascular and liver diseases, including NASH. The highest risk patients would benefit from a new therapy that can be added safely to all commonly prescribed statins at any dose. Gemcabene has been given to over 950 patients to date and it appears to be a safe and effective therapeutic option for millions of cardiometabolic patients who are already on maximally-tolerated statins to reduce LDL-C, hsCRP and other potentially atherogenic lipid particles. As a once daily oral therapy at an affordable price point, gemcabene has the potential to be a valuable new approach that will provide benefits to patients, physicians and payors.
“Gemcabene has demonstrated efficacy across a broad array of important lipid parameters, such as LDL-C, non-HDL-C, total cholesterol, apolipoprotein B and triglycerides, that have been associated with cardiovascular events, such as heart attacks, stroke and death. Gemcabene has also demonstrated significant effects on reducing hsCRP, a marker of inflammation, which may be an important new target of therapy in patients with cardiovascular disease, based on the CANTOS trial results. Importantly, gemcabene has demonstrated an excellent safety profile without evidence of hepatic or muscle toxicities, even when combined with the most potent statins,” stated Dr. Lee Golden, Chief Medical Officer of Gemphire.
COBALT-1 study to be presented at the FH Foundation’s Summit
Gemphire will also be announcing full results of the COBALT-1 (HoFH) study at the FH Foundation’s Summit meeting in Miami, Florida on Monday, September 25th at 9:00 am ET. The results will be presented by Dr. Marina Cuchel, MD, PhD, Research Associate Professor at the Perelman School of Medicine at the University of Pennsylvania. The FH Summit is an invitation-only event that convenes global experts within various fields to tackle the most pressing issues facing FH populations today. The 2017 FH Global Summit will include topics on the challenges and opportunities of diverse FH subpopulations navigating diagnosis, care and access. For more information, refer to https://thefhfoundation.org/event/2017-fh-global-summit.
Gemphire to Soon Launch Proof of Concept Program in NASH
As previously announced, Gemphire will be initiating its proof of concept study in patients that suffer from fatty liver disease and nonalcoholic steatohepatitis (NASH) in the fourth quarter of 2017. Unmanaged cardiometabolic disease is the underlying cause of atherosclerosis and fatty liver disease. Gemcabene’s unique mechanism of action has demonstrated positive attributes that may be protective to both the heart and liver. Approximately 6 million patients in the U.S. are affected by NASH for which there is currently no effective treatment available.
Conference Call and Webcast
Gemphire management will host a conference call for investors at 4:30 pm ET today. To participate, please dial (844) 494-0188 (domestic) or (425) 278-9114 (international) and reference conference ID 86185879. A webcast replay will be available on the News & Events section of the Gemphire website for all interested parties following the call and will be archived and available for 90 days.
Gemcabene’s Mechanism of Action and Safety Profile Are Highly Differentiated
Gemphire’s product candidate, gemcabene (CI-1027), is a first-in-class, once-daily, oral therapy that may be suitable for patients who are unable to achieve normal levels of LDL-C or triglycerides with currently approved therapies, primarily statins. Gemcabene’s mechanism of action is designed to enhance the clearance of very low-density lipoproteins (VLDLs) in the plasma and inhibition of the production of cholesterol and triglycerides in the liver. The combined effect for these mechanisms has been clinically observed to result in a reduction of plasma non-HDL-C, VLDL-C, LDL-C, apolipoprotein B and triglycerides. In addition, gemcabene has been shown to markedly lower C-reactive protein and improve insulin sensitization. Gemcabene is liver-directed and reduces apoC-III mRNA and plasma levels. Gemcabene also reduces acetyl-CoA carboxylase (ACC1) and CCR2/CCR5 receptor mRNA levels, which may have applications in non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD). Gemcabene has demonstrated proof of concept efficacy for NASH in the STAM™ model developed at SMC Laboratories in Tokyo, Japan. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in 956 subjects across 20 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.
About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its complementary, convenient, cost-effective product candidate gemcabene as add-on to the standard of care especially statins that will benefit patients, physicians, and payors. Gemphire has initiated 3 clinical trials for homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH)/atherosclerotic cardiovascular disease (ASCVD), and severe hypertriglyceridemia (SHTG) under NCT02722408, NCT02634151, and NCT02944383, respectively with a fourth planned trial in NASH to initiate in second half of 2017. Please visit www.gemphire.com for more information.
Forward Looking Statements
Any statements in this press release about Gemphire’s future expectations, plans and prospects, including statements about Gemphire’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Gemphire’s product candidate, expectations regarding future clinical trials, regulatory submissions and meetings and future expectations and plans and prospects for Gemphire, expectations regarding operating expenses and cash used in operations, and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” “scheduled” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the success and timing of Gemphire’s regulatory submissions and pre-clinical and clinical trials; regulatory requirements or developments; changes to Gemphire’s clinical trial designs and regulatory pathways; changes in Gemphire’s capital resource requirements; Gemphire’s ability to obtain additional financing; Gemphire’s ability to successfully market and distribute its product candidate, if approved; Gemphire’s ability to obtain and maintain its intellectual property protection; and other factors discussed in the “Risk Factors” section of Gemphire’s Annual Report on Form 10-K for the year ended December 31, 2016, Gemphire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and in other filings Gemphire makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof. Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change. However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.
Contact:
Andrew McDonald, Ph.D.
LifeSci Advisors, LLC
(646) 597-6987
Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
(734)-245-1700
– Monaker Group inked private placement deals with prominent financial institutions and board members.- The company moves ahead with the NASDAQ listing process, as stipulated by the private placement deal.
– The company is working on finalizing its deal with Trisept.
Monaker Group Inc. (OTC: MKGI) is an emerging player in the online travel market, offering its Alternative Lodging products and services in both B2C and B2B segments. The company is well positioned to augment its position in the fast growing online travel market, which is expected to touch $1 trillion by 2022. Monaker is taking a holistic approach to boosting its visibility in the segment. The company is going full steam ahead to augment the product inventory on its Booking Engine by entering into new collaborations. It is also constantly upgrading its technology as it recently launched its apps for Android and iOS platforms. The company has taken steps to solidify its financial position, to fund its operating activities. Monaker is moving ahead with the process seeking to list its shares on NASDAQ, which is likely to be completed by the end of this year.
Monaker has taken several steps to boost its financial position as the company goes ahead with developing and marketing its new alternative lodging products and white label solutions. The company recently announced completion of a private placement of its stock. The deal yielded over $3 million for the company in gross proceeds. 21 percent of the proceeds or $635,000 from the board members and certain insiders, while remaining proceeds are attributed to prominent financial institutions including Pacific Grove Capital, an up and coming hedge fund launched by former Scout Capital Management executive Jamie Mendola. Venture capitalist Mendola has a strong pedigree behind him. A Stanford business school graduate, Mendola has worked with JPMorgan Chase and other major institutions. His latest venture Pacific Grove Capital specializes in small to midsize companies. The strategy allows the venture capital to have in-depth knowledge about its investee companies. Monaker thus stands to benefit from personalized expertise and mentoring provided by Pacific Grove Capital.
The deals entitle the purchasers to one common share and one warrant for a purchase price of $2.00. Each warrant entitles the holder to purchase one common share at an exercise price of $2.10 per share, with an expiration date five years from the date of issuance.
The deal was timely as Monaker moves ahead with making technological upgradations and other improvements in its products. The company intends to use the proceeds for augmenting its alternative lodging rentals inventory as well. The placement was also a step forward towards the company gaining listing on a stock exchange. The terms of the agreement require Monaker to apply for a listing of its common shares on the NASDAQ Capital Market within 60 days following the closing of the offering.
The company had its intention clear to seek NASDAQ membership for the stock. Monaker recently carried out a number of board appointments to comply with the requirements of NASDAQ listing. Recent appointments included Robert Post, president and CEO of Cloud5 Communications and executive chairman of The Knowland Group, to the company’s board of directors. Mr. Post has held a number of c-level positions at large hospitality and travel companies including Open Table, Micros and TravelClick. His appointment took the number of independent directors on the board to four, thus complying with NASDAQ requirement of having a majority of independent directors on the board.
Monaker also benefits from the collective expertise of its seasoned management. Among its prominent directors is Don Monaco who has nearly thirty years of high profile corporate experience with companies such as Accenture. He is the principal owner of Monaco Air Duluth, LLC a full-service, fixed-base operator aviation services business at Duluth International Airport and provides Monaker with deep understanding of the travel market. Another noteworthy director of the company is Simon Orange whose expertise lies in corporate finance and M&A. He is the co-founder of CorpAcqu, which maintains long-term investments in a diverse portfolio of successful businesses. With the recent appointments, Monaker is well positioned to harness the knowledge and skills of its directors to forge new collaborations and grow.
The company is also working on forming additional distribution channels and relationships with major players in the online travel segment. It recently reported developments about its deal with Trisept Solutions, which is a sister company to Mark Travel. The agreement pertains to Monaker’s alternative lodging product for uploading and distribution through the Trisept distribution channels and partners. Trisept’s travel distribution platforms and channels include VAX VacationAccess, Xcelerator and Synapse. The Monaker and Trisept began integration in 2016 and completion is likely to be finalized in the near-term.
Monaker’s B2B offering is centered around providing travel distributors such as agents, airlines and cruise companies access to large global inventory of alternative lodging (or commonly called “vacation rental”) properties in a white label solution. The company’s platform provides these properties on instant bookable basis, helping travel partners capture their portion of the rapidly growing segment looking for alternative stay options. More and more tourists are now exploring rental accommodations over traditional hotel or resort stays. In order to help its travel associates,Monaker is further boosting its B2B initiative by supplying ALR products, along with optional tour activities. The company also offers its partners the ability to mark listings up or down to meet their own internal requirements. A main differentiator for Monaker to other peer Vacation Rental companies, is that all the properties available in Monaker’s inventory are open for instant bookings. This feature helps in removing uncertainty for the vacationers as it also makes the booking process smoother and faster. The company also gets an edge over its peers such as Airbnb, which generally require the users to wait for the confirmation of their bookings. Monaker is all set to carve a niche for itself in online travel market on the back of its robust product, solid technological innovation and experienced management to steer it through the competition.
With technology upgrades and the recent capital infusion, Monaker is positioning to stake ground and customers with its alternative lodging white label B2B solution, while more established peers such as Airbnb, Expedia ($EXPE) and Priceline ($PCLN) continue to focus directly on the consumer with tedious request-accept B2C approach.
Disclaimer:
Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements. WFM, Inc. is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. For full disclosure, please visit: http://wwfinancial.com/legal-disclaimer/.
Contact:
Worldwide Financial Marketing, Inc.
http://wwfinancial.com/
Phone: 954.360.9998
LOS ANGELES, Sept. 18, 2017 — Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy (DMD) and other rare diseases, today announced that it will present six-month follow-up results from the randomized Phase I/II HOPE-Duchenne clinical trial of CAP-1002 in boys and young men with Duchenne muscular dystrophy (DMD) at the 22nd International Congress of the World Muscle Society. The late breaking abstract and results will be presented in the late breaking poster session starting at 10:30am CEST on Wednesday, October 4, 2017. The International Congress of the World Muscle Society will be held October 3 – 7, 2017 at the Palais du Grand Large in Saint Malo, France.
About CAP-1002
CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of progenitor cell that has been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials. The HOPE-Duchenne trial is funded in part by the California Institute for Regenerative Medicine.
About Duchenne Muscular Dystrophy
DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by an abnormality in the dystrophin complex, a structural element that plays a critical role in muscle fiber integrity, which leads to chronic muscle damage. Patients with DMD typically die in their twenties, most commonly due to heart disease. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies. Capricor’s lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is also exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; the timing of regulatory approvals; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 16, 2017, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, as filed with the Securities and Exchange Commission on August 14, 2017. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
CAP-1002 is an Investigational New Drug and is not approved for any indications. Capricor’s exosomes technology, including CAP-2003, has not yet been approved for clinical investigation.
For more information, please contact:
AJ Bergmann, Vice President of Finance
+1-310-358-3200
abergmann@capricor.com
– Lefamulin met all primary FDA and EMA endpoints with a favorable tolerability profile –
– Conference call and webcast today at 8:30 a.m. EDT to review results –
DUBLIN, Ireland and KING OF PRUSSIA, Pa., Sept. 18, 2017 — Nabriva Therapeutics plc (NASDAQ:NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, today announced positive topline results from the lefamulin evaluation against pneumonia (LEAP 1) trial, which evaluated the safety and efficacy of intravenous (IV) to oral lefamulin in patients with community-acquired bacterial pneumonia (CABP). CABP is the leading cause of infectious death in the United States.
In the LEAP 1 trial, Nabriva Therapeutics’ first of two pivotal Phase 3 clinical trials of lefamulin in patients with CABP, lefamulin met the U.S. Food and Drug Administration (FDA) primary endpoint of non-inferiority (NI, 12.5% margin) compared to moxifloxacin with or without adjunctive linezolid for early clinical response (ECR) assessed 72 to 120 hours following initiation of therapy in the intent to treat (ITT) patient population. In the trial, ECR rates were 87.3% for lefamulin and 90.2% for moxifloxacin with or without linezolid (treatment difference -2.9 [95% confidence interval (CI) -8.5, 2.8]).
“These Phase 3 data provide strong evidence of the potential of lefamulin to treat adults with CABP and provide an alternative to a current gold standard treatment regimen,” said Dr. Colin Broom, chief executive officer of Nabriva Therapeutics. “Due to lefamulin’s flexible dosing and targeted spectrum of activity against the pathogens most commonly associated with CABP, including multidrug-resistant strains, we believe that lefamulin is well suited to be a first-line empiric monotherapy. I am extremely proud and appreciative of the Nabriva Therapeutics team that has advanced lefamulin, which has the potential to be the first in a new class of antibiotics for CABP in more than 15 years, from initial discovery in our labs to this important milestone. We continue to execute on our second pivotal trial evaluating oral lefamulin for the treatment of CABP, with enrollment expected to complete in the fourth quarter of 2017 and topline results anticipated in the spring of 2018.”
Lefamulin also met the primary endpoints for the European Medicines Agency (EMA) of non-inferiority (NI, 10% margin) compared to moxifloxacin with or without adjunctive linezolid in the modified intent to treat (mITT) and clinically evaluable at test of cure (CE-TOC) populations based on an investigator assessment of clinical response (IACR) at a test of cure visit (5 to 10 days following the completion of study therapy). IACR rates for the mITT population were 81.7% for lefamulin and 84.2% for moxifloxacin with or without linezolid (treatment difference -2.6 [95% CI -8.9, 3.9]) and for the CE-TOC population were 86.9% for lefamulin and 89.4% for moxifloxacin with or without linezolid (treatment difference -2.5 [95% CI -8.4, 3.4]). IACR is also a key secondary endpoint for the FDA.
“Community-acquired bacterial pneumonia is a common and potentially life-threatening illness for which presently available recommended antimicrobials have potential limitations often associated with resistance or safety,” said Dr. Thomas M. File Jr., M.D., MS, chair of the Infectious Disease Section, Northeast Ohio Medical University, and chair of the Infectious Disease Division, Summa Health. “With bacterial resistance continuing to increase, patients and physicians are in need of new safe and effective treatment options that adhere to the principles of antibiotic stewardship. These positive topline results evaluating the efficacy and safety of lefamulin in patients with community-acquired bacterial pneumonia are promising.”
In addition, in LEAP 1, ECR by pathogen was similar to the overall response rates and was comparable between treatment arms. Detailed results on a pathogen-by-pathogen basis in the microbiological intent to treat (microITT) population are included in Appendix A to this release.
LEAP 1 enrolled 551 patients: 276 in the lefamulin arm and 275 in the moxifloxacin with or without linezolid arm. Patients who were aged 65 or older represented 47.8% of the patients in the lefamulin arm compared to 39.3% of the patients in the moxifloxacin with or without linezolid arm. The lefamulin arm enrolled 196 (71.0%), 76 (27.5%) and 4 (1.4%) patients with a Pneumonia Outcomes Research Team (PORT) class of 3, 4 and 5, respectively. The moxifloxacin with or without linezolid arm enrolled 1 (0.4%), 201 (73.1%), 70 (25.5%) and 3 (1.1%) patients with a PORT class of 2, 3, 4 and 5, respectively.
In the LEAP 1 trial, a similar rate of treatment-emergent adverse events (TEAEs) was observed in the lefamulin arm (38.1%) and the moxifloxacin with or without linezolid arm (37.7%). In addition, the rates of TEAEs leading to study drug discontinuation were 2.9% for lefamulin versus 4.4% for moxifloxacin with or without linezolid, and the rates of withdrawal from the trial were 1.8% for lefamulin versus 4.0% for moxifloxacin with or without linezolid. Death occurred with similar frequency in both arms, with 6 patients dying in the lefamulin arm (2.2%) and 5 patients dying in the moxifloxacin with or without linezolid arm (1.8%).
Adverse events reported in greater than 2.0% of patients receiving study drug (lefamulin versus moxifloxacin with or without linezolid, respectively) were hypokalemia (2.9% versus 2.2%), nausea (2.9% versus 2.2%), insomnia (2.9% versus 1.8%), infusion site pain (2.9% versus 0%), infusion site phlebitis (2.2% versus 1.1%), alanine aminotransaminase (ALT) increase (1.8% versus 2.2%) and hypertension (0.7% versus 2.2%).
Of note, while no documented cases of Clostridium difficile infection were reported in either treatment group, diarrhea was observed in 0.7% and 7.7% of subjects receiving lefamulin and moxifloxacin with or without linezolid, respectively, with a lower overall rate of gastrointestinal TEAEs in the lefamulin arm compared to the moxifloxacin with or without linezolid arm (6.6% versus 13.0%). In addition, no meaningful differences between the lefamulin and moxifloxacin with or without linezolid arms were observed in cardiac (2.9% versus 4.0%) or hepatobiliary (0.7% versus 1.5%) TEAEs.
Elevations in liver transaminases (>3 times the upper limit of normal (ULN)) were comparable in both treatment groups: ALT (7.1% versus 6.4%) and aspartate aminotransferase (AST) (4.1% versus 2.6%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively. Elevations in liver transaminases (>5 times the upper limit of normal (ULN)) occurred in both treatment groups: ALT (2.2% versus 1.9%) and aspartate aminotransferase (AST) (0.7% versus 0.7%) in the lefamulin and moxifloxacin with or without linezolid treatment groups, respectively. No patient in either treatment group met Hy’s Law criteria, which is an indicator for severe liver damage.
Changes in QT interval, a measure of the heart’s electrical cycle, that were of potential clinical concern were uncommon. At steady state, maximum increases in QT interval between 30 to 60 msec occurred in 12 (4.6%) and 14 (5.4%) of patients receiving lefamulin and moxifloxacin with or without linezolid, respectively. In addition, compared to no patients in the lefamulin arm, one patient in the moxifloxacin arm had an increase in QT interval greater than 60 msec, and one patient in each treatment arm had an increase in absolute QT interval to greater than 500 msec.
Further analysis of the LEAP 1 trial results including analysis of additional patient population groups in the trial and secondary and exploratory endpoints related to these populations groups is ongoing and additional results will be presented at upcoming scientific congresses.
About LEAP 1 Trial Design
LEAP 1 was a multi-center, randomized, controlled, double-blind, global study comparing lefamulin to moxifloxacin, a fluoroquinolone antibiotic, with or without linezolid. The trial was designed to evaluate the efficacy and safety of lefamulin (IV/oral) compared to moxifloxacin (IV/oral), with or without linezolid, in 551 adults with moderate to severe CABP. Linezolid (or matching placebo for the lefamulin arm) could be added to treatment if an investigator suspected that a patient was infected with methicillin-resistant S. aureus (MRSA) prior to randomization, as moxifloxacin is not approved to treat MRSA. Lefamulin was dosed at 150 mg IV every 12 hours. The comparator drugs were dosed according to their approved labeling, with moxifloxacin dosed at 400 mg IV daily and linezolid at 600 mg IV every 12 hours. Based on pre-defined criteria, investigators had the option to switch patients to oral therapy after three days (at least six doses) of IV study medication. Study drugs were administered orally as one lefamulin 600 mg tablet every 12 hours, moxifloxacin at 400 mg daily and linezolid at 600 mg every 12 hours. All patients enrolled in this trial had a PORT class severity of at least 3 on a scale of 1 to 5 (other than one patient in the moxifloxacin with or without linezolid treatment group), which corresponds to moderate to severe clinical disease. Randomization was 1:1 and was stratified by PORT risk class, geography and exposure to prior antibiotics. Patients who received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization were excluded from participating.
For LEAP 1, the primary efficacy endpoint for the FDA was the proportion of patients in the ITT population in each treatment group achieving ECR. ECR is achieved for patients who were alive, had improvement in at least two of the four cardinal symptoms of CABP as outlined in the current FDA guidance, had no worsening in any of the four cardinal symptoms of CABP and had not received a concomitant antibiotic (other than linezolid) for the treatment of CABP up through 120 hours after the first dose of study drug. The four cardinal symptoms of CABP, as outlined in the current FDA guidance, are difficulty breathing, cough, production of purulent sputum and chest pain. A number of population groups were evaluated in LEAP 1, including an ITT population consisting of all randomized patients regardless of whether they received study medication; a modified intent to treat (mITT) population consisting of all randomized subjects who received any amount of study drug; and a microITT population consisting of all subjects in the ITT population who had at least one baseline bacterial pathogen known to cause CABP, Legionella pneumophila from an appropriate microbiological specimen, or CABP caused by Mycoplasma pneumoniae or Chlamydophila pneumoniae.
Additional Phase 3 Clinical Trial Ongoing
Nabriva Therapeutics’ second pivotal Phase 3 clinical trial, LEAP 2, is a multi-center, randomized, controlled, double-blind, global study comparing oral lefamulin to moxifloxacin. LEAP 2 is designed to evaluate the efficacy and safety of oral lefamulin compared to oral moxifloxacin in patients with moderate CABP. All patients enrolled in LEAP 2 have a PORT class severity of 2 to 4 on a scale of 1 to 5, which corresponds to moderate disease. Nabriva is targeting the enrollment of approximately 738 patients in LEAP 2. The company expects to complete enrollment in the fourth quarter of 2017, and to have topline data available in the spring of 2018.
Conference Call and Webcast
The company will host a conference call and webcast at 8:30 a.m. EDT today. The live webcast can be accessed under “Events and Presentations” in the Investor Relations section of Nabriva Therapeutics’ website at www.nabriva.com and will be accessible for 90 days. The conference call can also be accessed by dialing 1-866-411-8292 (U.S./Canada) or 1-704-908-0383 (international) and providing the passcode 86032729.
About CABP
Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than 5 million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately 3.1 million of these adult CABP patients sought treatment in a hospital setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release.
About Nabriva Therapeutics plc
Nabriva Therapeutics is a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations. Nabriva Therapeutics’ lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of TEAEs comparable to moxifloxacin with or without linezolid. Nabriva Therapeutics intends to further pursue development of lefamulin for additional indications, including the treatment of acute bacterial skin and skin structure infections (ABSSSI), and is developing a formulation of lefamulin appropriate for pediatric use.
Nabriva Therapeutics owns exclusive, worldwide rights to lefamulin, which is protected by composition of matter patents issued in the United States, Europe and Japan.
Any statements in this press release about future expectations, plans and prospects for Nabriva, including but not limited to statements about the development of Nabriva’s product candidates, such as plans for the design, conduct and timelines of Nabriva’s ongoing Phase 3 clinical trial of lefamulin for CABP, the clinical utility of lefamulin for CABP and Nabriva’s plans for filing of regulatory approvals and efforts to bring lefamulin to market, the development of lefamulin for additional indications, the development of additional formulations of lefamulin, plans to pursue research and development of other product candidates, the sufficiency of Nabriva’s existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials, whether results of Nabriva’s first Phase 3 clinical trial of lefamulin will be indicative of the results for its second Phase 3 clinical trial of lefamulin, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in Nabriva’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva’s views as of the date of this release. Nabriva anticipates that subsequent events and developments will cause its views to change. However, while Nabriva may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva’s views as of any date subsequent to the date of this release.
Contact:
INVESTORS
Dave Garrett
Nabriva Therapeutics plc
david.garrett@nabriva.com
610-816-6657
MEDIA
Katie Engleman
Pure Communications
katie@purecommunications.com
910-509-3977
| Appendix A |
|
|
|
| |
Lefamulin |
Moxifloxacin
(with or without linezolid) |
| Microbiological ITT (microITT) |
N = 160 (58.0%) |
N = 159 (57.8%) |
| Baseline Pathogen |
N |
ECR (%) |
N |
ECR (%) |
| Gram Positive |
|
|
|
|
| S. pneumoniae (SP) |
82/93 |
88.2 |
% |
91/97 |
93.8 |
% |
| Penicillin-Susceptible SP (PSSP) |
17/21 |
81.0 |
% |
16/18 |
88.9 |
% |
| Penicillin-Intermediate SP (PISP) |
5/5 |
100 |
% |
2/2 |
100 |
% |
| Penicillin-Resistant SP (PRSP) |
2/2 |
100 |
% |
2/3 |
66.7 |
% |
| Multidrug-Resistant SP (MDRSP) |
6/6 |
100 |
% |
5/6 |
83.3 |
% |
| Macrolide-Resistant SP (MRSP) |
6/6 |
100 |
% |
5/6 |
83.3 |
% |
| S. aureus |
31/32 |
96.9 |
% |
13/13 |
100 |
% |
| Gram Negative |
|
|
|
|
| H. influenzae |
8/8 |
100 |
% |
6/7 |
85.7 |
% |
| M. catarrhalis |
47/52 |
90.4 |
% |
52/55 |
94.5 |
% |
| Atypicals |
|
|
|
|
| M. pneumoniae |
16/19 |
84.2 |
% |
18/20 |
90.0 |
% |
| L. pneumophila |
16/18 |
88.9 |
% |
12/14 |
85.7 |
% |
| C. pneumoniae |
10/11 |
90.9 |
% |
18/19 |
94.7 |
% |
Proposed Combination of Complementary Rare Disease Franchises Maximizes the Ability to Bring Needed New Therapies to Market
Proposal Delivers Superior Value To Dimension’s Shareholders Relative to the REGENXBIO Transaction; Provides Dimension Shareholders with Immediate Cash Premium Value of Over 358% to Unaffected Share Price
Ultragenyx to Host Conference Call Today at 10:30am ET
NOVATO, Calif., Sept. 18, 2017 — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) (“Ultragenyx” or the “Company”), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics, Inc. (NASDAQ:DMTX) (“Dimension”) for $5.50 per share, or approximately $138 million, in cash at close to be effectuated via a tender offer. The Ultragenyx offer represents a premium of over 358% to Dimension’s unaffected share price as of August 24, 2017 and premiums of 24% and 48% over the implied value of the all-stock consideration to be received by Dimension stockholders pursuant to the announced acquisition of Dimension by REGENXBIO Inc. (traded on NASDAQ under RGNX) (“REGENXBIO”), based on REGENXBIO’s last closing price and trailing 20-trading day volume-weighted average price as of September 15, 2017, respectively. As such, the proposal would provide Dimension stockholders with an immediate and certain return on their investment in Dimension and constitutes a superior alternative to the REGENXBIO transaction.
The proposal has been approved by the Board of Directors of Ultragenyx. Ultragenyx would fund the transaction from cash resources on its balance sheet and anticipates that customary closing conditions to the transaction could be satisfied so that the tender offer could complete as soon as 25 business days after merger agreement signing.
“This transaction provides a compelling opportunity to create value by leveraging Ultragenyx’s advanced clinical and regulatory expertise, as well as its rare metabolic disease commercial infrastructure to advance Dimension’s rare disease focused gene therapies and bring much needed new treatments to market,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “Based on my own experience as a scientific advisor to Dimension, I have the greatest respect for the deep expertise and knowledge of Dimension’s employees in AAV gene therapy and manufacturing. We share Dimension’s vision for bringing transformational new therapies to patients with rare genetic diseases and believe that bringing our two companies together would accelerate the process of bringing important new therapies to market for patients.”
Dr. Kakkis continued, “Our all-cash offer provides meaningfully greater value and certainty to Dimension shareholders compared to the proposed all-stock acquisition by REGENXBIO. We believe Ultragenyx and its product candidates are highly complementary to Dimension’s and present no competitive overlap, giving us confidence that we could combine our two companies quickly and seamlessly.”
Below is the text of a letter that has been sent concurrent with this announcement to Dr. Annalisa Jenkins, President and Chief Executive Officer of Dimension:
September 18, 2017
Dimension Therapeutics, Inc.
840 Memorial Drive, 4th Floor
Cambridge, Massachusetts 02139
Attention: Dr. Annalisa Jenkins, Chief Executive Officer
Dear Annalisa:
We at Ultragenyx Pharmaceutical Inc. have followed the progress of Dimension Therapeutics, Inc. (“Dimension” or the “Company”) with great interest and are impressed by the advances you have made with your product candidates. The Dimension team has built an innovative and valuable business with a strong portfolio of assets and an advanced manufacturing platform that are poised to make significant advances in the treatment of patients with rare genetic diseases.
We share your vision to expand treatment options and bring transformational therapies to patients in areas with significant unmet need and we have a strong track record of advancing rare disease focused product candidates through the clinical and regulatory processes, including submission of marketing applications for two products in both the US and EU during this last year. As we head to commercialization for two products in 2018, we are best prepared to support the advancement and eventual filing for any products successfully developed from your portfolio. As experts in the metabolic disease space, our scientific, clinical, regulatory, and commercial skills would be complementary with your technology, programs and people. As such, we believe that a combination of our respective organizations will maximize the impact we can have for patients by bringing much-needed new therapies to market.
Our vision would be to leverage our significant clinical and regulatory expertise, as well as our growing rare metabolic disease commercial infrastructure, to advance Dimension’s rare disease focused gene therapies through the clinic and to maximize their reach with patients. Furthermore, we recognize and value the deep expertise and knowledge that Dimension’s employees have developed in AAV gene therapy and manufacturing, and we believe that their collective talents would be an impressive addition to Ultragenyx. We would envision maintaining a gene therapy development unit and manufacturing development team at Dimension’s facilities in Massachusetts to continue to retain your strong team’s significant institutional knowledge and efficiently progress your critical manufacturing there.
We are pleased to submit this non-binding proposal (“Proposal”) to acquire Dimension for a value, consideration and structure that we believe represents a compelling opportunity for Dimension shareholders. In addition, this offer provides meaningfully greater value and certainty than the agreement recently reached with REGENXBIO Inc. (“REGENXBIO”).
- Price, Consideration and Structure. We are prepared to acquire 100% of the outstanding common stock of Dimension for $5.50 per share (“Purchase Price”) in cash to be effectuated via a tender offer.This represents a premium of 358% to Dimension’s unaffected share price as of August 24, 2017, and a 24% premium to the implied offer value of the REGENXBIO transaction, based upon REGENXBIO’s closing price on September 15, 2017. This also represents a 48% premium to the implied offer value of the REGENXBIO transaction, based upon REGENXBIO’s 20 trading day volume weighted average price of $23.68 per share (per Bloomberg) as of September 15, 2017.
The $5.50 per share offer implies an equity purchase price of approximately $138 million in cash at close.
- Financing. We have sufficient cash resources to fund this transaction with cash currently on our balance sheet, and our offer is not subject to any financing condition.
- Due Diligence and Timing. This Proposal is based on our current knowledge of Dimension from the Company’s public filings and disclosures and is subject to confirmatory due diligence that we expect can be addressed quickly and efficiently if we are afforded access to a customary data room and appropriate Company personnel. We are prepared to move expeditiously to complete diligence with your assistance in a two-week period.
- Merger Agreement. Concurrently with our due diligence review, we would anticipate working with you to negotiate a definitive agreement. We are prepared to accept identical or more favorable terms for Dimension than your existing merger agreement with REGENXBIO, as you will see in the enclosed version of our draft merger agreement showing changes from the existing agreement with REGENXBIO. Our draft merger agreement in fact offers greater speed and deal certainty than the pending transaction with REGENXBIO, in particular:
- We are proposing an all-cash transaction structured as a tender offer, which would expire as soon as 25 business days following entry into the merger agreement. We propose to close the deal on the business day after expiration of the tender offer. In contrast, the existing merger agreement with REGENXBIO is conditioned on SEC clearance of a registration statement by REGENXBIO and a Company shareholder approval.
- We are willing to agree to an absolute “hell or high water” covenant to demonstrate our comfort and commitment in securing antitrust clearance for our acquisition of the Company. We believe Ultragenyx and its product candidates present no competitive overlap with the Company. In contrast, the existing merger agreement with REGENXBIO specifically provides that REGENXBIO will not be obligated to sell, dispose of or hold separate any assets of REGENXBIO or the Company in order to secure antitrust clearance.
- We are proposing to bear any risk related to clinical data coming out of the Company’s ongoing trials before closing of the transaction, as reflected in our changes to the definition of “Company Material Adverse Effect” in our draft merger agreement.
The Ultragenyx board of directors has approved this Proposal. Subject to completing our due diligence and negotiating a mutually satisfactory definitive agreement to be executed upon your termination of the existing merger agreement with REGENXBIO, we will require final approval by our board of directors. No additional Ultragenyx internal approvals or shareholder approvals would be needed to consummate the transaction. Based on our current knowledge of Dimension from publicly available information, we do not believe that any other material approvals would be required for us to consummate the transaction, other than the expiration or early termination of the waiting period under the Hart-Scott-Rodino Act and, if applicable, any approvals under foreign antitrust laws.
This Proposal is not legally binding upon Ultragenyx, and no binding obligation shall arise for either party unless and until a definitive agreement has been duly executed between Ultragenyx and Dimension.
We believe that our Proposal constitutes a Superior Proposal (as defined in your existing merger agreement with REGENXBIO) and that your board of directors can and should, consistent with its fiduciary duties, make a determination to that effect. We urge you and your Board of Directors promptly to take those actions necessary under the existing merger agreement with REGENXBIO in order to afford us the opportunity to complete our due diligence and commence discussions with management and your advisors. The form of Acceptable Confidentiality Agreement (as defined in your existing merger agreement with REGENXBIO) can be provided to our General Counsel, Karah Parschauer, by email at KParschauer@ultragenyx.com. We have engaged Centerview Partners LLC and Skadden, Arps, Slate, Meagher & Flom LLP as financial and legal advisors, respectively, to assist us in this transaction and are prepared to move quickly to complete our diligence and negotiate a definitive agreement.
We have publicly disclosed this letter, simultaneously with sending it to you. We look forward to hearing from you and please do not hesitate to contact me or our advisors with any questions.
Sincerely,
Dr. Emil D. Kakkis
Chief Executive Officer and President
Ultragenyx Pharmaceutical Inc.
Advisors
Centerview Partners LLC is serving as financial advisor to Ultragenyx, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as Ultragenyx’s legal advisor.
Conference Call
Ultragenyx will host a conference call today at 10:30 a.m. Eastern (7:30 a.m. Pacific). The live and replayed webcast of the call will be available through the company’s website at www.ultragenyx.com. To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (international) and enter the passcode 86650959. The replay of the call will be available for one year.
About Ultragenyx Pharmaceutical Inc.
Ultragenyx is a biopharmaceutical company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. The Company has rapidly built and advanced a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The Company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the Company’s website at www.ultragenyx.com.
Forward Looking Statements / Additional Information
Except for the historical information contained herein, the matters set forth in this communication, including statements of anticipated changes in the business environment in which Ultragenyx operates and in Ultragenyx’s future prospects or results, statements relating to Ultragenyx’s intentions, plans, hopes, beliefs, anticipations, expectations or predictions of its future, or statements relating to Ultragenyx’s offer and the potential benefits of a transaction with Dimension Therapeutics, Inc. (“Dimension”), are forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, such as the regulatory approval process, the timing of our regulatory filings and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations and the availability or commercial potential of our drug candidates. There is no assurance that the potential transaction will be consummated, and it is important to note that actual results could differ materially from those projected in such forward-looking statements. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on July 28, 2017, and its subsequent periodic reports filed with the SEC.
The tender offer referred to in this communication (an “Offer”) has not yet commenced. Accordingly, this communication is for informational purposes only and does not constitute an offer to purchase or a solicitation of an offer to sell any shares of Dimension common stock or any other securities. On the commencement date of any Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related materials, will be filed with the SEC by Ultragenyx and a wholly owned subsidiary. The offer to purchase shares of Dimension common stock will only be made pursuant to the offer to purchase, letter of transmittal and related materials filed with the SEC by Ultragenyx as part of its Schedule TO. Investors and security holders are urged to read both the tender offer statement and any solicitation/recommendation statement filed by Dimension regarding the Offer, as they may be amended from time to time, when they become available, because they will contain important information about the Offer, including its terms and conditions, and should be read carefully before any decision is made with respect to the Offer. Investors and security holders may obtain free copies of these statements (when available) and other materials filed with the SEC at the website maintained by the SEC at www.sec.gov, or by directing requests for such materials to the information agent for the Offer, which will be named in the tender offer statement.
Contacts
Investor Relations:
Ryan Martins
415-483-8257
Media Relations:
Joele Frank, Wilkinson Brimmer Katcher
Tim Lynch / Trevor Gibbons / Leigh Parrish
212-355-4449
SAN JOSE, CA–(September 18, 2017) – ITUS Corporation (NASDAQ: ITUS), today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent 9,739,783, to inventors Dr. Amit Kumar, Chief Executive Officer, and John Roop, VP of Engineering, of ITUS Corporation. ITUS’s early cancer detection technology is being developed by its wholly owned subsidiary, Anixa Diagnostics Corporation.
Dr. Kumar stated, “This is the first patent to issue of several patents that we expect to issue garnering protection of our cancer detection technology. The claims of this patent were allowed in May of 2017, and now we have received the official issuance notification and patent number. We currently have one other key patent application pending at the USPTO and expect to file for additional patent protection as our research and development continues.”
Dr. Kumar added, “ITUS’s unique liquid biopsy approach utilizes flow cytometry to measure the presence and characteristics of certain circulating immune cells. We then use Artificial Intelligence to analyze the data in a manner that enables us to identify tumor bearing patients. The test utilizes a simple blood draw from the patient. To date, our technology has demonstrated its ability to identify 15 cancer types including breast, prostate, colon, lung, pancreatic, and others. Because we are measuring subtle changes in circulating immune cells, it is not surprising that our technology appears to work on multiple cancer types, and we expect the technology will eventually be able to identify all cancer types. ITUS is performing additional tests including the evaluation of benign conditions which may exist in patients but are not malignant tumors.”
ITUS Corporation
ITUS, a cancer-focused biotechnology company, through its wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the Cchek™ platform, a series of non-invasive blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. ITUS also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Drug Candidate for Alzheimer’s Shows Promise by Inhibiting Aβ Aggregation without Neuron Damage
BETHESDA, Md., Sept. 18, 2017 — India Globalization Capital, Inc. (NYSE-MKT:IGC) provides an update on compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s disease model, showing that at varying concentrations of THC, the aggregation of Aβ protein decreases by as much as 40%.
“As Alzheimer’s progresses, synaptic dysfunction and the death of neurons lead to memory loss. These study results, when combined with the earlier reported data that shows IGC-AD1 reduces Aβ40 and Aβ42 production by as much as 50%, and 40%, without any toxicity, represent a highly significant novel breakthrough that could potentially bring much needed relief from this devastating disease,” states IGC’s CEO Ram Mukunda.
It is believed that a primary cause of AD is the buildup of senile plaque composed of amyloid beta peptides (Aβ plaque) in the cerebral cortex and hippocampus. The key pathogenic event in the onset of AD is Aβ peptide monomers aggregating into prefibrillar oligomers (dimers, trimmers, tetramers and oligomers). As AD progresses Aβ oligomers directly cause synaptic dysfunction and the death of neurons, consequently leading to a loss of memory.
“A drug that (i) decreases production of Aβ, (ii) inhibits Aβ aggregation into oligomers, (iii) is not toxic to neurons, and (iv) does not cause inebriation (high), could be a powerful weapon against AD and the prevention of AD. In vitro, our product demonstrates these critical factors and we are pursuing a patent filing that protects this therapy.
AD starts 20 to 25 years before symptoms like memory loss are manifested. Statistically, there is an almost 50% chance of individuals over 80 years contracting AD and over 65% of AD patients are women. Based on the findings of these studies, our plan is two-fold. First, we will position IGC-AD1 as a drug that can be used both as a treatment for AD, and as a prophylactic treatment for the prevention of AD. Second, we will commercialize a supplement version to be sold as a medical dispensary product. This will allow our team to work through the FDA approval process for IGC-AD1, while securing market share in the medical dispensary segment. This is a very exciting time for all our shareholders and I look forward to providing updates on our progress in combatting this global disease,” concludes IGC’s CEO Ram Mukunda.
The summary in vitro data indicates that between 2.5nM and 25nM THC concentration, the formation of Aβ1-42 trimers and tetramers in N2aAPP cells are reduced by up to 40% as determined by both fluorescence and immuno blotting assays. Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.
About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia. It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion. AD currently affects more than 5.3 million Americans and over 65% of AD patients are women. Over the next 20 years, the number of those afflicted with the disease is expected to double. The forecast is staggering, considering that to date, no effective cure has been found.
About IGC
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.
For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/
Forward-looking Statements
Please see forward looking statements as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.
Contact:
Claudia Grimaldi
301-983-0998
SAN GABRIEL, California, September 18, 2017 –
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that its wholly owned foreign enterprise, CBD Biotechnology Co. Ltd., has completed the filing process with the China Food & Drug Administration (“CFDA”) for its first line of non-industrial hemp-infused skin care products. The Company expects to launch the CBD Magic Hemp Series skin care line in October positioning CBD Biotechnology as a leader in what it believes to be an untapped segment of China’s skin care industry.
The CBD Magic Hemp Series launch will include three (3) products:
• The CBDBIO TECH Brightening and Refreshing Moisturizer – intended to balance the skin’s moisture, while forming a protective, moisturizing layer;
• The CBDBIO TECH Perfecting Shield Primer – intended to even skin tone, while covering fine lines and minimizing the look of pores; and
• The CBDBIO TECH Peptide Collagen Solution – intended to moisturize and firm the skin, while smoothing fine lines, and reducing signs of aging.
The CBD Magic Hemp Series line is different from other skin care lines currently available in China because the products are infused with hemp extract, otherwise known as cannabidiol or CBD. CBD, a powerful antioxidant and anti-inflammatory agent, has been widely used in skin care products in western countries for some time. Although a catalogue provided by the CFDA entitled “Catalogue of Cosmetics Raw Materials in Use (2015)” includes Cannabis Sativa Leaf Extract, CBD Biotechnology is not aware of any other Chinese skin care manufacturers that have entered this emerging market, setting the stage for CBD Biotechnology to proudly take the lead with its innovative product line.
“I am very pleased to announce the upcoming launch of CBD Biotechnology’s hemp-infused skin care line, the CBD Magic Hemp Series,” says Summer Yun, CEO of CBD Biotechnology Co., Ltd. “We have not only completed the filing process with CFDA, but we have also contracted with a large processing factory in Shanghai, China, with over 14-years of experience in cosmetics production.”
“China has one of the world’s largest consumer markets for skin care products. Retail sales of skincare products and make-up products in China reached 169.1 billion yuan and 28.3 billionyuan respectively in 2016, with year-over-year growth of 5% and 12% respectively. Skin care is expected to reach 223.3 billion yuan in 2021 with growth driven by rising awareness of skin health and consumption upgrading Chinese consumers. As one of the first hemp infused skin care brands in China, we are confident that CBD Biotechnology will lead Chinese market, with potential for global expansion.
About ChineseInvestors.com (OTCQB: CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online sales and direct sales of non-industrial hemp-based products and other health related products.
For more information visit ChineseInvestors.com
Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom
Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh
Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;
https://www.facebook.com/Chineseinvestors.com.english
Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1.214.636.2548
Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com
WOBURN, Mass., Sept. 15, 2017 — Yield10 Bioscience, Inc. (NASDAQ:YTEN) announced today that it will be a subawardee on a new U.S. Department of Energy (DOE) Grant to conduct research aimed at boosting oilseed yield in Camelina, a promising biofuel crop. The 5-year, $10 million grant, which was recently recommended for funding, will be led by Michigan State University (MSU) and will involve a multidisciplinary team of researchers from MSU, North Carolina State University and Yield10 Bioscience as the industry partner. Yield10 Bioscience expects to receive approximately $3 million under the grant for research activities that are expected to begin in the fourth quarter of 2017.
Under the grant, the team of scientists will generate metabolic and gene expression models to predict in detail the gene combinations and pathways used by the Camelina plant to convert sucrose, the primary product of photosynthesis, into oil. Yield10’s work under the award will involve the use of its T3 gene discovery platform to identify novel global regulatory genes that are designed to increase oil and seed yield. The identification of new genetic targets to boost yield in Camelina may allow for the broader cultivation of Camelina for commercial use, and may have further application to other oilseed crops, such as canola and soybean.
“Current seed-oil based bioproduction relies heavily on food crop species, such as soybean, sunflower and canola oil,” said Danny Schnell, Ph.D., MSU plant biologist and grant coordinator. “Camelina doesn’t require as much water as these crops, it grows more quickly, and it has a higher resistance to pest and disease. By focusing on some key genetic control points, we’re hoping to unlock the relationship between carbon capture and increasing oil and seed production.”
“We look forward to working with Dr. Schnell and the other members of the multidisciplinary team that he has assembled to delve more deeply into the complex carbon metabolic pathways in Camelina responsible for converting the primary product of photosynthesis into seeds. We believe that this work will enable us to identify additional genes and gene combinations (or traits) to significantly improve yield in Camelina and a number of important food crops,” commented Kristi Snell, Ph.D., Chief Science Officer of Yield10 Bioscience. “We expect our T3 gene discovery platform to contribute to this effort by identifying genes that serve as control points or master switches for increasing oil and/or seed yield.”
The Schnell Lab discovered the novel algal gene which Yield10 is developing as the C3003 trait in major food crops including canola, soybean and rice. Further work to continue to unravel the molecular mechanism by which C3003 increases seed yield in Camelina is a key part of this new grant. This work in addition to the broader research program in the grant may enable further optimization of the impact of the C3003 trait on seed yield. Receiving this funding from DOE following an extensive scientific peer review process underlines the importance not only of the discovery that led to the C3003 trait but the importance of developing multi-gene approaches to significantly increase crop yield. Under the grant, work on C3003, as well as other seed yield and oil enhancing traits, will be integrated with Yield10’s T3 Platform activities to maximize oil and/or seed yield.
Camelina is an oilseed crop in limited cultivation in North America and Europe. The crop has received recent attention as an industrial oilseed for the production of biofuels, novel industrial lipids, and oleochemicals. Research suggests that efforts to improve seed yield, oil content and fatty acid composition may expand the commercial adoption and cultivation of Camelina. In the near term Yield10 is using work in Camelina to accelerate field testing of novel yield traits for major food crops including canola, soybean and rice.
Background on Yield10’s T3 Platform
Yield10 has previously used the T3 Platform, a novel gene discovery approach, to identify novel global regulatory genes that significantly impact photosynthesis and biomass yield in switchgrass. More recently, Yield10 reported that early work in rice with one of its global regulatory genes produced rice plants with more tillers, as well as an increased aboveground biomass. Results of this work are ongoing to determine the impact on seed yield. In the new DOE subaward, Yield10 will use the T3 Platform for gene discovery in Camelina.
About Yield10 Bioscience
Yield10 Bioscience, Inc. is focused on developing new technologies to achieve step-change improvements in crop yield to enhance global food security. Yield10 has an extensive track record of innovation based around optimizing the flow of carbon in living systems. Yield10 is leveraging its technology platforms and unique knowledge base to design precise alterations to gene activity and the flow of carbon in plants to produce higher yields with lower inputs of land, water or fertilizer. Yield10 is advancing several yield traits it has developed in crops such as Camelina, canola, soybean and corn. Yield10 is headquartered in Woburn, MA and has an Oilseeds center of excellence in Saskatoon, Canada.
For more information about the company, please visit www.yield10bio.com.
(YTEN-G)
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding the Company’s ability to achieve improvements in oil content and oil yield in oilseed crops, the work to be conducted pursuant to the DOE grant described in this press release, the potential for identification of new genetic targets to boost yield in Camelina and its effect on the cultivation of Camelina for commercial use and other oilseed crops, such as canola and soybean, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including the risks and uncertainties detailed in Yield10 Bioscience’s filings with the Securities and Exchange Commission. Yield10 assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
Contacts:
Yield10 Bioscience:
Lynne H. Brum, (617) 682-4693, LBrum@yield10bio.com
Investor Relations Contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com
SANTA CLARA, Calif., Sept. 15, 2017 — Echelon Corporation (NASDAQ:ELON), the original Industrial Internet of Things (IIoT) company, announced that Andy Lovit has been granted an inducement grant under NASDAQ listing rules. Mr. Lovit joined the company as Senior Vice President of Worldwide Sales on September 11, 2017.
Equity Grants
In accordance with NASDAQ Stock Market Rules, Echelon Corporation today reported equity inducement awards granted to Andy Lovit by the Company. As an inducement to Mr. Lovit entering into employment with the Company, and in accordance with NASDAQ Listing Rule 5635(c)(4), on September 12, 2017, the Compensation Committee of the Board of Directors of the Company approved an award of 60,000 restricted stock units (the “RSU Award”) with a grant date to be effective as of October 10, 2017 to Mr. Lovit. The RSU Award was made outside of the Company’s current equity plan, but will be subject to terms and conditions generally consistent with those in the Company’s 2016 Inducement Equity Incentive Plan. The RSU Award will vest as to one-half of the shares on October 10, 2018 and one-half on the annual anniversary thereafter, subject to Mr. Lovit’s continued service through each applicable vesting date. In the event Mr. Lovit’s employment is involuntarily terminated due to and within twelve months of a Change in Control Merger of the Company, all of the unvested shares subject to the RSU Award will be accelerated and shall vest immediately.
About Echelon Corporation
For 25 years Echelon (NASDAQ:ELON) has pioneered the development of open-standard networking platforms for connecting, monitoring and controlling devices in commercial and industrial applications. With more than 110 million devices installed worldwide, Echelon’s proven, scalable solutions host a range of applications enabling customers to reduce energy and operational costs, improve safety and comfort, and create efficiencies through optimizing physical systems. Echelon focuses today on two IoT (Internet of Things) market areas: creating smart cities and smart enterprises through connected outdoor lighting systems, and enabling device makers to bring connected products to market faster via a range of IoT-optimized embedded systems. More information about Echelon can be found at www.echelon.com.
Investor Relations Contact:
Annie Leschin
StreetSmart Investor Relations
(415) 775-1788
annie@streetsmartir.com
KVM and AV/IT System Management Platform Now Supports DKM Digital KVM Matrix
PITTSBURGH, Sept. 15, 2017 — Black Box, a leading technology solutions provider of high-performance KVM, switching solutions, and professional AV signal distribution and extension, today announced enhancements to Boxilla, an enterprise-level KVM and AV/IT management system. A core new feature of Boxilla 1.1 is the ability for DKM users to seamlessly access both physical and virtual servers across an IP network. Boxilla is an integral part of Black Box’s robust services portfolio of end-to-end solutions for mission-critical control room infrastructure, smart office configurations and digital retail technology.
Originally launched in January 2017, Boxilla, which is designed to support other Black Box products, offers a comprehensive and centralized command center that manages and deploys high-performance KVM. The platform was first integrated with InvisaPC, Black Box’s IP-based KVM system, to give users a virtualization solution that can scale to hundreds of users and unlimited devices.
“After a successful integration with InvisaPC, the next phase of Boxilla allows DKM systems to grow beyond private networks by connecting across IP networks to access physical or virtual servers in the same way the user accesses servers directly connected to DKM today,” said John Hickey, senior director of KVM and ProAV at Black Box. “Users will now be able to reach any server on their network in an instant, which will greatly improve their operations across the enterprise.”
Future enhancements to Boxilla will enable it to support other premier Black Box products, including DCX, MediaCento, Coalesce and ControlBridge.
Built for everything from conference rooms to 911 call centers, Boxilla streamlines and automates communication between KVM devices so that businesses can improve efficiency and performance. Some of its key elements include:
- Centralized system management: Features a real-time, user-friendly dashboard that manages authentication, access control, accountability, troubleshooting and device monitoring.
- Improved security: Detects potential breaches and quickly identifies refused or unauthorized login attempts.
- Instant performance updates: Offers a snapshot of the entire KVM system so users can immediately assess performance, including bandwidth usage and device status.
Boxilla won its third consecutive Best of Show award in 2017 at the June InfoComm conference in Orlando, Fla. It was also recognized at ISE in February and at NAB in April.
“This is just the beginning of Boxilla’s capabilities,” said Hickey. “We’re excited to see it continue to redefine KVM and AV/IT system management across the industry.”
About Black Box
Black Box (NASDAQ:BBOX) is the trusted digital partner. With more than 40 years of experience connecting people and devices, we are dedicated to helping clients embrace the intelligent edge and enable their digital transformation. Our award winning products and service connect you with your customers, your team, and the world. Every day, our customers trust us to design, deploy, and manage their digital needs including retail IoT solutions, healthcare, and mission-critical control room infrastructures across commercial enterprises and governmental organizations. With a global presence of more than 3,400 team members, we make digital transformation possible whether at one location or hundreds.
To learn more, visit the Black Box website at http://www.blackbox.com or follow us on Twitter @blackbox_ns.
Black Box® and the Double Diamond logo are registered trademarks of BB Technologies, Inc.
For Media Inquiries:
Black Box Corporation
Melissa Ott
Marketing Manager
Phone: +1(724) 873-7033
Email: media@blackbox.com
For Investor Relations Inquiries:
Black Box Corporation
David J. Russo
Senior Vice President and Chief Financial Officer
Phone: +1(724) 873-6788
Email: investors@blackbox.com
TORONTO, Sept. 15, 2017 – The Stars Group Inc. (Nasdaq: TSG; TSX: TSGI) today updated its previously announced guidance ranges for the full year 2017 and announced the prepayment of an additional $75 million of second lien debt. All dollar ($) amounts are in U.S. dollars.
“It’s been a great three months since joining The Stars Group and the team is energized,” said Brian Kyle, Chief Financial Officer. “As I am now fully familiar with our forecasting and given our solid trends across all business lines, which reinforce our conviction and commitment to our strategy, it is now appropriate to update our financial guidance. In addition, given our progress to date, we are also able to make another meaningful prepayment of our debt.”
Full Year Guidance
Based on year-to-date performance, The Stars Group has updated its previous full year 2017 guidance and now expects:
- Revenues of between $1,285 and $1,315 million, as compared to the prior range of $1,200 and $1,260 million. The revised guidance implies 2017 revenue growth of between 11% and 14% compared to the prior year and includes an expectation that real-money online poker revenue will be slightly higher year-over-year as The Stars Group, among other things, continues to experience a very positive consumer response to Stars Rewards, which was rolled out globally in July;
- Adjusted EBITDA of between $590 and $610 million, as compared to the prior range of $560 and $580 million. The revised guidance implies 2017 Adjusted EBITDA growth of between 13% and 16% compared to prior year;
- Adjusted Net Earnings of between $445 and $469 million, as compared to the prior range of $413 and $437 million and as compared to approximately $367 million in 2016; and
- Adjusted Net Earnings per Diluted Share of between $2.17 and $2.31, as compared to the previous range of between $2.01 and $2.15 and as compared to $1.88 in 2016.
These estimates reflect management’s view of current and future market and business conditions, including assumptions of (i) anticipated negative operating conditions in Poland primarily related to constraints on processing payments in that jurisdiction, the cessation of real-money online poker in Australia on September 11, 2017, and the cessation of real-money online gaming in Colombia on July 17, 2017, (ii) the introduction of Stars Rewards, The Stars Group’s previously disclosed cross-vertical customer loyalty program, (iii) no other material adverse regulatory events and (iv) no material foreign currency exchange rate fluctuations, particularly against the Euro which is the primary depositing currency of The Stars Group’s customers, that could impact customer purchasing power as it relates to The Stars Group’s U.S. dollar denominated product offerings. Such guidance is also now based on a Euro to U.S. dollar exchange rate of 1.18 to 1.00 and all other currencies at their average exchange rate for the month of August, in each case for the remainder of 2017, unaudited expected results and certain accounting assumptions.
Debt Prepayment
Next week, The Stars Group will prepay without penalty an additional $75 million under its second lien term loan using cash on the balance sheet and cash flow from operations. Following this prepayment, The Stars Group will have repaid $115 million of its second lien debt thus far in 2017, resulting in a total reduction in annual interest expense of approximately $9.5 million, and reducing the principal balance of the second lien term loan to $95 million.
About The Stars Group
The Stars Group is a leading provider of technology-based products and services in the global gaming and interactive entertainment industries. Through its Stars Interactive division, The Stars Group ultimately owns gaming and related consumer businesses and brands, including PokerStars, PokerStars Casino, BetStars, Full Tilt, StarsDraft, and the PokerStars Championship, PokerStars Festival and PokerStars Megastack live poker tour brands (incorporating aspects of the European Poker Tour, PokerStars Caribbean Adventure, Latin American Poker Tour and the Asia Pacific Poker Tour). These brands together have more than 113 million registered customers globally and collectively form the largest poker business in the world, comprising online poker games and tournaments, sponsored live poker competitions, marketing arrangements for branded poker rooms in popular casinos in major cities around the world, and poker programming and content created for television and online audiences. The Stars Group, through certain of these brands, also offers non-poker gaming products, including casino, sportsbook and daily fantasy sports. The Stars Group, through certain of its subsidiaries, is licensed or approved to offer, or offers under third party licenses or approvals, its products and services in various jurisdictions throughout the world, including in Europe, both within and outside of the European Union, the Americas and elsewhere. In particular, PokerStars is the world’s most licensed online gaming brand, holding licenses or related operating approvals in 17 jurisdictions.
Cautionary Note Regarding Forward Looking Statements
This news release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable securities laws, including, without limitation, certain financial and operational expectations and projections, such as full year 2017 financial guidance, and certain future operational and growth plans and strategies. Forward-looking statements and information can, but may not always, be identified by the use of words such as “anticipate”, “plan”, “continue”, “estimate”, “expect”, “may”, “will”, “project”, “predict”, “potential”, “targeting”, “intend”, “could”, “might”, “would”, “should”, “believe”, “objective”, “ongoing”, “imply” and similar references to future periods or the negatives of these words and expressions. These statements and information, other than statements of historical fact, are based on management’s current expectations and are subject to a number of risks, uncertainties, and assumptions, including market and economic conditions, business prospects or opportunities, future plans and strategies, projections, technological developments, anticipated events and trends and regulatory changes that affect us, our customers and our industries. Although The Stars Group and management believe the expectations reflected in such forward-looking statements and information are reasonable and are based on reasonable assumptions and estimates, there can be no assurance that these assumptions or estimates are accurate or that any of these expectations will prove accurate. Forward-looking statements and information are inherently subject to significant business, regulatory, economic and competitive risks, uncertainties and contingencies that could cause actual events to differ materially from those expressed or implied in such statements. Specific risks and uncertainties include, but are not limited to: the heavily regulated industry in which The Stars Group carries on business; interactive entertainment and online and mobile gaming generally; current and future laws or regulations and new interpretations of existing laws or regulations with respect to online and mobile gaming; potential changes to the gaming regulatory framework; legal and regulatory requirements; ability to obtain, maintain and comply with all applicable and required licenses, permits and certifications to distribute and market its products and services, including difficulties or delays in the same; significant barriers to entry; competition and the competitive environment within The Stars Group’s addressable markets and industries; impact of inability to complete future acquisitions or to integrate businesses successfully; ability to develop and enhance existing products and services and new commercially viable products and services; ability to mitigate foreign exchange and currency risks; ability to mitigate tax risks and adverse tax consequences, including, without limitation, the imposition of new or additional taxes, such as value-added and point of consumption taxes, and gaming duties; risks of foreign operations generally; protection of proprietary technology and intellectual property rights; ability to recruit and retain management and other qualified personnel, including key technical, sales and marketing personnel; defects in The Stars Group’s products or services; losses due to fraudulent activities; management of growth; contract awards; potential financial opportunities in addressable markets and with respect to individual contracts; ability of technology infrastructure to meet applicable demand; systems, networks, telecommunications or service disruptions or failures or cyber-attacks; regulations and laws that may be adopted with respect to the Internet and electronic commerce and that may otherwise impact The Stars Group in the jurisdictions where it is currently doing business or intends to do business; ability to obtain additional financing on reasonable terms or at all; refinancing risks; customer and operator preferences and changes in the economy; dependency on customers’ acceptance of its products and services; consolidation within the gaming industry; litigation costs and outcomes; expansion within existing and into new markets; relationships with vendors and distributors; and natural events. Other applicable risks and uncertainties include, but are not limited to, those identified in The Stars Group’s Annual Information Form for the year ended December 31, 2016, including under the heading “Risk Factors and Uncertainties”, and in The Stars Group’s management’s discussion and analysis for the three and six months ended June 30, 2017 (“Q2 2017 MD&A”), including under the headings “Risk Factors and Uncertainties”, “Limitations of Key Metrics and Other Data” and “Key Metrics”, each available on SEDAR at www.sedar.com, EDGAR at www.sec.gov and The Stars Group’s website at www.starsgroup.com, and in other filings that The Stars Group has made and may make with applicable securities authorities in the future. Investors are cautioned not to put undue reliance on forward-looking statements or information. Any forward-looking statement or information speaks only as of the date hereof, and The Stars Group undertakes no obligation to correct or update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.
Non-IFRS and Non-U.S. GAAP Measures
This news release references non-IFRS and non-U.S. GAAP financial measures, including Adjusted EBITDA, Adjusted Net Earnings and Adjusted Net Earnings per Diluted Share. The Stars Group believes these non-IFRS and non-U.S. GAAP financial measures will provide investors with useful supplemental information about the financial performance of its business, enable comparison of financial results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating its business. Although management believes these financial measures are important in evaluating The Stars Group, they are not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with IFRS or U.S. GAAP. They are not recognized measures under IFRS or U.S. GAAP and do not have standardized meanings prescribed by IFRS or U.S. GAAP. These measures may be different from non-IFRS and non-U.S. GAAP financial measures used by other companies, limiting its usefulness for comparison purposes. Moreover, presentation of certain of these measures is provided for year-over-year comparison purposes, and investors should be cautioned that the effect of the adjustments thereto provided herein have an actual effect on The Stars Group’s operating results. The Stars Group uses the following non-IFRS and non-U.S. GAAP measures in this release:
Adjusted EBITDA means net earnings (loss) before interest and financing costs, income taxes, depreciation and amortization, stock-based compensation, restructuring and certain other items.
Adjusted Net Earnings means net earnings (loss) before interest accretion, amortization of intangible assets resulting from purchase price allocation following acquisitions, deferred income taxes, stock-based compensation, restructuring, foreign exchange, and certain other items. Adjusted Net Earnings per Diluted Share means Adjusted Net Earnings divided by Diluted Shares. Diluted Shares means the weighted average number of common shares on a fully diluted basis, including options, other equity-based awards, warrants and convertible preferred shares. The effects of anti-dilutive potential common shares are ignored in calculating Diluted Shares. See note 5 to The Stars Group’s unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2017. For the purposes of the full year 2017 financial guidance provided in this release, Diluted Shares equals between 203,000,000 and 205,000,000 for the high and low ends of the Adjusted Net Earnings per Diluted Share range, respectively.
The Stars Group has not provided a reconciliation of the non-IFRS measures to the nearest IFRS measures included in its full year 2017 financial guidance provided in this release, including Adjusted EBITDA, Adjusted Net Earnings and Adjusted Net Earnings per Diluted Share, because certain reconciling items necessary to accurately project such IFRS measures, particularly net earnings (loss), cannot be reasonably projected due to a number of factors, including variability from potential foreign exchange fluctuations impacting financial expenses, and the nature of other non-recurring or one-time costs (which are excluded from non-IFRS measures but included in net earnings (loss)), as well as the typical variability arising from the audit of annual financial statements, including, without limitation, certain income tax provision accounting, and related accounting matters.
For additional information on The Stars Group’s non-IFRS measures, see the Q2 2017 MD&A, including under the headings “Management’s Discussion and Analysis” and “Selected Financial Information—Other Financial Information”.
HINGHAM, Mass., Sept. 15, 2017 — Microbot Medical Inc. (Nasdaq:MBOT), a medical device company specializing in the design and development of transformational micro-robotic medical technologies, today announced that Intellectual Property India granted patent No. 286765, covering the Company’s TipCAT™ technology platform.
“We continue to strengthen and expand our IP portfolio,” commented Harel Gadot, Chief Executive Officer, President, and Chairman. “As a pioneer in micro-robotic surgery, this will allow us to add value to our assets as it is expected to enhance our ability to access global markets and create additional competitive advantages and barriers to entry. India is a large and emerging market and we believe having a strong IP presence in this market further builds shareholder value. In addition to India, the TipCAT™ technology platform patent has already been granted in the largest markets such as the U.S., China, Europe and several other markets, which we believe continues to show the strength of our IP assets. With this specific IP, our objective is to leverage the TipCAT platform to develop multiple products that address serious unmet needs in multiple medical applications.”
Globally, the Company now has 23 patents which are already issued and an additional 13 patent applications pending worldwide. The Company’s patents cover its ViRob™ and TipCAT™ technology platforms.
About Microbot Medical, Inc.
Microbot, which was founded in 2010 and commenced operations in 2011, became a NASDAQ listed company on November 28, 2016. The Company specializes in transformational micro-robotic medical technologies leveraging the natural and artificial lumens within the human body. Microbot’s current platforms, ViRob™ and TipCAT™, are comprised of two highly advanced micro-robotic technologies, from which the Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS™, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com.
The ViRob™ technology is a revolutionary autonomous crawling micro-robot which can be controlled remotely or within the body. Its miniature dimensions allow it to navigate and crawl in different spaces within the human body, including blood vessels, the digestive tract and the respiratory system. Its unique structure gives it the ability to move in tight spaces and curved passages as well as the ability to remain within the human body for prolonged time. To learn more about ViRob™ please visit http://www.microbotmedical.com/technology/virob/.
TipCAT™ is a transformational self-propelled, flexible, and semi-disposable endoscope providing see & treat capabilities within tubular lumens in the human body such as the colon, blood vessels, and the urinary tract. Its locomotion mechanism is perfectly suitable to navigate and crawl through natural & artificial tubular lumens, applying the minimal necessary pressure to achieve the adequate friction required for gentle, fast, and safe advancement within the human body. To learn more about TipCAT™ visit http://www.microbotmedical.com/technology/tipcat/.
Safe Harbor
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Microbot Medical Inc. particularly those mentioned in the cautionary statements found in Microbot Medical Inc.’s filings with the Securities and Exchange Commission. Microbot Medical disclaims any intent or obligation to update these forward-looking statements.
Investor Contacts:
Analysts and Institutional Investors
Michael Polyviou
EVC Group
mpolyviou@evcgroup.com
646-445-4800
Individual Investors
Jeremy Roe
Integra Consulting Group llc
jeremy@integracg.net
(925) 262-8305
NEW YORK, NY–(Sep 15, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring ChineseInvestors.com, Inc. (OTCQB: CIIX), a client of NNW recognizing unprecedented opportunities in the U.S. cannabis industry and laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.
The publication is titled, “Innovative Cannabis Players Offer Promising Entry into Explosive Market.” It highlights multiple companies racing to stake their claim in the cannabis industry.
“CIIX is focused on the research, development and distribution of legalized cannabidiol (CBD) to the global Chinese-speaking community. Already one of the fastest growing segments in the U.S. hemp and legal marijuana industry, application of CBD is also gaining traction in China. CIIX operates an online store in the free trade zone of Shanghai, China, where CBD sales are legal, though marijuana use is not.
“In December 2016, CIIX entered into a wholesale agreement with a well-known CBD health brand and formally launched a website for its subsidiary, ChineseCBDoil.com, which went live in January 2017. This launch marked the introduction of the world’s first Chinese language online store for CBD health products. At that same time, CIIX debuted the first Chinese language Yelp-style social media app where users can discuss and review cannabis services and products, as well as find locations of dispensaries.
“The company has built a widespread user base of more than 100,000 individuals, and it continues its focus on investing in both the R&D and distribution of CBD products. Corporate objectives include plans to further its study into the effectiveness of CBD for medicinal purposes in an effort to become the first company in China to employ CBD oil as a means of mitigating the suffering of epilepsy and Alzheimer’s patients.”
About ChineseInvestors.com
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail and online sales of hemp-based products and other health related products. For more information visit www.ChineseInvestors.com.
About NetworkNewsWire
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
For more information please visit https://www.NetworkNewsWire.com
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
MIAMI & NEW YORK
MoviePass experiences benchmark breaking growth after announcing $9.95/month subscription
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) — MoviePass Inc., a company that Helios and Matheson has agreed to buy majority stake in, announced today it has surpassed over 400,000 paying monthly subscribers in the past 30 days and achieved outstanding movie theater attendance. Up from less than 20,000 subscribers on August 14, 2017, the viral subscriber growth is due in part by the innovative and disruptive technology MoviePass and Helios & Matheson offer in combination with massive interest for the new $9.95 per month subscription plan. To test the success of the MoviePass product, 30,000 new MoviePass subscribers were surveyed. We were thrilled to find that 75.3% asserted the only reason they went to the movies was the result of being a MoviePass subscriber. Furthermore, participating theaters have reported back with increased attendance by over 400% from MoviePass subscribers.
MoviePass surpasses over 400,000 paying monthly subscribers in the last 30 days (Photo: Business Wire)
“I think it’s positive for the industry,” said Eric Wold, an analyst at B. Riley & Co. The most visible opposition has come from AMC. “The exhibitors I have spoken with are very happy.”
Additionally, MoviePass projects that it will acquire at least 2.5 million additional paying subscribers during the next twelve months, and expects to retain at least 2.1 million of those additional paying subscribers at the end of that period.
Using the Helios and Matheson Analytics resources, MoviePass Inc. analyzes consumer trends, patterns and activities to engage subscribers with movie related merchandise, advertising, and concessions relevant to their MoviePass experiences. Helios and Matheson believes its technology stack combined with the MoviePass business model will transform the movie going experience and create great value for both companies.
“MoviePass is the ‘all-you-can-eat’ movie theater experience,” said Mitch Lowe, co-founder of Netflix Inc. (NASDAQ: NFLX), former president of RedBox, and current CEO of MoviePass. “Though expensive for the company in the short-term, it’s a significant benefit and more convenient for customers. With MoviePass, there’s no movie ticket prices to think about — going to the movies will become an everyday experience rather than an occasional treat.”
Helios and Matheson’s technology learns individual moviegoer’s tastes and makes recommendations based on recorded preferences for specific genres, actors and even the opinions of friends with similar likings. There currently is no end-to-end consumer analysis from the moment someone sees a movie ad on Facebook to the moment they take their seat at the movie theater. MoviePass is bridging that gap, which should prove to be of tremendous value to production studios.
“This explains our sustainable business model: Helios and Matheson is incorporating advertising models with the MoviePass application using artificial intelligence, algorithms, and machine learning so we can provide studios with more precise data for their advertising efforts. We want to understand the data generated by the movie goers and cater directly to their needs. For example, MoviePass will understand their genre choice films: horror, action-thrillers, drama, comedy, romance, animation, etc. Through testing, we found viewership is up 18% on films we choose to market more heavily in the MoviePass app,” said Ted Farnsworth, Chairman/CEO of Helios and Matheson, about the strategic investment being made by Helios and Matheson in MoviePass. “We will seek to sell our advertising to the studios, channeling MoviePass subscribers to see certain movies. Also, we plan to use the viewing history and habit information of each user to guide them to select upcoming movies that appeal to their interests. Our goal is to serve the interests of moviegoers, movie studios and movie theaters alike,” Mr. Farnsworth concluded.
About Helios and Matheson
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) is a provider of information technology services and solutions, offering a range of technology platforms focusing on big data, artificial intelligence, business intelligence, social listening, and consumer-centric technology. Its holdings include RedZone Map™, a safety and navigation app for iOS and Android users, a community-based ecosystem that features a socially empowered safety map app that enhances mobile GPS navigation using advanced proprietary technology. Through TrendIt, Helios and Matheson has acquired technology addressing crowd and migration patterns and consumer behavior in real-time. The patented technology predicts population behavior, along with a crowd’s population size, origin and destination. HMNY is headquartered in New York, NY and listed on the Nasdaq Capital Market under the symbol HMNY. For more information, visit www.hmny.com.
About MoviePass
MoviePass is a technology company dedicated to enhancing the exploration of cinema. As the nation’s premier movie-theater subscription service, MoviePass provides film enthusiasts the ability to attend unlimited movies. The service, now accepted at more than 91% of theaters across the United States, is the nation’s largest theater network. For more information, visit www.moviepass.com.
Additional Information for Stockholders of HMNY about the Proposed Transaction between HMNY and MoviePass and Where to Find It
HMNY plans to file with the SEC and furnish its stockholders with a proxy statement in connection with the proposed transaction with MoviePass and security holders of HMNY are urged to read the proxy statement and the other relevant materials when they become available because such materials will contain important information about HMNY, MoviePass and their respective affiliates and the proposed transaction. The proxy statement and other relevant materials (when they become available), and any and all other documents filed by HMNY with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov.
In addition, investors may obtain a free copy of HMNY’s filings from HMNY’s website at www.hmny.com or by directing a request to: Helios and Matheson Analytics Inc., Attn: Secretary, Empire State Building, 350 Fifth Avenue, Suite 7520, New York, New York 10118, (212) 979-8228.
INVESTORS AND SECURITY HOLDERS OF HMNY ARE URGED TO READ THE PROXY STATEMENT AND THE OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BETWEEN HMNY AND MOVIEPASS.
Participants in the Solicitation
HMNY and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the security holders of HMNY in connection with the proposed transaction between HMNY and MoviePass. Information about those directors and executive officers of HMNY, including their ownership of HMNY securities, is set forth in the annual report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on April 14, 2017. Investors and security holders may obtain additional information regarding the direct and indirect interests of HMNY and its directors and executive officers in the proposed transaction by reading the proxy statement and other public filings referred to above.
Cautionary Statement on Forward-looking Statements and Other Information in this Press Release
Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements, regarding the expected completion of the acquisition of a controlling interest of MoviePass by HMNY, the time frame in which this will occur, the expected benefits to HMNY and MoviePass from completing the acquisition, and the expected financial performance of HMNY following completion of the acquisition. Statements regarding future events are based on the parties’ current expectations and are necessarily subject to associated risks related to, among other things, the conditions to the closing of the acquisition may not be satisfied (including, without limitation, the requisite equity or equity-linked financing transaction of HMNY with gross proceeds of at least $10 million upon which the MoviePass transaction is conditioned), the occurrence of any event, change or other circumstances that could give rise to the termination of the securities purchase agreement between MoviePass and HMNY, and general economic conditions. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements.
Such forward-looking statements are based on a number of assumptions. Although the parties believe that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning HMNY are described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and other filings, including subsequent current and periodic reports, information statements and registration statements filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the parties’ current expectations and the parties do not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
Because the MoviePass $9.95 per month subscription pricing model is new, HMNY is providing the information in this press release to update investors regarding the resulting rate of increase in MoviePass subscribers in the month following the announcement of the transaction between HMNY and MoviePass. There can be no assurance that such rate of increase will continue or be sustained. Moreover, the increase in the number of MoviePass subscribers provides no assurance that the MoviePass business model will lead to profitability.
The Pollack PR Marketing Group
Stephanie Goldman, 310-556-4443
sgoldman@ppmgcorp.com
or
Mark Havenner, 310-556-4443
mhavenner@ppmgcorp.com
SAN DIEGO, Sept. 14, 2017 — Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), an ophthalmology-focused pharmaceutical company, provided an update regarding the FDA MedWatch Notice issued on August 4, 2017. The FDA’s letter dated September 5, 2017 to Imprimis Pharmaceuticals, states “non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier.” This statement is consistent with Imprimis’ previous statements in its press release on August 7, 2017. The company also confirms that upon discovery of the supplier’s mislabeling, it immediately terminated its business relationship with the supplier.
Mark L. Baum, CEO of Imprimis commented, “We are grateful for FDA’s diligence in investigating this unfortunate incident. Imprimis scrupulously follows state and federal laws and only purchases pharmaceutical ingredients from FDA registered and FDA inspected suppliers. In this case, the supplier’s mistake was exacerbated by an inaccurately written certificate to Imprimis regarding the quality of the subject ingredient. Imprimis will continue to strive to maintain the highest quality standards in our industry and will work collaboratively with the FDA and other regulatory bodies to employ best practices in order to prevent events like these from occurring again.”
Baum concluded, “Coupled with the FDA registered supplier’s misrepresentation is the fact that Imprimis never actually dispensed any medication to the patient referred to in the FDA’s MedWatch notice. This case related to the apparent improper administration of a medication to a patient by a practitioner who prescribed the medication for one patient and summarily, and without our knowledge, gave it to a completely different patient. Regardless, Imprimis will continue to review its operating procedures and make changes where appropriate to protect patient safety.”
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative medications in all 50 states. The company’s unique business model increases patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis owns and operates production and dispensing facilities located in California and New Jersey. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.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. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the outcomes of current or pending litigation, our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Other than drugs compounded at its FDA registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.
Investor Contact:
Jon Patton
jpatton@imprimispharma.com
858.704.4587
Media Contact:
Deb Holliday
deb@pascalecommunications.com
412.877.4519
NEW YORK
Offering the Veritone Platform to Dalet Galaxy Customers Will Enhance Content Production, Management and Delivery
Dalet Digital Media Systems, a leading provider of solutions and services for broadcasters and content professionals, and Veritone® Inc. (NASDAQ: VERI), a leading provider of artificial intelligence (AI) insights and solutions, today announced a new collaboration. The new alliance will allow Dalet Galaxy customers to leverage Veritone’s industry-leading AI technology for automated metadata extraction and analysis, including speech-to-text transcription, face recognition, translation, object recognition, content moderation, logo recognition and optical character recognition.
“Artificial Intelligence is one of our customers’ top priorities. They recognize the power of AI to seamlessly and automatically process, transform and analyze data.” noted Frederic Roux, vice president of sales, Americas at Dalet. “We’re pleased to collaborate with Veritone in this effort to help media organizations capture new opportunities with smart workflow services that can easily become part of their existing installation.”
The amount of multimedia content created and consumed is growing at an exponential pace in all verticals. As broadcasters and media organizations look at the best ways to tame the tsunami, streamline workflows and maximize the value of content, AI-enriched media management and workflow solutions will become a vital part for continued relevance and sustainable growth. Potential business benefits are immense and immediately tangible: augmented production workflows with smart and timely recommendations, better content insights and discovery thanks to intelligent auto-tagging features, automation of more complex tasks in the process and, in the near future, smart resource provisioning and system scaling with self-adaptive capacity planning.
However, managing artificial intelligence at scale and fielding it in relevant use cases for media organizations requires an advanced asset management and orchestration platform such as Dalet Galaxy. Leveraging on its flexible, media and business aware data model, as well as a fully featured integration framework, Dalet Galaxy offers a future-proof foundation to connect with Veritone’s open, extensible ecosystem of AI engines and applications. By taking advantage of the Veritone Platform, Dalet Galaxy users will be able to search and exploit every frame of video and every second of audio for objects, faces, brands, text, sentiment, keywords, and more. They will be able to discover unique insights, dissect and analyze content programmatically and by multivariate search, and monitor media in near real time.
“The rationale behind this collaboration is very simple: a common passion, focus and expertise in the media industry. The combination of the two complementary technologies spans across all media workflows, offering smarter services that unleash the potential of content, enhance the production experience, and reduce the complexity of content curation, ultimately enabling customers to create and deliver richer, better content to the right audience at the right time.” said Kevin Savina, Director of Product Strategy at Dalet.
“We are thrilled to team with Dalet, a leader in media asset and workflow management. The collaboration will empower Dalet Galaxy users with the new-found intelligence and impactful applications essential to remain competitive now and in the future,” added Ryan Steelberg, co-founder and president of Veritone.
Veritone makes AI accessible and actionable by combining more than 120 of the most advanced third-party engines across major cognitive functions with a suite of powerful applications and a proprietary orchestration layer, Conductor™, informed by machine learning. Deployable virtually anywhere, the Veritone Platform produces time-correlated, multi-dimensional metadata from audio and video data, unlocking new insights from linear files such as radio and TV broadcasts, call-center conversations, and CCTV footage.
This next generation of augmented media operations is a strategic focus for Dalet. The company has deep internal expertise in these topics. Michael Elhadad, co-founder and head of technology at Dalet is also a university professor and researcher in the fields of artificial intelligence and natural language processing.
A number of AI services have already been integrated with the Dalet Galaxy platform, such as automated collection and enrichment of advanced metadata. However, the unique AI capabilities of Veritone coupled with the Dalet Galaxy platform will provide broadcasters and media organizations with an end-to-end solution that will serve as an enabler to capture tomorrow’s business opportunities and generate new benefits.
Meet with us at IBC in Amsterdam
IBC Show attendees can book a private workflow consultation with a Dalet expert to learn how new product and solution enhancements can help them better create, manage and distribute content. Book a meeting via http://www.dalet.com/events/ibc-amsterdam-2017.
Veritone spokespeople are also available during IBC. Meet them at the Quantum booth (Hall 7, B27) and Microsoft booth (Hall 15, MS1) to discuss the partnership and how AI will impact the industry.
About Dalet Digital Media Systems
Dalet solutions and services enable media organizations to create, manage and distribute content faster and more efficiently, fully maximizing the value of assets. Dalet products are built on three distinct platforms that, when combined, form versatile business solutions that power end-to-end workflows for news, sports, program preparation, production, archive and radio. Individually, Dalet platforms and products offer targeted applications with key capabilities to address critical media workflow functions such as ingest, QC, edit, transcode and multiplatform distribution.
The foundation for Dalet productivity-enhancing workflow solutions, Dalet Galaxy is the enterprise orchestration and MAM platforms that unifies the content chain by managing assets, metadata, workflows and processes across multiple and diverse production and distribution systems. Specially tailored for news and media workflows, this unique technology platform helps broadcasters and media professionals increase productivity while providing operational and business visibility.
Dalet AmberFin is the high-quality, scalable transcoding platform with fully integrated ingest, mastering, QC and review functionalities, enabling facilities to make great pictures in a scalable, reliable and interoperable way. Addressing the demanding needs of studio production, multi-camera ingest, sports logging and highlights production, the innovative Dalet Brio video server platform combines density and cost-effectiveness with high reliability.
Dalet supports customers from the initial planning stages to well beyond project execution. Our global presence includes 17 offices strategically located throughout Europe, the Middle East, Asia Pacific, North America and South America, and a network of more than 60 professional partners serving 87 countries worldwide. This collective experience and knowledge enables our customers to realize potential increases in productivity, efficiency and value of their assets.
The comprehensive Dalet Care program ensures deployments remain up and running with 24/7 support 365 days a year.
Dalet systems are used around the world by many thousands of individual users at hundreds of TV and Radio content producers, including public broadcasters (ABS-CBN, BBC, CBC, DR, FMM, France TV, RAI, RFI, Russia Today, RT Malaysia, VOA), commercial networks and operators (Canal+, FOX, eTV, MBC Dubai, MediaCorp, Mediaset, Orange, Time Warner Cable, Warner Bros, Sirius XM Radio), and government organizations (Canadian House of Commons, Australian Parliament and UK Parliament).
Dalet is traded on the NYSE-EURONEXT stock exchange (Eurolist C): ISIN: FR0011026749, Bloomberg DLT:FP, Reuters: DALE.PA.
Dalet® is a registered trademark of Dalet Digital Media Systems. All other products and trademarks mentioned herein belong to their respective owners.
For more information on Dalet, visit www.dalet.com.
About Veritone
Veritone, Inc. is a leading artificial intelligence company that has developed the Veritone Platform, which unlocks the power of AI-based cognitive computing to transform and analyze unstructured public and private audio and video data for clients in the media, politics, legal and government markets. The open platform integrates an ecosystem of best-of-breed cognitive engines and powerful applications, which can be orchestrated together to reveal valuable, multivariate insights from users’ data. To learn more about Veritone, please visit Veritone.com.
Safe Harbor Statement
This news release contains forward-looking statements, including without limitation statements regarding the parties’ new business relationship and the expected benefits to Veritone, Dalet Digital Media Systems and their respective customers. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Assumptions relating to the foregoing involve judgments and risks with respect to various matters which are difficult or impossible to predict accurately and many of which are beyond the control of Dalet Digital Media Systems and Veritone. Although Dalet Digital Media Systems and Veritone believe that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the results contemplated in forward-looking statements will be realized. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of such information should not be regarded as a representation by Dalet Digital Media Systems and Veritone or any other person that their objectives or plans will be achieved. Neither Dalet Digital Media Systems nor Veritone undertakes any obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
CAMBRIDGE, Mass.
Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today announced that the Company will present results from the open-label extension of the MoveDMD trial following 24 and 36 weeks of edasalonexent treatment in boys with Duchenne Muscular Dystrophy (DMD) at the 22nd International Congress of the World Muscle Society. The late breaking abstract and results will be available in the late breaking poster session starting at 10:30am CEST on Wednesday, October 4, 2017. The International Congress of the World Muscle Society is being held October 3 – 7, 2017, at the Palais du Grand Large in Saint Malo, France.
About Edasalonexent
Edasalonexent (CAT-1004) is an investigational oral small molecule that is being developed as a potential disease-modifying therapy for all patients affected by DMD, regardless of their underlying mutation. Edasalonexent inhibits NF-kB, a protein that is activated in DMD and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration. We are currently conducting the MoveDMD trial, a three-part clinical trial investigating the safety and efficacy of edasalonexent in boys enrolled at ages 4 – 7 affected with DMD (any confirmed mutation). The third part of the trial, an open-label extension with edasalonexent, is ongoing. The FDA has granted orphan drug, fast track and rare pediatric disease designations and the European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. For a summary of clinical results reported to-date, please visit www.catabasis.com.
About Catabasis
At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our SMART (Safely Metabolized And Rationally Targeted) Linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. We are applying our SMART LinkerSM platform to build an internal pipeline of product candidates for rare diseases and plan to pursue partnerships to develop additional product candidates. For more information on the Company’s drug discovery platform and pipeline of drug candidates, please visit www.catabasis.com.
Investor and Media Contact
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com
NEW YORK & SAN DIEGO
Bristol-Myers Squibb is Committed to Enhancing Patient Care Through Delivery of Cancer Treatments by Subcutaneous Injection
Halozyme to Receive $105 Million Upfront Payment, Plus Future Milestones and Royalties
Provides Bristol-Myers Squibb Access to ENHANZEtechnology for up to 11 Targets
Bristol-Myers Squibb Company (NYSE:BMY) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement to develop subcutaneously administered Bristol-Myers Squibb immuno-oncology medicines using Halozyme’s ENHANZE® drug-delivery technology.
“We are excited to partner with Halozyme to pursue potential new approaches to how our medicines are delivered to patients,” said Murdo Gordon, chief commercial officer, Bristol-Myers Squibb. “Through our work with Halozyme, we hope to improve the patient treatment experience by developing flexible and convenient treatment delivery options.”
The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. This technology may allow for more rapid delivery of large volume injectable medications, such as medications that are currently delivered intravenously, through subcutaneous delivery.
“Bristol-Myers Squibb has one of the industry’s most advanced and extensive immuno-oncology portfolios with a clear commitment to patient-centered innovation,” said Dr. Helen Torley, president and chief executive officer of Halozyme. “Through this collaboration we are excited to explore the potential for ENHANZE to expand the number of cancer patients who may receive their therapies as a rapidly administered subcutaneous injection.”
Under the terms of the agreement, Halozyme will receive an initial $105 million for access to the ENHANZEtechnology. Bristol-Myers Squibb has designated multiple immuno-oncology targets including programmed death 1 (PD-1) and has an option to select additional targets within five years from the effective date. The collaboration may extend to a maximum of 11 targets. Halozyme has the potential to earn milestone payments of up to $160 million for each of the nominated collaboration targets and additional milestone payments for combination products, subject to achievement of specified development, regulatory and sales-based milestones. In addition, Bristol-Myers Squibb will pay Halozyme royalties on sales of products using the ENHANZE technology developed under the collaboration.
The agreement is subject to customary anti-trust clearance by the U.S. Justice Department and Federal Trade Commission pursuant to the Hart-Scott-Rodino Act.
For Bristol-Myers Squibb, the transaction is expected to be dilutive to Non-GAAP earnings per share (EPS) in 2017 and 2018 by approximately $0.01, and by approximately $0.05 in 2019.
About ENHANZE® Technology
Halozyme’s proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
About Bristol-Myers Squibb & Immuno-Oncology
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Bristol-Myers Squibb for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Halozyme Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved, and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in receipt of Hart-Scott-Rodino clearance, development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development, and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the proposed technology or medicine delivery system will be successfully developed or approved for any of the indications described in this release. The actual financial impact of this transaction may differ from the expected financial impact described in this press release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
CLARENCE, N.Y.
22nd Century Group, Inc. (NYSE American:XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that officials from the Global Tobacco & Nicotine Forum (GTNF) have invited the Company’s Chief Executive Officer, Henry Sicignano, III, to participate on a GTNF panel entitled “Future Next Generation Products” on September 14, 2017 in New York City.
The Global Tobacco & Nicotine Forum is the world’s foremost exchange of ideas and information for tobacco technologies and products. Attendees to the forum include public health advocates, policymakers, scientists, and international tobacco industry executives. Visit www.gtnf-2017.com for more on GTNF. Also speaking at this year’s forum are:
Mitch Zeller, Director, US Food and Drug Administration’s Center for Tobacco Products. Together with FDA Commissioner, Dr. Scott Gottlieb, in August 2017, Mr. Zeller, released an article entitled, “A Nicotine-Focused Framework of Public Health.” Published in The New England Journal of Medicine (NEJM), the article spells out the FDA’s regulatory authority for mandating non-addictive levels of nicotine in combustible cigarettes.
Dr. Dorothy Hatsukami, Forster Family Chair in Cancer Prevention; Associate Director, Masonic Cancer Center; and Professor of Psychiatry, University of Minnesota. In 2016, together with two other prominent scientists, Dr. Dorothy Hatsukami wrote in Tobacco Control that failure to act on the World Health Organization (WHO) recommendation of mandating nicotine reductions in cigarettes to non-addictive levels could lead to the loss of millions of lives.
Dr. Michael Cummings, Professor, Medical University of South Carolina Department of Psychiatry & Behavioral Sciences; and Co-Director, Tobacco Policy and Control Program at Hollings Cancer Center. As an expert in tobacco policy, Dr. Cummings is often called upon to guide global tobacco control policy initiatives around the world. Earlier in 2017, Dr. Cummings gave the keynote address at 22nd Century’s Annual Meeting of Stockholders.
“Since the FDA announced its intention to mandate that all cigarettes have very low, non-addictive levels of nicotine, the public health community has focused much of its attention on 22nd Century,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We look forward to working together with scientists and policymakers to make Very Low Nicotine cigarettes a public health reality in the United States and around the world.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic engineering and plant breeding which allows the increase or decrease of the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants. The Company’s primary mission in tobacco is to reduce the harm caused by smoking. The Company’s primary mission in cannabis is to develop proprietary hemp/cannabis strains for important new medicines and agricultural crops. Visit www.xxiicentury.com and www.botanicalgenetics.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2016, filed on March 8, 2017, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
22nd Century Group
James Vail, 716-270-1523
Director of Communications
jvail@xxiicentury.com
FREMONT, Calif., Sept. 13, 2017 — Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using our proprietary ADAM technology, presented data from its pivotal Phase 2/3 ZOTRIP study evaluating M207 as an acute treatment for migraine during the 18th Annual Congress of the International Headache Society in Vancouver, BC. The data were presented by Dr. Don Kellerman, Vice President of Clinical Development and Medical Affairs.
As previously reported, the 3.8mg dose of M207 met both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours. In addition, the 3.8mg dose showed durability of effect on pain freedom to 24 and 48 hours.
Two other poster presentations related to the results of the ZOTRIP study were presented at the meeting. Dr. Pete Schmidt and co-authors presented an abstract entitled “Experience with Delayed Treatment of Migraine and Morning Migraine Treatment Using Intracutaneous Zolmitriptan (M207).” Dr. David Dodick and co-authors presented a poster based on an abstract entitled “Use of Most Bothersome Symptom as an Endpoint in an Acute Treatment of Migraine Trial.”
M207 is designed to rapidly deliver zolmitriptan during a migraine attack utilizing Zosano’s proprietary Adhesive Dermally-Applied Microarray, or ADAM technology. Zosano’s ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. Our ADAM technology delivers zolmitriptan by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin.
“Presenting our results in a rigorous scientific forum, and discussing them with world-class headache experts is very valuable for helping us understand the types of patients who might benefit most from our unique drug delivery method,” said Dr. Kellerman. “We continue to receive positive input from experts in the field about how this product could be valuable in the treatment paradigm for migraine, once it is available for patients. We have been fortunate to work with a great group of Clinical Advisors who continue to provide valuable insight as we move forward with clinical development.”
Zosano’s novel delivery of zolmitriptan was confirmed by the results from the ZOTRIP study, where 41.5% of the patients treated with the 3.8mg dose of M207 achieved pain freedom at 2 hours, and the effect also appeared to be durable, with 31.7% and 26.8% of patients achieving sustained pain freedom from 2-24 hours and 2-48 hours respectively. In post-hoc analyses, M207 also demonstrated efficacy in traditionally difficult to treat established migraine headaches, as evidenced by a nearly identical therapeutic effect in those who treated prior to and after 2 hours. Additionally, 44 % of patients who awoke with their migraine headache were pain-free at 2 hours. Patients in this trial were instructed not to treat until their headache reached moderate to severe intensity and the mean time from headache onset to treatment was almost 5 hours.
The ZOTRIP Study
The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Subjects were enrolled in the ZOTRIP trial at 36 centers across the United States. Those recruited into the trial had a history of at least one year of migraine episodes with or without aura. Upon recruitment, the subjects entered a run-in period that ensured they met the key eligibility criteria of 2-8 migraine attacks per month, which was documented using an electronic diary or an app on their cell phone. Subjects also identified their most bothersome symptom and indicated the presence or absence of nausea, phonophobia or photophobia, during the episodes in the run-in period. Successfully screened subjects were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack, termed “qualifying migraine.” In which the most bothersome symptom had to be present.
During a qualifying migraine, subjects scored the severity of pain on a 4-point scale, and the presence or absence of migraine associated symptoms (photophobia, phonophobia or nausea), starting pre-dose and then at several intervals over 48 hours post-dose.
ZOTRIP Results
Five hundred and eighty nine subjects were enrolled in this study, of which 365 were randomized. Of those randomized, 333 subjects treated and are included in the safety analysis, and 321 qualified for the modified intent-to-treat (mITT) population. 51% of the subjects randomized were found to have severe migraine pain pre-treatment. Also at the time of treatment, 70% reported nausea, 37% aura, and 51% waking up with their migraine (morning migraine). With the multiple doses and multiple endpoints in the trial, a sequential testing procedure was used beginning with the highest dose and the co-primary endpoints. Since statistical significance was not achieved for most bothersome symptom in the 1.9 mg group, p-values for secondary endpoints should be considered nominal p-values.
The 3.8mg dose of M207 achieved statistical significance for both co-primary endpoints at two hours:
| Primary endpoint |
Placebo |
3.8mg M207 |
p-value |
| Pain freedom |
14.3 |
% |
41.5 |
% |
0.0001 |
| Most bothersome symptom free |
42.9 |
% |
68.3 |
% |
0.0009 |
Furthermore, secondary endpoints measuring pain freedom at additional time points for the 3.8mg dose of M207 showed M207 superior to placebo with a nominal p-value less than 0.05:
| Pain Freedom |
Placebo |
3.8mg M207 |
p-value* |
| Pain freedom at 45 minutes |
5.2 |
% |
17.1 |
% |
0.0175 |
| Pain freedom at 60 minutes |
10.4 |
% |
26.8 |
% |
0.0084 |
| Pain freedom at 24 hours |
39.0 |
% |
69.5 |
% |
0.0001 |
| Pain freedom at 48 hours |
39.0 |
% |
64.6 |
% |
0.0013 |
M207 was well-tolerated with no SAEs
- Overall, 13 subjects (3.9%) reported pain at the application site; application site pain was reported as mild in all but 3 subjects;
- The most frequently reported adverse event was redness at the application site (18.3% of subjects). All cases of redness resolved;
- Additionally, 5 (1.5%) patients across M207-treated groups reported dizziness vs 0% on placebo.
About Migraine
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine symptoms can include moderate to severe headache pain combined with nausea and vomiting, or abnormal sensitivity to light and sound. According to the Migraine Research Foundation, migraine affects 30 million men, women and children in the United States. Most migraines last between four and 24 hours, but some last as long as three days. According to published studies, 63% of migraine patients experience between one and four migraines per month. According to Decision Resources, prescription drug sales for migraine in the top seven countries were estimated to be $3.3 billion in 2015, and are expected to grow to $4.4 billion in 2020. Triptans, a family of tryptamine-based drugs first sold in the 1990s, account for almost 75% of anti-migraine therapies prescribed at office visits.
About M207
M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano’s proprietary Adhesive Dermally-Applied Microarray, or ADAM technology. Zosano’s ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. Our ADAM technology delivers drug by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin. In February 2017, the Company announced statistically significant results from the ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using our proprietary Adhesive Dermally-Applied Microarray, or ADAM technology. The Company recently announced positive results from our ZOTRIP study that evaluated M207, which is our proprietary formulation of zolmitriptan delivered via our ADAM technology, as an acute treatment for migraine. Zosano is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies. The Company anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding and other future events and expectations. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “unaudited,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K.. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
Zosano Contact:
Georgia Erbez
Chief Business Officer and
Chief Financial Officer
510-745-1200
Agreement will enable Bank of America customers to use their debit or credit cards with a range of new devices
MELBOURNE, Florida, September 7, 2017 —
Bank of America (NYSE: BAC ) and FitPay, Inc., a wholly-owned subsidiary of NXT-ID, Inc. (NASDAQ: NXTD), today announced an agreement to extend contactless payment capabilities to a range of new devices, giving Bank of America customers more payment options and accelerating the adoption of new payment devices. This collaborative effort enables Bank of America customers to use their credit or debit cards to make secure contactless payments directly from devices that are integrated with the FitPay[TM] payment platform at NFC-enabled point-of-sale locations and more than 9,000 Bank of America ATMs.
“As digital payments evolve, our goal is to give Bank of America customers access to payment options that are easy to use and highly secure,” said Mark Monaco, Head of Enterprise Payments at Bank of America. “Working with FitPay will allow our customers to use a range of new contactless payment devices to improve the payment experience, provide a high level of security, and fit seamlessly into any lifestyle.”
Under the agreement, Bank of America will participate in FitPay’s Digital Wallet Program, which enables manufacturers of Internet of Things (IoT) and wearable devices to add contactless payment capabilities to their product, making it possible for consumers to pay for goods and services at near-field communication-enabled (NFC) point-of-sale terminals with a simple tap. The platform uses tokenization, a payment security technology that replaces cardholders’ account information with a unique digital identifier (a ‘token’), to transact highly secure contactless payments.
“We are very pleased to be working with Bank of America to give their customers access to the latest payment technology,” said Michael Orlando, COO of NXT-ID and President of FitPay, Inc. “Broad adoption of digital payments requires fundamentally changing the payment experience and making new payments methods widely available. Our work with device manufacturers and Bank of America is driving both of these goals.”
Manufacturers of 15 IoT and wearable devices are currently integrating with the FitPay payment platform. Bank of America and FitPay are working together to enable Bank of America customers to use their credit or debit cards to make contactless payments or use NFC-enabled Bank of America ATMs with these devices. This collaboration includes ensuring that the devices meet Bank of America’s technical, usage, security, branding, and consumer experience requirements. Product announcements from the manufacturers of these devices are anticipated in 2017 and 2018.
Bank of America
Bank of America is one of the world’s leading financial institutions, serving individual consumers, small and middle-market businesses and large corporations with a full range of banking, investing, asset management and other financial and risk management products and services. The company provides unmatched convenience in the United States, serving approximately 47 million consumer and small business relationships with approximately 4,500 retail financial centers, approximately 16,000 ATMs, and award-winning digital banking with approximately 34 million active users, including 23 million mobile users. Bank of America is a global leader in wealth management, corporate and investment banking and trading across a broad range of asset classes, serving corporations, governments, institutions and individuals around the world. Bank of America offers industry-leading support to approximately 3 million small business owners through a suite of innovative, easy-to-use online products and services. The company serves clients through operations in all 50 states, the District of Columbia, the U.S. Virgin Islands, Puerto Rico and more than 35 countries. Bank of America Corporation stock (NYSE: BAC) is listed on the New York Stock Exchange.
Visit the Bank of America newsroom for more Bank of America news, and click here to register for news email alerts.
NXT- ID, Inc. and FitPay, Inc.
NXT-ID, Inc. (NASDAQ: NXTD) provides a comprehensive platform of technology products and services that enable the Internet of Things (IoT). With extensive experience in access control, biometric and behavior-metric identity verification, security and privacy, encryption and data protection, payments, miniaturization and sensor technologies, NXT-ID develops and markets groundbreaking solutions for payment and IoT applications. Its industry-leading technology products and solutions include MobileBio®, a suite of biometric solutions that secure consumers’ mobile platforms, the Wocket™, a next-generation smart wallet and the Flye, a digital credit card developed in collaboration with WorldVentures. NXT-ID includes three mobile and IoT-related subsidiaries: LogicMark, LLC, a manufacturer and distributor of non-monitored and monitored personal emergency response systems (“PERS”) sold through dealers/distributors and the United States Department of Veterans Affairs; FitPay, Inc., a proprietary technology platform that delivers end-to-end solutions to device manufacturers for contactless payment capabilities, credential management, authentication and other secure services within the IoT ecosystem, and 3D-ID LLC, which is engaged in biometric identification and authentication. Learn more about NXT-ID at http://www.nxt-id.com . NXT-ID Inc. Corporate Contact: info@nxt-id.com . FitPay and the FitPay Payment Platform are trademarks of FitPay, Inc.
Forward-Looking Statements for NXT-ID: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.
Media Contacts:
Bank of America
Betty Riess
+1-415-913-4416
FitPay, Inc. and NXT-ID
Chris Orlando
chris@fit-pay.com
+1-760-468-7273
D. Van Zant
press@nxt-id.com
+1-800-665-0411
STAMFORD, Conn., Sept. 13, 2017 — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that its investigators will present initial clinical data for LOXO-292 at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer to be held October 15-18, 2017, in Yokohama, Japan. The oral presentation will include case reports for two patients with RET fusion lung cancer, previously treated with multikinase inhibitors (MKIs), who received LOXO-292, Loxo Oncology’s highly selective RET inhibitor.
The schedule for the late-breaking oral presentation is as follows:
Presentation Date: October 18, 2017
Title: LOXO-292, a potent, highly selective RET inhibitor, in MKI-resistant RET fusion-positive lung cancer patients with and without brain metastases
Session Title: Emerging Genomic Targets
Presenter: Vamsidhar Velcheti, M.D.
About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as “oncogene addiction,” renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email clinicaltrials@loxooncology.com.
About Loxo Oncology
Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company’s website at www.loxooncology.com.
Contacts for Loxo Oncology, Inc.
Company:
Jacob S. Van Naarden
Chief Business Officer
jake@loxooncology.com
Investors:
Peter Rahmer
The Trout Group, LLC
646-378-2973
prahmer@troutgroup.com
Media:
Dan Budwick
1AB Media
973-271-6085
dan@1abmedia.com
- Performance evaluation studies confirm required concordance levels for all assays
- Verification and validation studies to commence shortly
- European field trials still expected to be completed in CY17
JERSEY, Channel Islands, Sept. 12, 2017 — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today reported progress on performance evaluation studies for MosaiQ.
“Our latest performance evaluation results represent a key final step prior to commencing our verification and validation studies, allowing us to reaffirm our goal of completing planned field trials in Europe for MosaiQ during the second half of this year,” said Paul Cowan, Chairman and Chief Executive Officer of Quotient.
Assay Performance
Results of internal performance evaluation studies for the MosaiQ IH Microarray (the initial blood grouping microarray) and the MosaiQ SDS Microarray (the initial disease screening microarray) indicate that MosaiQ achieved the required targeted performance compared with predicate technologies. The performance evaluation data were derived using microarrays manufactured in Quotient’s validated, high-volume manufacturing facility and run on field trial-ready instruments. Final internal verification and validation studies for the MosaiQ IH Microarray and MosaiQ SDS Microarray are the next step in preparation for European field trials later this year.
MosaiQ IH Microarray – Antigen Typing
A summary of the most recent performance evaluation data derived in our ongoing study for antigen typing is set out below:
Blood Group
Antigen |
A |
B |
D |
C |
c |
E |
e |
Cw |
K |
k |
| Concordance |
100.0% |
99.8% |
99.4% |
99.8% |
99.6% |
100.0% |
100.0% |
100.0% |
100.0% |
100.0% |
|
|
|
|
|
|
|
|
|
|
|
In this study 571 donor samples were tested.
MosaiQ IH Microarray – Antibody Detection
The most recent performance evaluation data for the antibody detection assay achieved 99.1% concordance compared with the predicate technology. In these studies, 788 donor samples and 28 known positive samples were tested.
MosaiQ SDS Microarray
The most recent performance evaluation study for the MosaiQ SDS Microarray achieved 100% sensitivity and 98% specificity for CMV and 100% sensitivity and 100% specificity for syphilis.
Regulatory and Commercial Milestones – For Next Twelve Months are Confirmed
- European Field Trials – Quotient expects to complete European field trials during CY17
- European Regulatory Approval – Upon the successful completion of European field trials Quotient expects to file promptly for European regulatory approval for MosaiQ
- European Commercialization – Quotient has commenced the commercialization of MosaiQ in Europe, where it has already received invitations to participate in tenders to be awarded in the middle of CY18
- U.S. Field Trials and subsequent Regulatory Filing will follow the successful completion of European field trials.
MosaiQ Platform
MosaiQ, Quotient’s next-generation platform is designed to deliver fast, comprehensive antigen typing, antibody detection and disease screening results, using a single low volume sample in a high throughput automated format. MosaiQ represents a transformative and highly disruptive unified testing platform for transfusion diagnostics. Feasibility has also been demonstrated with respect to the detection of nucleic acids (DNA or RNA) using the MosaiQ platform. Through MosaiQ, Quotient expects to deliver substantial value to donor testing laboratories worldwide by providing affordable, routine comprehensive characterization and screening of blood products, on a single automated instrument platform designed to radically reduce labor costs and complexity associated with existing practice.
About Quotient Limited
Quotient is a commercial-stage diagnostics company committed to reducing healthcare costs and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and serological disease screening, Quotient is developing its proprietary MosaiQTM technology platform to offer a breadth of tests that is unmatched by existing commercially available transfusion diagnostic instrument platforms. The Company’s operations are based in Edinburgh, Scotland; Eysins, Switzerland and Newtown, Pennsylvania.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include delays or denials of regulatory approvals or clearances for products or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expanded product development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect to manufacturing, product development or field trial studies; adverse results in connection with any ongoing or future legal proceeding; continued or worsening adverse conditions in the general domestic and global economic markets; as well as the other risks set forth in the Company’s filings with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-looking statements.
The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.
CONTACT: Chris Lindop, Chief Financial Officer – chris.lindop@quotientbd.com; +41 22 545 52 26
SAN DIEGO, Sept. 12, 2017 — Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health and biodefense, announced today that it has received an Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) to support the advancement of the Aethlon Hemopurifier® to treat life-threatening viruses. The FDA EAP program was established to facilitate more rapid patient access to breakthrough technologies with the potential to address life threatening disease conditions for which no approved or cleared treatment alternatives exist.
“We are honored to have our Hemopurifier® designated to the Expedited Access Pathway and additionally are pleased that FDA has also allowed our proposed “indication for use,” which provides the possibility of treating a wide-range of life-threatening viruses versus a single disease condition,” said Jim Joyce, Chairman and CEO of Aethlon Medical.
Aethlon proposed the following “indication for use” in its EAP submission; “The Hemopurifier is a single-use device indicated for the treatment of life-threatening highly glycosylated viruses that are not addressed with an approved treatment.” To date, the Hemopurifier has been validated to capture a broad-spectrum of viruses that are highly glycosylated, including life-threatening strains of pandemic influenza viruses, mosquito-borne viruses as well as hemorrhagic viruses that are not addressed with an approved treatment.
The FDA established the EAP program for medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA’s PMA approval standard of reasonable assurance of safety and effectiveness.
About Aethlon Medical, Inc.
Aethlon Medical is focused on addressing unmet needs in global health and biodefense. The Aethlon Hemopurifier® was designed to reduce the presence of life-threatening viral pathogens from the circulatory system of infected individuals. The technology provides a first-line candidate defense against viruses that are not addressed with approved therapies, including a broad-spectrum of naturally occurring pandemic threats and agents of bioterrorism. Aethlon Medical is also investigating the potential use of the Hemopurifier® to reduce the presence of tumor-derived exosomes, which contribute to immune-suppression and the spread of metastasis in cancer patients. Aethlon Medical is the majority owner of Exosome Sciences, Inc. (ESI), which is a diagnostic company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders, including Alzheimer’s disease (AD) and Chronic Traumatic Encephalopathy (CTE). Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and Google+.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company’s ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company’s clinical programs or provide market clearance of the Company’s products, the Company’s ability to raise capital when needed, the Company’s ability to complete the development of its planned products, the Company’s ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company’s proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2017, and in the Company’s other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-489-7800 x3300
Jfrakes@aethlonmedical.com
Media Contact:
David Schull or Maggie Beller
Russo Partners, LLC
David.Schull@RussoPartnersLLC.com
Maggie.Beller@RussoPartnersLLC.com
212-845-4271
Investor Relations:
John Marco
CORE IR
516 222 2560
johnm@coreir.com
Statistically and Clinically Significant Improvement Across Multiple Sign and Symptom Endpoints Onset of Action Observed Within One Week of Therapy Phase 2b Clinical Trial Expected to be Initiated in the First Half of 2018
LEXINGTON, Mass., Sept. 12, 2017 — Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage biotechnology company devoted to treating inflammation, inborn errors of metabolism, and other diseases related to endogenous aldehyde toxicity, today announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease.
“ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide,” commented John Sheppard, M.D., Professor of Ophthalmology, Eastern Virginia Medical School. “The evidence of rapid-onset activity and the tolerability profile demonstrated in the Phase 2a clinical trial suggests that ADX-102 could provide important patient benefits relative to existing therapies.”
The randomized, dose-ranging, parallel-group, double-masked Phase 2a clinical trial investigated three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) in 51 dry eye disease patients (17 per arm) treated for 28 days. The results from the pooled data over the 28-day treatment period demonstrated statistically significant improvement from baseline in Symptom Assessment in Dry Eye (SANDE) Score (p=0.003), Ocular Discomfort Score (p=0.00002), Overall Four-Symptom Score (p=0.0004), Schirmer (tear volume) Test (p=0.008), tear osmolarity (p=0.003), and Lissamine Green ocular surface staining score (p=0.002). Improvements in dry eye disease signs and symptoms were evident within one week of therapy. A modest dose-response was observed, and activity increased over the duration of therapy, supporting evidence of the effect of drug. Levels of malondialdehyde, a pro-inflammatory aldehyde mediator sequestered by ADX-102, were significantly reduced in the tears of patients (p=0.009), supporting the differentiated mechanism of action relative to other therapies in dry eye disease.
The primary objective of the trial was to select a formulation and dose range for a Phase 2b clinical trial. Based on consistent statistically and clinically significant activity across multiple sign and symptom endpoints, and tolerability consistent with that of standard of care, 0.1% ADX-102 was nominated for advancement. Relative to baseline, improvement after 28 days of 0.1% ADX-102 therapy was statistically significant or approached statistical significance for Ocular Discomfort Score (p=0.002), the dryness component of the Four-Symptom Score (p=0.01), Overall Four-Symptom Score (p=0.048), SANDE Score (p=0.09), Schirmer Test (p=0.04), tear osmolarity (p=0.06), and tear aldehyde levels (p=0.007). Effect sizes generally correlated with clinical significance for patient-reported outcomes.
There were no safety concerns observed for any of the formulations of ADX-102, and no serious adverse events were reported.
“These data represent the fourth set of positive Phase 2 results with ADX-102 in ocular inflammation. The breadth of activity across noninfectious anterior uveitis, allergic conjunctivitis, and now dry eye disease confirms the potential of ADX-102 as an important and differentiated therapy in ophthalmology,” commented Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “We are particularly excited about the potential of ADX-102 in the dry eye disease population, which is generally perceived to be inadequately treated but accounted for approximately $1.8 billion in prescription sales in the United States in 2016. We look forward to the initiation of a Phase 2b clinical trial in dry eye disease in the first half of 2018.”
Conference Call
Aldeyra will hold a conference call on September 12, 2017 at 8:00 a.m. ET to discuss results of the clinical trial. The dial-in numbers are 1-877-870-4263 for domestic callers and 1-412-317-0790 for international callers. A live webcast of the conference call will also be available on the investor relations page of Aldeyra’s corporate website at ir.aldeyra.com. After the live webcast, the event will remain archived on Aldeyra’s website for one year.
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra’s lead product candidate, ADX-102, is an aldehyde trap in development as topical eye drops for the treatment of ocular inflammation. ADX-102 has now been tested in over 250 patients in Phase 2 clinical trials in dry eye disease, allergic conjunctivitis, and noninfectious anterior uveitis. A dermatologic form of ADX-102 is in late-stage clinical development for the treatment of ichthyosis due to Sjögren-Larsson Syndrome, an inborn error of aldehyde metabolism. ADX-102 has not been approved for sale in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in the United States, and is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, and in severe cases, decreased vision. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate. In patients with dry eye disease, pro-inflammatory aldehyde mediators may contribute to ocular inflammation. By diminishing aldehyde levels, Aldeyra’s topical ocular aldehyde trap platform represents a novel and differentiated approach for the treatment of dry eye disease.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra’s plans and expectations for the development of ADX-102 and the timing thereof; the potential of ADX-102 as an agent for the treatment of dry eye disease; the ability of ADX-102 to provide important patient benefits and a differentiated mechanism of action relative to existing therapies; and estimates of the market size for Dry Eye Disease. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “aim,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Aldeyra’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra’s clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra’s continuing review and quality control analysis of clinical data, Aldeyra’s ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities, the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize Aldeyra’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra’s product candidates; the size and growth of the potential markets for Aldeyra’s product candidates and the ability to serve those markets; Aldeyra’s expectations regarding Aldeyra’s expenses and revenue, the sufficiency of Aldeyra’s cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra’s product candidates; Aldeyra’s expectations regarding competition; Aldeyra’s anticipated growth strategies; Aldeyra’s ability to attract or retain key personnel; Aldeyra’s ability to establish and maintain development partnerships; Aldeyra’s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra’s ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra’s business and the market in which it operates; and other factors that are described in the “Risk Factors ” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations ” sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which are on file with the Securities and Exchange Commission(SEC) and available on the SEC’s website at www.sec.gov. All of Aldeyra’s development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.
In addition to the risks described above and in Aldeyra’s other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 ext. 205
stulipano@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com
SAN GABRIEL, California, September 12, 2017 —
ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today provides an update on its financial and business achievements for the fiscal year of 2017, as well as its outlook for fiscal year 2018. At the same time, Warren Wang, founder and CEO of CIIX, comments on the recent stock price volatility as it may relate to recent news in the Digital Currency Industry.
The fiscal year ended May 31, 2017 represents a significant milestone in the Company’s 18-year history as both its long established Financial Services/Media Division, and the more recently established Consumer Division, have made substantial progress this year.
Financial Highlights:
- Filed form 10K with the U.S. Securities and Exchange Commission (SEC) reflecting significantly higher revenues for the fiscal year ended May 31, 2017, as compared to fiscal 2016 with total operating revenues increased by 76%.
- Revenues from both the investor relations business and the subscription business continued to grow this year, with an increase of 130% and 57% respectively.
Financial Services Business Highlights:
- Upgraded the US stocks live video platform and revealed details of real-money trading conducted by all analysts to paid VIP subscribers.
- Announced plans to launch a Cryptocurrency Education and Trading Subscription Service and the first Chinese daily video news broadcast from the NYSE covering digital currency and blockchain technology before the end of 2017.
Hemp Oil Business Highlights:
- Established CBD Biotechnology Co., Ltd., a wholly-owned foreign enterprise in Shanghai, China; appointed Summer Yun as Chief Executive Officer (CEO); and announced plans to launch of its hemp-infused skin care line in China before end of 2017.
- Established ChineseHempOil.com, Inc., a wholly-owned subsidiary in the US; launched its first hemp oil product line “OptHemp;” and appointed Keevin Gillespie as President.
- Engaged Launch Haus, LLC, a venture building firm and digital holding company specializing in direct response marketing including digital, E-commerce and direct sales channels.
- Retained Buyopsy, LLC, a wholly owned subsidiary of Launch Haus, LLC responsible for handling direct to consumer implementations and staff augmentation, and its Principal Chris J Snook (effective September 1, 2017) to provide day-to-day leadership in growth and E-commerce for ChineseInvestors.com, Inc., ChineseHempOil.com and CBD Biotechnology Co., Ltd.
“I am very pleased about the Company’s significant increase in revenue in the fiscal year ended May 31, 2017,” says Wang. “Although the blueprint of our Company’s business strategy has expanded through its entrance into the Hemp Industry, our core subscription and investors relations services remain strong with significant growth rates. I am thankful for the investors who have supported our ongoing development plans and look forward to a prosperous year ahead.”
Looking forward, Wang states, “although the business of our Consumer Division is still in the early stages, the recently launched ‘OptHemp’ product line is gaining popularity among Chinese consumers in the US, and the Company’s first hemp-infused skin care product line will launch in China in the coming months. We believe that through the efforts of our business strategists such as Buyopsy, LLC and its principal Chris Snook, our E-commerce partners such as Elevated.com and Quiverr.com, and our talented management team, we will generate substantial revenues in FY 2018 via sales of our hemp-based products in the United States and China. Our overall goal in 2018 is for the Company is to achieve annual revenue growth of more than 100%, while cutting costs and achieving profitability.”
The Company recently announced that its Financial Services/Media Division will also be providing ancillary services in the popular Digital Currency Industry. Digital Currency has attracted a lot of attention in recent years from the creation of Bitcoin, the world’s first decentralized digital currency, to blockchain technology, which allows digital currency to transfer value across the globe without resorting to traditional intermediaries such as banks. This industry has also created new phenomena such as currency mining, trading, tender, and storage related businesses and has paved the way for companies such as ChineseInvestors.com, Inc. to provide its educational subscription services to the many market investors that see the unique opportunity that digital currency poses and that desire to capitalize on this market opportunity. These interested investors may not have a full understanding of the concept of digital currency or access to the latest market news; therefore the Company sees this as an opportunity to provide fundamental knowledge to Chinese speaking newcomers to digital currency, including straightforward explanations of the basics of digital currency, how to buy it and straightforward trading guidelines. For those with digital currency experience, the Company will provide more detailed information regarding currency mining, blockchain technology, stock trends and ETFs. As part of its plan to enter the Digital Currency Industry, the Company also recently announced its plans to launch a Chinese Daily Video News Broadcast from the NYSE floor covering the Digital Currency Market.
“The Company is excited about the opportunity to enter the Digital Currency Market as an ancillary service provider,” says Wang. “Although the Company’s stock price may have recently been affected short term due to recent news in the Digital Currency Industry, as an ancillary service provider the Company does not anticipate that it will be affected long term by the ban prohibiting Chinese exchanges from providing digital currency trading services, Chinese regulators’ efforts to limit the use of digital currencies, the recent release by Chinese authorities declaring initial coin offerings (“ICOs”) illegal in China, or the US SEC’s warnings that securities laws apply to ICOs. While these regulatory measures and the recent global news surrounding digital currency exchanges may slow the interest surrounding digital currency and ICOs, they may also make the terrain more reliable and safer for investors. Moreover, with large investors becoming more involved in the Digital Currency Market, we believe that the need to overcome the limitations of digital currency exchanges has become imperative. Although CIIX does not currently have plans for an ICO, we are excited about the opportunity to expand our subscription services and media services division on the opportunities that we expect to emerge from the Digital Currency Market.”
“However, CIIX has neither set up a cryptocurrency exchange in China, nor raised capital through an ICO. Some investors have a misunderstanding of our business,” clarifies Wang.
About ChineseInvestors.com (OTCQB: CIIX)
Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.
For more information visit ChineseInvestors.com
Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom
Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh
Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;
https://www.facebook.com/Chineseinvestors.com.english
Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776
Investor Relations:
Alan Klitenic
+1-214-636-2548
Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
+1-212-418-1217 Office
Editor@NetworkNewsWire.com
CAMBRIDGE, Mass. and OXFORD, United Kingdom, Sept. 11, 2017 – Summit Therapeutics (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’), today announces that the Biomedical Advanced Research and Development Authority (‘BARDA’), an agency of the US government’s Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, has awarded Summit a contract worth up to $62 million. The funds will support the clinical and regulatory development of ridinilazole for the treatment of CDI, including Summit’s planned Phase 3 development program.
Ridinilazole is a highly selective, novel class antibiotic aimed at both treating the initial infection and reducing recurrent disease, which is the key clinical issue in the treatment of CDI. In a Phase 2 proof of concept clinical trial conducted in North America, ridinilazole was shown to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin, and achieved a substantial reduction in rates of recurrent disease.
The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
“CDI is a serious public health threat that is a significant burden on the US population, and BARDA has committed to the development of innovative treatments capable of addressing all aspects of this serious illness, including recurrent disease. BARDA’s selection of ridinilazole for an award is testament to ridinilazole’s promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease,” commented Glyn Edwards, Chief Executive Officer of Summit. “This non-dilutive funding award begins to deliver on our strategy of maximizing the value of ridinilazole for patients with CDI, Summit and our shareholders, and we look forward to initiating the Phase 3 clinical program of ridinilazole.”
The BARDA contract provides for a cost-sharing arrangement under which BARDA would fund a specified portion of estimated costs for specified activities related to the continued clinical and regulatory development of ridinilazole for CDI. Under the terms of the contract, Summit is initially eligible to receive from BARDA $32 million to fund, in part, obtaining regulatory approval for and commencing enrollment and dosing into Summit’s two planned Phase 3 clinical trials of ridinilazole. In addition, Summit is eligible for additional funding under the contract pursuant to three independent option work segments, which may be exercised by BARDA in its sole discretion upon the achievement of certain development and other milestones for ridinilazole. If the three option work segments are exercised in full, Summit would be eligible for an additional $30 million from BARDA. Activities in these three option work segments include the completion of enrollment and treatment in the two planned Phase 3 clinical trials and other activities related to the preparation for the potential submission of application for marketing approval for ridinilazole in the United States.
With this contract award, Summit remains on track to initiate two Phase 3 clinical trials of ridinilazole for CDI in the first half of 2018. The Company continues to explore various funding options for completion of its Phase 3 clinical development program, with these including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.
This project will be funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600002C.
Summit will file on Form 6-K with the US Securities and Exchange Commission (‘SEC’) additional information about the agreement with BARDA. A copy of the Form 6-K will be available to download, from the date of this press release, either from the Investors section of the Company’s website at www.summitplc.com, or from the SEC website at www.sec.gov.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (MAR).
About BARDA
BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, makes available medical countermeasures to address public health emergencies arising from natural and intentional threats through an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools. For more information about BARDA, visit www.phe.gov/about/BARDA/Pages/default.aspx.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with over one million estimated cases of CDI each year in the United States and Europe. There are an estimated 29,000 death per year from CDI in the United States alone. The Centers for Disease Control and Prevention highlighted C. difficile as one of three pathogens that pose an immediate public health threat. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the United States.
CDI is a bacterial infection of the colon that produces toxins that cause inflammation and severe diarrhea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad spectrum antibiotics, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs.
About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. The Phase 2 trial was conducted in North America with the majority of sites located in the United States. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.
About Summit Therapeutics
Summit Therapeutics is a biopharmaceutical company with operations in the United States and United Kingdom and is focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.Summitplc.com and Summit can be followed on Twitter (@Summitplc).
For more information, please contact:
Summit
Glyn Edwards / Richard Pye (UK office)
Erik Ostrowski / Michelle Avery (US office) |
|
|
|
Tel: +44 (0)1235 443 951
+1 617 225 4455 |
|
|
|
|
|
Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson |
|
|
|
Tel: +44 (0)20 7213 0880 |
|
|
|
|
|
N+1 Singer
(Broker)
Aubrey Powell / Lauren Kettle |
|
|
|
Tel: +44 (0)20 7496 3000 |
|
|
|
|
|
MacDougall Biomedical Communications
(US media contact)
Karen Sharma |
|
|
|
Tel: +1 781 235 3060
sharma@macbiocom.com |
|
|
|
|
|
Consilium Strategic Communications
(Financial public relations, UK)
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville |
|
|
|
Tel: +44 (0)20 3709 5700
summit@consilium-comms.com |
Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including but not limited to, statements about the potential benefits and future operation of the BARDA contract, including any potential future payments thereunder, the clinical and preclinical development of our product candidates and the potential for their commercialization, the therapeutic potential of our product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, any other potential third-party collaborations, expectations regarding the sufficiency of our cash resources to fund operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the ability of BARDA to terminate our contract for convenience at any time, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, laws and regulations affecting government contracts, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that we make with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the fiscal year ended 31 January 2017. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
