$HMNY, Matheson Analytics and RedZone Acquire IsItYou Facial Recog Tech

Helios and Matheson Analytics Inc. (NASDAQ:HMNY) and RedZone, creator of the RedZone Map™ navigation app, a tool for situational awareness and enhancement of personal safety, announced today that Helios and Matheson Analytics has acquired global licensing rights to IsItYou’s facial recognition technology in the field of crime and terrorism for integration with RedZone Map.

RedZone plans to integrate RedZone Map’s artificial intelligence technology and proprietary real-time crime database with IsItYou’s facial recognition technology. Through the integration of IsItYou and RedZone Map, RedZone plans to enable RedZone Map users to identify persons whose image they are able to capture on the user’s smartphone camera or video, if the identification can be obtained through RedZone’s available data sources and artificial intelligence technology.

In the future, RedZone plans to develop the capability of delivering real-time notifications of criminally active individuals in a user’s area – such as large events or public spaces, by seeking permitted access to publicly located surveillance cameras operated by private enterprises or government entities.

RedZone expects that the integration of IsItYou’s facial recognition technology with RedZone’s real time crime map will further enhance the personal safety of its users in the United States and internationally.

“Through artificial intelligence and facial recognition technology, we will seek to develop the capability to identify dangerous people entering an area and notify our users in real time,” said Ted Farnsworth, founder of RedZone. “Sending notifications to our users of when their safety is more likely at risk, whether at a concert, in a shopping mall, or simply walking down the street, would greatly increase the utility of RedZone Map to our users. This is a key goal in our continuing development of RedZone Map.”

RedZone has begun integrating and plans to continue integrating the facial recognition technology with its real-time crime/navigation app over the coming months.

About RedZone Map

RedZone (Zone Technologies, Inc.) is a state-of-the-art mapping and spatial analysis company with operations in the U.S. and Israel. It has created a community-based ecosystem that features a socially empowered safety map app that enhances mobile GPS navigation using advanced proprietary technology to guide users to their destinations, giving them a choice of a safer route vs. a riskier route. The app incorporates a social media component, which allows for “it’s happening now” crime reporting coupled with real-time crime data from more than 1,400 local, state, national and global sources. RedZone Map is currently available to iOS and Android users. More information is available on the RedZone Map website. Zone Technologies, Inc., a wholly-owned subsidiary of Helios and Matheson Analytics, Inc. (NASDAQ:HMNY) is the creator of RedZone Map.

About Helios and Matheson

Helios and Matheson Analytics Inc. (NASDAQ:HMNY) provides information technology consulting, training services, software products and an enhanced suite of services of predictive analytics. Servicing Fortune 500 corporations and other large organizations, HMNY focuses mainly on BFSI technology verticals. HMNY’s solutions cover the entire spectrum of IT needs, including applications, data, and infrastructure. HMNY is headquartered in New York, NY, and listed on the NASDAQ Capital Market under the symbol HMNY. For more information, visit us www.hmny.com.

Cautionary Statement on Forward-looking Information

Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe,” “may,” “plan,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions. All statements other than statements of historical fact included in this communication are forward-looking statements.

Such forward-looking statements are based on a number of assumptions. Although HMNY’s management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning HMNY are described in its Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2016, and any subsequent current and periodic reports, information statements and registration statements filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on HMNY’s current expectations and HMNY does not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

$PBYA Signs Binding Letter of Intent to Acquire W Marketing

HOUSTON, TX–(May 23, 2017) – ProBility Media Corp. (OTCQB: PBYA) today announces that it has executed a binding letter of intent to acquire W Marketing, Inc., a profitable, revenue-generating provider of National Electrical Codes (NECs) to the electrical and construction industries. The acquisition is expected to strengthen ProBility’s financial position and enable the Company to become one of the nation’s largest wholesalers of National Fire Protection Association (NFPA) electrical codes.

W Marketing provides the latest NECs through its nationwide network of electrical distributors, which includes bookstores, trade/vocational schools, universities, retail chains, specialty retailers, and independent hardware stores. The company is located in Hauppauge, New York.

The NEC is a regionally adoptable standard for the safe installation of electrical wiring and equipment in the United States. It is part of the National Fire Codes series published by the National Fire Protection Association (NFPA), a private association. First published in 1897, the NEC is updated and published every three years, with 2017 being the most recent addition. In 2017, W Marketing achieved $2.7 million in revenues. ProBility expects 2018 and 2019 revenues to be less than 2017, and to increase again in the year 2020 when the new codes will be released.

W Marketing’s vast library of published products includes courses and exam preparation materials. The company is also the official publisher and producer of the Dr. Watts companion electrical guides for the electrical and construction trades. With a complete line of NEC books, reference guides, training DVDs and CD-ROMs, W Marketing is a strong advocate for continued learning within the electrical, plumbing, building and construction industries.

“We are pleased to announce this corporate milestone and look forward to demonstrating the short- and near-term value it creates. The acquisition of W Marketing positions ProBility to become one of the largest wholesalers of NFPA electrical codes in the United States, and we expect to provide codes to over 175,000 electricians in each three-year cycle,” states Noah Davis, President and Chief Operating Officer of ProBility. “When the acquisition is complete, ProBility’s buying power will surpass any wholesaler on the market, and open the doors to thousands of electricians who could benefit from our certification courses, continuing education and code books. Additionally, we expect this acquisition of W Marketing will have a positive impact on forward-looking financials.”

About ProBility Media Corp.

ProBility Media Corp. is an EdTech company building the first full-service training and career advancement brand for the skilled trades. Through its divisions Brown Technical Media Corp., Brown Technical Publications Inc., Brown Book Shop, Inc., National Electrical Wholesale Providers, One Exam Prep, LLC, and its partnership with Globalsim Inc., ProBility is executing a disruptive strategy of defragmenting the skilled trades training market place by offering high quality training courses and materials and preparing the workforce for excellence. ProBility services customers from the tradesman to the small business to the enterprise level corporation.

For more information, visit http://www.ProBilityMedia.com

Forward-Looking Statements

This Press Release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect the Company’s current beliefs and are based upon information currently available to it. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance or achievements to differ materially from those expressed in or implied by such statements. The Company undertakes no obligation to update or advise in the event of any change, addition or alteration to the information included in this Press Release including such forward-looking statements.

Company Contact:
Evan Levine
Chairman and Chief Executive Officer
Noah Davis
President and Chief Operating Officer
713.652.3937

Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

$FLXN to Present New Cost-Effectiveness Data on Zilretta

Findings suggest Zilretta could potentially provide a cost-effective treatment option for patients with osteoarthritis of the knee

BURLINGTON, Mass., May 22, 2017  — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the findings from a new health economics analysis of Zilretta (also known as FX006), the company’s lead investigational candidate for the treatment of knee osteoarthritis (OA) pain. The study, which utilized established health economic metrics, demonstrated that Zilretta has the potential to be a cost-effective therapy in this indication. The findings will be presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22^nd International Meeting, taking place May 20-24 in Boston.

The study was designed to estimate the impact of Zilretta on overall quality of life in patients with knee OA and to evaluate its cost-effectiveness compared with other therapeutic interventions including conventional care (over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, physical therapy and assistive devices)¹, diclofenac (a prescription NSAID)^2,3,4 and hyaluronic acid (HA)¹ injections. With respect to Zilretta, the study utilized previously collected WOMAC⁵ scores from 324 patients enrolled in three separate Phase 2 and Phase 3 randomized clinical trials of Zilretta in patients with knee OA pain.

Using an established algorithm, the authors were able to convert the WOMAC assessments to Health Utilities Index Mark 3 (HUI-3) scores. The cost-effectiveness analyses were based on a Quality Adjusted Life Year (QALY) gain, which was calculated from the improvement in HUI-3 scores over six months.⁶

For the analysis, Zilretta was assigned a hypothetical cost of $500 per treatment and the comparator treatments were assigned their respective 2016 wholesale acquisition costs. Key study findings include:

• Zilretta produced an average QALY gain from baseline of 0.189 per six months, which suggests a greater improvement in quality of life compared with the average values for conventional care (0.030), diclofenac (0.078) and HA injections (0.109).
• Zilretta yielded a cost per QALY estimate of $3,201, compared with cost per QALY estimates for conventional care ($10,717), diclofenac ($2,708) and an average HA treatment course ($13,389).

“OA is a chronic, debilitating condition accounting for more than $185 billion⁷ in healthcare expenditures annually. We conducted this study to determine whether Zilretta, if approved for commercialization, may have the potential to help ease the significant burden that OA places on the healthcare system,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “While the potential clinical benefit of an extended-release treatment for knee OA pain is supported by our clinical trial results, these are the first data to show the potential pharmacoeconomic value of Zilretta as a cost-effective treatment option for these patients.”

The poster (PMS28) is scheduled to be displayed at ISPOR on Monday, May 22 from 3:45 – 7:45 p.m. ET. The abstract and the poster can be found on the ISPOR website: https://www.ispor.org/ScientificPresentationsDatabase/Presentation/72176?pdfid=49648.

About Osteoarthritis of the Knee
While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45. In 2015, more than 14 million Americans were diagnosed with OA of the knee. OA represents an enormous burden on the U.S. healthcare system, affecting approximately 31 million individuals and accounting for more than $185 billion in annual expenditures. About 13 percent of women and 10 percent of men aged 60 years and older have symptomatic OA of the knee, with rates likely to increase due to the aging of the population and the rate of obesity or overweight individuals in the general population.

Each year, more than five million OA patients in the United States receive either an immediate-release corticosteroid or hyaluronic acid intra-articular injection for knee pain.

About Zilretta
Zilretta is being investigated as the first intra-articular, extended-release treatment for patients with OA related knee pain. Zilretta employs proprietary microsphere technology combining triamcinolone acetonide – a commonly administered, short-acting corticosteroid – with a poly lactic-co-glycolic acid (PLGA) matrix. In February 2017, the U.S. Food and Drug Administration (FDA) accepted Flexion’s New Drug Application (NDA) for Zilretta in OA of the knee. Under the Prescription Drug User Fee Act (PDUFA), the agency has established a user fee goal date of October 6, 2017. To date, more than 800 patients have been treated with Zilretta in clinical trials.

About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesia for the millions of U.S. patients who receive intra-articular injections for OA related knee pain annually.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; the potential benefits of Zilretta and cost-effectiveness compared to other treatments, if approved; our interpretation of the data and results from the health economics analysis; and the potential therapeutic and other benefits of Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that the assumptions used in the health economics analysis may be different than actual circumstances if and when Zilretta is commercialized; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta; the risk that Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

References
¹ Rosen J, Sancheti P, Fierlinger A, Niazi F, Johal H, Bedi A. Cost-Effectiveness of Different Forms of Intra-Articular Injections for the Treatment of Osteoarthritis of the Knee. Adv Ther. 2016;33(6):998-1011.
² Latimer N, Lord J, Grant RL, et al. Cost effectiveness of COX 2 selective inhibitors and traditional NSAIDs alone or in combination with a proton pump inhibitor for people with osteoarthritis. BMJ. 2009;339:b2538.
³ Brereton N, Winn B, Akehurst R. The cost-effectiveness of celecoxib vs diclofenac in the treatment of osteoarthritis in the UK; an update to the NICE model using data from the CONDOR trial. J Med Econ. 2012;15(3):465-72.
⁴ National Collaborating Centre for Chronic Conditions. Osteoarthritis: national clinical guideline for care and management in adults. London: Royal College of Physicians, 2008.
⁵ WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints
⁶ Glossary. National Institute for Health and Care Excellence. https://www.nice.org.uk/glossary?letter=q. Accessed April 6, 2017
⁷ Kotlarz, H., Gunnarsson, C.L., Fang, H., & Rizzo, J.A. (2009). Insurer and out-of-pocket costs of osteoarthritis in the US: Evidence from national survey data. Arthritis & Rheumatology. 60(12), 3546 – 3553.

Corporate Contact:

Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

Media Contact:

Danielle Lewis
Lazar Partners
T: 212-867-1768 
flexionpr@lazarpartners.com

Investor Contact:

David Carey
Lazar Partners 
T: 212-867-1768 
dcarey@lazarpartners.com

$VTNR Exclusive Agreement With Penthol for Group III Base Oil Sales Into US

Vertex Energy, Inc. (NASDAQ:VTNR), a refiner and marketer of high-quality specialty hydrocarbon products, announced that The Abu Dhabi National Oil Company (ADNOC) announced this week that it has signed an exclusive agreement with Penthol, a global organization in the supply and distribution of oil products and petrochemicals, appointing them as exclusive seller of their Group III base oils into the United States of America (USA).

In line with its strategy to maximize value from its refining and petrochemical business, ADNOC produces up to 500,000 metric tonnes per year of high quality Group III base oils through the Abu Dhabi Oil Refining Company (Takreer), an ADNOC Group Company. Group III base oils are typically used to manufacture top tier, high performance, engine oils.

Vertex Energy, Inc, (NASDAQ:VTNR) a refiner and marketer of high-quality specialty hydrocarbon products, announced last year, that it had entered into an agreement with Penthol to act as Penthol’s exclusive agent to market these new high quality base oils for the United States (U.S.).

In the past year, Vertex has taken on the responsibilities, in cooperation with Penthol LLC (A Penthol subsidiary in the United States), for Sales, Marketing, Technical Support, and Supply Chain for the U.S. Market. The two companies are currently offering High VI Group III base oils in 4 cSt, 6 cSt and 8 cSt viscosities under the Vertex-Penthol name of “AD Base” Base Oils.

Benjamin P. Cowart, Chairman and CEO of Vertex Energy, stated, “We are very pleased as Vertex-Penthol to finalize this exclusivity agreement between Penthol and ADNOC. This completes the alignment between Vertex and Penthol, where Vertex, on behalf of Penthol, is responsible for the Technical Support, Sales, and Distribution of AD Base products here in the United States.”

Faruk Erkoc, Chairman of Penthol LLC, said, “We are very excited to work with Vertex as our exclusive agent. Their Group II Base Oil sales and logistical infrastructure fits perfectly with our long-term commitment to deliver high quality AD Base Group III Base Oils to our customers throughout the United States.”

Today’s announcement strengthens Vertex-Penthol’s commitment to providing their customers maximum Value with Consistent High Quality, High VI Group III Base Oils as well as Security of Supply for the United States.

ABOUT VERTEX ENERGY, INC.

Vertex Energy, Inc. (VTNR) is a specialty refiner and marketer of high-quality hydrocarbon products. Our business divisions include aggregation and transportation of refinery feedstocks such as used motor oil and other petroleum and chemical co-products to produce and commercialize a broad range of high purity intermediate and finished products such as fuel oils, marine grade distillates and high purity base oils used for lubrication. Vertex operates on a regional model with strategic hubs located in key geographic areas in the United States. With its headquarters in Houston, Texas, Vertex Energy’s processing operations are located in Houston and Port Arthur (TX), Marrero (LA), and Columbus (OH). For more information on Vertex Energy please contact Porter, LeVay & Rose, Inc.’s investor relations representative Marlon Nurse, D.M. at 212-564-4700 or visit our website at www.vertexenergy.com.

Forward-Looking Statements

This press release may contain forward-looking statements, including information about management’s view of Vertex Energy’s future expectations, plans and prospects, within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 (the “Act”). In particular, when used in the preceding discussion, the words “believes,” “hopes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements within the meaning of the Act, and are subject to the safe harbor created by the Act. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of Vertex Energy, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in documents Vertex Energy files with the Securities and Exchange Commission, including but not limited to, its Form 10-Ks, Form 10-Qs and Form 8-Ks. Other unknown or unpredictable factors also could have material adverse effects on Vertex Energy’s future results. The forward-looking statements included in this press release are made only as of the date hereof. Vertex Energy cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, Vertex Energy undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by Vertex Energy.

$LTRX Beta Release of Multi-Dimensional IoT Application Platform

MACH10™ Dramatically Simplifies the Process for OEMs to Deliver Web-Scale IoT Applications

IRVINE, Calif., May 22, 2017 — Lantronix, Inc. (the “Company”) (NASDAQ:LTRX), a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets, today announced availability of the beta release of MACH10™, a multi-dimensional IoT application development and deployment platform that dramatically simplifies the process for OEMs to deliver web-scale IoT applications.

“Following a successful preview and demonstration of MACH10 to early access customers during the March quarter, we’re pleased to announce the availability of the MACH10 beta,” said Jeff Benck, president and CEO of Lantronix. “This beta release marks another important milestone as we move towards general availability of MACH10 later this calendar year and accomplishing Lantronix’s mission to deliver easy-to-deploy solutions that enable companies to leverage the benefits of the Internet of Things.”

Utilizing APIs built on industry standard protocols, MACH10 allows OEMs to significantly reduce the amount of time spent in developing IoT applications through extensible ready-to-use management applications that can be deployed immediately and a suite of essential microservices that allow OEMs to jumpstart their IoT application development while preserving their existing IoT software investments.

Interested OEMs can find more information on MACH10, request a demo or apply for access to the beta release by going to www.lantronix.com/mach10 or contacting a Lantronix sales office.

About Lantronix 
Lantronix, Inc. is a global provider of secure data access and management solutions for Internet of Things (IoT) and information technology (IT) assets. Our mission is to be the leading supplier of IoT gateways that enable companies to dramatically simplify the creation, deployment, and management of IoT projects while providing secure access to data for applications and people.

With more than two decades of experience in creating robust machine to machine (M2M) technologies, Lantronix is an innovator in enabling our customers to build new business models and realize the possibilities of the Internet of Things. Our connectivity solutions are deployed inside millions of machines serving a wide range of industries, including data center, medical, security, industrial, transportation, retail, financial, environmental and government.

Lantronix is headquartered in Irvine, California. For more information, visit www.lantronix.com.

Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.

© 2017 Lantronix, Inc. All rights reserved. Lantronix, is a registered trademark of Lantronix, Inc. MACH10 is a trademark of Lantronix Inc.

Media and Investors:    
E.E. Wang
Director, Corporate Marketing and Investor Relations
investors@lantronix.com
ee.wang@lantronix.com 
949-614-5879

Sales:
Americas: 800-422-7055 
Europe, Middle East and Africa: +31 (0)76 52 36 744
Asia Pacific: + 852 3428-2338
Japan: +81 3-3273-8850
India: +91 994-551-2488

$OCX Presents Positive Lung Cancer Blood Test Data at American Thoracic Society

– Continues Plans to Commercialize Lung Cancer Diagnostic Test in 2017 –

– Conference Call Today at 4:30 PM Eastern Daylight Time –

ALAMEDA, Calif., May 22, 2017 — OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood-based liquid biopsy tests for the early detection of cancer, today reported positive new results in its development of a highly-accurate blood-based lung cancer diagnostic. Data from a multi-site study further validate the test’s commercial potential and support OncoCyte’s plans to commercialize its first product, a confirmatory test for lung cancer, later this year. If successful, OncoCyte’s test could eventually replace a high percentage of invasive, risky, and expensive lung biopsies with simple blood tests, improving outcomes for patients while also capturing significant cost savings for the U.S. healthcare system. The results were reported today in a poster presentation by Dr. Anil Vachani, at the American Thoracic Society 2017 International Conference in Washington, D.C.

A PDF accompanying this release is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b3ce3fea-2aa3-4f97-ae67-54a3905094df

Dr. Vachani, Associate Professor of Medicine at the Hospital of the University of Pennsylvania, reported that in a study of 299 samples collected prospectively from 29 U.S. sites, the optimized final predictive algorithm demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92.

Results from this study of the optimized final predictive algorithm confirmed the data from a previous 610-sample study that was reported in October 2016 by the Wistar Institute (OncoCyte’s research partner) at the American College of Chest Physicians CHEST 2016 Annual Meeting. The development of the lung cancer diagnostic test is a result of nearly ten years of research and the analysis of thousands of samples by Wistar, followed by improvement from OncoCyte’s current study.

Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The reported score of 0.92 means that 92% of samples were correctly identified.

OncoCyte believes the results reported today significantly exceed levels necessary for a commercially successful test.

“The robust lung cancer diagnostic test study data suggest that OncoCyte’s potential lung cancer confirmatory diagnostic could result in a major reduction in the number of risky and costly lung biopsies performed annually in the U.S.,” said Dr. Vachani. “I believe this test could represent a fundamental advancement in the more accurate diagnosis of suspicious lung nodules by allowing physicians to determine those who need biopsies as opposed to those who need follow-up imaging.”

William Annett, President and Chief Executive Officer, commented, “Based on the predictive level of our new algorithm, we believe we are well positioned to be the first company to provide a novel, highly accurate test to a patient market that could reach $4 billion annually, depending on market penetration and reimbursable pricing. We believe we will have the first-mover advantage that could be sustained for at least several years.”

The Company’s health economics research indicates that its lung cancer diagnostic test could mitigate the need for hundreds of thousands of unnecessary lung biopsies. Because lung biopsies have significant safety risks, these unnecessary lung biopsies could result in thousands of consequent hospitalizations and deaths annually.  Reducing the number of these biopsies therefore would also reduce their cost burden to private health insurers and Medicare by billions of dollars. OncoCyte’s surveys of physicians and payors have consistently indicated a strong desire for a test that could reduce the number of lung biopsies, and the expectation is that such a test would be adopted quickly by both prescribers and payors.  Based on published sources, Lung RADS guidelines and NLST (National Lung Screening Trial) data, the Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from its test.

Development and Commercialization Path

For the study presented at the ATS conference, OncoCyte and its investigative partners first created an algorithm that roughly matched the Wistar study results using all 200 biomarkers included in the Wistar algorithm, and OncoCyte then optimized the algorithm’s performance by using only those biomarkers with the highest predictive ability. In addition, the Company’s new algorithm also factors in size of the lung nodule.

OncoCyte has now locked the algorithm of its test and is preparing to commercialize it. During the next few months, the Company plans to complete analytical validation studies and anticipates CLIA certification of its testing laboratory in mid-2017. Upon CLIA certification, OncoCyte will conduct a small CLIA lab validation study to demonstrate that the full assay system utilized in the CLIA lab provides the same results on clinical samples as those obtained in its R&D lab.

Upon CLIA certification, OncoCyte will carry out a final clinical validation study using the locked algorithm and finalized operational procedures on a new set of blinded prospectively collected samples in order to confirm that the sensitivity and specificity of the test remains within commercial parameters in the CLIA operational setting. This final study is not required before commercialization. However, the Company believes that the results of this study should enhance the probability of rapid adoption as the new standard of care for confirming diagnoses of lung cancer. Assuming successful completion of these steps, OncoCyte anticipates launching the test in the second half of 2017. Subsequent to the launch, OncoCyte plans a continued program of clinical utility and health economics studies to support adoption of the test by the medical community, and reimbursement from third party payers such as Medicare and health insurers. OncoCyte also plans to conduct additional biomarker research and clinical studies to develop improved versions of its test that could have even higher accuracy or extend the intended use to additional patient profiles.

About the Lung Cancer Diagnostic Test Study and Poster Presentation

OncoCyte’s lung cancer diagnostic study utilized Wistar’s biomarker panel, which has been exclusively licensed to OncoCyte. The study developed and tested OncoCyte’s proprietary algorithm using approximately 300 samples collected from patients at 29 community-based, academic, and government sites across the United States. OncoCyte developed its algorithm by combining data from the top mRNA biomarkers with clinical data such as nodule size.

The samples were collected from patients with nodules ranging in size from five to 30 millimeters, the size range presenting the greatest diagnostic challenge to clinicians. For patients with these size nodules, physicians must weigh the risk of cancer against the risks posed by costly and potentially dangerous invasive biopsies to confirm whether the nodules are malignant or benign.

The original abstract was submitted in December 2016 for presentation at the American Thoracic Society 2017 International Conference, and was based on the analysis of 106 samples completed at that time.  Subsequent to the submission of that abstract, which was published in the ATS conference guide, the analysis was completed on the full set of 299 samples and the results of that analysis were presented in the final poster, which is attached to this release.

Conference Call

OncoCyte will host a conference call today at 4:30 p.m. EDT / 1:30 p.m. PDT to discuss the study results.

The dial-in number in the U.S./Canada is 888-359-3610, for international participants the number is +1 719-457-2648. For all callers, refer to Conference ID 7395442. To access the live webcast, go to the investor relations section on the Company’s website, http://investors.oncocyte.com/events-and-presentations.

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling 888-203-1112 toll-free (from U.S./Canada); international callers dial +1 719-457-0820. Use the Conference ID 7395442. Additionally, the archived webcast will be available at http://investors.oncocyte.com/events-and-presentations.

About OncoCyte Corporation

OncoCyte is focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. While current biopsy tests use invasive surgical procedures to provide tissue samples in order to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, breast and bladder cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.

Forward Looking Statements

Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements. These statements include those pertaining to the implementation and results of our validation study and other studies, commercialization plans, future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for OncoCyte, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the need and ability to obtain future capital, and maintenance of intellectual property rights, and the need to obtain third party reimbursement for patient’s use of any diagnostic tests we commercialize. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of OncoCyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in OncoCyte’s Securities and Exchange Commission filings. OncoCyte disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Investor Contact:

EVC Group, Inc.
Doug Sherk / Matt Haines
646-445-4800
dsherk@evcgroup.com / mhaines@evcgroup.com

Financial Media Contact:

GIBSON Communications, LLC
Tom Gibson
201-476-0322
tom@tomgibsoncommunications.com

$NUTR Enters Into A Definitive Agreement To Be Acquired By HGGC

PARK CITY, Utah, May 22, 2017 — Nutraceutical International Corporation (NASDAQ: NUTR) (“Nutraceutical” or the “Company”) and HGGC, LLC (“HGGC”), a leading middle-market private equity firm, today announced that they have entered into a definitive agreement under which Nutraceutical will be acquired by an affiliate of HGGC in a transaction valued at approximately $446 million, including debt to be refinanced.  Under the terms of the agreement, Nutraceutical stockholders will receive $41.80 in cash (without interest) for each outstanding share of Nutraceutical common stock they own, which represents a 49% premium to the Company’s closing stock price on May 19, 2017, the last full trading day before today’s announcement, and a 15.6% premium to the Company’s all-time high closing stock price.

“We are pleased to announce this transaction, which delivers significant value to our stockholders, many of whom have been with us since our initial IPO in 1998,” said Bill Gay, Chairman and Chief Executive Officer of Nutraceutical. “We are excited to be joining forces with HGGC, which is a world-class private equity firm.  HGGC’s expertise in formulating strategic growth plans for middle-market companies will be a great platform for the future of Nutraceutical.  We expect that the combination of HGGC’s strategic insights and the deep industry experience and knowledge of our management team will help us continue to build and grow.  We remain committed to our employees and their families, to our customers, to our world-wide consumers and to the natural products industry.  Our management team is looking forward to working with HGGC to pursue the next chapter of our successful story.  We especially want to thank our employees for their years of dedication and hard work.  We truly believe that HGGC will be a great partner as we go forward as a private company.”

Rich Lawson, Co-founder and Chief Executive Officer of HGGC, said “We congratulate the management team and employees of Nutraceutical for building an industry-leading nutritional supplement business, and we look forward to working with the Nutraceutical team to continue to pursue growth opportunities globally.”

“Nutraceutical is an impressive company with a diverse portfolio of brands and thousands of satisfied retail customers, as well as millions of loyal consumers who rely on its products,” commented Les Brown, Managing Director and Chief Operating Officer of HGGC. “Nutraceutical is a great example of a successful roll-up strategy carried out with consistency and dedication over the last 25 years.  We have long admired their disciplined market approach, which has allowed the Company to consistently generate strong financial returns and positive cash flow.”

The agreement has been unanimously approved by Nutraceutical’s board of directors, acting on the recommendation of a special committee of independent and disinterested directors.  The special committee negotiated the terms of the agreement with the assistance of its financial and legal advisors.

The Company will undertake a 60-day “go-shop” period, commencing immediately, during which the special committee, with the assistance of its financial and legal advisors, will actively solicit, evaluate and potentially enter into negotiations with parties who offer alternative proposals. There can be no assurance that this process will result in a superior offer or that any other transaction will be approved or completed.  The Company does not expect to disclose developments with respect to the solicitation process unless and until the special committee has made a decision with respect to any potential superior proposal.

The transaction, which is expected to close in the second half of 2017, is subject to customary closing conditions, including Company stockholder approval and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.  There are no financing conditions associated with the transaction.  Bill Gay and Jeff Hinrichs, Chief Operating Officer and Executive Vice President of the Company, who own approximately 7.9% and 2.5% of the Company’s outstanding common stock, respectively, have entered into customary voting agreements pursuant to which they have agreed to vote all of their shares in favor of the transaction.

Peter J. Solomon Company is acting as financial and strategic advisor to the Company and Paul, Weiss, Rifkind, Wharton & Garrison LLP is acting as its counsel. Piper Jaffray & Co. is acting as financial advisor to HGGC and Kirkland & Ellis LLP is acting as its counsel.

ABOUT NUTRACEUTICAL

Nutraceutical is an integrated manufacturer, marketer, distributor and retailer of branded nutritional supplements and other natural products sold primarily to and through domestic health and natural food stores.  Internationally, Nutraceutical markets and distributes branded nutritional supplements and other natural products to and through health and natural product distributors and retailers.  Nutraceutical’s core business strategy is to acquire, integrate and operate businesses in the natural products industry that manufacture, market and distribute branded nutritional supplements.  Nutraceutical believes that the consolidation and integration of these acquired businesses provides ongoing financial synergies through increased scale and market penetration, as well as strengthened customer relationships.

Nutraceutical manufactures and sells nutritional supplements and other natural products under numerous brands, including Solaray®, KAL®, Dynamic Health®, Nature’s Life®, LifeTime®, Natural Balance®, NaturalCare®, Health from the Sun®, Zhou Nutrition®,  Pioneer®, Nutra BioGenesis®, Life-flo®, Organix South®, Heritage Store® and Monarch Nutraceuticals®.

Nutraceutical owns neighborhood natural food markets, which operate under the trade names The Real Food Company™, Thom’s Natural Foods™, Cornucopia Community Market™ and Granola’s®.  Nutraceutical also owns health food stores, which operate under the trade name Fresh Vitamins®.

Nutraceutical manufactures and/or distributes one of the broadest branded product lines in the industry, with approximately 7,500 SKUs, including approximately 750 SKUs exclusively sold internationally.  Nutraceutical believes that, as a result of its emphasis on innovation, quality, loyalty, education and customer service, its brands are widely recognized in health and natural food stores and among their customers.

ABOUT HGGC

HGGC is a leading middle-market private equity firm with over $4.25 billion in cumulative capital commitments.  Based in Palo Alto, California, HGGC is distinguished by its Advantaged Investing strategy that is designed to enable the firm to source and acquire scalable businesses at attractive multiples through partnerships with management teams, founders and sponsors who reinvest alongside HGGC, creating a strong alignment of interests.  Over its history, HGGC has completed more than 60 platform investments, add-on acquisitions, recapitalizations and liquidity events with an aggregate transaction value of more than $12 billion.  More information, including a complete list of current and former portfolio companies, is available at www.hggc.com.

Additional Information and Where to Find It

The Company will furnish to the Securities and Exchange Commission a report on Form 8-K regarding the proposed transactions described in this press release, which will include the merger agreement. All parties desiring details regarding the merger are urged to review these documents, which will be available at the Securities and Exchange Commission’s web site at www.sec.gov.

In connection with the merger, the Company plans to file with the Securities and Exchange Commission and furnish its stockholders a proxy statement.  Additionally, the Company will file other relevant materials with the Securities and Exchange Commission in connection with the proposed transaction. The materials to be filed by the Company with the Securities and Exchange Commission may be obtained free of charge at the Securities and Exchange Commission’s web site at www.sec.gov.  In addition, stockholders also may obtain free copies of the proxy statement from the Company by contacting Nutraceutical Investor Relations at 1400 Kearns Blvd., 2^nd Floor, Park City, UT  84060, telephone number (435) 655-6106  or investor@nutraceutical.com.  Investors and STOCKHOLDERS of the Company are urged to read the proxy statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed merger because they will contain important information about the merger and the parties to the merger.

This press release is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell any securities and it is not a substitute for any proxy statement or other filings that may be made with the Securities and Exchange Commission should the merger proceed.

Participants in the Solicitation

The Company and its directors, executive officers and other members of their management and employees, under the Securities and Exchange Commission rules, may be deemed to be participants in the solicitation of proxies of the Company’s stockholders in connection with the proposed merger. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests of certain of the Company’s executive officers and directors in the solicitation by reading the Company’s proxy statement for its 2017 annual meeting of stockholders and the proxy statement and other relevant materials which may be filed with the Securities and Exchange Commission in connection with the merger when and if they become available. Information concerning the interests of the Company’s participants in the solicitation, which may, in some cases, be different than those of the Company’s stockholders generally, will be set forth in the proxy statement relating to the merger when and if it becomes available. Additional information regarding the Company’s executive officers and directors in the solicitation is available by reading the Company’s proxy statement for its 2017 annual meeting of stockholders.

Forward Looking Statements

Any statements in this press release about future events or future results, the expected timing of the completion of the proposed merger and the ability to complete the proposed merger, and other statements containing the words “estimates,” “believes,” “anticipates,” “plans,” “expects,” “will,” and similar expressions, other than historical facts, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The actual results of the merger could vary materially as a result of a number of factors, including, but not limited to: (i) the possibility that competing offers will be made; (ii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; and (iii) the inability to complete the proposed merger due to the failure to obtain stockholder approval for the proposed merger or the failure to satisfy other conditions to completion of the proposed merger. Other factors that may cause actual results to differ materially include those set forth in the reports that Nutraceutical files from time to time with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended September 30, 2016 and quarterly and current reports on Form 10-Q and 8-K. These forward-looking statements reflect Nutraceutical’s expectations as of the date of this press release. Nutraceutical undertakes no obligation to update the information provided herein.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

$MNGA Updates Florida Expansion Success

Sarasota Branch Revenues Grow 265% in 2017 vs 2016

TAMPA, Florida, May 22, 2017  —

MagneGas Corporation (“MagneGas” or the “Company”) (MNGA) a leading clean technology company in the renewable resources and environmental solutions industries, announced today that revenues for its newest Florida location for industrial gas and welding supply have grown 265% measured April 2017 versus December 2016.

Know in the industry as ESSI, MagneGas’ wholly-owned subsidiary MagneGas Welding Supply LLC (MWS) is an established competitor in the industrial gas and welding supply industry in Florida. MWS opened its newest branch in January of 2017, and has enjoyed immediate market penetration, revenue growth and profitability.  This branch is the fastest growing location within the MWS operation in 2017.

“This is another clear indication that the MagneGas2® product is a disruptive technology in a commoditized industry that is quickly gaining traction in the local market,” stated Ermanno Santilli, CEO of MagneGas. “Not only is MagneGas2® opening doors as an excellent wedge product, it is enabling our experienced sales team to present our full suite of industrial gas and welding supply products.”

“When combined with superior customer service, our team has been highly successful in quickly generating profitable cross-sales opportunities,” continued Mr. Santilli.  “We are actively adding experienced industry sales members to our team today.  We are excited to expand our team and drive accelerated revenue growth so that we can fully capitalize on our opportunities for success in the near term.”

“We are excited to bring on so many new clients that have quickly demonstrated their trust in our team to consistently deliver excellent service and competitive solutions,” stated Scott Mahoney, CFO of MagneGas.  “We are hopeful that our Sarasota location will become a $1 million location as measured by annualized revenue in the coming quarters.  We plan on replicating this success as we expand our Huntington, IN location next, followed by additional locations planned in Florida in the coming quarters.  We seek to drive organic growth to rapidly enhance profitability in 2017 and beyond.  This is a very cost-effective mechanism to self-fund accelerated revenue growth within a low risk business model.   At the same time, we expect to selectively execute on near term acquisition opportunities in complementary markets in the coming quarters.”

About MagneGas Corporation

MagneGas® Corporation (MNGA) owns a patented process that converts various renewables and liquid wastes into MagneGas fuels. These fuels can be used as an alternative to natural gas or for metal cutting. The Company’s testing has shown that its metal cutting fuel “MagneGas2®” is faster, cleaner and more productive than other alternatives on the market. It is also cost effective and safe to use with little changeover costs.  The Company currently sells MagneGas2® into the metal working market as a replacement to acetylene.

The Company also sells equipment for the sterilization of bio-contaminated liquid waste for various industrial and agricultural markets. In addition, the Company is developing a variety of ancillary uses for MagneGas® fuels utilizing its high flame temperature for co-combustion of hydrocarbon fuels and other advanced applications.  For more information on MagneGas®, please visit the Company’s website at http://www.MagneGas.com.

The Company distributes MagneGas2® through Independent Distributors in the U.S and through its wholly owned distributor, ESSI (Equipment Sales and Services, Inc). ESSI has four locations in Florida and distributes MagneGas2®, industrial gases and welding supplies. For more information on ESSI, please visit the company’s website at http://www.weldingsupplytampa.com

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events, including our ability to raise capital, or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The Company is currently using virgin vegetable oil to produce fuel while it configures its systems to properly process waste within local regulatory requirements.

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Investor Contacts:
Crescendo Communications
626 RXR Plaza
Uniondale, NY 11556
T: +1-844-589-8760
mnga@crescendo-ir.com

$ENT Announces Receipt of NASDAQ Notification

LOS ANGELES, May 19, 2017 — On May 15, 2017, Global Eagle Entertainment Inc. (NASDAQ:ENT) (the “Company” or “we”) received a notification from the Listing Qualifications Department of The NASDAQ Stock Market LLC (“NASDAQ”) stating that the Company is in continued non-compliance with NASDAQ Listing Rule 5250(c)(1) because it has not yet filed its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017 and remains delinquent in filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “Annual Report”).  The NASDAQ letter has no immediate effect on the listing of the Company’s common stock on The NASDAQ Capital Market.

On May 19, 2017, the Company submitted to NASDAQ the Company’s plan to regain compliance with the NASDAQ Listing Rule.  If it accepts the Company’s plan, NASDAQ can grant an exception of up to 180 calendar days from the due date of the Annual Report (which would be September 12, 2017) for the Company to regain compliance.  If NASDAQ does not accept the Company’s plan, then the Company will have the opportunity to appeal that decision to a NASDAQ Hearings Panel before any delisting occurs.

About Global Eagle Entertainment (GEE)

Global Eagle Entertainment Inc. (NASDAQ:ENT) is a leading provider of satellite-based connectivity and media to fast-growing, global mobility markets across air, sea and land. Supported by proprietary and best-in-class technologies, GEE offers a fully integrated suite of rich media content and seamless connectivity solutions that cover the globe. With approximately 1,500 employees and 50 offices on six continents, GEE delivers exceptional service and rapid support to a diverse base of customers around the world. Find out more at: www.globaleagle.com/.

Kevin Trosian
Senior Vice President, Corporate Development and Investor Relations
+1 310-740-8624
investor.relations@geemedia.com

$CBMG Publication on CD20 Efficacy

SHANGHAI, China and CUPERTINO, Calif., May 19, 2017 — Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced the publication of an abstract exploring the application of B-cell antigen, CD20, for targeted Chimeric Antigen Receptor T cells (CAR-T) therapy. The abstract has been published in conjunction with the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 2 – 6, 2017.

Abstract e14548, J Clin Oncol 35, 2017 – Target cell killing effects of CD20 targeting chimeric antigen receptor T cells derived from the type II anti-CD20 antibody.

The complete text of the abstract can be found at http://abstracts.asco.org/199/AbstView_199_192206.html

About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards.  CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat Refractory Diffuse Large B-cell Lymphoma (DLBCL), a Phase I human clinical trial to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL), as well as an ongoing Phase I trial in China for AlloJoin^TM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoin^TM for Knee Osteoarthritis in the United States. The Company also recently announced a strategic partnership with GE Healthcare Life Sciences China to establish a joint technology laboratory to develop control processes for the manufacture of CAR-T and stem cell therapies. To learn more about CBMG, please visit www.cellbiomedgroup.com.

Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com

$REFR and PPG Aerospace to do SPD-Smart EDW for Aircraft

WOODBURY, NY–(May 19, 2017) – In a joint press release today, Research Frontiers (NASDAQ: REFR) licensee Vision Systems, and PPG Aerospace, announced that they have reached a commercial agreement to work together on developing new applications utilizing Vision Systems’ electronically dimmable window (EDW) shading solutions for aircraft. These solutions use Research Frontiers SPD-Smart EDW technology and also combine the considerable experience that both PPG Aerospace and Vision Systems have in supplying the aircraft industry with EDW systems.

As stated in today’s press release, “The agreement provides a framework for PPG and Vision Systems to pursue opportunities in commercial, regional, military and general aviation applications that capitalize on each company’s expertise.”

To learn more, we invite you to read the PPG and Vision Systems press release.

SPD-Smart EDWs deliver unprecedented passenger benefits. By enabling users to precisely control the amount of daylight and glare coming through windows, passengers can instantly tune the tint to a comfortable level while continuing to enjoy views, rather than blocking their view with a shade. The system delivers many other practical benefits including a cooler cabin due to remarkable thermal insulation properties, and a quieter cabin due to acoustic insulation properties.

Joseph M. Harary, President and CEO of Research Frontiers noted: “Both PPG and Vision Systems are well-known pioneers in bringing state-of-the-art and elegant shading systems to their customers in multiple industries. Vision Systems has established the largest team in the world devoted to producing SPD-Smart products, with production facilities in Europe and North America. PPG Aerospace also brings considerable resources and experience in electronically dimmable window systems for the aircraft industry. The combination of these two companies with their focus, resources, and combined experience and expertise, is a major win for aircraft customers around the world who want the finest and best performing systems to enhance the passenger experience.”

About Research Frontiers Inc.

Research Frontiers is the developer of SPD-Smart light-control technology which allows users to instantly, precisely and uniformly control the shading of glass or plastic, either manually or automatically. Research Frontiers has an infrastructure of over 40 licensed companies that collectively are capable of serving the growing global demand for smart glass products in automobiles, homes, buildings, museums, aircraft and boats. For more information, please visit our website at www.SmartGlass.com, and on Facebook, Twitter, LinkedIn and YouTube.

Note: From time to time Research Frontiers may issue forward-looking statements which involve risks and uncertainties. This press release contains forward-looking statements. Actual results could differ and are not guaranteed. Any forward-looking statements should be considered accordingly. “SPD-Smart” is a trademark of Research Frontiers Inc.

CONTACT:
Michael LaPointe
Vice President – Aerospace Products
Research Frontiers Inc.
+1-516-364-1902
Info@SmartGlass.com

$VNET Partners with $MSFT and $TCEHY $TCTZF to Deliver Office Online

The partnership will enable collaboration on Microsoft Office documents via multi-terminal access

CONTACT: Investor Relations Contact:

Calvin Jiang
+86 10 8456 2121
IR@21Vianet.com

ICR, Inc.
Xueli Song
+1 (646) 405-4922
IR@21Vianet.com

$INVE Announces Pricing of Public Offering of Common Stock

FREMONT, Calif., May 19, 2017 — Identiv, Inc. (NASDAQ:INVE) today announced the pricing of an underwritten public offering of 2,474,226 shares of its common stock at a public offering price of $4.85 per share. The gross proceeds to Identiv from this offering, before deducting underwriting discounts and commissions and offering expenses payable by Identiv, are expected to be approximately $12 million.  All of the shares are being offered by Identiv. The offering is scheduled to close on or about May 24, 2017, subject to customary closing conditions. In addition, Identiv has granted to the underwriter a 30-day option to purchase up to an additional 371,134 shares of its common stock at the public offering price, less underwriting discounts and commissions.

Identiv intends to use the net proceeds from the offering for working capital and other general corporate purposes. Identiv may also use a portion of the net proceeds from the offering to acquire or invest in complementary businesses, technologies or other assets, although it has no present commitments or agreements to do so.

Northland Capital Markets is acting as the sole bookrunner for the offering.

The shares will be issued pursuant to a shelf registration statement previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC.  A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting Northland Capital Markets at 45 South Seventh Street, Suite 2000, Minneapolis, Minnesota 55402, attention: Heidi Fletcher, by calling toll free at (800) 851-2920, or by e-mailing hfletcher@northlandcapitalmarkets.com.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

About Identiv
Identiv, Inc. is a global provider of physical security and secure identification. Identiv’s products, software, systems, and services address the markets for physical and logical access control and a wide range of RFID-enabled applications. Customers in the government, enterprise, consumer, education, healthcare, and transportation sectors rely on Identiv’s access and identification solutions. Identiv’s mission is to secure the connected physical world: from perimeter to desktop access, and from the world of physical things to the Internet of Everything. Identiv is a publicly traded company and its common stock is listed on the NASDAQ Capital Market in the U.S. under the symbol “INVE.” For more information, visit identiv.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements relating to Identiv’s expectations regarding the anticipated closing date of the offering, and its intentions with respect to the use of net proceeds from the offering. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, those relating to the satisfaction of conditions to the closing of the offering, and other risks set forth in Identiv’s filings with the Securities and Exchange Commission, including the risks set forth in Identiv’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. These forward-looking statements speak only as of the date hereof and Identiv specifically disclaims any obligation to update these forward-looking statements.

Investor Relations Contact: 
IR@identiv.com

$HOTR Announces Reverse Stock Split

$FNJN to Present at Two Upcoming Conferences

Company to host presentations at B. Riley on May 25, 2017 and LD Micro on June 6, 2017

$ATHN More Disruption Please (MDP) Program Launches ‘MDP Labs’

Application Process Opens Today; Join athenahealth CEO for Reverse Pitch Day® at San Francisco Office June 13

WATERTOWN, Mass., May 18, 2017 — athenahealth, Inc. (NASDAQ:ATHN), a leading provider of network-enabled services for hospital and ambulatory clients nationwide, today announced the launch of MDP Labs, a new innovation program hosted in the company’s San Francisco office, and invites all entrepreneurs with novel technologies that can help fix what is broken in healthcare to apply.

“In 2011, we launched the athenahealth Marketplace wherein we opened a door for entrepreneurs to deliver new innovations to thousands of providers via our national cloud platform,” said Jonathan Bush, chief executive officer at athenahealth. “We are now supersizing our efforts—committing to fill 200 seats of our San Francisco office with the next generation of doers and big thinkers —and ushering in the next stage of the healthcare internet. By consolidating fresh talent, we can help fast track innovative solutions to market, making healthcare IT much more relevant, valuable, and ‘shop-able’ for providers and their patients.”

MDP Labs is open to all healthcare and technology entrepreneurs, from seed-stage startups to mature companies. Companies will be evaluated based on their team, business model, stage of development, demonstrated traction, and strategic fit with athenahealth’s service portfolio and business model. Unlike many accelerator and incubator programs, MDP Labs will not take equity in participating companies.

MDP Labs participants will have access to:

• Workspace and Community – Office space in athenahealth’s downtown San Francisco (SoMA) location with a welcoming community of like-minded entrepreneurs.
• Tailored Programming – Internal R&D and business experts to help design a program catered to your company’s needs.
• Mentorship – Ongoing, dedicated mentorship and feedback from athenahealth’s product teams, senior leadership, super users, and curated network of advisors.
• Partnerships and Funding Opportunities – Opportunities to fast track an athenahealth partnership or investment.
• Exposure to Clients – Broad exposure to the athenahealth provider network and beta programs.

Join athenahealth and Elevar at the San Francisco athenahealth office on June 13, 2017, for Reverse Pitch Day®, where athenahealth CEO Jonathan Bush will call on the startup community to solve some of healthcare’s most pressing pain points.

“Elevar is proud to support athenahealth’s vision to build a game-changing digital health ecosystem nationwide,” said Chris Edell, chief executive officer of Elevar. “Entrepreneurs interested in making a positive impact in the lives of patients and physicians are encouraged to apply.”

To learn more about MDP Labs, Reverse Pitch Day or to submit an application, please visit:  https://www.athenahealth.com/more-disruption-please/labs. Applications for MDP Labs close July 7.

About ‘More Disruption Please’
The athenahealth More Disruption Please (MDP) partnership and innovation program brings together entrepreneurs, investors, clinicians and industry experts who share the company’s vision of disrupting the status quo in healthcare. Through collaboration and seamless integration on athenahealth’s open cloud platform, MDP provides easy access to the world’s most innovative thinking, offering solutions to help healthcare professionals thrive in the face of industry change and pressure. For more information, please visit: https://www.athenahealth.com/more-disruption-please/more-disruption.

About athenahealth, Inc.
athenahealth partners with hospital and ambulatory clients to drive clinical and financial results. We offer medical record, revenue cycle, patient engagement, care coordination, and population health services. We combine insights from our network of 99,000 providers and 88 million patients with deep industry knowledge and perform administrative work at scale. For more information, please visit www.athenahealth.com.

About Elevar
Elevar was founded on the belief that long-standing healthcare challenges can be solved in new and unique ways by entrepreneurs, with the guidance of industry experts. Our mission is to bring visionaries front-and-center to these challenges to improve the collective healthcare experience. We want to see the most innovative minds build projects that matter. Our unique Elevar Labs® builds partnerships between enterprise and top startups, creating solutions aligned to specific industry needs. As pioneer of Reverse Pitch Day® (RPD), Elevar flips the script by having healthcare executives pitch their problems to the startup community. Rather than spending precious time, money and resources building a product that there may, or may not be a market for helping startups to validate business models and enterprise to identify potential solutions (early on). At Elevar, we connect today’s leading enterprises to tomorrow’s innovations.

Press Contacts:

Holly Spring
athenahealth, Inc. (Media)
617-402-1631
media@athenahealth.com

Dana Quattrochi
athenahealth, Inc. (Investors)
617-402-1329
investorrelations@athenahealth.com

$ARQL to Present Preclinical Data for BTK Inhibitor, ARQ 531

ArQule, Inc. (Nasdaq: ARQL) today announced that preclinical data for ARQ 531 in diffuse large B-cell lymphoma (DLBCL) in vitro and in vivo tumor models will be presented on June 23, 2017 at EHA Congress in Madrid, Spain. The data supports clinical trials with ARQ 531 in the ibrutinib resistant patient population. A phase 1 trial with ARQ 531 in patients with B-cell malignancies refractory to other therapeutic options, including ibrutinib, is planned to commence by the third quarter of 2017. ARQ 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant Bruton’s tyrosine kinase (BTK).

Presentation Details

Friday, June 23, 2017: Non-Hodgkin and Hodgkin Lymphoma – Biology

ARQ 531
Abstract E1400
ARQ 531, a reversible BTK inhibitor, demonstrates potent anti-tumor activity in ABC-DLBCL and GCB-DLBCL
E-poster Screens
Time: 9:30 AM CET

About BTK and ARQ 531

ARQ 531 is an investigational, orally bioavailable, potent and reversible Bruton’s tyrosine kinase (BTK) inhibitor. Biochemical and cellular studies have shown that ARQ 531 inhibits both the wild type and C481S-mutant forms of BTK. The C481S mutation is a known emerging resistance mechanism for first generation irreversible BTK inhibitors. In preclinical studies ARQ 531 has demonstrated high oral bioavailability as well as good ADME, pharmacokinetic and metabolic properties. The company plans to initiate a phase 1 trial by the third quarter of 2017. BTK is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers.

About ArQule

ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. ArQule’s mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of our patients. Our clinical-stage pipeline consists of four drug candidates, all of which are in targeted, biomarker-defined patient populations, making ArQule a leader among companies our size in precision medicine. ArQule’s proprietary pipeline includes: ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, in phase 2 for iCCA and in phase 1b for multiple oncology indications; ARQ 092, a selective inhibitor of the AKT serine/threonine kinase, in phase 1/2 company sponsored study for Overgrowth Diseases, in phase 1 for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH), as well as in multiple oncology indications; ARQ 751, a next generation AKT inhibitor, in phase 1 for patients with AKT1 and PI3K mutations; and ARQ 761, a β-lapachone analog being evaluated as a promoter of NQO1-mediated programmed cancer cell necrosis, in phase 1/2 in multiple oncology indications in partnership with the University of Texas Southwestern Medical Center. In addition, we have advanced ARQ 531, an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant BTK, through toxicology testing and plan to initiate a phase 1 trial by the third quarter of 2017. ArQule’s current discovery efforts are focused on the identification and development of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds. You can follow us on Twitter and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements regarding preclinical experiments and planned clinical trials with ARQ 531. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical results does not ensure that clinical trials will be successful. For example, ARQ 531 may not demonstrate promising therapeutic effect in man; in addition, it may not exhibit an adequate safety profile in planned or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing ARQ 531 that could lead the Company to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

$GLYC High Overall Response Rates, Low Induction Mortality GMI-1271 in AML

GlycoMimetics, Inc. (NASDAQ: GLYC) today announced the release of abstracts containing new data from the ongoing Phase 2 clinical trial of its product candidate GMI-1271, an E-selectin antagonist, in patients with acute myeloid leukemia (AML). The data will be presented at the June annual meetings of the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA). The data released by ASCO and EHA, which reflect a late-January analysis, will be updated in posters presented at both meetings.

In the ongoing Phase 2 trial, AML patients treated with GMI-1271, combined with chemotherapy, continue to experience higher-than-expected remission rates and lower-than-expected induction-related mortality rates in both arms of the trial. In addition, researchers have observed that baseline expression of the E-selectin ligand biomarker on leukemia cells was predictive of clinical response and tied to greater likelihood of achieving remission in the cohort of AML patients with relapsed/refractory disease, which supports the mechanism of action of GMI-1271. Treatment with GMI-1271 continues to be well tolerated, with no obvious incremental toxicity observed when GMI-1271 is added to chemotherapy.

According to Helen Thackray, MD, Chief Medical Officer, “The data has consistently shown good tolerability and high remission rates as well as lower than expected 30- and 60-day mortality rates in early evaluations of patients. We are increasingly confident that our investigational drug, GMI-1271, may play a role in addressing unmet needs in this cancer. It is particularly noteworthy to see in the relapsed/refractory cohort that patients who have higher levels of the E-selectin ligand biomarker on their leukemic blasts appear to be more likely to achieve remission of their disease. This observation builds directly on what we and others have reported in the preclinical and clinical settings about the key role E-selectin plays in many forms of cancer, including AML. Importantly, this provides what we believe is the first direct clinical evidence of the potential benefit of targeting of E-selectin in this difficult-to-treat population of AML patients.”

Relapsed or Refractory Disease Arm: Abstract Data

Consistent with GlycoMimetics’ prior published research, the addition of GMI-1271 to mitoxantrone, etoposide and cytarabine (MEC) chemotherapy has been well-tolerated, with patients achieving a high overall response rate (ORR), low induction mortality, and promising initial survival outcomes. The data show that baseline expression of the E-selectin ligand biomarker was predictive of response. GlycoMimetics believes these results are better than what would be expected in this population, based on published historical controls in similar patients.

Highlights of the data reported in the published abstract include:

• 47 patients were enrolled.
• 30- and 60-day mortality were 0 and 7%, respectively.
• ORR was 21/42 evaluable (50%).
• Median Overall Survival in the Phase 1 portion was 7.6 months.
• The median E-selectin ligand binding at baseline was 35% of blasts (range, 1-75%) and, importantly, was higher in those achieving remission.

The data from the ongoing Phase 2 trial were submitted to the U.S. Food and Drug Administration (FDA). As announced yesterday, GMI-1271 was granted Breakthrough Therapy designation from the FDA for the treatment of adult AML patients with relapsed/refractory disease. The FDA had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 for the treatment of AML.

Newly Diagnosed, Treatment-Naïve, Elderly Arm: Abstract Data

In the published abstract, data reflects 17 of 24 enrolled and evaluable elderly patients. Highlights from the abstract include:

• The remission rate (CR/CRi) was 12/17 (71%).
• CR/CRi rate was 75% for patients with de novo disease and 67% for patients with secondary AML.

GlycoMimetics noted that the safety profile of the investigational drug, GMI-1271, in combination with chemotherapy is encouraging. Outcomes for elderly patients with AML remain poor, and tolerability of treatments is a key concern.

Conference Call Today

Company management will host a conference call today, Thursday, May 18, 2017 at 8:30 a.m. Eastern time to provide a clinical data update from the abstracts for the upcoming ASCO conference. A question and answer session with the GlycoMimetics team will follow the company’s remarks. The call can be accessed by dialing (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 4110139. To access the live audio webcast, or the subsequent archived recording, visit the “Investors – Events & Presentations” section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

About the Phase 1/2 Trial

The trial is comprised of two arms, one treating newly diagnosed AML patients 60 years of age and older and the other, treating adult patients with relapsed or refractory disease. The enrollment of the cohort of newly diagnosed patients is complete; enrollment of the cohort with relapsed/refractory disease is expected to complete by mid-year. GlycoMimetics intends to enroll a total of approximately 90 patients in the trial, of which approximately 25 have newly diagnosed disease and approximately 65 have relapsed or refractory disease. Initial results of this study were first reported at the EHA 2016 meeting in Copenhagen, and GlycoMimetics provided an update at the December 2016 American Society of Hematology (ASH) meeting.

Details of the ASCO Presentations

Abstract #2520

Poster with discussion. DeAngelo, D.J., et al. “GMI-1271, a Novel E-Selectin Antagonist, in Combination with Chemotherapy in Relapsed/Refractory AML.” Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics. Monday, June 5, 8:00-11:30 a.m. CT. Poster Discussion Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics, Monday, June 5, 11:30 a.m.-12:45 p.m. CT.

Presenter: Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute Director of Clinical and Translational Research, Adult Leukemia; Harvard Medical School Associate Professor of Medicine

Abstract #2560

Poster. DeAngelo, D.J. et al. “GMI-1271, a Novel E-Selectin Antagonist, Combined with Induction Chemotherapy in Elderly Patients with Untreated AML.” Session Title: Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics. Monday, June 5, 8:00-11:30 a.m. CT.

Presenter: Dr. DeAngelo

The ASCO Annual Meeting 2017 takes place from June 2 to 5, at McCormick Place in Chicago. Meeting abstracts are available at ASCO’s website.

Details of the EHA presentations

Abstract Code: P547

Poster. DeAngelo, D.J., et al. “GMI-1271, A Potent E-Selectin Antagonist, In Combination With Chemotherapy In Relapsed/Refractory AML: A Novel, Well-Tolerated Regimen With A High Remission Rate.” Session Title: Acute myeloid leukemia – Clinical 4. Saturday, June 24, 17:30 – 19:00. Poster area (Hall 7).

Presenter: Dr. DeAngelo

Abstract Code: P203

Poster. DeAngelo, D.J., et al. “GMI-1271, A Potent E-Selectin Antagonist, Combined With Induction Chemotherapy In Elderly Patients with Untreated AML: A Novel, Well-Tolerated Regimen With A High Remission Rate.” Session Title: Acute myeloid leukemia – Clinical 2. Friday, June 23, 17:15 – 18:45. Poster area (Hall 7).

Presenter: Dr. DeAngelo

The 22^nd Congress of EHA (European Hematology Association) takes place from June 22 to 25, 2017 in Madrid, Spain. Meeting abstracts will be available at EHA’s website.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics’ most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics’ wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial in multiple myeloma. GlycoMimetics has also recently initiated a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding GlycoMimetics’ planned activities with respect to the clinical development of its drug candidate GMI-1271. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for GlycoMimetics’ foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of GlycoMimetics’ drug candidates and other factors discussed in the “Risk Factors” section of GlycoMimetics’ Annual Report on Form 10-K that was filed with the U.S. Securities and Exchange Commission on March 1, 2017, and other filings GlycoMimetics makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent GlycoMimetics’ views as of the date hereof. GlycoMimetics anticipates that subsequent events and developments may cause its views to change. However, while GlycoMimetics may elect to update these forward-looking statements at some point in the future, GlycoMimetics specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing GlycoMimetics’ views as of any date subsequent to the date hereof.

$INCY New Data for Presentation at ASCO 2017 Reinforce Clinical Profile of Epacadostat

Incyte Corporation (Nasdaq:INCY) today announced the publication of new data from the ongoing ECHO-202 trial, evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with Keytruda^® (pembrolizumab), Merck’s anti-PD-1 therapy. Abstracts published online by the American Society of Clinical Oncology (ASCO) in advance of its annual meeting in Chicago, Illinois, June 2-6, 2017 include ECHO-202 Phase 1/2 efficacy and safety data from the following cohorts: non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), bladder cancer, squamous cell carcinoma of the head and neck (SCCHN), triple-negative breast cancer (TNBC), and ovarian cancer (OVC). Pooled Phase 2 safety data across cohorts were also released today.

“We are very pleased to share these new data for epacadostat in combination with pembrolizumab. The combination is well-tolerated and preliminary efficacy outcomes for these cohorts demonstrate encouraging clinical activity, both within and across tumor types, which compares favorably to contemporary data in the second-line setting. These data, including updated data which will be presented at ASCO next month, supported the recently-announced progression of the epacadostat and pembrolizumab combination into pivotal trials in NSCLC, RCC, bladder cancer and SCCHN,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

ECHO-202 abstract data for the tumor types entering Phase 3 (data cut as of October 29, 2016) include:

In a pooled analysis evaluating 244 patients in the ECHO-202 Phase 2 safety population (abstract #3012), treatment-related adverse events (TRAEs) that occurred in ≥5 percent of patients, included fatigue (23 percent); rash (16 percent); diarrhea and nausea (7 percent each); increased alanine aminotransferase, increased aspartate aminotransferase, and pruritus (6 percent each); and pyrexia (5 percent). A total of 37 patients (15 percent) experienced Grade ≥3 TRAEs; the most common of which were increased lipase (asymptomatic) and rash (3 percent each). TRAEs led to discontinuation of treatment in 3 percent of study patients.

These abstracts, including data for TNBC and OVC (abstract #1103), were made available today on the ASCO website at www.asco.org.

About ECHO-202 (KEYNOTE-037)

The ECHO-202 study (NCT02178722) is evaluating the safety and efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in combination with pembrolizumab. Patients previously treated with anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial. Enrollment is complete for the Phase 1 dose escalation (epacadostat 25, 50, 100 mg BID + pembrolizumab 2 mg/kg IV Q3W and epacadostat 300 mg BID + pembrolizumab 200 mg IV Q3W) and Phase 1 dose expansion (epacadostat 50, 100, and 300 mg BID + pembrolizumab 200 mg IV Q3W) portions of the trial. For more information about ECHO-202, visit https://clinicaltrials.gov/ct2/show/NCT02178722.

About ECHO

The ECHO clinical trial program was established to investigate the efficacy and safety of epacadostat as a core component of combination therapy in oncology. Ongoing Phase 1 and Phase 2 studies evaluating epacadostat in combination with PD-1 and PD-L1 inhibitors collectively plan to enroll over 900 patients in a broad range of solid tumor types as well as hematological malignancies. ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind, placebo-controlled study investigating KEYTRUDA in combination with epacadostat or placebo for the treatment of patients with unresectable or metastatic melanoma, is also underway. For more information about the ECHO clinical trial program, visit www.ECHOClinicalTrials.com.

About Epacadostat (INCB024360)

Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that regulates the tumor immune microenvironment, thereby restoring effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation and discussion of data regarding the Company’s ECHO-202 study and the planned pivotal trials of epacadostat in combination with pembrolizumab, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2017. Incyte disclaims any intent or obligation to update these forward-looking statements.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. KEYTRUDA is marketed by Merck (known as MSD outside the United States and Canada).

Incyte Corporation
Media
Catalina Loveman, +1 302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1 302-498-5914
mbooth@incyte.com

$OMER Announces Completion of IgA Nephropathy Cohort in OMS721 Phase 2 Clinical Trial

Omeros Corporation (NASDAQ: OMER) today announced completion of the IgA nephropathy cohort and reported additional positive results from the first stage of the company’s Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders. All patients in the cohort have now completed the OMS721 treatment and follow-up periods. The additional Phase 2 results in IgA nephropathy patients expand on the data reported earlier this year and further demonstrate marked and statistically significant improvement in urine protein levels (proteinuria). Proteinuria reduction is associated with slowing progression of kidney functional loss, and greater proteinuria reductions are associated with progressively better prognoses. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system’s lectin pathway.

“I have never seen the clinical responses that I’ve observed in IgA nephropathy patients treated with OMS721,” stated Geoffrey Block, M.D., Director of Clinical Research at Denver Nephrology and Principal Investigator of the trial. “All of these patients had significant renal impairment when they entered the trial and each patient dramatically improved. The improvements in these patients continued to increase after the end of treatment and persisted following completion of the trial. As an active clinical investigator, given the strength of these data, I am working hard to move this promising drug through the clinical trial process.”

The first stage in this Phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy. All patients had pre-existing renal impairment. To meet enrollment criteria, patients must have high levels of proteinuria despite well-controlled blood pressure with stable dosing of renin-angiotensin system inhibitors and ongoing (at least three months) corticosteroid treatment prior to receiving OMS721. Patients in this cohort are treated open-label with OMS721 for a total of 12 weeks and then followed post-treatment for six weeks. The trial endpoints are measured throughout the treatment and follow-up periods and assess the effect of OMS721 on urine protein measures that are predictive of kidney failure, namely urine albumin-to-creatinine ratio (uACR) and total 24-hour urine protein excretion.

All IgA nephropathy patients had Stage 3B chronic kidney disease and three of the four patients had nephrotic range proteinuria. All patients demonstrated marked improvement in uACRs and in 24-hour urine protein excretion while concurrently tapering corticosteroid treatment. The mean baseline uACR in these patients was 1,457 mg/g and reached 332 mg/g at the end of the follow-up period (77 percent decrease; p = 0.026). One patient’s uACR normalized by the National Kidney Foundation criterion. Results of 24-hour urine protein excretion were highly consistent with the uACR results, with a reduction from a mean of 3,935 mg/day at baseline to a mean of 1,067 mg/day at the end of the follow-up period (73 percent decrease; p = 0.013). All patients achieved partial remission based on proteinuria and one patient with nephrotic range proteinuria achieved a 95 percent reduction, reaching reference laboratory-established normal urine protein levels. All patients also were able to eliminate or greatly reduce their corticosteroid dosing.

“The OMS721 results in patients with IgA nephropathy continue to be striking,” said Jonathan Barratt, Ph.D., F.R.C.P., Professor of Renal Medicine in the Department of Infection, Immunity & Inflammation at University of Leicester and Honorary Consultant Nephrologist at Leicester General Hospital. “The degree of improvement observed with OMS721 is the largest I have seen and I expect will result in significant improvement in renal outcomes.”

Consistent with all other OMS721 clinical trials, no significant safety concerns have been observed. The most commonly reported adverse events in this trial are fatigue and anemia.

“We are pleased with the continued consistency of the results seen in these patients treated with OMS721,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “Despite being an orphan disease, IgA nephropathy is the most common primary glomerular disease worldwide, and we are keenly focused on this indication for OMS721. We are aggressively advancing to our Phase 3 clinical trial and look forward to beginning patient enrollment as soon as possible.”

No treatments are approved for IgA nephropathy. With an annual incidence of approximately 1 per 100,000, it is estimated that 1 in 1,400 persons in the U.S. will develop IgA nephropathy in his or her lifetime. As many as 40 percent of them will develop end-stage renal disease.

While preparing for its Phase 3 clinical trial in IgA nephropathy, Omeros is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy. As previously reported, 4 of 5 lupus nephritis patients in the Phase 2 trial also demonstrated marked reduction in 24-hour urine protein levels (mean reduction of 69 percent) with OMS721 treatment. Further analyses are in progress.

About Omeros’ MASP Programs

Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 is the effector enzyme of the lectin pathway, one of the principal complement activation pathways. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros’ lead human MASP-2 antibody. Following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is in progress. Also, two Phase 2 trials are ongoing. One is evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis; the other has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, Omeros has established a compassionate-use program for OMS721, which is active in both the U.S. and Europe. The FDA has granted OMS721 both orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS.

Omeros also has identified MASP-3 as the critical activator of the human complement system’s alternative pathway, which is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway.

About Omeros Corporation

Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Part of its proprietary PharmacoSurgery^® platform, the company’s first drug product, OMIDRIA^® (phenylephrine and ketorolac injection) 1% / 0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor (GPCR) platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

$CETX Reports Record Month of New Incoming Orders, Over $21 Million

Farmingdale, NY, May 17, 2017 – Cemtrex (Nasdaq: CETX, CETXP, CETXW), a world leading industrial and manufacturing leader, announced today that it has received more than $21 million in new orders during the month of April, including contracts with PPG, Covanta, US Mint, Mitsubishi Heavy Industries and Kelvion, just to name a few.

One of the orders Cemtrex secured during the period is a three year agreement estimated to be worth $15 million for Cemtrex’s electronics manufacturing services business in Germany. The order is the largest single order ever placed with the Company. The remaining orders were split approximately even between the IPS and EMS segments and are expected to be executed over the next twelve months.

Cemtrex’s Chairman and CEO, Saagar Govil, commented, “We are experiencing a build out of customer activity as our sales and marketing team ramps up their outreach.  The activity we are seeing in our sales pipeline validates our expanded investments in sales and marketing activity over the past several months. Our plan is to continue to make investments in these areas of our business in order to take advantage of the additional bandwidth we have to grow.”

“A great example of how our sales team is building relationships with customers is a $15 million deal we just secured with an existing customer operating in information technology markets.  While we have worked with this company previously, this is the largest deal to date and it spans a three year period, which far exceeds the commitment this customer has shown us in the past.  Our goal is to have our sales team build off these types of customer wins in order to grow the business, while establishing greater visibility for the business.”

About Cemtrex

Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides manufacturing services of advanced custom engineered electronics, industrial services, monitoring instruments for industrial processes and environmental compliance, and systems for controlling particulates, hazardous gases, emissions of Greenhouse gases, and other regulated pollutants used in emissions trading globally.
www.cemtrex.com

Safe Harbor Statement
This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date.

For further information, please contact: 

Investor Relations
Cemtrex, Inc.
Phone: 631-756-9116
investors@cemtrex.com

$GLYC GMI-1271 Receives FDA Breakthrough Therapy Designation in AML

GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. The U.S. Food and Drug Administration (FDA) had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 in AML.

In the ongoing clinical trial, GMI-1271 is being administered, along with chemotherapy, to patients with relapsed or refractory AML as well as those 60 years of age and older with newly diagnosed disease. Data from this trial were presented in 2016 at meetings of the European Hematology Association (EHA) and the American Society of Hematology (ASH). In the trial, patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients. In March 2017, the Company announced that the first of two patient cohorts in the Phase 2 portion of the trial of GMI-1271 had completed enrollment. In April 2017, the Company announced plans to present further data updates on both patient populations in the ongoing AML trial at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in June.

The FDA grants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDA standards for new drug approval.

“The FDA’s granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population,” said Helen Thackray, MD, Chief Medical Officer of GlycoMimetics. “We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible.”

About AML

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die from all forms of the disease, according to the American Cancer Society. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics’ most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics’ wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial in multiple myeloma. GlycoMimetics has also recently initiated a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding GlycoMimetics’ planned activities with respect to the clinical development of its drug candidate, GMI-1271. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for GlycoMimetics’ foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of GlycoMimetics’ drug candidates and other factors discussed in the “Risk Factors” section of GlycoMimetics’ Annual Report on Form 10-K that was filed with the U.S. Securities and Exchange Commission on March 1, 2017 and other filings GlycoMimetics makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent GlycoMimetics’ views as of the date hereof. GlycoMimetics anticipates that subsequent events and developments may cause its views to change. However, while GlycoMimetics may elect to update these forward-looking statements at some point in the future, GlycoMimetics specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing GlycoMimetics’ views as of any date subsequent to the date hereof.

$NEPT Unique Medical Cannabis Partnership Creates Hub in Sherbrooke, Quebec

Neptune Technologies:
MaisonBrison CommunicationS
Pierre Boucher (Canada)
514-731-0000 #237
pierre@maisonbrison.com

Hayden IR
James Carbonara
Investor Relations Contact (U.S.)
1.646.755.4712
james@haydenir.com

$CHNR Discloses Delay In Filing Of Annual Report

HONG KONG, May 16, 2017  — CHINA NATURAL RESOURCES, INC. (NASDAQ: CHNR), a company based in the People’s Republic of China, today disclosed a delay in the filing of its annual report on Form 20-F for the year ended December 31, 2016 with the United States Securities and Exchange Commission (“SEC”). The delay occurred because an audit of the Company’s recently acquired Bolivian subsidiary has not yet been completed. The Company acquired its Bolivian subsidiary on December 23, 2016. The Company currently anticipates that the audit of its Bolivian subsidiary will be completed on or before June 19, 2017; and that the annual report on Form 20-F will be filed with the SEC on or before June 30, 2017. However, unforeseen delays or events could further delay completion of the audit and filing of the annual report.

About China Natural Resources, Inc.:

China Natural Resources, Inc., a British Virgin Islands corporation, through its operating subsidiary, is currently engaged in trial production at its copper smelting plant in western Bolivia, and anticipates that commercial production will commence in the latter part of 2017. Revenues are expected from sales of copper cathodes in markets including Bolivia, Germany and China.

Forward-Looking Statements:

This press release includes forward-looking statements within the meaning of federal securities laws. Words such as “anticipates,” “expects,” “intends,” “may,” “should,” “plans,” “believes,” “predicts,” “potential” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. These statements include, without limitation, statements regarding the intent, belief and current expectations of management with respect to the Company’s policies regarding investments, dispositions, financings, conflicts of interest and other matters; and trends affecting the Company’s financial condition or results of operations. Forward-looking statements are not a guarantee of future performance and involve risks and uncertainties, many of which are outside of our control, and actual results may differ materially from those in the forward-looking statement. Among the risks and uncertainties that could cause our actual results to differ from our forward-looking statements are: uncertainties relating to our business operations and operating results; uncertainties regarding the governmental, economic and political environment in Bolivia and in the People’s Republic of China; uncertainties associated with metal and coal price volatility; uncertainties associated with the Company’s reliance on third-party contractors and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including without limitation the information set forth in our Annual Report on Form 20-F under the heading “Risk Factors.”

$WFBI Acquired By $SASR, Creating Largest, Locally-Headquartered Community Bank

OLNEY, Md., May 16, 2017 — Sandy Spring Bancorp, Inc. (Nasdaq:SASR) (“Sandy Spring”), the parent company of Sandy Spring Bank, and WashingtonFirst Bankshares, Inc. (Nasdaq:WFBI) (”WashingtonFirst”), the parent company of WashingtonFirst Bank, jointly announced today they have entered into a definitive agreement for Sandy Spring to acquire the Virginia-based WashingtonFirst to create one of the premier banks in the Greater Washington, D.C. region.

With combined assets of approximately $7.5 billion, the acquisition creates the largest, locally-headquartered community bank and brings together two well-known financial services brands that focus on providing remarkable client experiences, building lasting relationships and helping people and businesses reach their financial goals. While Sandy Spring Bank has served clients from Maryland, Virginia and Washington, D.C. since its inception nearly 150 years ago, the acquisition will significantly expand access for clients to the bank’s expertise and services, particularly in Northern Virginia. Upon closing, Sandy Spring Bank will merge WashingtonFirst Bank into Sandy Spring Bank.  WashingtonFirst’s Chairman, Joseph Searcy Bracewell; President and CEO, Shaza L. Andersen; and two other directors will join Sandy Spring’s board.

“Following our record earnings announcement, this expansion and the combination of two strong local banks will create a premier bank that will better serve clients across the Greater Washington D.C. region and preserve the tradition of true community banking,” said Sandy Spring President and CEO, Daniel J. Schrider, who will continue to serve in this role.  “Our mix of products and services are complementary, our cultures are aligned, and we share a commitment to providing the best possible service to our clients over a lifetime. Together, we look forward to serving more than 60,000 individuals and families, and nearly 30,000 local businesses, helping to create jobs and fuel the regional economy.”

In addition to serving clients through online and mobile banking, Sandy Spring operates 44 community banking offices and six financial centers in Maryland, Northern Virginia and Washington, D.C. It has more than $5.2 billion in assets (as of 3/31/17). WashingtonFirst, headquartered in Reston, Va., has 19 community banking offices and more than $2.1 billion in assets (as of 3/31/17).

“We are excited to become a part of Sandy Spring,” said Andersen, WashingtonFirst President and CEO.  “Sandy Spring Bank offers a comprehensive set of products and services well beyond what most community banks offer – from mortgages and commercial loans to insurance, trust and wealth management services.  We share an impressive history of investing in our local communities, as well as a deep dedication to providing superior client service to individuals and businesses right here in the region.”

Under the terms of the agreement, WashingtonFirst shareholders are expected to receive 0.8713 shares of Sandy Spring common stock for each share owned of WashingtonFirst common stock, subject to adjustment if Sandy Spring’s average stock price during a specified measurement period prior to closing is more than $50.15 or less than $37.07 per share. The transaction, which is expected to close in the fourth quarter, has a value of $489 million in the aggregate, based on Sandy Spring’s closing price of $41.89 on May 12, 2017. Upon closing, Sandy Spring shareholders will own approximately 67.8% of the combined company and WashingtonFirst’s shareholders will own approximately 32.2% of the combined company.

The transaction has been unanimously approved by the Board of Directors of each company and is subject to shareholder and regulatory approval and other customary closing conditions.

Clients of Sandy Spring Bank and WashingtonFirst Bank will not notice any immediate changes, and both banks will continue to conduct business as usual. At a later date, WashingtonFirst Bank’s branding will change to Sandy Spring Bank, with the full conversion of systems expected to occur in early 2018.

The Kafafian Group, Inc. served as financial advisor to Sandy Spring and Sandler O’Neill & Partners, L.P. provided a fairness opinion. Keefe, Bruyette & Woods, A Stifel Company, served as financial advisor to WashingtonFirst. Kilpatrick Townsend & Stockton LLP provided legal counsel to Sandy Spring and Troutman Sanders LLP provided legal counsel to WashingtonFirst.

Conference Call

The company will hold a conference call on May 16, 2017 at 11:00 a.m. (ET) to discuss the transaction and answer questions. The conference call will be webcast live through the Sandy Spring Bank website.  Those who wish to participate in order to ask questions may do so by calling 1-866-235-9910; a password is not necessary.  Those who wish to listen to the call should go to the Investor Relations page of www.sandyspringbank.com and log on 10 minutes ahead of the scheduled start of the call. An internet-based replay will be available on the Investor Relations page of the website until May 30, 2017. A telephone voice replay will also be available during that same time period at 1-877-344-7529. Please use conference number 10107593 to access. An investor presentation is available on Sandy Spring’s website at www.sandyspringbank.com under investor relations.

About Sandy Spring Bancorp, Inc./Sandy Spring Bank

Sandy Spring Bancorp, Inc., headquartered in Olney, Maryland, is the holding company for Sandy Spring Bank. Independent and community-oriented, Sandy Spring Bank offers a broad range of commercial banking, retail banking, mortgage and trust services throughout central Maryland, Northern Virginia, and the greater Washington, D.C. market. Through its subsidiaries, Sandy Spring Insurance Corporation and West Financial Services, Inc., Sandy Spring Bank also offers a comprehensive menu of insurance and wealth management services. With $5.2 billion in assets, the bank operates 44 community offices and six financial centers across the region. Visit www.sandyspringbank.com for more information.

About WashingtonFirst Bankshares, Inc.

WashingtonFirst Bankshares, Inc., headquartered in Reston, Virginia, is the holding company for WashingtonFirst Bank, which operates 19 full-service banking offices throughout the Washington, D.C. metropolitan area. In addition, the Company provides wealth management services through its subsidiary, 1st Portfolio Wealth Advisors, and mortgage banking services through the Bank’s subsidiary, WashingtonFirst Mortgage Corporation. The Company’s common stock is traded on the NASDAQ Stock Market under the quotation symbol “WFBI” and is included in the ABA NASDAQ Community Bank Index and the Russell 2000® index. For more information about the Company, please visit: www.wfbi.com.

Forward-looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to the financial condition, results of operations, plans, objectives, future performance and business of Sandy Spring and WashingtonFirst. Forward-looking statements, which may be based upon beliefs, expectations and assumptions of Sandy Spring’s and WashingtonFirst’s management and on information currently available to management, are generally identifiable by the use of words such as “believe,” “expect,” “anticipate,” “plan,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “may,” “will,” “would,” “could,” “should” or other similar words and expressions. These forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and neither Sandy Spring nor WashingtonFirst undertakes any obligation to update any statement in light of new information or future events. Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.

In addition to factors previously disclosed in Sandy Spring’s and WashingtonFirst’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”), the following factors among others, could cause actual results to differ materially from those in its forward-looking statements: (i) the possibility that any of the anticipated benefits of the proposed transaction between Sandy Spring and WashingtonFirst will not be realized or will not be realized within the expected time period; (ii) the risk that integration of operations of WashingtonFirst with those of Sandy Spring will be materially delayed or will be more costly or difficult than expected; (iii) the inability to complete the proposed transaction due to the failure of required stockholder approvals; (iv) the failure to satisfy other conditions to completion of the proposed transaction, including receipt of required regulatory and other approvals; (v) the failure of the proposed transaction to close for any other reason; (vi) the effect of the announcement of the transaction on customer relationships and operating results; (vii) the possibility that the transaction may be more expensive to complete than anticipated, including as a result of unexpected factors or events; (viii) general economic conditions and trends, either nationally or locally; (ix) conditions in the securities markets; (x) changes in interest rates; (xi) changes in deposit flows, and in the demand for deposit, loan, and investment products and other financial services; (xii) changes in real estate values; (xiii) changes in the quality or composition of Sandy Spring’s or WashingtonFirst’s loan or investment portfolios; (xiv) changes in competitive pressures among financial institutions or from non-financial institutions; (xv) the ability to retain key members of management; and (xvi) changes in legislation, regulations, and policies.

Additional Information About the Acquisition and Where to Find It

In connection with the proposed merger transaction, Sandy Spring will file with the Securities and Exchange Commission a Registration Statement on Form S-4 that will include a Joint Proxy Statement of Sandy Spring and WashingtonFirst, and a Prospectus of Sandy Spring, as well as other relevant documents concerning the proposed transaction. Shareholders are urged to read the Registration Statement and the Joint Proxy Statement/Prospectus regarding the merger when it becomes available and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they will contain important information about Sandy Spring, WashingtonFirst and the proposed merger.

A free copy of the Joint Proxy Statement/Prospectus, as well as other filings containing information about Sandy Spring and WashingtonFirst, may be obtained at the SEC’s Internet site (http://www.sec.gov). You will also be able to obtain these documents, free of charge, from Sandy Spring at www.sandyspringbank.com under the tab “Investor Relations,” and then under the heading “SEC Filings” or from WashingtonFirst by accessing WashingtonFirst’s website at www.wfbi.com under the tab “Investor Relations,” and then selecting “SEC Filings” under the heading “Documents and Filings.” Alternatively, these documents, when available, can be obtained free of charge from Sandy Spring upon written request to Sandy Spring Bancorp, Inc., Corporate Secretary, 17801 Georgia Avenue, Olney, Maryland 20832 or by calling (800) 399-5919, or from WashingtonFirst, upon written request to WashingtonFirst Bankshares, Inc., Corporate Secretary, 11921 Freedom Drive, Suite 250, Reston, VA 20190 or by calling (703) 840-2410.

Participants in the Solicitation

Sandy Spring and WashingtonFirst and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Sandy Spring and WashingtonFirst in connection with the proposed merger. Information about the directors and executive officers of Sandy Spring is set forth in the proxy statement for Sandy Spring’s 2017 annual meeting of shareholders, as filed with the SEC on a Schedule 14A on March 22, 2017. Information about the directors and executive officers of WashingtonFirst is set forth in the proxy statement for WashingtonFirst’s 2017 annual meeting of shareholders, as filed with the SEC on a Schedule 14A on March 14, 2017. Additional information regarding the interests of those participants and other persons who may be deemed participants in the transaction may be obtained by reading the Joint Proxy Statement/Prospectus regarding the proposed merger when it becomes available. Free copies of this document may be obtained as described in the preceding paragraph.

For additional information or questions, please contact:
Daniel J. Schrider, President & Chief Executive Officer, or
Philip J. Mantua, E.V.P. & Chief Financial Officer
Sandy Spring Bancorp
17801 Georgia Avenue
Olney, Maryland 20832
1-800-399-5919 
Email: DSchrider@sandyspringbank.com 
PMantua@sandyspringbank.com
Website: www.sandyspringbank.com

Media Contact:
Jen Schell
Vice President, Marketing 
Sandy Spring Bank
301.570.8331
jschell@sandyspringbank.com

$NATR Receives Direct Selling License in China

LEHI, Utah, May 16, 2017 — Nature’s Sunshine Products (NASDAQ:NATR), “the Company”, a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that it has received its direct selling license from MOFCOM, China’s Ministry of Commerce.

The license allows Nature’s Sunshine to begin to expand its business scope, including direct selling activities within China. Headquartered in Shanghai, a leading economic center with an urban population of more than 24 million residents, Nature’s Sunshine China began to apply for the direct selling license with MOFCOM following the formation of a joint venture with Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma), a leading, local healthcare company, in 2014. The joint venture was the first of its kind between a U.S. company and a Chinese company for direct selling products in China, representing a significant competitive differentiator in the marketplace.

“We are greatly honored to receive our license from the People’s Republic of China,” commented Gregory L. Probert, Chairman and Chief Executive Officer. “This marks an important step toward realizing the vision and potential we saw when we joined forces with Fosun Pharma almost three years ago. By bringing Nature’s Sunshine to the people of China, we are opening a tremendous new chapter and growth opportunity in our Company’s 45-year history, and fulfilling our mission to transform lives around the world through our innovative, industry-leading products.”

“This is the culmination of more than two years of hard work and dedication in laying the foundation of Nature’s Sunshine China,” said Paul E. Noack, President of China and New Markets. “Today is an historic day for our Company, as this license makes it official that Nature’s Sunshine’s direct selling business has arrived in China. Having made significant investments over the last couple of years, building the infrastructure to support the commencement of operations, we are in a position to begin direct selling activities in the near-term. We are immensely proud of the accomplishments of the China management team, and we are optimistic about the opportunity the China market provides.”

China is the world’s second largest direct selling market in terms of retail sales, according to 2015 data from the World Federation of Direct Selling Associations. In 2015, direct selling retail sales in China increased 19.0% to USD $35.5 billion and accounted for 19.3% of global sales.

About Nature’s Sunshine Products

Nature’s Sunshine Products (NASDAQ:NATR), a leading natural health and wellness company, markets and distributes nutritional and personal care products through a global direct sales force of approximately 539,000 independent Managers, Distributors and customers in more than 40 countries.  Nature’s Sunshine manufactures most of its products through its own state-of-the-art facilities to ensure its products continue to set the standard for the highest quality, safety and efficacy on the market today. The Company has four reportable business segments that are divided based on the characteristics of their Distributor base, similarities in compensation plans, as well as the internal organization of NSP’s officers and their responsibilities (NSP Americas; NSP Russia, Central and Eastern Europe; Synergy WorldWide; and China and New Markets). The Company also supports health and wellness for children around the world through its partnership with the Sunshine Heroes Foundation.  Additional information about the Company can be obtained at its website, www.naturessunshine.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to, statements relating to the Company’s objectives, plans and strategies. All statements (other than statements of historical fact) that address activities, events or developments that the Company intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions, and are based on assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including the following.

• changes in laws and regulations, or their interpretation, applicable to direct selling or the nutritional supplement industry may prohibit or restrict the Company’s ability to sell its products in some markets or require the Company to make changes to its business model in some markets;
• legal challenges to its direct selling program or to the classification of its independent distributors;
• complex legal and regulatory requirements in China, including failure to obtain necessary approvals and licenses to engage in direct sales activities in China;
• extensive government regulations to which its products, business practices and manufacturing activities are subject;
• the impact of anti-bribery laws, including the U.S. Foreign Corrupt Practices Act;
• the full implementation of its joint venture for operations in China with Shanghai Fosun Pharmaceutical (Group) Co., Ltd.;
• registration of products for sale in China, or difficulty or increased cost of importing products into China;
• its business practices in some of the jurisdictions in which it operates, including China and South Korea, may be legal and compliant with local and foreign law, but still draw unwarranted media or regulatory attention;
• its ability to attract and retain independent distributors;
• the effect of fluctuating foreign exchange rates;
• negative consequences resulting from difficult economic conditions, including the availability of liquidity or the willingness of its customers to purchase products;
• geopolitical issues and conflicts;
• restrictions on the repatriation of money;
• uncertainties relating to the application of transfer pricing, duties, value-added taxes, and other tax regulations, and changes thereto;
• changes in tax laws, treaties or regulations, or their interpretation;
• taxation relating to its independent distributors;
• high levels of inflation in one or more of the countries in which the Company operates;
• cyber security threats and exposure to data loss;
• reliance on information technology infrastructure;
• liabilities and obligations arising from improper activity by its agents, employees or independent distributors;
• its relationship with, and its inability to influence the actions of, its independent distributors, and other third parties with whom it does business;
• its reliance upon, or the loss or departure of any member of, its senior management team;
• challenges in managing rapid growth in China;
• the slowing of the Chinese economy;
• negative effects from its independent distributor promotions or compensation plans;
• risks associated with the manufacturing of the Company’s products;
• availability and integrity of raw materials;
• obsolescence of product inventory;
• changing consumer preferences and demands;
• the competitive nature of its business and the nutritional supplement industry;
• negative publicity related to its products, ingredients, or direct selling organization and the nutritional supplement industry;
• product liability claims;
• the sufficiency of trademarks and other intellectual property rights; and
• reliance on third-parties to distribute its products and provide support services to independent distributors.

These and other risks and uncertainties that could cause actual results to differ from predicted results are more fully detailed under the caption “Risk Factors” in our reports filed with the Securities and Exchange Commission, including our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.

All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by the cautionary statements included in or incorporated by reference into this press release. Except as is required by law, the Company expressly disclaims any obligation to publicly release any revisions to forward-looking statements to reflect events after the date of this press release.

Contact:

Scott Van Winkle
Managing Director 
ICR
(617) 956-6736

$CIIX Projected Revenue of $14.8 Million by FY2020 in Consilium Global Research Report

May 15, 2017

$IGC Appoints Medical Advisor Craig Cheifetz, M.D.; Cannabis-Based, Combination Therapies

BETHESDA, Md., May 16, 2017  — India Globalization Capital Inc. (NYSE MKT:IGC) announces that Craig Cheifetz, M.D. has joined the company as an advisor to provide guidance on clinical trials, biotechnology, neuroscience, immunology and microbiology.

Dr. Cheifetz is currently Regional Dean at Virginia Commonwealth University Inova Fairfax Campus and is the Medical Director of Inova VIP 360 (Northern Virginia’s premier Concierge Medicine Program).  Dr. Cheifetz received his M.D. from the State University of New York College at Buffalo and trained in Internal Medicine at Georgetown University.  From 2011 to 2013, he served as the National GRMC Chairman.

“I welcome Dr. Cheifetz to the IGC advisory team and look forward to his contributions as we move forward in developing cannabis-based, combination therapies.  We remain committed to accelerating our initiatives and building a robust portfolio of compounds to address large market conditions,” states Ram Mukunda, CEO of IGC.

About IGC

India Globalization Capital is engaged in the development of cannabis-based therapies to treat pain, PTSD, seizures, cachexia, chronic and terminal neurological and oncological diagnoses, and other life altering conditions.  In support of this mission, IGC has assembled a portfolio of patent filings for its phytocannabinoid-based treatments. The company is based in Bethesda, Maryland.

For more information visit www.igcinc.us

Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements

Please see forward-looking statements as discussed in detail in IGC’s Form 10-K for fiscal year ended March 31, 2016, and in subsequent reports filed with the U.S. Securities and Exchange Commission.

Contact Info:
Claudia Grimaldi
301-983-0998

$NERV Announces Outcome of End-of-Phase 2 Meeting With FDA

Pivotal Phase 3 trial design to include monotherapy administration of MIN-101 and primary endpoint of improvement in negative symptoms of schizophrenia

Planned initiation of MIN-101 Phase 3 development in second half of 2017

WALTHAM, Mass., May 15, 2017  — Following a recent “end-of-Phase 2” meeting with the U.S. Food and Drug Administration (FDA), Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced its plans to initiate Phase 3 development of MIN-101, a drug targeting negative symptoms in schizophrenia patients.  A pivotal Phase 3 trial with MIN-101 is expected to be initiated in the second half of 2017.

The Phase 3 trial design will be a 12-week, double-blind, randomized, placebo-controlled, monotherapy study testing two doses of MIN-101 in patients with negative symptoms and a diagnosis of schizophrenia.  To be eligible for this study, patients will be required to have stable negative and positive symptoms over several months prior to enrollment, with a specified minimum threshold baseline score on the Positive and Negative Syndrome Scale (PANSS) negative sub-scale.

After the double-blind phase, patients may enter a 36-week open label extension phase in which all patients will receive active treatment. This multi-center, international trial is expected to enroll approximately 500 patients at approximately 60 clinical sites across the U.S. and Europe.

The primary endpoint will be improvement in negative symptoms at 12 weeks as measured by the PANSS Marder negative factor score, a widely recognized instrument for quantifying severity of negative symptoms.   Secondary efficacy endpoints will include the Clinical Global Impression of Severity (CGI-S) scale and Personal and Social Performance (PSP) total score. The overall design of the planned Phase 3 trial is similar to the Phase 2b trial completed in 2016, in which improvement was observed in schizophrenic patients with negative symptoms treated with MIN-101 compared to placebo.

The Company shared pre-clinical and clinical efficacy and safety data at the FDA meeting, and safety and tolerability of MIN-101 will continue to be assessed during the duration of the Phase 3 trial, including cardiac function via electrocardiograms (ECGs).  Discontinuation criteria based on PANSS and cardiac electrophysiological criteria will be incorporated into the study protocol.

“Minerva is finalizing its plan for the Phase 3 development of MIN-101, an innovative investigational treatment for schizophrenia, following our recent meeting with the FDA,” said Dr. Remy Luthringer, president and chief executive officer of Minerva.  “Our discussion with the agency has helped to confirm our Phase 3 trial design, which is similar to our previous Phase 2b trial design.  We believe that positive data from the Phase 3 trial, along with the positive data from the Phase 2b trial, may form the basis for the future submission of a New Drug Application for MIN-101 to the FDA.”

“The constructive feedback from the agency supports the further development of MIN-101 for schizophrenia,” said Dr. Philip D. Harvey, Leonard M. Miller Professor of Psychiatry and director of the Division of Psychology at the University of Miami Miller School of Medicine.  “Negative symptoms currently continue to represent a significant unmet need and contribute substantially to poor quality of life and functional outcomes for the large worldwide population of patients with this disease.”

Updates and further details regarding the Phase 3 trial, including anticipated timing of recruitment, participating centers and investigators will be provided later this year and posted on www.clinicaltrials.gov.

About schizophrenia and the impact of negative symptoms

Schizophrenia remains among the top ten disabling conditions worldwide for young adults and affects more than 21 million people worldwide.  According to Datamonitor, an independent market research firm, in 2016 approximately 3.3 million people suffered from schizophrenia in the United States, Japan and the five major European Union markets of France, Germany, Italy, Spain and the United Kingdom.

Although positive psychotic symptoms are characteristic of schizophrenia, negative symptoms constitute one of the main sources of burden of illness, represent an important treatment target and are a major cause of the poor vocational and social capabilities of these patients.  These symptoms, which include a-motivation, avolition, lack of initiative, and restricted personal interaction, are associated with poor psychosocial functioning.

In the majority of schizophrenia patients, acute positive symptoms remit due to treatment with antipsychotics (dopamine-blocking drugs) or spontaneously. Antipsychotic drugs also reduce the risk for recurrence of psychosis. However, many patients maintain remission of psychosis without antipsychotic dopamine blocking drugs.  Nevertheless, they continue to suffer negative symptoms, for which no FDA-approved treatments are specifically indicated.

About MIN-101

MIN-101 is a drug candidate with equipotent affinities for sigma 2 and 5-hydroxytryptamine-2A (5-HT_2A) and lower affinity at alpha1-adrenergic receptors. MIN-101 has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like extrapyramidal symptoms, sedation, prolactin increases and weight gain.

The Phase 2b trial with MIN-101, announced in 2016 and presented at the annual meeting of the American College of Neuropsychopharmacology, met its primary endpoint of statistically significant improvement in negative symptoms as measured by the PANSS pentagonal structure model and in the higher dose showed statistically significant benefit in multiple secondary endpoints that included general psychopathology.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of products to treat CNS diseases.  Minerva’s proprietary compounds include: MIN-101, in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); MIN-202 (JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease.  Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.”  For more information, please visit www.minervaneurosciences.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.  Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties.  Forward-looking statements include statements herein with respect to the timing and results of future clinical milestones with MIN-101, including the planned Phase 3 trial of MIN-101, the timing and scope of future clinical trials and results of clinical trials with this compound; the potential for a single Phase 3 trial with supportive Phase 2b results to support the basis for an NDA; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize MIN-101; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether MIN-101 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-101, if any, will be consistent with the results of past clinical trials; whether MIN-101 will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.  These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 4, 2017.  Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376

$RXDX Granted Breakthrough Therapy Designation for Entrectinib by FDA

Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation (BTD) to entrectinib “for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.” Entrectinib is the company’s investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.

The FDA’s Breakthrough Therapy Designation is intended to expedite development and review timelines of potential new medicines for use in the treatment of a serious or life-threatening condition when preliminary clinical evidence indicates the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints [1].

“The granting of Breakthrough Therapy Designation enables us to continue high quality engagement with the FDA during the development of entrectinib, and we greatly appreciate the commitment by FDA to move this investigational drug forward,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “We believe this designation validates the broad potential of entrectinib as a novel treatment for patients, regardless of age, with TRK-positive tumors, a group of cancers for which there currently is no approved treatment and which represents a clear unmet medical need.”

About Entrectinib

Entrectinib is a novel, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TRKA/TRKB/TRKC), ROS1 or ALK. Entrectinib is the only TRK inhibitor with clinically demonstrated activity against primary and metastatic CNS disease, and does not have undesirable off-target activity. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the “Studies of Tumor Alterations Responsive to Targeting Receptor Kinases.” The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.

About Ignyta, Inc.

Blazing a New Future for Patients with Cancer™

At Ignyta, we work tirelessly on behalf of patients with cancer to offer potentially life-saving, precisely targeted therapeutics (Rx) guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter uncharted territory, illuminating the molecular drivers of cancer and quickly advancing treatments to address them. This approach embraces even those patients with the rarest cancers, who have the highest unmet need and who may otherwise not have access to effective treatment options. With our pipeline of potentially first-in-class or best-in-class precision medicines, we are pursuing the ultimate goal of not just shrinking tumors, but eradicating cancer relapse and recurrence in precisely defined patient populations.

For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Ignyta’s ability to successfully conduct clinical trials for its product candidates, the impact of entrectinib breakthrough therapy designation on Ignyta’s interactions with FDA and the FDA’s commitment to the advancement of entrectinib. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for final results of the ongoing clinical trials of entrectinib or other product candidates, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained; the potential for the company to fail to maintain the CAP accreditation and CLIA certification of its diagnostic laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2016, and subsequent Quarterly Reports on Form 10-Q.

References

[1] U.S. Food and Drug Administration Safety and Innovation Act. Available at: http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf Accessed May 12, 2017.