Archive for November, 2013

(QLTI) Oral Retinoid Program, Clinical & Regulatory Update Review of Strategic Alternatives

Plans for Phase IIa Proof-of-Concept Trial for QLT091001 in Impaired Dark Adaptation

Company to Provide Guidance on Pivotal Studies in Orphan Indications Before the End of Q1 2014

VANCOUVER, British Columbia, Nov. 20, 2013  — QLT Inc. (Nasdaq:QLTI) (TSX:QLT) (“QLT” or the “Company”) today announced a clinical and regulatory update related to its synthetic oral retinoid program, as well as the initiation of a review of strategic alternatives. For the review, the Board of Directors has engaged Credit Suisse to act as financial advisor.

QLT announced that, following meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the Company believes that it is close to finalizing a pivotal trial protocol for QLT091001 for the treatment of inherited retinal disease such as Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP) due to mutations in the LRAT and RPE65 genes, both orphan indications. The Company expects to provide final guidance on its development plans in these indications before the end of the first quarter of 2014 after final feedback from the European regulatory agency. Additionally, QLT has initiated recruitment of subjects for a Phase IIa proof-of-concept trial of its drug candidate, QLT091001, in adult subjects with Impaired Dark Adaptation (IDA), a condition that results in decreased ability to recover visual sensitivity in the dark after exposure to bright lights. The Company also announced the launch of a compassionate use program for QLT091001 in LCA and RP, as well as plans for a patient registry and an update on its retreatment study in these indications.

“While we undertake a broad review of strategic options for QLT with Credit Suisse, we will continue to focus our resources and efforts on our promising synthetic oral retinoid programs,” said Mr. Jason M. Aryeh, Chairman of the Board. “We are excited with the progress QLT has made with the program this past year and look forward to a productive next few months as we prepare this important therapy for a pivotal trial.”

QLT091001 Clinical and Regulatory Update in Detail

  • Pivotal trial guidance in LCA and RP. With regard to the orphan drug program for the treatment of LCA and RP due to inherited mutations in the LRAT and RPE65 genes, over the course of 2013, the Company has met with the FDA and the EMA, including a recent end-of-Phase II meeting with the FDA, to discuss proposed pivotal trial design, protocol requirements and development plans. The Company plans to finalize its communications with the EMA in the coming months in connection with the pivotal trial design, with the goal of having the protocol conform to both U.S. and EU guidance, after which the Company expects to provide final guidance on the program. QLT believes that it has made significant progress on multiple fronts with regards to its orphan oral retinoid program, and will be pivotal trial ready in the first half of 2014.
  • Phase IIa proof-of-concept trial of QLT091001. The Company has initiated recruitment of subjects for enrollment into the newly announced Phase IIa proof-of-concept trial of QLT091001 in adults with IDA. The Company’s goal is to initiate dosing subjects in the trial by the first quarter of 2014.  See “About the IDA Proof-of-Concept Trial” below for details.
  • Compassionate use program. Following requests from physicians and patients, the Company has begun a compassionate use program for QLT091001 on a named-patient basis. Under the compassionate use program, QLT091001 may be made available to patients who participated in the Company’s completed Phase Ib clinical trial of QLT091001 for the treatment of LCA and RP. The program commenced in Ireland and participation for other patients will be determined on a case-by-case basis in accordance with applicable regulatory laws. Compassionate use programs provide experimental therapeutics to patients with serious or life-threatening diseases that cannot be treated satisfactorily with authorized therapies prior to final FDA, EMA or other applicable regulatory approval.
  • Patient registry. Given the ultra-orphan nature of LCA and RP due to inherited mutations in the LRAT and RPE65 genes, the Company is in the process of establishing a central patient registry to identify and characterize patient status and then follow disease progression to track the natural history of the disease. The Company plans to launch the patient registry in conjunction with the advancement of the orphan program into pivotal trials.
  • LCA and RP retreatment study. Dosing in the Company’s retreatment study in LCA and RP subjects is now completed and follow-up of subjects is ongoing. This study was initiated in early 2012 to provide retreatment for the subjects treated in the initial Phase Ib study, in order to examine the safety, efficacy and tolerability of repeat dosing cycles of QLT091001 administered over seven days. The Company expects to complete its preliminary analysis of the data in the first quarter of 2014.

About the IDA Proof-of-Concept Trial

The Phase IIa proof-of-concept trial of QLT091001 is a randomized, multi-center, parallel-group, placebo-controlled study in adult subjects with IDA. Subjects (age 60 or older) with IDA, or impaired low luminance low contrast best corrected visual acuity (“LLLC BCVA”) in at least one eye and having no known ophthalmic pathologies to explain their condition other than early age-related macular degeneration (AMD) will be enrolled at sites in the U.S. Subjects will be randomized to receive placebo or one of two different doses (10 or 40 mg/m2) of QLT091001 once per week for three consecutive weeks with one additional dose the day after the third dose. The trial is designed to evaluate the safety profile and effects of QLT091001 on impaired dark adaptation time, glare recovery time and LLLC BCVA.

About Impaired Dark Adaptation

Impaired Dark Adaptation (IDA) is a condition that results in decreased ability of the eye to recover visual sensitivity in the dark following exposure to bright lights (photobleaching) that gets worse with age. Profoundly impaired dark adaptation is commonly associated with inherited retinal degenerations. More recently, mild to moderate impaired dark adaptation has been associated with AMD and is proportionate to the severity of the disease. IDA (and/or impaired low luminance vision) may occur due to age-related inefficiencies in the retinoid cycle which results in slower regeneration of the light sensing pigment 11-cis-retinal in the eye and increased levels of free unbound opsin that lead to delayed dark adaptation and reduced retinal sensitivity.  Ultimately, these factors impair vision in low light or dark environments. The kinetics of the rod function have also been reported to be age-related, with the rod-mediated portion of the dark adaptation function significantly slower in older patients with normal retinal function than in younger adults. This rod-mediated dark adaptation time is further slowed down in patients with early signs of AMD but with good visual acuity.

IDA in this population causes symptomatic difficulties for functioning in dim light, especially after exposure to bright ambient light, and can hamper daily living activities such as driving, mobility, and workplace tasks. Impaired mobility, in the form of falling, is one of the most common problems of old age. IDA is not a disease but a condition that can arise as a result of a number of pathologic or physiologic factors. Improving this condition has the potential to not only improve a subject’s quality of life but also delay the development of degenerative retinal conditions with more severe visual outcomes.

About QLT

QLT is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. We are focused on developing our synthetic retinoid program for the treatment of inherited retinal diseases.

QLT is based in Vancouver, Canada and the Company is publicly traded on NASDAQ (symbol: QLTI) and the Toronto Stock Exchange (symbol: QLT). For more information about the Company’s products and developments, please visit our web site at www.qltinc.com.

Certain statements in this press release constitute “forward-looking statements” of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute “forward-looking information” within the meaning of applicable Canadian securities laws.  Forward-looking statements include, but are not limited to: statements concerning our plans, timing and our ability to initiate dosing of patients in the IDA Phase IIa proof-of-concept study; statements concerning our timing to provide further guidance on our development plans for QLT091001, including timing for potential pivotal trials, for the treatment of LCA and RP; statements concerning the timing to announce preliminary data from the retreatment study of QLT091001 in LCA and RP; statements concerning our plans and timing to launch a patient registry; and statements which contain language such as: “assuming,” “prospects,” “goal,” “future” “projects,” “potential,” “could,” “believes,” “expects”; “hopes” and “outlook.” Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the risks, uncertainties and other factors following: the effect that QLT’s announcements and actions will have on the market price of our securities; our development plans, timing and results of the clinical development of our synthetic retinoid program; assumptions related to pre-screening, screening and enrollment of patients, efforts and success, and the associated costs of our synthetic retinoid program; outcomes for our clinical trials may not be favorable or may be less favorable than interim/preliminary results and/or previous trials; varying interpretations of data produced by one or more of our clinical trials; the timing, expense and uncertainty associated with the regulatory approval process for products to advance through development stages; risks and uncertainties associated with the safety and effectiveness of our synthetic retinoid program; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; the Company’s future operating results, which are uncertain and likely to fluctuate; currency fluctuations; and general economic conditions and other factors described in detail in QLT’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law.

CONTACT: QLT Inc. Contacts:

         Investor & Media Relations
         Andrea Rabney or David Pitts
         Argot Partners
         212-600-1902
         andrea@argotpartners.com
         david@argotpartners.com
Wednesday, November 20th, 2013 Uncategorized Comments Off on (QLTI) Oral Retinoid Program, Clinical & Regulatory Update Review of Strategic Alternatives

(UNIS) Signs Long-Term Supply Agreement with Hikma to Enhance Delivery of Generic Injectables

Unilife to receive $40MM in upfront and milestone payments 15-year supply agreement to launch initial 20 generic injectable drugs in syringes from Unifill platform Unilife to begin commercial supply in FY 2014, annual minimum unit volume to exceed 175MM

YORK, Pa., Nov. 20, 2013 — Unilife Corporation (“Unilife”) (NASDAQ: UNIS, ASX: UNS) today announced the signing of a long-term commercial supply contract with Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) for the use of Unifill® prefilled syringes with a range of generic injectable drugs.

Under the 15-year global agreement, Unilife will supply Hikma with customized prefillable delivery systems from its Unifill® platform, including the Unifill syringe and the Unifill Nexus(“Unifill products”).

Hikma has selected an initial list of 20 of its generic injectable products to be used with Unifill products. Unilife has granted Hikma exclusive global rights to its Unifill products for use with these specific generic injectable products. Additional injectable drugs may also be added to the exclusivity list subject to agreement by both parties.

Unilife will commence product sales to Hikma in early 2014. Under the terms of the contract, Unilife will supply Hikma a minimum volume of 175MM units per year following a rapid high-volume ramp up period.

In addition to product sales, Hikma will pay Unilife $40 million in upfront and milestone payments. An initial upfront payment of $5 million will be paid to Unilife immediately, with an additional $15 million in payments expected during 2014. The final $20 million in milestone-based payments will be paid the following year.

Market demand for generic injectables is rapidly shifting from vials to prefilled syringes.  However, conventional prefilled devices prevent universal attachment with any ISO standard needle hub or IV connector and are also associated with patient safety risks, including spontaneous disconnection and the leakage or occlusion of medication.  The superior design of Unilife’s Unifill Nexus addresses these issues and is expected to rapidly become the preferred choice to deliver generic injectable drugs.

Mr. Said Darwazah, Chief Executive Officer of Hikma, stated: “This agreement supports our strategy of developing higher value products and we are extremely pleased to be partnering with Unilife to develop our generic injectables capabilities.  We look forward to leveraging Unilife’s innovative platform of Unifill syringes to differentiate our injectable products and to increase our market share.”

Mr. Alan Shortall, Chief Executive Officer of Unilife, stated: “Unilife has developed a full range of innovative and highly differentiated syringes under our Unifill platform to accommodate the needs of all prefilled biologics, drugs and vaccines. This strategic partnership with Hikma enables us to rapidly penetrate the large and fast-growing market for generic injectables. Hikma is one of the world’s fastest growing pharmaceutical companies, and a top three supplier by volume in the $7 billion U.S. market for generic injectables. Together with our recently announced long term supply contract with Sanofi, this partnership with Hikma instantly positions Unilife to become one of the largest suppliers of prefilled syringes in the world.”

The Unifill® Platform

Unilife has developed an extensive proprietary platform of prefilled syringes under its Unifill® brand. Unifill is the world’s first and only known platform of prefilled syringes with automatic and fully integrated needle retraction.  Designed for intuitive use by healthcare workers or self-injecting patients, an audible, tactile click signals the injection of the full dose and the automatic activation of the needle retraction mechanism. Users can control the speed of needle retraction directly from the body into the syringe barrel by relieving thumb or finger pressure on the plunger to eliminate the risk of needlestick injuries or the aerosolization (splatter) of blood or tissue residue.  Unifill syringes are compatible with standard filling and packaging processes, with USP compliant materials in the primary drug container.

The Unifill Nexus™

The Unifill Nexus is a glass prefilled syringe that can be universally attached to ISO standard needless luer access devices (NLADs). The Unifill Nexus is designed to address patient safety concerns relating to the reported malfunction, breaking or clogging of some conventional glass prefilled syringes when attached to NLADs. Unlike some other needleless prefilled syringes, it features an ISO standard luer lock tip that is designed for universal attachment onto standard needle hubs and IV connectors and prevents the risk of spontaneous disconnection or leakage of medication. Like other syringes within the Unifill platform, the Unifill Nexus is compatible with standard filling and packaging processes and has USP compliant materials in the primary drug container.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife’s broad portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, intraocular delivery systems and novel devices. Each of these innovative, differentiated technology platforms can be customized to address specific customer, drug and patient requirements. Unilife’s global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

About Hikma

Hikma Pharmaceuticals is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in-licensed products. Hikma’s operations are conducted through three businesses: “Branded”, “Injectable” and “Generics” based principally in the Middle East and North Africa (MENA) region, where it is a market leader, the United States and Europe. In 2012, Hikma achieved revenue of US$1,108.7 million and profit attributable to shareholders of US$100.3 million.

Forward-Looking Statements

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

General: UNIS-G

Investor / PR Contacts (US): Analyst Enquiries Investor Contacts (Australia)
Todd Fromer / Garth Russell Lynn Pieper Jeff Carter
KCSA Strategic Communications Westwicke Partners Unilife Corporation
P: + 1 212-682-6300 P: + 1 415-202-5678 P: + 61 2 8346 6500
Wednesday, November 20th, 2013 Uncategorized Comments Off on (UNIS) Signs Long-Term Supply Agreement with Hikma to Enhance Delivery of Generic Injectables

(CYTR) Initiates Phase 2 Clinical Aldoxorubicin Trial in Brain Cancer

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced initiation of a Phase 2 clinical trial with the Company’s aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. The open-label, multi-center study is designed to investigate the preliminary efficacy and safety of aldoxorubicin in subjects with unresectable GBM whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.

The clinical trial is expected to enroll up to 28 subjects randomly assigned equally to two groups that will be administered either 350 mg/m2 (260 mg/m2 doxorubicin equivalent) or 250 mg/m2 (185 mg/m2 doxorubicin equivalent) of aldoxorubicin intravenously on Day 1, and every 21 days thereafter until evidence of tumor progression, unacceptable toxicity or withdrawal of consent. Tumor response will be monitored every 6 weeks by MRI until disease progression occurs. The trial is being conducted at the John Wayne Cancer Center/Sarcoma Oncology Center in Santa Monica, Calif., City of Hope in Duarte, Calif. and the Louisiana State University Health Sciences Center in New Orleans.

The primary objective of the clinical trial is to determine progression-free survival (PFS) and overall survival (OS), and the principal secondary objective is an evaluation of the safety of aldoxorubicin in the study subjects.

This Phase 2 study follows positive, confirmatory results reported earlier this year from a preclinical study in which aldoxorubicin demonstrated statistically significant efficacy (p<.0001) in the treatment of rapidly growing human brain (glioblastoma) cancer in the brains of animals. In that study, animals treated with aldoxorubicin had median survival of more than 63 days, compared with approximately 25 days for animals treated with doxorubicin or saline. In addition, because aldoxorubicin uptake was confined only to the tumor in the brain and did not enter normal brain tissue, the principal investigator concluded that aldoxorubicin has the potential to safely shrink glioblastoma tumors, which could dramatically prolong patient survival. This study was replicated by Crown Biosciences, an independent research laboratory.

“We were highly encouraged by aldoxorubicin’s apparent ability to cross the blood-brain barrier, potentially creating a new approach to attacking brain tumors. We are on track with the rapid development of aldoxorubicin for unresectable GBM, and look forward to having preliminary results from this Phase 2 trial in 2014,” said CytRx President and CEO Steven A. Kriegsman. “Should the data from this trial be positive, we plan to file for breakthrough therapy designation with the U.S. Food and Drug Administration, which could expedite marketing approval.”

Dr. Brian Boulmay of the LSU Health Sciences Center and the principal investigator in the study commented, “Patients with unresectable GBM who have failed prior surgery, radiation and chemotherapy have an extremely poor prognosis, with progression-free survival of around 16 weeks and median overall survival of approximately 31 weeks following treatment. Our Phase 2 study will provide important data on aldoxorubicin’s potential to effectively treat these patients.”

About Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common and most malignant brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. Despite surgical resection, radiotherapy and chemotherapy, the median survival after diagnosis is about 12 to 14 months. Although treatment failure may be due to several factors, limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood-brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is conducting a global Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and has completed a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a potential pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx also is initiating Phase 2 clinical trials with aldoxorubicin in patients with late-stage glioblastoma (brain cancer) and AIDS-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that any future human testing of aldoxorubicin, including the Phase 2 study of aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), might not produce results similar to those seen in past human or animal testing, including the mouse study described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Wednesday, November 20th, 2013 Uncategorized Comments Off on (CYTR) Initiates Phase 2 Clinical Aldoxorubicin Trial in Brain Cancer

(RDCM) Wins 3.6 Million Dollar Deals From Asian LTE Provider

TEL AVIV, Israel, November 19, 2013 —

RADCOM Ltd. (NASDAQ: RDCM) a leading Service Assurance provider, today announced that it received new orders amounting to 3.6 million dollars with a tier 1 operator in Asia. This is an expansion of an existing deployment with this operator.

RADCOM’s Customer Experience solution enables this service provider to provide its customers with extremely high quality service on their mobile devices. This service provider is contending with a rapid growth in the use of mobile devices, and the consequent demands on its network. With these new orders, RADCOM will provide this customer with an expansion of dozens of gigabytes to its existing RADCOM Quality of Experience system, monitor its LTE network and enhance the service provider’s marketing analytics capabilities.

Marketing analytics is becoming a critical need. Operators need to analyze their customer behavior and see how various subscriber groups are using the mobile data services, in order to monetize their networks. One of the core methodologies to measure marketing effectiveness is the collection of Quality of Experience data.

“We are very satisfied to see further repeat orders from this customer. RADCOM’s solutions have become an integral part of this service provider’s operation, helping it provide exemplary Quality of Service to its customers.” said David Ripstein, RADCOM’s President and CEO. “This expansion is a realization of the big potential we have identified for repeat business from our satisfied existing customers, as their networks expand and they add new technologies and thus require more sophisticated applications.”

About RADCOM

RADCOM provides innovative service assurance and customer experience management solutions for leading telecom operators and communications service providers. RADCOM specializes in solutions for next-generation mobile and fixed networks, including LTE, VoLTE, IMS, VoIP, UMTS/GSM and mobile broadband. RADCOM’s comprehensive, carrier-grade solutions are designed for big data analytics on terabit networks, and are used to prevent service provider revenue leakage and to enhance customer care management. RADCOM’s products interact with policy management to provide self-optimizing network solutions. RADCOM’s shares are listed on the NASDAQ Capital Market under the symbol RDCM. . For more information, please visit http://www.RADCOM.com.

Risks Regarding Forward-Looking Statements

Certain statements made herein that use the words “estimate,” “project,” “intend,” “expect,” “believe” and similar expressions are intended to identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties that could cause the actual results, performance or achievements of RADCOM to be materially different from those that may be expressed or implied by such statements, including, among others, changes in general economic and business conditions and specifically, decline in the demand for RADCOM’s products, inability to timely develop and introduce new technologies, products and applications, and loss of market share and pressure on prices resulting from competition. For additional information regarding these and other risks and uncertainties associated with RADCOM’s business, reference is made to RADCOM’s reports filed from time to time with the United States Securities and Exchange Commission. RADCOM does not undertake to revise or update any forward-looking statements for any reason.

Contact:
Eyal Harari
VP Products and Marketing
+972-77-774-5030
eyalh@radcom.com

Tuesday, November 19th, 2013 Uncategorized Comments Off on (RDCM) Wins 3.6 Million Dollar Deals From Asian LTE Provider

(SPEX) Settlement Agreement and Continued Monetization of Patent Portfolio

TYSONS CORNER, Va., Nov. 19, 2013  — Spherix Incorporated (SPEX)  an intellectual property development company committed to the fostering and monetization of intellectual property, announced today that its wholly owned subsidiary, CompuFill LLC, has entered into a settlement and license agreement with a leading technology company.

This is the first settlement and license agreement for the CompuFill portfolio since Spherix acquired North South Holdings Inc. in September of 2013. Ongoing infringement enforcement continues as Spherix’s model of patent monetization grows in both scope and size.

The CompuFill patents, each in the “on-line pharmacy automated refill system” sector, trace priority back to October 1997.

Commenting on the announcement, Anthony Hayes, Spherix CEO, stated, “The value of having this suite of patents cannot be emphasized enough. Our team of patent monetization experts brought this opportunity to Spherix only a few short months ago and we have already started generating revenue. This is a great example of how Spherix continues working to drive value for our investors.”

About Spherix

Spherix Incorporated was launched in 1967 as a scientific research company. Spherix presently offers a diversified commercialization platform for protected technologies. The company continues to work on life sciences and drug development and presently is exploring opportunities in nutritional supplement products relying on its D-Tagatose natural sweetener as a GRAS ingredient. Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation.

Forward Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:
Investor Relations
Phone: (703) 992-9325
Email: info@spherix.com

Tuesday, November 19th, 2013 Uncategorized Comments Off on (SPEX) Settlement Agreement and Continued Monetization of Patent Portfolio

(HZNP) Announces Pricing of $150 Million of 5.00% Convertible Senior Notes

DEERFIELD, IL–(Nov 19, 2013) – Horizon Pharma, Inc. (NASDAQ: HZNP) (“Horizon” or the “Company”) today announced that it has entered into note purchase agreements with investors to issue $150 million aggregate principal amount of 5.00% Convertible Senior Notes due 2018 (the “Notes”). The initial conversion price of the Notes will be $5.36, representing a conversion premium of approximately 20% over the last reported sale price of Horizon’s common stock on the NASDAQ Global Market on November 18, 2013. In connection with the pricing of the offering, the Company also entered into capped call transactions described below, which are generally intended to reduce the potential dilution to Horizon’s common stock upon conversion of the Notes, and thereby are expected to raise the effective conversion premium of the Notes for Horizon to approximately 50% over the last reported sale price of Horizon’s common stock on the NASDAQ Global Market on November 18, 2013.

The purchase of the Notes is expected to close on November 22, 2013, subject to the satisfaction of customary closing conditions. The Notes will be issued at a price equal to 100% of the principal amount thereof. The net proceeds from the sale of the Notes, after deducting fees and expenses, are expected to be approximately $143.8 million. Of the net proceeds from the offering, Horizon anticipates using $18.7 million to pay the cost of the capped call transactions, $35.0 million to fund the Horizon’s proposed acquisition of VIMOVO®, $70.4 million to repay all obligations under the Company’s existing senior secured loan, including required make-whole payments, and the remainder of approximately $19.7 million for working capital and general corporate purposes.

The Notes will bear interest at a fixed rate of 5.00% per annum, payable semiannually in arrears on May 15 and November 15 of each year, beginning on May 15, 2014, and will mature on November 15, 2018, unless earlier repurchased or converted.

The Notes will be convertible at the option of the holders at any time prior to the close of business on the business day immediately preceding August 15, 2018 only under certain conditions. On or after August 15, 2018 until the close of business on the second scheduled trading day immediately preceding the maturity date for the Notes, holders will be able to convert their Notes at their option at the conversion rate then in effect at any time, regardless of these conditions. Subject to certain limitations, Horizon may settle conversions of the Notes by paying or delivering, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. If Horizon undergoes a fundamental change prior to the maturity date for the Notes, the holders may require the Company to repurchase for cash all or any portion of their notes at a price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest.

The initial conversion rate will be 186.4280 shares of common stock for each $1,000 principal amount of Notes, which represents an initial conversion price of approximately $5.36 per share of common stock. The capped call transactions described below will increase the effective conversion price of the Notes for Horizon to approximately $6.71 per share. The conversion rate of the Notes, and the corresponding conversion price, will be subject to adjustment for certain events, but will not be adjusted for accrued and unpaid interest.

Horizon may not redeem the Notes prior to their maturity date, and there is no sinking fund provided for the Notes.

In connection with the pricing of the Notes, Horizon entered into privately negotiated capped call transactions with certain financial institutions (the “hedge counterparties”). The capped call transactions are generally expected to reduce potential dilution to Horizon’s common stock upon conversion of the Notes in excess of the principal amount of such converted Notes. The cap price of the capped call transactions will initially be approximately $6.71, which represents a premium of approximately 50% over the last reported sale price of the Company’s common stock on the NASDAQ Global Market on November 18, 2013 and is subject to certain adjustments under the terms of such capped call transactions.

Horizon has been advised by the hedge counterparties that in connection with establishing their initial hedges of the capped call transactions, the hedge counterparties (or their affiliates) expect to enter into various derivative transactions with respect to Horizon’s common stock concurrently with, and/or purchase shares of Horizon’s common stock shortly after, the pricing of the Notes. These activities could have the effect of increasing, or reducing the size of any decrease in, the price of the Notes and/or Horizon’s common stock.

The offering of the Notes was limited to accredited investors and qualified institutional buyers pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Neither the Notes nor any shares of Horizon’s common stock issuable upon conversion of the Notes have been or are expected to be registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

About Horizon Pharma

Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing products to primary care, orthopedic surgeons and rheumatologists. The Company markets DUEXIS® and RAYOS®/LODOTRA® and will market VIMOVO®, which target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.

Forward Looking Statements

This press release contains forward-looking statements, including statements regarding the expected acquisition of the U.S. rights to VIMOVO, the expected closing of Horizon’s offering of the Notes and Horizon’s receipt and use of the net proceeds therefrom, the terms of the Notes and the anticipated impacts of the capped call transactions. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to risks regarding the closing of the acquisition and the offering of the Notes, Horizon’s ability to satisfy the closing conditions for the offering of the Notes, and Horizon’s ability to complete the offering of the Notes on the anticipated terms, or at all. For a further description of these and other risks facing the Company, please see the risk factors described in the Company’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and the Company undertakes no obligation to update or revise these statements, except as may be required by law.

Contacts
Investors
Robert J. De Vaere
Executive Vice President and Chief Financial Officer
Email Contact

Media
Justin Jackson
Burns McClellan, Inc.
212-213-0006
Email Contact

Tuesday, November 19th, 2013 Uncategorized Comments Off on (HZNP) Announces Pricing of $150 Million of 5.00% Convertible Senior Notes

(CXM) Third Quarter 2013 Financials, Recent Business Developments

SAN DIEGO, Nov. 19, 2013 — Cardium Therapeutics (NYSE MKT: CXM) today presented its financial results for the third quarter ended September 30, 2013, and reported on recent highlights and other business developments including:

  • Sale of To Go Brands® business to Cell-nique Corporation and Healthy Brands Collective® in an asset purchase for approximately $2.5 million through the exchange of a preferred equity position in Healthy Brands. Healthy Brands is a private operating company that has acquired eight brand platforms in the health and nutraceutical space and has previously reported plans to move forward as a public company as its businesses advance through internal growth and by further acquisition.
  • Market introduction of LifeAgain’s BlueMetric Select term life insurance program for men with active localized prostate cancer issued by Symetra Life Insurance Company. The BlueMetric Select program is based on LifeAgain’s Advanced Medical Data Analytics Platform Technology (ADAPT™), which was internally developed by researchers at Cardium.
  • Publication of “Serial Sharp Debridement and Formulated Collagen Gel to Treat Pressure Ulcers in Elderly Long-term Care Patients: A Case Study”, in the November 2013 issue of Ostomy Wound Management, highlighting Excellagen’s capability of promoting rapid granulation and healing in chronic pressure ulcers in elderly long-term care facility residents.
  • Distribution agreements with (1) AvKARE Inc. for the sale and distribution of Excellagen into government medical facilities throughout the United States. AvKARE services a diverse customer base that includes government (federal, state and municipal) and commercial sectors, and (2) international distribution agreement with Kasiak Holdings AG for the marketing and sale of Excellagen in Germany and Switzerland.
  • New FDA 510(k) submission for Cardium’s current FDA-cleared Excellagen to reflect additional and specific structural and functional properties based on the Company’s supplemental research and development activities.
  • Research collaborations with (1) Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Excellagen in pre-clinical studies as a delivery agent for Orbsen’s proprietary stromal cell therapy for the potential treatment of diabetic foot ulcers, and (2) researchers at Boston Children’s Hospital, to assess the medical utility of Excellagen as a scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to potentially repair prenatally diagnosed birth defects.
  • Completion of a 1:20 reverse stock split of the Company’s common stock and closing of the second tranche of the securities purchase agreement with one of its institutional investors consisting of 1,656 shares of Series A convertible preferred stock for gross proceeds of approximately $1.7 million, both of which were approved at the 2013 annual meeting of stockholders.
  • Instituted a series of cost reduction actions that include relocation of the corporate offices to a smaller and lower cost facility, reduced employee headcount and across the board salary reductions. The impact of these measures will be reflected in the fourth quarter.

Report on LifeAgain Advanced Medical Analytics

During the third quarter, LifeAgain Insurance Solutions, Inc., Cardium’s newly-formed advanced medical data analytics business focused on the development, marketing and sale of “survivable risk” term life insurance programs, and AgencyONE, its commercialization partner, entered into agreements to market and sell term life insurance issued by Symetra Life Insurance Company under LifeAgain’s BlueMetric Select term life insurance program for men with active localized prostate cancer.  The BlueMetric Select program was developed based on LifeAgain’s Advanced Medical Data Analytics Platform Technology (ADAPT™) and was specifically designed to provide eligible men with term life insurance coverage following a prostate cancer diagnosis or upon the completion of a prostate cancer surgery, without the traditional multi-year waiting periods and additional medical re-qualifications generally required by most life insurance companies.

The BlueMetric Select program has been designed for men aged 45-65, who are in otherwise good health and who have low- to medium-risk active localized prostate cancer, which has been confirmed by a recent biopsy, and for men who have recently completed prostate cancer surgery. This program seeks to provide term life insurance coverage and may include an automatic renewal option (following the initial ten-year term), the right to convert into universal life insurance, and an accelerated benefit in the event of a terminal illness. The BlueMetric Select Program is designed to offer substantial coverage levels, ranging from $100,000 to $1,000,000, without waiting periods, so an individual can begin the application process on the day of his prostate cancer diagnosis, or immediately following completion of prostate cancer surgery.  Additional information is at www.lifeagain.com.

LifeAgain’s proprietary Advanced Medical Data Analytics Platform Technology enables a scalable, actuarial-based risk assessment based on a diagnostic histological biopsy or a prostate cancer surgery.  Together with an applicant’s overall health, these factors may be used to support favorable underwriting decisions and to establish appropriate premium pricing based on the level of prostate cancer progression of each applicant.  LifeAgain is developing additional new and innovative insurance solutions for other medical conditions currently considered uninsurable by traditional underwriters.

Excellagen Update

Cardium recently announced the publication of “Serial Sharp Debridement and Formulated Collagen Gel to Treat Pressure Ulcers in Elderly Long-term Care Patients: A Case Study”, in the November 2013 issue of Ostomy Wound Management, highlighting Excellagen’s capability of promoting rapid granulation and healing in chronic pressure ulcers in elderly long-term care facility residents.  The paper can be accessed at http://www.o-wm.com/article/serial-sharp-debridement-and-formulated-collagen-gel-treat-pressure-ulcers-elderly-long-term.

In third quarter 2013, Cardium filed a 510(k) submission for its current FDA-cleared Excellagen advanced wound care product to reflect additional and specific structural and functional properties based on the Company’s supplemental research and development activities.  The new 510(k) submission is designed to provide further mechanistic insight into the significantly accelerated and activated healing response seen with Excellagen.  In addition, the Company plans to modify Excellagen’s packaging to include individually pouched applicator syringes and a large volume syringe applicator to allow for easier use in larger-sized wounds such as those found in limb salvage, orthopedic surgery and other surgical applications.

The Company entered into a distribution agreement with AvKARE Inc., its new sales and distribution partner for Excellagen in Veterans Hospitals and other governmental medical facilities throughout the United States. The new agreement and commercialization arrangement with AvKARE effectively replaces an earlier arrangement with Academy Medical, LLC.  Cardium elected to transfer the Excellagen distribution responsibilities to AvKARE, which provides five direct wound care experts and allows Cardium’s distributor representatives access to all government accounts.  AvKARE services a diverse customer base that includes government (federal, state and municipal) and commercial sectors.

In addition, during third quarter Cardium entered into a distribution agreement with Kasiak Holdings AG for the marketing and sale of Excellagen in Germany and Switzerland, with the potential for expansion into additional European markets.  Kasiak Holdings is focused on developing stem cell-based therapeutics for the treatment of diabetic foot ulcers.  Kasiak Holdings is affiliated with Kasiak Research, which is an operating unit of India-based Bharat Serums and Vaccines, that develops and manufactures specialized biological, pharmaceutical and biotechnology products.

The Company also announced research collaborations with (1) Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Excellagen in pre-clinical studies as a delivery agent for Orbsen’s proprietary stromal cell therapy for the potential treatment of diabetic foot ulcers, and (2) researchers at Boston Children’s Hospital, to assess the medical utility of Excellagen as a scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to potentially repair prenatally diagnosed birth defects.

Regarding Excellagen’s CE mark submission, Cardium has reported that based on the current status, all information requests have been provided to the notified body, BSI and that the Company believes this process should lead to CE mark certification for its FDA-cleared advanced wound care product.

Report on To Go Brands and Health Sciences Businesses

On November 18, 2013, the Company announced that Cell-nique Corporation, which owns a variety of innovative businesses that are part of the Healthy Brands Collective®, has acquired To Go Brands® in an asset purchase for approximately $2.5 million through an exchange of a preferred equity position in Healthy Brands.

Consistent with Cardium’s business model of developing businesses that can be partnered or monetized with larger enterprises, Healthy Brands has been making significant acquisitions and has previously reported plans to move forward as a public company as its businesses advance through internal growth and by further acquisition.

Through recent acquisitions and the purchase of Cardium’s To Go Brands business,  Healthy Brands’ portfolio now includes nine independent brand product platforms including Cell-nique®, Cherrybrook Kitchen®, Yumnuts®, Living Harvest/Tempt®, Bites of Bliss®, Funky Monkey®, High Country Kombucha® drinks and Organics European Gourmet Bakery™ (Dr. Oetker) natural and organic baking mixes.

Cell-nique is not yet a public reporting company, but annualized revenue is currently estimated to exceed $13.0 million, without giving effect to its recently-completed acquisitions of the Funky Monkey and To Go Brands businesses. Cardium’s preferred stock position in Cell-nique is convertible into common stock currently representing approximately 4% of the fully-diluted common stock, it accrues an 8% annual dividend, and it comes with certain rights and preferences described in Cell-nique’s articles of incorporation. For more information on Cell-nique and the Healthy Brands Collective, visit www.healthybrandsco.com.

Cardium, through its health sciences unit, will retain the trademarks and technology relating to the MedPodium® Nutra-apps® and nutraceutical product line, and will retain its investment interest in SourceOne, a nutraceutical and health sciences ingredient supplier.

The sale of the To Go Brands unit is Cardium’s second development and monetization of a portfolio business. Its InnerCool subsidiary was advanced and sold to a U.S. affiliate of Philips for approximately $12.5 million.

Financial Report

Product sales for the three months ended September 30, 2013 totaled $472,000, compared to $5,600 for the same period in 2012.  Product sales for the nine months ended September 30, 2013 were $1.7 million, compared to $39,000 for the nine months ended September 30, 2012.  The increase in product sales was comprised of sales from the Company’s To Go Brands health sciences business, which Cardium acquired in late September 2012.

Cardium’s research and development costs for the third quarter ended September 30, 2013 totaled $0.3 million, and selling, general and administrative expenses were $1.6 million, compared to $0.5 million and $1.4 million, respectively, for third quarter ended September 30, 2012.  For the nine months ended September 30, 2013, research and development costs were $1.6 million, and selling, general and administrative expenses were $5.3 million, compared to $2.1 million and $4.4 million, respectively, for the nine months ended September 30, 2012.  Research and development expenses for the nine months ended September 30, 2013 included milestone payments and out-of-pocket costs for the ASPIRE study and product and testing costs for validating production volume and cost efficiency improvements for Excellagen.

For the three months ended September 30, 2013, the Company reported a net loss of $1.9 million, or $(0.28) per share, when compared to a net loss of $1.9 million, or $(0.32) per share for the three months ended September 30, 2012.  For the nine months ended September 30, 2013, the Company reported a net loss of $6.6 million, or $(0.99) per share, compared to a net loss for the nine months ended September 30, 2012 of $6.4 million, or $(1.10) per share.  As of September 30, 2013, the Company had $585,000 in cash and cash equivalents, compared to $2.3 million in cash and cash equivalents on December 31, 2012.  On September 30, 2013, 7,747,228 million shares of Cardium’s common stock were outstanding.

The sale of To Go Brands is intended to monetize that business by positioning it with a diversified, fast growing platform.  Cardium’s preferred stock position in Cell-nique is convertible into common stock currently representing approximately 4% of the fully-diluted common stock, it accrues an 8% annual dividend, and it comes with certain rights and preferences described in Cell-nique’s articles of incorporation. Cardium could also elect to sell or otherwise monetize its preferred stock position in Cell-nique in one or more transactions.

The To Go Brands transaction also included the transfer of certain operating expenses and liabilities to Healthy Brands Collective, which will further reduce the Company’s operating expenses. In addition, during third quarter, Cardium implemented certain cost reductions that include relocating the Company to a smaller corporate office, as well as headcount and salary reductions.

The Company intends to consider additional corporate development transactions designed to place its product candidates or businesses into larger organizations or with partners having existing commercialization, sales and marketing resources, and a need for innovative products. Such transactions could involve the sale, partnering or other monetization of particular product opportunities or businesses. In parallel, as the Company’s businesses are advanced and corresponding valuations established, it plans to pursue new product opportunities and acquisitions with strong value enhancement potential.

Cardium has also been approached by a strategic investor interested in potentially acquiring a stake in the company at a premium to market, although we have not entered into definitive agreements for such a transaction.

Depending on the extent and timing of such product advancements, business monetizations and strategic or other investments, and based on recently-issued amendments to Rule 506 and Rule 144A under the Securities Act of 1933 that were implemented under Section 201(a) of the Jumpstart Our Business Startups Act (the “JOBS Act”), we may also consider financings through the sale of private equity interests to qualified investors or strategic partners based on the JOBS Act amendments, and/or through other private placements or a public offering of securities, which could potentially be made in the parent company or independently in one or more of our subsidiary business units.

In third quarter 2013, Cardium completed a 1:20 reverse split of the Company’s common stock and announced the completion of the second tranche of a registered direct offering with one of its institutional investors consisting of 1,656 shares of Series A convertible preferred stock for gross proceeds of approximately $1.7 million.  During third quarter 2013 and as of the date of this report, the Company has not sold any common stock under its “at-the-market” facility.

As previously reported, a communication from the staff of the Company’s current listing exchange, NYSE MKT, indicated that the Company was considered to be noncompliant with certain listing requirements based on its quarterly report for the period ended September 30, 2012, and provided that the company should submit a plan to staff of the exchange that would reestablish compliance with the NYSE MKT listing requirement by March 31, 2013.  On December 6, 2012, the company reported that it had submitted a plan designed to reestablish compliance with the exchange’s requirement in advance of the March 31, 2013 time frame, and on January 6, 2013, announced that the plan had been accepted by the listing exchange.  On April 5, 2013, the Company reported that the NYSE MKT had granted an additional quarterly extension of the listing exchange compliance plan from March 31 to June 30, 2013.  On July 2, 2013, the Company reported that its exchange had granted an additional quarterly extension of the listing exchange compliance plan from June 30, 2013 to September 30, 2013.  On October 7, 2013, the Company reported that the NYSE MKT had granted an additional quarterly extension of the listing exchange compliance plan from September 30, 2013 to December 31, 2013.  If Cardium does not achieve and maintain compliance in accordance with its plans, it could be subjected to delisting proceedings. However, as part of the Company’s overall cost reduction efforts, Cardium has also considered relisting its common stock on the OTC Market, on which its stock regularly traded prior to its listing on the American Stock Exchange.

About Excellagen

Excellagen is a sterile, syringe-based, professional-use, physiologically formulated homogenate of purified bovine dermal collagen (Type I) in its native, 3-dimensional fibrillar configuration, providing a structural scaffold for cellular infiltration and wound granulation. Excellagen activates platelets, triggering release of essential growth factors and functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue.    Excellagen’s FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.  Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.  Excellagen’s unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.  For more information about Excellagen, visit www.excellagen.com.

About Generx

Generx [Ad5FGF-4] alferminogene tadenovec is a disease-modifying regenerative medicine biologic that is being developed to offer a one-time, non-surgical therapy for the treatment of cardiac microvascular insufficiency due to myocardial ischemia in patients with stable angina due to advancing coronary artery disease.  Similar to surgical and mechanical revascularization approaches, the goal of Cardium’s Generx product candidate is to improve blood flow to the heart muscle, following a single, non-surgical administration using a standard balloon angioplasty catheter.  The ASPIRE Phase 3 registration study is currently being conducted at leading cardiology centers in the Russian Federation to evaluate the continued safety and therapeutic effects of Generx.  For more information about Generx and the ASPIRE clinical study, visit www.cardiumthx.com/generx.html.

About LifeAgain

LifeAgain Insurance Solutions is an advanced medical data analytics business and life insurance agency that is focused on the development, marketing and sale of “survivable risk” term life insurance programs for cancer survivors or others with medical conditions who are currently considered uninsurable based on traditional underwriting standards.  Working in cooperation with large and established life insurance companies, LifeAgain uses new actuarial methods, and scientific and medical data-driven insights to design life insurance solutions for those who may otherwise not be able to obtain coverage.  LifeAgain’s initial focus is on the development, marketing and sale of survivable risk life insurance for men with active localized prostate cancer.  LifeAgain plans to develop additional new and innovative life insurance solutions for men and women with other medical conditions. For more information about LifeAgain, visit www.lifeagain.com.

About Cardium

Cardium is a health sciences and biotechnology regenerative medicine company. Cardium has three business units: (1) Angionetic Therapeutics™, focused on the late-stage clinical development of Generx® , an angiogenic gene therapy product candidate for the treatment for cardiac microvascular insufficiency due to advancing coronary artery disease; (2) Activation Therapeutics™, a regenerative medicine wound healing technology and commercialization platform, that includes Excellagen®, an FDA-cleared advanced wound care product and (3) LifeAgain® Insurance Solutions, an advanced medical data analytics platform that supports the Company’s BlueMetric Select term life insurance program, which is underwritten by Symetra Life Insurance for men with active localized prostate cancer.  For more information about Cardium visit www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that Cell-nique and Healthy Brands will be successful in their business development efforts, that their company will go public, or that Cardium’s preferred stock position will result in an increase in value that can be realized by Cardium; that Cardium will be successful in advancing, capitalizing and partnering or monetizing its other businesses and technology platforms; that the Company can raise capital through the private or public sale of equity interests on a company-by-company basis or otherwise; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the Company or its partners will be successful in developing and marketing survivable risk life insurance programs or that any intellectual property developed in the area will be effective for excluding potential competitors; that the Company will satisfy the requirements of its exchange listing compliance plan and will otherwise continue to satisfy the listing requirements of its exchange or that its shares can continue to be listed on a national exchange; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; that the Company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that our or our licensor’s intellectual property can be successfully developed and enforced and that we will not be accused of infringing on intellectual property developed by third parties; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized and their use reimbursed, or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; or that the Company will not be adversely affected by risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2013 Cardium Therapeutics, Inc.  All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics®, Generx®, Excellagen®, LifeAgain®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics, Activation Therapeutics™, MedPodium® and Nutra-Apps® are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.  Other trademarks belong to their respective owners.

-Continued-

 

Cardium Therapeutics, Inc.Selected Condensed Consolidated Results of Operations
Three months ended September 30, Nine months ended September 30,
2013 2012 2013 2012
Product sales $        471,566 $     5,589 $  1,655,342 $    39,241
Cost of goods sold (288,522) (3,640) (977,912) (15,191)
Gross profit 183,044 1,949 677,430 24,050
   Operating expenses
Research and development (315,178) (508,342) (1,566,988) (2,097,675)
Selling, general and administrative (1,636,871) (1,389,731) (5,258,129) (4,358,706)
Loss from operations (1,769,005) (1,896,124) (6,147,687) (6,432,331)
Interest income (expense), net __ 1,204 (1,221) 3,771
Change in fair value of derivative liabilities __ ___ ___ 64,157
Net loss $  (1,769,005) $   (1,894,920) $ (6,148,908) $ (6,364,403)
Deemed dividend on preferred stock (172,861) __ (  405,872) __
Net loss applicable to common stockholders $  (1,941,866) $   (1,894,920) $  (6,554,780) $  (6,364,403)
Basic and diluted loss per common share $      (0.28) $      (0.32) $      (0.99) $      (1.10)
Weighted average common shares outstanding  – basic and diluted 6,995,494 5,952,237 6,595,209 5,774,671

 

Selected Condensed Consolidated Balance Sheet Data
September 30,2013 December 31,2012
Cash and cash equivalents $        585,201 $         2,328,074
Restricted cash 0 50,000
Accounts receivable 105,174 328,953
Inventory 823,235 1,174,323
Prepaid expenses and other current assets 332,682 407,389
Property and equipment, net 65,010 97,582
Intangible assets 1,489,477 1,604,403
Other long-term assets 1,728,431 1,818,154
Total assets $     5,129,210 $         7,808,878
Accounts payable and accrued liabilities $      1,166,912 $         1,392,718
Long-term liabilities 11,813 50,370
Total liabilities 1,178,725 1,443,088
Stockholder’s equity 3,950,485 6,365,790
Total liabilities and stockholder’s equity $      5,129,210 $         7,808,878

SOURCE Cardium Therapeutics

Tuesday, November 19th, 2013 Uncategorized Comments Off on (CXM) Third Quarter 2013 Financials, Recent Business Developments

(ATOS) Reports on 510(k) Pre-Submission Meeting With FDA

SEATTLE, WA–(Nov 18, 2013) – Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company™, today announced that on November 14, 2013, Atossa attended a pre-510(k) submission meeting with the Food and Drug Administration and discussed the regulatory pathway and data requirements to support Atossa’s planned 510(k) Premarket Notification submission for the ForeCYTE Breast Pump and patient kit. Atossa reports that the meeting was productive and will help inform the strategy, content, and timing of the regulatory requirements for the medical device.

Based partially on feedback from the meeting, Atossa plans to submit a 510(k) notification to the FDA related to the ForeCYTE Breast Pump and patient kit. Atossa believes that it has the data and other information to support this submission and intends to file the 510(k) with the FDA as soon as possible. Atossa intends to continue working with the FDA as the 510(k) is prepared, submitted, and reviewed by the FDA for its specific claims.

About Atossa Genetics

Atossa Genetics, Inc. is focused on proprietary products and services related to breast health through the commercialization of medical devices and, through its wholly-owned subsidiary, The National Reference Laboratory for Breast Health, Inc., the offering of laboratory services and tests. For additional information, please visit www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the feedback from the pre-submission meeting and actions related thereto, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa’s ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa’s products and services, the market demand for and acceptance of Atossa’s products and services, performance of distributors, estimated future expenses and cash needs, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Contact:

Atossa Genetics, Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
Email Contact

MBS Value Partners
Matthew D. Haines (Investors and Media)
Managing Director
(O) 212-710-9686
Email Contact

Monday, November 18th, 2013 Uncategorized Comments Off on (ATOS) Reports on 510(k) Pre-Submission Meeting With FDA

(ERB) Exhibits at MEDICA 2013, Dusseldorf Germany “World Forum for Medicine”

ERBA Diagnostics, Inc. (NYSE MKT:ERB), a fully integrated in vitro diagnostics company, is pleased to announce that it will be exhibiting its full range of products at the World’s largest medical show, MEDICA 2013 in Dusseldorf Germany Nov. 20-23.

While ERBA group will be showcasing its entire product range from its Global Subsidiaries that include the Elisa range for Auto Immune and Infectious Disease, Chemistry Analyzers, Hematology analyzers, Urine Analyzers and Coagulation systems along with the wide range of reagent kits we offer, we are particularly excited about the launching of two new high tech product offerings – the Laura XL and Hb–Vario.

The Laura XL is a fully automated Urinalysis and sedimentation processor with the capability to automate Urine strip reading as well as performing sedimentation cell analysis for abnormal samples. The estimated IVD Urinalysis market is approximately $600 Million USD per year.

ERBA will also be showcasing the Hb-Vario, an automated HPLC system that is capable of measuring both HbA1c/ and A2 for the monitoring of diabetes. Diabetes continues to be one of the major challenges worldwide to the healthcare industry. The benefits of monitoring A1c values to better manage diabetes is well documented in numerous studies. The measurement control of A1c values is key to reducing co-morbidity complications within this population.

Glycated hemoglobin (HbA1c) testing is poised to emerge as a popular technology with outpatient clinics and other small hospital-based laboratories according to a Global Industry Analyst report. The same report also forecasts that the global market for Diabetes Diagnostics is estimated to reach US$26 billion by the year 2015. Bio-Rad and Tosoh are the market leaders in this segment. Diabetes testing is a focus area for growth for ERBA.

With the launching of these two exciting products, ERBA expects to further grow its existing global market share in these two segments.

ERBA is now strongly focused on new product developments and looks forward to the ever increasing product portfolio to serve the health care providers and patients worldwide.

About ERBA Diagnostics, Inc.

ERBA Diagnostics, Inc. (www.erbadiagnostics.com), headquartered in Miami, Florida, is a fully integrated in vitro diagnostics company that develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, through its three subsidiaries: Diamedix Corporation (U.S.), Delta Biologicals S.r.L. (Europe) and ImmunoVision, Inc. (U.S.).

Monday, November 18th, 2013 Uncategorized Comments Off on (ERB) Exhibits at MEDICA 2013, Dusseldorf Germany “World Forum for Medicine”

(CPRX) Publication of Preclinical Proof-of-Principle, Infantile Spasms in Epilepsia

Phase I Multiple-Ascending Dose Study to Be Initiated in 2014

CORAL GABLES, Fla., Nov. 18, 2013 — Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, today announced that the journal Epilepsia has accepted for publication an original research paper that demonstrates proof of concept of CPP-115 suppressing infantile spasms (IS) in a pre-clinical study. CPP-115 is Catalyst’s next-generation GABA aminotransferase inhibitor being developed for the treatment of IS. Catalyst also announced plans to initiate a Phase I multiple-dose ascending study in the first half of 2014 to evaluate the safety and tolerability of multiple ascending oral doses of CPP-115.

The lead author (Dr. Aristea Galanopoulou) and principal investigator of the preclinical rodent study described in this publication stated, “This publication provides the first proof-of-principle preclinical evidence in support of CPP-115 as a candidate treatment for IS.” Dr. Galanopoulou continued “Because vigabatrin is particularly effective in tuberous sclerosis–related IS, these patients are likely an ideal target for this analogue that seems to be more potent and less toxic.”

Epilepsia, the official journal of the International League Against Epilepsy, has published Dr. Galanopoulou’s paper, “CPP-115, a vigabatrin analogue, decreases spasms in the multiple-hit rat model of infantile spasms” online as an early view of its upcoming publication. The research paper describes the following study conclusions:

  • CPP-115 suppresses spasms in the multiple-hit model of IS, with onset of effect as early as the day after the first dose.
  • The therapeutic doses of CPP-115 were well tolerated in the preclinical model.
  • CPP-115 showed efficacy at lower doses which were better tolerated than the previously tested therapeutic vigabatrin doses.

“There is a significant unmet medical need in this area, as parents of children who have infantile spasms have a very difficult choice when it comes to treatment options, as they must choose between drug-related risks and adequate treatment,” said Patrick J. McEnany, Chairman and CEO of Catalyst. “Thanks to Dr. Galanopoulou and her team at Albert Einstein College of Medicine, we are able to take next steps in the development of CPP-115 shown in this study to be a better and safer treatment option for Infantile Spasms than current options. This study demonstrates that CPP-115 likely has more than a hundred-fold increase in potency and a better safety profile in the expected therapeutic dose range compared to vigabatrin, as well as increased overall efficacy in this model.”

About the Upcoming Phase I Study

The Phase I study for CPP-115 will be a randomized, double-blind, placebo-controlled, safety, tolerability and pharmacokinetic study of multiple ascending oral doses of CPP-115 in healthy volunteers. The primary objective will be to evaluate the safety and tolerability of multiple ascending oral doses of CPP-115. Secondary objectives will be to determine the pharmacokinetic profile of CPP-115 and to determine the effects of CPP-115 on brain GABA levels as measured by Magnetic Resonance Spectroscopy (MRS) following administration of multiple oral daily doses.

Like vigabatrin (SABRIL®), CPP-115 irreversibly inhibits GABA-aminotransferase, raising brain GABA concentrations. Therefore, the anticipated MRS findings of increased brain GABA are a well characterized biomarker, which can be correlated to the potential efficacy of CPP-115 to treat infantile spasms and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette Syndrome.

About the Published Paper

The research paper was authored by Stephen W. Briggs, Wenzhu Mowrey, Charles B. Hall, and Aristea Galanopoulou (corresponding author), of the Saul R. Korey Department of Neurology, Albert Einstein College of Medicine of Yeshiva University, Laboratory of Developmental Epilepsy and Dominick P. Purpura Department of Neuroscience, Albert Einstein College of Medicine of Yeshiva University, Bronx, New York. The abstract can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/epi.12424/abstract.

About Albert Einstein College of Medicine

The Albert Einstein College of Medicine of Yeshiva University is a premier, research-intensive medical school dedicated to innovative biomedical investigation and to the development of ethical and compassionate physicians and scientists. Inspired by the words of its namesake, the school welcomes students, faculty and staff from diverse backgrounds who strive to enhance human health in the community and beyond.

About West Syndrome / Infantile Spasms

West Syndrome is a rare disease having a prevalence in the U.S. of under 200,000 patients. Its estimated prevalence is 2.5 to 6 cases per 10,000 live births or between 2150 and 5160 patients. An infantile spasm is a type of seizure seen in an epilepsy syndrome of infancy and childhood known as West Syndrome. The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. Spasms often occur in clusters of up to 100 at a time, and infants may have dozens of clusters and several hundred spasms per day. Infantile spasms usually stop by age five, but may be replaced by other seizure types. Many underlying disorders, such as birth injury, metabolic disorders and genetic disorders can give rise to spasms, making it important to identify them (symptomatic IS). In some children, no cause can be found (cryptogenic IS). Mental retardation occurs in 70-90% of persons with infantile spasms, usually involving severe to profound retardation. Early control of seizures is critical for reducing developmental delays and levels of mental retardation, but ~5% of infants with this condition eventually die from complications caused by the seizures.

About Catalyst Pharmaceutical Partners

Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), infantile spasms, and Tourette Syndrome. Catalyst’s lead candidate, Firdapse™ for the treatment of LEMS, is currently undergoing testing in a global, multi-center, pivotal Phase 3 trial and recently received “Breakthrough Therapy Designation” from the U.S. Food and Drug Administration (FDA). In 2012, Catalyst licensed Firdapse™ from BioMarin and Catalyst assumed management of the Phase 3 pivotal trial, initiated by BioMarin. Firdapse™ is the first and only European approved drug for symptomatic treatment in adults with LEMS.

Catalyst is also developing a potentially safer and more potent vigabatrin analog (designated CPP-115) to treat infantile spasms, and epilepsy, as well as other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette Syndrome. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted EU orphan medicinal product designation for the treatment of West Syndrome by the European Commission.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause the Company’s actual results in future periods to differ materially from forecasted results. A number of factors, including whether CPP-115 will prove to be an effective treatment for infantile spasms in humans, whether CPP-115 will ultimately prove to have significantly reduced risks of visual field defects compared to vigabatrin, whether CPP-115 will ever be approved for commercialization, and those other factors described in the Company’s filings with the SEC, could adversely affect the Company. Copies of the Company’s filings with the SEC are available from the SEC, may be found on the Company’s website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.

CONTACT: Media/Investor Contacts
         Donna LaVoie or David Connolly
         LaVoie Group
         (617) 374-8800
         dlavoie@lavoiegroup.com
         dconnolly@lavoiegroup.com

         Company Contact:
         Patrick J. McEnany
         Catalyst Pharmaceutical Partners
         Chief Executive Officer
         (305) 529-2522
         pmcenany@catalystpharma.com
Monday, November 18th, 2013 Uncategorized Comments Off on (CPRX) Publication of Preclinical Proof-of-Principle, Infantile Spasms in Epilepsia

(CXM) To Go Brands® Acquired By Cell-nique And Healthy Brands Collective

SAN DIEGO, Nov. 18, 2013  — Cardium Therapeutics (NYSE MKT: CXM) today announced that Cell-nique Corporation, which owns a variety of innovative businesses that are part of the Healthy Brands Collective®, has acquired To Go Brands® in an asset purchase for approximately $2.5 million through an exchange of a preferred equity position in Healthy Brands.

Consistent with Cardium’s business model of developing businesses that can be partnered or monetized with larger enterprises, Healthy Brands has been making significant acquisitions and has previously reported plans to move forward as a public company as its businesses advance through internal growth and by further acquisition.

Through recent acquisitions and today’s purchase of Cardium’s To Go Brands business,  Healthy Brands’ portfolio now includes nine independent brand product platforms including Cell-nique®, Cherrybrook Kitchen®, Yumnuts®, Living Harvest/Tempt®, Bites of Bliss®, Funky Monkey®, High Country Kombucha® drinks and Organics European Gourmet Bakery™ (Dr. Oetker) natural and organic baking mixes.

Cell-nique is not yet a public reporting company, but annualized revenue is currently estimated to exceed $13.0 million, without giving effect to its recently-completed acquisitions of the Funky Monkey and To Go Brands businesses. Cardium’s preferred stock position in Cell-nique is convertible into common stock currently representing approximately 4% of the fully-diluted common stock, it accrues an 8% annual dividend, and it comes with certain rights and preferences described in Cell-nique’s articles of incorporation. For more information on Cell-nique and the Healthy Brands Collective, visit www.healthybrandsco.com.

Cardium, through its health sciences unit, will retain the trademarks and technology relating to the MedPodium nutra-apps and nutraceutical product line, and will retain its investment interest in SourceOne, a nutraceutical and health sciences ingredient supplier.

The sale of the To Go Brands unit is Cardium’s second development and monetization of a portfolio business. Its InnerCool subsidiary was advanced and sold to a U.S. affiliate of Philips for approximately $12.5 million.

About Cardium

Cardium is a health sciences and biotechnology regenerative medicine company. Cardium has three business units: (1) Angionetic Therapeutics™, focused on the late-stage clinical development of Generx®, an angiogenic gene therapy product candidate for the treatment for cardiac microvascular insufficiency due to advancing coronary artery disease; (2) Activation Therapeutics™, a regenerative medicine wound healing technology and commercialization platform, that includes Excellagen®, an FDA-cleared advanced wound care product; and (3) LifeAgain® Insurance Solutions, an advanced medical data analytics platform that supports the Company’s BlueMetric Select term life insurance program underwritten by Symetra Life Insurance for men with active localized prostate cancer.  For more information about Cardium visit www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there is no assurance that Cell-nique and Healthy Brands will be successful in their business development efforts, that the company will go public, or that Cardium’s preferred stock position will result in an increase in value that can be realized by Cardium; that planned product development efforts and clinical studies can be performed in an efficient and effective manner; that regulatory approvals can be obtained in a timely manner or at all; that partnering, distribution or other commercialization efforts can be achieved; that our products or proposed products will prove to be sufficiently safe and effective; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that third parties on whom we depend will behave as anticipated; or that necessary regulatory approvals will be obtained.  Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of biologics, medical devices and other products, and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new products and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission.  We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2013 Cardium Therapeutics, Inc.  All rights reserved.

For Terms of Use Privacy Policy, please visit www.cardiumthx.com.

Cardium Therapeutics®, Generx®, Excellagen®, LifeAgain®, BlueMetric™, Decision Rule Adaption™, ADAPT™, Angionetic Therapeutics, Activation Therapeutics are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.  Other trademarks belong to their respective owners.

Monday, November 18th, 2013 Uncategorized Comments Off on (CXM) To Go Brands® Acquired By Cell-nique And Healthy Brands Collective

(BTHE) Presents at the Elsevier Therapeutic Area Partnerships 2013 Conference

Company Chosen as One of 10 “Top Projects to Watch” in Area of Cardiovascular/Metabolic Diseases

MANCHESTER, NH–(Nov 18, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovative developer of drugs that address diabetes using complex carbohydrate chemistry, will be presenting at the Elsevier Therapeutic Area Partnerships (“TAP”) 2013 Conference at The Hyatt Regency in Boston on Tuesday, November 19 from 2:15 pm to 3:05 pm ET within Track 4 (Cardiovascular/Metabolic Diseases).

Kenneth A. Tassey, Jr., President of Boston Therapeutics, will present information about PAZ320, an investigational non-systemic chewable tablet that when taken as an adjunctive therapy helped 45% of the patients with Type II diabetes manage the post-meal elevation of their blood sugar in a Phase IIa clinical trial.

For the conference, Boston Therapeutics was chosen as one of 10 “Top Projects to Watch” within the area of cardiovascular/metabolic diseases. These are handpicked by a panel of independent experts who screen hundreds of compounds and weigh their potential as future products. The criteria were: large market, large unmet need, with increasing opportunity; history of the molecule and drug; strong science; strong company; diversity of indications; potential for new opportunities beyond the initial indications; and multilevel partnering opportunities.

Mr. Tassey said, “TAP 2013 promises to be one of the key meetings of the year within the cardiovascular/metabolic disease area. We are pleased with this opportunity to educate attendees about the potential benefits of PAZ320, and are honored to be named a ‘Top Project to Watch’ by the independent panel.”

About the Therapeutic Area Partnerships Conference

Since its launch eight years ago, Therapeutic Area Partnerships (TAP) has come to be regarded as the industry’s premier biopharmaceutical partnering event and a meeting for the sharpest minds in biopharma. A uniquely efficient gathering, TAP brings together decision-makers to assess the most promising drug programs available for partnering in oncology, cardiovascular/metabolic diseases, neuroscience, infectious diseases, anti-inflammatory/autoimmune diseases and advanced therapies. Attendees have the opportunity to hear from and meet some of the industry’s most talented biotechnology entrepreneurs and pharmaceutical leaders. Casual gatherings and one-on-one partnering meetings bring together business development decision makers from large pharmaceutical firms and executive leadership from innovative biotechnology firms to make this one of the industry’s most productive events. More information is available at www.elsevierbi.com/mkt/Conf/TAP2013/TAP2013.

About PAZ320

PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose and release it into the bloodstream.

About Boston Therapeutics, Inc.

Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.

Forward Looking Statements

This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.

Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

Contact:

Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com

Monday, November 18th, 2013 Uncategorized Comments Off on (BTHE) Presents at the Elsevier Therapeutic Area Partnerships 2013 Conference

(INOC) Buyout, Shareholder Rights Law Firm Seeks Higher Price

NEW YORK, Nov. 15, 2013  — Tripp Levy PLLC, a leading securities and shareholder rights law firm that represents shareholders nationwide, announces that it is investigating the acquisition Innotrac Corporation (NASDAQ: INOC) (“Innotrac” or the “Company”) on behalf of shareholders.  It was announced that an affiliate of Sterling Partners has entered into a definitive merger agreement to acquire all of the outstanding shares of Innotrac of $8.20 per share in cash.

The investigation concerns whether the senior management and board of directors of Innotrac breached their fiduciary duties to shareholders by not engaging in a full and fair process to insure shareholders received the maximum value for their shares, while, at the same time, seeking to benefit themselves for their own self-interests.  Indeed, Scott Dorfman, Innotrac’s CEO, Chairman and largest shareholder, and other members of the Company’s management will continue their leadership of the Company and will retain a significant equity position in the Company.  Mr. Dorfman has also agreed to contribute all of his shares, representing 44% of the Company’s outstanding stock to Sterling.

If you are a shareholder of Innotrac and would like additional information regarding this matter, at no cost or expense, please contact us at:

Tripp Levy PLLC
New York, New York
Toll free: 1-877-772-3975
Email: contact@tripplevy.com
www.tripplevy.com

Tripp Levy PLLC is a leading securities and shareholder rights law firm that has extensive experience in mergers and takeovers, and has assisted in the recovery of millions of dollars for shareholders around the globe.  Attorney advertising.  Prior results do not indicate a similar outcome.

Friday, November 15th, 2013 Uncategorized Comments Off on (INOC) Buyout, Shareholder Rights Law Firm Seeks Higher Price

(PRAN) Responds to Media Segment Under ASX Guidance Note 8

MELBOURNE, AUSTRALIA–(Nov 15, 2013) – Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) has become aware of a news story which indirectly reference the company’s Phase II clinical drug trial of PBT2 for Alzheimer’s disease, IMAGINE.

It appears one of the patients participating in IMAGINE has suggested certain symptoms associated with Alzheimer’s disease have improved during the trial. Whilst the company was not named, images of Prana’s drug under development for Alzheimer’s disease PBT2 were used.

Prana was not aware of the segment and did not participate in the segment. The IMAGINE trial is a randomised, double-blind trial. Prana, the clinical investigators and the patients involved are unaware of the treatment assignment (PBT2 or a placebo).

The clinical benefit, if any, of PBT2 compared to a placebo will not be known until treatment assignment is un-blinded and the trial data analysed.

Prana expects to release the results of IMAGINE in March 2014.

Prana has made this release under ASX Guidance Note 8 Continuous Disclosure to avoid any uncertainty and has not received a request from the ASX.

About Prana Biotechnology Limited

Prana Biotechnology was established to commercialise research into age-related neurodegenerative disorders. The Company was incorporated in 1997 and listed on the Australian Securities Exchange in March 2000 and listed on NASDAQ in September 2002. Researchers at prominent international institutions including The University of Melbourne, The Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.

For further information please visit the Company’s web site at www.pranabio.com.

Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “may,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, PBT2, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, PBT2, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, PBT2, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to PBT2, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.

Contacts:

USA:
Vivian Chen
Grayling
T: +1 646-284-9472
Vivian.Chen@grayling.com

Australia:
Investor Relations
Rebecca Wilson
T: +61 3 8866 1216
E: rwilson@buchanwe.com.au

Media Relations
Ben Oliver
T: +61 3 8866 1233
E: boliver@buchanwe.com.au

Friday, November 15th, 2013 Uncategorized Comments Off on (PRAN) Responds to Media Segment Under ASX Guidance Note 8

(HOTR) Asset, Revenue Growth, Improvement in Gross Margins, Restaurant EBITDA

CHARLOTTE, NC–(November 15, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer” or “the Company”), a franchisee of international Hooters® restaurants and a minority owner in the privately held parent company of the Hooters® brand, Hooters of America (“HOA”), and owner of American Roadside Burgers Inc (“ARB”), a Charlotte, N.C. based chain, announced its financial results for the three and nine months ended September 30, 2013.

Highlights Include:

  • On September 30, 2013, the Company completed our acquisition of 100% of American Roadside Burgers, Inc. (“ARB”). The Company issued 740,000 shares of its common stock and warrants to acquire 740,000 shares of common stock for $5.00 per share. In connection with the acquisition of ARB and the related management team, the Company acquired a strategic opportunity to participate in a high-growth space with an already established brand. The Company’s plan is to continue to expand the American Roadside chain as opportunities occur, which has the potential to bring additional revenue and profits to the Company in the future. The acquisition provides the Company with advisory services from one of the nation’s leading restaurant executives, Tom Lewison. The Company also hired Rich Adams, a 35 year food service veteran, as Chief Operating Officer.
  • Restaurant revenue for the third quarter 2013 decreased 7.6% to $1.6 million, compared with $1.7 million in the third quarter 2012. This decrease is primarily from a decrease in the South African (“SA”) currency exchange rate to the U.S. dollar (“USD”); revenues measured in local currency increased 3.6%. Restaurant revenue for the nine months ended September 30, 2013 increased 1.5% to $4.9 million, compared with $4.8 million in the third quarter 2012. This increase occurred from having five Hooters locations operating for the full nine months of 2013, offset by the aforementioned exchange rate decline.
  • As of September 30, 2013, the Company had eleven restaurants (10 consolidated and one joint venture) compared with six restaurants (five consolidated and one joint venture) as of September 30, 2012.
  • Restaurant gross profit margins for the third quarter 2013 improved 5.3% to 63.5% compared with 58.2% in the same period a year ago. Restaurant gross profit margins for the nine months ended September 30, 2013 improved 4.0% to 62.2% compared with 58.2% in the third quarter 2012.
  • Same-store net sales for restaurants opened more than a year increased 3.6% and 5.3% in South Africa currency (Rands) for the three and nine months ended September 30, 2013, respectively compared with last year.
  • Restaurant EBITDA for the three months ended September 30, 2013 and 2012 was approximately $83,000 and $54,000, respectively, an increase of 53.7%. Restaurant EBITDA for the nine months ended September 30, 2013 and 2012 was $195,000 and $153,000, respectively, an increase of 27.5%. Our improved gross margins were offset by an increase in operating expenses, including professional fees and higher payroll costs.
  • Net loss attributable to Chanticleer Holdings, Inc. from continuing operations for the third quarter 2013 was $1.4 million or $0.38 per share, compared with $721,000 or $0.19 per share for the year-ago third quarter. Total net loss for the 2013 third quarter was $1.4 million or $0.38 per share, compared with $740,000 or $0.20 per share. The increase was primarily attributable to an increase in general and administrative expenses (“G&A”) and interest expense.
  • Net loss attributable to Chanticleer Holdings, Inc. from continuing operations for the nine months ended September 30, 2013 was $2.8 million or $0.77 per share, compared with $2.2 million or $1.00 per share for the year-ago period. Total net loss for the nine months ended September 30, 2013 was $2.9 million or $0.77 per share, compared with $2.3 million or $1.06 per share. The increase was primarily attributable to an increase in G&A and interest expense.

Subsequent to September 30, 2013, the Company had significant announcements:

  • The Company assumed operating control of ARB on October 1, 2013. ARB is a five store burger chain currently operating 1 location in Smithtown, NY, 2 in Charlotte, NC, 1 in Columbia, SC and 1 in Greenville, SC.
  • On October 17, 2013, the Company raised $2,500,000 in a private placement, pursuant to which the Company sold an aggregate of 666,667 Units (the “Units”) at a purchase price of $3.75 per Unit (“Unit Price”). Each Unit consists of (a) one (1) share of the Company’s common stock, $0.001 par value per share (the “Common Stock”) and (b) one (1) five (5) year warrant, exercisable after twelve (12) months, to purchase one (1) share of common stock at an initial exercise price of five dollars ($5.00) (the “Warrants”).
  • On November 6, 2013, the Company finalized the acquisition of the Hooters Nottingham restaurant for it’s previously announced purchase price of $3,150,000. On November 7, 2013, the Company took operating control of Hooters Nottingham .The restaurant will continue under it’s current management team who have over 20 years combined experience at this restaurant.
  • On November 4, 2013, the Company entered into a Subscription Agreement with JF Restaurants, LLC (“JFR”), JF Franchising Systems, LLC (“JFFS”) (collectively “Just Fresh”), and the Preferred Members (the “Members” or collectively, the “Sellers”) for the purchase of a fifty one percent (51%) ownership interest in each entity. The total purchase price was $560,000 and the final closing is contingent upon the Members’ conversion of all outstanding Member notes and loans into ownership interest, to be held no later than November 20, 2013. Just Fresh currently operates five restaurants in the Charlotte, North Carolina area that offer fresh-squeezed juices, gourmet coffee, fresh-baked goods and premium-quality, made-to-order sandwiches, salads and soups.
  • On November 7, 2013, the Company entered into a Subscription Agreement (the “Subscription Agreement”) with three accredited investors (the “Investors”), pursuant to which the Company sold to the Investors an aggregate of 160,000 Units (the “Units”) at a purchase price of $5.00 per Unit (“Unit Price”), closing a $800,000 private placement (the “Private Placement”). The aggregate purchase price we received from the sale of the Units was $800,000. Each Unit consists of (a) one (1) share of the Company’s common stock, $0.001 par value per share (the “Common Stock”) and (b) one (1) five (5) year warrant to purchase one (1) share of common stock. One half (80,000) of the available warrants are available at an initial exercise price of five dollars and fifty cents ($5.50), while the remaining half (80,000) of the warrants are available at an initial exercise price of seven dollars ($7.00) (the “Warrants”).

Mike Pruitt, Chairman and CEO of Chanticleer, commented: “We are excited to add American Roadside Burgers and Hooters Nottingham to our portfolio of restaurant companies heading into the fourth quarter of 2013. Revenue growth, gross margin improvement and growth in restaurant EBITDA give us good momentum as we enter the fourth quarter. In November we closed our purchase of the existing Hooters restaurant in Nottingham, England, which has been profitable for some time. The purchase price was $3,150,000 and the current management team will remain to operate the restaurant. Going forward, we will continue to evaluate restaurant and other opportunities at home and abroad, as well as continue to focus on performance improvement in our existing operations.”

Use of Non-GAAP Measures

Chanticleer Holdings, Inc. prepares its condensed consolidated financial statements in accordance with United States generally accepted accounting principles (“GAAP”). In addition to disclosing financial results prepared in accordance with GAAP, the company discloses information regarding EBITDA, which differs from the term EBITDA as it is commonly used. In addition to adjusting net income (loss) from continuing operations to exclude taxes, interest, and depreciation and amortization, EBITDA also excludes pre-opening costs for our restaurants, non-cash expenses for services, change in fair value of derivative liability and gain on extinguishment of debt. EBITDA is not a measure of performance defined in accordance with GAAP. However, EBITDA is used internally in planning and evaluating the company’s operating performance. Accordingly, management believes that disclosure of this metric offers investors, bankers and other stakeholders an additional view of the company’s operations that, when coupled with the GAAP results, provides a more complete understanding of the company’s financial results.

EBITDA should not be considered as an alternative to net loss or to net cash used in operating activities as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the company’s performance. A reconciliation of GAAP net income (loss) to EBITDA is included in the accompanying financial schedules.

About Chanticleer Holdings, Inc.

Chanticleer Holdings (NASDAQ: HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets and American Roadside Burgers Inc (“ARB”), a Charlotte, N.C. based chain. Chanticleer currently owns in whole or part of the exclusive franchise rights to develop and operate Hooters restaurants in South Africa, Hungary and parts of Brazil, and has joint ventured with the current Hooters franchisee in Australia, while evaluating several additional international opportunities. The Company currently owns and operates in whole or part of seven Hooters restaurants in its international franchise territories: Durban, Johannesburg, Cape Town and Emperor’s Palace in South Africa; Campbelltown in Australia; Budapest in Hungary; and Nottingham in the United Kingdom. ARB, purchased by Chanticleer Holdings on October 1, 2013, has a total of 5 casual restaurants — 1 location in Smithtown, N.Y., 2 locations in Charlotte, N.C., 1 location in Columbia, S.C., and the newest location is in Greenville, S.C

For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR

For further information on Hooters of America, visit www.Hooters.com
Facebook: www.Facebook.com/Hooters
Twitter: http://Twitter.com/Hooters

Safe Harbor/Risk Factors
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on expectations, forecasts, and assumptions by our management and involve a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those stated, including, without limitation:

  • Operating losses continuing for the foreseeable future; we may never be profitable;
  • Our business strategy includes operating a new line of business that is distinct and separate from our primary existing operations, which could be subject to additional business and operating risks;
  • Inherent risks in expansion of operations, including our ability to acquire additional territories, generate profits from new restaurants, find suitable sites and develop and construct locations in a timely and cost-effective way;
  • General risk factors affecting the restaurant industry, including current economic climate, costs of labor and food prices;
  • Intensive competition in our industry and competition with national, regional chains and independent restaurant operators;
  • Our rights to operate and franchise Hooters-branded restaurants are dependent on the Hooters’ franchise agreements;
  • Our business depends on our relationship with Hooters;
  • We do not have full operational control over the businesses of our franchise partners;
  • Failure by Hooters to protect its intellectual property rights, including its brand image;
  • Our business has been adversely affected by declines in discretionary spending and may be affected by changes in consumer preferences;
  • Increases in costs, including food, labor and energy prices;
  • Our business and the growth of our Company is dependent on the skills and expertise of management and key personnel;
  • Constraints could effect our ability to maintain competitive cost structure, including, but not limited to labor constraints;
  • Work stoppages at our restaurants or supplier facilities or other interruptions of production;
  • Our food service business and the restaurant industry are subject to extensive government regulation;
  • We may be subject to significant foreign currency exchange controls in certain countries in which we operate;
  • Inherent risk in foreign operation;
  • We may not attain our target development goals and aggressive development could cannibalize existing sales;
  • Current conditions in the global financial markets and the distressed economy;
  • A decline in market share or failure to achieve growth;
  • Unusual or significant litigation, governmental investigations or adverse publicity, or otherwise;
  • Adverse effects on our operations resulting from the current class action litigation in which the Company is one of several defendants;
  • Adverse effects on our results from a decrease in or cessation or clawback of government incentives related to investments;
  • Adverse effects on our operations resulting from certain geo-political or other events.

Chanticleer cannot be certain that any expectation, forecast, or assumption made in preparing any forward-looking statements will prove accurate, or that any projection will be realized. It is to be expected that there may be differences between projected and actual results. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its Web site or otherwise. We undertake no obligation to update the forward-looking statements provided to reflect events or circumstances that occur after the date on which they were made. Further information on our business, including important factors which could affect actual results are discussed in the Company’s filings with the SEC, including its Annual Report on Form 10-K under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

Chanticleer Holdings, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited)
September 30, December 31,
2013 2012
ASSETS
Current assets:
Cash $ 213,229 $ 1,223,803
Restricted cash 3,000,000
Accounts receivable 156,235 161,073
Other receivable 159,666 85,473
Inventory 198,274 227,023
Due from related parties 116,305 117,899
Prepaid expenses 436,219 170,769
Assets of discontinued operations 51,804 44,335
TOTAL CURRENT ASSETS 4,331,732 2,030,375
Property and equipment, net 5,047,122 2,316,146
Goodwill 2,053,946 396,487
Intangible assets, net 2,398,919 559,832
Investments at fair value 12,062 56,949
Other investments 1,970,796 2,116,915
Deposits and other assets 213,437 169,727
TOTAL ASSETS $ 16,028,014 $ 7,646,431
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Line of credit and notes payable $ 625,959 $ 236,110
Derivative liability 2,341,500
Accounts payable and accrued expenses 1,550,827 1,108,305
Advances from investors 575,000
Other current liabilities 105,453 361,586
Current maturities of capital leases payable 47,186 27,965
Deferred rent 19,561 10,825
Due to related parties 12,191 13,733
Liabilities of discontinued operations 9,881 14,328
TOTAL CURRENT LIABILITIES 5,287,558 1,772,852
Capital leases, less current maturities 63,032 60,518
Convertible note payable, net of debt discount of $2,833,333 166,667
Deferred rent and occupancy liability 1,204,999 98,448
Other liabilities 100,647 186,060
TOTAL LIABILITIES 6,822,903 2,117,878
Commitments and contingencies
Stockholders’ equity:
Common stock: $0.0001 par value; authorized 20,000,000 shares; issued and outstanding 4,467,896 and 3,698,896 shares at September 30, 2013 and December 31, 2012, respectively 446 370
Additional paid in capital 21,501,399 14,898,423
Other comprehensive loss (155,872 ) (181,741 )
Accumulated deficit (12,126,946 ) (9,258,697 )
Non-controlling interest (13,916 ) 70,198
TOTAL STOCKHOLDERS’ EQUITY 9,205,111 5,528,553
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 16,028,014 $ 7,646,431
Chanticleer Holdings, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
For the Three Months Ended
September 30,
2013 2012
Revenue:
Restaurant sales, net $ 1,581,245 $ 1,710,632
Management fee income – non-affiliates 25,000 25,000
Total revenue 1,606,245 1,735,632
Expenses:
Restaurant cost of sales 577,299 714,551
Restaurant operating expenses 920,630 943,618
Restaurant pre-opening expenses 7,337 125,947
General and administrative expenses 943,632 614,980
Depreciation and amortization 129,126 97,883
Total expenses 2,578,024 2,496,979
Loss from operations (971,779 ) (761,347 )
Other income (expense)
Equity in (losses) gains of investments (13,131 ) 33,412
Miscellaneous income 1,153
Change in fair value of derivative liability (75,900 )
Interest expense (383,595 ) (39,583 )
Total other expense (472,626 ) (5,018 )
Loss from continuing operations before income taxes (1,444,405 ) (766,365 )
Provision for income taxes 6,019 7,997
Loss from continuing operations (1,450,424 ) (774,362 )
Loss from discontinued operations, net of taxes (4,403 ) (18,913 )
Consolidated net loss (1,454,827 ) (793,275 )
Less: Net loss attributable to non-controlling interest 31,355 53,509
Net loss attributable to Chanticleer Holdings, Inc. $ (1,423,472 ) $ (739,766 )
Net loss attributable to Chanticleer Holdings, Inc.:
Loss from continuing operations $ (1,419,069 ) $ (720,853 )
Loss from discontinued operations (4,403 ) (18,913 )
$ (1,423,472 ) $ (739,766 )
Other comprehensive (loss) income:
Unrealized loss on available-for-sale securities (none applies to non-controlling interest) $ (7,922 ) $ (26,404 )
Foreign currency translation gain 15,841 46,511
Other comprehensive loss $ (1,415,553 ) $ (719,659 )
Net loss per attributable to Chanticleer Holdings, Inc. per common share, basic and diluted:
Continuing operations attributable to common shareholders, basic and diluted $ (0.38 ) $ (0.19 )
Discontinued operations attributable to common shareholders, basic and diluted (0.00 ) (0.01 )
$ (0.38 ) $ (0.20 )
Weighted average shares outstanding, basic and diluted 3,704,526 3,698,896
Chanticleer Holdings, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
For the Nine Months Ended
September 30,
2013 2012
Revenue:
Restaurant sales, net $ 4,864,410 $ 4,794,250
Management fee income – non-affiliates 75,000 75,000
Total revenue 4,939,410 4,869,250
Expenses:
Restaurant cost of sales 1,840,535 2,005,714
Restaurant operating expenses 2,833,035 2,636,240
Restaurant pre-opening expenses 17,538 190,167
General and administrative expenses 2,294,370 1,669,956
Depreciation and amortization 373,226 265,068
Total expenses 7,358,704 6,767,145
Loss from operations (2,419,294 ) (1,897,895 )
Other income (expense)
Equity in losses of investments (46,184 ) (10,474 )
Gain on extinguishment of debt 70,900
Miscellaneous income 3,785 1,153
Change in fair value of derivative liability (75,900 )
Interest expense (438,941 ) (432,795 )
Total other expense (486,340 ) (442,116 )
Loss from continuing operations before income taxes (2,905,634 ) (2,340,011 )
Provision for income taxes 27,216 7,997
Loss from continuing operations (2,932,850 ) (2,348,008 )
Loss from discontinued operations, net of taxes (19,513 ) (124,872 )
Consolidated net loss (2,952,363 ) (2,472,880 )
Less: Net loss attributable to non-controlling interest 84,114 185,711
Net loss attributable to Chanticleer Holdings, Inc. $ (2,868,249 ) $ (2,287,169 )
Net loss attributable to Chanticleer Holdings, Inc.:
Loss from continuing operations $ (2,848,736 ) $ (2,162,297 )
Loss from discontinued operations (19,513 ) (124,872 )
$ (2,868,249 ) $ (2,287,169 )
Other comprehensive (loss) income:
Unrealized loss on available-for-sale securities (none applies to non-controlling interest) $ (44,887 ) $ (264,044 )
Foreign currency translation gain 70,756 45,464
Other comprehensive loss $ (2,842,380 ) $ (2,505,749 )
Net loss attributable to Chanticleer Holdings, Inc,. per common share, basic and diluted:
Continuing operations attributable to common shareholders, basic and diluted $ (0.77 ) $ (1.00 )
Discontinued operations attributable to common shareholders, basic and diluted (0.01 ) $ (0.06 )
$ (0.77 ) $ (1.06 )
Weighted average shares outstanding, basic and diluted 3,701,804 2,153,148
Chanticleer Holdings, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine Months Ended
September 30,
2013 2012
Cash flows from operating activities:
Net loss $ (2,932,850 ) $ (2,348,008 )
Less: net loss from discontinued operations (19,513 ) (124,872 )
Net loss from continuing operations (2,952,363 ) (2,472,880 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 373,226 265,068
Equity in losses of investments 46,184 10,474
Amortization of warrants 272,529 120,632
Common stock issued for services 124,720 25,606
Gain on debt extinguishment (70,900 )
Amortization of debt discount 166,667
Interest expense 150,200
Change in fair value of derivative liablility 75,900
Decrease (increase) in accounts and other receivables 46,427 (87,586 )
Increase in prepaid expenses and other assets (108,942 ) (178,976 )
Decrease (increase) in inventory 86,496 (75,289 )
Increase in accounts payable and accrued expenses 105,314 477,250
Increase in deferred rent 14,670 17,315
Increase in income taxes payable 7,997
Repayment (advance) from related parties for working capital 52 (89,587 )
Net cash used in operating activities from continuing operations (1,669,820 ) (1,979,976 )
Net cash used in operating activities from discontined operations (11,917 ) (16,007 )
Net cash used in operating activities (1,681,737 ) (1,995,983 )
Cash flows from investing activities:
Proceeds from non-controlling interests 90,000
Repayments (purchases) of investments 98,434 (1,213,391 )
Restricted cash (3,000,000 )
Franchise costs (75,000 ) (210,000 )
Cash acquired from business combination 53,684
Purchase of property and equipment (86,919 ) (1,169,191 )
Net cash used in investing activities from continuing operations (3,009,801 ) (2,502,582 )
Net cash used in investing activities from discontinued operations
Net cash used in investing activities (3,009,801 ) (2,502,582 )
(Continued )
Chanticleer Holdings, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows, continued
(Unaudited)
Nine Months Ended
September 30,
2013 2012
Cash flows from financing activities:
Sale of Common Stock 7,051,464
Advances from investors 575,000
Loan proceeds, net 3,342,000 2,915,000
Decrease in other liabilities (270,646 ) (32,313 )
Loan and capital lease repayments (36,821 ) (3,967,747 )
Net cash provided by financing activities from continuing operations 3,609,533 5,966,404
Net cash (used in) provided by financing activities from discontinued operations
Net cash provided by financing activities 3,609,533 5,966,404
Effect of exchange rate changes on cash 71,431 45,466
Net change in cash (1,010,574 ) 1,513,305
Cash, beginning of period 1,223,803 165,129
Cash, end of period $ 213,229 $ 1,678,434
Supplemental cash flow information:
Cash paid for interest and income taxes:
Interest $ 43,920 $ 237,604
Income taxes
Non-cash investing and financing activities:
Convertible notes payable exchanged for common stock $ $ 1,907,238
Purchase of equipment using capital leases 53,943
Common stock units issued for Hoot limited partner units 986,651
Common stock and warrants issued to acquire American Roadside Burgers, Inc. (ARB):
Current assets acquired $ 274,211 $
Property and equipment 2,948,102
Goodwill 1,653,016
Trade name/trademark 1,784,443
Deposits and other assets 98,035
Liabilities assumed (1,490,288 )
Common stock and warrants issued (5,321,203 )
Reconciliation of net loss from continuing operations to EBITDA
Unaudited
Three months ended September 30, 2013: Restaurants only
South Africa Hungary Management Totals
GAAP net loss from continuing operations $ (34,923 ) $ (28,815 ) $ (1,386,686 ) $ (1,450,424 )
Interest expense 5,617 377,978 383,595
Change in fair value of derivative liablility 75,900 75,900
Non-cash expenses related to services 303,650 303,650
Pre-opening expenses 7,337 7,337
Depreciation and amortization 96,150 31,891 1,085 129,126
Income taxes 6,019 6,019
EBITDA $ 80,200 $ 3,076 $ (628,073 ) $ (544,797 )
Total Restaurants EBITDA $ 83,276
Three months ended September 30, 2012:
South Africa Hungary Management Totals
GAAP net loss from continuing operations $ (66,829 ) $ (120,424 ) $ (587,109 ) $ (774,362 )
Interest expense 11,486 28,097 39,583
Non-cash expenses related to services 64,769 64,769
Pre-opening costs (537 ) 126,484 125,947
Depreciation and amortization 85,241 10,198 2,444 97,883
Income taxes 7,997 7,997
EBITDA $ 37,358 $ 16,258 $ (491,799 ) $ (438,183 )
Total Restaurants EBITDA $ 53,616
Nine months ended September 30, 2013: Restaurants only
South Africa Hungary Management Totals
GAAP net loss from continuing operations $ (71,602 ) $ (104,600 ) $ (2,756,648 ) $ (2,932,850 )
Interest expense 28,107 410,834 438,941
Change in fair value of derivative liablility 75,900 75,900
Non-cash expenses related to services and warrants 397,249 397,249
Pre-opening expenses 17,538 17,538
Gain on debt extinguishment (70,900 ) (70,900 )
Depreciation and amortization 281,103 87,763 4,360 373,226
Income taxes 27,216 27,216
EBITDA $ 211,462 $ (16,837 ) $ (1,868,305 ) $ (1,673,680 )
Total Restaurants EBITDA $ 194,625
Nine months ended September 30, 2012:
South Africa Hungary Management Totals
GAAP net loss from continuing operations $ (194,905 ) $ (145,424 ) $ (2,007,679 ) $ (2,348,008 )
Interest expense 37,515 395,280 432,795
Non-cash expenses related to services 146,238 146,238
Pre-opening costs 38,683 151,484 190,167
Depreciation and amortization 247,901 10,198 6,969 265,068
Income taxes 7,997 7,997
EBITDA $ 137,191 $ 16,258 $ (1,459,192 ) $ (1,305,743 )
Total Restaurants EBITDA $ 153,449

Contact:

Chanticleer Holdings, Inc.
Mike Pruitt
Chairman/CEO
Phone: 704.366.5122 x 1
mp@chanticleerholdings.com

Eric Lederer
CFO
Phone: 704.366.5736
elederer@chanticleerholdings.com

Friday, November 15th, 2013 Uncategorized Comments Off on (HOTR) Asset, Revenue Growth, Improvement in Gross Margins, Restaurant EBITDA

(PRKR) Patent Portfolio Continues to Rank Among the Top 25 Most Influential

JACKSONVILLE, Fla., Nov. 14, 2013 — ParkerVision, Inc. (Nasdaq:PRKR), a developer and marketer of semiconductor technology solutions for wireless applications, today announced that its patent portfolio once again ranked among the Top 25 companies in the telecom and communications industry according to an analysis conducted by The Patent Board that appeared in the November 11, 2013 edition of The Wall Street Journal.

The Patent Board, the leading independent provider of best practices research, tools and metrics for patent analysis and intellectual property investment, tracks and analyzes innovation, movement, and the business value of patent assets across all industries. Its tri-annual rankings on the telecom and communications industry are based on a comprehensive review of the quantity and quality of a company’s patents, including a detailed analysis of the technology’s science strength, industry impact and research intensity. ParkerVision earned the highest score among the top 50 companies in both the 13-week and 5-year cumulative science strength scores and ranked second among the top 50 companies in research intensity and industry impact.

With a worldwide portfolio of 236 patents, including 25 granted this year, ParkerVision’s performance on the Patent Scorecard marks the latest objective acknowledgement of the Company’s innovations for wireless technology solutions. Last month, an Orlando, Florida jury determined that Qualcomm Incorporated had directly and indirectly infringed four of the Company’s patents and awarded ParkerVision $172.7 million in damages for the unauthorized use of its technology in some of Qualcomm’s best-selling products in the United States.

“We are pleased to once again be recognized as a leading innovator in the telecom and communications industry,” said Jeffrey Parker, Chairman and Chief Executive Officer of ParkerVision. “This latest recognition by The Patent Board continues to validate the value and merit of our patent portfolio. We believe the strength of our patent portfolio, coupled with our recent court victory, paves the way for ParkerVision to become an active and rightful participant in the wireless market.”

About ParkerVision, Inc.

ParkerVision, Inc. designs, develops and markets its proprietary radio frequency (RF) technologies, which enable advanced wireless communications for current and next generation mobile communications networks. Its solutions for wireless transfer of RF waveforms enable significant advancements in wireless products, addressing the needs of the cellular industry for efficient use of power, reduced cost and size, greater design simplicity, and enhanced performance in mobile handsets as the industry migrates to next generation networks. For more information, please visit http://www.parkervision.com. (PRKR-G)

Safe Harbor Statement

This press release contains forward-looking information. Readers are cautioned not to place undue reliance on any such forward-looking statements, each of which speaks only as of the date made. Such statements are subject to certain risks and uncertainties, which are disclosed in ParkerVision’s SEC reports, including the Form 10-K for the year ended December 31, 2012 and the Forms 10-Q for the quarters ended March 31, 2013, June 30, 2013, and September 30, 2013. These risks and uncertainties could cause actual results to differ materially from those currently anticipated or projected.

CONTACT: Investor Contact:
         Cindy Poehlman
         Chief Financial Officer
         ParkerVision, Inc.
         904-732-6100, cpoehlman@parkervision.com

         or

         MaryBeth Csaby
         Vice President
         The Piacente Group
         212-481-2050, parkervision@tpg-ir.com

         Media Contact:
         Androvett Legal Media
         Robert Tharp
         800-559-4534, robert@androvett.com
Thursday, November 14th, 2013 Uncategorized Comments Off on (PRKR) Patent Portfolio Continues to Rank Among the Top 25 Most Influential

(OXYS) Reports Third Quarter 2013 Results

Company Posts Third Consecutive Quarter of Triple Digit Revenue Growth Rates

Company Posts Third Consecutive Quarter of Triple Digit Revenue Growth Rates

FRISCO, TX–(November 14, 2013) – OxySure®Systems, Inc. (OTCQB: OXYS) (“OxySure,” or the “Company”), today reported financial and operating results for the third quarter ended September 30, 2013.

Third Quarter 2013 Highlights :

  • Total revenue increased by approximately 428% to $545,820
  • Interest expense down by approximately 15% to $47,180
  • Working capital deficit improved by approximately $2,204,966
  • Stockholder deficit improved by approximately $2,080,000
  • Gross profit increased approximately 722% to $434,710
  • Net loss down by approximately 38.3% to $82,613 or $0.00 per share

The Company posted the third consecutive quarter of triple digit revenue growth rates as compared to year earlier quarters.

“We had an excellent building quarter and we are pleased to have sustained our positive momentum for the year so far,” said Julian T. Ross, Chairman of the Board and Chief Executive Officer of OxySure. “Our results for the third quarter reflect our continued success at executing on strategic initiatives aimed at generating superior top-line growth while staying focused on controlling our expenses. We plan to continue our strategy of building awareness for our new and innovative lifesaving products, while investing in branding, distribution, R&D and sales. We are excited about some of the initiatives we are currently working on.”

For the three months ended September 30, 2013, revenues increased to $545,820, representing an increase of approximately $442,493 or 428% as compared to revenues of $103,327 for the three months ended September 30, 2012. For the nine months ended September 30, 2013, revenues increased to $1,262,311, representing an increase of approximately $1,068,209 or 550% as compared to revenues of $194,102 for the nine months ended September 30, 2012. The increase in revenues is primarily attributable to an increase in product sales in the United States, an increase in licensing/service revenues and an increase in sales of products developed for the military as part of a teaming agreement.

Gross profit was $434,710 for the three months ended September 30, 2013, an increase of $381,855 or 722% from $52,855 in the same period last year, primarily due to increased product sales, service revenues and license revenues.

Selling, general and administrative expenses were $478,518 compared to $206,810 for the comparable three months in 2012. The Company increased sales and marketing expenses from $7,234 to $77,841 as it expanded its sales and branding efforts. OxySure also recorded an increase in research and development expenses primarily attributable to an increase in research and development expense recognized in connection with products for military markets. Research and development expense during the three months ended September 30, 2013 was $134,357 as compared to $579 for the three months ended September 30, 2012. Other general and administrative expenses also increased by 34% to $266,320 as compared to $198,997 for the prior period. The increase in other general and administrative expense was primarily as a result of increases in depreciation and amortization expense, sales and marketing expense, research and development expense, and salaries and wages.

Interest expense fell 15% to $47,180 for the third quarter of 2013 from $55,461 during the third quarter of 2012.

Net loss decreased to $82,613, or $(0.00) per share, as compared to $133,779 or $(0.01) per share for the third quarter of 2012. The weighted average diluted shares outstanding were 24,076,789 and 20,761,595 for third quarters of 2013 and 2012, respectively.

Business updates

OxySure continues to execute on its core growth strategy of:

  • Expand its sales and distribution footprint in the U.S. and internationally
  • Leverage distribution partnerships to enhance market penetration
  • Diversify product offerings through additions of complimentary or additive products/services
  • Promote market awareness and education
  • Pursue strategic alliances to further accelerate growth

Key milestones achieved so far in 2013 include:

  1. Signed a distribution agreement with Dutch conglomerate Medizon B.V. to distribute products in the Netherlands, Belgium and Luxembourg
  1. Signed a distribution agreement with Aero Healthcare to distribute products in Australia, New Zealand, and the United Kingdom
  1. Launched a new product, a double wall cabinet to house a combination AED/OxySure system
  1. Added new distributors in the United States to expand distribution footprint
  1. Made significant progress towards the development of the military market in connection with a teaming agreement for the military
  1. Made significant progress with regard to the CE Marking of the Company’s flagship product, the OxySure Model 615
  1. Added Jerry M. Jones, former Chairman & CEO of Apria Healthcare to the Board of Directors

A link to a presentation of the company’s results can be found here: http://oxysure.com/3Q13_Earnings/OxySure_Earnings_Presentation_3Q13.pdf

About OxySure Systems, Inc.

OxySure Systems, Inc. (OXYS) is a medical technology company that focuses on the design, manufacture and distribution of specialty respiratory and medical solutions. The company pioneered a safe and easy to use solution to produce medically pure (USP) oxygen from inert powders. The company owns numerous issued patents and patents pending on this technology which makes the provision of emergency oxygen safer, more accessible and easier to use than traditional oxygen provision systems. OxySure’s products improve access to emergency oxygen that affects the survival, recovery and safety of individuals in several areas of need: (1) Public and private places and settings where medical emergencies can occur; (2) Individuals at risk for cardiac, respiratory or general medical distress needing immediate help prior to emergency medical care arrival; and (3) Those requiring immediate protection and escape from exposure situations or oxygen-deficient situations in industrial, mining, military, or other “Immediately Dangerous to Life or Health” (IDLH) environments. www.OxySure.com

Forward-Looking Statements

Statements in this earnings release that are not historical facts are considered to be forward-looking statements. Such statements include, but are not limited to, statements regarding management beliefs and expectations, based upon information available at the time the statements are made, regarding future plans, objectives and performance. All forward-looking statements are subject to risks and uncertainties, many of which are beyond management’s control and actual results and performance may differ significantly from those contained in forward-looking statements. OxySure Systems, Inc. intends any forward-looking statement to be covered by the Litigation Reform Act of 1995 and is including this statement for purposes of said safe harbor provisions. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this news release. OxySure Systems, Inc. undertakes no obligation to update any forward-looking statements to reflect events or circumstances that occur after the date as of which such statements are made. A discussion of certain risks and uncertainties that could cause actual results to differ materially from those contained in forward-looking statements is included in OxySure Systems, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2012.

Contacts:
Christian Hansen
Maximum Performance Advisors, Inc.
858-381-4677
christian@maximumperformanceadvisors.com

DreamTeamGroup (DTG)
Indianapolis, IN
www.DTG.fm
+1-317-623-3050 Direct
Editor@DTG.fm

Thursday, November 14th, 2013 Uncategorized Comments Off on (OXYS) Reports Third Quarter 2013 Results

(CLPI) Indian Subsidiary Money-on-Mobile Announces October Increases

Calpian, Inc. (OTCQB:CLPI) announced today that, as of October 31, 2013, the Money-on-Mobile service offered by its Indian subsidiary is now being supported by 167,145 retail locations, an increase of 4,069 stores from 163,076 stores on September 30, 2013. Money-on-Mobile was accessed by more than 75 million unique phone number customers from inception through October 31, 2013. The monthly unique user count increased by 3.6 million between September 30 and October 31 of this year. Processed transaction volume for October 2013, which is measured in Indian rupees, was slightly over 824.5 million INR. At current exchange rates, October processed transaction volume was approximately $13.5 million, slightly down from $14 million in September partly due to currency fluctuations and extensive holidays during the month, including Diwali, India’s annual equivalent of the Christmas holiday season.

According to Calpian CEO, Harold Montgomery, “Money-on-Mobile showed a strong gain in revenue per user, which suggests that our core user base is conducting larger transactions such as utility payments. Monthly average revenue per user increased from Rs 110 in September to Rs 157 in October, a gain of 42.5%.”

Money-on-Mobile CEO Shashank Joshi stated, “October is festival time in India and the seasonality is reflected in our processed volume. There were only 17 business days in October, compared to 21 in September. However, we are encouraged that our users increased the frequency of their transactions from 1.48 transactions per user per month in September to 2.02 transactions per user per month in October, an increase of 37%.”

About Calpian, Inc.

Calpian, Inc. (OTCQB: CLPI) is a publicly traded company with corporate offices in Dallas, Texas and mobile payments emerging-market operations through its subsidiary in India. Calpian’s Indian subsidiary offers Money-on-Mobile, a pre-paid mobile payment solution, to more than 167,000 Indian retail locations with over 75 million unique users. Calpian’s management team has over 70 years in combined experience in the payments business. Calpian’s CEO, Harold Montgomery, is a recognized industry leader who has provided expert testimony to the U.S. Congress and Federal Reserve Bank on payments-related issues and regularly appears in numerous industry publications, such as Transaction World Magazine. Please visit our website at www.calpian.com for more information.

Note to Investors:

This press release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our Form 10-K-A filed on April 30, 2013 and the Form 10-Q filed on August 14, 2013. Forward-looking statements include statements regarding our expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

 

Thursday, November 14th, 2013 Uncategorized Comments Off on (CLPI) Indian Subsidiary Money-on-Mobile Announces October Increases

(BTHE) Exhibits at Obesity Week 2013 Conference

World’s Largest Event on Obesity Treatment and Prevention

MANCHESTER, NH–(Nov 14, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovator developer of drugs that address diabetes using complex carbohydrate chemistry, will provide information about PAZ320, an investigational non-systemic chewable tablet, that when taken as an adjunctive therapy, helped patients with Type II diabetes manage the post meal elevation of their blood sugar in a Phase IIa clinical trial, at booth #127 at the inaugural Obesity Week 2013 Conference in Atlanta, Georgia, November 13 to 15.

Edward Shea, Vice President of Business Development, Boston Therapeutics, Inc., commented, “Our participation in Obesity Week 2013 — the world’s largest event on obesity treatment and prevention — will further demonstrate Boston Therapeutics’ commitment to those patients suffering from obesity and one of its devastating complications: diabetes.”

About Obesity Week

Obesity Week 2013 is the inaugural event co-locating the American Society of Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS) annual meetings. In doing so, more than 60 years of combined experience in the study of obesity and its management are reflected in an interdisciplinary program from which all attendees will benefit. Both organizations have worked to give attendees the greatest value for their registration fee as they are able to attend both ASMBS and TOS Scientific Sessions. These sessions will include debates, key lectures, keynote speakers, networking/social events, oral presentations, panel discussions, paper and video sessions, poster presentations, partner and organizational symposiums. For more information, visit www.obesityweek.com.

About PAZ320

PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose and release it into the bloodstream.

About Boston Therapeutics, Inc.

Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.

Forward Looking Statements

This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.

Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

Contact:

Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com

Thursday, November 14th, 2013 Uncategorized Comments Off on (BTHE) Exhibits at Obesity Week 2013 Conference

(IRIX) To Introduce Four New Products At Annual AAO Meeting

Fifteen physicians, seven new to the IRIDEX podium, will discuss their experiences using MicroPulse™ for retinal and glaucoma therapies

MOUNTAIN VIEW, Calif., Nov. 13, 2013 — IRIDEX Corporation (Nasdaq:IRIX) today announced that it would introduce four new products at the annual meeting of the American Academy of Ophthalmology to be held November 16-19 at the Ernest N. Morial Convention Center in New Orleans.  There will also be several presentations featuring IRIDEX products and its proprietary MicroPulse laser for retinal and glaucoma treatments.

The products include:

  • A new version of the TxCell™ Pattern Scanning Laser Delivery System. The new iteration of the high-speed delivery device is compatible with the largest market of physician-owned slit lamps.
  • A new IRIDEX MicroPulse Laser Trabeculoplasty (MLT) lens manufactured by Ocular Instruments.  The new product, distributed exclusively through IRIDEX, is designed to increase efficiency and precision of MLT for the treatment of glaucoma.
  • A portfolio of single-use 27-gauge laser probes, Peregrine Surgical-branded, that are compatible with the growing number of 27-gauge vitrectomy systems used in retina surgery.
  • A GreenTip™ Membrane Scraper, available in 23 & 25 gauges, offering a single-use surgical device intended for specialized retinal surgery.  The new device is designed to maximize visualization against the retina and is a derivative of the proprietary GreenTip product family.

“These are each significant new products that represent what we see as important niches and opportunities in the ophthalmology marketplace,” said Will Moore, IRIDEX President and CEO. “Furthermore, they are prime examples of our ability to identify growing needs in the marketplace and quickly design and launch consumable products to meet those needs.”

To schedule a demonstration of IRIDEX products in advance, click on the following link: http://www.iridex.com/Contact/ScheduleADemo.aspx.

IRIDEX also announced the growing number of new speakers to its podium regarding its proprietary MicroPulse solutions for physicians challenged with a growing number of patients suffering from glaucoma and retinal diseases.  Select presentations from this year’s program include the following:

  • MicroPulse Laser in the Forefront of Macular Disease Treatment (in Portuguese), presented by Alessandro Dare, M.D., Ph.D., head of Retina Department of Hospital Olhos do Interior Paulista, Sao Paulo, Brazil; and Renato Peroni, M.D., Retina Department, Ophthalmology, Santa Casa de Jau, Sao Paulo; Hospital de Ohlos de Araraquara, Araraquara, Sao Paulo, Ophthalmology Department University of Sao Paulo; 10 a.m. Sunday, Nov. 17.
  • Laser-Assisted, Non-Incisional Glaucoma Therapy Benefits of Versatile Laser Systems for TSCPC & MLT Procedures in the MIGS World, presented by Iqbal (Ike) Ahmed, MD, FRCSC, Assistant Professor and Research Fellowship Director, Department of Ophthalmology, University of Toronto; and Nathan M. Radcliffe, M.D., Assistant Professor of Ophthalmology, Weill Cornell Medical College, New York-Presbyterian Hospital; 1 p.m. Sunday, Nov. 17.
  • MicroPulse Laser Therapy for the Comprehensive Ophthalmologist: From the Anterior to the Posterior Segment, presented by David Gossage, D.O., FAOCO, FAAO, Medical Director, Gossage Eye Institute, Hillsdale, MI; 1 p.m. Saturday Nov. 16.

For a complete program of speakers, go to http://www.iridex.com/speakersforum.  The IRIDEX booth at the conference will be located in Hall E, Booth #1135.

About IRIDEX

IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into over 100 countries. For further information, visit the IRIDEX website at http://www.iridex.com/.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, relating to the Company’s anticipated product releases and the markets for the Company’s products.  These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors.  Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K for the fiscal year ended December 29, 2012, and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 30, 2013, June 29, 2013, and September 28, 2013, each of which was filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Wednesday, November 13th, 2013 Uncategorized Comments Off on (IRIX) To Introduce Four New Products At Annual AAO Meeting

(BSPM) Regains Compliance With NASDAQ $1.00 Minimum Bid Price Rule

XIANYANG, China, Nov. 13, 2013 — Biostar Pharmaceuticals, Inc. (NASDAQ: BSPM) (“Biostar”), a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, today announced that on November 11, 2013, NASDAQ notified the Company that it had regained compliance Rule 5550(a)(2), which requires a minimum bid price of $1.00 for continued listing on the NASDAQ Stock Market and that the matter was now closed.

Ronghua Wang, Biostar’s Chairman, commenting on the announcement, stated: “We strongly believe that regaining compliance with NASDAQ’s continued listing requirements is an important achievement for the Company. Having resolved this issue, we can continue focusing on maximizing shareholder value and strengthening the Company’s business going forward.”

 

About Biostar Pharmaceuticals, Inc.

Biostar Pharmaceuticals, Inc., through its wholly owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company’s most popular product is its Xin Aoxing Oleanolic Acid Capsule, an over-the-counter medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. For more information please visit: http://www.biostarpharmaceuticals.com.

Safe Harbor relating to the Forward-Looking Statements

Certain statements in this release concerning our future growth prospects are forward-looking statements, within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The company uses words and phrases such as “guidance,” “forecasted,” “projects,” “is expected,” “remain confident,” “will” and similar expressions to identify forward-looking statements in this press release, including forward-looking statements. Undue reliance should not be placed on forward-looking information. Forward-looking information is based on current expectations, estimates and projections that involve a number of risks, which could cause actual results to vary and in some instances to differ materially from those anticipated by Biostar and described in the forward-looking information contained in this news release. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the Company’s ability to complete the contemplated clinical trials and capitalize on such opportunities, the Company’s ability to recover its sales and revenue, the state of consumer confidence and market demand or the Company’s products, success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the year ended December 31, 2012, and other subsequent filings. These filings are available at www.sec.gov.  We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statements that may be made from time to time by or on our behalf.

For more information contact:

Biostar Pharmaceuticals, Inc.
Ally Gong
Tel: +86-29-3368-6638
Email: office@aoxing-group.com

Wednesday, November 13th, 2013 Uncategorized Comments Off on (BSPM) Regains Compliance With NASDAQ $1.00 Minimum Bid Price Rule

(SINA) Proposed Offering of US$600 Million Convertible Senior Notes

SHANGHAI, Nov. 13, 2013 — SINA Corporation (NASDAQ: SINA) (“SINA” or the “Company”), a leading Internet media company serving China and the global Chinese communities, today announced that it proposes to offer up to US$600 million in aggregate principal amount of convertible senior notes due 2018 (the “notes”), subject to market conditions. The conversion rate and other terms of the notes have not been finalized and will be determined at the time of pricing of the offering. The Company intends to grant to the initial purchaser a 30-day option to purchase up to an additional US$90 million principal amount of notes solely to cover over-allotments, if any. The notes will be convertible into the Company’s ordinary shares (“ordinary shares”), at the option of the holders, in integral multiples of US$1,000 principal amount, at any time prior to the close of business on the second business day immediately preceding the maturity date. SINA will not have the right to redeem the notes prior to maturity except for certain circumstances involving changes in the tax laws for the relevant taxing jurisdiction. Holders of the notes will have the right to require the Company to repurchase for cash all or part of their notes on December 1, 2016 or upon the occurrence of certain fundamental changes at a repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date.

The Company plans to use $100 million of the net proceeds from the offering to concurrently repurchase its own outstanding ordinary shares. The remainder of the net proceeds of the offering will be used for general corporate purposes, including working capital needs and potential acquisition of complementary businesses.

The notes, the ordinary shares deliverable upon conversion of the notes, have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws. They may not be offered or sold within the United States or to U.S. persons, except to qualified institutional buyers in reliance on the exemption from registration provided by Rule 144A under the Securities Act, or in reliance on other exemptions from registration under the Securities Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities, in the United States or elsewhere, and shall not constitute an offer, solicitation or sale of the notes, the ordinary shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. Any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer or the selling security holder and that will contain detailed information about the company and management, as well as financial statements.

This press release contains information about the pending offering of the notes, and there can be no assurance that the offering will be completed.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “future,” “intend,” “plan,” “believe,” “estimate,” “is/are likely to,” “confident” or other similar statements. SINA may also make forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties.  All information provided in this press release is as of the date of the issuance, and SINA assumes no obligation to update the forward-looking statements in this press release and elsewhere except as required under applicable law.  Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements.  Forward-looking statements involve inherent risks and uncertainties.  A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement.  Potential risks and uncertainties include, but are not limited to:  SINA’s limited operating history in certain new businesses; the global financial and credit market crisis and its impact on the Chinese economy; the uncertain regulatory landscape in China; fluctuations in the Company’s quarterly operating results; the Company’s reliance on online advertising sales and MVAS for a majority of its revenues; failure to successfully develop, introduce, drive adoption of or monetize new features and products, including portal, Weibo and MVAS products; failure to enter and develop the small and medium enterprise market by the Company or through cooperation with third parties, such a Alibaba; the Company’s reliance on mobile operators in China to provide MVAS and changes in mobile operators’ policies for MVAS in China; failure to successfully integrate acquired businesses; risks associated with the Company’s investments, including equity pick-up and impairment; and failure to compete successfully against new entrants and established industry competitors.  Further information regarding these and other risks is included in SINA’s annual report on Form 20-F for the year ended December 31, 2012 and other filings with the Securities and Exchange Commission.

For further information, please contact:

Investor Relations
SINA Corporation
Phone: 8610-8262-8888 x 3112
Email: ir@staff.sina.com.cn

Wednesday, November 13th, 2013 Uncategorized Comments Off on (SINA) Proposed Offering of US$600 Million Convertible Senior Notes

(HOTR) Announces Closing of Private Placement With Accredited Investors

CHARLOTTE, NC–(November 13, 2013) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (“Chanticleer Holdings” or “the Company”), headquartered in Charlotte, North Carolina, announced today that it closed a private offering, whereby the Company entered into a Subscription Agreement with three accredited investors, pursuant to which the Company sold to the Investors an aggregate of 160,000 Units at a purchase price of $5.00 per Unit, closing a $800,000 private placement. Each Unit consists of (a) 1 share of the Company’s common stock, $0.001 par value per share and (b) 1 5-year warrant to purchase 1 share of common stock. 80,000 warrants are available at an initial exercise price of $5.50, while the remaining 80,000 warrants are available at an initial exercise price of $7.00. Please see the accompanying Form 8-K filed for more details.

Mike Pruitt, the Company’s CEO stated, “Having access to capital at favorable rates allows us to continue to pursue opportunities as they present themselves.”

About Chanticleer Holdings, Inc.

Chanticleer Holdings (NASDAQ: HOTR) is focused on expanding the Hooters® casual dining restaurant brand in international emerging markets and American Roadside Burgers Inc (“ARB”), a Charlotte, N.C. based chain. Chanticleer currently owns in whole or part of the exclusive franchise rights to develop and operate Hooters restaurants in South Africa, Hungary and parts of Brazil, and has joint ventured with the current Hooters franchisee in Australia, while evaluating several additional international opportunities. The Company currently owns and operates in whole or part of six Hooters restaurants in its international franchise territories: Durban, Johannesburg, Cape Town and Emperor’s Palace in South Africa; Campbelltown in Australia; and Budapest in Hungary. ARB, purchased by Chanticleer Holdings on October 1, 2013, has a total of 5 casual restaurants — 1 location in Smithtown, N.Y., 2 locations in Charlotte, N.C., 1 location in Columbia, S.C., and the newest location is in Greenville, S.C. The Company also owns a majority interest in JF Restaurants, LLC and JF Franchising Systems, LLC, a fresh food-focused casual dining establishment with 5 restaurant locations.

For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts

Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Contact:

Chanticleer Holdings, Inc.
Mike Pruitt
Chairman/CEO
Phone: 704.366.5122 x 1
mp@chanticleerholdings.com

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(BTHE) Reports Corporate Update and Financial Results

MANCHESTER, NH–(Nov 13, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovator of drugs that address diabetes using complex carbohydrate chemistry, reports its corporate update and financial results for the three and nine months ended September 30, 2013.

David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, “During the third quarter, we continued to build upon the positive results for PAZ320 obtained in our Phase IIa safety and efficacy trial. Specifically, with the initiation of our Phase IIb trial in France and the ongoing preparation for our planned Phase III multinational trial, we continue to develop what we believe will be a significant new tool as an adjunctive therapy in combination with metformin to treat Type 2 diabetes. I am especially excited about our new research study at the University of Minnesota, which we believe will give us deeper insights into how well PAZ320’s mechanism of action works non-systemically in the gastro-intestinal tract to block the uptake of glucose into the bloodstream.

“We also are enhancing our outreach programs at diabetes conferences, to the media to communicate the importance of our drug development initiatives to address a large unmet medical need, and to build awareness of who we are and what we do to the investment community. I am confident that we are on the right track and will continue to make progress in the months and years ahead,” he concluded.

Corporate Update:

  • As of September 30, 2013, we had cash of approximately $3.9 million and current liabilities of approximately $340 thousand.
  • Began enrollment for Phase IIb trial in France to assess the efficacy and safety of PAZ320 in patients with Type 2 diabetes as adjunctive therapy in combination with metformin.
  • Began preparation for IND submission to the U.S. FDA for Phase III trial in the U.S., Europe, Hong Kong, and China to evaluate the effects of PAZ320 on post-meal glucose levels in patients with Type 2 diabetes as adjunctive therapy in combination with metformin.
  • Initiated research study at the University of Minnesota to provide molecular-level data on PAZ320 and its mechanism of action, specifically to better characterize PAZ320 galactomannan and assess interactions of PAZ320 with various carbohydrate-hydrolyzing enzymes.
  • Positive results from Phase II clinical trial was published by the principal investigator evaluating the safety and efficacy of PAZ320 (demonstrating significant 40% reduction in elevation of post-meal blood glucose) with no serious adverse events in patients in the July/August issue of peer-reviewed journal Endocrine Practice.
  • Appointed Ed Shea, (25 years of bio-pharmaceutical experience in business development, sales and marketing, including 15 years with Glaxo Smithkline), as new Vice President of Business Development and Tina Gagnon (former Corporate Controller for Micronetics, Inc.) as new Director of Finance.
  • Featured positive results from Phase II clinical trial at the 2013 American Association of Diabetes Educators Annual Meeting & Exhibition in Philadelphia.

Financial Results for the Third Quarter and Nine Months Ended September 30, 2013:

  • Significantly strengthened the balance sheet with the closing of approximately $5.3 million in total gross proceeds from private placement of common stock and warrants to existing and new accredited investors. Use of proceeds is to primarily fund the Company’s ongoing clinical trials for PAZ320.
  • Revenue for the third quarter was $217,520, compared with $2,520 in the prior year’s quarter. Nine-month revenue was $242,974, compared with $23,750 in the prior year’s nine-month period. The increase was primarily the result of shipments of the Company’s over-the-counter product to one customer.
  • Gross margin for the three months ended September 30, 2013 was $99,005 as compared with a negative gross margin of ($6,600) for the three months ended September 30, 2012. Gross margin for the nine months ended September 30, 2013 was $68,550 as compared to negative gross margin of $(17,127). The increase is primarily related to the shipment of product during the third quarter. The negative gross margin for the three months and nine months ended September 30, 2012 was primarily the result of fixed overhead costs related to moving to a new fulfillment operation and manufacturing scale-up from small to production grade equipment exceeding revenue.
  • Research and development expense for the three months ended September 30, 2013 was $151,946, an increase of $125,830 as compared to $26,116 for the three months ended September 30, 2012. Research and development expense for the nine months ended September 30, 2013 was $200,428, an increase of $54,760 as compared with $145,668 for the nine months ended September 30, 2012. The increase is primarily the result of increased activity for PAZ320’s Phase IIb trial in France and in preparation of PAZ320’s Phase III international trial.
  • Sales and marketing expense for the three months ended September 30, 2013 was $102,840, an increase of $9,321 or 10% as compared with $93,519 for the three months ended September 30, 2012. Sales and marketing expense for the nine months ended September 30, 2013 was $251,236, an increase of $23,639 or 10% as compared with $227,597 for the nine months ended September 30, 2012. The expense consists primarily of costs incurred with third parties for product marketing and public relations.
  • General and administrative expense for the three months ended September 30, 2013 was $954,261, an increase of $719,629 as compared with $234,632 for the three months ended September 30, 2012. Approximately $407,000 of the increase is related to non-cash stock-based compensation which includes $252,000 of expense due to the future vesting of stock options of a terminated employee and expense associated with stock option grants. Consulting and professional services increased $135,000 for investor relations and maintenance of the SUGARDOWN® website, accounting and legal professional fees increased $91,000 and payroll and payroll related expense increased $82,000 due to additional personnel.
  • General and administrative expense for the nine months ended September 30, 2013 was $1,904,008, an increase of $1,405,405 as compared with $498,603 for the nine months ended September 30, 2012. Approximately $677,000 of the increase is related to non-cash stock-based compensation which includes $252,000 of expense due to future vesting of stock options of a terminated employee and expense associated with stock option grants during 2012 and 2013. Additionally, consulting and professional fees increased approximately $345,000 for investor relations and maintenance of the SUGARDOWN® website, payroll and related payroll expense increased $162,000 due to additional personnel, accounting and legal professional fees increased $114,000 due to increased business operations and rent expense increased $50,000 due to the new office facility.
  • Net loss for the third quarter 2013 was $1,116,863 or $0.04 per share, compared with a net loss of $366,334, or $0.02 per share in the prior year’s third quarter. For the nine-month period, net loss was $2,303,532, or $0.11 per share, compared with $905,728 or $0.05 per share in 2012. Non-cash stock-based compensation of $472,820 and $857,851 is included in the net loss for the three months and nine months ended September 30, 2013.

About Boston Therapeutics, Inc.

Boston Therapeutics, headquartered in Manchester, NH (OTCQB: BTHE), is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.

Forward Looking Statements

This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.

Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

Contact:

Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com

Wednesday, November 13th, 2013 Uncategorized Comments Off on (BTHE) Reports Corporate Update and Financial Results

(JBLU) to Fly to 25 Caribbean Destinations This Winter

An Average of 200 Daily Flights Scheduled This Winter to, From, and Within Caribbean; New Destinations Available With Cape Air, LIAT, and Seaborne Airlines

An Average of 200 Daily Flights Scheduled This Winter to, From, and Within Caribbean; New Destinations Available With Cape Air, LIAT, and Seaborne Airlines

NEW YORK, NY–(November 12, 2013) – JetBlue Airways (NASDAQ: JBLU) today announces its expanded winter schedule in the Caribbean, featuring more flights than ever before. With the planned launch of service to two new island destinations, JetBlue will serve the Caribbean region this winter with an average of 200 daily flights.

In addition to its own network growth, JetBlue also announces the signing of two new interline agreements in the Caribbean, with LIAT and Seaborne Airlines, and a growth of its existing partnership with Cape Air. This expands the single-ticket options for JetBlue customers into a number of additional Caribbean destinations.

Two new cities and five new routes planned

JetBlue has announced five new Caribbean routes that will launch in the coming months, including service to two new destinations: Port-au-Prince, Haiti and Port of Spain, Trinidad and Tobago (a). New routes include:

  • Chicago (ORD) – San Juan, Puerto Rico (starts Nov. 20)
  • Fort Lauderdale-Hollywood – Port-au-Prince, Haiti (starts Dec. 5) (a)
  • Fort Lauderdale-Hollywood – Port of Spain, Trinidad and Tobago (starts May 1) (a)
  • New York (JFK) – Port-au-Prince, Haiti (starts Dec. 5) (a)
  • New York (JFK) – Port of Spain, Trinidad and Tobago (starts Feb. 24) (a)

 

Five destinations to see added capacity with larger aircraft

JetBlue plans to meet peak winter demand this winter by deploying its brand new Airbus A321 aircraft to a variety of Caribbean destinations. The A321 is outfitted with 190 seats, featuring the most legroom in coach (b), and boosting the number of seats per departure by 40 compared to JetBlue’s current 150-seat A320 aircraft. The following destinations will see select flights to/from New York (JFK) operated by the larger A321:

  • Bridgetown, Barbados
  • Nassau, Bahamas
  • San Juan, Puerto Rico
  • Santiago, Dominican Republic
  • Santo Domingo, Dominican Republic

Additionally, JetBlue will offer even more frequencies between New York (JFK) and Barbados during peak holiday times, including President’s Day and Easter.

JetBlue’s A321s will be operating fresh from the factory and will not yet have in-flight television, radio or movies.

More destinations with new and expanded interline partnerships

JetBlue has added two new interline agreements, with LIAT and Seaborne Airlines, and expanded its existing partnership with Cape Air, bringing a number of new Caribbean destinations within reach for JetBlue customers.

LIAT now offers JetBlue customers connections to several new destinations including Antigua, Grenada, St. Kitts, and Saint Vincent and the Grenadines, when transferring at Barbados and St. Maarten. Founded in 1956, LIAT is one of the largest and most experienced carriers in the Caribbean region. Tickets are now available for sale through travel agencies.

Seaborne Airlines also opens up several new destinations for JetBlue customers, including St. Kitts, Dominica, and Guadeloupe and Martinique in the French Caribbean, all via San Juan, as well as connections to La Romana, Dominican Republic on a daily basis. In addition, Seaborne will offer more flight options for customers connecting at San Juan to/from both the U.S. and British Virgin Islands. Seaborne’s regional network includes 11 destinations from San Juan and a total of 625 weekly departures. JetBlue-Seaborne itineraries are now available for sale through travel agencies.

JetBlue’s longstanding partnership with Cape Air also expands this winter, with new destinations available via San Juan: Culebra, Puerto Rico, and Virgin Gorda in the British Virgin Islands. With service to these two unspoiled island destinations, which is expected to kick off in early 2014, Cape Air will serve a total of nine destinations from San Juan including options like Anguilla and Nevis. Tickets for travel to all Cape Air destinations in the Caribbean are available for sale at www.jetblue.com.

“It’s shaping up to be a great winter in the Caribbean region, with more JetBlue flights and more choices for travelers than ever before,” said Scott Laurence, JetBlue’s vice president of network planning. “Destination after destination, the Caribbean continues to embrace JetBlue’s unique brand of service. We’re excited to offer flights to 25 great getaways this winter plus even more destinations through our partnerships with Cape Air, LIAT, and Seaborne Airlines.”

About JetBlue in the Caribbean and Latin America

JetBlue is a leading airline in the Caribbean, soon offering nonstop service to 25 destinations across the region including Aguadilla; Aruba; Barbados; Bermuda; Cancún; Cartagena; Grand Cayman; Kingston; La Romana; Montego Bay; Nassau; Ponce; Port-au-Prince (a); Port of Spain (a); Providenciales; Puerto Plata; Punta Cana; Saint Lucia (Hewanorra); Samaná; San Juan; Santiago; Santo Domingo; St. Croix; St. Maarten; and St. Thomas. This winter JetBlue will operate an average of 200 flights to, from, and within the region.

The carrier operates one of its six focus cities at San Juan’s Luis Muñoz Marín International Airport, where it offers more flights to more destinations than any other carrier. In fact, this winter JetBlue will connect San Juan to 17 cities across the United States and Caribbean with an average of 40 daily departures. JetBlue is also a leading carrier in the Dominican Republic, serving more airports and offering more flights and more seats than any other U.S. carrier.

(a) Subject to receipt of government approval.

(b) Based on average fleet-wide seat pitch of U.S. airlines.

About JetBlue Airways
As New York’s Hometown Airline™ and a leading carrier in Boston, Fort Lauderdale-Hollywood, Los Angeles/Long Beach, Orlando and San Juan, JetBlue carries 30 million customers a year to 80 cities in the U.S., Caribbean and Latin America with an average of 750 daily flights. With JetBlue, all seats are assigned, all fares are one-way, and an overnight stay is never required. JetBlue’s fleet totals 191 aircraft, comprising 130 Airbus A320s, 1 A321 and 60 Embraer 190s. Upcoming destinations include Detroit, Mich. and Savannah, Ga.; as well as Port-au-Prince, Haiti; Port of Spain, Trinidad and Tobago; and Lima, Peru, subject to receipt of government approval. For more information please visit JetBlue.com.

MEDIA CONTACTS
JetBlue Corporate Communications

Tel: +1 718 709 3089
corpcomm@jetblue.com

Tuesday, November 12th, 2013 Uncategorized Comments Off on (JBLU) to Fly to 25 Caribbean Destinations This Winter

(FUEL) to Present at Upcoming Investor Conferences

REDWOOD CITY, Calif., Nov. 12, 2013 — Rocket Fuel Inc. (Nasdaq:FUEL), a leading provider of artificial intelligence (AI) advertising solutions for digital marketers, today announced that members of the senior management team will present to the investment community at the following investor conferences:

Credit Suisse Annual Technology Conference
Date: Wednesday, December 4, 2013
Time: 10:30 AM MST (fireside chat)
Location: The Phoenician Hotel, Scottsdale, AZ
NASDAQ OMX 30th Investor Program
Date: Wednesday, December 4, 2013
Time: 8:00 AM GMT (company presentation)
Location: The Waldorf Hilton, London, UK
BMO Capital Markets Technology & Digital Media Conference
Date: Tuesday, December 10, 2013
Time: 11:00 AM EST (fireside chat)
Location: The Grand Hyatt Hotel, New York, NY

Webcasts will be accessible on the investor relations section of the Rocket Fuel website (http://investor.rocketfuel.com). Archived replays of the webcasts will be available following the live presentations.

About Rocket Fuel

Rocket Fuel delivers a leading programmatic media-buying platform at Big Data scale that harnesses the power of artificial intelligence to improve marketing ROI in digital media across web, mobile, video, and social channels. Rocket Fuel powers digital advertising and marketing programs globally for customers in North America, Europe, and Japan. Customers use Rocket Fuel’s Advertising That Learns ® platform to achieve brand and direct-response objectives in diverse industries from luxury cars to groceries to retail. Rocket Fuel currently operates in more than 20 offices worldwide and trades on the NASDAQ Global Select Market under the ticker symbol “FUEL.” For more information, please visit http://www.rocketfuel.com.

Rocket Fuel and Advertising That Learns are trademarks or registered trademarks of Rocket Fuel Inc. in the United States and other countries.

CONTACT: Investor Relations:
         Alex Wellins
         The Blueshirt Group
         (415) 217-5861
         ir@rocketfuel.com
Tuesday, November 12th, 2013 Uncategorized Comments Off on (FUEL) to Present at Upcoming Investor Conferences

(NSTG) Launches the nCounter Dx Analysis System for U.S. Market

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced the availability of the nCounter® Dx Analysis System for high-complexity, CLIA-certified laboratories. The nCounter Dx Analysis System is the only platform 510(k) cleared by the U.S. Food and Drug Administration to run the Prosigna™ Prognostic Breast Cancer Gene Signature Assay. For clinical laboratories that value flexibility, the FLEX configuration offered on the nCounter Dx Analysis System supports other translational research applications, and facilitates the ability of laboratories to develop their own assays. NanoString will showcase the new nCounter Dx Analysis System and its advanced capabilities at this week’s annual Association for Molecular Pathology (AMP) conference in Phoenix, Arizona.

The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The nCounter Dx Analysis System supports the Prosigna Breast Cancer Prognostic Gene Signature Assay, an in vitro diagnostic assay that uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. Using the nCounter Dx Analysis System, the Prosigna Assay can be performed in qualified clinical laboratories throughout the U.S. and countries that accept the CE Mark, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients for determining the risk of distant disease recurrence.

The nCounter Dx Analysis System is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the “Life Sciences” mode, process translational research experiments and multiplexed assays developed by the clinical laboratory. The nCounter Elements™ General Purpose Reagents (GPRs) offered by NanoString provide further flexibility by enabling laboratories to develop their own gene expression, copy number variation, and gene fusion signatures.

“We have received significant interest from laboratories seeking to perform the Prosigna Breast Cancer Assay as well as run genomic assays that they have developed independently,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “With the nCounter Dx Analysis System’s FLEX configuration, the Prosigna Breast Cancer Assay, and with our recently launched nCounter Elements GPRs, we have a compelling suite of products for these laboratories. We expect the versatility of this offering to help drive the adoption of the Prosigna Breast Cancer Assay and be particularly appealing to high-complexity CLIA laboratories in major U.S. cancer centers.”

“We’re excited to be the first laboratory in the U.S. to adopt the nCounter Dx Analysis System,” said Dr. Edward E. Partridge, Director of the University of the Alabama Comprehensive Cancer Center. “In addition to running the Prosigna Assay, which we believe will help inform the treatment decisions clinicians and patients make regarding breast cancer care, we find great value in also using the system to translate our research into our own Laboratory Developed Tests.”

When used together, the nCounter Dx Analysis System and Prosigna Breast Cancer Prognostic Gene Signature Assay provide the following key features:

  • High-throughput workflow allowing each nCounter Dx Analysis System to perform the Prosigna Assay on up to 30 patient samples per eight hour work day and obtain assay results in as little as two days
  • Ready-to-use Prosigna Assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue
  • Automated generation of personalized full-color Prosigna Assay patient reports that can be quickly and easily shared electronically with ordering oncologists, and which includes the patient’s Prosigna Score and risk category

The nCounter Dx Analysis System is now available for purchase or through reagent rental arrangements in the U.S. and countries that accept the CE Mark. Prosigna testing services are expected to be available from qualified laboratories in the U.S. beginning in the first quarter of 2014.

About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay

Prosigna provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score, which are then used to assess a patient’s risk of distant recurrence. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The Prosigna Assay will be available for diagnostic use when ordered by a physician in the U.S. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark and in which Prosigna is registered.

Prosigna™ Breast Cancer Prognostic Gene Signature Assay Intended Use:

The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence. The assay measures the gene expression profile using RNA extracted from formalin-fixed, paraffin embedded (FFPE) breast tumor tissue. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, for assessment of the risk of distant recurrence of disease. The assay is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma.

The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as:

1. A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
2. A prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with hormone receptor-positive (HR+), lymph node-positive (one to three positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes.

Special Conditions for Use:

Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.

For more information, please visit www.prosigna.com.

About NanoString Technologies, Inc.

NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company’s nCounter® Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 300 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company’s technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic assay to be marketed through the company’s diagnostics business. The nCounter Dx Analysis System is FDA 510(k) cleared for use with the Prosigna Breast Cancer Prognostic Gene Signature Assay. To date, it has not been cleared by the FDA for other indications or for use with other assays.

For more information, please visit www.nanostring.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected market acceptance of the nCounter Dx Analysis System, the Prosigna Assay, and nCounter Elements GPRs, and the expected adoption of the Prosigna Assay by clinicians and their patients. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with keeping pace with rapidly changing technology and customer requirements; risks regarding our ability to successfully introduce new products; risks that new market opportunities may not develop as quickly as expected; risks associated with competition in marketing and selling products; risks of increased regulatory requirements; as well as the other risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.

The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, Prosigna, and nCounter Elements are trademarks or registered trademarks of NanoString Technologies, Inc. in various jurisdictions.

Tuesday, November 12th, 2013 Uncategorized Comments Off on (NSTG) Launches the nCounter Dx Analysis System for U.S. Market

(MPAA) Announces Refinancing of Credit Facility

LOS ANGELES, Nov. 12, 2013 – Motorcar Parts of America, Inc. (Nasdaq:MPAA) today announced it has entered into an amended and restated $125 million credit facility, comprised of a $95 million term loan and a $30 million revolving credit facility with Cerberus Business Finance, LLC as collateral agent and PNC Bank National Association, a member of the PNC Finance Services Group, Inc. (NYSE:PNC), as administrative agent. The amended and restated credit facility replaces a previous $125 million credit facility, comprised of a $105 million term loan and a $20 million revolver.

Based on current interest rates, the interest rate for the new term loan is 6.75 percent, consisting of a LIBOR floor of 1.50 percent plus a margin of 5.25 percent. The revolving credit facility interest rate is LIBOR plus a margin of 2.50 percent. This represents a saving of approximately 3.75 percent for the term loan and 0.5 percent on the revolver. At closing, the company had a $95 million term loan outstanding in addition to $10 million of borrowings on the revolving credit facility, with a blended interest rate currently of approximately 6.4 percent. The company had approximately $30 million of cash on hand at closing.

“The amended and restated credit facility reduces our blended rates by approximately 4 percent and also gives the company the flexibility to repurchase stock and to pay down an incremental $10 million of the term loan within the next 120 days. The new facility will result in reduced interest expense and provides greater financial flexibility to execute management’s strategic growth plans,” said Selwyn Joffe, chairman, president and chief executive officer.

In conjunction with entering into the amended and restated financing agreement, the company incurred various fees and expenses, including a pre-payment premium stipulated in the original loan agreement of approximately $3.0 million on the company’s prior credit facility.

About Motorcar Parts of America

Motorcar Parts of America, Inc. is a remanufacturer, manufacturer and distributor of automotive aftermarket parts – comprised of alternators, starters and wheel hub assembly products utilized in imported and domestic passenger vehicles, light trucks and heavy duty applications. Motorcar Parts of America’s products are sold to automotive retail outlets and the professional repair market throughout the United States and Canada, with remanufacturing facilities located in California, Mexico and Malaysia, and administrative offices located in California, Tennessee, Mexico, Singapore and Malaysia. Additional information is available at www.motorcarparts.com.

CONTACT: Gary S. Maier
         Maier & Company, Inc.
         (310) 471-1288
Tuesday, November 12th, 2013 Uncategorized Comments Off on (MPAA) Announces Refinancing of Credit Facility

(BTHE) Enrolls Patients With Type 2 Diabetes in a Phase IIb Clinical Trial With PAZ320

MANCHESTER, NH–(Nov 12, 2013) – Boston Therapeutics, Inc. (OTCQB: BTHE) (“Boston Therapeutics” or “the Company”), an innovator in designing drugs that address diabetes using complex carbohydrate chemistry, today began enrolling patients in a Phase IIb clinical study on PAZ320, a complex carbohydrate-based drug designed to reduce the elevation of post-meal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes.

A total of 24 patients with Type 2 diabetes currently being treated with metformin will be administered PAZ320 under double-blind, placebo-controlled conditions. Patients’ blood glucose will be monitored using continuous glucose monitors (CGM) and their postprandial (after-meal) blood glucose levels will be measured following a test meal. The primary endpoint of the study is the evaluation of the effect of PAZ320 compared to placebo in the area under the curve (AUC) of glucose and on insulin levels in the blood for four hours following intake of the meal. The study is being conducted at Centre Hospitalier Robert Bisson, Lisieux, France.

David Platt, Ph.D., Chief Executive Officer, Boston Therapeutics, said, “This trial is designed to build upon the positive results from our Dartmouth Medical Center Phase IIa trial for PAZ320, recently published in the peer-reviewed journal, Endocrine Practice. In the Phase IIa study, PAZ320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The Phase IIb trial, which focuses on patients taking only metformin, is the next step in the investigation of this compound as a potential adjunct to metformin in patients living with Type 2 diabetes. We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes.”

Metformin is the most widely prescribed drug for diabetes and often the first drug prescribed to newly diagnosed diabetes patients.

About PAZ320

PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.

About Boston Therapeutics, Inc.

Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing drugs using complex carbohydrate chemistry. The Company’s product pipeline is focused on developing and commercializing therapeutic molecules that address Type 2 diabetes, including: PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com.

Forward Looking Statements

This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of our drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III with the current cash on hand.

Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our drugs, including PAZ320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.

Contact:

Boston Therapeutics, Inc.
Anthony Squeglia
Vice President of Strategic Planning
Phone: 603-935-9799
Email: anthony.squeglia@bostonti.com
www.bostonti.com

Tuesday, November 12th, 2013 Uncategorized Comments Off on (BTHE) Enrolls Patients With Type 2 Diabetes in a Phase IIb Clinical Trial With PAZ320

(GWPH) Commences Phase 1b/2a Clinical Trial In Glioblastoma Multiforme

-Study Features THC and CBD as the Primary Cannabinoids-

LONDON, Nov. 11, 2013  — GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW”) a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM).

Glioma describes any tumor that arises from the glial tissue of the brain. GBM is a particularly aggressive tumor that forms from abnormal growth of glial tissue. According to the New England Journal of Medicine, GBM accounts for approximately 50% of the 22,500 new cases of brain cancer diagnosed in the United States each year. Treatment options are limited and expected survival is a little over one year. GBM is considered a rare, or orphan, disease by the FDA and the European Medicines Agency, or EMA.

This study follows several years of pre-clinical research conducted by GW in the field of glioma which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivoi,ii via apoptosis or programmed cell death, may also affect angiogenesis, and have demonstrated tumor growth-inhibiting action and an improvement in the therapeutic efficacy of temozolomide, a standard treatment for glioma. In addition, GW has shown tumor response to be positively associated with tissue levels of cannabinoids. GW has identified the putative mechanism of action for our cannabinoid product candidate, where autophagy and programmed cell death are stimulated via stimulation of the TRB3 pathway.

“We are very excited about moving this compound into further human study and the prospects of cannabinoids as new anti-cancer treatments. This is GW’s first clinical study of cannabinoids as a potential treatment to inhibit tumor growth,” stated Dr. Stephen Wright, Director of Research and Development at GW. “We believe this clinical program demonstrates the flexibility and broad application of GW’s cannabinoid platform to treat significant, unmet therapeutic needs.”

This study is a 20-patient, multicentre, two part study with an open-label phase to assess safety and tolerability of GW cannabinoids in combination with temozolomide, and a double blind, randomised, placebo-controlled phase with patients randomised to active or placebo, and with a primary outcome measure of 6 month progression free survival. The study objective is to assess the tolerability, safety and pharmacodynamics of a mixture of two principal cannabinoids, THC and CBD in a 1:1 allocation ratio, in combination with temozolomide in patients with recurrent GBM. Secondary endpoints include additional pharmacokinetic and biomarker analyses and additional measurable outcomes of tumor response.

References:

i. Parolaro D, Massi P, Rubino T, Monti E. Endocannabinoids in the immune system and cancer. Prostaglandins Leukot Essent Fatty Acids 2002;66(2-3):319-32.
ii. Guzman M. Cannabinoids: potential anticancer agents. Nat Rev Cancer 2003;3(10):745-55.

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and has a deep pipeline of additional clinical-stage cannabinoid product candidates targeting epilepsy (including an orphan pediatric epilepsy program), Type 2 diabetes, ulcerative colitis, glioma and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding our clinical goals, our plans for a clinical trial, the ability to conduct clinical trials sufficient to achieve positive completion, and the therapeutic and commercial value of the company’s compounds. To the degree we are able to conduct clinical trials, we may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including the prospectus related to the NASDAQ offering filed by GW with the SEC on May 1, 2013. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Monday, November 11th, 2013 Uncategorized Comments Off on (GWPH) Commences Phase 1b/2a Clinical Trial In Glioblastoma Multiforme