Heat Biologics Prices Offering of 5,000,000 Shares of Common Stock

DURHAM, N.C., March 23, 2017 (GLOBE NEWSWIRE) — HEAT BIOLOGICS, INC. (“HEAT”) (NASDAQ:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $0.80 per share. The gross proceeds to Heat from this offering are expected to be $4,000,000 before deducting underwriting discounts and commissions and other estimated offering expenses payable by Heat. Heat intends to use the proceeds from this offering to continue to fund its and its subsidiaries’ preclinical and clinical programs, for working capital and general corporate purposes, as well as to acquire, license or invest in complementary businesses, technologies, product candidates or other intellectual property.  Heat has granted the underwriters a 45-day option to purchase up to 750,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about March 28, 2017, subject to customary closing conditions.

Aegis Capital Corp. is acting as the sole book-running manager for the offering.

The offering is being made only by means of a written prospectus supplement and the accompanying base prospectus forming part of a shelf registration statement (File No. 333-199274) that was previously filed with, and declared effective by, the Securities and Exchange Commission (“SEC”).  Copies of the prospectus supplement and the accompanying base prospectus relating to this offering may be obtained, when available, from Aegis Capital Corp., 810 7th Avenue, 18th Floor, New York, NY 10019 or via telephone at 212-813-1010 or email: prospectus@aegiscap.com. An electronic copy of the prospectus supplement and accompanying base prospectus may also be obtained at no cost from the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

/EIN News/ — About Heat Biologics, Inc.

Heat Biologics, Inc. (Nasdaq:HTBX) is an immuno-oncology company developing novel therapies that are designed to activate a patient’s immune system against cancer utilizing an engineered form of gp96, a protein that activates the immune system when cells die.  Heat’s highly specific T cell-stimulating therapeutic vaccine platform technologies, ImPACT and ComPACT, in combination with other therapies, such as checkpoint inhibitors, are designed to address three distinct but synergistic mechanisms of action: robust activation of CD8+ “killer” T cells (one of the human immune system’s most potent weapons against cancer); reversal of tumor-induced immune suppression; and T cell co-stimulation to further enhance patients’ immune response.  Currently, Heat is conducting a Phase 2 trial with HS-110 (viagenpumatucel-L) in combination with an anti-PD-1 checkpoint inhibitor to treat patients with non-small cell lung cancer (NSCLC) and a Phase 2 trial with HS-410 (vesigenurtacel-L) in patients with non-muscle invasive bladder cancer (NMIBC).

Heat’s wholly-owned subsidiary, Zolovax, Inc., is developing therapeutic and preventative vaccines to treat infectious diseases based on Heat’s gp96 vaccine technology, with a current focus on the development of a Zika vaccine in conjunction with the University of Miami.

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

Forward Looking Statements

This press release includes forward-looking statements on our current expectations and projections about future events, including statements regarding the proposed public offering. In some cases, forward-looking statements can be identified by terminology such as „may,” „should,” „potential,” „continue,” „expects,” „anticipates,” „intends,” „plans,” „believes,” „estimates,” and similar expressions.  These statements are based upon current beliefs, expectations and assumptions and include statements regarding the proposed public offering as well as Heat’s ongoing clinical programs and potential licensing or acquisition of assets.  These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, the satisfaction of customary closing conditions related to the proposed offering, the success of Heat’s clinical programs, the ability to locate suitable licensing and acquisition targets and the other factors described in Heat’s filings with the SEC.  The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

CONTACT:
                    Heat Biologics, Inc.
                    Jennifer Almond
                    Investor and Media Relations
                    919-240-7133
                    investorrelations@heatbio.com

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Microfiber Market Viewed As Ideal For Healthcare As The Material Helps Improve Moisture Retention – MarketIntelReports

Wilmington, Delaware, United States, March 23, 2017 (GLOBE NEWSWIRE) — The report “Global Microfiber Market by Manufacturers, Regions, Type and Application, Forecast to 2021”, available on MarketIntelReports, estimates that the Asia-Pacific will be a key future growth driver. Browse numerous Market Tables as well as Figures which are spread through 110 Pages and an in-depth TOC on the “Microfiber Market Forecast 2021http://www.marketintelreports.com/report/GIR0072/global-microfiber-market-by-manufacturers-regions-type-and-application-forecast-to-2021Scope & Regional Forecast of the Microfiber MarketMicrofiber is synthetic fiber finer than one denier or decitexthread. However, recently, there is no uniform definition of international fine fibers. In Japan, microfiber is less than 0.3 dtex. German Textile Association monofilament polyester fiber linear density of less than 1.2 dtex, polyamide fiber linear density of less than 1.0 dtex is called superfine fibers; and Montefibre company ‘s linear density of less than 0.55 dtex polyester fiber called microfiber; US PET Commission defines that 0.3 dtex ~ 1.0 dtex fiber is defined as ultra-fine fibers; AKZO company believes microfiber upper limit should be 0.3 dtex, but most people accepted definition dpf 1.0 dtex fibers are microfibers and dpf 0.1 dtex fibers called ultrafine fibers. In china microfiber is less than 2.2 dtex and most global manufacturers produce the microfibers that are less than 0.3 dtex.Request Sample PDF Brochure @ http://www.marketintelreports.com/pdfdownload.php?id=gir0072This report focuses on the Microfiber in Global market, especially in North America, Europe and Asia-Pacific, Latin America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application. There are 13 Chapters to deeply display the global Microfiber market.Inquiry before buying report @ http://www.marketintelreports.com/inquiry-before-buying.php?id=gir0072Prominent Segmentations Involved in the Microfiber MarketThe Microfiber Market can be broken down into various segmentations on the basis of –Type: Long microfiber and Short microfiber.Application: Microfiber Leather, Microfiber Cleaning Cloths and Others.Geographical Location: North America, Europe, Asia-Pacific, Latin America, Middle East and Africa.Some of the sample companies profiled in the Microfiber Market report are as follows:SISAViledaAcelon ChemicalHuafon MicrofibreDouble ElephantFar EasternMeishengHengliTricol Why buy this report?Get a detailed picture of the Microfiber Market.Pinpoint growth sectors and identify factors driving change.Understand the competitive environment, the market’s major players and leading brands.A five-year forecast method is used in order to assess how the market is predicted to develop.Purchase Microfiber Market Report @ http://www.marketintelreports.com/purchase.php?id=gir0072About Us:MarketIntelReports (MIR) aims to empower our clients to successfully manage and outperform in their business decisions. We do this by providing Premium Market Intelligence, Strategic Insights and Databases from a range of Global Publishers. MarketIntelReports currently has more than 150,000 plus titles and 100+ publishers on our platform and growing consistently to fill the “Global Intelligence Demand – Supply Gap”. We cover more than 15 industry verticals being: Automotive, Electronics, Manufacturing, Pharmaceuticals, Healthcare, Chemicals, Building & Construction, Agriculture, Food & Beverages, Banking & Finance, Media and Government, Public Sector Studies.Media Contact:Company Name: Market Intel Reports
Contact Person: Mayur S
Email: sales@marketintelreports.com  
Phone: 1-302-261-5343
Address: 2712 Centerville Road, Suite 400
City: Wilmington
State: Delaware
Country: United States

Eurocontrol’s Xenemetrix to Introduce P-Metrix at 2017 American Chemical Society Spring Conference, San Francisco

/EINPresswire.com/ — TORONTO, ONTARIO–(Marketwired – Mar 23, 2017) – Eurocontrol Technics Group Inc. (TSX VENTURE:EUO)(OTCQB:EUCTF) („Eurocontrol” or the „Company”), a Canadian public company specializing in the acquisition, development and commercialization of innovative test and measurement technologies for industry with application systems focused on the energy security, semiconductor and precision farming sectors, is pleased to announce that its wholly owned subsidiary Xenemetrix Ltd. („Xenemetrix”) will be presenting its diverse lines of X-ray fluorescence (XRF) instrumentation at the 2017 ACS Spring Conference being held April 3rd through April 6th at the Moscone Convention Center in San Francisco, California.

American Chemical Society (ACS) National Meetings provide researchers with current scientific, professional and product information news through various poster sessions, exhibitions, seminars and networking events and the theme for the ACS Spring Conference is „Advanced Materials, Technologies, Systems and Processes”. Xenemetrix will be featuring its cutting edge X-ray analytical instrumentation at booth 1706.

Analytical and industrial instrumentation from Xenemetrix range from portable field or at-line instrumentation, benchtop units ranging in performance to floor standing advanced capability laboratory instrumentation. Among the instruments on display at the event will be the Xenemetrix P- Metrix portable analyzer. The P-Metrix Portable ED-XRF analyzer is a compact ED-XRF system that is designed to produce lab quality results in the field or at-line. Also being featured at the convention will be X-Calibur, Xenemetrix’s powerful 50kV, 50W direct excitation system that has a selection of Primary Beam Filters / Collimators to enhance performance and for the ultimate in sensitivity and compact size, Xenemetrix will feature its Genius IF, a system that provides monochromatic excitation using the Xenemetrix WAG geometry secondary targets that provides sub ppm detection limits for a wide range of elements – features that push back the frontiers of performance providing a very sensitive analytical tool at a very affordable price point.

Bruce Rowlands, Chief Executive Officer stated, „Our participation of the ACS convention in San Francisco will provide a great opportunity to showcase Xenemetrix’s leading edge product line to the broader scientific community. Like Isranalytical, we anticipate that the Xenemetrix product line will be well received.”

About Xenemetrix Ltd.

With ~1,300 systems sold to leading institutions worldwide, Xenemetrix is a leader in Energy Dispersive X-Ray Fluorescence (ED-XRF) spectroscopy systems and components for a wide range of industries and applications. Located in Israel’s high tech industrial zone, Xenemetrix holds a number of certifications and is the recipient of Frost & Sullivan Best Practices Awards in 2015 and 2010 for Global Analytical X-Ray Instrumentation Price Performance Value Leadership and Global ED-XRF Analyzers Product Line Strategy of the Year, respectively. Xenemetrix continues to develop highly innovative technologies and solutions suitable for today’s ever-growing analytical challenges, performing non-destructive elemental analysis starting from Carbon (6) through Fermium (100), while providing detection limits from low parts-per-billion (ppb) to high weight percent (%wt). ED-XRF spectroscopy is one of the simplest, most accurate and economical analytical methods for the determination of the chemical composition of many types of materials. Xenemetrix combines the latest technological developments with innovative engineering, to provide cost-effective solutions to a wide range of industries including the petroleum, mining, marine, manufacturing, food and beverage, cosmetic and pharmaceutical industries to outline a few. Xenemetrix’s emphasis on quality combined with ongoing research and development has earned Xenemetrix an international reputation for excellence. For further information on Xenemetrix, visit www.xenemetrix.com.

About Eurocontrol Technics Group Inc.

Eurocontrol is a TSX Venture and OTCQB traded company that specializes in the acquisition, development and commercialization of innovative test and measurement technologies for industry with application technologies focused on the energy security, semiconductor and precision farming sectors based on Xenemetrix’s core technological platform of ED-XRF. Eurocontrol has three wholly owned subsidiaries, Xenemetrix Ltd., XwinSys Technology Development Ltd. and Croptimal Ltd. and an agreement with SICPA S.A. for semi-annual earn-out payments of 5% (minimum $9 million over six years) on revenues generated from the oil and gas marking and monitoring field relating to the sale of its former subsidiary Global Fluids International (GFI) S.A. Xenemetrix is a leading designer, manufacturer and marketer of ED-XRF systems, a technology that is the most accurate and economic method for determining the chemical composition of many types of materials, including the analysis of petroleum oils and fuel. Xenemetrix has an exclusive long-term supply, maintenance and support agreement with SICPA/GFI to supply SICPA/GFI with Xenemetrix products and services related to the oil and gas marking and monitoring field. XwinSys has developed a patented, fully automated metrology system for the semiconductor industry that combines 2D and 3D image processing technology with Xenemetrix’s ED-XRF technology. Croptimal, is introducing a new mobile ED-XRF spectroscopic material analysis laboratory for the precision agriculture industry that could dramatically change agricultural testing methodology and increase crop yields.

For further information on Eurocontrol, please visit the Company’s website at www.eurocontrol.ca.

For further information on P-Metrix and Xenemetrix X-ray analytical instrumentation equipment, visit the Xenemetrix website at www.xenemetrix.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

Forward-Looking Statements:

This press release contains forward-looking statements. More particularly, this press release contains statements. Forward-looking statements are frequently characterized by words such as „plan”, „expect”, „project”, „intend”, „believe”, anticipate”, „estimate”, „may”, „will”, „would”, „potential”, „proposed” and other similar words, or statements that certain events or conditions „may” or „will” occur. The forward-looking statements are based on certain key expectations and assumptions made by Eurocontrol. Although Eurocontrol believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because Eurocontrol can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. In addition to other risks that may affect the forward-looking statements in this press release are those set out in Eurocontrol’s management discussion and analysis of the financial condition and results of operations for the quarter ended September 30, 2016 and the year ended December 31, 2015 which are available on the Corporation’s profile at www.sedar.com. The forward-looking statements contained in this press release are made as of the date hereof and Eurocontrol undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

ANSI Releases Schedule of Events for World Standards Week 2017

Save the Date for October 16-20 Celebration in Washington, DC

NEW YORK, March 23, 2017 /PRNewswire-USNewswire/ -- The American National Standards Institute (ANSI) has announced the schedule of events for World Standards Week (WSW) 2017, which will be held October 1620 in Washington, DC. WSW is an annual event where members of the standards and conformity assessment community come together in the spirit of cooperation and collaboration.

The schedule for WSW 2017 is as follows:

MONDAY, OCTOBER 16, 2017

TUESDAY, OCTOBER 17, 2017

WEDNESDAY, OCTOBER 18, 2017

THURSDAY, OCTOBER 19, 2017

FRIDAY, OCTOBER 20, 2017

Registration for all events will open in late spring 2017.

Sponsorship opportunities are available at a variety of levels for companies and organizations wishing to show their valuable support for the voluntary standardization community.

For updated information on WSW, including further details on events and registration as they become available, visit www.ansi.org/wsweek.

Mark your calendar for next year: World Standards Week 2018 will be held October 15-19, 2018.

About ANSI
The American National Standards Institute (ANSI) is a private non-profit organization whose mission is to enhance U.S. global competitiveness and the American quality of life by promoting, facilitating, and safeguarding the integrity of the voluntary standardization and conformity assessment system. Its membership is made up of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations. The Institute represents the diverse interests of more than 125,000 companies and organizations and 3.5 million professionals worldwide.

The Institute is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC).

 

SOURCE American National Standards Institute

Mexichem Announces U.S. International Trade Commission Vote Will Impose Antidumping Duties on Imports of R-134a from China

TLALNEPANTLA DE BAZ, Mexico–(BUSINESS WIRE)–Mexichem, S.A.B. de C.V. (BMV: MEXCHEM*) (“The Company” or “Mexichem”) announces that the U.S. International Trade Commission today found that imports of R-134a are causing or threatening to cause material injury to the U.S. industry producing R-134a. Today’s decision follows a year-long investigation by the U.S. Department of Commerce, which found that imports of R-134a from China were being dumped in the U.S. market at prices below fair value. On February 22, 2017, Commerce announced that Chinese R-134a imports were being dumped and prescribed antidumping duties ranging from 148.79 percent to 167.02 percent.

Today’s vote by the Commission means that antidumping duties ranging from 148.79 percent to 167.02 percent of the value will be imposed on all imports of R-134a from China.

The American HFC Coalition believes that this decision is fully supported by the facts. The industry developed R-134a to succeed earlier-generation refrigerants without any negative impact on the ozone layer. The industry invested substantial sums to manufacture R-134a in the United States for automotive air-conditioning, stationary air-conditioning, and other applications. Yet, imports from China, sold at prices far below fair value, increased by an astonishing 100 percent from 2015 to 2016, and continued to increase even after the antidumping petition was filed. As a result of the dumped imports, the U.S. industry has suffered persistently low price levels and poor operating results.

The imposition of antidumping duties is a positive step to restore conditions of fair trade in this market. With these duties in place, the R-134a U.S. manufacturers believe they can earn an adequate return on investment and continue to supply the market.

ABOUT MEXICHEM

Mexichem is a global leader in plastic piping and one of the world’s largest chemical and petrochemical companies. It has more than 50 years of experience. The Company contributes to global development by delivering an extended portfolio of products to high growth sectors such as infrastructure, housing, datacom and water management, among others. With operations in over 30 countries, 120 facilities worldwide and more than 18,000 employees, Mexichem has the rights to produce fluorspar in two mines in Mexico, as well as 8 formation academies and 16 R&D lab. Operations are divided into two value chains and three business units: Ethylene Chain: Vinyl and Fluent Business and Fluor Value Chain, which includes Fluor business group. Mexichem has annual revenues of US$5.35 billion and has been traded on the Mexican Stock Exchange for more than 30 years. The company is member of the Mexican Stock Exchange Sustainability Index and the sustainability emerging markets index FTSE4Good.

Forward-looking Statements

In addition to historical information, this press release contains „forward-looking” statements that reflect management’s expectations for the future. The words “anticipate,” “believe,” “expect,” “hope,” “have the intention of,” “might,” “plan,” “should” and similar expressions generally indicate comments on expectations. The final results may be materially different from current expectations due to several factors, which include, but are not limited to, global and local changes in politics, the economy, business, competition, market and regulatory factors, cyclical trends in relevant sectors; as well as other factors that are highlighted under the title “Risk Factors” on the annual report submitted by Mexichem to the Mexican National Banking and Securities Commission (CNBV). The forward-looking statements included herein represent Mexichem’s views as of the date of this press release. Mexichem undertakes no obligation to revise or update publicly any forward-looking statement for any reason unless required by law.”

Mexichem has implemented a new Code of Ethics that rules its relationships with its employees, clients, suppliers and general groups. Mexichem’s Code of Ethics is available for consulting in the following link: http://www.mexichem.com/Codigo_de_etica.html Additionally, according to the terms contained in the Securities Exchange Act No 42, Mexichem Audit Committee established a mechanism of contact, which allows that any person that knows the unfulfilment of operational and accounting records guidelines and lack of internal controls of the Code of Ethics, from the Company itself or from the subsidiaries that this controls, file a complaint which is anonymously guaranteed. The whistleblower program is facilitated by a third party. The telephone number in Mexico is 01-800-062-12-03. The website is http://www.ethic-line.com/mexichem and contact e-mail is mexichem@ethic-line.com. Mexichem’s Audit Committee will be notified of all complaints for immediate investigation.

LegalShield CEO Jeff Bell Joined a Panel of Legal Experts at SXSW to Discuss Affordable Legal Services and Equal Access to Justice

AUSTIN, Texas–(BUSINESS WIRE)–Jeff Bell, Chief Executive Officer of LegalShield, one of North America’s leading providers of affordable legal plans and the IDShield identity theft solution for individuals, families and small businesses, moderated a panel session on Tuesday, March 14 at the South by Southwest (SXSW) Conference and Festivals in Austin, Texas. The session, titled “Affordable and Accessible Lawyers: Really?”, focused on the existing justice gap in the United States, where citizens are forced to play against law firms that are too expensive or simply trying to fill a capacity gap of billable hours.

The panelists included Michael Hunter, Attorney General of the State of Oklahoma, Judy Perry Martinez, chair of the American Bar Association Presidential Commission on the Future of Legal Services and Daniel B. Rodriguez, Dean of Northwestern University School of Law, who participated via video conferencing. All three participants spoke passionately about the need for affordable legal services, the need for law schools to enable students to better service those in need and how technology and the shared economy are transforming the way citizens access lawyers and law firms.

Hunter, the former Oklahoma Secretary of State and first assistant attorney general, was appointed to the position of attorney general in February 2017. He worked as chief legal advisor for the former administration, overseeing a staff of more than 200 lawyers, law enforcement agents and staff.

“There is going to be continuing disruption in the legal marketplace and increased competition,” he said. “You can do your research on the internet now and determine which law firms are good and will fit your needs, and that competition is going to cause rates to go down.”

Perry Martinez served as Vice President and Chief Compliance Officer of Northrop Grumman Corporation. Before being named CCO, Judy oversaw Northrop Grumman’s litigation for the western half of the country and was named to the Company’s Diversity and Inclusion Leadership Council. Prior to joining Northrop in 2003, she was a commercial litigator at the New Orleans law firm of Simon, Peragine, Smith & Redfearn for 21 years where she was a member of the management committee. Earlier this year, Judy retired from Northrop Grumman to pursue a full-time career in public service.

“One of the challenges and opportunities of the American Bar Association is to empower lawyers to be more efficient so they can spend more time doing what they do best, so they can help more people and do it at rates that will be affordable,” said Perry Martinez.

Rodriguez was appointed Dean and Harold Washington Professor at Northwestern Pritzker Law School in January 2012.

A nationally prominent law teacher and scholar, Rodriguez’s principal academic work is in the areas of administrative law, local government law, and constitutional law. He also has a special interest in the law-business-technology interface and its impact on the future of legal education. He is a leader in the application of political economy to the study of public law and has authored or co-authored a series of influential articles and book chapters in this vein.

“We are in the business of training students to become lawyers, but we are also in the business of advancing the rule of law,” said Rodriguez.

“LegalShield was founded over 45 years ago on the principle of providing all citizens with access to affordable legal services, and we were thrilled to have a high-profile platform at SXSW to share our insights on how technology and the shared economy are disrupting the legal profession,” said Bell.

About LegalShield

LegalShield is one of the North America’s leading providers of legal safeguards for individuals, families and small businesses. The company also offers one of the industry’s most affordable and comprehensive identity theft plans, IDShield. LegalShield plans provide protection to more than 4.2 million individuals, and IDShield provides identity monitoring and restoration services to more than one million individuals across North America. In addition, LegalShield and IDShield serve more than 141,000 businesses.

For as low as $20 per month, LegalShield members get access to attorneys with an average of 19 years of experience in areas such as family matters, estate planning, financial and business issues, consumer protection, tax, real estate, benefits disputes and auto/driving issues. Unlike other legal plans or do-it-yourself websites, LegalShield has dedicated law firms in 50 states and four provinces in Canada that members can call for help without having to worry about high hourly rates.

For more information, visit http://www.LegalShield.com or http://www.IDShield.com.

Advanced Accelerator Applications Reports 23% Sales Growth for Fiscal 2016; Continued NETSPOT® Launch Success

On Track to Resubmit NDA for lutetium Lu 177 dotatate (Lutathera®) to FDA in Mid-2017

Conference Call Today at 10:00 a.m. ET

2016 Key Events:

  • Sales for full-year 2016 increased 23% compared to 2015
  • Closed $150 million follow-on public offering and subsequent underwriters option to purchase additional $22.5 million
  • The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter on the New Drug Application (NDA) for investigational therapeutic, lutetium Lu 177 dotatate (Lutathera®)
  • Successfully launched NETSPOT® in the U.S. and received Transitional Pass-Through status from the Centers for Medicare & Medicaid Services (CMS) for drug reimbursement
  • The European Commission approved the Marketing Authorization Application for SomaKit TOC
  • Achieved marketing authorization in Switzerland for DOPAVIEW and AAACholine
  • Expanded theragnostic pipeline of oncology products by in-licensing two new compounds (NeoBomb1 and PSMA-R2)
  • Enhanced supply chain and manufacturing capabilities through key acquisitions and expansion of existing network
  • More than 40 patients and 14 centers in the U.S. participated in the lutetium Lu 177 dotatate (Lutathera®) Expanded Access Program (currently more than 60 patients and 15 centers)

SAINT-GENIS-POUILLY, France, March 23, 2017 (GLOBE NEWSWIRE) — Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for fiscal 2016.

Stefano Buono, Chief Executive Officer of AAA, commented, “2016 was a year of many achievements. We obtained approval for four new Positron Emission Tomography (PET) diagnostic products in a six-month period, and launched our first product in the U.S. Our supply chain and manufacturing capabilities were strengthened through several key acquisitions and the expansion of our own sites. We grew our theragnostic pipeline of oncology products by in-licensing two new compounds, NeoBOMB1 and PSMA-R2, both of which are transitioning into the clinic in 2017. Finally, we fortified our balance sheet to support our growth objectives for the coming years, including the anticipated approval and launch of lutetium Lu 177 dotatate (Lutathera®).”

“The first few months of 2017 have demonstrated continued momentum,” added Buono. Results of the Phase 3 NETTER-1 study were published in The New England Journal of Medicine, and demand for NETSPOT® continues to scale at a significant rate. With the help of our radiopharmacy partners, we have already delivered approximately 500 doses of NETSPOT® to institutions across the U.S. in the month of March; and we plan to increase our partner radiopharmacies from 20 to approximately 40 by mid-year. In December, NETSPOT® received pass-through status from CMS for drug reimbursement, and we recently announced its inclusion in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for neuroendocrine tumors (NETs), which should facilitate coverage by private payers. Following the enthusiastic response to NETSPOT® in the U.S., we are eager for the upcoming launch of SomaKit TOC in Europe next month.

“I am also quite pleased to report that our task force has made significant progress in addressing the issues identified by the U.S. Food and Drug Administration (FDA) in their Complete Response Letter on the New Drug Application (NDA) for lutetium Lu 177 dotatate (Lutathera®). We believe we have completed the majority of the work required to revise the datasets to meet the Agency’s stated requirements; and based on our current estimates, we further believe we are on track to complete our resubmission to the FDA in mid-2017. The revised clinical datasets are currently undergoing a rigorous review by our internal statistical team and specialized consultants with specific expertise in preparation and review of oncology submissions to the FDA. This same level of scrutiny will be applied to the entire clinical section of our NDA prior to resubmission to the FDA. Throughout this process, we have also been addressing certain clarifications requested by the European Medicines Agency (EMA) during their review of the Marketing Authorization for lutetium Lu 177 dotatate (Lutathera®); and we anticipate the completion of the review and receipt of an opinion from the EMA in the third quarter, with the European Commission approval following about two months after, as is customary.”

Year-end 2016 Financial Results

Total sales for 2016 were €109.3 million (US$115.4 million(1)), a 23% year-on-year increase compared to €88.6 million (US$93.5 million(1)) in 2015. This reflects a compound annual growth rate of 28% between 2012-2016.

Operating loss for 2016 was €19.5 million (US$20.6 million(1)), compared to a loss of €9.5 million (US$10.1 million(1)) for 2015.

For the full-year of 2016, the Company reported a net loss of €25.3 million (US$26.7 million(1)), compared to a net loss of €17.0 million (US$17.9 million(1)) for 2015.

Fiscal 2016 adjusted EBITDA (see corresponding reconciliation exhibit below) was a loss of €7.5 million (US$7.9 million(1)) compared to a profit of €1.8 million (US$1.9 million(1)) for 2015.

In October 2016, AAA closed a $150 million follow-on public offering of American Depositary Shares (“ADSs”). After the closing of the public offering, the underwriters exercised their option to purchase up to $22.5 million of additional ADSs.

/EIN News/ — (1) Translated solely for convenience into US$ at the noon buying rate of €1.00=$1.0552 at December 30, 2016.

Recent Operational Updates

In January 2017, The New England Journal of Medicine published the results of the Phase 3 NETTER-1 study evaluating efficacy and safety of investigational drug lutetium Lu 177 dotatate (Lutathera®) in patients with advanced, progressive somatostatin receptor-positive midgut NETs.

In February 2017, NETSPOT® was included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for NETs.

Conference Call Information

Advanced Accelerator Applications management will host a conference call today at 10:00 a.m. ET. Interested parties may participate by dialing 877-407-8133 (US) or +1-201-689-8040 (International), approximately five minutes before the call start time. A live webcast of the conference call will be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175722. A replay of the call will be available through April 23, 2017, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-481-4010 (US) or +1-919-882-2331 (International) and entering ID number 10274. An archived webcast of the conference call will be available for 90 days on the Investor Relations page of the Advanced Accelerator Applications website: www.adacap.com.

About lutetium Lu 177 dotatate (Lutathera®)

Lutetium Lu 177 dotatate (Lutathera®) is an investigational, Lu-177-labeled somatostatin analog peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutetium Lu 177 dotatate (Lutathera®) belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analog peptides. This novel, investigational compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Currently, lutetium Lu 177 dotatate (Lutathera®) is administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP) for midgut NETs. New Drug Application and Marketing Authorization Application submissions to the FDA and EMA for lutetium Lu 177 dotatate (Lutathera®) are currently under review.

About Advanced Accelerator Applications

Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, lutetium Lu 177 dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the U.S. and Canada). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com.

About Molecular Nuclear Medicine (“MNM”)

Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient’s body that accumulate in the organs or lesions and reveal specific biochemical processes. MNM can be divided in two branches: Molecular Nuclear Diagnostics and Molecular Nuclear Therapy. Molecular nuclear diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages. Molecular nuclear therapy uses radioactive sources (radionuclides) to treat a range of tumor types. Using short-range particles, this therapy can target tumors with little effect on normal tissues.

Reconciliation of adjusted EBITDA to net loss for the year from continuing operations for the years ended December 31, 2016 and 2015

    Twelve months   Twelve months
    December
31, 2016
  December
31, 2016
  December
31, 2015
    in USD
thousands(1)
  In € thousands
             
Net loss for the year from continuing operations      (26,690 )     (25,294 )     (17,001 )
             
Adjustments            
Finance income
(including changes in fair value of contingent consideration)
  (8,509 )   (8,064 )   (1,156 )
Finance costs
(including changes in fair value of contingent consideration)
  14,364     13,613     7,852  
Income taxes   263     249     771  
Depreciation and amortization   12,665     12,002     11,321  
             
Adjusted EBITDA     (7,908 )     (7,494 )     1,787  
Sales   115,360     109,325     88,615  
Adjusted EBITDA margin   -6.85 %   -6.85 %   2.02 %
             
(1) Translated solely for convenience into dollars at the noon buying rate of  EUR 1.00=USD 1.0552 at December 30, 2016.
 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words „anticipate,” „believe,” „estimate,” „expect,” „intend,” „may,” „plan,” „predict,” „project,” „target,” „potential,” „will,” „would,” „could,” „should,” „continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements that appear in a number of places in this press release include the Company’s current expectation regarding future events and various matters, including expected timing of filings with the FDA and EMA, approval dates, and expansion of NETSPOT®. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for lutetium Lu 177 dotatate (Lutathera®) and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of lutetium Lu 177 dotatate (Lutathera®) and our other products or product candidates; our estimates regarding the market opportunity for lutetium Lu 177 dotatate (Lutathera®), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

YEARS ENDED DECEMBER 31, 2016 AND 2015

     
    Twelve months
In € thousands   December
31, 2016
  December
31, 2015
         
Sales   109,325     88,615  
Raw materials and consumables used   (25,697 )   (18,335 )
Personnel costs   (41,704 )   (29,520 )
Other operating expenses   (53,655 )   (44,814 )
Other operating income   4,237     5,841  
Depreciation and amortization   (12,002 )   (11,321 )
         
Operating loss     (19,496 )     (9,534 )
         
Finance income
(including changes in fair value of contingent consideration)
  8,064     1,156  
Finance costs
(including changes in fair value of contingent consideration)
  (13,613 )   (7,852 )
         
Net finance loss     (5,549 )     (6,696 )
         
Loss before income taxes     (25,045 )     (16,230 )
         
Income taxes   (249 )   (771 )
         
Loss for the year     (25,294 )     (17,001 )
         
Attributable to:         
Owners of the company   (25,294 )   (17,001 )
         
Loss per share        
Basic (€ per share)   (0.31 )   (0.25 )
Diluted (€ per share)   (0.31 )   (0.25 )
         
Some figures, in the year December 31, 2015, were reclassified for comparison purpose, without net result impact.
         

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

YEARS ENDED DECEMBER 31, 2016 AND 2015

         
    Twelve months
In € thousands   December
31, 2016
  December
31, 2015
Loss for the year     (25,294 )     (17,001 )
         
Other comprehensive income / (expense):         
         
Items that may be reclassified subsequently to profit or loss        
Exchange differences on translating foreign operations   1,039     3,239  
         
Items that will never be reclassified subsequently to profit or loss        
Remeasurement of defined benefit liability   (237 )   (559 )
         
Other comprehensive income / (expense) net of tax (1)   802     2,680  
Total comprehensive loss for the year     (24,492 )     (14,321 )
         
Total comprehensive loss attributable to:         
Owner of the company   (24,492 )   (14,321 )
         
(1) Positive tax effect of €74 thousand at December 31, 2016 and €176 thousand at December 31, 2015
         
Some figures, in the year December 31, 2015, were reclassified for comparison purpose, without net result impact.
 

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AT DECEMBER 31, 2016

         
ASSETS (in € thousands)     December 31,
2016
  December 31,
2015
  Non-current assets   149,695     116,985  
    Goodwill   34,070     22,662  
    Other intangible assets   45,027     31,884  
    Property, plant and equipment   63,915     56,332  
    Financial assets   2,187     1,512  
    Other non-current assets 3,941     4,298  
    Deferred Tax assets   555     297  
  Current assets   269,048     157,118  
    Inventories   8,100     4,105  
    Trade and other receivables   31,079     23,625  
    Other current assets   7,789     10,502  
    Cash and cash equivalents   222,080     118,886  
TOTAL ASSETS       418,743       274,103  
             
EQUITY AND LIABILITIES (in € thousands)     December 31,
2016
  December 31,
2015
  Equity attributable to owners of the Company    299,461     169,754  
    Share capital   8,795     7,856  
    Share premium   360,085     213,982  
    Reserves and retained earnings   (44,125 )   (35,083 )
    Net loss for the year   (25,294 )   (17,001 )
  Total equity   299,461     169,754  
  Non-current liabilities   79,540     68,341  
    Non-current provisions   12,725     9,968  
    Non-current financial liabilities   12,302     16,205  
    Deferred tax liabilities   4,649     2,804  
    Other non-current liabilities   49,864     39,364  
  Current liabilities   39,742     36,008  
    Current provisions   1,135      
    Current financial liabilities   4,017     5,560  
    Trade and other payables 20,119     14,710  
    Other current liabilities   14,471     15,738  
  Total liabilities   119,282     104,349  
TOTAL EQUITY AND LIABILITIES       418,743       274,103  
             
Some figures, in the year December 31, 2015, were reclassified for comparison purpose, without net result impact.
 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

YEARS ENDED DECEMBER 31, 2016 AND 2015

   
  Twelve months
In € thousands December 31,
2016
December 31,
2015
Cash flows from operating activities  
Net loss for the year (25,294 ) (17,001 )
     
Adjustments:    
Depreciation, amortization and impairment of non-current assets 12,002   11,321  
Share based payment expense 7,157   1,794  
Loss / (Gain) on disposal of property, plant and equipment 253   367  
Financial result 5,549   6,696  
Income tax expense 249   771  
Negative goodwill recognized in other operating income and earn-out renegotiation (377 )  
Subtotal (461 ) 3,948  
     
Increase in inventories (3,354 ) (742 )
Increase in trade receivables (6,549 ) (3,572 )
Increase in trade  payables 6,018   156  
Change in other receivables and payables (299 ) (1,436 )
Increase in provisions 2,752   752  
Change in working capital  (1,432 ) (4,842 )
     
Income tax paid (3,062 ) (2,902 )
Net cash used in operating activities (4,955 ) (3,796 )
     
Cash flows from investing activities  
Acquisition of property, plant and equipment (11,351 ) (11,286 )
Acquisition of intangible assets (1,718 ) (910 )
Acquisition of financial assets (1,046 ) (99 )
Repayment of financial assets 406   278  
Interests received 569   200  
Proceeds from disposal of property, plant and equipment 108   118  
Proceeds from government grants 75    
Acquisition of subsidiaries, net of cash acquired (22,453 )  
Net cash used in investing activities (35,410 ) (11,699 )
     
Net cash from financing activities    
Payment of deferred and contingent liabilities to former owners of acquired subsidiaries (4,684 ) (1,494 )
Issuance of share capital 146,530   97,094  
Issuance of warrants 638    
Proceeds from borrowings   210  
Repayment of borrowings (5,459 ) (4,852 )
Interests paid (527 ) (827 )
Net cash from financing activities 136,498   90,131  
     
Net (decrease) / increase in cash and cash equivalents 96,133   74,636  
     
Cash and cash equivalents at the beginning of the year 118,886   45,096  
Effect of exchange rate changes on cash and cash equivalents 7,061   (846 )
Cash and cash equivalents at the end of the year 222,080   118,886  
         

Contacts:
                    
                    AAA Corporate Communications
                    Rachel Levine
                    Director of Communications
                    rachel.levine@adacap.com
                    Tel: + 1-212-235-2395
                    
                    AAA Investor Relations
                    Jordan Silverstein
                    Director of Investor Relations
                    jordan.silverstein@adacap.com
                    Tel: + 1-212-235-2394
                    
                    Media inquiries:
                    
                    Makovsky & Company
                    Lee Davies
                    ldavies@makovsky.com
                    Tel: +212-508-9651

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Massachusetts fraudster sentenced to 6 years for billion dollar pyramid scheme

BOSTON — The former head of a global pyramid scheme disguised as an Internet telecom company, was sentenced in federal court Wednesday to six years in prison and must also forfeit $140 million of in criminal gains.

This sentence resulted from an investigation by U.S. Immigration and Customs Enforcement (ICE) Homeland Security Investigations (HSI), the FBI, the Brazilian Federal Police, the Securities & Exchange Commission and the Commonwealth of Massachusetts.

James Merrill, 55, of Ashland, Massachusetts, was sentenced by U.S. District Court Judge Timothy S. Hillman to six years in prison and three years of supervised release. In October 2016, Merrill pleaded guilty to one count of wire fraud conspiracy and eight counts of wire fraud. He also agreed to forfeit approximately $140 million and other assets.

“Despite knowing that Telexfree was a pyramid scheme, Mr. Merrill profited for years at the expense of the hard-working individuals who invested in the fraudulent company,” said Acting U.S. Attorney William D. Weinreb. “For the hundreds of thousands of investors, here and around the world, who were taken in by the lies promoted by Mr. Merrill and Telexfree, today’s sentence provides a measure of justice. Mr. Merrill’s greed damaged the livelihoods of thousands of people who were simply struggling to make ends meet.”  

“While the harm and damage James Merrill caused by stealing more than $3 billion from innocent investors can never be repaired, his victims in more than 240 countries around the world can take some small measure of satisfaction that he is now looking at six years in federal prison and a substantial forfeiture as repayment for his crimes.” said Matthew Etre, Special Agent in Charge of Homeland Security Investigations in Boston. “HSI special agents will continue to aggressively investigate those who seek to profit by taking advantage of others.”

Between February 2012 and April 2014, Merrill was the President of TelexFree, Inc., which sold a “voice-over-internet-protocol” (VOIP) telephone service, similar to Skype, for which customers could sign up on a website maintained by TelexFree. TelexFree, however, was a pyramid scheme; all of the money TelexFree paid out came, not from sales of its product, but from new participants paying TelexFree to sign up as “promoters” for the company.

TelexFree’s website prominently featured Merrill as the leader of the company and as an experienced businessman in the telecom field. As the website advertised at various times, participants paid $1,425 or $339 to sign up with TelexFree, after which they would be paid $100 per week or $20 per week to post classified ads every day on the internet. The company couched those payments in terms of “buying back” unused VOIP packages the participants were unable to sell, but the reality was that participants were guaranteed an annual return of over 200% on their money without having to sell anything. Among other things, emails showed Merrill’s awareness that the ad-posting was intended only to ensure that people visited TelexFree’s web site as opposed to generating actual retail sale of the VOIP product. Participants spent minutes a day cutting and pasting ads into various classified ad sites provided by TelexFree, which were already saturated with thousands of ads posted by earlier participants.

Participants were also given substantial financial incentives to recruit others to join the scheme. To receive bonuses for recruiting others, in theory each participant needed to have one VOIP customer. But in reality, participants met this requirement simply by buying the product themselves and, in 97% of instances, never using it. In this way, TelexFree created the illusion that it had hundreds of thousands of legitimate VOIP customers. On paper the company sold about 12.4 million VOIP plans, but in reality it had a tiny number of legitimate customers, an even smaller number of which had actually paid money to TelexFree for the service. Overall, the nearly 2 million who participated in TelexFree made 96% of their compensation, not from selling the company’s VOIP service, but from ad-posting and recruiting others to join.

TelexFree derived only a fraction of its total revenue in a two-year period from sales of VOIP service – approximately 2%. The remaining 98% came from new people buying into the scheme. TelexFree could only pay the returns it had promised to its existing promoters by bringing in money from newly-recruited promoters.

Beginning in late 2012, involvement in TelexFree spread rapidly, and by April 2014, well over a million people worldwide had signed up with the company. This included over 20,000 people in Worcester, Mass. alone, and thousands more in Boston, Framingham, Chelsea and other communities statewide. Meanwhile, beginning in 2013, Merrill received increasingly frequent warnings that the company was a pyramid scheme. Beginning in August 2013, Merrill began to take steps to change how the company did business, but Merrill never alerted the public, even though over a million people signed up for TelexFree between that month and TelexFree’s collapse.

In December 2013, Merrill wired himself and two co-conspirators a total of $10 million from TelexFree accounts. On April 14, 2014, Telexfree filed for bankruptcy, at which point it owed approximately $6 billion to its participants, while having only about $120 million on hand (about 2% of what it owed). At that point, approximately 1,855,000 participants worldwide lost money in the scheme, with total losses of about $3,045,000,000. Overall, these victims came primarily from the United States (all 50 states), Brazil, China, Portugal, Peru, other Central and South American nations, Italy, and Russia, with smaller victim populations in dozens of other countries.

Assistant U.S. Attorneys Andrew E. Lelling and Neil J. Gallagher, Jr., of Weinreb’s Economic Crimes Unit are prosecuting the case.

WE Family Offices Endorses Program Giving Investors Access to Advisors Committed to Fiduciary Standard Of Service

Despite regulatory uncertainty, firms demonstrate commitment to putting clients first

NEW YORK, NY–(Marketwired – March 23, 2017) – Amid regulatory uncertainty WE Family Offices announces its support of the Best Practices Affirmation Program, recently launched by the Institute for the Fiduciary Standard. Through this program, investors can search for advisors who are committed to putting clients first and to adhering to the fiduciary standard of service.

Identifying fiduciary advisors has become increasingly important. The Department of Labor’s Fiduciary Rule would provide much-needed protection for investors. However, with the change in administration, the law is facing an uncertain future.

„This program is about helping investors identify a group of advisors who have essentially said, ‚we think client interests should come first, regardless of the regulatory back-and-forth and Washington’s reluctance to protect investors,'” said Michael Zeuner, founding member of The Institute for the Fiduciary Standard and managing partner of WE Family Offices. „Not only adhering to but clearly communicating these best practices is an important step an advisor can take to differentiate themselves and build trust with their clients, regardless of the outcome of the Fiduciary Rule.”

By seeking advisors who participate in the Best Practices Affirmation Program, investors can locate advisors who have committed to providing advice free from hidden fees or conflicted interests. By participating in the Program, advisors are actively demonstrating a commitment to acting in their clients’ best interests, regardless of the status of the Fiduciary Rule, or any other regulatory action or inaction.

The Best Practices Affirmation Program is based on the Institute’s „Best Practices” and defines tasks that are not required by other advisor groups to ensure truly client-focused service. Advisors who participate in the Best Practices Affirmation Program commit to adhere to these best practices on their website and in their disclosures filed with the Securities and Exchange Commission (known as the Form ADV).

About WE Family Offices

With offices in New York and Miami, WE Family Offices is an award-winning independent, family-focused wealth management firm, serving ultra-high net worth clients. The firm addresses the real-life challenges that deeply impact wealth so that clients are able to make the critical decisions necessary to manage, preserve and grow their wealth. WE is an independent advisory firm and has no interest in selling products, meaning there are no hidden sales agendas or conflicts of interest. As a result, the firm’s advisors are free to offer their clients independent advice and serve as their advocate for the long-term, focused only on their best interests. WE Family Offices was most recently named Multi-Family Office Team of the Year by Family Wealth Report and was listed among the Barron’s Top 1200 Advisors in 2017. The firm was also named among the Financial Times’ Top 300 Independent Advisors in the United States in 2016. As of June 30, 2016, WE now advises on approximately $5.0 billion and reports on an additional $1.8 billion for a total assets under advisement or reporting of $6.8 billion. WE currently works with 70 families in the U.S. and abroad. Learn more at www.wefamilyoffices.com.

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MamaMancini’s Reports Fiscal Year 2017 Financial Results

2017 Operating Income $0.4 million vs. Loss of $(2.3 million) in 2016

2017 Gross Margin Improved to 36% vs. 29%

EAST RUTHERFORD, NJ–(Marketwired – Mar 23, 2017) –  MamaMancini’s Holdings, Inc. (the „Company” or „MamaMancini’s”) (OTCQB: MMMB), a marketer of specialty pre-prepared, frozen and refrigerated all natural food products (as defined by the United States Department of Agriculture), today announced financial results for the fourth quarter and fiscal year 2017, ended January 31, 2017.

Fourth Quarter Highlights:

  • Fourth quarter of fiscal year 2017 revenue increased 65% to $5.4 million compared to $3.3 million in prior year period.
  • Gross margin for the fourth quarter increased to 36.4%, compared to 31.2% for fiscal 2016.
  • Cash EBITDA, a non-GAAP financial metric (please refer to Non-GAAP Financial Measures paragraph below), for the fourth quarter was $544,000, compared to a negative $32,000 in the fourth quarter a year ago.
  • Net income for the fourth quarter was $133,000 versus net loss of $441,000 in prior year period.
  • Net income available to common stockholders was $86,000, or $0.00 per diluted share, during the fourth quarter of fiscal 2017, compared to a net loss of $477,000, or $(0.02) per diluted share in the same quarter last year.

Fiscal Year Highlights:

  • Fiscal year 2017 revenue increased 43% to $18.0 million compared to fiscal 2016 revenue of $12.6 million.
  • Fiscal year 2017 gross margin increased to 36% compared to 29% for fiscal 2016.
  • Total operating expenses for the fiscal year 2017 increased 3.9% versus the comparable fiscal 2016. As a percentage of sales, operating expenses decreased to 33.7% of net sales from 46.5% in the comparable 2016 year.
  • Income from operations for fiscal 2017 improved to $407,009 versus $(2,259,317) in the prior year; an improvement of $2,666,326 from the prior fiscal year.
  • Placements on grocer’s shelves increased at the end of the fiscal 2017 to 38,700, up sequentially from approximately 37,700 at the end of the third quarter of this fiscal year, and up from 32,000 as of January 31, 2016.
  • Cash EBITDA for fiscal 2017 was approximately a positive $1.4 million compared with negative $1.7 million in fiscal 2016, an improvement of $3.1 million.
  • Net loss for fiscal year 2017 was $289,140, compared with a net loss of $3,511,618 in fiscal 2016.
  • Net loss available to common stockholders for the fiscal year was $0.5 million, or $(0.02) per diluted share, compared to a net loss of $3.6 million, or $(0.14) per diluted share, in fiscal 2016.

Carl Wolf, Chief Executive Officer of MamaMancini’s, commented, „Fiscal 2017 was a pivotal year for MamaMancini’s as revenue increased 43% and we achieved profitability in the third and fourth quarters of the fiscal year. Gross margin for the year improved to 36% from 29% and operating income for the fiscal year improved by more than $2.6 million, moving from negative to positive, as we continue to develop larger retail store accounts that drive revenue and as we operate more efficiently. Breaking into profitability has been an important strategic goal and we will look to achieving profitability for all of fiscal 2018.”

„Operationally, we will continue to focus on selling our products into the food service area, on the perimeter of the retail grocery store, where fresh, minimally or non-processed, healthy foods are offered, and where the superior revenue and margin opportunities exist,” added Mr. Wolf. „We continue to develop new product offerings that will add value to our end-user customers that rely on great tasting food with superior nutritional profiles and minimal prep time. During fiscal 2017, we added several new products, including meatloaves and a stuffed pepper kit, both of which have received positive feedback and several key orders.”

Mr. Wolf concluded, „Our new advertising and marketing campaign has commenced and has improved our reach by gaining several new media placements. On National Meatball Day –March 9th, we captured nearly 20 million new impressions via different mediums which we believe will expand our reach, contribute to attracting new large national accounts, and help us to gain a substantial number of new consumers around the country.”

Fourth Quarter 2017 Results
Sales, net of slotting fees and discounts, were $5.4 million for the fourth quarter of fiscal 2017, a 65% increase compared to $3.3 million reported in the fourth quarter of fiscal 2016. The increase in sales was primarily driven by the addition of new customers in the first half of fiscal 2017. As of January 31, 2017, the Company’s products were sold in approximately 11,700 stores, with an average of 3.3 product SKUs in each store, aggregating to approximately 38,700 retail and grocery shelf placements throughout the U.S.

Gross profit for the fourth quarter of fiscal 2017 was $1.97 million, or 36.4% of sales, compared to $1.02 million, or 31.2% of sales, in the year ago period. The increase in gross margin is primarily attributed to increased revenue during the fourth quarter of fiscal 2017 from new retail store customers and the exiting of a substantial number of underperforming low margin accounts during the previous fiscal year.

Net income for the fourth quarter of fiscal 2017 was $133,000, compared to a net loss of $441,000 in the fourth quarter of fiscal 2016.

Fiscal 2017 Results
Sales, net of slotting fees and discounts, were $18.0 million for fiscal 2017, a 43% increase compared to $12.6 million reported in fiscal 2016. The increase in sales was primarily driven by the addition of new customers in the first half of fiscal 2017 and in the final months of fiscal year 2016.

Gross profit for fiscal 2017 was $6.5 million, or 36% of sales, compared to $3.6 million, or 29% of sales, in the year ago period. The increase in gross margin is primarily attributed to increased revenue during the first half of fiscal 2017 from new retail store customers and the exiting of a substantial number of underperforming low margin accounts during the previous fiscal year.

Net loss for fiscal 2017 was $289,140, compared to a net loss of $3,511,618 for fiscal 2016.

Outlook
The Company’s strategy of developing larger customers and exiting underperforming accounts that do not generate attractive returns has achieved improving operating results. The Company expects a continuation of revenue growth for the foreseeable future as it continues to develop larger accounts and introduce new product lines. As a result, the company is anticipating fiscal 2018 revenues to increase substantially over prior year and report continued profitability.

Non-GAAP Financial Measures
The Company uses Cash EBITDA as a non-GAAP financial measure. The Company defines Cash EBITDA as earnings before income taxes, depreciation and amortization plus any non-cash stock payments for expenses. The Company believes that the use of Cash EBITDA is useful to investors and other users of its financial statements in evaluating the Company’s operating performance because it provides them with an additional tool to compare business performance across companies and across periods. The Company uses Cash EBITDA in conjunction with traditional GAAP operating performance measures as part of its overall assessment of its performance, for planning purposes, including the preparation of its annual operating budget, and to evaluate the effectiveness of its business strategies. Management does not place undue reliance on Cash EBITDA as its only measure of operating performance. Cash EBITDA should not be considered as a substitute for other measures of financial performance reported in accordance with GAAP.

Conference Call
The Company has scheduled a conference call for Friday, March 24, 2017, at 9:00 am ET to review the results.

Interested parties may participate on the conference call by dialing (844) 889-4326 or (412) 317-9264. A replay of the conference call will be available by dialing (877) 344-7529 or (412) 317-0088, confirmation code 10103610, through March 31, 2017.

About MamaMancini’s
MamaMancini’s is a marketer and distributor of a line of beef meatballs, turkey meatballs, and chicken meatballs all with sauce, five cheese stuffed beef, turkey and chicken meatballs all with sauce, original beef and turkey meatloaves and bacon gorgonzola beef meatloaf, and other similar Italian cuisine products. The Company’s sales have been growing on a consistent basis as the Company expands its distribution channel, which includes major retailers such as Publix, Shop Rite, Jewel, Save Mart, Lucky’s, Lunds and Byerlys, SUPERVALU, Safeway, Albertsons, Whole Foods Market, Shaw’s, Kings, Roche Bros., Key Foods, Stop & Shop, Giant, Giant Eagle, Foodtown, Sam’s Club, SpartanNash, Hy-Vee, Topps, Kroger, Shoppers, Marsh, King Kullen, Central Markets, Weis Markets, Ingles, and The Fresh Market. The Company sells to distributors such as Sysco, AWI, UNFI, Driscoll Foods, SUPERVALU, Monterrey Provision Co., Burris Logistics and C&S Wholesale Grocers. In addition, the Company sells a wide variety of its products through QVC, the world’s largest direct to consumer marketer, via on air presentations, auto ship programs, and direct purchases through the internet.

Forward Looking Statements
This press release may contain „forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. „Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as „may,” „future,” „plan” or „planned,” „will” or „should,” „expected,” „anticipates,” „draft,” „eventually” or „projected.” You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in the Company’s 10-K for the fiscal year ended January 31, 2017 and other filings made by the Company with the Securities and Exchange Commission.

Financial Tables to Follow

   
   
MamaMancini’s Holdings, Inc.  
Consolidated Balance Sheets  
   
    January 31,     January 31,  
    2017     2016  
             
Assets  
                 
Assets:                
Cash   $ 666,580     $ 587,422  
Accounts receivable, net     1,817,820       1,476,582  
Inventories     443,623       252,752  
Prepaid expenses     135,747       154,458  
Due from manufacturer – related party     2,079,708       2,248,781  
Total current assets     5,143,478       4,719,995  
                 
Property and equipment, net     1,175,508       1,047,455  
Total Assets   $ 6,318,986     $ 5,767,450  
                 
Liabilities and Stockholders’ Equity  
                 
Liabilities:                
Accounts payable and accrued expenses   $ 484,752     $ 769,551  
Line of credit, net     1,363,145       933,001  
Term loan     140,004       120,000  
Promissory notes           266,808  
Notes payable – related party           125,000  
Note payable – net     1,401,906        
Convertible note payable – net           2,540,000  
Total current liabilities     3,389,807       4,754,360  
                 
Term loan – net of current     513,328       320,000  
Promissory notes – net of current portion           69,767  
Note payable – net of current portion     1,298,819        
Notes payable – related party     117,656        
Total long-term liabilities     1,929,803       389,767  
                 
Total Liabilities     5,319,610       5,144,127  
                 
Commitments and contingencies                
                 
Stockholders’ Equity:                
Series A Preferred stock, $0.00001 par value; 120,000 shares authorized;                
  23,400 shares issued and outstanding, respectively            
Preferred stock, $0.00001 par value; 19,880,000 shares authorized;                
  no shares issued and outstanding            
Common stock, $0.00001 par value; 250,000,000 shares authorized;                
  27,810,717 and 26,507,516 shares issued and outstanding, respectively     278       265  
Additional paid in capital     15,825,029       14,954,928  
Common stock subscribed, $0.00001 par value; 66,667 shares, respectively     1       1  
Accumulated deficit     (14,676,432 )     (14,182,371 )
                 
Less: Treasury stock, 230,000 shares, respectively     (149,500 )     (149,500 )
Total Stockholders’ Equity     999,376       623,323  
Total Liabilities and Stockholders’ Equity   $ 6,318,986     $ 5,767,450  
                 
                 
   
   
MamaMancini’s Holdings, Inc.  
Consolidated Statements of Operations  
             
    For the Years Ended  
    January 31, 2017     January 31, 2016  
                 
                 
Sales – net of slotting fees and discounts   $ 18,048,792     $ 12,603,447  
                 
Cost of sales     11,555,976       9,006,220  
                 
Gross profit     6,492,816       3,597,227  
                 
Operating expenses                
  Research and development     144,013       107,632  
  General and administrative expenses     5,941,794       5,748,912  
    Total operating expenses     6,085,807       5,856,544  
                 
Income (loss) from operations     407,009       (2,259,317 )
                 
Other expenses                
  Interest expense     (667,623 )     (555,071 )
  Amortization of debt discount     (28,526 )     (261,670 )
  Amortization of closing costs           (55,471 )
  Loss on debt extinguishment           (380,089 )
    Total other expenses     (696,149 )     (1,252,301 )
                 
Net loss     (289,140 )     (3,511,618 )
                 
Less: preferred dividends     (204,921 )     (66,992 )
                 
Net loss available to common stockholders   $ (494,061 )   $ (3,578,610 )
                 
Net loss per common share – basic and diluted   $ (0.02 )   $ (0.14 )
                 
Weighted average common shares outstanding                
– basic and diluted     27,100,316       26,147,913  
                 
   
   
MamaMancini’s Holdings, Inc.  
Consolidated Statements of Cash Flows  
             
    For the Years Ended  
    January 31, 2017     January 31, 2016  
                 
CASH FLOWS FROM OPERATING ACTIVITIES:                
Net loss   $ (289,140 )   $ (3,511,618 )
  Adjustments to reconcile net loss to net cash provided by (used in) operating activities:                
      Depreciation     348,814       285,516  
      Amortization of debt discount and debt issuance costs     28,526       317,141  
      Amortization of deferred offering costs           10,021  
      Share-based compensation     598,200       245,547  
      Loss on extinguishment of debt           380,089  
  Changes in operating assets and liabilities:                
    (Increase) Decrease in:                
      Accounts receivable     (341,238 )     756,629  
      Inventories     (190,871 )     48,418  
      Prepaid expenses     18,711       (47,216 )
      Due from manufacturer – related party     169,073       (35,744 )
      Increase (Decrease) in:                
        Accounts payable and accrued expenses     140,717       290,958  
          Net Cash Provided by (Used In) Operating Activities     482,792       (1,260,259 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
Cash paid for fixed assets     (476,867 )     (208,226 )
          Net Cash Used In Investing Activities     (476,867 )     (208,226 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Proceeds from issuance of preferred stock           1,580,000  
Stock issuance costs           (436,330 )
Deferred offering costs           (10,021 )
Proceeds from demand notes           650,000  
Proceeds from notes payable – related party           125,000  
Repayment of note payable – related party     (7,344 )      
Repayment of note payable     (149,704 )      
Debt issuance costs     (50,000 )      
Borrowings (repayments) of line of credit, net     403,524       (449,477 )
Borrowings from term loan     340,000        
Repayment of term loan     (126,668 )     (120,000 )
Repayment of promissory notes     (336,575 )     (138,260 )
          Net Cash Provided By Financing Activities     73,233       1,200,912  
                 
Net Increase (Decrease) in Cash     79,158       (267,573 )
                 
Cash – Beginning of Period     587,422       854,995  
                 
Cash – End of Period   $ 666,580     $ 587,422  
                 
SUPPLEMENTARY CASH FLOW INFORMATION:                
Cash Paid During the Period for:                
  Income taxes   $     $  
  Interest   $ 399,106     $ 488,682  
                 
SUPPLEMENTARY DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:                
                 
Stock issued for Series A Preferred dividends   $ 271,914     $  
Accrued interest reclassified to principal balance of convertible note   $ 358,523     $ 220,000  
Accrued dividends   $     $ 66,992  
Stock issuance costs paid in the form of warrants   $     $ 241,769  
Conversion of demand notes to preferred stock   $     $ 650,000  
Stock issued for debt discount on convertible note   $     $ 39,600  
Repurchase of common stock issued for amendment of convertible note   $     $ 149,500  
Promissory note issued for accounts payable   $     $ 474,835  
Series A Preferred and warrants issued for accounts payable   $     $ 110,000