Cardium Therapeutics, Inc. (CXM) Sees Opportunity Outside The U.S.

When the FDA recently announced that it is considering a faster approval process for developers of drugs for serious diseases, it was important news for companies like Cardium Therapeutics, a San Diego-based health sciences and regenerative medicine developer. Development of a significant new drug is expensive and time consuming even without the regulatory requirements, and pressure has been mounting on the FDA to make the process more efficient. The goal of the new process is to allow quicker clinical trials, while also letting physicians administer the drugs to critical need patients where the benefits would outweigh the risks.

But pharmaceutical developers like Cardium are often not focused on the U.S. alone. Major markets can exist in other parts of the world where a given drug may fit special needs and conditions. In the case of Cardium, one of their lead products is Generx, a DNA-based angiogenic growth factor therapeutic designed to stimulate blood vessel growth around the heart. In places where costly and invasive surgical revascularization procedures, such as coronary artery bypass surgery and angioplasty/stents, may not be feasible, the kind of innovative and cost-effective treatment Generx represents is a good match.

It is expected that 80 percent of future increases in coronary heart disease will occur outside the United States, representing a significant opening for Cardium and Generx. Cardium CEO, Christopher Reinhard, recognizes the opportunity: “We believe that Generx may offer the potential for a one-time, non-surgical cost-efficient treatment option for patients with myocardial ischemia due to coronary artery disease.”

In June, Cardium announced that it had received clearance from the Russian Ministry of Health and Social Development to start the phase III registration study for Generx. The Russian Health Authority will brand Generx with the therapeutic drug trade name Cardionovo for purposes of marketing.

For additional information, visit www.CardiumTHX.com

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Issuer Direct Corp. (ISDR) Opens Q3 Books to Show YoY Improvements

Issuer Direct, a provider of disclosure management solutions and cloud-based compliance technologies, today reported its financial results for the third quarter of 2012.

The company reported GAAP earnings of $213,591, or $0.11 per share, marking a 200 percent improvement over net income of $71,081, or $0.04 per share, reported in the comparable quarter of 2011. Issuer Direct reported non-GAAP earnings of $300,429, or $0.15 per share, compared to non-GAAP net income of $156,325, or $0.09 per share, for the comparable quarter of 2011.

Revenues for the quarter increased by 36 percent to $1.25 million as compared to revenues of $891,576 reported for the third quarter the year prior.

“We are extremely pleased with the increases in revenue, earnings and gross profit margin that were achieved during the third quarter of 2012,” Wes Pollard, CFO of Issuer Direct stated in the earnings release. “During the quarter, we began to provide detail footnote tagging for most of our small reporting companies, which resulted in higher revenue per client and stronger gross margins from our compliance and reporting services business. As noted in prior periods, we have been able to transition a majority of our revenue from project-based work to renewable annual contracts. This results in recurring revenue that is more steady and predictable. Furthermore, our increase in net income has allowed us to increase our cash on hand, while at the same time continuing the dividend policy implemented earlier this year.”

Moving forward the company expects to dock continued growth stemming primarily from disclosure expansion and its reporting business.

“I am very pleased with the results for the most recent quarter, and we are looking forward to a strong fourth quarter and a record year for Issuer Direct,” said Brian R. Balbirnie, the company’s CEO. “We are not only continuing to expand our disclosure and reporting business, but also our other revenue streams. As an example, our transfer agency business generated an improvement in gross profits of more than 30 percent in the quarter ended September 30, 2012, when compared with the prior-year period.”

For more information visit www.issuerdirect.com

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InVivo Therapeutics, Inc. (NVIV) Receives $2 Million Loan from MassDevelopment; Releases Letter to Shareholders

InVivo Therapeutics, a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and neurotrauma, recently released a letter to Shareholders. The Shareholder letter detailed, among other things, Invivo’s excellent progress in recent months, as well as upcoming plans the company aims to capitalize on.

The following is an excerpt from InVivo’s Shareholder letter:

“InVivo has been making excellent progress in the past months and we are firing on all cylinders. I wanted to use this letter as a forum to provide an important update on how we are using InVivo’s resources to create and capture shareholder value. We expect the next six months to mark a major inflection point in our growth. The FDA has not put up any roadblocks or requested additional information that will delay the start of the study for the use of our biopolymer scaffolding to treat spinal cord injuries (SCI). Before the end of 2012, we expect to validate our clean room and then manufacture GMP batches which will be submitted to the FDA as part of the IDE application. We expect FDA approval to start the clinical study in early 2013.”

The Shareholder letter is available in its entirety on the company’s website.

Earlier in October, InVivo was awarded a $2 million loan by MassDevelopment. The funds were given to InVivo through MassDevelopment’s Emerging Technology Fund to aid in the commercialization of InVivo’s groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions.

“We are encouraged by the Commonwealth of Massachusetts’s continued support of InVivo, which began in 2009 with a $500,000 Accelerator Loan from the Massachusetts Life Science Center when InVivo had only five employees,” stated InVivo CEO Frank Reynolds. “Now, as we receive a $2 million loan from MassDevelopment, we exceed 30 employees in our new Kendall Square facility. We’ll continue to recruit the best and brightest minds in biomaterials and neuroscience. The proceeds from this loan will assist us in advancing multiple neurotrauma products into the clinic based on our innovative biopolymer scaffolding and hydrogel technologies.”

Additionally, InVivo recently announced the appointment of Bill D’Agostino as the Senior Director of Manufacturing and Engineering. Mr. D’Agostino joins the company as an executive leader focused on rapid market growth, with over fifteen years at Covidien and, most recently, seven years at Angiotech pharmaceuticals as Vice President of Engineering.

InVivo has stated that it intends to create a new paradigm of care by taking a novel approach to SCI. Instead of focusing exclusively on regeneration, InVivo concentrates on neuroprotection. Its products are intended to protect the spinal cord after primary injury by mitigating the bleeding, inflammation, and further cell death that result from the body’s immune response to SCI.

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Galectin Therapeutics, Inc. (GALT) to Present at American Association for the Study of Liver Disease

Galectin Therapeutics, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, recently announced that it has been asked to present at the American Association for the Study of Liver Disease (AASLD) Annual Meeting on November 12, 2012, in Boston MA.

Galectin Therapeutics’ lead galectin inhibitor compound, GR-MD-02 — based on preclinical data — has demonstrated the ability to prevent and reverse the formation of fibrosis in animal models of non-alcoholic steatohepatitis (NASH), or fatty liver disease. Galectin has stated that its presentation at AASLD will extend understanding about the mechanism by which GR-MD-02 improves pathology in NASH, which represents an important unmet medical need.

Galectin Therapeutics recently hosted the International Conference on Galectins and Disease, held at the Harvard Club in Boston, MA, on September 17-19, 2012. Proceedings from the international meeting have been accepted for publication by the American Chemical Society. Entitled “Galectins and Disease: Implications for Targeted Therapeutics”, the book is expected to be published in early 2013 and is edited by Dr. Anatole A. Klyosov, Chief Scientist and Founder, and Dr. Peter G. Traber, President, Chief Executive Officer and Chief Medical Officer.

Dr. Traber, President, CEO, and Chief Medical Officer of Galectin Therapeutics, noted, “Presentations by international experts in galectin biology and disease confirmed the critical importance of galectin proteins in organ fibrosis and cancer. We are pleased that our preclinical data and development programs in liver fibrosis and melanoma were well represented and received by the scientists at the meeting. It was broadly agreed by the participants that this decade will herald the realization of galectin-targeted therapeutics in multiple diseases.”

Dr. Traber continued, stressing the importance the data of this research represents, saying, “In addition to the importance in cancer, the critical role of galectin-3 protein in fibrosis of multiple organs was emphasized, including liver, lung, kidney and heart. In fact, one of the speakers indicated that fibrosis of these organs, the ultimate cause of organ failure, accounts for 45% of all mortality in the United States.”

Galectin became an industry leader in its use of unique carbohydrate technology to target galectin proteins, which are key mediators of biologic and pathologic function. Using this process, Galectin makes use of natural occurring carbohydrate polymers with galactose residues to create complex carbohydrates with specific weight. Using these newly formed carbohydrate compounds, which bind and inhibit galectin process, the company is developing therapies for indications where galectins have demonstrated role in the pathogenesis of a particular disease.

For more information on Galectin Therapeutics, visit www.galectintherapeutics.com

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Cleantech Solutions International, Inc. (CLNT) Set to Deliver on Two New Purchase Orders for Airflow-Dyeing Machines and Forging Components

Cleantech Solutions, a leading manufacturer of metal components and assemblies, primarily used in the wind power, solar, and other clean technology industries, announced yesterday that it has received purchase orders for airflow-dyeing machines and related components from two additional domestic customers.

Cleantech is set to deliver a total of 63 sets of airflow-dyeing machines and related components, as required by the first purchase order, for a total purchase price of approximately $1.7 million (RMB 10.4 million). In accordance with the purchase order, Cleantech has received an advance payment of $0.5 million, or 30% of the total purchase price. Upon installation, Cleantech will receive an additional 60%, with the remaining 10% set to be received within three months of installation. The company has stated that it anticipates the delivery of units to be completed in November and December 2012.

Cleantech’s airflow-dyeing machines use flowing air as opposed to water, which is the traditional method used in the dyeing process. The company believes that utilizing this method reduces input costs, creates less damage to textile creating fewer wrinkles, and produces a decreased level of emissions.

Mr. Jianhua Wu, Chairman and CEO of Cleantech Solutions, noted, “We are pleased with the steady sales momentum of our airflow-dyeing machines as we continue to attract new customers, which is a strong validation of the increasing need for our products and services within the textile industry. We are committed to growing our customer base alongside the industry-wide replacement cycle favoring energy friendly machines.”

Additionally, Cleantech received a second purchase order from a China-based heavy machinery customer, requesting it supply forged components for flanges. This purchase order totals a purchase price of $0.8 million and requires that Cleantech deliver a total of 36 units. In keeping with the first order, Cleantech received an advance payment of $0.2 million, representing 30% of the total purchase price, and will receive the remaining 70% upon installation. Cleantech has stated that it expects to complete delivery of the units by the end of November 2012.

For more information on Cleantech Solutions, visit www.cleantechsolutions.com

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Sigma Designs, Inc. (SIGM) Technology Nets Comtrend Win

Sigma Designs announced that the Comtrend PG-9141s Powerline Single Port Adapter won the 2012 Communications Technologies Platinum Award in home networking, which was announced at the 2012 SCTE Cable-Tec Expo in Orlando. This is significant because the PG-9141s contains Sigma technology, namely the HomePlug AV and ClearPath.

Sigma Design is focused on designing and building semiconductor technologies that are utilized in a wide array of consumer tech products, such as IPTV set-top boxes, DTV, connected media players, residential gateways, and home control systems.

Comtrend’s PG-9141s Power Adapter, containing Sigma Designs’ CG2210 HomePlug AV chipset with ClearPath technology, allows data transfer over the powerline at a PHY layer rate of up to 200 Mbps which is useful for home networking. It allows the use of all three wires in a powerline network to achieve extended coverage and higher throughputs to multiple points in a home network, even through surge protected power strips.

John DiFrenna, vice president of sales & marketing for Comtrend, said, “Winning the 2012 Platinum Award from Communication Technology in Home Networking is an unexpected honor. 2012 has been Comtrend’s groundbreaking year in the home networking market. To take a win right out of the gate with our PG-9141s Powerline Adapter is a credit to our team and the advisement from our knowledgeable customers. This is further evidence that Comtrend’s bold approach with new and diversified solutions is helping to shape the evolving landscape for home and business networks.”

“HomePlug AV with ClearPath is a remarkable technology, and receiving this award further substantiates the recognition to our innovative approach in every home networking technology area developed by Sigma,” said Gabi Hilevitz, vice president and general manager of Sigma’s Home Connectivity unit. “We are very pleased with our partnership with Comtrend and are happy for them for winning this prestigious award.”

For more information, visit www.sigmadesigns.com

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Astex Pharmaceuticals, Inc. (ASTX) Forms Drug Discovery Alliance with CRT and Newcastle

Astex Pharmaceuticals announced yesterday it has signed a five-year strategic drug discovery alliance with Cancer Research Technology Limited (CRT) and Newcastle University.

As partners, the three entities will discover and develop new cancer drugs in collaboration with researchers at the Cancer Research UK Drug Discovery Program at the Northern Institute for Cancer Research (NICR, Newcastle University).

Astex will provide Newcastle University with GBP1 million annual funding during the five-year alliance, supporting research across biology, chemistry, pharmacology, and imaging at the NICR in order to identify and develop new cancer drugs and associated biomarkers, to develop tests and to determine which patients to treat and whether new drugs are working. Astex will retain an option to an exclusive global license for developing and commercializing pharmaceutical products from each alliance project. CRT and Newcastle will be eligible to receive development and regulatory milestone payments on exercise of the options, as well as on products that Astex takes into development; they are also eligible to receive royalties on product sales. The financial terms relating to the milestone payments and royalties have not been disclosed.

This broad strategic drug discovery alliance will provide Astex with world-leading translational research in oncology. The alliance will also build on a previous collaboration between Astex, Newcastle and CRT for FGFr, which is a key cancer target that led to the development of a clinical candidate that Astex’s partners at Janssen have recently taken into a Phase I clinical trial.

This significant collaboration will build on the successes and track records of all involved partners, further developing Cancer Research UK’s world-class cancer treatment research.

Astex Pharmaceuticals is a company focused on the discovery and development of novel small molecule therapeutics with an emphasis on oncology. Currently developing a proprietary pipeline of novel therapies, Astex is creating de-risked products for partnership with leading pharmaceutical companies. The company developed Dacogen and receives significant royalties from its worldwide sales.

For more information, visit www.astx.com

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