Category Archives: Stocks to Watch

MediWound Ltd. (MDWD) Receives Consensus Analysts Rating of ‘Buy’

December 9, 2016

MediWound Ltd. (NASDAQ: MDWD) is a biopharmaceutical company in the business of developing, manufacturing, and globally commercializing products that treat severe burns and wounds. In 2012, MediWound’s innovative drug, NexoBrid™, a burn and wound eschar removal agent, was approved by the European Medicines Agency (EMA) via a centralized procedure. The drug was given orphan indication for removal of dead and damaged skin in adults with burns that are deep partial and full thickness thermal burns.

NexoBrid™ was launched throughout Europe and is now being used in patients with hospitalized burns and wounds. MediWound has initiated phase III clinical trials on NexoBrid™ in the U.S. and pediatric study. The company also has two other products in its pipeline: EscharEx, which is in its phase II study and is for use in patients with chronic wounds, and MWPC003, which is about to enter its phase I study and is for use in patients with connective tissues disorders.

In November of this year, MediWound Ltd. announced third quarter 2016 financial results for the three- and nine-month periods ended September 30, 2016. The company reported revenue for the quarter of $518,000, compared to just over $100,000 for the same quarter of 2015. This was put down to the growing sales of NexoBrid™. The nine-month period results showed total revenue of $1.1 million, compared to $0.3 million for the same nine-month period of the previous year. MDWD will be spending the remainder of 2016 investing primarily in sales and marketing activities relating to the further adoption of NexoBrid™ in Europe.

Aegis Capital Corp. (http://dtn.fm/l63Bn) initiated coverage on MediWound Ltd., giving the company a ‘Buy’ rating with a price target of $11 per share. This rating was given based on the fact that the company has made significant progress in the area of wound debridement. According to the report, MDWD’s NexoBrid™ is showing significantly faster, more selective, safer, and more cost efficient results compared to current treatments. The report also highlights the possibility for the company to integrate into the chronic wound care market with EscharEx and markets relating to connective tissue disorders with its pipeline product MWPC003.

Despite Zacks Investment Research lowering the company’s status from a ‘Buy’ rating to a ‘Hold’ rating, six other research analysts have given MDWD a ‘Buy’ rating, and Wells Fargo & Co. offered MediWound an ‘Outperform’ rating with a price target on the stock of $14. The company has a consensus ‘Buy’ rating with a consensus price target of $13.25, all according to Cerbat Gem Market News and Analysis (http://dtn.fm/Ch85p).

Institutional investors and hedge funds are now said to own over 27% of MediWound shares, after Migdal Insurance & Finance Holdings, Wells Fargo & Company MN, and Oppenheimer & Co. bought new positions in the company’s stock. Wellington Management Group LLP and United Services Automobile Association also increased their positions in MediWound. As of this writing, the company has a market cap of $107.17 million, with an enterprise value at $84.15 million, and shares currently selling at around $4.90 per share.

For more information, visit the company’s website at www.mediwound.com

Globus Medical, Inc. (GMED) Class A Stock Sees Significant Volume Spike Moving Into 2017

As an eventful year for Globus Medical, Inc. (NYSE: GMED) is nearing an end, the leading medical device company experienced a substantial surge in trading volume on December 06. Equities.com (http://dtn.fm/Rab1C) noted a 1.3% gain of Globus Medical, Inc. Class A stock, closing at $23.31. The stock, which averages a daily volume of 1.11 million shares over the last month, captured the attention of numerous institutional investors and analysts when a surge of 11.57 million shares traded hands on 28,116 trades. The article states, “Generally speaking, when a stock experiences a sudden spike in trading volume, it may be seen as a bullish signal for investors. An increase in volume means more market awareness for the company, potentially setting up a more meaningful move in stock price.”

Increased awareness has been building for the medical device company during 2016, including the unveiling of its investigational robotics system Excelsius at the 2016 North American Spine Society (NASS) meeting held in late October. Per articles from MassDevice.com (http://dtn.fm/Of7Fc), and Becker’s Spine Review (http://dtn.fm/9t2Mm), Globus Medical expressed its anticipation of an approval and launch of the platform in early to mid-2017 to investment bank Leerink Partners. The MassDevice.com article also states that Leerink spoke with surgeons who were very interested in a trial of the platform as it becomes available. This adds credence to the company’s position as one of the “three main players” in the burgeoning surgical robotics industry (http://dtn.fm/u9oeH), citing recent commentary from the Medical Device and Diagnostic Industry website. MDDI mentions that surgical robots are only used in roughly 5% of spine procedures today, but that a survey by RBC Capital Markets indicates the potential for rapid adoption growth.

This potential for mass adoption has also been noted by financial analysis firm, Aegis Capital (http://dtn.fm/s1Rhi), in a report from November 30th that preceded Tuesday’s surge in trading activity. The firm set a $31 target price that was achieved, in part, by Globus Medical’s promising pipeline of emerging technologies, namely the robotics platform and trauma. The report calls attention to the system’s ability to serve as a competitor to Medtronic’s O-Arm with Stealth Station navigation. Those systems, which do not include robotic assistance, retail for more than $1 million, placing Globus Medical in a position to charge a premium on its own systems, as they incorporate full feature navigation. As a result, the company believes the customers of the roughly 900 O-Arms installed worldwide to be prospective customers and early adopters. Globus Medical intends to demonstrate, through clinical studies, the system’s time and money-saving benefits, as well as the added layer of predictability and accuracy it affords.

Headquartered in Audubon, Pennsylvania, Globus Medical, Inc. is a leading musculoskeletal implant manufacturer with the singular focus of advancing spinal surgery through the development of innovative engineering and technology. To date, Globus Medical has developed and released more than 150 spine products.

For additional information, visit www.GlobusMedical.com

Intellipharmaceutics International, Inc. (IPCI) Receives Aegis Update

December 8, 2016

Intellipharmaceutics International, Inc. (NASDAQ: IPCI) is a pharmaceutical company in the business of researching, developing, and manufacturing new and generic controlled and targeted release oral solid dosage drugs. The company has a large product portfolio which all follow a New Drug Application (NDA) 505(b)(2) U.S. Food and Drug Administration (FDA) regulatory pathway. The company’s controlled-release generic products follow an Abbreviated New Drug Application (ANDA) pathway.

IPCI currently has 11 products in the pipeline, more than half of which have either been filed for FDA approval or have already been approved. Two products, Regabatin™ XR and Carvedilol, are still in clinical trial stages. The company utilizes its patented Hypermatrix™ technology as a drug delivery platform that can be used to efficiently develop an array of new and existing pharmaceuticals. IPCI’s portfolio covers therapeutics areas such as pain, neurology, cardiovascular, diabetes, and gastrointestinal tract.

In October of this year, Intellipharmaceutics International released its financial results for the fiscal quarter ended August 31, 2016. During the quarter, IPCI reported revenues of $600,000 relating to its license and commercialization agreement with Par Pharmaceuticals, Inc. At this time, the company also announced the tentative approval by the FDA of its generic Seroquel XR®. Additionally, IPCI announced that it had signed an exclusive license and commercial supply agreement with Mallinckrodt, LLC for its generic Lamictal® XR™, Seroquel® and Pristiq®.

Between May 31, 2016 and August 31, 2016, the company reported an increase in cash of $1.8 million. Intellipharmaceutics International, Inc. reported a cash balance of $4.5 million after the $3 million payment from Mallinckrodt. As a result of this recent activity, Aegis Capital Corp. (http://dtn.fm/zD6vt) offered a company update, giving IPCI a ‘Buy’ rating with a price target of $8 per share. The update was released after the company submitted an NDA for abuse-deterrent Rexista extended release tablets. In addition, Intellipharmaceutics International has developed a system to pair with Rexista in order to deter opioid abuse, which has been declared as an epidemic by the CDC.

According to the Cerbat Gem Market News and Analysis (http://dtn.fm/D3r4V), other equities research analysts, such as Maxim Group and Brean Capital, also gave the company a ‘Buy’ rating with price targets of $6 and $8 per share, respectively. Institutional investor Morgan Stanley raised its position in the company by over 4%, giving it just below 62,000 shares of IPCI worth $130,000. Hedge funds and institutional investors now own 1.68% of Intellipharmaceutics International, Inc., and the company’s market cap currently stands at $84.29 million.

For more information, visit the company’s website at www.intellipharmaceutics.com

FTE Networks, Inc. (FTNW) Appoints Industry Veterans as Initial Members of New Strategic Advisory Board

December 7, 2016

FTE Networks (OTCQX: FTNW) this morning said it has formed a strategic advisory board to provide senior counsel as it identifies and executes opportunities to advance the deployment of its disruptive multi-edge computing services. A leading network infrastructure company for Fortune 500 companies, FTE Network is filling this advisory board with a powerful caliber of experienced professionals.

“The establishment of our Strategic Advisory Board represents our commitment to build on the company’s recent momentum and pursue smart, strategic growth opportunities,” Michael Palleschi, FTE Networks’ chairman of the board and CEO, stated in the news release. “Each member brings extensive cloud and open compute expertise, and will be a tremendous asset as we develop our next generation business of data center and multi-edge computing services.”

Initial members of the Multi-Edge Computing Strategic Advisory Board include John Morgan, a 25-year veteran in the communications and IT industries. Morgan currently works with operators to improve network coverage and capacity through the adoption of open source hardware and software. He previously worked for Accenture (NYSE: ACN), where he was global technical lead for legacy network migrations, working with operators on product rationalization and simplification, copper to fiber migration platform implementations, and decommissioning strategies for copper and central office equipment. Prior to Accenture, Morgan held executive positions with several software start-up firms in the communications industry, as well as with leading operators such as Verizon (NYSE: VZ), Level 3 Communications (NASDAQ: LVLT), and Genuity. His background includes various roles in network planning and engineering, product management, OSS/BSS development, finance and operations.

David Kalinske has also been named to FTE Network’s new board. Kalinske is the chief of staff for A3 by Airbus Group (OTC: EADSY) and is a former aide to President Barack Obama and former President George W. Bush – a role in which he received the Defense Superior Service Medal for superior meritorious service. He also served as a research engineering leader with Lockheed Martin Aeronautics (NYSE: LMT) and founded Global Hybrid Company, an airborne logistics provider utilizing the revolutionary Hybrid Airship. A TOPGUN graduate and a Marine Corps fighter squadron commanding officer, Kalinske was selected via scholarship into the Harvard University, Kennedy School of Government, National Security Fellow program with a focus in the study of cybersecurity policy.

Also joining the board is Eric Salzman, senior managing director of Monarch Capital Group, LLC and independent director on several technology company boards. Salzman has 20 years of experience improving operations and finances of communications and software companies. He previously spent eight years at Lehman Brothers as a managing director in the Private Equity and Principal Investing Group, as well as a managing director in the Global Trading Strategies Division, including three years managing the operational and financial restructuring of dozens of companies within the Lehman Bankruptcy. Prior to Lehman Brothers, Salzman was a senior investment professional focused on the technology and communications industry at a multi-strategy hedge fund and at two growth-oriented private equity funds.

For more information, visit: www.ftenet.com

Professional Diversity Network, Inc. (IPDN) Helping Shape a More Demographic-Based Workforce

With diversity being both a legal and popular factor in business, and with businesses facing a more diverse customer base, companies are making a conscious effort to develop and maintain a more culturally diverse workforce. Immigration, politics, new generations, women in leadership, family dynamics, income, and a shift in religious beliefs are just some of the factors affecting diversity. According to the Pew Research Center (http://dtn.fm/9AhWg), America is expected to become significantly more ethnically diverse in the next 50 years, due partially to new Asian and Hispanic immigration.

With the U.S. and other countries becoming more diverse, new research has been underway surveying over 450 multi-million dollar companies across the globe looking at a total of 128 different aspects of talent management. According to a Forbes (http://dtn.fm/6KfWP) article, research shows that gender and ethnically diverse companies are more likely to outperform competitors by 15% and 35%, respectively. In addition, companies with women on their boards statistically outperform peers over longer time frames.

The mission of Professional Diversity Networks, Inc. (NASDAQ: IPDN) is to provide professionals a trusted network that pairs members with employers who are serious about creating a more diverse workforce, employers that value diversity within their companies. Professional Diversity Networks works off the principle that companies seek to meet the needs of an increasingly diverse customer base.

Network members looking for jobs can get started on their search with three simple steps: creating a profile, applying for jobs, and finding hiring employers. The technology IPDN offers allows for a more creative and productive job search due to the fact that employers on the site are looking to hire aspiring employees from a diverse range of backgrounds.

For more information, visit the company’s website at www.prodivnet.com

Cellceutix Corp. (CTIX) Advances Pipeline toward Multi-billion Dollar Opportunities, Piques Peer Interest along the Way

December 6, 2016

Cellceutix (OTCQB: CTIX) CEO Leo Ehrlich in September issued a fiscal year-end business statement recapping the company’s ability to usher its three unique compounds through various stages of clinical trials to successfully meet primary endpoints and drop anchors in several key markets. Advancements of its current pipeline – spanning dermatology, cancer, infectious disease and gastrointestinal indications – also set the company on course to achieve another season of remarkable progress.

Cellceutix’s lead cancer drug candidate is Kevetrin™, an Orphan Drug anti-cancer agent entering phase 2a clinical trials for the treatment of ovarian cancer. Upon commercialization, Kevetrin would be the world’s first p53-modulating drug. The company is also conducting research to develop an oral formulation of Kevetrin, taking advantage of the drug’s short half-life of roughly two hours.

“If we can develop an oral Kevetrin dosing possibilities are numerous. Perhaps two times or three times a day and seven days a week. Now you know why we are excited. A drug activating p53 and dosed orally, we think would have blockbuster potential. More research needs to be done to validate the clinical effectiveness of Kevetrin as well as developing an oral formulation. But I’d hope investors now understand why we get excited about the possibility of developing both the world’s first safe p53 modulating drug and an oral formulation,” Ehrlich stated in the company’s fiscal Q1 2017 earnings call in September (http://dtn.fm/2l0JR).

Another propellant of progress is an anti-psoriasis drug candidate the company once called a “dark horse” or “long shot.” Advancing through two successful clinical trials, however, the potential of Cellceutix’s Prurisol™, now in phase 2b trials, is starting to take shape.

“We believe that the potential safety profile of Prurisol may make this an attractive alternative to Celgene’s (NYSE: CELG) OTEZLA, which is on its way to achieving $1 billion in sales within just three years of its launch,” Arthur P. Bertolino, MD, PhD, MBA, president and chief medical officer at Cellceutix, stated in a recent news release.

In the previously mentioned September business update, Ehlrich also noted Allergan’s (NYSE: AGN) $639 million acquisition of Vitae Pharmaceuticals’ (NASDAQ: VTAE) two clinical drug candidates, one of which is an oral therapy for psoriasis (http://dtn.fm/JJ3mQ).

“I share this with you because it exemplifies the premium that the industry is placing on new, oral psoriasis drugs, even those in mid-stage development. I’m not in the business of analysis, but it seems to me that Allergan values VTP-43742 at more than our total market capitalization. As such, we see a tremendous market opportunity with Prurisol and greatly look forward to initiating our Phase 2b trial in patients with moderate to severe psoriasis with emphasis on the Psoriasis Area and Severity Index (PASI). We’ve just advanced substantial start-up payments to vendors towards the trial, an action that we feel will continue to grow shareholder value.

“I wish to point out that Dr. Bertolino is now introducing Prurisol to large pharmas, most of which are embracing it for the first time. We believe that the path to a large financial deal is generation of comparably encouraging data in Phase 2b as recently seen in our completed Phase 2a trial,” he said.

Interim analysis of top-line phase 2b results of Cellceutix’s study is expected in the second quarter of 2017.

The third candidate in the pipeline is Brilacidin, which has shown antibacterial, anti-biofilm and anti-inflammatory properties in various pre-clinical studies. Currently underway is a phase 2 trial evaluating the oral rinse Brilacidin-OM for the treatment of chemoradiation-induced oral muscositis (OM), an inflammatory condition, in head and neck cancer patients.

“Having data, demonstrating Brilacidin can fight inflammation and doesn’t accumulate in the blood is a major benefit for what can be a painful and expensive condition that doesn’t have any FDA approved treatments. We greatly look forward to additional data from this trial expected in the first half of 2017,” said Ehrlich.

Cellceutix’s pursuit of FDA approval for the products in its pipeline is piquing the interest of larger peers, according to Ehrlich, which in recent months has resulted in more “high-level” business development meetings than at any other time in the company’s history.

“Over the years we have gone from a company with only a single lead drug candidate in an early clinical study to a company that has effectively has three lead drug candidates at mid-state trials targeting multiple indications with new possibilities cropping up regularly underscored by our robust pipeline. We’re having success at targeting multi-billion dollar opportunities with new drugs that can provide relief for millions of people worldwide suffering from hard-to-treat maladies. I believe that is more than ample reason to be excited about all that we have accomplished our future and the litany of catalyst expected in 2017,” said Ehrlich.

For more information, visit the company’s website at www.cellceutix.com

Heron Therapeutics (HRTX) Helps Chemo Patients Prevent Vomiting with SUSTOL®

Cancer is the great scourge of our age. This year, 1.7 million Americans will find out they have the disease and some 600,000 will die from it. In total, approximately 40 percent of the population can expect to be diagnosed with cancer during their lifetime. The name “cancer” is derived from the Greek word for crab and may have been bestowed to indicate the tenacity of the disorder. Cancer tends to persist with the same relentlessness as the claws of a crab cling to a victim.

Yet despite its stubbornness, cancer treatments like chemotherapy have reduced fatalities. Cancer is a formidable foe, however, and the fight against it often leads to a Pyrrhic victory. Patients are left seriously debilitated. Now, SUSTOL® (granisetron) from Heron Therapeutics (NASDAQ: HRTX) is available to provide extended relief to chemo patients suffering from Chemotherapy-Induced Nausea and Vomiting (CINV).

About four million people worldwide receive chemotherapy, making it the most common treatment for cancer, but chemo comes with a number of pernicious side effects, one of which is CINV. Cancer patients identified CINV as the side effect of chemo they most wanted to avoid, ahead of depression, constipation, fatigue, diarrhea and sexual dysfunction. The abhorrence to CINV is thought to be the main reason leading to premature discontinuation of remedial chemo regimens.

Chemotherapy agents that give rise to the most intolerable bouts of nausea and vomiting are grouped as either Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy (HEC). About 30-90 percent of patients undergoing MEC treatments and more than 90 percent of those undergoing HEC ones experience vomiting without preventative treatment. Overall, some 70-80 percent of chemo patients experience CINV. These numbers show promising market potential for SUSTOL®.

SUSTOL® was launched in October and is the first and only approved
5-HT3 receptor antagonist offering an extended-release effect and five days of
CINV prevention for MEC and HEC regimens. The 5-HT3 receptor system regulates the body’s emetic (nausea and vomiting) responses. SUSTOL® has two important advantages over the market leader, Aloxi. First, it offers a true extended five-day release, as opposed to Aloxi, which drops off after three to four days, a period considered too short for most MEC and HEC regimens. Second, it has a higher profitability potential for oncologists. Over the past three and a half years, Aloxi has had unit sales in the U.S. of between 600,000-700,000 vials per quarter. Aegis Capital (http://dtn.fm/f2EEv), in a recent report, opines that ‘SUSTOL® represents at least a $300 million opportunity over the next five years’.

There’s more to Heron than SUSTOL®, however. The company’s present pipeline includes HTX-011 and HTX-019. HTX-011 is being tested for post-op pain in nerve block and post-op pain in local administration. HTX-019 is being evaluated for the treatment of CINV.

SUSTOL® and HTX-011 utilize Heron’s proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of otherwise short-acting pharmacological agents over a period of days to weeks with a single subcutaneous injection. The Biochronomer® technology consists of bio-erodible polymers, which comprehensive animal and human toxicology studies have established to be safe and well tolerated. When injected into subcutaneous tissue, the polymers undergo controlled hydrolysis, resulting in a controlled, sustained release of the pharmacological agent encapsulated within the Biochronomer-based composition.

Aegis has set a ‘Buy’ rating and a price target of $41.00 on Heron stock, which is currently trading on the NASDAQ under the symbol HRTX at around $15.50.

For more information, please visit www.herontx.com

Neuralstem, Inc. (CUR) Gets Aegis Update

December 5, 2016

Neuralstem, Inc. (NASDAQ: CUR) is a biotechnology company whose patented technology allows for the production, on a commercial level, of a number of types of central nervous stem cells. These are in the development stage for the treatment of conditions and diseases of the central nervous system. The company recently announced the start of enrollment of patients for its phase II trial of NSI-189, a drug developed after Neuralstem did research into neural stem cell lines from the human hippocampus, a part of the brain involved in memory and the generation of neurons.

On November 7 of this year, Aegis Capital Corp. (http://dtn.fm/ep5M8) initiated coverage on Neuralstem, Inc., offering the company a 12-month target price of $2.25 with investment highlights including the enrollment of its phase II trial for NSI-189, the investment of $20 million from Tianjin Pharmaceuticals Holdings Group for completion of the phase II trial, the development of a stem cell platform, and its strong cash position.

Later, on November 10, 2016, Aegis Capital Corp. (http://dtn.fm/hF8ex) released an update to the report, reiterating the company’s ‘Buy’ rating and target price of $2.25 due to the release of Neuralstem’s quarterly results and the update on NSI-189. The company ended the third quarter of 2016 with $5.7 million in cash and cash equivalents with additional proceeds of $20 million from Tianjin Pharmaceuticals Holding Group being used mainly for the future development of NSI-189, the upcoming clinical trial for which is over 50% enrolled and is expected to deliver results as early as 2017.

Aegis Capital Corp. is not the only research analysts firm to take an interest in CUR. According to an article by Cerbat Gem Market News and Analysis (http://dtn.fm/YWjF2), a number of equities research analysts undertook coverage of the company, offering a similar ‘Buy’ rating. Brean Capital offered the company a target price on shares at $4.00 and Roth Capital set the company’s target price on shares at $1.20.

The article also pointed out that numerous hedge funds and other investors have modified their stakes in the company. Sabby Management LLC and Blair Williams & Co. both purchased new positions in CUR worth approximately $1.8 million and $122,000, respectively. CEO Richard J. Daly bought over 35,000 shares of the company worth just under $29,000. In addition, Vanguard Group, Inc. increased its position in shares by over 21%, giving the group ownership of over three million shares worth just under $1 million. Neuralstem is currently trading near $0.27 per share.

For more information, visit the company’s website at www.neuralstem.com

European Patent Dispute Spurs Buying Opportunity with Higher Price Target for Alder Biopharmaceuticals (ALDR)

A legal dispute with the European Patent Office over the European patent for its lead product candidate surprisingly presents a strong buying opportunity for clinical stage biopharmaceutical company Alder Biopharmaceuticals, Inc. (NASDAQ: ALDR), according to an analysis report (http://dtn.fm/9UkRd) released by Aegis Capital Corp on November 23. As such, Aegis analysts reiterated a ‘Buy’ rating for the company and proposed a higher stock price target of $41, compared to the $25.28 stock price at the time the report was issued.

The report acknowledges that the ruling by the European Patent Office’s Opposition Division is unfavorable to product candidate ALD403 and a setback for Alder Biopharmaceuticals and Eli Lilly and Company (NYSE: LLY) in their intellectual property legal proceedings. However, Aegis analysts view the decision as a buying opportunity for Alder, as the valuation impact to the company is minimal. Since the primary market for ALD403, a promising innovative product for migraine prevention and treatment, is still the United States, the European Patent Office ruling is unlikely to have a major impact, the Aegis report says, estimating only an approximate $2 per share decrease from its expected target price.

The dispute stems from opposition to a European patent filed for ALD403 by Alder and Eli Lilly back in July 2014. The European Patent Office’s Opposition Division on November 18 of this year issued an oral ruling unfavorable to the product, insisting that the entire patent should be revoked because it puts forth claims that are too broad and go beyond what is allowed under the European Patent Convention. The patent in question initially claimed proprietary rights over the use of calcitonin gene-related peptide (CGRP) antibodies in therapies designed to prevent vasomotor symptoms associated with CGRP. In the meantime, it has been amended heavily to cover only narrower claims over the use of CGRP antagonist antibodies for the treatment and prevention of headaches, such as migraines and cluster headaches.

The European Patent Office’s Opposition Division’s written ruling is expected in the following weeks. In the meantime, Alder and Eli Lilly already have plans to file an appeal against the decision, based on their initial argument that the broad claims the European Patent Office granted originally should not have been allowed and therefore should be revoked entirely. According to the Aegis Capital Corp report, it’s very likely that the Technical Board of Appeal of the European Patent Office will not uphold the initial ruling of the Opposition Division, since the original claims made by the patent were indeed too broad and went against European Patent Convention provisions and requirements.

Regardless of the outcome, the Aegis report notes, it is unlikely to impact Alder’s U.S. business, given the substantial patent system differences between the United States and the European Union. So even if Alder loses the European Patent Office Case, this will not block the company’s right to move forward with ALD403 clinical development and eventual commercialization in the U.S.

The Aegis Capital Corp report also reiterated a ‘Buy’ rating with a stock price target of $41 for Alder and identified a series of potential risks for investors, including typical risks associated with investments into pre-clinical healthcare development companies (regulatory, research and development, commercialization and manufacturing) and specific risks associated with investing in Alder Biopharmaceuticals (intellectual property rights over ALD403, binary events related to the company’s development programs, the company showing no history of profitability and the possibility of needing more funds to commercialize its products).

For more information, visit the company’s website at www.alderbio.com

SQI Diagnostics, Inc. (SQIDF) Changing How Diagnostics Testing Works

December 2, 2016

Diagnostic labs and drug developers are in a constant search for cheaper, better, faster test results, and SQI Diagnostics (OTCQX: SQIDF) is focused on meeting this demand. The company reduces the timeline for urgently-needed test results and the amount of labor needed, all without forfeiting quality.

SQI Diagnostics is a life sciences and diagnostics company that supports better health care through the development and marketing of technologies and products that propel faster and more accurate advanced multiplexing diagnostics. From SQI’s base in Toronto, a team of expert scientists develops custom research and diagnostic assays that are multiplexed to consolidate and automate many individual tests into one.

The company’s portfolio of automated systems and platforms includes:

  • sqidworks diagnostic platform, a fully-automated microarray processing and analytical system;
  • sqidlite bench-top diagnostic system, a fully automated bench top microarray processing system; and
  • sqid-X, a semi-automated bench-top platform.

SQI delivers these market-leading, quality tests and automated systems for customers who need to measure a broad range of biomarkers in blood and/or other common sample types. Its team supports these customers, who have the skills and ideas to considerably improve quality of life, by providing the tools and services that will bring those ideas to the market sooner.

SQI has 12 patents and the knowledge base to simplify the multiplex testing needs of three key markets, including pharmaceutical and biotechnology drug development, human diagnostic testing and animal health diagnostic testing.

The company’s multiplexed tests and automated systems, combined with its full service product commercialization, hands-free processing and automated data analysis and reporting, shorten the work flow for these markets. This way, the SQI team assists in generating more comprehensive data. By delivering many diagnostic results from single tests and single specimens while using an automated process, SQI increases sample throughput; reduces time, cost and chance for human error; and provides excellent data quality.

To take a closer look at this company, visit www.sqidiagnostics.com

Fortress Biotech, Inc. (FBIO) set to Profit from Profuse Product Portfolio

Fortress Biotech, Inc. (NASDAQ: FBIO) is not putting all its eggs in one basket. This is a biopharmaceutical company with multiple revenue streams and a profuse product portfolio so diversified that Harry Markowitz, the father of modern portfolio theory, might tip his hat to the way the company has sought to mitigate developmental risks. Fortress’ diverse product pipeline also gives it multiple shots at hitting its financial goals, increased by the symbiotic relationship between development areas. The research platforms are structured so that success in one area is likely to add impetus to another.

Fortress is parent to a group of companies dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. The company plans to develop and commercialize products that it acquires both directly and indirectly by establishing subsidiary companies, also known as Fortress Companies. The company will then leverage its biopharmaceutical business expertise and drug development capabilities to help the Fortress Companies achieve their goals. Additionally, Fortress will provide funding and management services to each of the Fortress Companies, and, from time to time, the company and the Fortress Companies will seek licensing, partnerships, joint ventures, and/or public and private financing to accelerate and provide additional funding to support their research and development programs.

The current pipeline ranges over products in various stages of development. Still in the pre-clinical stage are programs for oncolytic virus (a virus to destroy cancer cells); the CK-103 BET Inhibitor, also directed at cancer; and at least five others.

At the phase I/II stage, Fortress and its subsidiaries have at least a dozen programs underway. These include N-acetyl-D-mannosamine (ManNAc) Triplex for kidney disease and GNE myopathy, CNDO-109 and CD123 CAR for acute myeloid leukemia (AML), and CEVA101 for adult and pediatric traumatic brain injury (TBI).

This year, under subsidiary Journey Medical Corporation (JMC), the company took four products, Targatox, Dermasorb, Ceracade and Luxamend, to market. In July 2016, JMC received FDA approval to manufacture Targadox™, its product for the treatment of severe acne. Sales commenced in October 2016. During the second quarter of 2016, JMC began sales of “Journey” branded products including Luxamend®, its prescription wound cream, and Ceracade™, its emollient for the treatment of various types of dermatitis. At the end of the third quarter (September 30, 2016), JMC product sales had reached $1.8 million, a sign of very good things to come.

Several analysts have taken notice. The Cerbat Gem (http://dtn.fm/kd16B) reports that ‘Fortress Biotech Inc. stock had its “buy” rating reaffirmed by stock analysts at FBR & Co in a note issued to investors on November 18.’ On October 3, Roth Capital initiated coverage of Fortress, setting a ‘Buy’ rating and a price target of $9.00. In addition, Zacks Investment Research raised Fortress Biotech from a ‘Hold’ rating to a ‘Buy’ rating and set a $3.00 price objective for the company in a research report issued on September 20th. Fortress stock currently trades at around $2.30 on the NASDAQ under the symbol FBIO.

For more information, visit www.fortressbiotech.com

Akebia Therapeutics (AKBA) ‘Buy’ Rating Reiterated with Higher Stock Price Target of $18

Akebia Therapeutics, Inc. (NASDAQ: AKBA), a biopharma company that focuses on the development of innovative treatments for chronic kidney disease-related anemia, is maintaining its ‘Buy’ rating, with a recommended stock price target of $18 compared to the current $8.90, according to an Aegis Capital Corp. report (http://dtn.fm/2z8XE) released on November 15. The rating and suggested stock price were based on discounted cash flow analysis and the estimated 2016-2022 EBITDA, with a discount rate of eight percent, the report said.

The analysis also assumed a 60 percent probability of clinical success for Akebia’s lead product candidate Vadadustat, currently in development as an oral treatment for anemia in patients with chronic kidney disease. The treatment was developed based on hypoxia inducible factor (HIF) and more specifically based on a novel action mechanism called HIF Prolyl-hydroxylase inhibition. It was designed to help regulate hemoglobin levels by activating red blood cell production in a way that mimics the human body’s natural adjustments when exposed to the lower oxygen levels of higher altitudes.

Vadadustat is currently in phase III trials, after encouraging results were reported during phase II testing. The first trial is called PRO2ECT and is focused on non-dialysis dependent chronic kidney disease patients, with 3,100 patients expected to enroll by the second half of 2017. The second phase III trial is called INNO2VATE and targets dialysis-dependent chronic kidney disease patients, with 2,600 patients to enroll by the first half of 2018. Both trials have been vetted and approved by the Food and Drug Administration (FDA).

According to Aegis Capital, Akebia’s current cash and cash equivalents of $163 million, as reported by the company in its Q32016 results, should be sufficient to fund operations through the second quarter of 2017. The estimate did not include cash from the company’s Asian distributor, Mitsubishi Tanabe Pharma Corporation (OTC: MTZPY), or possible contributions from a potential EU partner. The valuation was based solely on estimated Vadadustat sales of approximately $515 million by 2022, the report said. As for Akebia’s Q32016 results, the analysis underlines that they were in line with estimates, with a $0.96 loss per share amounting to $36.3 million.

Akebia entered a partnership agreement with Japan’s Mitsubishi Tanabe Pharma Corporation in December 2015, under which the latter was provided with exclusive Vadadustat development and commercialization rights in Japan and Asia. In exchange, Akebia is receiving funding for phase III trials of the therapy, being eligible to receive up to $350 million. So far, the Japanese company paid a $100 million milestone. According to Aegis Capital, Akebia is looking for a similar agreement with an EU corporation, and it is very likely for a European partnership to become reality in early 2017.

Reiterating a ‘Buy’ rating with a stock price target of $18, Aegis Capital analysts also outlined the risks of which potential Akebia investors should be aware. The report identified a series of typical risks associated with investments into healthcare companies such as regulatory, R&D and manufacturing risks, as well as specific risks derived from investing in Akebia, such as intense competition, pricing and reimbursement pressure, potential multiple binary events, the fact that the company has no history of profitability and that more funds might be required to actually develop and commercialize its therapies successfully.

For more information, visit the company’s website at www.akebia.com

Zogenix, Inc. (ZGNX) Develops Orphan Drug for Dravet Syndrome Epilepsy

December 1, 2016

Zogenix, Inc (NASDAQ: ZGNX) is a clinical stage pharmaceutical company committed to the development and commercialization of therapies for central nervous system disorders that address specific clinical needs for people living with orphan diseases. The company’s lead product candidate, ZX008, is currently being evaluated for the treatment of one such disease – Dravet Syndrome.

Despite the name, orphan diseases affect adults as well. The soubriquet ‘orphan disease’ arose because pharmaceutical companies showed no interest in ‘adopting’ them due to their comparatively small market size. However, the Orphan Drug Act (ODA) of 1983 created financial incentives for drug and biologics manufacturers to devote resources to developing treatments for such diseases, including tax credits for costs of clinical research, government grant funding, and assistance for clinical research. Most importantly, the FDA promised to give a seven-year period of marketing exclusivity to the sponsor of an orphan-designated product who first obtains market approval for that indication.

Dravet Syndrome is a rare genetic epileptic encephalopathy (brain disorder) that, typically, begins during the first year of life. Up until 1989, the condition was referred to as either epilepsy with polymorphic seizures, polymorphic epilepsy in infancy (PMEI) or severe myoclonic epilepsy in infancy (SMEI).

In June, Zogenix initiated the second phase III clinical trial, a multi-national study, of ZX008 as an adjunctive treatment of seizures in children with Dravet Syndrome. ZX008 is designated as an orphan drug in both the U.S. and Europe, and received Fast Track designation in the U.S. for the treatment of Dravet syndrome.

Zogenix is also exploring the efficacy of ZX008 (Fenfluramine) in treating Lennox-Gastaut Syndrome (LGS). LGS is a particularly debilitating type of epilepsy that, in many cases, impairs intellectual development. Sufferers exhibit different types of seizures, particularly tonic (stiffening) and atonic (drop) seizures. Although LGS accounts for only two to five percent of childhood epilepsies, its seizures are hard to control and require life-long treatment.

Interim data from that efficacy study will be presented at a poster session, or presentation of research information or findings, on December 3 at the 70th Annual Meeting of the American Epilepsy Society. Data covering eight weeks from the open label dose finding study will be made public in a presentation entitled ‘Effectiveness and Tolerability of Low Dose Fenfluramine (ZX008) in Lennox Gastaut Syndrome: A Pilot, Open-Label Dose Finding Study’.

A recent report from Aegis Capital (http://dtn.fm/V1JFd) has put a price target of $28.00 on Zogenix. The stock is currently trading at about $12.80 on the NASDAQ under the symbol ZGNX. The current valuation of $329.8 million based on outstanding shares of 24.8 million at $13.30, the market price at November 23, is based on an 80 percent chance of success in the clinical development process of ZX008 for the treatment of Dravet Syndrome.

For more information, visit www.zogenix.com

Recro Pharma, Inc. (REPH) Says No to Opioids for Post-Operative Pain Control with IV Meloxicam

November 30, 2016

An announcement earlier this week from revenue-generating specialty pharmaceutical company Recro Pharma, Inc. (NASDAQ: REPH) is good news for those suffering from pain after major surgery. From its headquarters in Malvern, Pennsylvania, the company announced positive results from a phase III clinical trial evaluating intravenous (IV) Meloxicam for the treatment of acute post-operative pain.

In this trial, the second of two phase III trials, IV Meloxicam achieved the primary endpoint of a statistically significant differential in Summed Pain Intensity Difference over the first 24 hours (SPID-24) in patients who had undergone abdominoplasty surgery, as compared to placebo. With the positive data from this study, the company believes this completes the efficacy program for IV Meloxicam and opens the way for a New Drug Application (NDA).

A report from Aegis Capital (http://dtn.fm/Kx7Za), released earlier this month when it initiated coverage on Recro Pharma, shows why this is a big deal. Aegis estimates the size of the U.S. post-operative pain market at around $5.9 billion. At present, many of the analgesics employed, such as morphine, codeine, and hydrocodone, are opioids. But such powerful anodynes are notoriously addictive and their use is often subverted from pain relief. According to the Centers for Disease Control (CDC), 29,000 Americans die every year from opioid-related overdoses.

Consequently, there is growing demand for less addictive pain medications, particularly in the post-op environment, where conventional pain management drugs such as morphine are still commonly used. In addition to being less addictive than morphine, IV Meloxicam can be delivered as a 15-second infusion and has been shown to have fast onset of action in clinical trials. As a result of these factors, Aegis expects peak year revenue for IV Meloxicam to be in the range of $150-200 million.

This trial focused on testing the efficacy of IV Meloxicam in combating pain following abdominoplasty surgery, a complicated procedure that generally involves the removal of excess fat and skin and may include the restoration of weakened or separated muscles from the abdominal area. The American Society for Aesthetic Plastic Surgery reports that abdominoplasty is among the top five most common cosmetic surgeries in the U.S., with more than 164,000 performed in 2014. It is a procedure that, typically, results in intense postoperative pain.

In July, Recro announced positive top-line data from the IV Meloxicam (30 mg dose per 24 hours) in bunionectomy phase III trial. This first phase III trial measured its primary endpoint in terms of Summed Pain Intensity Difference over 48 hours (SPID-48) and showed a statistically significant reduction in SPID-48 versus placebo. It also achieved statistical significance across 15 of 19 secondary endpoints.

With the successful completion of these two phase III trials, an NDA is expected to be filed in summer 2017, followed by potential FDA approval in mid-summer 2018.

Recro Pharma is a clinical development-stage pharmaceutical company geared toward the development of non-opioid treatments for the management of acute pain in hospital and ambulatory care (outpatient) settings. The company currently earns revenue from a contract manufacturing, royalty and formulation business in Gainesville, Georgia, acquired in April 2015 from Alkermes, the Irish drug maker. Its lead product candidate, IV Meloxicam, is a cyclo-oxygenase 2 (COX-2) inhibitor, exclusive worldwide rights to which were acquired as part of the 2015 Alkermes deal.

Aegis originally put a price target on Recro Pharma stock, currently trading on the NASDAQ at around $9.00 under the symbol REPH, of $21.00. This was based on a 70% probability that the abdominoplasty phase III trial would be successful. With that study yielding such decidedly positive results, the price target was raised to $25.00 in an updated report (http://dtn.fm/Lvu6Y).

For more information, please visit www.RecroPharma.com

Axsome Therapeutics, Inc. (AXSM) Shedding New Light on Old Drugs

November 29, 2016

New York-based Axsome Therapeutics, Inc. (NASDAQ: AXSM) is tending to a major and thriving market where current treatment options are insufficient. This young company (founded in 2012) is striving to establish a fully-integrated biopharmaceutical business that will develop and bring to the healthcare marketplace therapies for the management and treatment of central nervous system (CNS) disorders.

Axsome Therapeutics has a laser-like focus on differentiated therapies, in particular. To improve the lives of patients living with pain and various CNS disorders, Axsome has set its sights on working with both internally-derived drug candidates and in-licensed drug candidates in order to create a path to development and commercialization that will, ultimately, expand the treatment alternatives available to caregivers.

Axsome Therapeutics has moved into the clinical stage at this time. It holds a product candidate portfolio that includes two late-stage candidates, AXS-02 and AXS-05, which it is developing for multiple indications, as well as AXS-06.

  • AXS-02, a non-opiod therapeutic in development for chronic pain, is Axsome’s leading product candidate. It is currently being evaluated in phase III trials for the treatment of complex regional pain syndrome, knee osteoarthritis with bone marrow lesions (BMLs) and chronic low back pain with modic changes.
  • AXS-05 is a fixed-dose combination of dextromethorphan and bupropion, both of which have shown to be effective in activating central nervous system receptors. AXS-05 is currently in a phase III trial indicated for treatment resistant depression and agitation in patients with Alzheimer’s disease.
  • The company is also developing AXS-06 for the treatment of chronic pain disorders.

Analysts have pointed to the value in Axsome’s focus on complex regional pain syndrome, treatment resistant depression and agitation in patients with Alzheimer’s disease, indicating that these disorders possess lower-than-average research and development risks and a tested business model that leans toward a faster commercialization timeline (http://dtn.fm/Urt7t).

For more information, visit www.Axsome.com

Chanticleer Holdings, Inc. (HOTR) Preparing for Grand Opening of Little Big Burger in Portland, Oregon

Chanticleer Holdings, Inc. (NASDAQ: HOTR) kicked off November with the announcement that, during the fiscal quarter ended September 30, 2016, the company achieved its second consecutive quarter of adjusted EBITDA profitability. This milestone came alongside an 18.3 percent year-over-year increase in total revenue, which was attributed primarily to Chanticleer’s rapidly expanding fast casual better burger segment. In a news release, Mike Pruitt, chairman and chief executive officer of Chanticleer, noted that the company’s Little Big Burger restaurants were performing “particularly well” before adding that the brand contributed “significantly to the 19% sequential growth in Adjusted EBITDA from continuing operations” and further validated Chanticleer’s regional brand strategy.

With this regional brand strategy at the forefront of Chanticleer’s near-term growth efforts, it came as little surprise when, before the opening bell on Monday, the company announced plans for the launch of a new Little Big Burger restaurant in Portland, Oregon. The grand opening of the new location, which will be Chanticleer’s ninth Little Big Burger and 40th fast casual better burger store, is set to take place next week in Oregon’s largest city, whose metropolitan area is home to roughly 60 percent of the state’s overall population. Pruitt used Monday’s news release to speak toward the company’s excitement ahead of next week’s grand opening.

“We are very pleased to open up a new Little Big Burger in the Portland area,” he stated. “This store is our first store opening financed with EB-5 capital, which provides attractive, non-dilutive capital to expand our regional brands. Little Big Burger has been performing well with particularly attractive store economics, and we look forward to continuing to strategically utilize EB-5 financing for additional Little Big Burger restaurants as well as our other regional brands.”

As referenced by Pruitt, EB-5 capital stems from a federal government program created to encourage foreign investment in U.S. businesses. In addition to serving as one of the fastest methods for foreign investors to gain permanent residency in the U.S., the program is used nationwide to finance the construction and development of new projects in an increasingly diverse number of industries. EB-5 financing is particularly attractive to those operating within the hospitality sector, as it provides a low cost alternative to more traditional sources of capital while typically presenting favorable financing terms that result in reduced financial risk.

Chanticleer’s newest Little Big Burger restaurant will be located in Portland’s bustling Lloyd District at 1088 NE 7th Avenue.

For more information, visit www.chanticleerholdings.com

bBooth, Inc. (BBTH) Introduces Virtual Representatives to the Marketing Mix

November 28, 2016

Hollywood-based entertainment technology company bBooth, Inc. (OTCQB: BBTH) is set to disrupt the entire Software-as-a-Service (SaaS), Customer Relationship Management (CRM), and sales lead generation software industry with its novel bNotifi platform. With bNotifi, marketers get two boons for the price of one. First, marketing reach is expanded with the employment of virtual representatives and, second, the message gets told with motion pictures, which, as we now know, are worth much, much more than a thousand words. The bNotifi technology has completely re-invented what a CRM, lead-generation tool should be in today’s video-centric social environment.

If, in today’s online marketing realm, content is king, then video must surely be the crown. A feature this month on Search Engine Watch (http://dtn.fm/xIl5F) predicts ‘that video will account for 69% of all internet traffic by 2017.’ It goes on to say ‘for brands, video content is a powerful way to introduce themselves, spread their message, promote a product, increase their reach, boost engagement, and explain their service.’

The company that eschews video in the marketing mix risks missing the boat. eMarketing reports that ‘during mid-2015, online video overtook social media relative to the amount of time spent per day online’. And a survey from HighQ confirms this: ‘…approximately 55% of Americans watch online videos every day, with the average American adult spending one hour and 16 minutes each day watching video on digital devices. Growth relative to this area has been staggering as consumers spent only 21 minutes per day watching online videos in 2011.’

bBooth CEO Rory J. Cutaia is certainly aware of these trends, but points out that ‘video marketing is no longer (just) about YouTube videos or brands distributing clips on social media’.

“More and more thought leaders have begun to recognize that targeted interactive video communications that track the level of viewers’ actual engagement is far and away more effective in generating, and more importantly, in recognizing hot sales leads,” argues Cutaia in a press release (http://dtn.fm/n5y1O).

The bNotifi platform originated from bBooth’s mall-based kiosks and mobile apps that were focused on talent discovery (http://dtn.fm/k9NfU). The technology has been improved and upgraded to a cloud-based, enterprise level SaaS platform, developed to address a much larger target market that includes celebrities and sports personalities, corporate users, consumer brands and media companies. The bNotifi technology represents a new innovative platform for CRM, lead-generation, advertising, fan engagement, and consumer brand activation.

Through fully integrated mobile, desktop, and web-based applications, the bNotifi technology provides push-to-screen, media-rich, interactive audio and video messaging and communications for higher levels of social engagement and interactive online training and teaching applications, as well as an enterprise scale lead generation and customer retention platform for sales professionals and others.

The bNotifi platform also includes a robust back-end administration console with data collection capabilities, among other features, designed to provide small, medium and large-scale enterprise users, among others, with the ability to send, receive and manage enhanced, media-rich, highly-engaging messaging for both internal and external communications.

In September, bBooth announced it had agreed to provide The Matrix Group, and its 890,000 independent representatives in affiliate organizations, with the bNotifi CRM and Lead Generation technology. And in October, The Matrix Group began a global launch of bNotifi, which will give its associates the power to engage customers and prospects in an entirely new, interactive media-rich format. Building on this progress, BBooth announced the release of bNotifi 2.0 earlier this month.

For more information, visit www.bbooth.com

Trans-Lux Corp. (TNLX) is Helping America Flick the Switch to LED Lighting

LED (Light-Emitting Diode) lighting is brightening the homes, offices, factories and public spaces of America. A report from ResearchandMarkets (http://dtn.fm/6RlaJ), issued last month, estimates that the U.S. LED market is set to grow at a CAGR of 8.8 percent from 2016, reaching $8.9 billion by 2022, with as much as half of this growth coming from general lighting. And America is just the beginning. As the world switches from incandescent and fluorescent lighting, the market to replace these legacy systems globally is set to grow even faster. This forecast growth is lighting a bright future for Trans-Lux Corp. (OTC: TNLX), a premier global supplier of engaging LED-based digital display and lighting solutions.

The first lights powered by electricity appeared in the mid-nineteenth century. The arc lamp, invented by Humphry Davy, worked by allowing an electric current to ‘jump’ between two close, but separated, carbon electrodes. The arc of luminous ionized air that resulted provided a bright light. By the late nineteenth century, Edison and others were working on ways to develop incandescent bulbs, which issued light when electricity passed through a filament. In 1904, the adoption of incandescent lighting accelerated after the introduction of tungsten filaments. By the 1930s, however, fluorescent lights were making their debut, and, by the 1950s, they were everywhere. Now, after reigning for over a half a century, fluorescent lighting is about to be deposed by LEDs.

LEDs use semiconductors to convert electricity into light. Their rise to the top of the lighting pecking order stems mainly from their “luminous efficacy”, i.e., their efficient use of power. A light bulb’s efficiency is a measure of emitted light (lumens) divided by the power it draws (watts). A bulb that is 100 percent efficient at converting energy into light would have an efficacy of 683 lumens per watt. To put this in context, a 60- to 100-watt incandescent bulb has an efficacy of 15 lumens per watt, an equivalent fluorescent tube has an efficacy of 73 lumens per watt, and current LED-based replacement bulbs on the market range from 70-120 lumens per watt, with an average efficacy of 85 lumens per watt.

Trans-Lux is certainly playing a part in guiding America through its transition to LED. This is a company that has been innovating since 1920, known globally as a leader in indoor and outdoor digital signage, scoreboards, and lighting solutions for numerous industries, including commercial, education and sports markets. Trans-Lux product offerings fall into three broad categories: scoreboards, video displays and LED lighting.

The LED systems that Trans-Lux designs, manufactures, distributes and services are programmable in real time. They can be fashioned to meet the digital signage needs for a venue of any size, whether indoor or outdoor, and have found application in the financial, banking, gaming, corporate, advertising, transportation, entertainment and sports markets. Trans-Lux lighting fixtures save energy and offer a comprehensive range of the latest LED lighting technologies. This provides private facilities and public infrastructure with “green” lighting solutions that emit less heat, save energy and enable creative designs.

The company recently filed its latest 10-Q for the quarter ended September 30, 2016. Although it managed quarterly revenues of $5.9 million and income of $140,000 ($0.05 per share), performance was down compared to the third quarter of 2015. CEO Jean-Marc Allain, former president of Panasonic System Solutions, attributed the lower revenues to logistical issues.

“In the third quarter, construction of our new state-of-the art manufacturing facility in St. Louis and the coordination of several facilities has impacted deliveries. However, we fully believe that when complete, our new manufacturing base will provide great and sustained returns and efficiencies. We are confident that shipments that were delayed in third quarter, will be delivered in fourth quarter,” Allain stated in a recent news release (http://dtn.fm/blTA2).

For more information, visit www.trans-lux.com

MiMedx Group, Inc. (MDXG) set to Triple Revenues by Healing Wounds Faster

To paraphrase the renowned German playwright, Bertolt Brecht, nature does not remember kisses on the cheek. Wounds, on the other hand, perversely leave scars. Perhaps fortunately, kisses leave no mark, but injuries to the body do. And the scars of such damage not only disfigure appearances but result in adhesion, which occurs when scars bind with surrounding tissue.

Luckily, however, advances in the field of regenerative medicine may soon relegate scar tissue to the indecipherable lyrics of a Red Hot Chili Peppers ballad. MiMedx Group, Inc. (NASDAQ: MDXG) is now bringing comfort to the wounded with its groundbreaking amniotic tissue allografts that promote tissue regeneration.

Scar tissue, however, is not the only issue that MiMedx is addressing. Its regenerative therapies based on amniotic tissue not only reduce scarring but modulate inflammation and enhance the healing process. This trifecta of winning outcomes has driven MiMedx to the top. In the span of eight years, the company has risen to become the world’s premier processor and supplier of human amniotic tissue and has, to date, distributed over 700,000 amniotic tissue grafts worldwide. Successful clinical outcomes have been achieved in a variety of therapeutic settings, including ophthalmology, spinal, chronic wounds, dental, orthopedic surgery, sports medicine, and urology.

Tissue derived from the amniotic membrane, which is the innermost layer of the placenta, is the building block of the MiMedx regenerative therapies. Normally, a mother’s placenta, or afterbirth, along with the amniotic membrane, is discarded as medical waste. However, through its Placenta Donation Program (http://dtn.fm/Mvz2R), MiMedx allows mothers, delivering healthy babies by planned Caesarean section, to donate their placentas. The amniotic membrane is then separated from the rest of the placenta and subjected to MiMedx’s proprietary Purion® technology, which is the foundation of its two lead products: AmnioFix® and EpiFix®.

The AmnioFix® and EpiFix® allograft solutions are MiMedx’s chief wound care (and company) products. Both allografts have an advantage over competitive products in that they can be stored at room temperature for five years without the need for refrigeration or freezing. As a result, they can be used right out of the package without a complicated thawing process. These critical qualities of the MiMedx® allografts allow hospitals, clinics, and surgeons to quickly provide the appropriate treatment while effectively managing their inventory of allografts.

The care of wounds is an undeveloped market. In a report issued earlier this month, Aegis Capital (http://dtn.fm/LOl14) estimated that MiMedx commanded a 60 percent share of the amniotic tissue market, a market that is, at present, growing by roughly 15 percent annually. MiMedx derives about three-quarters of its revenues from its amniotic tissue business. Together with its Surgical, Sports Medicine, and Other (SSO) business lines, Aegis expects that by 2020, the company will triple revenues to $560 million and earn one dollar in EPS (earnings per share). There are numerous caveats, however. Gross margin must stay in the low 80 percent range; operating margin must hover around 30 percent; and sales, general and administration (SG&A) expenses must not exceed half of sales.

Management is certainly expecting growth. The company has been engaged in an aggressive $60 million share buyback program, which could be signaling undervaluation. The Aegis analysts certainly think so. They have put a ‘Buy’ rating and price target of $12.00 on MiMedx. The stock is current trading at around $9.90 on the NASDAQ under the symbol MDXG.

For more information, visit www.mimedx.com

Vanda Pharmaceuticals, Inc. (VNDA) Receives Consensus Rating of “Buy”

November 21, 2016

Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of pharmaceutical products to help in the treatment of central nervous system disorders, now has a product portfolio made up of HETLIOZ® (tasimelteon), Fanapt® (iloperidone), Tradipitant (VLY-686), Trichostatin A, and AQW051, all of which address high unmet medical needs and improve the lives of patients.

The company recently released its financial results for the third quarter of 2016 (ended September 30) highlighting that total revenues grew to $38.5 million, an increase of 7% over the second quarter of this year. This was also a 36% increase compared to Vanda’s $28.3 million during the third quarter of 2015, with an increase to cash of $6.6 million.

As a result, several research firms across the U.S. have commented on VNDA. Aegis Capital Corp. (http://dtn.fm/G6slI) initiated coverage of Vanda Pharmaceuticals, giving the company a ‘Buy’ rating with a target price of $24. The report’s investment highlights included HETLIOZ® for non-24, Fanapt®’s asset life extension through November 2027 due to the company’s ‘610 patent win, and the fact that Vanda R&D programs in the pipeline carry lower than average development risks.

Jefferies Group, Brean Capital, and Piper Jaffray Cos. also gave Vanda Pharmaceuticals a ‘Buy’ rating, with a target price ranging between $19 and $24. JMP Securities gave Vanda a “Market Outperform” rating, upping its price target on shares from $18 to $22. In addition, many large investors have also upgraded their positions with Vanda Pharmaceuticals, Inc.

According to the Cerbat Gem Market News and Analysis (http://dtn.fm/bQS1s) site, the Bank of Montreal in Canada bought a new stake in shares worth approximately $132,000; UBS Asset Management Americas, Inc. increased its position within the company by just under 11%, making them the proud owners of 16,300 shares; and Paloma Partners Management Co. bought a new position worth approximately $192,000. Jane Street Group LLC and TFS Capital LLC bought new positions worth about $200,000 and $210,000 respectively.

Vanda Pharmaceuticals, Inc.’s earnings per share beat the consensus estimate by $0.13, and it beat the earning consensus estimate by approximately $0.43 million. The company’s non-GAAP EPS came in above street estimates of $0.01 at a huge $0.11, and full year revenue has gone from $143 million to $153 million.

For more information, visit the company’s website at www.vandapharmaceuticals.com

Professional Diversity Network, Inc. (IPDN) Closes Stock Sale Transaction with Cosmic Forward Limited

In a recent news release by Professional Diversity Network, Inc. (NASDAQ: IPDN), it was announced that Cosmic Forward Limited (“CFL”), a Seychelles-based private company, now owns 51% of the Internet software and services company, which specializes in providing career networking for women and diverse professionals.

IPDN recently completed the sale of 1,777,417 shares of its common stock to CFL for $9.60 per share, generating gross proceeds of approximately $17.1 million, prior to expenses and debt repayment. The capital, along with the newly-formed strategic partnership, is expected to play a role in IPDN’s efforts to expand its operations into a number of global markets, including China. Cosmic Forward Limited is wholly-owned by Maoji (Michael) Wang, Jingbo Song, Yong Xiong Zheng, and Nan Nan Kou.

The National Association of Professional Women (NAPW), a subsidiary of IPDN, provides an online platform offering employer clients covering more than 200 industries and professions a way to find professional talent while helping them comply with the Office of Federal Contract Compliance Programs.

In the news release, Star Jones, president of IPDN, added, “I am extremely proud that our partnership with CFL allows Professional Diversity Network to capture a new audience and grow exponentially by taking women’s empowerment, diversity recruiting, skills training and innovative technology global.”

In a related move, IPDN announced results of an earlier self-tender offer to repurchase up to 312,500 shares of its common stocks. IPDN has accepted 312,500 shares of its common stock at a purchase price of $9.60 per share, for a total purchase price of approximately $3.0 million net to the seller in cash, less any applicable withholding taxes and without interest.

See http://dtn.fm/F1xD2 for the detailed press release.

For more information on Professional Diversity Network, please visit www.prodivnet.com

Park Place Energy (PKPL) Expects Exponential Growth after Turkish Assets Acquisition

Park Place Energy, Inc. (OTCQB: PKPL), a Texas-based gas and oil exploration company focused on running international development and exploration projects, anticipates significant growth in terms of cash flow and share prices once it completes the acquisition of three oil and gas companies in Turkey next month. The company, which already has an established presence and offices in the Balkan region via its gas exploration in northeast Bulgaria, entered a purchase agreement with Tiway Oil B.V. in December of last year for the acquisition of three Tiway subsidiaries controlling three oil and gas explorations in Turkey – one offshore and two onshore, for $2.1 million. A $500,000 deposit toward the purchase was already made when the deal was initiated, and plans are to complete the transaction by the end of the year, once all regulatory approvals are received from the Turkish authorities.

The three producing areas that will be purchased from Tiway under the agreement have significant potential, in particular the South Akcakoca Sub-Basin (SASB) offshore gas field. Production from the three assets has averaged 417 barrels of oil equivalent per day (POE/D) in the first nine months of the year. Park Place intends to begin programs to maximize production as soon as the transaction is completed, most likely starting in January of next year.

The main focus will be the SASB gas field in the Black Sea, which is described as having substantial untapped potential, with a total of four platforms, 22 wells of which 10 are fully functional, and an onshore gas processing plant. Tiway has a 36.75% non-operated working interest in SASB. Since its discovery in 2004, the field has produced an estimated 37 billion cubic feet of gas and has yielded roughly $277 million in gross proceeds. Park Place has identified four undeveloped discoveries with the potential of producing up to 60 billion cubic feet of gas in the near future. The company expects the SASB field to generate initial revenue of more than $200 million by the end of 2018, once it launches its production enhancement program consisting of the drilling of four additional wells, construction of a gas lift and re-drilling of some of the existing wells.

The two onshore assets – the Cendere oil field and the Bakuk gas field – are also expected to generate significant revenue and to consolidated Park Place’s presence in the region. Although in operation since the 1990s, Cendere is likely to continue production for another 10 years or more. The field currently has 16 wells producing gross 600 barrels per day, with 110 barrels net to Tiway. Cendere has produced more than 19 million barrels from the 45 million estimated initially. Park Place intends to increase the field’s production further through additional infill well opportunities, possibly extending the field laterally and through low cost perforation in the upper pay zones. The Bakuk gas field, located near the border with Syria, has only one well in operation, averaging roughly 48 Mcf/D during the first six months of the year. There is an estimated 5.8 Bscf gas still in place, according to Park Place figures.

In addition to the Turkish assets, Park Place holds the rights to a gas field in Bulgaria. The Vranino 1-11 Block, located in the northeast portion of the country, is currently not in operation, as the regulatory approvals issued by the Bulgarian government were disputed by local NGOs. Until the situation is resolved, Park Place cannot commence operations to extract gas from coal seams in the area. The company is planning on drilling up to five wells using the latest and safest gas extraction techniques not involving underground coal gasification or hydraulic fracking, which was banned in Bulgaria in 2012. It is believed that the Vranino block may contain more than one trillion cubic feet of recoverable gas and that successful extraction, in addition to the field’s close proximity to a major gas pipeline, can eventually lead to lower gas prices for the entire region.

For more information, visit www.parkplaceenergy.com

Ampio Pharmaceuticals, Inc. (AMPE) Targeting Common Inflammatory Conditions with Two Late-Stage Product Candidates

November 18, 2016

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) is a development stage biopharmaceutical company focused on the discovery and development of novel therapies aimed at treating common inflammatory conditions for which there are limited treatment options. The company’s development pipeline currently features two product candidates advancing through late-stage clinical trials in the United States, including Ampion™ for the treatment of osteoarthritis of the knee (OAK) and Optina™ for the treatment of diabetic macular edema (DME).

Osteoarthritis, the most common form of arthritis, currently affects more than 100 million people in the United States alone, with over 48 million suffering from OAK. Meanwhile, the prevalence of DME is estimated at about 30 percent of patients inflicted by type I or type II diabetes mellitus for 20 years or more. For reference, roughly 11.3 percent of the U.S. population over the age of 20 lives with some form of diabetes.

Late last week, Ampio issued a news release updating its shareholders on the status its clinical development programs. The company is in ongoing discussions with the FDA’s Center for Biologics Evaluation and Research regarding the best path forward to obtain a Biological License for Ampion™ for the treatment of OAK. According to Michael Macaluso, chief executive officer of Ampio, the FDA has provided a “number of fair and reasonable paths forward to a Biological License” and Ampio hopes to “have a final decision on the path we will follow by year-end.”

In addition to its late-stage Ampion™ development program for the treatment of OAK, Ampio also recently completed a pilot study designed to examine the safety and efficacy of the candidate as a treatment for patients with osteoarthritis of the hand (OAH). Macaluso described the trial as “a small pilot study designed to examine the safety of a single injection of Ampion™ into the basal thumb joint of patients with hand OA, which is common, troublesome, and has limited treatment options.” After four weeks, 66.7 percent of patients treated with Ampion™ demonstrated an improvement in pain, while just 33 percent of patients in the control group noticed an improvement.

“These preliminary results were not unexpected as they are consistent with the results from over 1800 patients in our OA of the knee studies,” Macaluso added in a news release.

The most recent update regarding the development program for Optina™, issued early last month, notes that a manuscript, titled ‘Potential Beneficial Effect of Low Dose Danazol in Combination With Renin Angiotensin Inhibitors in Diabetic Macular Edema’, was accepted for publication in Acta Ophthalmologica, an international peer-reviewed journal in the field of ophthalmology. The article reports on the clinical benefits of Optina™, as observed from a 12-week multi-center, placebo-controlled, double-masked randomized trial. The findings were also presented at the 2016 annual meeting of the Retina Society in San Diego, California.

For more information, visit www.ampiopharma.com

Inovio Pharmaceuticals, Inc. (INO) opens New Front Line in War against Cancer & Infectious Diseases with DNA Vaccines

November 17, 2016

Over 2,000 years ago, Plato, in his immortal Socratic dialogue, had the great philosopher express his astonishment at the new diseases plaguing Athenian society and their bizarre and horrible names. Our position today is very similar. Strange, horrible afflictions with bizarre, frightening names like cancer, Ebola and Zika, unknown or unrecognized until modern times, threaten us with epidemics and pandemics. For a hundred years or so, we’ve fought them off with traditional vaccines and pharmaceuticals. Now, a new battlefront is set to open with the advent of DNA vaccines from companies like Inovio Pharmaceuticals, Inc. (NASDAQ: INO).

Traditional vaccines stimulate the immune system to respond to threats from antigens in the lymph and blood. The lymph is a colorless fluid containing white blood cells that bathes the tissues. These traditional vaccines are said to stimulate humoral immunity. (Humor is a medieval term for body fluid.) The most famous of them, perhaps, and certainly the first was Edward Jenner’s smallpox vaccine in 1796. Traditional vaccines have been developed against numerous bacterial and viral pathogens, but their development against many life-threatening viruses has been elusive.

DNA vaccines, by contrast, stimulate cell-mediated immunity, which is good, since most of the scientific community believes that it is cell-mediated immunity, rather than humoral immunity, that has the dominant role in fighting viral infections. The problem is that viruses live and replicate inside cells. They seize the synthetic machinery of the host and, therefore, are sheltered from antibody surveillance. Cell-mediated immunity, however, can detect and destroy these infected cells.

Inovio Pharmaceuticals is revolutionizing the fight against cancers and other infectious diseases with a range of these DNA immunotherapies (vaccines). Its technology platform is applicable to cancers and infectious diseases and the company has developed antigen-targeting immunotherapy and vaccine product candidates for HPV-caused pre-cancers and cancers of the breast, lung, pancreas, and prostate, as well as hepatitis, HIV, influenza, and Ebola. Its lead program targets cervical dysplasia and has just completed a phase II clinical study.

In March, the company announced (http://dtn.fm/3PRmG) that this immunotherapy to treat cervical dysplasia (VGX-3100) had earned recognition as the “Best Therapeutic Vaccine” by the World Vaccine Congress held that month in Washington, D.C. The Vaccine Industry Excellence (ViE) Awards honor outstanding vaccine advancements and achievements of therapeutic and preventive vaccine developers across the global industry, as judged by a panel of global biotech industry stakeholders.

At present, Inovio’s proposed phase III clinical program for the VGX-3100 program is under clinical hold. The FDA has requested additional data to support the shelf life of the newly designed and manufactured disposable parts of the CELLECTRA® 5PSP immunotherapy delivery device. The hold does not pertain to any of Inovio’s other ongoing clinical studies. Management expects the VGX-3100 issue to be resolved by the first quarter of 2017, with potentially no delay in the overall completion of a phase III trial.

By year-end, Inovio expects several clinical read-outs, including those from the 40 patient Zika trial and the INO-3112 head and neck cancer study, in addition to interim data from its Middle East Respiratory Syndrome (MERS) vaccine. A research report from Aegis Capital (http://dtn.fm/3J2eg), issued last week, set a price target of $12.00 for Inovio’s stock, which is currently trading at just over $8.00.

For more information, visit www.inovio.com

Aegis Capital Supports ‘Buy’ Rating, Higher Stock Price Target for Progenics (PGNX) Following Strong Q3 Results

Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), a company focused on the development of innovative treatments and therapies for cancer, in particular prostate cancer, recently released its financial results for the third quarter of 2016, reporting higher revenue and net income compared to the third quarter of 2015. The growth can be primarily attributed to the FDA approval and U.S. commercial launch of its flagship product, oral Relistor®, for the treatment of opioid induced constipation in patients suffering from chronic non-cancer pain, according to an Aegis Capital Corp. analysis (http://dtn.fm/8EJce) released on November 8, one day after the Q3 results.

The Aegis report underlines that the strong Q3 results warrant the designation of a ‘Buy’ rating for Progenics and a higher stock price target of $11, compared to the current $5.71. In the third quarter, Progenics reported $53.9 million in revenue, compared to $1.4 million in Q3 2015, which reflects the significantly higher royalty income of $3.3 million from Relistor®, compared to $1.2 million during the same reporting period of 2015. Relistor®, in its tablet form, was approved by the Food and Drug Administration in July of this year, which triggered a $50 million milestone from the company’s commercialization partner, Valeant Pharmaceuticals International, Inc. (NYSE: VRX), along with subsequent royalties and the potential of sales milestones of up to $200 million. This was followed by the launch of oral Relistor® on the U.S. market in September. Total Relistor® sales (for both the oral and the subcutaneous versions of the product) amounted to $22.1 million, which resulted in $3.3 million in royalties.

In addition to the higher revenue, Progenics also announced a $50 million royalty-backed loan from HealthCare Royalty Partners. The loan matures on June 30, 2025, and will be repaid exclusively from royalties on future Relistor® sales, with a 9.8% per annum interest rate. Any future sales milestones from Valeant are excluded from the agreement. The loan helped Progenics end the quarter with $98.9 million in cash and cash equivalents, which is $24.8 million higher than the figure reported at the end of last year.

According to Aegis Capital, this loan will allow Progenics to have a cash balance large enough to support the launch of its next pipeline product Azedra®, a late-stage candidate being evaluated for the treatment of rare sympathetic nervous system tumors (pheochromocytoma and paragangliomas). Currently undergoing registration trials for the treatment, Progenics expects topline results in the first quarter of 2017. If the results are encouraging and the Azedra® trial meets the requirements of the Special Protocol Assessment, Progenics plans to submit a new drug application to the FDA in the first half of next year, with approval likely to happen by the end of 2017.

The Aegis report also mentions that, with its current cash balance and the expected Relistor® sales royalties, Progenics will be able to continue development of its oncology pipeline, which includes PSMA (prostate specific membrane antigen)-targeted imaging agents such as 1404 (SPECT/CT imaging agent currently undergoing a phase III study of 450 prostate cancer patients), PyL™ (a PET/CT agent that will begin to undergo phase II/III trials by the end of the year) and 1095 (with a phase I study in metastatic prostate cancer patients set to begin in the fourth quarter of 2016).

For more information, visit the company’s website at www.progenics.com

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