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Biocept, Inc. (BIOC) Utilizing Proprietary Diagnostic Tools to Improve the Lives of Cancer Patients

Biocept is dedicated to improving the outcomes for cancer patients by developing innovative diagnostic solutions. The company’s primary diagnostic tool, known as a liquid biopsy, allows patients and doctors to gather a host of important information from a simple blood test. Using its patented methodology, the company allows for the isolation of rare cells – such as circulating tumor cells, which are a type of seed that can promote additional tumor growth – without the need for a tissue sample.

The company’s liquid biopsy test is intended to assist physicians in understanding the status of a patient’s disease while contributing to the development of current and future therapy plans. Though treatments for metastic cancer, or cancer that is spread from one organ to another organ in a different area of the body, have advanced in recent years, timely diagnosis of the disease remains critical for the patient’s overall odds of survival. According to a report from the American Cancer Society, the chances of surviving metastic cancer are greatly increased if it is diagnosed in its early stages.

While doctors have already used the company’s biomarker technology to successfully assist thousands of patients, Biocept is continuing to study the diagnostic potential of its blood-based tools. The company recently completed a trial that showed the effectiveness of its proprietary technology in determining hormonal status in metastatic breast cancer patients.

“We are encouraged that the results of this study further support the validity of Biocept’s liquid biopsy in the continuous monitoring and treatment of breast cancer,” said Veena Singh, M.D., Senior Vice President and Senior Medical Director of Biocept.

Comments from doctors involved in the recent study indicated that the company’s diagnostic tool could have significant implications on the treatment of cancer patients for whom tissue samples are not feasible.

Biocept currently offers CLIA validated tests for breast, lung and gastric cancers, and the company plans to conduct additional studies for colorectal, prostate and other solid tumors using its proprietary platforms in the future.

For more information, visit www.biocept.com

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ENGlobal Corp.’s (ENG) Diverse Engineering & Secure Systems Integration Expertise Just the Ticket for Evolving DOE Guidance & Objectives

The recent announcement by Department of Energy that they intend to issue a new funding opportunity in the neighborhood of $12 million to develop next-gen electric machines (NGEM), which fuse together a combination of integrated power electronics with high RPM motors and power density, is right up ENGlobal’s alley. ENGlobal possesses a tremendous amount of expertise developing and manufacturing complex integrated systems like power islands for remote oil and gas fields, as well as pipelines, rigs and offshore platforms, in addition to a variety of industrial applications. From fuel processing hardware and micro-turbine generator units, to electrical distribution equipment and SCADA (supervisory control and data acquisition) systems, all with onboard automation capabilities, ENGlobal’s custom built power island know-how, and the company’s experience developing process control systems, lends itself quite readily to the DOE’s new NGEM objectives.

The DOE’s NGEM funding opportunity will be doled out in the form of two to three year cooperative agreements organized to provide the kind of integrated medium voltage motors and wide bandgap-based variable speed drives needed to transform the chemical, oil and gas industries via enhanced energy savings and improved environmental sustainability. The extensive track record ENGlobal has established engineering and constructing diverse hydrocarbon transport and distribution systems for the upstream, midstream and downstream sectors, which includes everything from pipeline and pump stations, to compressor and metering stations, and even high-pressure gas and water injection systems, puts the company in the pole position to aggress such opportunities.

DOE has said that there is a chance here for the U.S. to emerge as a leader in integrated NGEM design and manufacturing, and the agency is keen on funding projects that can established functional proofs of concept, particularly if they are also extremely reliable, which would help to accelerate widespread adoption of such systems. ENGlobal’s established ability to handle a wide range of highly specialized automation and engineering, spanning custom design, fabrication and implementation of distributed control, instrumentation and process analysis systems, further enables the company to help satisfy the recently released DOE guidance on cybersecurity risk management.

Developmental work on ENG’s Universal Master Control Station (UMCS) and Master Control Station (MCS) platforms for standardizing and streamlining secure communications and control between topside and subsea hardware in offshore drilling operations, is a huge advantage for the company when it comes to assuaging concerns over cybersecurity risks. ENGlobal’s development of standardized and secure communication interfaces that function seamlessly yet securely, irrespective of individual components having come from different subsea or topside equipment vendors, speaks directly to the requirement for robust integrated systems that live up to NIST Cybersecurity Framework protocols.

ENGlobal’s successful integration of critical control execution and data monitoring in their patented UMCS technology, which is not based on proprietary communication interfaces or custom hardware, is a prime example of the kind of cost-effective, interoperable, yet highly secure architecture the company is capable of engineering. Because such a pre-engineered and standardized system also eliminates a great deal of the potential for human error and operational costs, its design is a hallmark of the kinds of solutions energy sector clients will need in order to stay on par with evolving DOE specs.

For more information, visit www.englobal.com

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Economic Impacts of Depression Impacts are Staggering – VistaGen Therapeutics (VSTA) Aggressively Pursues Treatment

If you think depression only affects the individual suffering from the disorder, or even their friends and family, think again. As a nation, depression affects all of us in one way or another. According to a report from the Journal of Clinical Psychology, a staggering amount of that impact is economic.

Depression (MDD) is the leading cause of disability for people aged 15-44, reports OptumHealth Reporting and Insights. Financially, that equates to billions of dollars spent on workplace costs, direct costs (which includes medical claims and pharmaceuticals) and suicide-related costs. Annual costs of MDD rose 21% to $210.5 billion in 2010, according to the Journal of Clinical Psychology, compared to costs in 2005.

Most experts agree that depression rates worldwide are on the rise. While there are nearly 50 variations of anti-depressants available in the U.S. alone, the often extensive trial and error process of finding a drug combination that reduces a patient’s depression symptoms is known to take months, even more than a year, and involves risks of serious side effects, including suicide. Studies show that fewer than 40% of depression sufferers benefit from first round treatments with current antidepressants, and the likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt. Even more atrocious, as many as 15% of individuals suffering with MDD commit suicide.

There is an obvious, unarguable need for a breakthrough – a new generation of safe and faster-acting antidepressants.

One such candidate is ketamine, often used as an anesthetic but also popular as a dangerous street drug. The risk of potential abuse of ketamine, its intravenous administration, and its psychosis-like side effects somewhat crimp widespread acceptance in the medical field. And yet, ketamine’s rapid-acting effectiveness against treatment-resistant MDD is hard to ignore.

In San Francisco, a publicly traded, clinical-stage biopharmaceutical company is hard at work advancing its equally, if not more promising, solution – AV-101, an orally active NMDA receptor modulator.

Backed with funding by the U.S. National Institutes Health (NIH), VistaGen Therapeutics is collaborating with Dr. Carlos Zarate – a highly esteemed NIH clinician known for his deep experience with ketamine and other NMDA receptor antagonists – on a phase 2 clinical study of the efficacy and safety of AV-101 in subjects with MDD. As reflected by the NIH’s support, VistaGen’s AV-101 has the potential to deliver the rapid-acting antidepressant effects of ketamine, but without any of ketamine’s serious side effects.

Dr. Carlos Zarate is among the NIH’s leading clinical researchers on depression and other mood disorders, serving as the Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the National Institutes of Mental Health (NIMH). He will be the principal investigator of the NIH-funded Phase 2 study of AV-101 in MDD. VistaGen and the NIH anticipate completing this important study in 2015.

In two prior NIH-funded randomized, double-blind, placebo-controlled phase 1 safety studies, AV-101 was well-tolerated and not associated with any severe adverse events. Nor were there any signs of sedation, hallucinations or schizophrenia-like side effects often associated with ketamine.

In addition to its candidacy as an effective MDD treatment, preclinical studies have also shown AV-101 as a potential as a treatment for other widespread CNS-related conditions, including chronic neuropathic pain and epilepsy, Parkinson’s and Huntington’s disease.

For more information, visit www.vistagen.com

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Vuzix Corp. (VUZI) Announces Exercise of Majority of Warrants and Capital Structure Improvements

Vuzix, a supplier of video eyewear and smart glasses products designed for the consumer, commercial and entertainment markets, today announced the exercise of a majority of the company’s outstanding warrants issued in conjunction to its August 2013 public offering.

The company reports that holders of its common stock purchase warrants have elected to exercise into common shares – this includes outstanding warrants held by executive management.

Since the beginning of 2015, Vuzix has received requests to exercise 4,605,892 warrants associated with its 2013 stock offering which were exercisable into common stock at $2.25 per share. To-date, 469,500 of these have been exercised for cash for net proceeds to the company totaling approximately $1.0 million. The 4,158,092 balance was exercised on a cashless basis resulting in the issuance of 3,534,972 common shares. Of these cashless exercises, a total of 3,822,442 were exercised on February 25, 2015. The company did not offer the holders of warrants any inducement to exercise. There are currently now only 125,100 warrants outstanding from the August 2013 offering and the total warrants outstanding are now only 597,643.

Vuzix also announced that it has received $337,500 in convertible note conversions during this time period. Total convertible notes outstanding today, excluding accrued interest is now $2.0 million, which is convertible into 905,556 shares.

As of February 26, 2015, following the exercise of these warrants and note conversions, Vuzix now has 15,800,489 commons shares. The company’s outstanding preferred shares are convertible into an additional 4,962,000 common shares.

“The exercise of warrants, receipt of cash and reduction of debt all help to further bolster Vuzix’ balance sheet and improve our capital structure,” stated Vuzix founder and CEO Paul Travers. “We are pleased to see this vote of confidence from our investors following our recent investment from Intel and the company’s listing onto NASDAQ. We strongly believe in the value of share ownership in the company, which is why CFO, Grant Russell and I have also decided to exercise all our warrants into common shares with our other warrant holders. This is yet another step in strengthening our capital structure and bolstering the balance sheet of the company.”

Improvements in Vuzix’ balance sheet will be reflected in the company’s Form 10-Q filing for the period ending March 31, 2015.

For more information, visit www.vuzix.com

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NV5 Holdings, Inc. (NVEE) is “One to Watch”

Helmed by a 35-year industry veteran with a continuous track record of success managing and developing engineering companies, NV5 Holdings, Inc. (NASDAQ: NVEE) has rapidly emerged as one of the leading providers of professional and technical engineering, as well as consulting to the energy (33% of 2014 gross revenues), infrastructure (24%), construction quality assurance (19%), program management (18%), and environmental (6%) markets in the U.S., both for public and private entities. President, CEO and Board Chairman, Dickerson Wright, who founded NVEE back in 2009 before taking the company public shortly thereafter, is the man who previously founded the highly successful construction validation and structural materials integrity analysis firm, U.S. Laboratories, Inc. back in 1993. U.S. Laboratories was later sold for $83 million in 2002, after a highly successful IPO in 1999 and a superb run up from around $80M in revenues to over $300M, to France-based Bureau Veritas, the NA construction quality assurance (CQA) business line of which was subsequently rolled up into NVEE’s CQA division as of 2010.

NVEE has the luxury of operating in a highly fragmented industry, where there are over 144k engineering firms throughout the U.S. alone according to IBIS World, a fact which dovetails exceptionally well with the company’s acquisitive growth strategy. Moreover, the company has executed an impressive storm of key acquisitions already in just a handful of years, significantly expanding their operating footprint, with 13% organic expansion into choice growth markets, bottom line improvement of roughly 33% across the portfolio, and a robust stable of acquisition opportunities to boot.

With multiple parallel verticals and a healthy public/private client mix, NVEE has the distinct advantage of being able to cross-sell its services, while also benefitting from stable activity throughout varying economic cycles. This key advantage is further enhanced by a wealth of local market expertise across their operational footprint, which is defined by 28 offices throughout California, Colorado, Florida, New Jersey, Ohio, Pennsylvania, and Utah. Many of whom have a successful track record spanning over five decades and who are recognized for their expertise, as well as high quality service, both by the industries they serve and their peers. These cumulative tactical advantages, combined with a wealth of experience residing in the company’s 700-plus employees, has made NVEE an M&A powerhouse amid a fragmented industry.

The company’s most recent acquisition, executed in early February of 2015, was program management and owner’s representation consulting firm, Joslin, Lesser & Associates, Inc. (JLA). An acquisition which will be immediately accretive to NVEE’s earnings and which has annualized revenue in the neighborhood of $10 million, as well as a considerable footprint in the Boston, MA area servicing K-12 and government-owned facilities. This acquisition gives NVEE a nice boost to their already solid presence in the northeastern U.S., as JLA boasts a distinguished record of service managing public capital improvement projects throughout the region.

Also previously rolled up into the company’s program management vertical were Zollinger Buric, Inc. and Buric Global, LLC, as well as Owner’s Representative Services (all three in 2014), and Consilium Partners (2013). NVEE’s program management division services a wide range of clients from federal, state and municipal government agencies, to school districts, healthcare facilities and hospitality companies, as well as insurance, REITs, and financial institutions, providing a broad array of project initiation and preconstruction/construction services, as well as FFE (furniture, fixtures, and equipment) services. From building new hospitals and schools, to hotel renovations and various other projects across multiple industries, NV5 Holdings delivers tailored program management services that are fully customized to suit the individual client’s needs.

The company’s core division is focused on delivering cutting-edge energy project construction, as well as distribution, generation and transmission engineering, in addition to comprehensive consulting services – all targeted primarily on the natural gas supply and associated energy generating markets. This fact has allowed NVEE’s energy division to sidestep complications and flagging market activity related to slumping oil prices. Having acquired AK Environmental in 2014, NV5 Holdings has subsequently set about positioning the company on the leading edge of sustainable design and value-added services for the energy sector, emphasizing their “Beyond Engineering” philosophy and deep bench of talent in sustainable practices, which stretches back through over 25 LEED (Leadership in Energy and Environmental Design) registered projects, including Gold and Platinum projects certified by the U.S. Green Building Council. The company has numerous LEED Accredited Professionals on staff and has established a wining reputation for having sustainability champions in each of their offices that actively promote sustainable business practices, as well as overseeing associated reviews on client projects.

The company’s commitment to sustainable infrastructure runs as deep as their roots in the engineering sector and NV5 Holdings was actually one of the earliest adopters of sustainable practices, long before it was made trendy, with in-house R&D beginning in the 1990′s and the company’s first sustainable design guide published back in 2004. NV5 Holdings has played crucial roles in the development of thousands of megawatts of clean, renewable energy over the years and the company was even recently honored by environmental industry strategic business intelligence publication, Environmental Business Journal (EBJ), with EBJ’s 2014 award for business achievement in M&A. This coveted award signifies that NVEE is one of only a handful of companies recognized by EBJ for their acquisitions and revenue growth during 2014, as well as for having shown important industry leadership through innovative project design, the application of emergent technologies, pioneering efforts into new practices, and making proactive social contributions.

Speaking of revenue growth, NVEE’s Q3 2014 performance was impressive indeed, with gross revenue up 69% to $31.4 million, net income up 85% to $1.7 million, and a 34% increase in the company’s backlog to $80.7 million when compared with end of year 2013 figures. Income from operations was particularly strong year over year, with $2.8 million reported, or an increase of 143%, and NVEE was also pleased to be able raise their FY14 revenue guidance to as much as $108 million, with diluted EPS guidance of as much as $0.94/share. These are attractive figures given the incredibly strong tailwinds represented by INGAA Foundation estimates of some $641 billion in energy-related CAPEX that is projected over the next two decades throughout the U.S. and Canada. Even more so when one takes into account the whopping $3.6 trillion in investments the American Society of Civil Engineers has estimated over the next five years alone here in the U.S., which will be required in order to address rapidly deteriorating national infrastructure.

Nationwide NV5 Holdings is truly an infrastructure development leader, with a focus on turn-key solutions that are impeccably sustainable, making environmental, economic, and social sense, both for the present and well on into the future. This approach has won the company many adherents who look to NVEE as a preferred provider across the gamut of infrastructure design, from energy and program management, to forensic engineering, geographical information systems (GIS), land development, surveying, transportation, and even water resource management. The company made two key acquisitions in for their infrastructure division historically, rolling up Pitman Hartenstein & Associates in 2013 and Nolte Associates during 2010.

As a recent testament to the company’s extensive CQA expertise, particularly in the field of geotechnical investigations, evaluations and materials testing, NV5 was awarded a $1 million dollar contract in mid-February 2015 with the City of El Centro, California to provide architectural design, geotechnical, inspection, landscaping, on-call engineering, plan checking, and surveying services in support of ongoing capital programs, development reviews, and major repair projects. This deal handsomely extended the company’s existing working relationship with the City of El Centro and allows the city to take full advantage of NVEE’s impressive ability to efficiently and cost-effectively deliver on mission critical projects. The company previously acquired the central elements of their CQA division during 2012 and 2010 respectively, with the Kaderabek Company and aforementioned Bureau Veritas acquisitions, which have collectively placed NV5 in an ideal position to offer a multiplicity of such services as those mentioned in the El Centro deal, as well as other important services, like code compliance and technical drilling, to cities and municipalities throughout the country.

Earlier in 2015, the company was also selected by the City of Colorado Springs to deliver capital program and construction management, as well as inspection services and pavement management, under a contract which has the company directly serving the Colorado Springs Streets Division PPRTA (Pikes Peak Rural Transportation Authority). This is a huge deal for NVEE, as Colorado Springs is the second largest city in the state, second only to Denver and because Colorado Springs is the most expansive municipality in all of Colorado, with over 200 square miles of land.

NV5 Holdings’ fifth and final division is their environmental services segment, which is focused specifically on tasks like preserving cultural resources and doing environmental risk management and permitting, as well as more specialized services like archeological and wetland studies. The company’s environmental division also handles hydrogeology and hydrogeological engineering tasks, and it even provides comprehensive occupational health and safety services to NVEEs clients.

Investors will have a great opportunity to pop the hood on NVEE at the upcoming 27th annual ROTH Capital Partners Growth Stock Conference this March 9, which is being held at the Ritz-Carlton Laguna Niguel in Orange County, California. California continues to be a primary operational center for NVEE and the company’s rock-solid commitment to sustainability plays quite well to public and private concerns in the environmentally conscious state. CEO Wright will be making a presentation on the company at 12:30 p.m. PST and will then stick around to do one-on-one meetings with interested parties for the rest of the day. Interested investors and potential clients who want to schedule a meeting should contact [email protected] or Lauren Wright at [email protected]

For more information on the company, visit www.NV5.com

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ENGlobal Corp.’s (ENG) Vast Energy Sector Services Exceed Core Capabilities

Founded in 1985, ENGlobal has decades of experience folded into each of its global project delivery solutions. Today, the specialty engineering services firm focuses on automation and select EPCM projects for alternative energy and government entities, in addition to a wide range of services for the upstream, midstream and downstream oil sectors.

The consolidation of resources in the upstream energy sector put pressure on individual companies to expand their capabilities and provide a strong and cost-effective response to oil and gas production needs. Leveraging its deep knowledge of oil and gas production, separation and conveyance, ENGlobal helps these achieve this need by providing full service engineering, procurement and construction capabilities including enhanced oil recovery, gas treating, dehydration, gas compression and distribution, oil processing, and more. Services for clients in the upstream sector include program management, feasibility studies, concept development, innovative plant, layout, definitive estimates, process engineering, control systems, detail engineering and design, procurement, construction management, commission and start-up.

When it comes to midstream services, ENGlobal covers the full gamut of both simple and complex onshore and offshore projects from design through construction. The company’s expertise in the midstream arena ranges from project conceptual feasibility studies through detail design, permitting and construction management. Leveraging a full range of technical and administrative personnel, ENGlobal offers innovative and cost-effective solutions for crude natural gas liquids, refined products pipelines and facilities, as well as natural gas pipelines and facilities. The company has engineered and constructed a wide range of hydrocarbon transportation and distribution systems, including pipelines, flow stations, pump stations, compressor and metering stations around the world.

Engineering for refineries and petrochemical plants starts with the development of the Front End Loading (FEL) package or Front End Engineering Development (FEED) package, which provides the basis for the appropriations cost estimates and feasibility studies. To this accord, ENGlobal has reliably served the petroleum refining and petrochemical industry with conceptual engineering and detailed design of numerous grass roots units and upgrade projects. In addition, ENGlobal has extensive experience with cat crackers, hydrotreaters, amine treating and regeneration units, sulfur recovery units and sour-water stripping units. Whether it involves stress analysis or 3D computer aided design, ENGlobal utilizes the latest available software and systems to perform the required engineering and design, and a staff of control system specialists to engineer the application of distributed control systems, signal transmission, data collection and information processing.

For 30 years, ENGlobal has diligently worked to establish a solid and reputable presence in the world’s energy market. With a massive suite of products and services, ENGlobal caters to a wide and growing base of client seeking highest-level standards for their automation and engineering needs.

For more information, visit www.englobal.com

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CVSL, Inc. (CVSL) Pioneers Advanced Stages of Social Media Evolution

Social media was born in 1969 with the first commercial online service by CompuServe. In an impressive evolutionary trudge to its current state, social media officially grew legs the business world in 2011, and within the last four years alone has made tremendous advances in application and mass utilization. Today, as evidenced by the progressive business model of a Texas-based innovator, social media has come to its next phase of evolution at the convergence of social media and commerce.

CVSL is only one of innumerous businesses using social media, but while social media companies wrangle and experiment to find an effective strategy to turn their social networks into commerce – often relying on what many consumers consider bothersome advertising – CVSL has already found its formula, sans advertising.

CVSL is a growing group of micro-enterprise companies that connect social media networks into a perpetually expanding virtual “community.” The company has amassed a growing base of millions of connections in what it calls the “consumer cloud.” Each time a new micro-enterprise company joins CVSL, the number of connections in the consumer cloud – as well as the number of connections with whom CVSL has a relationship – expands. Everyone connected to the CVSL cloud is offered economic incentives, such as discounts and other benefits on an unlimited number of products and services, to join, sell, buy from and remain with CVSL’s virtual community.

Aside from its U.S. headquarters in Dallas, Texas, CVSL operates its international headquarters in Luzern, Switzerland. CVSL initiated its strategy of acquisitions in the direct-to-consumer space in March of 2013, and has built a current portfolio of eight micro-enterprise companies and a presence in multiple categories, including home décor, gourmet foods and spices, nutritionals, skincare, home improvement and home security. In early December 2014, CVSL successfully advanced its stock to the NYSE. With these significant milestones in the bag, CVSL has assumed a stronger position from which to better focus on mergers and acquisitions.

There are hundreds of micro-enterprise companies worldwide, and CVSL’s acquisition strategy calls for consideration of each potential history, culture, product, career plan, market and most importantly, the owners’ objectives. CVSL isn’t interested in being part of an exit strategy, but rather seeks to acquire businesses from owners desiring to grow their company as part of CVSL’s consumer cloud.

Earlier this year, CVSL found a company that fit the bill and in early February 2015 signed an agreement to acquire Kleeneze, a United Kingdom-based direct-to-consumer company with more than 7,000 independent distributorships offering a wide variety of several thousand cleaning, health, beauty, home, outdoor and other products to customers across the U.K. and Ireland. Founded in 1923, Kleeneze is one of the UK’s longest-operating direct-to-consumer businesses.

Upon completion of the transaction, Kleeneze will be the ninth company in CVSL’s portfolio and will mark an important step in its international expansion. According to the news release, the combined trailing 12-month revenue of CVSL and Kleeneze, as of September 30, 2014, was more than $180 million.

In August 2014, CVSL reported a 19.5% increase in Q2 gross revenue compared to Q2 2013. The company had gross revenue of $24.6 million and an operating loss of $4.1 million in the current quarter, compared to gross revenue of $20.6 million and an operating loss of $3.3 million in Q2 2013. Gross revenue for the first six months of 2014 was $51.3 million, more than double the gross revenue reported for the first half of last year. Most notably, CVSL eliminated roughly $8.5 million in bank debt at the beginning of 2014 and paid off its last remaining bank debt in early fall.

CVSL is guided by an impressive team of directors, members of which include former U.S. Senator Kay Bailey Hutchison; and John P. Rochon, a highly accomplished investor and business strategist with more than three and a half decades of wide-ranging success in finance, operations, business planning, sales, brand-building and marketing.

Backed by a growing portfolio, strong acquisition strategy, increasing global presence, and strengthening financial position facilitated by solid leadership you’ll find CVSL at the convergence of social media and commerce ushering in a new era of micro-enterprise.

For more information, visit www.cvsl.us.com

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Cellceutix Corp. (CTIX) is “One to Watch”

Clinical-stage biopharma company Cellceutix has been getting a lot of attention lately, thanks in large part to their milestone successes developing what is arguably a world-class drug portfolio pipeline. The company’s portfolio ranges from dermatology and oncology, to a potentially game-changing class of wholly novel antibiotics modeled on the human body’s own defense proteins.

The company’s advancement of their lead antibiotic drug candidate, Brilacidin, which was obtained alongside several other development candidates back in late 2013 when Cellceutix picked up the PolyMedix assets, has gone extremely well by all accounts. Successful Phase 2b clinical trialing of Brilacidin in Acute Bacterial Skin & Skin Structure Infections (ABSSSI), designed in conjunction with the FDA, showed that a lower single-dose regimen of the drug was well-tolerated and demonstrated comparable efficacy when compared to a 7-day regimen of the active control, daptomycin.

Moreover, Brilacidin’s unique mechanism of action, which works on both gram-positive and gram-negative bacteria, as well as drug-resistant bacteria like MRSA (Methicillin-resistant Staphylococcus aureus) and VRE (Vancomycin-resistant enterococci), indicates the drug’s immense potential in helping to address an increasingly critical need for antibiotics that can offset adaptive resistance among dangerous bacteria. The rising threat of multi-drug resistant bacteria, which are linked to some 23k deaths and over two million infections each year in the U.S. alone, has even promoted some in the scientific community to argue that we are approaching the end of standard antibiotics as we know it. The overuse and misuse of antibiotics is fueling the rapid evolution of bacteria towards a potential nightmare scenario and some bacteria has already developed a strong or even unassailable resistance to common antibiotic classes like penicillins and cephalosporins. The handwriting is on the wall and the demand for novel antibiotics that can circumvent bacterial adaptation with innovative mechanisms of action will steadily increase as the problem mounts.

This ominous problem has even driven the Obama Administration to recently seek some $1.2 billion to address the issue as part of the fiscal 2016 budget. This strong move by the current administration would nearly double last year’s federal spending on efforts to address such superbugs, channeling $650 million to the NIH and BARDA (Biomedical Advanced Research and Development Authority) in order to speed up the development of new antibiotics that can cope with resistant bacteria, antibiotics just like Brilacidin. Under this proposal, $280 million would also go to the CDC just to shore up monitoring antibiotic use and resistance, with the VA and DOD getting around $160 million combined to go after antibiotic-resistant infections in health care settings.

The landmark 21st Century Cures Initiative legislation put forth in the U.S. House Energy and Commerce Committee recently would bring in major changes to the FDA as well, effectively streamlining the process for inventing new medicines, as well as finding new uses for older ones. Designed to sheer-off a huge chunk of the roughly $2.6 billion it costs to develop a new medicine these days (a nearly three-fold increase of the cost around a decade ago), this new legislation also seeks to help address problems like the rise of drug-resistant bacteria by clearing the decks for pharmaceutical innovation. The research put forth by Deloitte and Thomson Reuters in 2013 says it all, with twelve of the biggest R&D budgeted pharma developers spending around $1.3 billion to bring a new drug to market and peak sales declining on a per-asset basis by about 43%, a noticeable crisis has formed in the market when it comes to the development of new drugs.

This is where a drug like Brilacidin, the lead candidate of an entirely new class of antibiotics called defensin-mimetics, comes into play, as Brilacidin’s unique mechanism of action actually penetrates the cell wall of bacteria, making adaptation highly unlikely. Brilacidin is modeled directly on the body’s own host defense proteins and has even been shown to have distinct anti-inflammatory, as well as anti-biofilm properties during Phase 2b testing. Facts which will be highlighted this April 25 through 28 at the European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, when CTIX’s CMO, Dr. Daniel Jorgensen, walks attendees through the ABSSSI trial’s clinical data, as well as some choice preclinical data.

Cellceutix has a variety of specialized Brilacidin indications currently in the works, like Brilacidin-Ocular for eye infections and Brilacidin-Otic for ear infections, and the company’s defensin-mimetic compounds have generally shown low toxicity in mammalian cells during laboratory studies funded via government grants, while simultaneously showing solid activity against a host of the most problematic pathogens. The capacity of the company’s novel defensin-mimetic compounds to battle infection, while acting as both a tissue healer and anti-inflammatory, looks to have tremendous potential for treating a vast array of gastrointestinal diseases and the company has even recently submitted a request to the FDA to do a pre-IND meeting on the subject. CTIX sees a huge market emerging for their defensin-mimetic compounds in the treatment of ulcerative colitis, the global market for which was forecast last year by GlobalData as being on track to hit $6.6 billion by 2022, on a CAGR of 4.7%. With over half of that sizeable market coming from just the U.S., and the additional potential for these compounds to cover significant territory in other diseases of the GI tract like Crohn’s disease, Cellceutix’s defensin-mimetic franchise likely has a very bright future indeed.

On the cancer front, Cellceutix is continuing their work in Kevetrin™, a novel small-molecule compound with a highly unique structure that sets it apart from other anti-cancer agents on the market today. Noteworthiness that is reinforced by the drug’s consistently solid good-or-better activity when compared to standard chemotherapies across an entire range of different cancer cell lines. Kevetrin’s apparent ability to handle multiple types of cancer could make CTIX’s oncology pipeline a strong money maker for the company and there have been some extremely encouraging results thus far to reinforce this outlook.

The report earlier this year, which specified a patient enrolled in the company’s Phase 1 clinical trial of Kevetrin in ovarian cancer at Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center showed an almost total disappearance of a metastatic spleen lesion as well as markedly reduced peritoneal fluid during three-dose cycle treatments, is a glowing endorsement for the drug’s apparent anti-cancer properties. The fact that a serious lesion became essentially undetectable in a patient with Stage 4 ovarian cancer after completing the second and third cycles of treatment, and that the patient’s disease subsequently was classified as being in a clinically stable condition, roundly verifies Kevetrin’s ability to circumvent cancer cell drug resistance, one of the leading reasons most that most cancer treatments fail.

Increased levels of the key biomarker p21 in patient’s peripheral blood cells during the study firmly suggest that Kevetrin is helping p53, the so-called guardian angel gene, to reestablish its role as a tumor suppressor, given that p21 is a notable downstream target of activated p53. Perhaps more importantly, ongoing research at the hospital is lending credence to the idea that Kevetrin’s efficacy ceiling is dosage-related, meaning that higher dosages could indeed provide an answer for hard to treat diseases like metastatic ovarian cancer. This would be another big market for CTIX, as the American Cancer Society currently estimates that in the U.S. this year alone, more than 21k women will be diagnosed with ovarian cancer and that tragically more than 14k women will die from it.

Given that the principal investigators in the ovarian cancer trial have urged Cellceutix to put together a presentation on the safety and pharmacology of Kevetrin in multiple cancer cell lines, the drug could go way beyond a successful trial and rapidly develop into a leading broad-spectrum anti-cancer indication. When you stack this up against the company’s other oncology indication, Brilacidin-OM, whose defensin-mimetic properties have been shown in laboratory studies to slash ulcerative oral mucositis occurrences by a whopping 94%, the oncology pipeline at CTIX starts to look like a real winner, with far-reaching implications when it comes to future treatments and further development options.

The final drug candidate in Cellceutix’s arsenal is a dermatology indication for treating psoriasis. A small-molecule immune modulator named Prurisol™ (abacavir acetate), which is being developed under an FDA-recommended 505(b)(2) designation, whose active component, abacavir, is already well-documented as an FDA-approved HIV/AIDS treatment. With Phase 2 clearance secured for Prurisol and successful Phase 1 clinical trial data in animal models showing the drug converts readily to abacavir, and that the drug is effective against psoriasis, Phase 2/3 trialing will largely be focused on validating this same conversion in humans and clearing the way for eventual commercialization.

For more information, visit www.Cellceutix.com

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Vuzix Corp. (VUZI) Partnership with Pristine Optimizes Smart Glasses Technology for Business

Vuzix Corp., an award-winning supplier of video eyewear and smart glasses products in the consumer, commercial and entertainment markets, has entered into a partnership to utilize Vuzix M100 Smart Glasses for Pristine’s Eyesight platform for the enterprise market. The alliance combines industry-leading hardware and software to produce powerful telepresence solutions that empower enterprises to improve how teams remotely collaborate for hands-on activities.

Pristine’s EyeSight is a video communication platform that allows colleagues to securely collaborate and solve problems hands-free using wearables. The platform offers multiple advantages such as superior video quality, strong integrations into safety goggles, and a vertically adjustable camera, useful for surgery and hands-on repair tasks.

Users simply power on the glasses, and say “request support.” Relevant colleagues are notified, and can call into Vuzix’ smart glasses powered by Pristine’s EyeSight platform. The cross-platform architecture utilizes open source technologies and is hosted in the cloud, which means users can quickly get started with zero capital investment and no on-site hardware. For healthcare organizations, EyeSight also fulfills strict requirements for HIPAA-compliance.

“Our customers are generating incredible ROI. What used to cost them $2,500 per day now costs next to nothing. Using Vuzix technologies, we are delivering an incredible telepresence solution for clients in life sciences, industrial equipment, field service and healthcare,” Kyle Samani, co-founder and CEO of Pristine stated in the news release.

The Vuzix M100 Smart Glasses are the world’s first commercially available hands-free display and wearable computer designed for enterprise users. The M100 contains a virtual display with an integrated camera and a powerful processing engine, running the Android® OS to wirelessly connect via Bluetooth or Wi-Fi directly to most standard networks or to a smartphone.

“Pristine’s EyeSight platform is a killer app for the exploding smart glasses market and enables users to collaborate in industries and locations never before imagined,” said Dan Cui, vice president of Business Development at Vuzix. “Having Pristine’s solution optimized for our award-winning smart glasses will open new opportunities and deliver real value and ROI to customers around the world.”

Vuzix holds 39 patents and 12 additional patents pending and numerous IP licenses in the video eyewear field. The company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2014 and several wireless technology innovation awards, among others.

For more information, visit www.vizix.com or www.pristine.io

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5 Decades of Experience Looks Good on Continental Stock Transfer & Trust

Performing its core functions, the typical stock transfer agent manages equity recordkeeping by serving as an intermediary for publicly traded companies. When that transfer agent goes beyond the fundamentals to provide personal attention and numerous offerings via innovative technology and an exceptional execution strategy, the result is a lengthy tenure solidified by sound reputation.

Established in 1964, family-owned Continental Stock Transfer & Trust for decades has remained true to its vision of fully supporting emerging and growth companies with superior attention and uniquely tailored business solutions. Today Continental is staffed with some of the industry’s most experienced experts and has become the fourth largest agent in the United States.

In addition to transfer agent essentials, Continentals’ extended offerings include employee plan administration, IPO and SPAC services, annual meeting and proxy services, corporate actions and escrow services, EDGAR/XBRL filing, stock plan administration, dividend reinvestment plan and direct purchase plan administration, and dividend disbursement services.

When it comes to size, bigger isn’t always better. While large transfer agents work on larger companies with hundreds of thousands of shareholders, Continental focuses on companies with 50,000 or fewer shareholders. The result is hands-on, immediate access. In fact, Continental offers 24/7 access to its senior-level experts.

When it boils down to it, emerging and growth companies need an agent that will value the partnership, remain committed to business at hand, utilize tools and technology to meet company needs, and one that will conscientiously care for client shareholders at a fair and reasonable cost.

Backed by more than 50 years of experience, Continental has established a solid reputation for commitment in a consolidated industry where weak agents are quickly blotted out of the picture.

For more information visit www.continentalstock.com

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