$ICAD Announces More Than 3,000 Early-Stage Breast Cancer Patients Treated

Company to showcase breakthrough one-day breast cancer treatment technology and host in-booth clinician expert at Physicians’ Education Resource® 34th Annual Miami Breast Cancer Conference

NASHUA, N.H. and MIAMI, March 9, 2017 — (Booth #T6) – iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that more than 3,000 early-stage breast cancer patients have been treated with intraoperative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. The Xoft System and its suite of products will be showcased in the Xoft booth (#T6) during Physicians’ Education Resource® (PER)’s 34^th Annual Miami Breast Cancer Conference at the Fontainebleau Miami Beach Hotel in Miami Beach, FL from March 9-12, 2017.

“The growing adoption and utilization of Xoft IORT further validates that it is a safe and effective treatment option, offering valuable benefits to early-stage breast cancer patients who meet specific selection criteria,” said Ken Ferry, President and Chief Executive Officer of iCAD. “The treatment of more than 3,000 patients with IORT using the Xoft System is a significant milestone and highlights the continued commitment by leading clinicians to make this clinically proven treatment option available to their patients.”

IORT is a procedure that allows radiation oncologists and breast cancer surgeons to work together to deliver a full course of radiation treatment in one day to select women diagnosed with early-stage breast cancer. Traditional external beam radiation therapy (EBRT) involves daily radiation treatments for six to eight weeks, while IORT with the Xoft System can be completed in as little as eight minutes. IORT delivers a full course of targeted radiation from inside the body, directly within the tumor cavity, targeting cancer cells and reducing the risk of damage to nearby healthy tissue including tissue in the heart, lungs, and ribs. A growing body of favorable clinical data supports the use of IORT in candidates meeting specific selection criteria.

“IORT with the Xoft System offers patients a number of unique benefits, including shorter treatment times, fewer side effects, reduced costs and added convenience compared to traditional treatment,” said Barbara Schwartzberg, M.D., FACS, breast surgeon, Sarah Cannon/HealthONE, Rose Medical Center. “By treating early-stage breast cancer in just one day, eligible patients are often able to return to their daily lives within days and better maintain their quality of life.”

Dr. Schwartzberg will be present in the Xoft booth (#T6) during exhibit breaks on March 9-11 to discuss her clinical experience with Xoft IORT with conference attendees.

In addition, Olga Ivanov, MD, FACS, medical director, Comprehensive Breast Health Center, Celebration Health, will discuss her clinical experiences with IORT in an oral presentation entitled “Breast IORT – Technical Aspects” on Saturday, March 11 from 4:55 pm to 5:10 pm ET in the Luster Gallerie. Dr. Ivanov will also discuss IORT in an oral presentation entitled “Intraoperative Radiotherapy” on Sunday, March 12 from 8:15 am to 8:30 am ET in the Luster Gallerie.

The multidisciplinary Miami Breast Cancer Conference brings together surgical, medical, and radiation oncology experts with the aim of fostering awareness of state-of-the-art treatments for breast cancer in each therapeutic area, encouraging cross-team cooperation in the clinic.

The Xoft System is FDA-cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.

About Xoft Axxent Electronic Brachytherapy System

The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. The Axxent Hub is a cloud-based oncology collaboration software solution that enables centers to monitor treatment workflow and enhance communication between clinical specialists. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.

About iCAD, Inc.

iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:

For iCAD investor relations:

The Ruth Group
Zack Kubow, 646-536-7030
www.theruthgroup.com
iCAD@theruthgroup.com

or

For iCAD media inquiries:

Berry & Company Public Relations, LLC
Lynn Granito, 212-253-8881
lgranito@berrypr.com

$TGTX Announces Pricing of $50 Million Public Offering of Common Stock

NEW YORK, March 09, 2017 — TG Therapeutics, Inc. (NASDAQ:TGTX) today announced the pricing of an underwritten public offering of 5,128,206 shares of its common stock at a price of $9.75 per share, with expected gross proceeds to TG Therapeutics of $50 million.  In addition, TG Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 769,230 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about March 14, 2017 subject to the satisfaction of customary closing conditions.

Jefferies LLC is acting as sole book-running manager for the offering. SunTrust Robinson Humphrey, Inc. and Ladenburg Thalmann & Co. Inc. are acting as lead managers.  H.C. Wainwright & Co., Aegis Capital Corp., Roth Capital Partners and OPN Capital Markets are acting as co-managers for the offering.

TG Therapeutics intends to use the net proceeds of this offering to fund the ongoing development of TG-1101 and TGR-1202, to potentially in-license, acquire, develop and commercialize additional drug candidates, for research and development activities and for general corporate purposes.

The offering is being made pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the “SEC”) on December 31, 2014. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering has been filed with the SEC and is available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, or by telephone at 877-821-7388, or by email at prospectus_department@jefferies.com.

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

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Forward-Looking Statements

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: statements regarding the proposed public offering and the intended use of proceeds from the proposed offering; the success and timing of our clinical trials and preclinical studies for our product candidates, including site initiation, internal review board approval, scientific review committee approval, patient accrual, safety, tolerability and efficacy data observed, and input from regulatory authorities; our plans to develop and commercialize our product candidates; market acceptance of our products; reimbursement available for our products; our available cash and investments; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to manufacture; the performance of third-party manufacturers, clinical research organizations, clinical trial sponsors and clinical trial investigators; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TGTX-G

Contact
Jenna Bosco
Vice President, Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

$CUR Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury

-NSI-566 Achieved Robust Engraftment and Long-Term Survival After Transplantation-

– Data Published in Journal of Neurotrauma-

GERMANTOWN, Md., March 09, 2017  — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced the recent publication of preclinical data on NSI-566 spinal cord-derived neural stem cells in Journal of Neurotrauma.  These data showed robust engraftment and long-term survival of NSI-566 post transplantation in a rat model of penetrating ballistic-like brain injury (PBBI).  NSI-566 is Neuralstem’s lead stem cell therapy candidate.

The study entitled, “Amelioration of penetrating ballistic-like brain injury induced cognitive deficits after neuronal differentiation of transplanted human neural stem cells,” was led by Ross Bullock, M.D., Ph.D., The Miami Project to Cure Paralysis, University of Miami School of Medicine.  These are the first data from the 4-year proof-of-concept research program, funded by the United States Department of Defense, for NSI-566 in traumatic brain injury.

“These data on NSI-566 are encouraging, particularly since researchers have long been challenged to achieve durable engraftment and survival of neural stem cells after transplantation,” said Dr. Bullock.   “No long-term treatment beyond physical therapy is currently available to restore cognition after a traumatic brain injury.  Transplantation of stem cells into the injured brain may allow a unique replacement therapy and fill a significant medical need.”

Researchers transplanted NSI-566 into rats 7-10 days after PBBI.  The rats were immunosuppressed to enable survival of NSI-566 neural stem cells.  Robust engraftment with evidence of prominent neuronal differentiation was observed after 4 months, and axons from grafted cells extended a significant distance from the graft site along host white matter tracts.

“These data continue to support our research and development platform. The results provide additional insight into our proprietary regionally specific stem cells and their potential benefits in nervous system disorders,” said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem.  “We look forward to additional preclinical data from this collaboration with Dr. Bullock’s group to support the potential use of NSI-566 in traumatic brain injury.”

About Neuralstem
Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstem’s technology enables the discovery of small molecule compounds by systematic screening chemical compounds against its proprietary human hippocampal stem cell line.  The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brain’s capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstem’s stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China.  In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS.  Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward Looking Information
This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

Contact:
Danielle Spangler
Investor Relations
Neuralstem, Inc
301.366.1481

Lori Rosen
Public Relations
LDR Communications
917.553.6808

$PAVMW Announces Closing of Additional Financing

PAVmed Inc. (Nasdaq:PAVM, PAVMW), a highly differentiated, multi-product medical device company, today announced the closing of approximately $1.0 million in additional financing, bringing the aggregate gross proceeds of our private placement to $2.5 million. The private placement consists of shares of Series A Convertible Preferred Stock and Series A Warrants. The initial closing was previously announced in February.

Dr. Lishan Aklog, Chairman and CEO of PAVmed, stated, “Investor interest in our Company continues to be very strong. Robust demand has enabled us to engage in a deliberate process focused on bringing in long-term and value-added investors. We feel extremely fortunate to have the opportunity to be highly selective as we continue to build our shareholder base.”

PAVmed employs a unique business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than traditional medical device companies. This model enables its multi-product pipeline strategy. Its initial two products, PortIO^TM and CarpX^TM, have meaningful milestones in the coming months and possess combined addressable market opportunities in excess of $1 billion dollars.

Dr. Aklog added, “We remain highly focused on building shareholder value. We are confident that our recent product developments, as well as our financing and capitalization initiatives, have the potential to deliver such value creation.”

About PAVmed Inc.

PAVmed Inc. (Nasdaq:PAVM, PAVMW) is a highly differentiated, multi-product medical device company employing a unique business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding multi-product pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs, have attractive regulatory pathways and market opportunities and encompass a broad spectrum of clinical areas including carpal tunnel syndrome (CarpX™), medical infusions (NextFlo™ and NextCath™), interventional radiology (PortIO™ and NextCath), tissue ablation and cardiovascular intervention (Caldus™) and pediatric ear infections (DisappEAR™). For further information, please visit www.pavmed.com.

Safe Harbor Statement

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, the uncertainties inherent in research and development, including the cost and time required advance our products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from our pre‐clinical studies; whether and when our products are cleared by regulatory authorities; market acceptance of our products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market any of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item IA, “Risk Factors,” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Reports on Form 10-Q filed by us after our most recent Annual Report. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

$CBAY to Present at Two Investor Conferences in March

NEWARK, Calif., March 09, 2017  — CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company developing therapies to treat specialty and orphan diseases with high unmet medical need, today announced that management will provide a corporate overview at the 29^th Annual ROTH Conference, being held March 12-15, 2017 at the Ritz Carlton in Laguna Niguel, California, and the Oppenheimer 27^th Annual Healthcare Conference, being held March 21-22 at the Westin New York Grand Central in New York City.

29^th Annual ROTH Conference Presentation Details
Date: Monday, March 13
Time: 5:00pm Pacific Time
Location: Ritz Carlton, Laguna Niguel, CA
Webcast: http://ir.cymabay.com/events

Oppenheimer 27^th Annual Healthcare Conference Presentation Details
Date: Tuesday, March 21
Time: 4:30pm Eastern Time
Location: Westin New York Grand Central, New York City, NY
Webcast: http://ir.cymabay.com/events

About CymaBay
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. Seladelpar is a potent, selective, orally active PPARδ agonist. A Phase 2 study of seladelpar in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay has completed Phase 2 studies for seladelpar in subjects with primary biliary cholangitis and homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications. Arhalofenate, CymaBay’s other product candidate, is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in subjects with gout. Arhalofenate has been found to reduce painful flares in joints while at the same time lowering serum uric acid by promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia.  Arhalofenate has been licensed in the U.S. to Kowa Pharmaceuticals America, Inc.  CymaBay retains full development and commercialization rights for arhalofenate outside the U.S.

For additional information about CymaBay visit www.cymabay.com.

Contact:	
Sujal Shah 			
CymaBay Therapeutics, Inc. 	
(510) 293-8800 			
Investors@CymaBay.com	

Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
Hans@LifeSciAdvisors.com

$KTOV Announces License Agreement for KIT-302 in South Korea

TEL AVIV, Israel, March 8, 2017 —

Definitive agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea

Transaction is Kitov’s First License Agreement for KIT-302

Celecoxib is the leading NSAID product in South Korea with reported sales of over $55 Million in 2015
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the Company has signed a definitive License Agreement for its lead product candidate, KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and to treat hypertension, for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd., a leading South Korea-based pharmaceutical company.  Upon receipt of marketing authorization in South Korea, Kuhnil will have the exclusive right and license to manufacture, distribute and sell KIT-302 in South Korea.  Kuhnil will be responsible for seeking regulatory approval for KIT-302 in South Korea.

Under the terms of the agreement, Kitov is entitled to receive milestone payments upon achievement of certain predefined regulatory milestones, as well as double digit royalties on net sales.  The initial term of the definitive agreement with Kuhnil is for ten years from the date of first commercial sale and shall automatically renew for an additional one-year term. Commercial launch in South Korea is estimated to take place in 2019.

Dr. Gil Ben-Menachem, Kitov’s Vice President of Business Development, said: “We are extremely pleased to enter into our first commercialization agreement for KIT-302 and look forward to building a long-term relationship with Kuhnil in South Korea and potentially to expanding the collaboration into other territories in the Far East. Kuhnil has a proven track record in successfully launching and marketing pharmaceutical products in South Korea, and is perfectly positioned to introduce KIT-302 into the Korean market. Kitov continues to work diligently towards executing additional commercialization agreements for KIT-302, in the US and other regions.”

“We believe that KIT-302 has significant commercial potential in South Korea and Asia,” said Young J. Kim, Kuhnil’s President & Chief Executive Officer.  “Based on our decades of pharmaceutical development, regulatory and manufacturing experience and expertise in South Korea, we are well positioned to maximize the value of this product in the marketplace.  We look forward to seeking regulatory approval and initiating launch preparations for KIT-302 in South Korea.”

About Kitov Pharmaceuticals

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial and its New Drug Application for the U.S. Food and Drug Administration is currently being finalized, and is expected to be completed by the end of March 2017 and to be submitted to the FDA within two to three weeks thereafter. Kitov’s newest drug, NT219 is a small molecule that presents a new concept in cancer therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.

About Kuhnil Pharmaceutical Co., Ltd.

Kuhnil Pharmaceutical Co., Ltd. engages in the research and development, manufacture, and sale of pharmaceuticals products with strengths for the therapeutic areas of musculoskeletal, gastrointestinal, cardiovascular, respiratory, infection and neurology. The company is also specialized in research and development in the areas of advanced DDS and drug formulation, and combination drug development. Kuhnil focuses on improving quality of life by developing, licensing and commercializing medicines that address unmet medical needs. http://www.kuhnil.com

Forward-Looking Statements and Kitov’s Safe Harbor Statement

Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; the uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to commercialize our products, and other factors that are discussed in our Registration Statements on Form F-3 filed with the U.S. Securities and Exchange Commission (the “SEC”) (file numbers 333-211477, 333-207117, and 333-215037), in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the SEC, including our cautionary discussion of risks and uncertainties under “Risk Factors” in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, http://www.sec.gov.

Contact:
Simcha Rock
Chief Financial Officer
+972-3-9333121 ext. #105
simcha@kitovpharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
+1-646-597-6989
bob@LifeSciAdvisors.com

$BLCM to Present at the Barclays Global Healthcare Conference

HOUSTON, March 08, 2017  — Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that Rick Fair, President and CEO, is scheduled to present a corporate overview at the Barclays Global Healthcare Conference on Wednesday, March 15 at 4:20 p.m. EDT in Miami, FL.

A live webcast of the presentation may be accessed from the News & Events section of the Bellicum website. An archived version of the webcast will be available for replay for at least two weeks following the event.

About Bellicum Pharmaceuticals
Bellicum is a leader in developing novel, controllable cellular immunotherapies for cancers and for orphan inherited blood disorders. Bellicum is using its proprietary Chemical Induction of Dimerization (CID) technology platform to engineer and control components of the immune system. Bellicum is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.

Investors:
Bellicum Pharmaceuticals
Alan Musso, CFO
832-384-1116
amusso@bellicum.com

Media:
BMC Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com

$HMNY Appoints Raymond T. Crosier President and COO of Financial Services

Helios and Matheson Analytics Inc. (NASDAQ: HMNY) today announced the appointment of Raymond T. Crosier president and chief operating officer of financial services.

Mr. Crosier brings more than 30 years of management and executive experience to this new role. HMNY believes the addition of Mr. Crosier will accelerate the creation of new financial services technology (FinTech) opportunities for HMNY, expanding HMNY’s footprint in the FinTech arena. He will focus on growth, revenues and product innovation related to HMNY’s legacy business, as well as leading HMNY’s existing engagements serving companies such as TD Ameritrade and BMW and seeking new client engagements for other large organizations. He will also be part of HMNY’s internal M&A team and work to accelerate HMNY’s expansion opportunities in the FinTech space.

“Ray is an inspirational leader and a valuable asset to our executive team as we continue to fulfill our vision of creating cutting-edge technologies,” said Ted Farnsworth, chairman and CEO of HMNY. “He brings with him a long and successful track record in the financial services sector, and we look forward to leveraging his expertise as we seek to accelerate our growth.”

“I am excited to join HMNY to help take the company’s FinTech business to the next level,” said Crosier. “We have transformational projects in development, as well as new products and services to offer that I believe will drive HMNY’s organic growth. We look forward to bringing critically needed security to the industry’s infrastructure to deliver safe, secure and expeditious financial transactions in the U.S. and abroad.”

Mr. Crosier has managed companies with full P&L responsibility that specialize in financial services, internet mobile applications, transaction processing and electronic payment systems. He currently serves as a board member and was former chairman of the board of the Electronic Funds Transfer Association (EFTA), the nation’s leading inter-industry professional association promoting the adoption of electronic payment systems and e-commerce. He led the EFTA through the Dodd Frank Financial Reform Act, Durbin amendment interchange legislation and the creation of the Consumer Financial Protection Bureau, which comprised the most sweeping changes in financial reform affecting the industry in more than 20 years.

Mr. Crosier served as president & COO of Online Resources Corporation (NASDAQ: ORCC), a large financial technology provider dedicated to the online channel. The company powered transactions between millions of consumers and financial institutions and biller clients that included one-third of the top 50 U.S. banks and one-half of the top 12 U.S. card issuers. His responsibilities included P&L as well as managing the day-to-day operations and 675 employees. After successfully integrating several acquisitions, he managed Online Resources’ three major operating divisions and its banking technology unit. Prior to those acquisitions, he managed the company’s seven operating groups: sales and distribution; client services; corporate and consumer marketing; product management; operations; technology and systems network development; and professional services.

Mr. Crosier received his B.A. from the University of Virginia.

MEDIA, PLEASE NOTE: To request data, images, or an interview with Raymond T. Crosier, president and chief operating officer of financial services, HMNY, or Theodore Farnsworth, chairman and chief executive officer of HMNY and its wholly-owned subsidiary, Zone Technologies, Inc., please contact Greg Bortkiewicz at (415) 359-2306 or hmny@landispr.com.

TD Ameritrade is a trademark jointly owned by TD Ameritrade IP Company, Inc. and the Toronto-Dominion Bank.

BMW is a trademark of BMW AG.

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. HMNY focuses mainly on the BFSI and Technology verticals for companies including 500 and other large organizations. 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, 2015, its registration statement on Form S-3 declared effective on January 13, 2017 and other filings, including subsequent current and periodic reports 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.

$PLCE Expands Capital Return Program

INCREASES AUTHORIZED STOCK REPURCHASES BY $250 MILLION

ANNOUNCES A 100% INCREASE IN ITS QUARTERLY DIVIDEND

SECAUCUS, N.J., March 08, 2017 — The Children’s Place, Inc. (Nasdaq:PLCE), the largest pure-play children’s specialty apparel retailer in North America, today announced that its Board of Directors has approved a new $250 million share repurchase program and has increased the Company’s quarterly dividend to $0.40 per share from $0.20 per share.

Jane Elfers, President and Chief Executive Officer, commented, “Since 2009, we have returned over $790 million to shareholders through share repurchases and dividends. The significant increase in our quarterly dividend brings our annual dividend yield more in line with that of our specialty peers. This dividend increase and the new share repurchase authorization reflect our confidence in our ability to execute on our strategic initiatives and our continuing commitment to return excess capital to shareholders.”

The Board declared a quarterly cash dividend of $0.40 per share to be paid May 1, 2017 to shareholders of record at the close of business on April 10, 2017. Future declarations of quarterly dividends and the establishment of future record and payment dates are subject to approval by the Company’s Board of Directors based on a number of factors, including business and market conditions, the Company’s future financial performance and other investment priorities.

The share repurchase authorization announced today permits the Company to repurchase shares in the open market at current market prices at the time of purchase or in privately negotiated transactions. The timing and actual number of shares repurchased under the program will depend on a variety of factors including price, corporate and regulatory requirements, and other market and business conditions, and the Company may suspend or discontinue the program at any time, and may thereafter reinstitute purchases, all without prior announcement.

About The Children’s Place, Inc.
The Children’s Place is the largest pure-play children’s specialty apparel retailer in North America.  The Company designs, contracts to manufacture, sells at retail and wholesale, and licenses to sell fashionable, high-quality merchandise at value prices, primarily under the proprietary “The Children’s Place,” “Place” and “Baby Place” brand names.  As of January 28, 2017, the Company operated 1,039 stores in the United States, Canada and Puerto Rico, an online store at www.childrensplace.com, and had 150 international points of distribution open and operated by its 6 franchise partners in 17 countries.

Forward Looking Statement

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to statements relating to the Company’s strategic initiatives and adjusted net income per diluted share.  Forward-looking statements typically are identified by use of terms such as “may,” “will,” “should,” “plan,” “project,” “expect,” “anticipate,” “estimate” and similar words, although some forward-looking statements are expressed differently.  These forward-looking statements are based upon the Company’s current expectations and assumptions and are subject to various risks and uncertainties that could cause actual results and performance to differ materially. Some of these risks and uncertainties are described in the Company’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of its Annual Report on Form 10-K for the fiscal year ended January 30, 2016. Included among the risks and uncertainties that could cause actual results and performance to differ materially are the risk that the Company will be unsuccessful in gauging fashion trends and changing consumer preferences, the risks resulting from the highly competitive nature of the Company’s business and its dependence on consumer spending patterns, which may be affected by weakness in the economy that continues to affect the Company’s target customer, the risk that the Company’s strategic initiatives to increase sales and margin are delayed or do not result in anticipated improvements, the risk of delays, interruptions and disruptions in the Company’s global supply chain, including resulting from foreign sources of supply in less developed countries or more politically unstable countries, the risk that the cost of raw materials or energy prices will increase beyond current expectations or that the Company is unable to offset cost increases through value engineering or price increases, and the uncertainty of weather patterns. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to release publicly any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact:  Robert Vill, Group Vice President, Finance, (201) 453-6693

$APRI Sale of Ex-U.S. Vitaros Assets and Rights to Ferring

Apricus Expects to Receive Approximately $12.7 Million from Ferring

Apricus to Focus on Vitaros U.S. NDA Re-Submission and Pipeline Assets Post-Closing

SAN DIEGO, March 08, 2017 — Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that it completed the sale to Ferring International Center S.A. (“Ferring”) of Apricus’ ex-U.S. assets and rights related to Vitaros^®, Apricus’ on-demand topical cream indicated for the treatment of patients with erectile dysfunction pursuant to a definitive agreement with Ferring.  Ferring is Apricus’ existing commercialization partner for Vitaros in Latin America and certain parts of Europe and Asia. Apricus will retain its Vitaros rights in the U.S. and it remains on track to re-submit the Vitaros NDA to the FDA in the third quarter of 2017.

“This transaction reflects the continued execution of our corporate strategy of developing, obtaining regulatory approval for, and partnering novel topical prescription treatments in areas of significant unmet need,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, this transaction will allow us to focus our financial resources on obtaining U.S regulatory approval for Vitaros, accelerate the advancement of our clinical pipeline, strengthen our balance sheet with non-dilutive capital, extinguish our existing debt facility, eliminate certain future ex-U.S. Vitaros liabilities and lower our quarterly operating expenses by approximately 30%. I want to thank all of our commercial partners, including Ferring, for their commitment to making Vitaros a successful global brand.  We look forward to their continued success as we work towards a U.S. Vitaros NDA re-submission in the third quarter of this year.”

Associated with the acquisition of the ex-U.S. assets and rights related to Vitaros, Ferring has agreed to pay Apricus an upfront payment of $11.5 million, due upon closing, and up to an additional $700,000 with respect to certain product inventory. Furthermore, the parties have entered into a transition services agreement, whereby Ferring has agreed to pay Apricus an amount equal to $500,000, payable over two calendar quarters, in exchange for Apricus’ assistance in facilitating the transfer of such assets and know-how to Ferring, subject to certain limitations. Ferring will be responsible for managing all Vitaros-related activities outside the U.S. at its cost and working with existing Vitaros commercialization partners outside the United States.

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

For further information on Ferring or its products, visit www.ferring.com.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development.  Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which we own worldwide rights.

For further information on Apricus, visit http://www.apricusbio.com.

Vitaros^™ is Apricus’ trademark in the United States, which is pending registration and subject to the agreement with Allergan.  Vitaros^® is a registered trademark of NexMed International Limited, and will be assigned to Ferring B.V. worldwide, excluding the United States.  RayVa^™ is Apricus’ trademark, which is registered in certain countries throughout the world and pending registration in the United States.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this report that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: statements regarding the cash proceeds from the sale of the purchased assets and under the transition services agreement, the extinguishment of outstanding debt and Apricus’ plans to  resubmit the Vitaros NDA. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus’ control, including, but not limited to: disruption of Apricus’ business and diversion of its management’s time and attention in order to provide transition services under the transition services agreement; Apricus not realizing the full economic benefit from the transaction, including as a result of indemnification claims under the asset purchase agreement and the retention by Apricus’ of certain liabilities associated with the product business; long-term financial risks associated with selling Apricus’ commercialized and registered products; risks related to Apricus’ planned resubmission of the Vitaros NDA; and other risks detailed in Apricus’ public periodic filings with the SEC. These forward-looking statements are made as of the date of this press release, and the Company 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. Readers are urged to read the risk factors set forth in the Company’s most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC’s website at www.sec.gov or without charge from the Company.

CONTACT:    

Matthew Beck
mbeck@troutgroup.com
The Trout Group
(646) 378-2933

$OCRX Positive Phase 2b STOP-HE Study, IV OCR-002, Encephalopathy

IV OCR-002 statistically significantly normalized ammonia faster than standard of care

Ammonia reduction statistically significantly correlated with clinical improvement in HE symptoms

Ocera plans to meet with FDA in Q3 2017 to inform development paths forward for IV OCR-002

Company presentation scheduled for today, March 8, 2017 at 11:20 AM ET

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 08, 2017  — Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced it will report additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy (HE) at the Cowen and Company 37^th Annual Healthcare Conference at 11:20 AM Eastern Time today.

“Further analysis of the data from our STOP-HE trial confirms that OCR-002 rapidly and safely lowered ammonia and, importantly, the ammonia reduction correlated statistically with clinical improvement,” said Linda Grais, M.D., Chief Executive Officer of Ocera. “With greater confidence, we believe the most relevant efficacy considerations likely include earlier timing of drug administration, measuring efficacy sooner after drug administration, and administering the appropriate and tolerable dose regimen of OCR-002. We look forward to discussing these data as well as Phase 3 development with FDA later this year.”

“We are very encouraged by the additional study data indicating IV OCR-002 provided clinical benefit over placebo in other parameters as well, such as the Physician Overall Evaluation, Model for End-Stage Liver Disease (MELD) scores, and in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels,” said Stan Bukofzer, M.D., Chief Medical Officer of Ocera.

Initial STOP-HE results reported in January 2017 included:

• OCR-002 demonstrated a highly statistically significant reduction in ammonia levels over placebo, p=0.028;
• Higher doses (15g, 20g) showed strong evidence of benefit across multiple endpoints;
• Clinical improvement dose trend observed; responder rate increased as dose increased and was superior to placebo at all doses; and
• OCR-002 was safe and well-tolerated; higher doses had a lower percentage of deaths and life threatening adverse events compared to placebo

Additional results to be presented today include:

• Ammonia reduction correlates with clinical improvement, p=0.0006;
• Dose proportional response and pharmacokinetic data indicate some patients were under-dosed;
• Earlier timing of drug administration and efficacy assessment is important:
  – Patients who improve within 48 hours are discharged earlier than patients who do not improve within 48 hours;
  – Patients on OCR-002 are more likely to respond within 48 hours compared to placebo, p=0.026;
• Pre-defined measures of improvement were statistically significant: ammonia reduction, p=0.017 and Physician overall evaluation, p= 0.026;
• OCR-002 demonstrated improvement in the Model for End-Stage Liver Disease (MELD) scores, p=0.051; and
• OCR-002 showed improvement in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels, p=0.04

A live webcast of the presentation will be available in the “Investors” section of Ocera’s website, www.ocerainc.com. A replay of the presentation will be available for 60 days following the conference for those unable to listen live.

STOP-HE Study Design

STOP-HE was a placebo-controlled, randomized, double-blind clinical trial designed to evaluate the safety, pharmacokinetics and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in 231 hospitalized patients with liver cirrhosis and elevated serum ammonia (hyperammonemia). Either OCR-002 or placebo was administered to patients intravenously as a continuous infusion for up to five days along with standard of care. The OCR-002 arm was dosed with 10, 15 or 20 grams over 24 hours based on the patient’s degree of liver impairment and modeling of OCR-002 metabolism, in addition to safety considerations in this high-risk patient population.

About Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a debilitating and progressive complication of liver cirrhosis or liver failure, marked by increasing ammonia levels, mental changes including confusion, impaired motor skills, disorientation, and in its more severe form, stupor, coma and even death. HE is categorized as either covert or overt depending on the degree of neurocognitive impairment, with overt HE (OHE) typically precipitating the need for hospitalization. Patients frequently cycle from remission to recurrence following an initial overt episode. The number of OHE episodes appears to be directly linked to persistent neurological impairment and seems to be cumulative; thus the need to manage HE patients is vital. It is estimated that HE-related hospitalization costs exceed $7 billion¹ annually in the U.S. alone.

¹ Clinical Gastroenterology and Hepatology 2012; 10:1034-1041

About Ocera

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease.

Ocera’s HE clinical development efforts also include a recently completed Phase 1 clinical trial of an oral formulation of OCR-002 in patients with cirrhosis as a potential chronic use option to maintain remission of HE. The Company expects to initiate a multi-dose Phase 2a study of oral OCR-002, also in cirrhotic patients, in the first half of 2017. For additional information, please see www.ocerainc.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements related to the OCR-002 clinical development program, including but not limited to the potential benefits of OCR-002 to help patients with hepatic encephalopathy, the timing of our planned meeting with the FDA, our ability to identify a development path forward for OCR-002, whether any future studies of OCR-002 we may conduct will demonstrate similar results to our Phase 2b study, the timing of our planned Phase 2a study of the oral formulation of OCR-002 in cirrhotic patients, and the timing and nature of our future clinical development plans. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including the risk that we may need to conduct one or more additional studies in light of the fact our Phase 2b trial did not meet its clinical endpoints, including related cost and timing issues associated with future studies, if any, our ability to raise sufficient capital or consummate other strategic transactions to enable the continued development of OCR-002, as well as those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

OCRX-G

Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109

$CYCC CDK Inhibitor CYC065 Causes Anaphase Catastrophe in Cancer

CYC065 found effective against lung cancer cell lines including those with KRAS mutations

BERKELEY HEIGHTS, N.J., March 07, 2017  — Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (“Cyclacel” or the “Company”), today announced the publication of a peer-reviewed journal article featuring the company’s cyclin dependent kinase 2/9 (CDK2/9) inhibitors. In an article published in the Journal of National Cancer Institute (JNCI), preclinical data demonstrated that both Cyclacel’s CYC065, a second-generation, clinical stage, CDK2/9 inhibitor, and CCT68127, a pre-clinical stage CDK2/9 inhibitor, demonstrated prominent antitumor activity against lung cancer through anaphase catastrophe, a novel, cancer specific mechanism of action.

The Journal of National Cancer Institute article entitled, “Next-Generation CDK2/9 Inhibitors and Anaphase Catastrophe in Lung Cancer,” demonstrates that CYC065 and CCT68127 cause multipolar anaphase and apoptosis in lung cancer cells with supernumerary centrosomes, known as anaphase catastrophe. This novel mechanism of action offers an innovative approach to combat aneuploid cancer cells which contain abnormal numbers of chromosomes. Aneuploidy is a hallmark for cancer development and occurs in virtually every cancer, but is particularly found in lung cancer. Approximately 90 percent of cancer cells in solid tumors and blood cancer are aneuploid.

The article further reported that inhibition of CDK2 was the key mechanism of action and, as a consequence, lung cancer cells underwent apoptosis or cell suicide by induction of a novel mechanism called anaphase catastrophe. Similarly to a previous report on seliciclib (Cyclacel’s first generation CDK inhibitor), lung cancer cells with mutant KRAS were particularly sensitive to CYC065 and CCT68127. Combination of CCT68127 with the MEK inhibitor, trametinib, was synergistic. An efficacy study in syngeneic cancer models of lung cancer with mutant KRAS demonstrated tumor growth inhibitory effect and a significant decrease of circulating tumor cells.

Citation:
Kawakami M, Lisa, Mustachio M, Rodriguez-Canales J, Mino B, Roszik J, Tong P, Wang J, J. Lee J, Myung JH, Heymach JV, Johnson FM, Hong S, Zheng L, Hu S, Villalobos PA, Behrens C, Wistuba I, Freemantle S, Liu X, Dmitrovsky E. Next-Generation CDK2/9 Inhibitors and Anaphase Catastrophe in Lung Cancer. J Natl Cancer Inst (2017) 109(6): djw297.

About CYC065

Cyclacel’s second generation CDK2/9 inhibitor, CYC065, is being evaluated in an ongoing, first-in-human, Phase 1 trial in patients with advanced solid tumors. In addition to determining safety and recommended dosing for Phase 2, the study aims to investigate CYC065’s effects on the Mcl-1 biomarker, which is implicated in the evolution of resistance in cancer. Evidence of target engagement with prolonged Mcl-1 suppression in peripheral blood cells was observed in patient samples from the study, as well as decreases in kinase substrate phosphorylation and increases in PARP cleavage, which were consistent with the Company’s preclinical data. CYC065 is mechanistically similar but has much higher dose potency, in vitro and in vivo, and improved metabolic stability than seliciclib, Cyclacel’s first generation CDK inhibitor.  Similar to palbociclib, the first CDK inhibitor approved by FDA in 2015, CYC065 may be most useful as a therapy for patients with both liquid and solid tumors in combination with other anticancer agents, including Bcl-2 antagonists, such as venetoclax, or HER2 inhibitors, such as trastuzumab.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel’s DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. The transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. Cyclacel is analyzing stratified and exploratory subgroups from a Phase 3 study of sapacitabine in elderly patients with AML. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

© Copyright 2017 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

Contacts

Company:  
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com

Investor Relations:  
Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com

$MYSZ Announces Plans are Underway to Open a Subsidiary in Poland

AIRPORT CITY, Israel, March 7, 2017 —

MySize Inc. (the “Company”) (NASDAQ: MYSZ; TASE: MYSZ), developer of proprietary, smartphone measurement applications, announced today that the company, in cooperation with PNO Consultants, has started the planning phase of opening a subsidiary in Poland, which will include an R&D facility. A team in Poland will be hired to develop a new product for an existing market.

MySize also announced today that, through PNO, the Company intends to submit the previously reported grant proposal to the European Union during Q2/2017. PNO is preparing and processing the funding applications. The aforementioned R&D facility will become operational only after a grant has been approved by the Polish government.

“We are moving forward as planned on this as well as other fronts,” said MySize founder and CEO Mr. Ronen Luzon. “Our product pipeline is growing and we plan to continue working hard at finalizing development and introducing new products to the market that will improve the shopping experience for the customer and retailer alike. No matter the product, if it can be measured, our applications will be there to help.”

About PNO Consultants

PNO Consultants provides advice, tools and solutions for foreign investors interested in green-field or local joint-venture investments that support development of new projects with international potential. PNO also helps companies to secure and leverage public grants and state aid. PNO is actively engaged in 1500 projects spanning 20 countries and services 450 clients, for which it has raised, collectively, in excess of 897 million euros to date.

About MySize Inc.

MySize Inc. (TASE: MYSZ) (NASDAQ: MYSZ) has developed a unique measurement technology based on sophisticated algorithms and cutting-edge technology with broad applications including apparel industry, e-commerce, shipping and parcel industry measurement. This proprietary technology is driven by several patent-pending algorithms which are able to calculate and record measurements in a variety of novel ways. To learn more about MySize, please visit our website. http://www.mysizeid.com

Follow us on Facebook, LinkedIn and Twitter

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements. All forward-looking statements speak only as of the date of this press release. You should not place undue reliance on these forward-looking statements. Although we believe that our plans, objectives, expectations and intentions reflected in or suggested by the forward-looking statements are reasonable, we can give no assurance that these plans, objectives, expectations or intentions will be achieved. Forward-looking statements involve significant risks and uncertainties (some of which are beyond our control) and assumptions that could cause actual results to differ materially from historical experience and present expectations or projections. Known material factors that could cause actual results to differ materially from those in the forward-looking statements include: an active trading market for our common stock may not develop on NASDAQ; the trading price for our common stock may fluctuate significantly; and the Company will continue to be a “controlled company,” as defined under NASDAQ rules, and the interests of our controlling stockholder may differ from those of our public stockholders. Forward-looking statements also are affected by the risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.
Press Contact
Marjie Hadad
MH Communications
marjierhadad@gmail.com
+972-54-536-5220

$LPTX to Present at 2017 Barclays Global Healthcare Conference

CAMBRIDGE, Mass., March 07, 2017 — Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced that Christopher K. Mirabelli, Ph.D, Chairman, President, and Chief Executive Officer, will present a corporate overview at the 2017 Barclays Global Healthcare Conference, being held in Miami on March 14-16, 2017.

Barclays Global Healthcare Conference – Leap Presentation Details

Date: Tuesday, March 14, 2017

Time: 4:20 p.m. Eastern Time

Dr. Mirabelli’s presentation will be webcast live and may be accessed under the investors tab on http://www.investors.leaptx.com.

About Leap Therapeutics
Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer in combination with paclitaxel and in patients with biliary tract cancers in combination with gemcitabine and cisplatin. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/.

FORWARD LOOKING STATEMENTS

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events of Leap’s development of DKN-01, TRX518, and other programs, future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Leap has attempted to identify forward looking statements by terminology including ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘potential,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ ‘‘approximately’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360

$BAM to Acquire $GLBL

BETHESDA, Md., March 07, 2017  — TerraForm Global, Inc. (Nasdaq:GLBL) (“TerraForm Global” or the “Company”), an owner and operator of clean energy power plants, today announced that it has entered into a definitive merger agreement under which Brookfield Asset Management Inc. (NYSE:BAM) (TSX:BAM.A) (EURONEXT AMSTERDAM:BAMA) (“Brookfield”), a leading global alternative asset manager, will acquire TerraForm Global for approximately $787 million in cash and will assume approximately $455 million in net debt, representing an enterprise value of approximately $1.3 billion. TerraForm Global owns and operates, or has contracts to acquire, a fleet of 31 wind and solar power plants totaling 952 MW of capacity spread across Brazil, India, China, South Africa, Thailand, Malaysia, and Uruguay.

Transaction Details

Under the terms of the merger agreement, Brookfield will purchase all of the outstanding Class A shares of TerraForm Global for $5.10 per share in cash. For Class A shareholders, this represents a premium of approximately 50% to TerraForm Global’s closing share price on September 16, 2016, the last trading day prior to TerraForm Global’s announcement that its Board of Directors had initiated an exploration of strategic alternatives to maximize shareholder value. Immediately prior to the merger, pursuant to a settlement agreement entered into between TerraForm Global and SunEdison, Inc. (“SunEdison”) will exchange all of its Class B shares and TerraForm Global, LLC Class B units into 25% of the outstanding Class A shares on a fully diluted basis. The transaction has been approved by the Board of Directors of TerraForm Global, acting on the recommendation of its Corporate Governance and Conflicts Committee, and has also been approved by the Board of Directors of Brookfield. This transaction also has the support of SunEdison.

Compelling Strategic and Financial Rationale

“We are pleased to have reached a successful completion of TerraForm Global’s strategic alternatives process to maximize value for our shareholders,” said Peter Blackmore, Chairman and Interim Chief Executive Office of TerraForm Global. “After a thorough review of alternatives and the significant steps taken by the Board and management to best position TerraForm Global for success, we are confident a sale to Brookfield is the best possible transaction for our shareholders. We look forward to working closely with Brookfield’s experienced team to achieve a timely closing and a seamless transition.”

“SunEdison is supportive of this transaction which we believe maximizes value for the estate and the independent shareholders of TerraForm Global,” said John Dubel, Chief Executive Officer and Chief Restructuring Officer of SunEdison.

Approvals and Timing to Close

The transaction is expected to be completed in the second half of 2017 and is subject to certain closing conditions, including shareholder approval by the majority of Class A shareholders (excluding SunEdison and Brookfield), regulatory approvals, the resolution of certain litigation against TerraForm Global, and certain approvals from the U.S. bankruptcy court overseeing the SunEdison Chapter 11 bankruptcy case, including the Court’s approval of the settlement agreement between TerraForm Global and SunEdison, and the Court’s approval of SunEdison’s vote in favor of the Brookfield transaction. The completion of this transaction is not subject to the completion of Brookfield’s transaction with TerraForm Power, Inc. also announced today.

TerraForm Global’s Settlement Agreement with SunEdison

TerraForm Global also announced today that it has entered into a settlement agreement with SunEdison in connection with the Chapter 11 bankruptcy case of SunEdison (the “SunEdison Bankruptcy”). This agreement is subject to the approval of the U.S. bankruptcy court overseeing the SunEdison Bankruptcy.

The settlement agreement contains certain terms to resolve the complex legal relationship between TerraForm Global and SunEdison, including, among other things, an allocation of the total consideration paid in connection with the Brookfield transaction and, with certain exceptions, the full mutual release of all claims between SunEdison and its affiliated debtors and non-debtors and TerraForm Global and its subsidiaries. Under the settlement terms, following the exchange of all of its Class B shares and TerraForm Global, LLC Class B units for Class A shares, SunEdison will receive consideration equal to 25% of the total consideration paid to all of TerraForm Global’s shareholders, reflecting the settlement of intercompany claims and cancellation of incentive distribution rights. The remaining 75% of the consideration will be distributed to existing Class A shareholders.

In connection with the merger agreement, SunEdison, TerraForm Global and Brookfield entered into a voting and support agreement under which SunEdison agreed to vote all of its shares of TerraForm Global in favor of the Brookfield transaction. This agreement is also subject to the approval of the U.S. bankruptcy court overseeing the SunEdison Bankruptcy.

The settlement agreement has been approved by the Board of Directors of TerraForm Global, acting on the recommendation of its Corporate Governance and Conflicts Committee.

Additional information about the merger agreement and the settlement agreement can be found in the Current Report on Form 8-K that TerraForm Global filed with the Securities and Exchange Commission today. A copy of the filing is available on the Investors page of TerraForm Global’s website at http://www.terraformglobal.com.

Advisors

Greentech Capital Advisors, Centerview Partners, and AlixPartners acted as financial advisors to TerraForm Global on this transaction. Sullivan & Cromwell LLP acted as legal counsel for TerraForm Global. Greenberg Traurig, LLP and Robbins, Russell, Englert, Orseck, Untereiner & Sauber, LLP acted as legal counsel for the independent directors and the Corporate Governance and Conflicts Committee.

Rothschild and Ankura Consulting acted as financial advisors to SunEdison. Skadden Arps acted as legal counsel for SunEdison. For certain of SunEdison’s second lien creditor constituents, J.P. Morgan Securities LLC and Houlihan Lokey acted as financial advisors, and Akin Gump acted as legal counsel.

About TerraForm Global

TerraForm Global is a renewable energy company that is changing how energy is generated, distributed and owned. TerraForm Global creates value for its investors by owning and operating clean energy power plants in high-growth emerging markets. For more information about TerraForm Global, please visit: www.terraformglobal.com.

Cautionary Note Regarding Forward-Looking Statements

This news 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.  Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts.  These statements involve estimates, expectations, projections, goals, assumptions, known and unknown risks, and uncertainties and typically include words or variations of words such as “expect,” “anticipate,” “believe,” “intend,” “plan,” “seek,” “estimate,” “predict,” “project,” “goal,” “guidance,” “outlook,” “objective,” “forecast,” “target,” “potential,” “continue,” “would,” “will,” “should,” “could,” or “may” or other comparable terms and phrases.  All statements that address operating performance, events, or developments that the Company expects or anticipates will occur in the future are forward-looking statements.  They may include financial metrics such as estimates of expected adjusted earnings before interest, taxes, depreciation and amortization, cash available for distribution, earnings, revenues, capital expenditures, liquidity, capital structure, future growth, financing arrangement and other financial performance items (including future dividends per share), descriptions of management’s plans or objectives for future operations, products, or services, or descriptions of assumptions underlying any of the above.  Forward-looking statements are based on the Company’s current expectations or predictions of future conditions, events, or results and speak only as of the date they are made.  Although the Company believes its respective expectations and assumptions are reasonable, it can give no assurance that these expectations and assumptions will prove to have been correct and actual results may vary materially.

By their nature, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements.  Factors that might cause such differences include, but are not limited to, the expected timing and likelihood of completion of the Merger, including the timing, receipt and terms and conditions of any required governmental approvals of the Merger that could cause the parties to abandon the transaction; the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement; the risk of failure by the Bankruptcy Court to confirm the Settlement Agreement, the Voting and Support Agreement and any other agreement entered into in connection with the Merger or the other transactions contemplated by the Merger Agreement to which SunEdison or any other debtor will be a party; the risk of failure of the holders of a majority of the outstanding Shares to adopt the Merger Agreement and of the holders of a majority of the Class A Shares other than SunEdison and its affiliates and Brookfield and its affiliates to approve the Merger Agreement and the transactions contemplated by the Merger Agreement; the risk that the parties may not be able to satisfy the conditions to the Merger in a timely manner or at all; risks related to disruption of management time from ongoing business operations due to the Merger; the risk that any announcements relating to the Merger could have adverse effects on the market price of the Company’s common stock; the risk that the proposed transaction and its announcement could have an adverse effect on the Company’s ability to retain and hire key personnel and maintain relationships with its suppliers and customers and on its operating results and businesses generally; the Company’s relationship with SunEdison, including SunEdison’s bankruptcy filings; risks related to events of default and potential events of default arising under project-level financings and other agreements due to various factors; risks related to the Company’s failure to satisfy continued listing requirements of NASDAQ; the Company’s ability to acquire projects at attractive prices as well as to integrate the projects the Company acquires from third parties or otherwise realize the anticipated benefits from such acquisitions, including through refinancing or future sales; actions of third parties, including but not limited to the failure of SunEdison to fulfill its obligations and the actions of the Company’s bondholders and other creditors; price fluctuations, termination provisions and buyout provisions in offtake agreements; delays or unexpected costs during the completion of projects the Company intends to acquire; regulatory requirements and incentives for production of renewable power; operating and financial restrictions under agreements governing indebtedness; the condition of the debt and equity capital markets and the Company’s ability to borrow additional funds and access capital markets; the impact of foreign exchange rate fluctuations; the Company’s ability to compete against traditional and renewable energy companies; hazards customary to the power production industry and power generation operations, such as unusual weather conditions and outages or other curtailment of the Company’s power plants; departure of some or all of SunEdison’s employees, particularly key employees and operations and maintenance or asset management personnel that the Company significantly relies upon; pending and future litigation; and the Company’s ability to operate the Company’s business efficiently, including to manage the transition from SunEdison information technology, technical, accounting and generation monitoring systems, to manage and complete governmental filings on a timely basis, and to manage the Company’s capital expenditures, economic, social and political risks and uncertainties inherent in international operations, including operations in emerging markets and the impact of foreign exchange rate fluctuations, the imposition of currency controls and restrictions on repatriation of earnings and cash, protectionist and other adverse public policies, including local content requirements, import/export tariffs, increased regulations or capital investment requirements, conflicting international business practices that may conflict with other customs or legal requirements to which we are subject, the inability to obtain, maintain or enforce intellectual property rights, and being subject to the jurisdiction of courts other than those of the United States, including uncertainty of judicial processes and difficulty enforcing contractual agreements or judgments in foreign legal systems or incurring additional costs to do so. Many of these factors are beyond the Company’s control.

The Company disclaims any obligation to update or revise any forward-looking statement to reflect changes in underlying assumptions, factors, or expectations, new information, data, or methods, future events, or other changes, except as required by law.  The foregoing list of factors that might cause results to differ materially from those contemplated in the forward-looking statements should be considered in connection with information regarding risks and uncertainties which are described in the Company’s Form 10-K for the 2015 fiscal year and Forms 10-Q for the first, second and third quarters of 2016, as well as additional factors it may describe from time to time in other filings with the SEC or incorporated herein.  You should understand that it is not possible to predict or identify all such factors and, consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.

Additional Information and Where to Find It

This communication may be deemed to be solicitation material in respect of the proposed acquisition of the Company by Parent.  In connection with the proposed acquisition, Parent and the Company intend to file relevant materials with the SEC, including the Company’s proxy statement on Schedule 14A.  STOCKHOLDERS OF THE COMPANY ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE COMPANY’S PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.  Investors and security holders will be able to obtain the documents free of charge at the SEC’s website, http://www.sec.gov.  The Company’s stockholders will also be able to obtain, without charge, a copy of the proxy statement and other relevant documents (when available) by directing a request by mail or telephone to TerraForm Global, Inc., 7550 Wisconsin Avenue, 9th Floor, Bethesda, Maryland 20814: (240) 762-7700, or from the Company’s website, https://www.terraformglobal.com/.

Contacts

Investors for TerraForm Global:
Brett Prior
Head of Investor Relations
investors@terraform.com
(650) 889-8628

Media for TerraForm Global:
Meaghan Repko / Joseph Sala
Joele Frank, Wilkinson Brimmer Katcher
media@terraform.com
(212) 355-4449

$NAKD to Present at the 29th Annual ROTH Conference

Naked Brand Group Inc. (NASDAQ:NAKD) (“Naked”), an innovative fashion and lifestyle brand, today announced that Joel Primus, President & Founder of Naked, and Justin Davis-Rice, a Director of Naked and Executive Chairman of Bendon Limited, will be presenting at the 29th Annual ROTH Conference at The Ritz Carlton in Dana Point, CA, on Tuesday, March 14, 2017, at 4:30 pm PDT.

The audio portion of the presentation will be webcast live over the internet and can be accessed under the Investor Relations section at http://www.nakedbrands.com. An online archive will be available for a period of 90 days following the presentation.

About Naked Brand Group Inc.:

Naked was founded on one basic desire–to create a new standard for how products worn close to the skin fit, feel, and function. Naked’s women’s and men’s collections are available at www.wearnaked.com, and Naked has a growing retail footprint for its innovative and luxurious innerwear products in some of the leading online and department stores in North America including Nordstrom, Bloomingdale’s, Dillard’s, Soma, Saks Fifth Avenue, Amazon.com, BareNecessities.com, and more. In 2014, renowned designer and sleepwear pioneer Carole Hochman joined Naked as Chief Executive Officer, Chief Creative Officer, and Chairwoman with the goal of growing Naked into a global lifestyle brand. In June 2015, Naked announced a strategic partnership with NBA Miami HEAT (now Chicago Bulls) star Dwyane Wade. The 3-time NBA Champion, 11-time All Star, and Olympic Gold Medalist joined Naked’s Advisory Board, and is the Creative Director for a signature collection of men’s innerwear which launched in 2016. Naked is headquartered in New York City and plans to expand in the future into other apparel and product categories that can exemplify the mission of the brand, such as activewear, swimwear, sportswear and more. http://www.nakedbrands.com/

About Bendon Limited:

Bendon is a global leader in intimate apparel and swimwear renowned for its best in category innovation in design, and technology and unwavering commitment to premium quality products throughout its 70-year history. Bendon has a portfolio of 10 highly productive brands, including owned brands Bendon, Bendon Man, Davenport, Evollove, Fayreform, Hickory, Lovable (in Australia and New Zealand) and Pleasure State, as well as licensed brands Heidi Klum Intimates and Swimwear and Stella McCartney Lingerie and Swimwear.

In October 2014 Bendon announced supermodel and television host Heidi Klum as the Creative Director and face of Bendon’s flagship Intimates collection, succeeding Elle Macpherson after 25 years with the brand. Bendon products are distributed through over 4,000 doors across 34 countries as well as through a growing network of 60 company-owned Bendon retail and outlet stores in Australia, New Zealand and Ireland. Bendon’s global supply chain is one of its strongest assets, controlling sourcing, manufacturing and production at over 30 partner facilities across Asia. The company has more than 700 staff at offices and stores in Auckland, Sydney, New York, London and Hong Kong and is poised for continued meaningful growth as it opens additional retail stores and expands its current portfolio of products. http://www.bendongroup.com/

Additional Information and Where to Find It

This press release does not constitute the solicitation of any vote or approval. On January 18, 2017, Naked announced that it had entered into a letter of intent (“LOI”) with Bendon Limited (“Bendon”), for a proposed business combination (the “Business Combination”). The LOI was amended on February 9, 2017. Completion of the Business Combination is subject to the negotiation of a definitive agreement (the “Definitive Agreement”) between the parties, satisfaction of the conditions negotiated therein and approval of the Business Combination by Naked’s stockholders. Accordingly, there can be no assurance that a Definitive Agreement will be entered into or that the proposed Business Combination will be consummated. Further, those portions of the previously announced LOI, as amended, that described the proposed Business Combination, including the consideration to be issued therein, is non-binding. Assuming Naked and Bendon enter into the Definitive Agreement, the parties will look to seek shareholder approval from Naked’s shareholders. In connection therewith, Naked intends to file relevant materials with the Securities and Exchange Commission (the “SEC”), including a definitive proxy statement. Such documents are not currently available. Before making any voting or investment decision with respect to the Business Combination, investors and security holders of Naked are urged to read the definitive proxy statement and the other relevant materials filed or to be filed with the SEC carefully and in their entirety when they become available because they will contain important information about Naked, Bendon and the proposed Business Combination. The definitive proxy statement and other relevant materials (when they become available), and any other documents filed by Naked with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov. In addition, investors and security holders of Naked may obtain free copies of the documents filed with the SEC by Naked by directing a written request to: Naked Brand Group Inc., 95 Madison Avenue, 10th Floor, New York, New York 10016, Attention: Investor Relations.

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

Participants in the Solicitation

Naked and its directors, executive officers and certain other members of management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Naked in connection with the proposed Business Combination. Information regarding the participants in the proxy solicitation of the stockholders of Naked and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the definitive proxy statement regarding the proposed Business Combination and other relevant materials to be filed with the SEC by Naked when they become available. Additional information regarding the directors and executive officers of Naked is also included in Naked’s Annual Report on Form 10-K for the year ended January 31, 2016, and the proxy statement for Naked’s 2016 Annual Meeting of Stockholders. These documents are available free of charge at the SEC’s web site (www.sec.gov) and from Investor Relations at Naked at the address described above.

Forward-Looking Statements

Certain statements contained in this press release, other than purely historical information, including estimates, projections and statements relating to Naked’s, Bendon’s and/or the combined company’s business plans, objectives and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in or incorporated by reference into this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the structure, timing and completion of the proposed Business Combination; Naked’s continued listing on the NASDAQ Capital Market until closing of the proposed Business Combination; the combined company’s listing on the NASDAQ Capital Market after closing of the proposed Business Combination; when Naked expects to seek shareholder approval of the Business Combination; expectations regarding the capitalization, resources and ownership structure of the combined company; the adequacy of the combined company’s capital to support its future operations; Naked’s, Bendon’s and combined company’s plans, objectives, expectations and intentions; the nature, strategy and focus of the combined company; anticipated growth rates; potential future acquisitions; the executive and board structure of the combined company; and expectations regarding voting by Naked’s stockholders. Naked and/or Bendon may not actually achieve the plans, carry out the intentions or meet the expectations disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with stockholder approval of and the ability to consummate the proposed Business Combination through the process being conducted by Naked and Bendon, the ability of Naked to enter into a definitive agreement regarding the Business Combination and to consummate such transaction, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources of the combined company to meet its business objectives and operational requirements, the ability to realize the expected synergies or savings from the proposed Business Combination in the amounts or in the timeframe anticipated, the risk that competing offers or acquisition proposals will be made, the ability to integrate Naked’s and Bendon’s businesses in a timely and cost-efficient manner, the inherent uncertainty associated with financial projections, and the potential impact of the announcement or closing of the proposed Business Combination on customer, supplier, employee and other relationships. Naked disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made.

$MOSY Regains Compliance with NASDAQ Minimum Bid Price Listing Requirement

SANTA CLARA, Calif., March 07, 2017  — MoSys, Inc. (NASDAQ:MOSY), a leader in semiconductor solutions that enable fast, intelligent data access for Cloud, network and communications systems, today announced that it has received a letter from The NASDAQ Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the Nasdaq Capital Market’s minimum bid price continued listing requirement.  The letter noted that, as of March 2, 2017, the Company evidenced a closing bid price of its common stock in excess of the $1.00 minimum requirement for the last 10 consecutive trading days. Accordingly, the Company has regained compliance with Nasdaq Marketplace Rule 5550(a)(2) and NASDAQ considers the matter closed.

About MoSys, Inc.
MoSys, Inc. (NASDAQ:MOSY) is a fabless semiconductor company enabling leading equipment manufacturers of Cloud, networking, communications, and data center systems to address the continual increase in Internet users, data and services. The company’s solutions deliver data path connectivity, speed and intelligence while eliminating data access bottlenecks on line cards and systems scaling from 100G to multi-terabits per second. Engineered and built for high-reliability carrier and enterprise applications, MoSys’ Bandwidth Engine®, Programmable Search Engine, and LineSpeed™ IC product families are based on the company’s patented high-performance, high-density intelligent access and high-speed serial interface technology, and utilize the company’s highly efficient GigaChip® Interface. MoSys is headquartered in Santa Clara, California. More information is available at www.mosys.com.

Bandwidth Engine, GigaChip, and MoSys are registered trademarks of MoSys, Inc. in the US and/or other countries. LineSpeed and the MoSys logo are trademarks of MoSys, Inc. All other marks mentioned herein are the property of their respective owners.

Contacts:
Jim Sullivan, CFO
MoSys, Inc.
+1 (408) 418-7500
jsullivan@mosys.com

Beverly Twing, Sr. Acct. Manager
Shelton Group, Investor Relations
+1 (214) 272-0089
btwing@sheltongroup.com

$CCIH Announces Definitive Agreements to Sell Data Center Assets

BEIJING, March 06, 2017  — ChinaCache International Holdings Ltd. (“ChinaCache” or the “Company”) (Nasdaq:CCIH), the leading total solutions provider of Internet content and application delivery services in China, today announced that it has entered into definitive agreements to sell 79.0% equity interest of ChinaCache Xin Run Technology (Beijing) Co., Limited (“Xin Run”) to Tianjin Shuishan Technology Co., Ltd. (“Tianjin Shuishan”), Shanghai Qiaoyong Equity Investment Fund Management Co., Ltd. (“Shanghai Qiaoyong”) and Tianjin Dingsheng Zhida Technology Co., Ltd. (“Tianjin Dingsheng”), for a total consideration of RMB221.2 million in cash before fees and expenses.  Xin Run owns and operates ChinaCache’s Internet data center business.

Pursuant to the agreements, Tianjin Shuishan, Shanghai Qiaoyong and Tianjin Dingsheng agree to purchase 47.67%, 26.33% and 5.0%, respectively, of the equity interest in Xin Run for a consideration of RMB133.5 million, RMB73.7 million and RMB14.0 million, respectively. Shanghai Qiaoyong may designate a self-established fund as general partner, Tianjin Shuishan and Tianjin Dingsheng may respectively designate wholly-owned subsidiaries, to complete the transaction. After completion of the transaction, ChinaCache will, through a subsidiary, own 20.0% equity interest of Xin Run and will cease to consolidate the financial results of Xin Run and its subsidiaries. As of September 30, 2016, Xin Run had a shareholders’ equity value of approximately RMB14.8 million and a registered capital of approximately RMB126.6 million. ChinaCache plans to apply the proceeds from the transaction to R&D, working capital and other purposes.

“This transaction will significantly strengthen our balance sheet. In addition, by divesting the majority interest in this capital intensive business, we can focus on our asset-light and technology-driven CDN business,” commented Mr. Song Wang, Chairman and Chief Executive Officer of ChinaCache.

“We believe the transaction will enable Xin Run to achieve growth and unlock value, which may further benefit our shareholders. After the transaction, ChinaCache and Xin Run may explore partnership opportunities to provide our enterprise customers with premium total solutions,” concluded Mr. Wang.

Tianjin Shuishan and Tianjin Dingsheng are controlled by Mr. Song Wang, Chairman of the Board of Directors and Chief Executive Officer of ChinaCache. Tianjin Shuishan will obtain a loan from Shanghai Qiaoyong or its affiliates to finance its acquisition.

The completion of the transaction is subject to customary closing conditions, including obtaining of requisite governmental registration. The transaction has been approved by the Board of Directors of the Company, acting upon the unanimous recommendation of its audit committee, consisting of independent and disinterested directors. The Company has terminated the agreement to sell 60.0% of Xin Run as disclosed in its press release on December 2, 2015.

About ChinaCache International Holdings Ltd.

ChinaCache International Holdings Ltd. (Nasdaq:CCIH) is the leading total solutions provider of Internet content and application delivery services in China. As a carrier-neutral service provider, ChinaCache’s network in China is interconnected with networks operated by all telecom carriers, major non-carriers and local Internet service providers. With more than a decade of experience in developing solutions tailored to China’s complex Internet infrastructure, ChinaCache is a partner of choice for businesses, government agencies and other enterprises to enhance the reliability and scalability of online services and applications and improve end-user experience. For more information on ChinaCache, please visit ir.chinacache.com.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. ChinaCache may also make written or oral forward-looking statements in its reports filed or furnished to the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statements, including but not limited to the following: the Company’s goals and strategies, expansion plans, the expected growth of the content and application delivery services market, the Company’s expectations regarding keeping and strengthening its relationships with its customers, and the general economic and business conditions in the regions where the Company provides its solutions and services. Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission. All information provided in this press release is as of the date of this press release, and ChinaCache undertakes no duty to update such information, except as required under applicable law.

For investor and media inquiries please contact:

Investor Relations Department
ChinaCache International Holdings
Tel: +86 10 6408 5307
Email: ir@chinacache.com

Mr. Ross Warner
The Piacente Group | Investor Relations
Tel: +86 10 5730-6200
Email: chinacache@tpg-ir.com

Ms. Brandi Piacente
The Piacente Group | Investor Relations
Tel: +1 212-481 2050
Email: chinacache@tpg-ir.com

$AUPH Acceptance of Voclosporin Late-Breaking Presentation for NKF

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that its late-breaking abstract for voclosporin has been accepted for oral presentation at the National Kidney Foundation (NKF) 2017 Spring Clinical Meetings taking place April 18-22, 2017 in Orlando, FL. The oral presentation, titled “Treatment of Active Lupus Nephritis with Voclosporin: 48 Week Data from the AURA-LV Study,” will be made by lead author Dr. Samir Parikh, a clinical investigator for the study and Assistant Professor, Clinical Nephrology at the Ohio State University, on Thursday, April 20, 2017 from 4:00 p.m. – 5:30 p.m. ET.

A corresponding Late Breaking poster presentation of the 48-week AURA-LV study data will also be presented at the NKF 2017 Scientific Clinical Meetings. A copy of the abstract will be available on the conference’s website at: https://www.kidney.org/spring-clinical.

“We’re pleased that the AURA-LV 48-week data have been accepted for a late-breaking oral presentation and look forward to sharing these important results with the nephrology scientific and medical communities,” said Richard M. Glickman, Aurinia’s Chief Executive Officer.

About AURA-LV
The AURA–LV study (Aurinia Urinary protein Reduction in Active Lupus with Voclosporin) is a 48-week study comparing the efficacy of two doses of voclosporin added to current standard of care of MMF against standard of care with placebo in achieving CR in patients with active LN. All arms also received low doses of corticosteroids as background therapy. 265 patients were enrolled at centers in 20 countries worldwide. On entry to the study, patients were required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features indicative of highly active nephritis. The 24-week primary and secondary endpoints were released in Q3 2016 where the primary and all secondary endpoints were met. CR is a composite endpoint that includes: confirmed UPCR of ≤0.5 mg/mg; normal, stable renal function (≥60 mL/min/1.73m² or no confirmed decrease from baseline in eGFR of ≥20%); presence of sustained, low dose steroids (≤10mg prednisone from week 16-24); and no administration of rescue medications. PR in the trial is measured by a ≥50% reduction in UPCR with no concomitant use of rescue medication.

About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.

About Lupus Nephritis (LN)
LN in an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Aurinia
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN. The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com

Forward Looking Statements
This press release contains forward-looking statements, including statements related to Aurinia’s ability to execute a successful Phase III program and voclosporin potentially shifting the treatment paradigm for LN, Aurinia’s analysis, assessment and conclusions of the results of the AURA-LV clinical study. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of the AURA-LV clinical study set forth in this release may change based on further analyses of such data, and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2015 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.

$PIRS IND-enabling Data Immuno #Oncology Drug Candidate #PRS343

$DXTR MicroCutter 5/80 Shorter Hospital Stays Thanks to Less Invasive Lobectomy

Dextera Surgical Inc. (Nasdaq:DXTR), manufacturer of the smallest-profile and most maneuverable articulating surgical stapling platform on the market for minimally invasive surgery, today announced that Marco Nardini, M.D., from James Cook University Hospital in Middlesbrough, UK, presented the latest data on the results of 82 patients undergoing Microlobectomy. The data demonstrated that for Microlobectomy procedures, the median hospital stay is reduced by at least two days when compared to traditional open lobectomy procedures, with over 20 percent of patients going home the day after surgery.

“The Microlobectomy procedure, enabled by the MicroCutter 5/80 surgical stapler, due to the slim profile of the five-millimeter diameter with 80 degrees of articulation, reduces postoperative pain and complications compared to traditional open procedures and overall, improves a patient’s recovery after a major lung resection,” commented Dr. Nardini. “These data further support what surgeons around the world are experiencing when performing the Microlobectomy – that the less invasive nature of this procedure shortens hospital stays when compared to a traditional open lobectomy, with 20.7% of patients able to return home within 24 hours.”

For the 82 patients undergoing a Microlobectomy, the median length of hospital stay was three days, with 17 patients (20.7%) discharged the day after surgery and an additional 14 patients (17%) discharged two days after surgery. Data were presented at the Scandinavian Society for Research in Cardiothoracic Surgery 2017 held in Geilo, Norway.

Liam Burns, vice president worldwide sales and marketing of Dextera Surgical, commented, “The interest in the presentation at the meeting reflects the global interest in technologies like the MicroCutter 5/80 that enable less invasive approaches to lobectomy that may accelerate the adoption of video-assisted thoracic surgery (VATS) techniques and other surgical procedures.”

MicroCutter Indication Information

The MicroCutter 5/80 Stapler is manufactured and cleared for use in the United States for transection and resection in multiple open or minimally invasive urologic, thoracic and pediatric surgical procedures, as well as application for transection, resection and/or creation of anastomoses in the small and large intestine, and the transection of the appendix. The MicroCutter 5/80 may be used with both MicroCutter 30 White Reloads in vascular/thin tissue and MicroCutter 30 Blue Reloads for standard tissue.

About Dextera Surgical

Dextera Surgical (Nasdaq:DXTR) designs and manufactures proprietary stapling devices for minimally invasive surgical procedures. In the U.S., surgical staplers are routinely used in more than one million minimally invasive laparoscopic, video-assisted or robotic-assisted surgical procedures annually.

Dextera Surgical also markets the only automated anastomosis devices for coronary artery bypass graft (CABG) surgery on the market today: the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System. These products, sold by Dextera Surgical under the Cardica brand name, have demonstrated long-term reliable clinical performance for more than a decade.

Forward-Looking Statements

The statements in this press release regarding Dextera Surgical’s expectations as to the benefits of using the MicroCutter 5/80 are “forward-looking statements.” There are a number of important factors that could cause Dextera Surgical’s results to differ materially from those indicated by these forward-looking statements, including the risks detailed from time to time in Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended December 31, 2016, under the caption “Risk Factors.” Dextera Surgical expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. You are encouraged to read Dextera Surgical’s reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.

$VRTX to Acquire #CTP656 $CNCE, Cystic Fibrosis

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has signed a definitive asset purchase agreement with Vertex Pharmaceuticals, Inc. (NASDAQ: VRTX) under which Vertex will acquire CTP-656. CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of CF. As part of the agreement, Vertex will pay Concert $160 million in cash for all worldwide development and commercialization rights to CTP-656. If CTP-656 is approved as part of a combination regimen to treat CF, Concert could receive up to an additional $90 million in milestones based on regulatory approval in the U.S. and reimbursement in the UK, Germany or France. The agreement is subject to approval by Concert’s shareholders and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Concert’s Board of Directors unanimously support the transaction and recommend that Concert’s shareholders vote in favor of it.

“With Vertex’s clinical and commercial expertise in CF, this agreement provides the optimal pathway to rapidly advance the development of CTP-656 for the benefit of cystic fibrosis patients,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “The financial strength provided to Concert by this agreement will allow us to advance CTP-543 into pivotal testing and broaden our proprietary development pipeline.”

CTP-656 was developed by Concert through the application of deuterium chemistry to modify Vertex’s CFTR potentiator ivacaftor. Ivacaftor was discovered by Vertex scientists and is approved in the U.S., Europe, Canada and Australia for people with CF who have specific mutations in the CFTR gene. CTP-656 has the potential to play a key role in future once-daily combination regimens to treat CF. Concert is currently conducting a Phase 2 study of CTP-656 in people with CF who have gating mutations. As part of the agreement, Vertex will acquire rights to all of Concert’s other CF research and preclinical programs.

Conference Call to Discuss Asset Purchase and 2016 Financial Results

The Company will host a conference call and webcast today at 8:30 a.m. EST to discuss this announcement and discuss full year 2016 financial results. To access the conference call, please dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International) five minutes prior to the start time.

A live webcast may be accessed in the Investors section of the company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.

Additional Information about the Transactions and Where to Find It

This press release is being made in respect of the proposed asset sale with Vertex. The proposed asset sale and the asset purchase agreement will be submitted to the shareholders of the Company for their consideration and approval. In connection with the proposed asset sale, the Company will file a proxy statement with the SEC. This press release does not constitute a solicitation of any vote or proxy from any shareholder of the Company. Investors are urged to read the proxy statement carefully and in its entirety when it becomes available and any other relevant documents or materials filed or to be filed with the SEC or incorporated by reference in the proxy statement, because they will contain important information about the proposed asset sale. The definitive proxy statement will be mailed to the Company’s shareholders. In addition, the proxy statement and other documents will be available free of charge at the SEC’s internet website, www.sec.gov. When available, the proxy statement and other pertinent documents may also be obtained free of charge at the Investors section of the Company’s website, www.concertpharma.com, or by directing a written request to Concert Pharmaceuticals, Inc., Attn: Investor Relations, in writing, at 99 Hayden Ave, #500, Lexington, MA 02421.

The Company and its directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed asset sale. Information about the Company’s directors and executive officers is included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 6, 2017. Additional information regarding these persons and their interests in the transaction will be included in the proxy statement relating to the proposed asset sale when it is filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

About Concert

Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The Company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, autoimmune and inflammatory diseases and central nervous systems (CNS) disorders. For more information please visit www.concertpharma.com.

Cautionary Note on Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about the asset purchase agreement, potential payments to be received pursuant to the asset purchase agreement, clinical development of CTP-656 and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.

Concert Pharmaceuticals, Inc.
Justine Koenigsberg (Investors), 781-674-5284
ir@concertpharma.com
or
The Yates Network
Kathryn Morris (Media), 845-635-9828

$TGTX Positive Topline Data, Phase 3 Study #TG1101 in #CLL Leukemia

Study met its primary endpoint, with TG-1101 (ublituximab) plus ibrutinib increasing Overall Response Rate (ORR) by >70% over ibrutinib alone

The combination was well tolerated with a safety profile consistent with the Phase 2 study of ublituximab plus ibrutinib recently published in the British Journal of Haematology

Targeting full data presentation at a medical meeting in 1H17 and meeting with FDA in 2H17 to discuss the results and filing for accelerated approval

Conference call to be held today, Monday March 6, 2017 at 8:30 am ET, with Dr. Anthony Mato from the University of Pennsylvania, a lead enroller in the GENUINE trial

NEW YORK, March 06, 2017 — TG Therapeutics (NASDAQ:TGTX) today announced positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).  For the study, high risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.

The multicenter, randomized trial (NCT02301156), which assessed the efficacy and safety of TG-1101 plus ibrutinib, met its primary endpoint, demonstrating a statistically significant improvement in Overall Response Rate (ORR) compared to ibrutinib alone in both the Intent to Treat (ITT) population (p=0.001) and Treated population (p<0.001).  The ITT population includes all 126 randomized patients (64 in the TG-1101 + ibrutinib arm and 62 in the ibrutinib alone arm) while the Treated population includes all ITT patients that received at least one dose of either study drug (59 in the TG-1101 + ibrutinib arm and 58 in the ibrutinib alone arm).

Overall Response Rates

All responses were assessed by independent blinded central review using the iwCLL 2008 guidelines.  Per iwCLL guidelines, responders require confirmation of response for a minimum duration of 2 months.  As of the date of the analysis, each arm had responders that were awaiting confirmation visits which are scheduled to occur over the next two months.  During the study it was infrequent (less than 3% in the combination arm) for initial responses to fail to be confirmed.  Median follow-up for the study was approximately 12 months.

The GENUINE study was designed to demonstrate the value of adding TG-1101, a highly potent next generation glycoengineered anti-CD20 monoclonal antibody to ibrutinib monotherapy in high risk CLL, and was powered to show a statistically significant improvement in ORR, with a minimal absolute detectable difference between the two arms of approximately 20%.  The absolute difference between the arms was approximately 30% resulting in a p-value of ≤ 0.001.  Results from registration directed studies included in the ibrutinib prescribing information demonstrate single agent ibrutinib response rates ranging from 43% to 58% in patients with previously treated CLL, with the findings from the GENUINE study of 47% ORR for ibrutinib fitting well within historical experience.

In addition to ORR, observed advantages were seen for the combination in a number of secondary and other efficacy measures, including radiographic Complete Response (CR) rate, Progression Free Survival and Time to Response. Sufficient data on MRD negative status and bone marrow confirmation of radiographic CRs were not available at the time of analysis. From a safety standpoint, the combination was well tolerated with a safety profile consistent with the Phase 2 study of ublituximab plus ibrutinib recently published in the British Journal of Haematology.

A full analysis of the Phase 3 GENUINE data along with detailed efficacy and safety results will be submitted for presentation at a medical meeting in the first half of 2017 and the Company plans to meet with the FDA as soon as possible thereafter to discuss the filing of the data for accelerated approval.

“TG-1101 is a highly potent next generation glycoengineered anti-CD20 monoclonal antibody.  We believe the data today demonstrate that the addition of TG-1101 to ibrutinib enhances the therapeutic benefit of ibrutinib in patients with previously treated high risk CLL, the patient population with the poorest outcome on ibrutinib.  We believe the results observed in the combination arm are extremely compelling and the regimen has the potential to become the standard of care for treating patients with high risk CLL that have progressed from other therapies,” said Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. Mr. Weiss continued, “We believe that using combination therapy to accelerate and deepen response in poor prognosis high risk CLL is critically important for patient outcomes and we look forward to sharing these data with the FDA in the coming months to discuss filing for accelerated approval.  Most importantly, we would like to thank the investigators and their patients for participating in this significant research.”

Dr. Jeffrey Sharman, the GENUINE Phase 3 Study Chair and the Medical Director for Hematology Research for the US Oncology Network, commenting on the results stated, “Ibrutinib has been a great addition to our CLL armamentarium, however we have long believed that ibrutinib alone may not be enough, particularly for patients with high-risk disease.  This study demonstrates that the addition of ublituximab, can significantly enhance the response rates without compromising safety.  We believe that the rapid responses seen in our Phase 2 study with ublituximab plus ibrutinib are validated here in our Phase 3 GENUINE study and are important markers of improved overall efficacy and patient outcomes.  I look forward to the presentation of the results at an upcoming medical meeting.”

ABOUT THE PHASE 3 GENUINE STUDY

The Phase 3 GENUINE study is a randomized, open label, multicenter clinical trial to evaluate the safety and efficacy of TG-1101 (ublituximab) plus ibrutinib compared to ibrutinib alone in adult patients with high risk Chronic Lymphocytic Leukemia (CLL) who received at least one prior therapy for their disease.

The study was conducted at 160 clinical trial sites in the US and Israel and randomized 126 patients.  Patients received ibrutinib orally at 420 mg once daily in both arms and in the treatment arm those patients also received intravenous infusions of TG-1101 at 900 mg dosed on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6.  Patients in the treatment arm who had not progressed received quarterly infusions of TG-1101 maintenance at 900 mg.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Monday March 6, 2017 at 8:30 am ET to discuss the Phase 3 GENUINE Trial Topline Data.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Phase 3 GENUINE Topline Data Call.  A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 also in clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Statements included in this press release, including without limitation those with respect to expected results and results to date of the GENUINE Phase 3 study, the potential efficacy of TG-1101 in combination with ibrutinib, anticipating the timing of and data to be included in the full presentation and analysis of the GENUINE Phase 3 data, the willingness of the FDA to review the data for approval and any likelihood of FDA approval or disapproval and the timing of filing of a BLA for TG-1101, if any may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE or the UNITY-CLL trials; the risk that the clinical results from the GENUINE or UNITY-CLL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the pending GENUINE confirmation scans may have a negative effect on the topline data presented; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE trial or the UNITY-CLL trial; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study or the UNITY-CLL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL study, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX – G

CONTACT:

            Jenna Bosco
            Vice President, Investor Relations
            TG Therapeutics, Inc.
            Telephone: 212.554.4351
            Email: ir@tgtxinc.com

$DERM New Data in Hyperhidrosis, Acne at American Academy of Dermatology 2017

Data from glycopyrronium tosylate Phase 3 program and olumacostat glasaretil Phase 2 trial show patients experienced early and sustained clinical effects with each treatment

ORLANDO, Fla., March 03, 2017 — Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced new data, from its glycopyrronium tosylate (formerly DRM04) and olumacostat glasaretil (formerly DRM01) clinical programs, were presented in separate poster sessions at the 75^th Annual Meeting of the American Academy of Dermatology (AAD) in Orlando, Florida.

Glycopyrronium tosylate is formulated as a topical, once-daily anticholinergic agent that is currently in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating). Olumacostat glasaretil is a novel, small molecule designed to target sebum production following topical application, in development for the treatment of acne vulgaris.

Building on previously reported results from the glycopyrronium tosylate Phase 3 clinical program and the olumacostat glasaretil Phase 2b dose-ranging trial, new data presented today at AAD showed that patients who received treatment with these investigational topical therapies in the respective trials experienced early and sustained clinical effects compared to vehicle.

“Hyperhidrosis has historically been an undertreated and underserved skin condition. As a result, millions of patients have been suffering silently,” said David Pariser, M.D., professor at Eastern Virginia Medical School, Department of Dermatology. “These new time course data are exciting because treatment with glycopyrronium tosylate not only resulted in statistically significant improvements in sweating severity at four weeks, but patients began to see reductions in sweating severity after the first week of treatment.”

“Dermira is advancing clinical programs in primary axillary hyperhidrosis and acne vulgaris, both areas of great unmet need where the standard of care hasn’t changed significantly in several decades,” said Eugene A. Bauer, M.D., chief medical officer of Dermira and a dermatologist. “These new data demonstrate that patients applying glycopyrronium tosylate and olumacostat glasaretil topically began to experience reductions in sweating severity and acne lesions early in their treatment cycles.”

Glycopyrronium Tosylate Phase 3 Clinical Program in Primary Axillary Hyperhidrosis

• In June 2016, Dermira reported data from ATMOS-1 and ATMOS-2, two identical Phase 3 multi-center clinical trials that evaluated the efficacy and safety of glycopyrronium tosylate 3.75% compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis.
• In the ATMOS-1 trial, 229 patients were randomized to receive glycopyrronium tosylate and 115 patients were randomized to receive vehicle; and in the ATMOS-2 trial, 234 patients were randomized to receive glycopyrronium tosylate and 119 patients were randomized to receive vehicle. Patients were instructed to apply the study product to each underarm once daily for four weeks using topical wipes containing either glycopyrronium tosylate or vehicle only.
• The co-primary endpoints were the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument, and the average absolute change from baseline in gravimetrically-measured sweat production.
• In both trials, the effect of treatment with glycopyrronium tosylate compared to vehicle, as measured by both ASDD and reduction in sweat production, were observed at week 1, and continued through week 4 of the 4-week trial.
• Glycopyrronium tosylate-treated patients began to see an improvement in sweating severity compared to vehicle, as measured by ASDD, at week 1 in ATMOS-1 (22.9% vs. 5.3%) and ATMOS-2 (29.0% vs. 4.2%), that continued through the completion of the 4-week treatment period.
• Patients also began to experience a reduction in gravimetrically-measured sweat production compared to vehicle beginning at week 1 in ATMOS-1 (-75.5 mg vs. -58.0 mg) and ATMOS-2 (-108.0 mg vs. -56.8 mg).

Consistent with the results from the Phase 2 clinical program, glycopyrronium tosylate was generally well-tolerated with side effects that were primarily mild to moderate in severity. The most frequently reported adverse events across both trials compared to vehicle were dry mouth, application site pain, dilated pupil (mydriasis), headache, sore throat (oropharyngeal pain), upper respiratory tract infection, blurred vision, urinary hesitation and dry eye. There was one treatment-related serious adverse event reported in the ATMOS-1 trial for a patient treated with glycopyrronium tosylate who reported a dilated pupil. There were no treatment-related serious adverse events reported in the ATMOS-2 trial.

Dry mouth, dilated pupil, blurred vision, urinary hesitation and dry eye are well-known, reversible side effects of anticholinergic agents.

Olumacostat Glasaretil Phase 2b Dose-Ranging Study in Acne Vulgaris

• In May 2016, Dermira reported topline results from the Phase 2b dose-ranging study evaluating the efficacy and safety of olumacostat glasaretil in patients with facial acne vulgaris compared to vehicle.
• In the Phase 2b dose-ranging trial, 420 patients were randomized into five separate arms and instructed to apply olumacostat glasaretil at concentrations of 4.0% once daily (n=106), 7.5% once daily (n=110) or 7.5% twice daily (n=101), or to apply vehicle once or twice daily (n=53 and n=50, respectively), in all cases for 12 weeks.
• The primary endpoints were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured at the end of the 12-week treatment period.
• Olumacostat glasaretil demonstrated statistically significant improvements from baseline to week 12 relative to the combined vehicle group in all primary efficacy endpoints at the highest dose of olumacostat glasaretil tested and in most primary endpoints at the two lower doses tested.
• Patients in the trial began to experience a reduction in inflammatory lesions with olumacostat glasaretil compared to vehicle at week 4 (-9.2, -8.6, -8.7 for olumacostat glasaretil 7.5% twice daily, 7.5% once daily and 4.0% once daily, respectively, vs. -7.2 for vehicle), which continued through week 8 (-12.3, -12.8, -12.3 vs. -9.7) and through to the end of the 12-week treatment period (-15.0, -14.5, -14.6 vs. -10.7).
• Reductions in non-inflammatory lesions with olumacostat glasaretil compared to vehicle were seen at week 4 (-8.6, -7.7, -8.3 for olumacostat glasaretil 7.5% twice daily, 7.5% once daily and 4.0% once daily, respectively, vs. -6.8 for vehicle), which continued through week 8 (-12.5, -11.9, -13.3 vs. -8.7) and through to the end of the 12-week treatment period (-17.5, -13.4, -15.3 vs. -9.3).

Consistent with an earlier Phase 2a study, olumacostat glasaretil was well-tolerated. Adverse events were primarily mild or moderate in severity. The most frequently reported adverse events across all three treatment groups were the common cold (nasopharyngitis), upper respiratory tract infection and application site itching (pruritus). No treatment-related serious adverse events were reported.

Based on the results of the two Phase 2 trials, in December 2016 Dermira initiated a Phase 3 clinical program evaluating the safety and efficacy of olumacostat glasaretil in patients with facial acne vulgaris.

About Glycopyrronium Tosylate
Glycopyrronium tosylate is formulated as a topical, once-daily anticholinergic agent that is currently in clinical development for the treatment of primary axillary hyperhidrosis. Glycopyrronium tosylate is designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation. Dermira intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in the second half of 2017, subject to the completion of registration-enabling activities.

About Hyperhidrosis
Hyperhidrosis is a condition of sweating beyond what is physiologically required to maintain normal thermal regulation. Sweat is produced by glands in the skin and released to the skin surface through ducts. Sweat gland activity is controlled by the nervous system. The nervous system transmits signals to the sweat glands through acetylcholine, which is a known neurotransmitter. Primary hyperhidrosis, which is excessive sweating without a known cause, can affect the underarms, palms of the hands, soles of the feet, face and other areas. Several studies have demonstrated that excessive sweating often impedes normal daily activities and can result in occupational, emotional, psychological, social and physical impairment. Studies also suggest that the negative impact caused by excessive sweating has been reported to be similar to, if not greater than, the negative impact caused by conditions, such as psoriasis and other chronic diseases. According to a survey published in 2016, the prevalence of hyperhidrosis in the United States is estimated to be 4.8% of the population, or approximately 15.3 million people. According to this published study, 65% of hyperhidrosis sufferers in the United States have axillary hyperhidrosis, and approximately half of those axillary hyperhidrosis sufferers, or 5.2 million Americans, have severe disease that is barely tolerable and frequently interferes or is intolerable and always interferes with daily activities.¹

About Olumacostat Glasaretil
Olumacostat glasaretil is a novel, small molecule designed to target sebum production following topical application. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect of acne that is not addressed by available topical therapies. Olumacostat glasaretil is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids. Olumacostat glasaretil is currently being evaluated in two Phase 3 trials, CLAREOS-1 and CLAREOS-2, assessing its safety and efficacy. An additional open-label trial, CLARITUDE, is evaluating the long-term safety of olumacostat glasaretil. Topline results from the CLAREOS-1 and CLAREOS-2 trials are expected in the first half of 2018.

About Acne
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting approximately 50 million Americans and 85% of all teenagers. Acne is caused by the accumulation of dead skin cells, oil and bacteria in pores. It is characterized by clogging of the pores and associated local skin lesions. Acne lesions are believed to result from an interaction of multiple pathogenic, or contributing, factors, including excessive sebum production. Acne is not just about blemishes on the skin; it can also affect a person’s quality of life, resulting in social, psychological and emotional impairments.

1. Doolittle et. al., Hyperhidrosis: an update on prevalence and severity in the United States. Arch. Dermatol Res 308:743-749, 2016.

About Dermira
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate, in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.

Forward-Looking Statements
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to timing expectations for the receipt and announcement of topline results from, and the successful completion of, Dermira’s CLAREOS-1, CLAREOS-2 and CLARITUDE trials; and the timing and submission of an NDA to the FDA for glycopyrronium tosylate. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcome of Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to obtain regulatory approval for its product candidates; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

Media:  
Erica Jefferson
Senior Director, Head of Corporate Communications
650-421-7216
erica.jefferson@dermira.com

Investors:
Andrew Guggenhime
Chief Operating Officer and Chief Financial Officer 
650-421-7200
investor@dermira.com

Robert H. Uhl
Westwicke Partners
Managing Director
858-356-5932
robert.uhl@westwicke.com

$POLA to Present at the 29th Annual ROTH Conference on March 14, 2017

$AAOI Announces Completion of At the Market Offering

SUGAR LAND, Texas, March 03, 2017 — Applied Optoelectronics, Inc. (NASDAQ: AAOI), a leading provider of fiber-optic access network products for the internet datacenter, cable broadband, fiber-to-the-home (FTTH) and telecom markets, today announced the completion of its previously-announced $50.0 million “at the market” common stock offering. The company sold a total of 1,584,620 shares, raising net proceeds (after sales commissions) of $49.0 million. Of the total shares issued under the offering, 459,020 shares were sold in 2017 and 1,125,600 shares were sold in 2016.

“As AOI continues its rapid growth, this additional capital will enable us to continue to invest in our manufacturing and R&D capabilities, particularly for our 200 Gbps and 400 Gbps datacenter transceiver products, as well as further increase our laser production capacity,” commented Dr. Stefan Murry, AOI’s chief financial officer and chief strategy officer.

Forward-Looking Information

This press release contains forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions and current expectations, which could cause the company’s actual results to differ materially from those anticipated in such forward-looking statements. These risks and uncertainties include but are not limited to: reduction in the size or quantity of customer orders; change in demand for the company’s products due to industry conditions; changes in manufacturing operations; volatility in manufacturing costs; delays in shipments of products; disruptions in the supply chain; change in the rate of design wins or the rate of customer acceptance of new products; the company’s reliance on a small number of customers for a substantial portion of its revenues; potential pricing pressure; a decline in demand for our customers’ products or their rate of deployment of their products; general conditions in the internet datacenter, CATV, FTTH or Telecom markets; changes in the world economy (particularly in the United States and China); the negative effects of seasonality; and other risks and uncertainties described more fully in the company’s documents filed with or furnished to the Securities and Exchange Commission. More information about these and other risks that may impact the company’s business are set forth in the “Risk Factors” section of the company’s quarterly and annual reports on file with the Securities and Exchange Commission. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “could,” “would,” “target,” “seek,” “aim,” “believe,” “predicts,” “think,” “objectives,” “optimistic,” “new,” “goal,” “strategy,” “potential,” “is likely,” “will,” “expect,” “plan,” “project,” “permit”  or by other similar expressions that convey uncertainty of future events or outcomes. You should not rely on forward-looking statements as predictions of future events. All forward-looking statements in this press release are based upon information available to us as of the date hereof, and qualified in their entirety by this cautionary statement. Except as required by law, we assume no obligation to update forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in the company’s expectations.

About Applied Optoelectronics
Applied Optoelectronics Inc. (AOI) is a leading developer and manufacturer of advanced optical products, including components, modules and equipment. AOI’s products are the building blocks for broadband fiber access networks around the world, where they are used in the internet datacenter, CATV broadband, FTTH and telecom markets. AOI supplies optical networking lasers, components and equipment to tier-1 customers in all four of these markets. In addition to its corporate headquarters, wafer fab and advanced engineering and production facilities in Sugar Land, TX, AOI has engineering and manufacturing facilities in Taipei, Taiwan and Ningbo, China. For additional information, visit www.ao-inc.com.

Investor Relations Contact:

The Blueshirt Group, Investor Relations
Maria Riley & Chelsea Lish
+1-415-217-7722
ir@ao-inc.com

$XBIT Announces Registered Direct Offering of Common Shares

AUSTIN, Texas, March 03, 2017 — XBiotech Inc. (NASDAQ:XBIT) today announced that it has entered into definitive agreements to sell an aggregate of approximately US$31,000,000 of common shares in a registered direct offering. The transaction was completed from the Company’s shelf registration at $13 per share.

The closing of this offering is expected to take place on or about March 8, 2017, subject to the satisfaction of customary closing conditions. XBiotech’s president & CEO, John Simard, stated, “I am very pleased to complete this strategic offering, giving us secure runway while we await outcomes of key near-term milestones. Our ability at this time to execute this substantial direct offering is testament to the strength, commitment and confidence of our shareholder base.”

Net proceeds of the offering will be used primarily for continued development of XBiotech’s clinical programs, commercialization expenses upon possible EMA/FDA approval(s), manufacturing operations and general corporate purposes.

The common shares are being offered pursuant to an effective shelf registration statement on Form S-3 previously filed with and declared effective by the Securities and Exchange Commission.  The prospectus supplement and accompanying prospectus relating to the offering contain important information relating to the XBiotech common shares. The prospectus supplement will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov, or may be obtained, when available, by contacting XBiotech Inc.., Attn: Investor Relations, 8201 E. Riverside Drive Bldg. 4, Ste. 100 Austin, TX 78744, or by telephone at: (512) 386-2900.

This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  This offering may only be made by means of a prospectus supplement and related base prospectus.

About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including with respect to the proposed offering of common shares, declarations regarding management’s beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “could,” “expects,” “plans,” “contemplate,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “intend” or “continue” or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the “Risk Factors” section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

$NOVN Announces SB204 Program Update Conference Call and Webcast

MORRISVILLE, N.C., March 03, 2017 — Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced that the Company will host a conference call on Monday, Mar. 6, at 8 a.m. Eastern Time to provide an update on the SB204 development program. Callers should dial in approximately 10 minutes prior to the start of the call. No reservation is necessary to participate on the call. The phone number to join the conference call is +1 (844) 707-0661 (toll-free in the United States and Canada) or +1 (703) 318-2240 (international). The conference ID for the live call is 77470993. A live webcast will be accessible from the Events page of the Company’s website at http://Events.Novan.com. The webcast will be archived on the Company’s website for 90 days following the live call.

About Novan

Novan, Inc. is a late-stage pharmaceutical company focused on redefining the standard of care in dermatology through the development and commercialization of innovative therapies using the Company’s nitric oxide-releasing platform. Nitric oxide plays a vital role in the natural immune system response against microbial pathogens and is a critical regulator of inflammation. Our ability to harness nitric oxide and its multiple mechanisms of action has enabled us to create a platform with the potential to generate differentiated, first-in-class product candidates. We are rapidly advancing programs in five dermatological conditions with significant unmet medical need. We believe that our ability to conveniently deploy nitric oxide on demand in topical formulations allows us the potential to significantly improve patient outcomes in a variety of skin diseases and positions us to be a commercially successful leader in the dermatology market.

For more information, visit the Company’s website at www.Novan.com.

CONTACT:

(Investors)
Sean Andrews, Senior Director of Investor Relations
Novan, Inc.
919-627-6847
investors@novan.com

(Media)
Deb Holliday
Pascale Communications, LLC
412-877-4519
deb@pascalecommunications.com

$RTNB to Participate in 29th Annual ROTH Conference

COLORADO SPRINGS, Colo., March 2, 2017 — root9B Holdings, Inc. (NASDAQ: RTNB) (“Company”) today announced that it will attend the 29th Annual ROTH Conference in Dana Point, CA.   The Company’s management will conduct one-on-one meetings with interested investors throughout the day on Monday, March 13, 2017 and host a formal presentation at 9:30 am Pacific Time on Wednesday, March 15, 2017.  A copy of the presentation will be available under the “Investor Relations” section of the Company’s website at www.root9bholdings.com

Conference participation is by invitation only and registration is mandatory. For more information on the conference or to schedule a one-on-one meeting, please contact conference@roth.com or your ROTH representative at (800) 933-6830.

About root9B

Ranked as the #1 Cybersecurity company for five consecutive quarters by Cybersecurity Ventures (Jan 2016), root9B stands in defiance of the unwanted human presence within our clients’ networks by attacking the root of the problem—the adversary’s ability to gain entry and remain undetected. root9B’s application of advanced technology developed through cutting-edge R&D and engineering and refined through relevant, hands-on training is revolutionary. root9B combines next generation technology, tactics development, specialty tools, and deep mission experience. root9B personnel leverage their extensive backgrounds in the U.S. Intelligence Community to conduct advanced vulnerability analysis, penetration testing, digital forensics, incident response, Industrial Control System (ICS) security, and Active Adversary Pursuit (HUNT) engagements on networks worldwide. For more information, visit www.root9B.com.

About root9B Holdings, Inc.

root9B Holdings is a leading provider of Cybersecurity and Regulatory Risk Mitigation Services. Through its wholly owned subsidiaries root9B and IPSA International, the Company delivers results that improve productivity, mitigate risk and maximize profits. Its clients range in size from Fortune 100 companies to mid-sized and owner-managed businesses across a broad range of industries including local, state and government agencies. For more information, visit www.root9bholdings.com

$CLUB Takes Over Shuttered David Barton Gym

New York Sports Clubs to Open “Elite” Gym at Newmark Holdings’ 4 Astor Place