POMPANO BEACH, Fla., April 4, 2014 (GLOBE NEWSWIRE) — DS Healthcare Group, Inc. (DSKX), a leading developer of personal care products, today announced financial results for the three and twelve months ended December 31, 2013.

2013 Year-End Highlights:

• Record net revenues of $13,652,000, up 22% over 2012
• Gross margin increases to 50% in 2013 from 40% in 2012
• Gross profits increase to $6,709,000, up 50% over 2012
• Net loss narrows 11% from 2012 to $(3,225,000)
• Adjusted EBITDA, a non-GAAP financial measure, in 2013 was a loss of $(1,170,000)
• Files first patent for its proprietary hair loss formula
• Begins preparation to file Investigational New Drug application with FDA for prescription hair loss product
• Continues global expansion with launch of products in Brazil and China, two of the world’s largest beauty markets, and integrates acquired Mexican distributor
• $3.144 million fund raise in December 2013 and January 2014 strengthens balance sheet
• Cash on hand of $2,873,000 as of December 31, 2013

Fourth Quarter (Q4) 2013 Highlights:

• Q4 net revenues up 10% year-over-year to $3,059,000
• Gross margin increases to 49% in Q4 resulting in a gross profit of $1,570,000
• Net loss narrows 66% from Q4 of 2012 to $(945,000)
• Adjusted EBITDA, a non-GAAP financial measure, in Q4 was a loss of $(110,000)

“In 2013 we continued to solidify our position as the leader in innovative over-the-counter hair thinning products as evidenced by our fifth consecutive year of record top line growth. Revenue growth was driven primarily by sales of our Revita Shampoo and Spectral treatment lines that are recognized around the world for their efficacy in hair re-growth. During the year we also made a very strategic start into the prescription hair loss market, where there is a clear and underserved need for effective solutions without side effects,” stated DS Healthcare President and CEO Daniel Khesin.

Mr. Khesin continued, “We are increasing market share for our over-the-counter branded products which are now sold through over 10,000 outlets in the U.S. and internationally. In 2013 48% of our sales were from outside of the U.S. We made key market moves into Brazil, the second largest beauty market in the world, and we fully integrated our former Mexican distributor, which we acquired at the end of 2012. Sales in Mexico made a significant contribution to our revenue growth in 2013 and we believe Brazil could do the same in 2014 and beyond. Notable milestones achieved in 2013 include our efforts that led to a 5-year agreement we executed in February of 2014 with one of the world’s largest healthcare companies. Through this agreement, we will provide one of our proprietary formulations, ingredients and technology to this Fortune 500 global healthcare company for use in a topical product to be launched and distributed by them. This kind of agreement validates the recognized uniqueness and value of our innovative formulations in the market.”

“During 2014 we plan to begin the clinical development of our pharmaceutical hair loss product, which we believe addresses a $10 billion market in need of a product that works. We laid the foundations in 2013 by filing for a U.S. patent for this prescription grade formulation, retaining Aptiv Solutions as our clinical research organization, and by preparing to file our investigational new drug application with the Food and Drug Administration. If approved, we believe our product would be only the third prescription grade hair loss product and the second topical prescription grade hair loss product to receive FDA approval in the U.S.,” Khesin concluded.

For the year ended December 31, 2013, DS Healthcare’s net revenues increased to a record $13,651,661, up $2,427,237 or 22%, from $11,224,424 in 2012. Revenue increase was driven by the Company’s Mexican subsidiary acquired at the end of 2012 and the fulfillment of backlog orders from the fourth quarter of 2012. The Company’s Revita and Revita COR hair re-growth stimulating shampoos and conditioners were the primary contributors to revenues, representing 40% of total sales.

Gross margin increased to 49% in 2013 from 40% in 2012, as a direct result of the Company’s ongoing effort to reduce chemical, packaging and labor costs, while continuing to deliver effective and cutting edge products worldwide. Gross profits in 2013 grew by 50% to $6,708,619 over $4,474,767 in 2012.

Selling and marketing costs decreased by 2% to $3,747,213 in 2013 from $3,836,540 in 2012. General and administrative costs increased 47% to $6,254,170 in 2013 from $4,249,470 in 2012, driven by an increase in costs from the Company’s acquired Mexican subsidiary, non-cash depreciation charges, and cash and non-cash professional fees for accounting and financial services, which were partially offset by a 56% reduction in bad debts as a result of improved collection results.

DS Healthcare’s net loss narrowed by 11% to $(3,225,289) or $(0.25) per basic and diluted share in 2013 from $(3,623,109) or $(0.33) per basic and diluted share in 2012, driven by record revenues and higher gross margins, partially offset by higher general and administrative costs.

On December 31, 2013 the Company had cash and cash equivalents of $2,872,946 and working capital of $4,049,402. Total stockholders’ equity on December 31, 2013 was $5,632,830 up 36% over December 31, 2012.

For the three months ended December 31, 2013, DS Healthcare’s net revenues were $3,058,626, an 11% increase over net revenues of $2,768,573 in the fourth quarter of 2012. The revenue increase was driven by increased demand for DS Healthcare’s products and the acquisition of the Company’s Mexican subsidiary.

Gross margin increased to 49% in the fourth quarter of 2013 from 7% in the same period of 2012, when the Company sustained a number of one-time charges that had downward pressure on the margins for that quarter. Fourth quarter 2013 margin also benefitted from increased efficiency, better formulations and improved packaging sources. Gross profits grew by 761% to $1,570,423 in the fourth quarter of 2013 from $182,304 in the same period of 2012.

Selling and marketing costs decreased by 30% to $913,951 in the fourth quarter of 2013 from $1,300,342 in the same period of 2012. General and administrative costs declined by 5% to $1,723,994 in the fourth quarter of 2013 from $1,639,480 in the same period of the prior year.

For the fourth quarter of 2013, DS Healthcare’s net loss narrowed by 67% to $(944,860) or $(0.07) per basic and diluted share from $(2,774,323) or $(0.23) per basic and diluted share in fourth quarter of 2012, driven by increased sales, improved gross profit margins and an overall restructuring of expenses.

 

ROCKVILLE, Md.–(BUSINESS WIRE)–

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that it will have two poster presentations at the 2014 American Association for Cancer Research (AACR) Annual Meeting. The conference will take place in San Diego, California, on April 5-9, 2014 at the San Diego Convention Center.

The first poster entitled, “A novel small molecule cytidine analog, RX-3117, shows potent efficacy in xenograft models, even in tumors that are resistant to treatment with gemcitabine,” will be presented on Sunday, April 6, 2014, during the “Experimental and Molecular Therapeutics 6” poster session from 1:00 pm — 5:00 pm in Hall A-E, Poster Section 34. The second poster entitled, “Synthesis of targeted docetaxel-polymer conjugate and its anti-tumor efficacy,” for RX-21101 will be presented on Tuesday, April 8, 2014, during the “Chemistry 8” poster session from 1:00 pm — 5:00 pm in Hall A-E, Poster Section 27.

Peter D. Suzdak, Ph.D., CEO of Rexahn, commented, “The inhibition of tumor growth produced by RX-3117 in human cancer cells already resistant to gemcitabine is a very important finding. Approximately 25% of patients treated with gemcitabine become resistant after one cycle of therapy, representing a large unmet medical need and a significant opportunity for the clinical development and potential commercialization of RX-3117.” Rexahn initiated a Phase Ib clinical trial of RX-3117 in cancer patients with solid tumors in January 2014.

RX-21101 is the first development candidate derived from the Company’s Nano-Polymer-Drug Conjugate Systems (NPDCS) platform. This technology targets the delivery of currently marketed chemotherapeutic agents directly into cancerous tumors. RX-21101 is a polymer conjugated form of docetaxel, a common chemotherapy agent that is now generic but is marketed worldwide under the trade name Taxotere® and had annual sales of $3.1 billion when still under patent.

“In preclinical studies, RX-21101 has demonstrated increased efficacy and reduced toxicity, as compared to intravenously administered free docetaxel,” explained Dr. Suzdak. “RX-21101 contains a signaling moiety that directs the delivery of docetaxel into tumor cells while minimizing the free circulating levels of docetaxel. This approach reduces potential adverse events and maximizes the anti-tumor activity of docetaxel.”

“The NPDCS platform has the potential to generate multiple development candidates using other pharmaceutical companies’ cytotoxic anticancer compounds, transforming them into cancer cell specific compounds with reduced side effects and increased efficacy. This represents a clinical development approach for Rexahn with lower risk, using FDA approved anticancer compounds. Rexahn looks forward to utilizing the NPDCS platform to develop multiple development candidates for either internal development or out licensing,” Dr. Suzdak concluded.

WILMINGTON, Mass., April 7, 2014 /PRNewswire/ — Implant Sciences Corporation (IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, today announced it has signed its second Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Homeland Security’s Transportation Security Laboratory (TSL). The Company’s first CRADA with the TSL for its QS-B220 desktop explosives trace detector (ETD) began November, 2011. The purpose of the new 12-month CRADA is for the TSL to use the QS-B220, having passed TSA qualification testing, as a gold standard explosives trace detector. Information gathered with the QS-B220 at the TSL will be shared with Implant Sciences and used by the Company to develop next generation trace detection technology.

TSL’s core mission is to enhance homeland security, including the research, development and validation of solutions to detect and mitigate the threat of improvised explosive devices (IEDs). TSL, part of the DHS Science and Technology Directorate (S&T), establishes CRADAs as public-private partnerships designed to expeditiously mature and deploy security technologies and to prepare products to achieve Transportation Security Administration (TSA) certification/qualification.

TSL conducts research, test and, evaluation at its 110 acre facility located at the FAA William J. Hughes Technical Center, Atlantic City International Airport, New Jersey.

“Our first CRADA with the TSL provided critical input, which was used to improve the performance of our QS-B220 to meet the TSA’s standards,” stated Implant Sciences’ Vice President of Technology, Todd Silvestri. “We believe that the partnership that was developed and the valuable feedback we received from the endeavor helped us tremendously in the QS-B220 attaining the TSA’s qualified status for air cargo screening and in passing the QT&E portion of the TSA qualification for checkpoint and checked baggage.”

“We believe these studies with the TSL will help to leverage the QS-B220’s capabilities and will prove essential to advancing the standards of the trace detection market,” stated Implant Sciences’ President and CEO Glenn Bolduc. “We are proud to work with the Department of Homeland Security and we look forward to furthering our relationship with the TSL and our technology with this new CRADA.”

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced it has expanded its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the U.S. with the addition of a new site in Scottsdale, Arizona. The 21st Century Oncology clinic in Scottsdale, along with the Arizona Cancer Research Alliance, has just joined the study and is actively screening patients for enrollment into the trial. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer.

“Our clinical trial is now active in over 40 medical centers internationally and we are pleased to expand the number of sites in the U.S. More American patients now have the option of enrolling in this trial for Multikine, which aims to use the body’s own natural immune system to fight cancer. We look forward to working with 21st Century Oncology, and the Arizona Cancer Research Center to bring the potential of this innovative new method of treating cancer patients to Arizona,” stated CEL-SCI Chief Executive Officer Geert Kersten.

The Arizona Cancer Research Alliance (ACRA) is a community-based network for testing and validating medical interventions with the potential to diagnose, treat, ameliorate or cure cancer. The alliance is focused on creating infrastructure to support physicians who are believed to be responsible for over 80% of the care provided to patients with cancer.

21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centers, with 133 centers in 16 states in the U.S. and 33 centers in six Latin American countries.

The Principal Investigator for the Scottsdale site is Dr. Steven Finkelstein, whose clinical expertise includes radiation oncology, surgical oncology and clinical immunotherapy in the treatment of head and neck malignancies, prostate, breast, lung, and colorectal cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation Oncologist, National Director of the Translational Research Consortium, Adjunct Associate Professor at Translational Genomic Research Institute, and Executive Director of the Arizona Cancer Research Alliance.

21st Century Oncology’s Scottsdale clinic is the organization’s second clinic to join CEL-SCI’s trial as part of the CEL-SCI trial expansion. CEL-SCI recently announced 21st Century Oncology’s Greenville, North Carolina site had also joined the study.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of March the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial. This marks the largest number of patients enrolled in the Company’s trial with its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in any month to date.

CEL-SCI’s trial, the largest Phase III head and neck cancer trial in the world, is now active in 12 countries through about 40 clinical sites. During the month of March five clinical centers were added to the study. By the end of 2015 the study is expected to complete enrollment of 880 patients through over 100 clinical centers. As the number of clinical centers increases, patient enrollment is scheduled to accelerate each month.

“In the balance of 2014 and 2015 we plan to add about 60 additional clinical centers to our study. With our new clinical research organizations, Ergomed and Aptiv Solutions, on board we are confident that we will meet our objective of completing patient enrollment by the end of 2015. We anticipate consistent month-over-month increases in the number of new patients enrolled,” commented CEL-SCI Chief Executive Officer Geert Kersten.

Multikine was well tolerated and used safely in CEL-SCI’s Phase II studies in head and neck cancer, as reported by the Phase II study investigators. In the trial, which formed the basis for the Phase III study, Multikine administration appeared to have caused, on average, the disappearance of about 50% of the cancer cells of treated patients. Based on pathology reports, 12% of patients had no remaining cancer cells after treatment with Multikine. These results were published in the Journal of Clinical Oncology.

JERUSALEM, March 27, 2014 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (NASDAQCM:ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the first patient has been enrolled in its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801, in the treatment of type 1 diabetes (T1DM).

“We are pleased to be initiating this U.S. clinical trial with ORMD-0801 in patients with type 1 diabetes following successful trials outside of the US,” said Nadav Kidron, CEO of Oramed Pharmaceuticals. “This initiation is in parallel to the company gearing up for its multi-center Phase IIb study for the treatment of type 2 diabetics.”

This Phase 2a clinical trial is a prospective, randomized, double-blind, placebo-controlled study designed to enroll up to 24 patients with type 1 diabetes in-clinic for 10 days. Patients will be randomized in a 2:1 ratio to receive either ORMD-0801 or placebo. The primary endpoint of the trial is to evaluate the change from baseline in exogenous insulin requirements (basal, bolus, and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. Secondary endpoints include evaluating the change from baseline in mean nighttime, daytime, and fasting glucose levels in type 1 diabetes patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. For more details on the trial, please visit http://www.clinicaltrials.gov.

About ORMD-0801 Oral Insulin and T1DM

Oramed proposes to introduce ORMD-0801 to reduce the mealtime insulin doses, introducing a treatment regimen which would allow for fewer daily injections. Moreover, oral administration offers the benefit of reduced systemic exposure and may enable tighter regulation of blood sugar levels by directly affecting glucose control in the liver.

WILMINGTON, Mass., March 25, 2014 /PRNewswire/ — Implant Sciences Corporation (OTCQB:IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today that its QS-B220 desktop explosives trace detector (ETD) has received regulatory approval from the German Federal Ministry of the Interior  for aviation security applications at German airports. The QS-B220 fulfills specifications set by the German Federal Police. With the German Federal Ministry of the Interior approval, the QS-B220 may now be deployed at all non-passenger airport checkpoints for screening of deliveries, food service, and other airport service functions.

Testing and evaluation was conducted at the German National Test Center for the Evaluation of Explosives Detection Systems, established by the German Federal Police, in conjunction with the Fraunhofer Institute for Chemical Technology (ICT). The realistic testing environment provided by the Center is essential for security services and end users such as airport operators to obtain reliable performance data and ensure a uniform security standard throughout Europe.

“This testing was performed at the request of an airport in Germany that plans to use the QS-B220 to speed up their inspection process at apron checkpoints. Successful completion of the approval process opens up opportunities at airports through the region,” stated Implant Sciences’ Vice President of Sales and Marketing, Dr. Darryl Jones.

“This product approval, which was performed using the latest test protocols and obtained through a key testing facility, further solidifies Implant Sciences’ role as the new standard of trace detection. Our plan is to continue to expand our range of certifications, which includes the U.S., France, China, and now Germany. We believe this will allow us to increase sales volumes and revenues for our Company,” added Implant Sciences’ President and CEO, Glenn D. Bolduc.

On February 4, 2013, the EU implemented an amendment to Regulation (EU) No 185/2010, in regards to the screening of passengers and persons other than passengers by Explosives Trace Detection (ETD) equipment in combination with Handheld Metal Detection (HHMD) equipment, which stated that “trials have demonstrated the effectiveness of the combined use of ETD and HHMD.  Moreover, the use of ETD and HHMD may facilitate the screening process and be experienced to be a less intrusive means of screening than a hand search, thus constituting an improvement in the experience of persons screened.”

 

HAIFA, Israel, March 25, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced its participation in the 2nd UK-Israel Regenerative Medicine Conference (BIRAX), which is being held on March 25th and 26th, 2014 in Haifa at the Ruth and Bruce Rappaport Faculty of Medicine, Technion – Israel Institute of Technology.

Ohad Karnieli, Pluristem’s Vice President of Development & Manufacturing will be a panelist on a session focused on commercialization of regenerative medicine titled, “Road to Clinical Translation — The viewpoint from Industry,” on March 26th, at 4:20 pm.

Shani Raveh, Ph.D., Pluristem’s Scientist will present a scientific poster titled, “Prevention of GvHD by PLX-PAD Cells via intravenous (IV) or intramuscular (IM) Administration”. Preliminary results from Pluristem’s preclinical study of its Placental eXpanded cells (PLX) in the prevention of graft versus host disease (GvHD) were announced in October, 2013. Dr. Raveh will present this data. Conclusions of the preclinical study include:

a) PLX-PAD administration mitigates GvHD symptoms, suggesting that it may be an effective and novel prophylactic treatment for GvHD; and

b) The beneficial effect of PLX-PAD is achieved by both IM and IV routes of administration implying that the systemic effect can be achieved also by local administration.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

HAIFA, Israel, March 26, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that a delegation from the UK made an official visit to Pluristem on March 25, 2014. Officials visiting Pluristem included the UK’s Minister for Universities and Science, David Willetts, whose responsibilities include overseeing the Department of Business Innovation and Skills (BIS), and Dr. Stephen Ward, Chief Operating Officer of the Cell Therapy Catapult, a non-profit organization which aims to grow the UK cell therapy industry.

British Prime Minster David Cameron recently launched a call for ground breaking collaborative research between Britain and Israel into Alzheimer’s, Type 1 Diabetes, heart disease, and Parkinson’s. British delegates including Mr. Willetts and Mr. Ward were in Israel to participate in the 2nd UK-Israel Regenerative Medicine Conference (BIRAX), which is being held on March 25th and 26th, 2014 in Haifa.

Minister David Willets stated, “In recent years, Israel has emerged as a leading player in the biomedical arena and in particular in the cell therapy space. Our objective is to deepen cooperation in scientific and clinical trials between Israel and the United Kingdom by establishing strategic partnerships with leading medical centers in the UK and Israeli companies.”

“It was an honor to host Minister Willetts, Dr. Ward, and members of their delegation here at Pluristem. We look forward to further talks regarding cooperation and collaboration with the British government and UK-based companies. As we accelerate our clinical pipeline, we are evaluating various locations for our clinical trials as well as other business partnership initiatives. We see the UK as an attractive territory that potentially enables a shorter path to market for our PLX products, particularly if the UK approves the Promising Innovation Medicine legislation that would speed up patients’ access to innovative new therapies,” commented, Pluristem CEO Zami Aberman.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.

BOTHELL, WA–(Marketwired – Mar 21, 2014) – Borneo Resource Investments Ltd. (OTCQB: BRNE), (the “Company” or “Borneo”), today announced that it hired Terrence Kirk Filbert to serve as Managing Director – Asia. Mr. Filbert previously served as the Managing Director of Big Blue Resources (Holdings) Limited, an owner of thermal coal mining concession licenses in East and Central Kalimantan, and high grade Silica concessions in Central Kalimantan, Indonesia. Mr. Filbert has intimate knowledge of the coal and mineral businesses in Indonesia and will be instrumental in increasing Borneo’s presence in the Asian markets and increasing Borneo’s gold and coal land portfolios.

Borneo is looking to expand its land portfolio beyond its four gold properties in and around Talawaan and Ratatotok. The Company is moving forward on developing a second steady stream of revenue on its Ratatotok South property. Borneo is currently near the end of its processing cycle at Ratatotok and the ore enhanced carbon will be moved from the site to the Company’s facilities in Manado for final processing.

With the revenue generated in Ratatotok, the Company plans to repay the two remaining notes it has with Asher Enterprises, Inc. These notes are due in April and June 2014 in the amounts of $32,500 and $42,500, respectively. In February 2014, the Company repaid its first convertible note with Asher that had a principal balance of $37,500.

“Bringing aboard Terry Filbert will allow Borneo to increase its visibility in the Asian financial markets, and the coal and mineral marketplace. As Borneo grows with Terry and its current management team, we plan to generate an increasing amount of capital through our business operations and connections in the mineral markets in Asia,” commented Borneo CEO Nils Ollquist.

About Borneo Resource Investments Ltd.

Borneo Resource Investments Ltd. (OTCQB: BRNE) is a mining company that mines gold and develops producing gold mines as well as coal mining properties in the Republic of Indonesia. Borneo’s current assets include three gold properties, two of which are producing gold. Cash flow-producing investments in gold properties help fund Borneo’s operations and investments in gold, while the Company develops high value, longer-term investments in thermal “coal concessions,” which are properties that can be mined for coal. Borneo currently has one coal concession in the Borneo region of Indonesia. Indonesia was the 8th largest gold producing nation in 2012 and the world’s largest exporter of coal, with $25 billion exported in 2012.