VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that the Henry Ford Health System in Detroit, Michigan is the latest U.S. clinical center to join the Company’s Phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). CEL-SCI is currently expanding and accelerating patient enrollment in its trial. The Company expects to rapidly expand the number of clinical sites active in the U.S. As the world’s largest Phase III trial for head and neck cancer, CEL-SCI’s study is already active in dozens of clinical centers in 12 countries and is expected to expand to a total of 20 countries by the end of 2015.

CEL-SCI’s Multikine investigational cancer immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of patients. If approved for use following completion of CEL-SCI’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

According to a report published by the Metropolitan Detroit Cancer Surveillance System in 2010, there were 24,651 new invasive and in situ cancers diagnosed in residents of the metropolitan Detroit area of Wayne, Oakland, and Macomb Counties. In a national study researchers estimated that more than 52,000 men and women would be diagnosed in the U.S. with head and neck cancers in 2012, according to the National Cancer Institute.

Founded in 1915 by auto pioneer Henry Ford and now one of the nation’s leading health care providers, Detroit’s Henry Ford Health System is comprised of hospitals, medical centers and one of the nation’s largest group practices, which includes more than 1,200 physicians practicing in over 40 specialties.

The Josephine Ford Cancer Institute at Henry Ford is a leader in groundbreaking techniques, offering the most advanced diagnostic testing, and multiple treatment approaches including surgery and radiation therapy. Dr. Haythem Ali, a medical oncologist, is the Principal Investigator for CEL-SCI’s study at Henry Ford. His specialties include head and neck cancer and he has published several articles in peer reviewed journals.

“This is our first U.S. clinical center to open in the Midwest. Our intention is to rapidly add more clinical research centers located across North America so that patients seeking to enroll in our immunotherapy trial may have the opportunity to access a site. We are pleased that Dr. Haythem and one of the leading healthcare providers in the country, Henry Ford Health System, have chosen to participate in our groundbreaking study,” stated CEL-SCI Chief Executive Officer Geert Kersten.

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.”