Archive for September, 2016

$GBSN Announces Effectiveness of #ReverseStockSplit

Company has 1.0 million shares of common stock outstanding post-split

First paragraph, second sentence of release should read: The Company’s common stock will begin trading at the open of today’s market on a split-adjusted basis under new CUSIP number 39013L601 (instead of … new CUSIP number 39013L502).

The corrected release reads:

GREAT BASIN ANNOUNCES EFFECTIVENESS OF REVERSE STOCK SPLIT OF COMMON STOCK

Company has 1.0 million shares of common stock outstanding post-split

Great Basin Scientific, Inc. (Nasdaq:GBSN), a molecular diagnostics company, announced today that it has effected a 1-for-80 reverse split of its common stock, par value $0.0001. The Company’s common stock will begin trading at the open of today’s market on a split-adjusted basis under new CUSIP number 39013L601. The reverse split reduced the number of shares outstanding from 78.4 million to approximately 1.0 million.

The reverse stock split impacts all holders of the Company’s common stock uniformly, and does not affect any stockholder’s percentage ownership interest in the Company or proportionate voting power.

Additional information regarding Great Basin’s reverse stock split is available in the definitive proxy statement filed by the Company with the U.S. Securities and Exchange Commission on August 22, 2016.

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the Company’s website at www.gbscience.com.

Forward-Looking Statements

This press release includes forward-looking statement regarding events, trends and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding the timing and effect of the reverse stock split and statements regarding the Company’s general development plans of sample-to-result technology and products. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. These forward-looking statements speak only as of the date hereof, and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.

 

Investor Relations:
Great Basin Scientific
Betsy Hartman, 385-215-3372
ir@gbscience.com
or
Media:
ICR
Nirav Suchak, 646-277-1257
Nirav.Suchak@icrinc.com

Friday, September 16th, 2016 Uncategorized Comments Off on $GBSN Announces Effectiveness of #ReverseStockSplit

$ACRX Positive Results for #ARX04 In #AcutePain

– Majority of Patients Had No Adverse Event; Similar Across All Subgroups – Pain Intensity Was Reduced by 27% at 1 Hour, 49% at 2 Hours, 57% at 12 Hours – Phase 3 Program Now Complete; AcelRx Intends to Submit ARX-04 NDA This Year

REDWOOD CITY, Calif., Sept. 15, 2016  — AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that in an open-label Phase 3 trial (SAP303), investigational product candidate ARX-04 (sufentanil sublingual tablet 30 mcg) was well tolerated in the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment. Regardless of age and organ function, approximately 2 in 3 patients had no adverse events during the study (63% of all patients, 63% of those aged ≥65 years, 62% of those with hepatic impairment, 70% of those with renal impairment). The most common adverse events were nausea and headache. On a global assessment of ARX-04 as a method of pain control, 90% of healthcare professionals and 87% of patients responded “good” or “excellent.”

“Following short-stay in-hospital surgery, post-operative patients who do not require long-term analgesia still need safe and effective short-term pain management for efficient discharge,” said Pamela Palmer, MD, PhD, co-founder and Chief Medical Officer of AcelRx Pharmaceuticals. “In the SAP303 trial, I was impressed that the majority of patients—including the majority of higher-risk patients—did not experience any adverse events.”

SAP303 (NCT02662556) is a multicenter, single-arm, open-label Phase 3 trial that enrolled 140 patients aged ≥40 years who were expected to have moderate-to-severe acute pain after surgery. The primary objective of SAP303 was to study the safety of ARX-04 in the post-operative management of moderate-to-severe acute pain. Recruitment included patients aged ≥65 years and patients with comorbidities.

The mean age for all patients in SAP303 was 54.7 years, and 17% of patients were aged ≥65 years. More than 1 in 4 patients (29%) had some degree of baseline hepatic and/or renal impairment. Nearly 7 in 10 patients (69%) were American Society of Anesthesiologists Physical Status Classification II or III (mild or severe systemic disease). During the 12-hour study period, the mean total number of ARX-04 doses administered was 3.3, which was similar for patients with normal and impaired liver function and for patients with normal and impaired renal function. The mean inter-dosing interval was more than 3 hours (193 minutes).

Safety variables included the assessment of adverse events, vital signs (blood pressure, heart rate, and respiratory rate), and oxygen saturation. The primary efficacy variable was the time-weighted summed pain intensity difference over the 12-hour study period (SPID12), and secondary efficacy variables included pain intensity by evaluation time point.

Safety results showed that, overall, there were no differences in adverse events between patients with normal and impaired liver function or between patients with normal and impaired renal function. No clinically meaningful changes from baseline in vital signs or oxygen saturation were observed, and no opioid reversal agents were needed in the study.

The primary and secondary efficacy endpoints showed a reduction in pain intensity starting at 30 minutes after the first dose of ARX-04, followed by 27%, 49%, and 57% reductions in mean pain intensity from a baseline mean pain score of 6.2 at 1 hour, 2 hours, and 12 hours, respectively.

“Following surgery, and especially following short-stay in-hospital surgery, there is a significant unmet need for an efficacious opioid with good tolerability, particularly in higher-risk patients,” said Maurice Jové, MD, who is Medical Director of the Joint Solutions Center at DeKalb Medical and an orthopedic surgeon at Atlanta Knee and Sports Medicine in Decatur, Ga. “ARX-04, if approved, could be the treatment option to meet that need.”

Today’s announcement marks the completion of the ARX-04 Phase 3 clinical program, which comprises SAP303 and 2 earlier Phase 3 trials in patients with moderate-to-severe acute pain:

  • SAP301, an ambulatory surgery study that reported positive results in 2015 at the American Society of Anesthesiologists annual meeting
  • SAP302, an emergency room study that reported positive results in 2016 at the Military Health System Research Symposium (MHSRS)

With positive data from all 3 studies, AcelRx intends to submit a new drug application (NDA) for ARX-04 for the treatment of moderate-to-severe acute pain in medically supervised settings with the U.S. Food and Drug Administration (FDA) by the end of 2016.

Conference Call
AcelRx will conduct a conference call and webcast this morning, September 15, at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss the trial results. To listen to the conference call, dial in approximately ten minutes before the scheduled call 877-407-9129 for domestic and Canadian callers, or 201-493-6753 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors section of the company’s website at www.acelrx.com. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investors section of the company’s website at www.acelrx.com.

Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries.

In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About ARX-04
ARX-04 is a non-invasive investigational product candidate consisting of 30-mcg sufentanil tablets delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites.

About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. The Company’s late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, non-invasive, patient-controlled analgesia device. Zalviso is approved in the E.U. as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.

For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx’s product candidates, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso® (sufentanil sublingual tablet system), including the ARX-04 clinical trial results; anticipated submission of the New Drug Application, or NDA, for ARX-04 to the U.S. Food and Drug Administration, or FDA; AcelRx’s pathway forward towards gaining approval of Zalviso in the U.S.; and the therapeutic and commercial potential of AcelRx’s product candidates, including potential market opportunities for ARX-04 and Zalviso. These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals’ ARX-04 development program, including anticipated submission of the ARX-04 NDA and the fact that the FDA may dispute or interpret differently clinical results obtained to date from the Phase 3 studies of ARX-04; AcelRx’s ability to successfully execute the pathway towards a resubmission of the Zalviso NDA, including the successful initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical development process, including adverse events; the risk that planned clinical trials, including the IAP312 clinical study for Zalviso, may not begin on time, have an effective clinical design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx’s U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on July 29, 2016. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Thursday, September 15th, 2016 Uncategorized Comments Off on $ACRX Positive Results for #ARX04 In #AcutePain

$BTX Affiliate Positive #Efficacy Data, Cervical #SpinalCordInjury

BioTime, Inc. (NYSE MKT:BTX), a clinical stage regenerative medicine company with a focus on pluripotent stem cell technology, today announced that its affiliate, Asterias Biotherapeutics, announced positive interim efficacy data from the AST-OPC1 SCiSTAR Phase 1/2a clinical study in patients with complete cervical spinal cord injuries at the 55th Annual Scientific Meeting of the International Spinal Cord Society (ISCoS) on September 14, 2016.

For additional information on the data, please see the ISCoS conference presentation on Asterias’ website at: http://asteriasbiotherapeutics.com/wp-content/uploads/2016/09/Wirth-ISCoS-14SEP2016-talk-FINAL.pdf as well as: http://www.multivu.com/players/English/7924251-asterias-ast-opc1-spinal-cord-injury/?tc=eml_cleartime

“The positive efficacy data from the AST-OPC1 SCiSTAR study reinforces our belief in the unique regenerative potential of pluripotent stem cell-derived therapeutics. An additional example is OpRegen®, which is in a Phase 1/2a study for treating dry-AMD. These and other products in our pipeline have the potential to be first-in-class products addressing the large unmet needs associated with degenerative disease,” said Michael D. West, Ph.D., BioTime’s Co-Chief Executive Officer.

About BioTime

BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what we believe to be the world’s premier collection of pluripotent cell assets. The foundation of our core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.

In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.

BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com.

 

BioTime, Inc.
Dan L. Lawrence, 510-775-0510
dlawrence@biotimeinc.com
or
Investor Contact:
EVC Group, Inc.
Michael Polyviou, 646-445-4800
mpolyviou@evcgroup.com
or
Media Contact:
Gotham Communications, LLC
Bill Douglass, 646-504-0890
bill@gothamcomm.com

Thursday, September 15th, 2016 Uncategorized Comments Off on $BTX Affiliate Positive #Efficacy Data, Cervical #SpinalCordInjury

$VIVE Distribution Agreement for #Viveve System With #Melon Ltd. in #Finland

SUNNYVALE, CA–(September 15, 2016) – Viveve Medical, Inc. (“Viveve”) (NASDAQ: VIVE), a medical technology company focused on women’s health, today announced the entry into a distribution agreement for the Viveve System with Melon Ltd., a leading distributor of healthcare and aesthetic products including treatment devices, instruments and cosmetics. Melon Ltd. is based in Tampere, Finland and offers an extensive selection of high-quality products from leading manufacturers in Europe, USA and Israel.

“We are pleased to be able to bring the Viveve System, which has been clinically proven to offer an effective and painless treatment for vaginal laxity, to physicians and their female patients in Finland in partnership with Melon Ltd.,” said Patricia Scheller, chief executive officer of Viveve. “We believe that Melon Ltd. is well positioned to successfully introduce our unique technology and rapidly bring the benefits of the Viveve System to women throughout Finland who are living with the challenges of vaginal laxity.”

Including this distribution agreement with Melon Ltd., Viveve has distribution partnerships in place for the Viveve System in 69 countries around the world. To date, the technology has received regulatory clearance in 30 of those countries.

“The Viveve System is a great reflection of our commitment to work with leaders in medical technology that are bringing important advances in healthcare to Finland. We offer only what we believe are the finest technologies with evidence of safety and optimal results,” said Juha Hiltunen, executive vice president of Melon Ltd. “The Viveve System fits perfectly into our product portfolio and we’re excited to offer this proven safe and effective technology to address a significant unmet need in women’s health in the years ahead.”

About Viveve

Viveve Medical, Inc. is a women’s health company passionately committed to advancing new solutions to improve women’s overall well-being and quality of life. The company’s lead product, the internationally patented Viveve System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue with only one treatment session. The Viveve System treats the condition of vaginal laxity that can result in decreased physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten vaginal tissue in one 30-minute out-patient treatment in a physician’s office. The Viveve System has received regulatory approval in many countries throughout the world and is available through physician import license in Japan. It is currently not available for sale in the U.S. For more information, please visit Viveve’s website at www.viveve.com.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are “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. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve® is a registered trademark of Viveve, Inc.

Investor Relations contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

Media contact:
Jessica Burns
Berry & Company Public Relations
(212) 253-8881
jburns@berrypr.com

Thursday, September 15th, 2016 Uncategorized Comments Off on $VIVE Distribution Agreement for #Viveve System With #Melon Ltd. in #Finland

$CLBS Enters Into Agreements To Raise $25 Million in Common Equity

$21 Million in Private Placements, Funded in Two Tranches, Including $5 Million from
Sanford Health to Support Type 1 Diabetes Candidate Development

$4 Million in a Registered Direct Offering to an Existing Institutional Shareholder

BASKING RIDGE, N.J., Sept. 15, 2016  — Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider through its subsidiary PCT, LLC a Caladrius Company™ (“PCT”) with a select therapeutic development pipeline, today announced that on September 14, 2016, it entered into Securities Purchase Agreements with several accredited investors for the sale of 4,449,153 shares of its common stock in private placements of $21 million. Caladrius has a pre-existing relationship with each of these investors, including its now largest institutional shareholder and its strategic collaborator, Sanford Health (“Sanford”), one of the largest health systems in the United States.  The private placements were priced at $4.72 per share of common stock, which represented the closing price of the Company’s common stock on September 13, 2016.  These private placements do not include any stock purchase warrants or any future price adjustments. Sanford, which includes Sanford Research, a non-profit research organization focused on finding a cure for type 1 diabetes, agreed to invest $5 million in this transaction.

Each of the investors in the private placements will invest pro rata in two tranches: (i) $12.6 million is expected to close- on or about September 19, 2016, subject to satisfaction of customary closing conditions, and (ii) $8.4 million is expected to close upon the enrollment of 70 patients in the Company’s Phase 2 Sanford Project: T-Rex Study clinical trial for CLBS03 and the satisfaction of other customary closing conditions. The Company presently anticipates that it could achieve the enrollment of 70 patients as early as mid-2017.

Concurrently with these private placements, the Company entered into a definitive Securities Purchase Agreement with Aspire Capital Fund, LLC (“Aspire Capital”), providing for the sale of 847,458 shares of its common stock in a registered direct offering for $4 million.  This offering was also priced at $4.72 per share of common stock and does not include any stock purchase warrants or any future price adjustments. Aspire Capital has also been a long-term shareholder of the Company.

Caladrius intends to use the net proceeds from the transactions for execution of the Company’s T-Rex Study, principal and interest payments on its loan from Oxford Finance, LLC, and working capital and general corporate purposes.

The shares were offered directly to the investors without a placement agent or underwriter.

The shares of common stock to be issued in the registered direct offering described above were offered pursuant to a “shelf” registration statement (File No. 333-206175), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on August 28, 2015.

The shares of common stock to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company will file a registration statement to cover the “resale” of the shares of common stock to be purchased in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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. When filed with the SEC, copies of the prospectus supplement and the accompanying base prospectus relating to this offering may be obtained at the SEC’s website at http://www.sec.gov.

About The Sanford Project: T-Rex Study 

The landmark study, which is being conducted in collaboration with Sanford Research, a Sanford Health subsidiary, is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for recent-onset T1D with residual beta cell function, in approximately 111 patients age 12 to 17 in two cohorts of subjects. Enrollment of the first cohort, designated for a preliminary safety evaluation, was completed in August 2016.  The result of this evaluation is expected by the end of 2016 and, if satisfactory, will enable the initiation of enrollment of the second subject cohort to reach a total enrollment of approximately 111 subjects.  Patients are randomized into one of three groups to receive either a high dose of CLBS03, a low dose of CLBS03 or placebo.  The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and glucose and hemoglobin A1c levels. For more information on the T-Rex Study, please visit https://clinicaltrials.gov/ct2/show/NCT02691247.

About Sanford Health

Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 43 hospitals and nearly 250 clinics in nine states and four countries. Sanford Health’s 27,000 employees, including 1,400 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children’s clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org.

About Caladrius Biosciences, Inc.

Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of T regulatory cells as an innovative therapy for recent onset type 1 diabetes.  The product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial (The Sanford Project: T-Rex study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency.  The Company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry.  PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise.   For more information, visit www.caladrius.com.

Cautionary Statement on Forward-Looking Statements

Certain matters discussed in this release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Such forward-looking statements include, without limitation, statements with respect to the completion, timing and size of the offering, the expected proceeds from the offering and the anticipated use of the proceeds from the offering.  Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.

Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this release can be found in the Company’s filings with the Securities and Exchange Commission including the Company’s Reports on Forms 10-K and 10-Qs for the year ended December 31, 2015 and the quarter ended June 30, 2016. For forward-looking statements in this release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

Contacts:
Investors:
LHA
Anne Marie Fields
Senior Vice President
Phone: +1-212-838-3777
Email: afields@lhai.com                    

Media:
Caladrius Biosciences, Inc.
Eric Powers
Director, Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
Thursday, September 15th, 2016 Uncategorized Comments Off on $CLBS Enters Into Agreements To Raise $25 Million in Common Equity

$RADA Reports Backlog Growth Following new orders of over $11 million

NETANYA, Israel, Sept. 15, 2016  — RADA Electronic Industries Ltd. (Nasdaq:RADA) announced today that it has received new orders totaling over $11 million since the beginning of 2016. 60% of the new orders are due to its avionics business, while 40% came from the tactical radars line of business. As a result, the Company’s backlog has begun to resume growth.

The Company also reported that it expects its revenues in the second half of 2016 to be significantly improved over the first half, which will positively impact the operating and net income during this period.

It is also anticipated that the rate of new orders from the radars’ line of business is expected to further increase during the remainder of this year and 2017.

Zvi Alon, RADA’s CEO, commented: “While we did not stop our advanced development activity, we are now transitioning our radar business from the R&D and demonstration phase into orders and sales. We are starting to see the fruits of this strategic change through the improving performance of our business and we believe that this trend will continue, and grow, in the near future.”

About RADA

RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The Company specializes in the development, production, and sales of Tactical Land Radars for Force and Border Protection, Inertial Navigation Systems for air and land applications, and Avionics Systems and Upgrades.

Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such risk uncertainties and other factors include, but are not limited to, changes in general economic conditions, risks in product and technology developments, market acceptance of new products and continuing product demand, level of competition and other factors described in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission.

Company Contact:
RADA Electronics Industries
Dov Sella, CBDO
Tel: +972-9-8921111
mrkt@rada.com			

Investor Relation Contact
GK Investor Relations
Ehud Helft / Gavriel Frohwein 
Tel: +1 646 688 3559
Rada@gkir.com
Thursday, September 15th, 2016 Uncategorized Comments Off on $RADA Reports Backlog Growth Following new orders of over $11 million

$AERI Announces #PublicOffering of Common Stock

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today announced that it has commenced a registered underwritten public offering of $50 million of shares of its common stock.

Cantor Fitzgerald & Co. is acting as the sole underwriter for the offering.

Aerie intends to use the net proceeds of the offering for general corporate purposes, including the complete funding of RhopressaTM commercialization costs, execution of clinical trials in Japan, commencement of construction of a manufacturing plant in Ireland and continuation of preclinical activity in support of its product pipeline, along with ongoing working capital requirements.

A shelf registration statement relating to the shares is effective with the Securities and Exchange Commission. The shares may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement related to the offering will be filed with the Securities and Exchange Commission today. An electronic copy of the preliminary prospectus supplement and the accompanying prospectus relating to the offering will be available on the website of the Securities and Exchange Commission at www.sec.gov. Copies of the preliminary prospectus supplement and the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 5th Floor, New York, New York 10022, or by telephone at 212-829-7122, or by e-mail at prospectus@cantor.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of Aerie, and shall not constitute an offer, solicitation or sale of any security 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 Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie’s two lead product candidates are once-daiIy IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA filing for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted in the third quarter of 2016. The second product candidate, RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of RhopressaTM and widely prescribed PGA latanoprost, currently has two Phase 3 registration trials underway, named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM NDA filing is expected to take place near year-end 2017. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to request, obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the offering discussed in this press release, including the use of proceeds from the offering; the potential advantages of our product candidates; and our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). 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.

 

Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com

Thursday, September 15th, 2016 Uncategorized Comments Off on $AERI Announces #PublicOffering of Common Stock

$NNDM First Delivery of #DragonFly2020 #3DPrinter to the United States

The platform was delivered to FATHOM, an advanced manufacturer with expertise in 3D printing, which is collaborating with Nano Dimension on U.S. market entry

NESS ZIONA, Israel, Sept. 14, 2016  — Nano Dimension Ltd., a leader in the field of 3D Printed Electronics (NASDAQ, TASE: NNDM), announced today that its wholly owned subsidiary, Nano Dimension Technologies Ltd., has delivered its DragonFly 2020 3D Printer to FATHOM. FATHOM is a beta and go-to-market partner with expertise in advanced manufacturing and 3D printing that serves the Silicon Valley region and greater West Coast area. This marks the company’s first delivery of the DragonFly 2020 3D Printer to the United States. The revenues from this transaction will begin to be recognized in Q4 2016 and will continue in 2017.

“Last month, we announced the supply of our 3D printer to a leading Israeli defense company, and we are continuing to expand our go-to-market infrastructure to distribute the company’s products in the United States,” said Amit Dror, CEO of Nano Dimension. “The presence of the DragonFly 2020 in the U.S. will provide Nano Dimension the ability to showcase the capabilities of the DragonFly 2020 3D Printer to potential U.S. customers. We are excited to have FATHOM as a key partner in this effort.”

The DragonFly 2020 3D Printer will be installed at FATHOM’s Oakland, California headquarters in the coming weeks and will be used for evaluations and demonstrations over the next year. Earlier this year, Nano Dimension signed an agreement with FATHOM to collaborate on the introduction of the DragonFly 2020 3D Printing platform to the U.S. market, with a focus on Silicon Valley and the greater West Coast area.

“Both FATHOM and Nano Dimension share the same vision of changing the way products are designed and manufactured,” said Rich Stump, Co-Founder and Principal at FATHOM. “We are excited to receive this system because it builds on FATHOM’s focus to augment conventional methods with cutting-edge technologies and advanced processes.”

“We are excited to be able to provide our customers access to this technology which has the potential to greatly compress their development process,” said Michelle Mihevc, Co-Founder and Principal at FATHOM.

Business partners Stump and Mihevc founded FATHOM in 2008. Today, FATHOM’s advanced prototype fabrication, low volume manufacturing, and bridge-to-production capabilities are used by Fortune 500 companies throughout the country.

ABOUT FATHOM

FATHOM is driven by advanced technologies that enhance and accelerate a company’s product development process. The FATHOM team is changing the way products are being designed and manufactured by helping designers and engineers make the unmakeable while innovatively compressing industry standard lead-times so products go to market faster and more efficiently. FATHOM uniquely blends additive technologies and materials with legacy manufacturing methods to help companies put satellites into orbit, electric cars on freeways, and a variety of devices into people’s hands and homes.

// Professional 3D Printer and Manufacturing System Sales
// Prototype Fabrication, Low Volume, and Bridge-to-Production Services
// Concept Development, Software, and R&D

About Nano Dimension Ltd.

Nano Dimension, founded in 2012, focuses on development of advanced 3D printed electronics systems and advanced additive manufacturing. Nano Dimension’s unique products combine three advanced technologies: 3D inkjet, 3D software and nanomaterials. The company’s primary products include the first 3D printer dedicated to printing multi-layer PCBs (printed circuit boards) and advanced nanotechnology-based conductive and dielectric inks. In addition to the trading of the company’s American Depositary Shares on NASDAQ, the company’s ordinary shares are also traded on the TASE in Israel. The Bank of New York Mellon serves as the depositary for Nano Dimension.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward looking statements in this press release when we discuss the collaboration with Fathom, recognizing revenues and the timing thereof, continuing to expand our go-to-market infrastructure to distribute products in the United States, and our ability to showcase the capabilities of the DragonFly 2020 3D printer to potential U.S. customers. Because such statements deal with future events and are based on Nano Dimension’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Nano Dimension could differ materially from those described in or implied by the statements in this press release.

The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Nano Dimension’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 8, 2016, and in any subsequent filings with the SEC. Except as otherwise required by law, Nano Dimension undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

FATHOM MEDIA CONTACT

Elizabeth Griffin-Isabelle
Director of Marketing
FATHOM
elizabeth@studiofathom.com
www.studiofathom.com

NANO DIMENSION INVESTOR RELATIONS

Miri Segal-Scharia

Hayden/ MS-IR LLC

917-607-8654

msegal@ms-ir.com

Wednesday, September 14th, 2016 Uncategorized Comments Off on $NNDM First Delivery of #DragonFly2020 #3DPrinter to the United States

$MHGC Receives Revised #Takeover Proposal

The Morgans Board has not made any change in its recommendation in favor of the merger with SBEEG Holdings, LLC

NEW YORK, Sept. 14, 2016  — Morgans Hotel Group Co. (NASDAQ:MHGC) today announced that it has received a letter dated September 13, 2016, the redacted text of which is included in this press release, from the group identified in Morgans’ proxy materials as “Bidder V.” This letter reconfirms the interest of Bidder V in pursuing an acquisition of the common stock of Morgans for $2.75 per share. As part of its submission, Bidder V also furnished to Morgans a letter of intent from a new potential financing source which indicated that this financing source is prepared, subject to due diligence and definitive documentation, to provide up to $500 million in capital to support the transaction. Bidder V also provided to Morgans an executed non-disclosure agreement in the form previously requested by Morgans.

As disclosed in proxy materials previously filed by Morgans with the SEC, Bidder V had, on July 18, 2016, submitted an unsolicited, preliminary proposal for an acquisition of the common stock at $2.75 per share. Subsequent to July 18, 2016, members of management of Morgans, individual Board members and the Company’s legal and financial advisors had reached out on various occasions and had discussions with Bidder V and its representatives to encourage Bidder V to execute a non-disclosure agreement and to work towards a definitive proposal, and to do so in a timely fashion given the rapidly approaching date (September 14, 2016) for the stockholder vote on the SBE transaction. However, Bidder V had declined to sign a non-disclosure agreement in the form required by Morgans and had not made any further proposal to Morgans following its preliminary proposal. On September 8, 2016, Bidder V had contacted a member of the Board to indicate that Bidder V was continuing to work on a proposal, but no proposal was received until the evening of September 13, 2016.

At a meeting of the Board of Directors on the morning of September 14, 2016, the members of the Board present (who did not include Brad Nugent, who recused himself), concluded after receiving advice from Morgans’ legal advisors that, in light of the latest proposal from Bidder V, Morgans is required to adjourn the special meeting of stockholders scheduled for 2:00 p.m., Eastern time, on September 14, 2016, in order to allow stockholders additional time to consider supplemental disclosures regarding the latest proposal from Bidder V. This adjournment will also allow the Board and its advisors, consistent with the Board’s fiduciary obligations to evaluate any third party proposal that would reasonably be expected to lead to a superior proposal, to obtain, and provide to stockholders, additional information concerning the proposal by Bidder V. Accordingly, at today’s special meeting of stockholders, Morgans will adjourn the meeting until 2:00, p.m., Eastern Daylight Time, on September 26, 2016, at Hudson hotel, 358 West 58th Street, New York, NY 10019.

At today’s Board meeting, the Board noted that there are significant concerns with regard to the certainty and timing of any potential transaction with Bidder V, including concerns relating to the credibility and financial capacity of Bidder V and its financing source, and Bidder V’s ability to assume or refinance Morgans’ existing mortgage debt and otherwise to obtain the necessary financing to consummate a transaction.  The Board noted that almost two months have passed since the initial proposal by Bidder V, Bidder V has not addressed these significant concerns during that time period and Bidder V’s proposed financing source differs from Bidder V’s initial proposal. The Board directed its legal and financial advisers to assist the Board in discussions with Bidder V, its financing source and representatives in order to obtain additional relevant information and to make an appropriate recommendation to the stockholders of Morgans. Morgans and its advisers intend to engage promptly in these discussions, and to keep stockholders informed of material developments in this regard.  However, there can be no assurance that Bidder V will deliver, or be able to deliver, a definitive proposal at a price of $2.75 per share, nor as to what action the Board may take with respect to any such proposal. As of the date hereof, the Board of Directors of Morgans has not made, nor does it currently propose to make, any change in its recommendation in favor of the proposed merger with SBEEG Holdings, LLC.

A redacted form of the September 13 letter from Bidder V follows.

September 13, 2016

Howard M. Lorber
Chairman of the Board of Directors
Morgans Hotel Group Co.
475 Tenth Avenue
New York, NY 10018

Dear Mr. Lorber:

Following our letter of July 18 (the “July 18 Letter”), [REDACTED] and our affiliate [REDACTED] have continued to work with potential financing sources in order to complete the work necessary to formulate a definitive bid to acquire Morgans Hotel Group Co. (“MHGC”). We are writing to reaffirm our proposal to acquire 100% of MHGC’s common stock at an all cash price of $2.75 per share. We recognize that you have scheduled a stockholder meeting for tomorrow, but we believe that your stockholders will find our proposal more attractive than the transaction with SBE to be considered at that meeting.

We are now working with [REDACTED] and are pleased to present this proposal. [REDACTED] has committed to provide the full amount necessary to complete the transaction pursuant to the attached letter. As I’m sure you are aware, [REDACTED].

As mentioned in the July 18 Letter, we anticipate redeeming in full MHGC’s outstanding Series A Preferred Securities, including the liquidation preference plus any accrued distributions and anticipate assuming or refinancing MHGC’s outstanding mortgage debt. In addition, concurrently with entering into definitive documentation, we would be willing to pay the termination fee payable by MHGC under the merger agreement with SBE.

Given the work we have done to date and our knowledge of MHGC and the industry, our remaining due diligence requirements are confirmatory only and, with your cooperation, can be completed in very short order. We have attached an executed version of the confidentiality agreement that was negotiated with your counsel and are prepared to move expeditiously to reach agreement on transaction terms as soon as possible. We anticipate we will be in a position to promptly execute definitive documentation on substantially similar terms to those contained in the merger agreement with SBE, subject to any necessary changes to reflect our transaction and obviously with at least the level of deal certainty that you have with SBE.

This letter does not create any binding obligation on the part of either us or MHGC. No such obligation will exist until a mutually acceptable definitive agreement is executed and delivered. We would ask that you keep the terms and existence of this letter confidential.

We are eager to start moving forward on this mutually beneficial transaction, and to that end look forward to your response by September 14, 2016.

Sincerely,

[REDACTED]
[REDACTED]

About Morgans Hotel Group
Morgans Hotel Group Co. (NASDAQ:MHGC) is widely credited as the creator of the first “boutique” hotel and a continuing leader of the hotel industry’s boutique sector. The Morgans Hotel Group portfolio includes Delano in South Beach and Las Vegas; Mondrian in Los Angeles, London and South Beach; Hudson, Morgans and Royalton in New York; Clift in San Francisco; Shore Club in South Beach; Sanderson and St Martins Lane in London; and 10 Karaköy in Istanbul, Turkey. Morgans Hotel Group has ownership interests in some of these hotels. Morgans Hotel Group has other hotels in various stages of development to be operated under management agreements, including three hotels under construction: Mondrian in Doha and Dubai, and Delano in Dubai. For more information please visit www.morganshotelgroup.com.

Forward-Looking and Cautionary Statements

This press release may contain certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are generally identifiable by use of forward-looking terminology such as “may,” “will,” “should,” “potential,” “intend,” “expect,” “endeavor,” “seek,” “anticipate,” “estimate,” “overestimate,” “underestimate,” “believe,” “could,” “project,” “predict,” “continue” or other similar words or expressions.   These forward-looking statements reflect the Company’s current views about future events and are subject to risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ materially from those expressed in any forward-looking statement. Forward-looking statements in this press release include, without limitation, risks related to the proposed acquisition of the Company by SBEEG Holdings, LLC.

Important risks and factors that could cause the Company’s actual results to differ materially from those expressed in any forward-looking statements include, but are not limited to economic, business, competitive market and regulatory conditions such as: a downturn in economic and market conditions, both in the U.S. and internationally, particularly as it impacts demand for travel, hotels, dining and entertainment; the Company’s level of debt under its outstanding debt agreements, the Company’s obligations under its preferred equity instruments, its ability to restructure or refinance the current outstanding debt and preferred equity instruments, the Company’s ability to generate sufficient cash to repay or redeem outstanding debt and preferred equity instruments or make payments on guarantees as they may become due; the impact of any dividend payments or accruals on the Company’s preferred equity instruments on its cash flow and the value of its common stock; the impact of any strategic plans established by the Company’s Board of Directors; the impact of restructuring charges on the Company’s liquidity; general volatility of the Company’s stock price, the capital markets and the Company’s ability to access the capital markets and the ability of its joint ventures to do the foregoing; the impact of financial and other covenants in the Company’s loan agreements and other debt instruments that limit the Company’s ability to borrow and restrict certain of its operations; the Company’s history of losses; the Company’s liquidity position; the Company’s ability to compete in the “boutique” or “lifestyle” hotel segments of the hospitality industry and changes in the competitive environment in the Company’s industry and the markets where it invests; the Company’s ability to protect the value of its name, image and brands and its intellectual property; risks related to natural disasters, outbreaks of contagious diseases, terrorist attacks, the threat of terrorist attacks and similar disasters, including a downturn in travel, hotels, dining and entertainment resulting therefrom; risks related to the Company’s international operations, such as global economic conditions, political or economic instability, compliance with foreign regulations and satisfaction of international business and workplace requirements; the Company’s ability to timely fund the renovations and capital improvements necessary to sustain the quality of the properties of the Morgans Hotel Group and associated brands; risks associated with the acquisition, development and integration of properties and businesses; the Company’s ability to perform under management agreements and to resolve any disputes with owners of properties that the Company manages but does not wholly own; potential terminations of management agreements and the timing of receipt of anticipated termination fees; the impact of any material litigation, claims or disputes, including labor disputes; the seasonal nature of the hospitality business and other aspects of the hospitality and travel industry that are beyond the Company’s control; the Company’s ability to maintain state of the art information technology systems and protect such systems from cyber-attacks; the Company’s ability to comply with complex U.S. and international regulations, including regulations related to the environment, labor, food and beverage operations and data privacy; ownership of a substantial block of the Company’s common stock by a small number of investors and the ability of such investors to influence key decisions; the risk that the proposed acquisition by SBE, or an alternative thereto, may not be completed in a timely manner or at all, including by reason of the unavailability of financing, which may adversely affect the Company’s business and the price of the common stock of the Company; the failure to satisfy any of the conditions to the consummation of the proposed merger with SBE, including the adoption of the acquisition agreement by the stockholders of the Company, the assumption or refinancing of the Company’s mortgage loan agreements and the receipt of governmental and regulatory approvals; the occurrence of any event, change or other circumstance that could give rise to the termination of the SBE acquisition agreement; the effect of the announcement or pendency of the transaction on the Company’s business relationships, operating results and business generally; risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention as a result of the transaction; risks related to diverting management’s attention from the Company’s ongoing business operations; the outcome of any legal proceedings that may be instituted against us related to the acquisition agreement or the transaction  and other risk factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, Quarterly Report on Form 10-Q for the period ended June 30, 2016, and other documents which we file with the Securities Exchange Commission from time to time. All forward-looking statements in this press release are made as of the date hereof, based upon information known to management as of the date hereof, and the Company assumes no obligations to update or revise any of its forward-looking statements even if experience or future changes show that indicated results or events will not be realized.

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 a new holding company to be established SBEEG Holdings, LLC. In connection with the proposed transaction, the Company has filed a definitive proxy statement, and the Company may file or furnish other relevant materials relating to the proposed acquisition with or to the Securities and Exchange Commission.  STOCKHOLDERS ARE URGED TO READ ALL RELEVANT MATERIALS FILED WITH OR FURNISHED TO THE SECURITIES AND EXCHANGE COMMISSION, INCLUDING THE DEFINITIVE PROXY STATEMENT, AS AMENDED, BECAUSE IT CONTAINS IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Stockholders may obtain a free copy of the definitive proxy statement, as amended, and other documents filed with or furnished to the SEC by the Company at the SEC’s website at www.sec.gov.  The Company will make available a copy of its public reports, without charge, upon written request to the General Counsel, Morgans Hotel Group Co., 475 Tenth Avenue, 11th Floor, New York, NY 10018.

Participants in the Solicitation

The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information about the directors and executive officers of the Company is contained in the Company’s Form 10-K for the year ended December 31, 2015, its proxy statement filed on April 15, 2016, and its definitive proxy statement filed on August 4, 2016, as amended, which are filed with the SEC.

 

Contact:
Richard Szymanski
Morgans Hotel Group Co.
212.277.4188
Wednesday, September 14th, 2016 Uncategorized Comments Off on $MHGC Receives Revised #Takeover Proposal

$NAVB to Present at Upcoming Investor Conferences

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today announced that management will present at two upcoming investor conferences. An audio webcast of each presentation will be available live at the URL links noted below. An archived version of the webcasts will be available approximately two hours following the presentations and can be accessed within the Investors’ section of the Navidea website http://ir.navidea.com.

2016 Aegis Growth Conference in Las Vegas on Thursday, September 22, 2016 at 9:30 a.m., Pacific Time (12:30 p.m. ET). Webcast Link: http://wsw.com/webcast/aegis3/navb

Ladenburg Thalmann 2016 Healthcare Conference in New York on Tuesday, September 27, 2016 at 4:00 p.m., Eastern Time. Webcast link: http://wsw.com/webcast/ladenburg2/navb

About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. The development activities of the Manocept immunotherapeutic platform will be conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

 

Navidea Biopharmaceuticals
Investors & Media:
Sharon Correia, 978-655-2686
Senior Director, Corporate Communications

Wednesday, September 14th, 2016 Uncategorized Comments Off on $NAVB to Present at Upcoming Investor Conferences

$AERI Reports Positive #Roclatan Phase 3, #Topline #Efficacy Results

RoclatanTM Successfully Achieves Primary Efficacy Endpoint in Mercury 1 StudyConference Call and Webcast Today, September 14, at 5:00 p.m. ET

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today reported the successful 90-day primary efficacy results of its 12-month Phase 3 “Mercury 1” clinical trial for its fixed-dose combination product candidate, RoclatanTM. The study achieved its primary efficacy endpoint demonstrating statistical superiority over each of its components, including Aerie product candidate RhopressaTM (netarsudil ophthalmic solution) 0.02%, and market leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg (millimeters of mercury). The IOP-lowering effect of RoclatanTM was 1 to 3 mmHg greater than monotherapy with either latanoprost or RhopressaTM throughout the duration of the study. Management will host a conference call with accompanying slides to discuss these results at 5:00 p.m. ET today. The accompanying slides are available at Aerie’s web site, aeriepharma.com.

RoclatanTM Phase 3 Highlights for Mercury 1

  • RoclatanTM dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both latanoprost and RhopressaTM at the primary endpoint range of baseline IOPs from above 20 to below 36 mmHg for each of the nine measured time points.
  • IOPs were measured at 8 a.m., 10 a.m., and 4 p.m. at week 2, week 6, and day 90. RoclatanTM IOP lowering exceeded that of latanoprost in a range of 1.3 to 2.5 mmHg, and exceeded RhopressaTM IOP lowering in a range of 1.8 to 3.0 mmHg. Efficacy levels were consistent across the 90-day period for all arms in the study.
  • RoclatanTM mean diurnal IOP-lowering exceeded that of latanoprost by an average across the study duration of 1.9 mmHg and exceeded RhopressaTM by 2.6 mmHg.
  • RoclatanTM reduced mean diurnal IOPs to 16 mmHg or lower in 61 percent of patients, a significantly higher percentage than observed in the comparator arms.
  • The most common RoclatanTM adverse event was hyperemia, or eye redness, which was reported in approximately 50 percent of patients, or 30 percent above baseline, and was scored as mild for the large majority of these patients. There were no drug-related serious adverse events for any of the comparators in the trial.
  • Aerie will hold an “Investor Day” in New York City on October 5, 2016 to cover further details from the Mercury 1 trial and to provide a general business update.

“We are very pleased by these RoclatanTM 90-day efficacy results from the Mercury 1 clinical trial. As expected, the topline efficacy demonstrated in this trial clearly reconfirms the potential for RoclatanTM to become the most efficacious IOP-lowering therapy to enter the market, if approved. If Mercury 1 and 2 are successful, we expect to file the NDA for RoclatanTM near year-end 2017,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

Dr. Anido continued, “We also noted that the RhopressaTM arm demonstrated high levels of efficacy across the full range of baseline IOPs studied, and the efficacy was maintained for the 90-day period. Importantly, RhopressaTM demonstrated comparable levels of IOP lowering to latanoprost at baseline IOPs ranging from 20 to 25 mmHg in Mercury 1. This performance for RhopressaTM is consistent with levels observed in the previous Phase 2b trials for RhopressaTM and RoclatanTM.”

Richard A. Lewis, M.D., Aerie’s Chief Medical Officer added, “Once-daily RoclatanTM has shown a degree of IOP lowering in Mercury 1 that is quite impressive, especially when considering its ability to bring patient pressures down to levels as low as 8 to 14 mmHg. The safety profile of RoclatanTM observed thus far in Mercury 1 points to a safe and tolerable product.”

About RoclatanTM

RoclatanTM is a once-daily eye drop that combines RhopressaTM, as described below, with latanoprost, a PGA that is the most widely prescribed glaucoma drug in the world. Based on our preclinical studies and clinical trials, we believe that RoclatanTM, if approved, would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the trabecular meshwork, the eye’s primary drain, (ii) increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain, (iii) reducing fluid production in the eye, and (iv) reducing episcleral venous pressure (EVP). By covering the full spectrum of known IOP-lowering mechanisms, RoclatanTM has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product.

The first Phase 3 registration trial for RoclatanTM, named Mercury 1 is a 12-month safety trial in 718 patients with a 90-day efficacy readout, which is the subject of this press release. The topline efficacy readout demonstrated that RoclatanTM was statistically superior to each of its components. The second Phase 3 registration trial, named Mercury 2, is a 90-day efficacy trial that commenced in March 2016, and a third Phase 3 registration trial, named Mercury 3, is expected to commence in Europe in the first half of 2017. Mercury 3 is not necessary for approval in the U.S., but rather to facilitate regulatory approval and commercialization in Europe.

About RhopressaTM

RhopressaTM (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that we believe, if approved, would become the only once-daily product available that, based on Aerie’s preclinical studies, specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma. Preclinical studies have also demonstrated that RhopressaTM lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie’s preclinical studies, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM has been shown in Aerie studies to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that RhopressaTM may have disease-modifying properties, including an anti-fibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork. Preclinical research is also currently underway to evaluate the potential neuroprotective benefits of RhopressaTM.

The results of two Phase 3 registration trials (Rocket 2 and Rocket 1) for RhopressaTM were included in a NDA filing submitted to the FDA in the third quarter of 2016. Rocket 2 represents the pivotal trial, and Rocket 1 is supportive. There are two additional Phase 3 trials currently underway for RhopressaTM, named Rocket 3 and Rocket 4. Rocket 3 is a 12-month safety-only study in Canada that is not needed for the NDA filing. Rocket 4 is designed to provide adequate six-month safety data for regulatory filing purposes in Europe, and is also not needed for the NDA filing.

Conference Call / Web Cast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. Eastern Time today to discuss the RoclatanTM Phase 3 efficacy results from Mercury 1, including a review of the associated slides that are posted on Aerie’s web site, aeriepharma.com.

The live webcast and a replay may be accessed by visiting Aerie’s website at http://investors.aeriepharma.com. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live conference call. The conference ID number for the live call is 81417412. Please dial in approximately 10 minutes prior to the call. Telephone replay will be available approximately two hours after the call. To access the replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 81417412. The telephone replay will be available until September 21, 2016.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie’s two lead product candidates are once-daily IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA filing for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted in the third quarter of 2016. The second product candidate, RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of RhopressaTM and widely prescribed PGA latanoprost, currently has two Phase 3 registration trials underway, named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM NDA filing is expected to take place near year-end 2017. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “exploring,” “pursuing” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to request, obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; and our ability to protect our proprietary technology and enforce our intellectual property rights. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading “Risk Factors” in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, the topline Mercury 1 data presented herein is preliminary and based solely on information available to us as of the date of this press release and additional information about the results may be disclosed at any time, including at our Investor Day on October 5, 2016. In addition, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of the outcome of later clinical trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release. 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.

 

Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com

Wednesday, September 14th, 2016 Uncategorized Comments Off on $AERI Reports Positive #Roclatan Phase 3, #Topline #Efficacy Results

$ACST Reports Positive #CaPre #Omega3 Bridging #Study Data

Results Support Streamlined Regulatory Pathway for Novel Hypertriglyceridemia Drug

LAVAL, QUÉBEC–(Sept. 14, 2016) – Acasti Pharma (NASDAQ:ACST)(TSX VENTURE:APO) today announced that its bridging study for novel drug candidate CaPre® (omega-3 phospholipid) has successfully met its objectives, supporting Acasti’s strategy to pursue the U.S. Food and Drug Administration’s (FDA) 505(b)(2) regulatory pathway for approval. Acasti is developing CaPre for the treatment of patients with severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. The 505(b)(2) regulatory pathway allows Acasti to streamline the overall development program required to support a New Drug Application (NDA) by relying on the safety data of an approved drug.

“We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre,” said Jan D’Alvise, president and CEO of Acasti Pharma. “With this momentum, we look forward to working with the FDA to confirm the pathway and optimize the design of our Phase 3 program, which will seek to demonstrate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia.”

Acasti’s open-label, randomized, four-way, cross-over, bioavailability study compared CaPre given as a single dose of 4 grams in fasting and fed states with the approved hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters) in 56 healthy volunteers. The study met its primary objective and demonstrated that the levels of omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) following administration of CaPre did not exceed the levels following administration of LOVAZA in subjects who were fed a high-fat meal. These results support the basis for claiming a comparable safety profile of the two products.

Furthermore, among subjects in the fasting state, CaPre demonstrated better bioavailability than LOVAZA, as measured by blood levels of EPA and DHA. As previously reported, the bioavailability of CaPre is not significantly reduced when taken with a low-fat meal versus a high-fat meal. This could represent a significant clinical advantage for CaPre since the administration with a low-fat meal represents a more attractive regimen for patients with hypertriglyceridemia who follow a restricted diet.

CaPre is a novel composition of omega-3 phospholipids sourced from krill. Its omega-3s, principally EPA and DHA, are naturally either “free” or bound to phospholipids that help them to be better absorbed into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the “esterified” fish-oil omega-3 options such as LOVAZA. CaPre is designed to modulate the major lipids associated with cardio-metabolic disease: in two previously reported Phase 2 clinical trials, CaPre reduced triglyceride levels, lowered non-high density lipoprotein (non-HDL-C, a useful marker of cardiovascular disease), and increased levels of high density lipoprotein (HDL-C, or “good cholesterol”) while having a neutral to positive effect on lowering low density lipoprotein (LDL-C, or “bad cholesterol”).

“The CaPre bioavailability study has reinforced the compound’s unique attributes in comparison with the leading pharmaceutical agent for hypertriglyceridemia,” said Roderick Carter, M.D., chairman of Acasti Pharma. “CaPre demonstrates clinically meaningful effects on many key markers of cardio-metabolic health. With high rates of obesity and diabetes fueling the number of patients with elevated triglycerides and cholesterols, CaPre could fill the need for a best-in-class omega-3 medication that addresses the full lipid profiles of these patients.”

About CaPre

Sourced from krill oil, CaPre seeks to provide a full scope of health benefits to patients with hypertriglyceridemia, filling a medical need that no other omega-3 treatment option has been able to address. CaPre successfully completed Phase 2 clinical trials for the treatment of hypertriglyceridemia, a very common metabolic condition in which blood levels of triglycerides, a type of lipid, are elevated, posing a risk to cardiovascular health. Severe hypertriglyceridemia, affecting more than 4 million adults in the U.S. is associated with an increased risk of coronary artery disease and pancreatitis and is often caused or exacerbated by uncontrolled diabetes mellitus, obesity and sedentary habits. CaPre is intended to be taken orally once per day in capsule form.

About Acasti Pharma

Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre, for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one-third of the U.S. population. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can address patients’ complete lipid profile, making a positive impact on all major lipids associated with cardiovascular disease risk. For more information, visit www.acastipharma.com.

Forward Looking Statements

Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “will,” or “plans” to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement and the “Cautionary Note Regarding Forward-Looking Information” section contained in Acasti’s latest Annual Information Form, which also forms part of Acasti’s latest annual report on Form 20-F, and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Acasti’s website at acastipharma.com (the “AIF”). All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in Acasti’s public securities filings with the Securities and Exchange Commission and the Canadian securities commissions. Additional information about these assumptions and risks and uncertainties is contained in the AIF under “Risk Factors.”

Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Acasti Contact:
Jan D’Alvise
Chief Executive Officer
450-686-4555
info@acastipharma.com
www.acastipharma.com

Media & Investor Contact:
Jessica Dyas
Canale Communications
619-849-5385
jessica@canalecomm.com

Wednesday, September 14th, 2016 Uncategorized Comments Off on $ACST Reports Positive #CaPre #Omega3 Bridging #Study Data

$VTAE to be #Acquired by $AGN

– Acquisition Adds Differentiated Development Programs to Strengthen Allergan’s Medical Dermatology Pipeline – – VTP-43742, First-in-Class Oral RORγt Inhibitor for Potential Treatment of Psoriasis, Other Autoimmune Disorders – – VTP-38543, Topical LXRβ Agonist, Unique Mechanism of Action for Potential Treatment of Atopic Dermatitis – – Vitae’s Contour Drug Discovery Platform and Team Bolsters Allergan’s Discovery Research Capabilities –

DUBLIN and FORT WASHINGTON, Pa., Sept. 14, 2016  — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, today announced that they have entered into a definitive agreement under which Allergan will acquire Vitae for $21.00 per share, in cash, for a total transaction value of approximately $639 million. The Boards of Directors of both companies have unanimously approved the transaction.

The acquisition will strengthen Allergan’s dermatology product pipeline, with the addition of VTP-43742, a Phase 2 first-in-class, orally active RORγt (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders. VTP-43742 acts through the potent inhibition of IL-17 activity. In preclinical studies, VTP-43742 has been observed to inhibit RORγt activity, is highly selective versus other ROR isotypes and may provide a treatment that could be administered as a once-daily oral dose. The compound recently completed a Phase 2 proof-of-concept multiple ascending dose trial in patients with moderate to severe psoriasis.

The acquisition also adds VTP-38543, a topical LXRβ (Liver X Receptor beta) selective agonist for the potential treatment of atopic dermatitis. It is believed that VTP-38543 works by decreasing inflammation in damaged skin tissue and repairing the damaged outer layer of skin. VTP-38543 is currently in a Phase 2a proof-of-concept clinical trial assessing the safety, tolerability and efficacy in patients with mild to moderate atopic dermatitis.

Vitae has developed and utilizes its Contour® structure-based drug design platform to discover product candidates for validated therapeutic targets where biopharmaceutical research and development has traditionally struggled to develop drugs due to challenges related to potency, selectivity and pharmacokinetics. This has provided Vitae’s R&D team the ability to create first-in-class product candidates for challenging therapeutic targets.

“The acquisition of Vitae is a strategic investment for Allergan that adds strength and depth to our innovative medical dermatology franchise,” said Brent Saunders, CEO and President of Allergan.  “Vitae has pioneered the discovery and development of highly differentiated first-in-class compounds in atopic dermatitis, psoriasis and autoimmune diseases, areas of medicine where innovation is needed for patients.”

“The Vitae team has been tremendously successful in discovering and conducting early development work in areas of medicine that can benefit from significant innovation,” said Jeff Hatfield, President and Chief Executive Officer of Vitae. “Allergan has a long track record in developing and commercializing innovative dermatologic treatments. I believe our programs will be poised for successful development as part of Allergan’s portfolio. I am very proud of the tremendous contributions of our research teams and the clinical community who have led the discovery and development of our pipeline programs, and I thank them for their dedication to this science that may one day help many patients with dermatologic conditions, autoimmune disorders and potentially other conditions.”

“Both the VTP-43742 and VTP-38543 programs offer the potential for highly differentiated mechanisms of action for the treatment of dermatologic conditions where patients are underserved by currently approved treatments,” said David Nicholson, Chief Research & Development Officer, Allergan. “In addition, Vitae’s novel Contour drug discovery platform and its team, which have been instrumental in the discovery of novel ‘difficult to drug’ compounds, will be highly complementary to Allergan’s existing R&D discovery efforts in key therapeutic areas.”

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Vitae common stock for $21.00 per share. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Vitae common stock. The merger agreement contemplates that Allergan will acquire any shares of Vitae that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016.

Additional information about Vitae, VTP-43742 and VTP-38543, as well as the unmet medical need in the treatment of psoriasis and atopic dermatitis, is available as a slide presentation on the Allergan web site at http://ir.allergan.com.

Debevoise & Plimpton LLP is serving as Allergan’s legal counsel. J.P. Morgan is serving as financial advisor to Vitae and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as Vitae’s legal counsel.

About Psoriasis

Psoriasis, which affects approximately 7.5 million people in the U.S., is a chronic autoimmune disorder affecting the skin. It causes cells to rapidly multiply and build up on the skin’s surface, resulting in red scaly patches that are often itchy and painful. Increased activity of a class of lymphocytes called Th17 cells, and the subsequent excess production of pro-inflammatory cytokines, including IL-17A and IL-17F, by those cells are critical parts of the pathophysiology of psoriasis. RORγt is a nuclear hormone receptor that is essential for the formation and function of Th17 cells.

About Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition affecting approximately 17.5 million infants, adolescents and adults in the U.S. It is characterized by intense itching and is caused by both inflammation and a breakdown of the skin’s barrier function. Activation of LXR in skin keratinocytes, the most common cell type in the outer layer of skin, has been shown to increase the formation of corneocytes and the production of lamellar lipids. LXR activation also has been shown to have an anti-inflammatory effect in skin equivalent to a high potency corticosteroid.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.

Our Company’s success is powered by our more than 15,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives everyday.

For more information, visit Allergan’s website at www.Allergan.com.

About Vitae Pharmaceuticals

Vitae Pharmaceuticals is a clinical-stage biotechnology company developing first-in-class product candidates with potential to transform the treatment paradigm for patients with significant unmet medical needs. Initial indications being pursued include psoriasis, other autoimmune disorders, and atopic dermatitis. Vitae’s lead clinical assets include VTP-43742, an oral RORyt inhibitor currently being studied in patients with moderate to severe psoriasis, and VTP-38543, an LXRβ selective agonist being studied in patients with mild to moderate atopic dermatitis.

For additional information, please visit the company’s website at www.vitaepharma.com.

Allergan Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

Vitae Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” relating to the acquisition of Vitae by Allergan. Such forward-looking statements include the ability of Vitae, Parent and Merger Sub to complete the transactions contemplated by the merger agreement, including the parties’ ability to satisfy the conditions to the consummation of the offer and the other conditions set forth in the merger agreement and the possibility of any termination of the merger agreement. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Actual results may differ materially from current expectations because of risks associated with uncertainties as to the timing of the offer and the subsequent merger; uncertainties as to how many of Vitae’s stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer or the merger may not be satisfied or waived; the effects of disruption from the transactions contemplated by the merger agreement on Vitae’s business and the fact that the announcement and pendency of the transactions may make it more difficult to establish or maintain relationships with employees, suppliers and other business partners; the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; other uncertainties pertaining to the business of Vitae, including those set forth in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, which are on file with the Securities and Exchange Commission and available on the Securities and Exchange Commission’s website at www.sec.gov. In addition to the risks described above and in Vitae’s other filings with the Securities and Exchange Commission, other unknown or unpredictable factors could also affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information contained in this press release is provided only as of the date of this report, and Vitae undertakes no obligation to update any forward-looking statements either contained in or incorporated by reference into this report on account of new information, future events, or otherwise, except as required by law..

Notice to Investors

The tender offer for the outstanding common stock of Vitae referred to in this press release has not yet commenced. The description contained in this press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Vitae common stock will be made pursuant to an offer to purchase and related materials that Allergan intends to file with the Securities and Exchange Commission. At the time the offer is commenced, Allergan will file a tender offer statement on Schedule TO with the Securities and Exchange Commission, and thereafter Vitae will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully and considered before any decision is made with respect to the tender offer. Additionally, Vitae and Allergan will file other relevant materials in connection with the proposed acquisition of Vitae by Allergan pursuant to the terms of the merger agreement. These materials will be sent free of charge to all stockholders of Vitae when available. In addition, all of these materials (and all other materials filed by Vitae with the Securities and Exchange Commission) will be available at no charge from the Securities and Exchange Commission through its website at www.sec.gov. Free copies of the offer to purchase, the related letter of transmittal and certain other offering documents will be made available by Allergan and when available may be obtained by directing a request to Allergan’s Investor Relations Department at  (862) 261-7488. Investors and security holders may also obtain free copies of the documents filed with the Securities and Exchange Commission by Vitae by contacting Vitae Investor Relations at (215) 461-2000.

INVESTORS AND SHAREHOLDERS OF VITAE ARE ADVISED TO READ THE SCHEDULE TO AND THE SCHEDULE 14D-9, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER OR MERGER, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO.

CONTACTS:        

ALLERGAN:
Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
Mark Marmur
(862) 261-7558

Vitae:
Investors:
Richard S. Morris
Chief Financial Officer
(215) 461-2000

Westwicke Partners
John Woolford
(443) 213-0506

Media:
6 Degrees PR
Tony Plohoros
(908) 591-2839

Wednesday, September 14th, 2016 Uncategorized Comments Off on $VTAE to be #Acquired by $AGN

$PYDS to Present at 2016 #AegisGrowthConference, Sept 21

SAN ANTONIO, Sept. 13, 2016  — Payment Data Systems (NASDAQ:PYDS), an integrated payment solutions provider, announced today that the Company will be presenting at the upcoming Aegis Growth Conference at the Encore at Wynn in Las Vegas, Nevada.

Habib Yunus, Chief Financial Officer, and Houston Frost, Senior Vice President, Corporate Development, will be presenting at the conference on Wednesday, September 21, at 2:30 p.m. Pacific Time/5:30 p.m. Eastern Time. The Company will also be attending one-on-one meetings at the conference on September 21 and September 22.

Investors may access the Company’s presentation on their investor relations website at www.paymentdata.com/invest. To receive additional information or to schedule a one-on-one meeting, please contact Elizabeth Brossy at ebrossy@finprofiles.com or your Aegis sales representative.

About Aegis Capital Corporation

Aegis Capital has been in business for over 30 years and maintains a conflict free service platform catering to the needs of private clients, institutions and corporations. Aegis Capital Corp. was founded in 1984 by the current CEO and Chairman. Aegis origins were based on servicing the specific needs of its customer base. Today, we have become a premiere full-service investment banking firm with 25 locations and employees stretching from Portland, Oregon to Rochester, New York. We have clients in all 50 states and overseas. Aegis has been able to bring quality service through its clearing relationships with RBC, COR and APEX.

For more information, please refer to www.aegiscapcorp.com.

About Payment Data Systems, Inc.

Payment Data Systems (NASDAQ:PYDS), a leading integrated payment solutions provider, offers a wide range of payment solutions to merchants, billers, banks, service bureaus and card issuers. The Company operates credit, debit/prepaid and ACH payment processing platforms to deliver convenient, world-class payment solutions and service to their clients. The strength of the Company lies in its ability to provide tailored solutions for card issuance, payment acceptance, and bill payments as well as its unique technology in the prepaid sector. Payment Data is headquartered in San Antonio, Texas, and has offices in New York, New York; and Long Beach, California.

For additional information please visit www.paymentdata.com. Other websites: www.akimbocard.comwww.ficentive.com. Find us on Facebook®.

Investor Contacts:
Kristen Papke
Elizabeth Brossy
Financial Profiles, Inc.
PYDS@finprofiles.com
Tuesday, September 13th, 2016 Uncategorized Comments Off on $PYDS to Present at 2016 #AegisGrowthConference, Sept 21

$CNXR Selects #AmendolaCommunications as New #PR Agency

SCOTTSDALE, Ariz., Sept. 13, 2016  — Amendola Communications, a nationally recognized, award-winning healthcare and healthcare IT public relations and marketing agency, announced today that it has been selected as the agency of record for Connecture (Nasdaq: CNXR), a provider of web-based information systems used to create health insurance marketplaces. Amendola will effectively serve as the company’s public relations arm, leveraging its many relationships with industry media and analysts to broadly publicize Connecture’s brand, solutions and thought leaders, and aggressively pursue top-tier speaking and award opportunities.

“Amendola comes highly recommended to Connecture as the health IT industry’s premier public relations agency,” said Stephanie Meyer, Connecture’s Chief Marketing Officer. “We’re looking forward to putting those assets to work for us.” The agency will provide full account management, media relations, content for earned media placements and other PR and marketing resources to establish the Connecture brand at the forefront of the healthcare insurance marketplace.

Publicizing an emerging trend in the payer market

The influx of millions more insured consumers has arrived in tandem with what is shaping up to be a permanent, but still evolving trend in the healthcare payer market—more tailored health and financial coverage. Connecture offers carriers, brokers and employers an intuitive platform they can use to create a personalized benefits shopping experience for their own targeted audiences.

“Connecture develops technology that helps consumers achieve health and financial security and make informed, intelligent choices about their healthcare and ancillary coverage,” said Jodi Amendola, CEO of Amendola Communications.  “Offering tools that enroll millions of consumers in such plans helps healthcare achieve its holy grail of better outcomes at a lower cost—an exciting message that Amendola can’t wait to publicize.”

About Connecture

Connecture (NASDAQ: CNXR) is a leading web-based consumer shopping, enrollment and retention platform for health insurance distribution. Connecture offers a personalized health insurance shopping experience that recommends the best fit insurance plan based on an individual’s preferences, health status, preferred providers, medications and expected out-of-pocket costs. Connecture’s customers are health insurance marketplace operators such as health plans, brokers and exchange operators, who must distribute health insurance in a cost-effective manner to a growing number of insured consumers. Connecture’s solutions automate key functions in the health insurance distribution process, allowing its customers to price and present plan options accurately to consumers and efficiently enroll, renew and manage plan members. www.connecture.com

About Amendola Communications
Amendola Communications is an award-winning national public relations, marketing communications, social media and content marketing firm. Named one of the best information technology (IT) PR firms in the nation four times by PRSourceCode, Amendola represents some of the best-known brands and groundbreaking startups in the healthcare and HIT industries. Amendola’s seasoned team of PR and marketing pros delivers strategic guidance and effective solutions to help organizations boost their reputation and drive market share. For more information about the PR industry’s “A Team,” visit www.acmarketingpr.com, and follow Amendola on Twitter and LinkedIn.

Media Contact:
Marcia Rhodes
Amendola Communications
480.664.8412 ext. 15
mrhodes@acmarketingpr.com

Tuesday, September 13th, 2016 Uncategorized Comments Off on $CNXR Selects #AmendolaCommunications as New #PR Agency

$QUMU Selected as #UK #Government #GCloud8 Approved Supplier

The leader in enterprise video expands its footprint in the public sector

Qumu (NASDAQ: QUMU), the leader in enterprise video, today announced that it has been selected as a UK Government G-Cloud 8 approved supplier.

Qumu offers a secure, flexible and scalable video content management platform that includes advanced video capabilities for enterprises, media companies and public institutions.

“Our innovative video cloud-based solution responds to the public sector’s demand for secure and easy-to-use video platform,” said Vern Hanzlik, president and CEO of Qumu. “Our presence on G-Cloud 8 makes it easier than ever to deploy and scale.”

Qumu has long been delivering video solutions to the public sector organizations, meeting their specific needs in compliance and content distribution. As a selected G-Cloud 8 supplier, Qumu is part of the Government’s Digital Marketplace and can continue to work with Government agencies and public sector organizations across the UK.

About Qumu Corporation

Qumu (NASDAQ: QUMU) provides the tools businesses need to create, manage, secure, distribute and measure the success of their videos. Qumu’s innovative solutions release the power in video to engage and empower employees, partners and clients. Qumu helps thousands of organizations around the world realize the greatest possible value from video and other rich content they create and publish. Whatever the audience size, viewer device or network configuration, Qumu solutions are how business does video. Additional information can be found at www.qumu.com.

 

Qumu Corporation
Pete Steege, +1 612-638-9084
Director of Marketing Communications

Tuesday, September 13th, 2016 Uncategorized Comments Off on $QUMU Selected as #UK #Government #GCloud8 Approved Supplier

$ATOS Regains Compliance With #NASDAQ #ListingRequirement

SEATTLE, WA–(Sep 13, 2016) – Atossa Genetics, Inc. (NASDAQ: ATOS) today announced it has received notice from NASDAQ that Atossa has regained compliance with NASDAQ minimum closing bid price listing rule 5550(a)(2). On September 12, 2016, Atossa received notice from NASDAQ stating, in part, that the “Staff has determined that for the last 10 consecutive business days, from August 26 to September 9, 2016, the closing bid price of the Company’s common stock has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2) and this matter is now closed.”

About Atossa Genetics

Atossa Genetics, Inc. is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies and timing of publication of those results, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others including with respect to Fulvestrant, such as patent rights, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Atossa Genetics Company Contact:

Atossa Genetics, Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
kyle.guse@atossagenetics.com

Investor Relations Contact:

Scott Gordon
CorProminence LLC
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516.222.2560
scottg@corprominence.com

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$ACLS Announces Multi System Order For #PurionM

System Features Innovative High Temperature Silicon Carbide Capability for the Power Device Market

BEVERLY, Mass., Sept. 13, 2016  — Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry,  announced today a multi system order for the Company’s Purion M™ medium current implanter from a leading power device chipmaker, as well as the shipment of several Purion M systems to specialty device manufacturers. The systems feature Axcelis’ innovative new solution for high temperature silicon carbide processing, and will be used in high volume production of power devices and specialty logic chips supporting automotive, mobile and the Internet of Things market spaces.  The systems are scheduled to ship in the third and fourth quarter.

Executive Vice President of Engineering and Marketing, Bill Bintz, commented, “Interest in the Purion M continues to grow as we extend its capabilities to meet the needs of key customers in emerging technologies. Utilizing an innovative beam line design coupled with proprietary source technology, the Purion M provides customers with an unmatched level of purity and precision with over 2X the productivity of competitive offerings.”

John Aldeborgh, executive vice president, customer operations, added, “We’re excited about building on our relationship with these customers in the medium current segment, and look forward to a close collaboration as they expand their manufacturing capabilities in these emerging markets. The Purion platform’s common, flexible architecture has allowed us to extend our presence into these high growth market spaces, as evidenced by these new shipments.”

About Axcelis:

Axcelis (Nasdaq: ACLS), headquartered in Beverly, Mass., has been providing innovative, high-productivity solutions for the semiconductor industry for over 35 years. Axcelis is dedicated to developing enabling process applications through the design, manufacture and complete life cycle support of ion implantation systems, one of the most critical and enabling steps in the IC manufacturing process. Learn more about Axcelis at www.axcelis.com.

CONTACTS:

Maureen Hart (editorial/media) 978.787.4266
Doug Lawson (investor relations) 978.787.9552

Tuesday, September 13th, 2016 Uncategorized Comments Off on $ACLS Announces Multi System Order For #PurionM

$MGT Announces Successful Launch of #Bitcoin #Mining Operations

Next Phase Expected to Double Processing Power to Over 5 PetaHash

HARRISON, N.Y., Sept. 13, 2016  — MGT Capital Investments, Inc. (NYSE MKT: MGT), today reported that its previously announced large scale Bitcoin mining operation has reached full phase one production output with a larger than expected 2.6 PetaHash of processing power.  At the present difficulty level, the facility is mining over 90 Bitcoin per month with a value of $55,000.  The company is already preparing modifications to expand its processing power to approximately 5.2 PetaHash by the end of the fourth quarter of 2016.  The Company’s current goal for this facility is to increase the processing capacity to nearly over 10 PetaHash.

With its processing power already in place, MGT is one of the top five Bitcoin mining operations in the U.S.  MGT’s facility has contracted low cost hydro power and hosting services in central Washington state. The size and power efficiency of the facility has allowed MGT to emerge as a domestic leader. The current pricing environment of bitcoin and other digital assets coupled with the availability of 16 nanometer ASIC chips provides a significant opportunity to generate excellent profit margins.

“The early success of our Bitcoin mining business has quickly provided us with the financial proof of concept to move ahead and implement the next phase of our expansion strategy, with a goal of achieving over 5 PetaHash by the end of the year, and the overall goal of 10 PetaHash for the facility,” stated Robert Collazo, Director of Operations for MGT’s Bitcoin mining operations.

“The opportunity in the Bitcoin market is tremendous for MGT and is quickly providing a financial benefit for our shareholders.  Since announcing the program in July, we have implemented and then ramped up this facility’s processing power to 2.6 PetaHash, which we believe makes MGT one of the top five Bitcoin miners in the U.S. We believe our overall goal of 10 PetaHash for this facility would put us in a leadership position in the global Bitcoin network,” stated John McAfee, Executive Chairman of MGT.

About MGT Capital Investments, Inc.

MGT Capital Investments, Inc. (NYSE MKT: MGT) is in the process of acquiring a diverse portfolio of cyber security technologies. With cyber security industry pioneer John McAfee at its helm, MGT Capital is positioned to address various cyber threats through advanced protection technologies for mobile and personal tech devices, including tablets and smart phones.  The Company is currently in the process of acquiring D-Vasive, a provider of leading edge anti-spy software, and Demonsaw, a provider of a secure and anonymous file sharing software platform.

MGT Capital intends to change its corporate name to “John McAfee Global Technologies, Inc.” upon closing of the D-Vasive transaction.

For more information on the Company, please visit http://ir.stockpr.com/mgtci.

Forward–looking Statements

This press release contains forward–looking statements. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions are intended to identify “forward–looking statements.” MGT’s financial and operational results reflected above should not be construed by any means as representative of the current or future value of its common stock. All information set forth in this news release, except historical and factual information, represents forward–looking statements. This includes all statements about the Company’s plans, beliefs, estimates and expectations. These statements are based on current estimates and projections, which involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include issues related to: rapidly changing technology and evolving standards in the industries in which the Company and its subsidiaries operate; the ability to obtain sufficient funding to continue operations, maintain adequate cash flow, profitably exploit new business, license and sign new agreements; the unpredictable nature of consumer preferences; and other factors set forth in the Company’s most recently filed annual report and registration statement. Readers are cautioned not to place undue reliance on these forward–looking statements, which reflect management’s analysis only as of the date hereof. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof. Readers should carefully review the risks and uncertainties described in other documents that the Company files from time to time with the U.S. Securities and Exchange Commission.

Investor Contact
Garth Russell
Managing Director
KCSA Strategic Communications
grussell@kcsa.com
212.896.1250

Grace Livingston
Director of Investor Relations
MGT Capital
glivingston@mgtci.com
205.999.2524

Media Contact
Tiffany Madison
Director of Corporate Communications
MGT Capital Investments, Inc.
tmadison@mgtci.com
469.236.9569

Tuesday, September 13th, 2016 Uncategorized Comments Off on $MGT Announces Successful Launch of #Bitcoin #Mining Operations

$CETX Looks to Tap New Market By Turning #AGW #GreenhouseGas Into #Graphene

FARMINGDALE, NY, Sept. 12, 2016  – Global climate change is back in the headlines, led by the Paris climate agreement deadline approaching and news that this year is going to be even hotter than the record-setting heat in 2015, which was hotter than the record set in 2014.  China and the United States, the two biggest air polluters in the world, recently agreed to lead by example by ratifying the Paris agreement in the battle to combat global warming by reducing greenhouse emissions.  The world’s two biggest economies pledging to, as President Obama puts it, “put your money where your mouth is,” makes it even more likely that the Paris agreement will be put into effect.  President Obama and China President Xi Jinping putting other differences aside and vowing to act as ambassadors for slowing global warming is a big step in the right direction towards getting a requisite of 55 countries representing 55 percent of global emissions to ratify the Paris agreement.

If put into force, the agreement will mean that roughly 200 countries worldwide will work united to slash emissions and meet the goal of maintaining temperatures below 1.5 degrees Celsius above pre-industrial levels.  This will truly take worldwide cooperation and necessitate the sharing of technological advancements (and wealth) globally for the good of future generations.

The U.S. and China have already curbed coal consumption as a means to lower greenhouse gas pollution, but make no mistake, both countries still rely on coal for power generation.

While it is certainly fair to point a demonstrable finger at coal as a leading culprit in greenhouse gases, different countries face various challenges.  For example, Canada generates 44 percent of its greenhouse gases in the industrial sector, which includes oil and gas production and refining.  For most developing markets, such as India and Southeast Asia, coal, as an affordable product for dependable energy production, is now and for the foreseeable future will remain the only viable option.

To that point, it’s necessary to use technology to make the dirty energy source cleaner.

Saagar Govil, CEO at Cemtrex Inc. (NASDAQ: CETX), sees an opportunity to capitalize on a growing greenhouse gas reduction market and has kept the diversified company’s Industrial Products & Services division squarely focused on the $47 billion air pollution control industry.  Amongst other products and services for commercial and industrial applications, the IPS unit provides monitoring instruments for industrial processes and environmental compliance, and equipment for controlling particulates, hazardous pollutants, and greenhouse gases used in carbon trading globally.

In particular, a large market opportunity exists for Cemtrex’s VAMOX methane abatement technology.  Moving in lockstep with tightening regulations, the market could be catalyzed by leading countries working to implement cap and trade programs to reduce harmful emissions.  As countries like China, who has long been criticized for being unreceptive to changing emissions regulations, turn to cap and trade, it’s probable that other countries, the U.S. not withstanding, will follow.  With VAMOX, Cemtrex boasts being one of only two companies in the world with carbon-capture technology succinctly aligned with cap and trade programs and the Paris agreement.

At $2 million per VAMOX system and with thousands of potential installations worldwide, Govil says it is a multi-billion-dollar opportunity for Cemtrex.

For the future, Cemtrex is looking beyond monitoring and reducing greenhouse gases to strengthen its foothold in the sector.  Late in July, the company disclosed a new initiative to set up a research pilot plant for the production of graphene by isolating carbon dioxide from flue gases at its Farmingdale, NY facility.

In the simplest sense, graphene is a single layer of carbon atoms.  A million times thinner than a piece of paper, it’s so thin that it is considered to be the first two-dimensional material ever, yet stronger than diamond and more conductive than copper.  Discovered just over a decade ago, graphene is hailed as a super-material with infinite potential applications in electronics, communications, lubricants and much more.

Cemtrex initially plans on researching new concepts to generate graphene nanoparticles while capturing Sulfur dioxide, nitrogen oxides and carbon dioxide from flue gases (gases from furnaces, boilers, generators, etc. exhausted into the atmosphere).  Ultimately, what Cemtrex is aiming to accomplish is capturing pollutants and repurposing the carbon into what is arguably the world’s most advanced material.

“We want to have a stake in the production of the graphene nanoparticles and are looking at ways to accomplish this, using sustainable and ecofriendly methods,” said Sagaar Govil in the news announcement of the upcoming research.

The U.S. Energy Information Administration estimates that coal-fired global electric production in 2040 will likely rise 23 percent from 2012 levels.  Despite best efforts, some countries turning away from nuclear power due to disastrous accidents and others that simply can’t afford the cost and possible intermittent nature of renewables underscore the rise in coal usage.  With that in mind, the world will be best served to employ innovation to control greenhouses gases, especially those that can take carbon emission and turn it into something productive.  Cemtrex hopes to commence its pilot project by mid-January.

To learn more about Cemtrex, visit the corporate website at www.cemtrex.com.

Financial Press Media Group, Inc. is a leading publisher of market news, commentary, proprietary research and videos from seasoned journalists, analysts and contributors covering the financial markets, specific industries and global economies. Leveraging our extensive distribution network and social media presence, we have cultivated a valuable audience of engaged market enthusiasts interested in all segments, which in turn delivers a variety of unique opportunities for industry partnerships, corporate communications and market exposure.

Legal Disclaimer: Financial Press Media Group, Inc. is not registered with any financial or securities regulatory authority and does not provide, nor claims to provide, investment advice or recommendations to readers of this release to buy, sell or hold any securities. Investing intrinsically involves substantial risk and readers are reminded to consult an investment professional and complete their own due diligence, including SEC filings, when researching any companies mentioned in this release. This release is based upon publicly available information and, while vetted, is not considered to be all-inclusive or guaranteed to be free from errors. With respect to Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader’s attention to the fact that Financial Press Media Group, Inc. has received compensation from the companies mentioned in this release.

Monday, September 12th, 2016 Uncategorized Comments Off on $CETX Looks to Tap New Market By Turning #AGW #GreenhouseGas Into #Graphene

$SYNT Announces Special #Dividend

TROY, Mich., Sept. 12, 2016  — Syntel, Inc. (Nasdaq:SYNT), a global provider of digital transformation, information technology and knowledge process services to Global 2000 companies, today announced that its Board of Directors has declared a special cash dividend of $15 per share.

The special cash dividend, is payable on October 3, 2016, to shareholders of record at the close of business on September 22, 2016.  Due to the size of the dividend, it is anticipated that the Company’s common stock will begin trading ex-dividend (without the dividend), the first business day following the dividend payable date, or October 4, 2016.

The special cash dividend will be funded through dividends to the Company by U.S. subsidiaries, the one-time repatriation of approximately $1.24 billion of cash held by the Company’s foreign subsidiaries and a portion of borrowings under a new senior credit facility. The Company has expanded its borrowing capacity to $500 million under the new senior credit facility while paying in full and terminating the $200 million prior existing senior credit facility.

In connection with the one-time repatriation, the Company expects to recognize a one-time tax expense of about $264 million (net of foreign tax credits) in the third quarter of 2016. As a result of the additional tax expense and anticipated changes to “other income” which will result from the issuance of the special cash dividend, the Company is revising its outlook for 2016 EPS from the previously announced $2.55 to $2.70 earnings per share to a loss of $0.60 to $0.75 per share. There is no update at this time to the outlook for 2016 revenue or margins.

Additional details can be found in the Company’s Form 8-K filed with the Securities and Exchange Commission on September 12, 2016.

About Syntel

Syntel (Nasdaq:SYNT) is the global leader in digital modernization services, with a core suite of automation-driven IT and knowledge process services. Syntel helps global enterprises thrive in the Two-Speed World™ by building agile, efficient technology infrastructures that blend legacy business models with disruptive digital innovations. Syntel’s recursive automation platform, SyntBots®, enables clients to manage, migrate, and modernize their business and technology ecosystems. Syntel believes in a “Customer for Life” philosophy to build collaborative partnerships and creates long-term business value for its clients by investing in IP, solutions and industry-focused delivery teams with deep domain knowledge.    To learn more, visit us at: www.syntelinc.com

Safe Harbor Provision

This news release may include forward-looking statements, including those with respect to the future level of business for Syntel, Inc. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements as a result of certain risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 or from other factors not currently anticipated.

Contact:  Zaineb Bokhari, Syntel 646-538-9898, zaineb_bokhari@syntelinc.com
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$FOMX Positive Topline Results, Phase 2 #FMX103 #Minocycline in #Rosacea

FMX103 Demonstrated Statistically Significant Improvement Compared with Vehicle in the Main Efficacy Endpoints Conference Call and Webcast Today at 9:00 a.m. Eastern Time

REHOVOT, Israel and BRIDGEWATER, N.J., Sept. 12, 2016  —

Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), (“Foamix”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, today announced the topline results of its Phase 2 clinical trial of FMX103 for the treatment of papulopustular rosacea. Statistically significant differences were demonstrated for improvement in the primary and secondary efficacy endpoints (reduction in the number of inflammatory lesions – papules and pustules and improvement of Investigator Global Assessment score) for FMX103 compared with the vehicle-treated group.

“We are extremely encouraged that our Phase 2 dose-finding study demonstrated that FMX103 appears to be safe and effective in the treatment of moderate-to-severe papulopustular rosacea,” said Dov Tamarkin, Ph.D., CEO of Foamix. “We believe the positive data from our clinical trial could support advancement into Phase 3, and look forward to reviewing these results with the FDA.  Our goal is to bring innovative therapies to market in order to address the unmet needs of patients suffering from various dermatological conditions.  Based on our current results, FMX103 has the potential to provide significant benefits to the millions of patients who currently struggle with the physical effects of rosacea and the quality of life impact inherent with this disease,” he added.

Trial Design and Results

The double-blind, randomized, placebo-controlled Phase 2 trial included 233 subjects with moderate-to-severe rosacea enrolled at 18 sites in Germany.  Subjects were randomized to receive either 1 of 2 doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a 4-week post-treatment evaluation.  The efficacy endpoints were the absolute change in the number of inflammatory lesions – papules and pustules (primary endpoint) and improvement of the Investigator Global Assessment of severity, or IGA (first secondary endpoint).  Safety and tolerability were also evaluated.

1.      Baseline severity

The mean baseline lesion count for all groups ranged from 30.6 to 34.5 and the IGA scores were all moderate (score 3) or severe (score 4); with about 50-60% of the subjects having a severe rating.

2.      Significant reduction in the number of inflammatory lesions

At the Week 12 timepoint designated for the primary efficacy analysis, the 1.5% and 3% doses of FMX103 both significantly reduced the number of papules and pustules vs. the vehicle (1.5% and 3%, both p<0.001, ANCOVA, intent-to-treat analysis).  The mean reduction in lesion count of each treatment group vs. its baseline was 21.1 for the 1.5% dose, 19.9 for the 3% dose and 7.8 for vehicle; the corresponding percent reductions were 61.4% and 55.5% for the FMX103 1.5% and 3% groups, respectively, and 29.7% for the vehicle.

3.      Significant Improvement in Investigator’s Global Assessment (IGA) scores

Both the 1.5% and 3% doses of FMX-103 were significantly better compared to vehicle in reducing the IGA score by 2 grades and in reaching a “clear” (score=0) or “almost clear” (score=1) rating at Week 12 (P < 0.01 and P < 0.05, respectively, Cochran–Mantel–Haenszel test). Both the 1.5% and 3% doses were efficacious and there was no statistically significant difference between doses.

4.      Safety and tolerability

FMX103 appeared to be generally safe and well-tolerated.  There were no serious treatment‑related AEs and few subjects overall reported any treatment-related AEs (2, 4 and 5 in the 1.5%, 3% and vehicle groups, respectively).  A total of 4 subjects discontinued the study due to an adverse event (3 in the 3% group and 1 in the vehicle group).

Conference Call Information

Monday, September 12, 2016 @ 9am Eastern Time
Investors: 877-627-6590
International: 719-325-4794
Israel Investors: 1 80 925 8243
Conference Id: 5339326
Webcast: http://public.viavid.com/index.php?id=121064

Replays, Available Through September 26th:
Toll-free: 877-870-5176
International: 858-384-5517
Replay Pin: 5339326

About Rosacea         

Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.  It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that adversely affect quality of life.  Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than sixteen million people in the United States. Although the exact root cause of rosacea remains unknown, both genetic and environmental factors are thought to have an impact on causing this disease.

There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin and ivermectin), azelaic acid or retinoids, while the mainstay for the treatment of moderate-to-severe rosacea are systemic antibiotics such as minocycline and doxycycline (Drugs (2014) 74:1457-1465)

The current U.S. market size for rosacea is estimated to be approximately $1.2 billion (Symphony Health Services PHAST (Pharmaceutical Audit Suite). Weighted Values – rosacea indication only).

About Foamix Pharmaceuticals

Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological conditions.

Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX103 for the treatment of moderate-to-severe rosacea, and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.

In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Mylan.

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

Forward Looking Statements

This press release may include forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations.  Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.  Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital.  We discuss many of these risks in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 20-F (File No. 161477078) filed on March 2, 2016, and elsewhere in that Annual Report. Any forward-looking statements that may be made herein speak only as of the date of this release and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contact:                                                         U.S. Investor Relations
Dorit Hayon Michael Rice
Foamix Pharmaceuticals Ltd. LifeSci Advisors, LLC
+972-8-9316233 646-597-6979
IR@foamixpharma.com mrice@lifesciadvisors.com
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$RESN to Present New #RF Filter Dev. Tech at #IEEE Ultrasonics Symposium

Dr. Victor Plessky, Resonant’s Director of Engineering & Founder of GVR Trade SA, to Present a New FEM Simulation Method that is believed to be Highly Accurate and Significantly Faster than Traditional Methods

Resonant Inc. (NASDAQ:RESN), a designer of filters for radio frequency, or RF, front-ends that specializes in delivering designs for difficult bands and complex requirements, today announced that Dr. Victor Plessky, Resonant’s Director of Engineering and Founder of Swiss-Based GVR Trade SA, a wholly owned subsidiary of Resonant, will present the Company’s recent breakthroughs in the development of RF filters at the IEEE International Ultrasonics Symposium in Tours, France, on September 18-21.

At the symposium, Dr. Plessky will present a paper titled, “Hierarchical cascading in 2D FEM simulation of finite SAW devices with periodic block structure.” Electroacoustic simulation using the finite element method (FEM) can be employed to develop surface acoustic wave (SAW) filters and has the key advantage of being highly-flexible; however, FEM simulations typically require significant time and computing power. Dr. Plessky will present a new FEM simulation method that the Company believes is highly-accurate and significantly faster than traditional methods. In the future, Resonant believes it will be possible to apply these same techniques to other acoustic resonator technologies, such as bulk acoustic wave (BAW) and Film Bulk Acoustic Resonator (FBAR).

The presentation is based on a paper written by key researchers at Resonant, including Dr. Panagiotis Maniadis, Dr. Balam Willemsen, Dr. Patrick Turner, Dr. Bob Hammond and Neal Fenzi, as well as Dr. Julius Koskela and Dr. Victor Plessky of GVR Trade SA.

A leading driver of today’s RF filter market are smartphones that can contain in excess of 30 RF filters to support the increasing number of data bands used by carriers. This number of filters is expected to nearly double in the coming years, which will require more board space, increased product costs and higher battery draw in the absence of more complex filter designs and architectures.

“We expect Resonant’s simulation breakthrough to provide SAW filter developers significant benefits by offering the ability to quickly develop and iterate new products, thereby driving down costs without sacrificing phone design flexibility,” said Terry Lingren, CEO and Co-Founder of Resonant. “We’re excited to have Victor introduce this key capability of our Infinite Synthesized Network (ISN) platform to an international audience of peers and showcase our ability to deliver some of the most sophisticated techniques in advanced filter design available today.”

About Resonant® Inc.

Resonant is creating innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise.

About Resonant’s ISN® Technology

Resonant can create designs for hard bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. The Company’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (e.g. SAW) and can perform as well as those using higher cost methods (e.g. BAW). While most of the industry designs surface acoustic wave filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements about the capabilities and uses of our simulation methods and technologies. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our ability to continue development of our methods and technologies; the ability of our customers (or their manufacturers) to fabricate filter designs created using our methods and technologies in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our methods, technologies and filter designs less useful or obsolete; and our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.

 

MZ North America
Matt Hayden, 1-949-259-4986
Matt.hayden@MZGroup.us

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$AFCO & $FPI #Merger

– Creates Largest and Most Diverse Public Farmland REIT – Combined Company to Own More than $850 Million of Prime U.S. Farmland Assets Spanning 133,000 Acres – Fully Diluted Market Cap. Expected to be Greater than $400 Million, Excluding Preferred Equity – Anticipated to be 10% Accretive to FPI’s AFFO per Share in 2017 and 20% Accretive When Synergies are Fully Realized – Creates High-Quality Diversified Portfolio of Farmland Assets in 16 States and Across 25+ Major Crops – Portfolio to be ~75% Row Crop Farmland and ~25% Specialty Crops by Value – Transaction Value Represents a Meaningful Premium to AFCO’s Common Stock Price

DENVER, and NEW YORK, Sept. 12, 2016 — Farmland Partners Inc. (NYSE: FPI) (“FPI”) and American Farmland Company (NYSE MKT: AFCO) (“AFCO”) jointly announced today that they have entered into a definitive agreement (the “Agreement”) pursuant to which FPI has agreed to acquire all of the outstanding common stock of AFCO in a stock-for-stock transaction.

The combined company will be the largest public farmland REIT in the nation spanning more than 133,000 acres across 16 states, along both Coasts, the Midwest, the Plains and the Delta. The merger brings together two highly complementary leading farmland portfolios. FPI’s assets are comprised primarily of premier row crop farmland, while AFCO’s portfolio is concentrated in high-quality specialty and permanent crop farms across the U.S.  On a consolidated basis, the combined company’s portfolio is expected to consist of approximately 75% row crop farmland and 25% specialty crops by value. FPI expects to consolidate AFCO’s operations into FPI’s existing Denver-based headquarters and to realize significant cost synergies through eliminating duplicate administrative and other public company costs.

Paul A. Pittman will continue as FPI’s Chairman and CEO. D. Dixon Boardman and Thomas S. T. Gimbel, AFCO’s Chairman and CEO, respectively, will join FPI’s Board of Directors.

Commenting on the merger, Paul Pittman, FPI Chairman and CEO, said, “FPI’s acquisition of these great assets assembled by AFCO will strengthen FPI’s role as the leading public farmland real estate platform in the U.S. This merger will significantly increase FPI’s diversification across crops and geographies. Thanks to increased scale, we also expect to realize a reduction in overall costs as a percentage of portfolio value, creating superior value for our and AFCO’s stockholders and our respective farmer partners.”

Thomas S.T. Gimbel, AFCO’s Chief Executive Officer, commented, “We believe this opportunity to join FPI’s robust platform presents a meaningful opportunity to our stockholders. As the end result of a thorough process we commenced in April of this year, we are confident that the complementary nature of this transaction will accomplish our goal of enhancing stockholder value while preserving our core principles and continuing to execute on our vision for a scalable institutional, well-diversified and high-quality portfolio of farmland assets.”

Under the terms of the Agreement, each share of AFCO common stock and each AFCO operating partnership unit will be converted into the right to receive 0.7417 shares (or units) of newly issued FPI common stock (or units). On a pro-forma fully diluted basis, following the merger, former FPI equity holders will hold approximately 65% of the combined company’s equity, and former AFCO equity holders will hold approximately 35%. The stock-for-stock merger is intended to qualify as a tax-free reorganization. The transaction is subject to customary closing conditions, including receipt of the requisite approval of both FPI and AFCO stockholders.

Both company’s boards of directors have approved the transaction and recommend the transaction for approval by their respective stockholders. The parties currently expect the transaction to close in the later part of this year or early during the first quarter of 2017.

Strategic Benefits

Upon consummation of the merger, FPI will significantly increase its scale and improve the quality and diversification of its portfolio while expanding its market presence in key farming regions across the U.S., which is expected to result in strategic and financial benefits for stockholders:

  • Larger, More Diversified Portfolio of High-Quality Assets: The combined company’s portfolio is expected to be comprised of institutional-quality farmland assets located in key farming regions in 16 states around the U.S. along both Coasts, the Midwest, the Plains and the Delta. The portfolio will also be diversified by crop type, with approximately 75% of the portfolio (by value) to be comprised of row crop farmland and approximately 25% of the portfolio to be comprised of specialty and permanent crops.
  • Increased Scale: The combined company is expected to maximize operational efficiencies and lead to significant cost savings resulting from consolidating overhead expenses into FPI’s existing operations.  The increased scale of the combined enterprise is also expected to provide an enhanced platform to pursue accretive acquisitions in row, specialty and permanent crop farmland across a wider geographic footprint.
  • Reinforces FPI’s Position as the Leading Farmland REIT: The acquisition of AFCO further reinforces FPI’s position as the largest, most diversified and most liquid public farmland REIT.
  • Increased Revenues: On a pro-forma basis, the transaction is expected to contribute approximately $16 million of revenue in 2016, increasing FPI’s total revenue from $26 million to approximately $42 million.
  • Transaction Accretion to both AFCO and FPI Stockholders: The transaction is expected to be approximately 10% accretive to FPI’s AFFO per share in 2017 growing to 20% accretive as synergies are fully realized.
  • Greater Access to Capital: After giving effect to the transaction, the combined company is expected to have a fully-diluted market cap of approximately $400 million. The size and scale of the combined company is expected to provide greater access to global investors targeting investments in U.S. farmland assets.

Leadership

Paul A. Pittman, FPI’s Chief Executive Officer and Chairman of FPI’s Board of Directors, will serve as Chief Executive Officer and Chairman of the Board of Directors of the combined company. Luca Fabbri will remain CFO of the combined company. Additionally, Robert L. Cowan is expected to join FPI as President upon completion of the transaction. Upon consummation of the transaction, the number of directors comprising FPI’s Board of Directors will be increased from six to eight, of which two directors from AFCO, its Chairman and its CEO, have been designated by AFCO from its existing Board of Directors and will be elected to the FPI Board.

Advisors

Robert W. Baird & Co. acted as financial advisor and Morrison & Foerster LLP and Venable LLP acted as legal advisors to FPI. Citigroup Global Markets Inc. and Raymond James & Associates, Inc. acted as financial advisors and Goodwin Procter LLP acted as legal advisors to AFCO.

Conference Call and Webcast 

The companies will host a joint conference call on Monday, September 12, 2016 at 10:30 am Eastern Time to discuss the proposed transaction. The conference call-in number is (866) 262-6804 (Domestic); or (412) 902-4107 (International) or interested parties can join the live webcast of the conference call by accessing the Investor Relations section of each company’s website at ir.farmlandpartners.com or at http://investors.americanfarmlandcompany.com. A replay of the conference call will be available beginning September 12, 2016 at 1:00 p.m. (Eastern Time) until September 26, 2016 at 11:59 p.m. (Eastern Time), by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International); passcode: 10092625.  A replay of the webcast will also be accessible on the FPI Investor Relations website for a limited time following the event.

About Farmland Partners Inc.

Farmland Partners Inc. is an internally managed real estate investment trust that owns and seeks to acquire high-quality North American farmland and makes loans to farmers secured by farm real estate. The Company’s portfolio is comprised of 271 farms with an aggregate of 115,308 acres (including four farms totaling 1,668 acres under contract) in Arkansas, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Mississippi, Nebraska, North Carolina, South Carolina, Texas and Virginia. The Company elected to be taxed as a real estate investment trust, or REIT, for U.S. federal income tax purposes, commencing with the taxable year ended December 31, 2014.

About American Farmland Company

American Farmland Company is an internally managed real estate investment trust and a Maryland corporation focused on owning and acquiring a diversified portfolio of high-quality farmland, consisting of mature permanent, specialty/vegetable row and commodity row crop farms, as well as farmland development, located in select major agricultural regions throughout the United States. As of June 30, 2016, AFCO’s portfolio consisted of 22 farms located on both Coasts as well as in the Corn Belt and the Delta regions covering approximately 18,322 gross acres of farmland and more than 21 major crop types.

Cautionary Statement Regarding Forward-Looking Statements

This communication includes forward-looking statements. These forward-looking statements generally can be identified by phrases such as “will,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. These statements are based on current expectations, estimates and projections about the industry, markets in which FPI and AFCO operate, management’s beliefs, assumptions made by management and the transactions described in this communication. While the FPI’s and AFCO’s management believes the assumptions underlying the forward-looking statements and information are reasonable, such information is necessarily subject to uncertainties and may involve certain risks, many of which are difficult to predict and are beyond management’s control. These risks include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (2) the outcome of any legal proceedings that may be instituted against the parties and others following announcement of the merger agreement; (3) the inability to consummation the transaction due to the failure to obtain the requisite stockholder approvals or the failure to satisfy other conditions to completion of the transaction; (4) risks that the proposed transaction disrupts current plans and operations of FPI and AFCO; (5) the ability to recognize the benefits of the transaction; and (6) the amount of the costs, fees, expenses and charges related to the transaction; and the other risks and important factors contained and identified in FPI’s and AFCO’s filings with the Securities and Exchange Committee (“SEC”), such as their respective Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, any of which could cause actual results to differ materially from the forward-looking statements in this communication.

There can be no assurance that the transaction will in fact be consummated. We caution investors not to unduly rely on any forward-looking statements. The forward-looking statements speak only as of the date of this communication. Neither FPI nor AFCO is under any duty to update any of these forward-looking statements after the date of this communication, nor to conform prior statements to actual results or revised expectations, and neither FPI nor AFCO intends to do so.

Important Information for Investors and Stockholders

In connection with the proposed transaction, FPI expects to file with the SEC a registration statement on Form S-4 that will include a joint proxy statement of FPI and AFCO that also constitutes a prospectus of FPI, which joint proxy statement will be mailed or otherwise disseminated to FPI’s and AFCO’s respective stockholders when it becomes available. FPI and AFCO also plan to file other relevant documents with the SEC regarding the proposed transaction. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

Investors and security holders may obtain free copies of the registration statement and the joint proxy statement/prospectus (if and when it becomes available) and other relevant documents filed by FPI and AFCO with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by the companies will be available free of charge on their websites at www.farmlandpartners.com and www.americanfarmlandcompany.com.

Participants in Solicitation 

FPI, AFCO and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of FPI is set forth in its Annual Report on Form 10-K for the year ended December 31, 2015, which was filed with the SEC on March 15, 2016, and its proxy statement for its 2016 annual meeting of stockholders, which was filed with the SEC on April 14, 2016. Information about the directors and executive officers of AFCO is set forth in its Annual Report on Form 10-K for the year ended December 31, 2015, which was filed with the SEC on March 30, 2016, and its proxy statement for its 2016 annual meeting of stockholders, which was filed with the SEC on April 28, 2016. These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the joint proxy statement/prospectus and other relevant materials to be filed with the SEC when they become available.

No Offer or Solicitation

This communication is not intended to and 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 or a solicitation of any vote of approval, 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. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Monday, September 12th, 2016 Uncategorized Comments Off on $AFCO & $FPI #Merger

$ALDX Announces 2016 Research and Development Day

LEXINGTON, MA–(Sep 9, 2016) – Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today announced that it will host a Research and Development Day to discuss the company’s late-stage clinical programs in ocular inflammation and inborn errors of aldehyde metabolism. Aldeyra will also provide a summary of recent discussions with the U.S. Food and Drug Administration. Management and speaker presentations will begin at 8:00 a.m. Eastern Time on Monday, September 26, 2016 at the offices of Dechert, LLP in New York City.

A live webcast of the presentation and slide deck will be available via the Company’s Investor Relations website at http://ir.aldeyra.com. Following the live webcast, an archived version will be available on the website until September 25, 2017.

About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra’s lead product candidate, NS2, is an aldehyde trap in development for ocular inflammation, as well as for Sjögren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism. NS2 has not been approved for sale in the U.S. or elsewhere.

Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 Ext. 205
Email Contact

Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Email Contact

Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
Email Contact

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$CLCD Announces Pricing of #PublicOffering of Common Stock

CAMBRIDGE, Mass., Sept. 09, 2016  — CoLucid Pharmaceuticals, Inc. (“CoLucid”) (Nasdaq:CLCD), a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, today announced the pricing of an underwritten public offering of 3,250,000 shares of its common stock at a public offering price of $20.00 per share, for aggregate gross proceeds of $65.0 million. In addition, CoLucid has granted the underwriters a 30-day option to purchase up to an additional 487,500 shares of common stock on the same terms and conditions. All of the shares of common stock in the offering are being sold by CoLucid. The offering is expected to close on September 14, 2016, subject to the satisfaction of customary closing conditions.

Piper Jaffray & Co. and Barclays Capital Inc. are acting as joint book-running managers for the offering. Stifel is acting as lead manager for the offering, and Ladenburg Thalmann is acting as co-manager for the offering.

CoLucid anticipates the aggregate net proceeds from the offering will be approximately $60.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by CoLucid, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. CoLucid intends to use the net proceeds from the offering to fund the continued clinical development of lasmiditan and the remainder for working capital and general corporate purposes.

A shelf registration statement relating to these securities has been filed with the Securities and Exchange Commission (“SEC”) and was declared effective on June 24, 2016. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on September 8, 2016. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, by contacting: Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at prospectus@pjc.com, or by contacting: Barclays Capital Inc., Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at barclaysprospectus@broadridge.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 CoLucid Pharmaceuticals, Inc.
CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.

Forward-Looking Statements
This press release contains or may imply “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “estimate,” “anticipate,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “seek,” “approximate” or “plan,” or similar words or phrases.  Because such statements deal with future events and are based on CoLucid’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of CoLucid could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements related to current market conditions and the satisfaction of customary closing conditions in connection with the public offering. More information about the risks and uncertainties faced by CoLucid are contained in its periodic reports filed with the Securities and Exchange Commission. CoLucid disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT
Thomas Mathers
Chief Executive Officer
CoLucid Pharmaceuticals, Inc.
(857) 285-6494 

Hans Vitzthum
Managing Director
LifeSci Advisors, LLC.
(212) 915-2568
Friday, September 9th, 2016 Uncategorized Comments Off on $CLCD Announces Pricing of #PublicOffering of Common Stock

$VRAY Receives #Chinese #Regulatory #Approval for its #MRIdian System

Brings Benefits of MRI-Guided Radiation Therapy to Large and Growing Chinese Market

CLEVELAND, Sept. 9, 2016  —  ViewRay, Inc. (Nasdaq: VRAY) announced today that the company has received China Food and Drug Administration (CFDA) approval for its MRIdian System, the world’s first and only clinical MRI-guided radiation therapy system.

The MRIdian system is a unique medical instrument that integrates full-time MR imaging, cobalt radiation delivery, and intelligent software automation to treat cancers throughout the body. Using the MRIdian system, clinicians can see soft tissue, and visualize and adjust the dose — all in real time, on live anatomy. With MRIdian this is done without exposing the patient to the additional ionizing radiation that is common with other imaging modalities.

“China is one of the largest markets for medical devices in the world, so securing CFDA approval is an important step in our growth strategy,” said Chris A. Raanes, president and chief executive officer of ViewRay. “Given its population and rising cancer incidence, we believe MRI-guided radiation therapy will be an important cancer fighting tool for doctors and their patients throughout China.”

ViewRay is represented in China by Cowealth Medical Holding Co.

“We’re pleased to partner with ViewRay to bring the benefits of MRIdian to China,” said Duane Lee, president and chief executive officer of Cowealth.  “We believe MRI-guided radiation therapy is an essential advancement in radiation oncology and look forward to helping expand access to this vital treatment option.”

About ViewRay
ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.

ViewRay and MRIdian are registered trademarks of ViewRay, Inc.

Forward Looking Statements:

This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the rate of cancer incidence in China’s population, the benefits of the MRIdian System for physicians and patients in China and the expected reception of the MRIdian System in China. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay 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, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.

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$LXRX Positive TopLine Results, Phase 3 #Sotagliflozin in #Diabetes

First Successful Phase 3 Trial of an Oral Anti-diabetic for Type 1 Diabetes Conference call and webcast September 9, 2016 at 8:00 a.m. Eastern Time

THE WOODLANDS, Texas, Sept. 9, 2016  — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the pivotal inTandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin.

Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% on placebo after 24 weeks of treatment, meeting the study’s primary endpoint.  This statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo.

“We are extremely pleased with these top-line results and the potential long-term benefits that sotagliflozin may bring to people with type 1 diabetes,” said Lexicon President and Chief Executive Officer Lonnel Coats.  “We believe these results provide evidence that sotagliflozin, with its novel dual inhibition of both SGLT-1 and SGLT-2, is particularly well suited to help these individuals achieve better A1C levels without increasing and possibly reducing the risk of severe hypoglycemia.”

“Our companies are working together to develop this compound for the treatment of type 1 and type 2 diabetes,” said Jorge Insuasty, Senior Vice President, Head of Global Development, Sanofi.  “These top-line results highlight potential benefits of sotagliflozin when treating adults with type 1 diabetes.  We congratulate our partners on this positive outcome and look forward to further exploring this compound for the treatment of adults with type 2 diabetes when Sanofi begins the Phase 3 program later this year.”

“The inTandem1 study is part of the largest Phase 3 program for an oral anti-diabetic agent in type 1 diabetes to date,” said Anne Peters, M.D., Professor of Medicine at the Keck School of Medicine of USC, Director of the USC Clinical Diabetes Programs and Chairman of the Sotagliflozin Type 1 Diabetes Steering Committee.  “Sotagliflozin demonstrated compelling, significant and clinically meaningful A1C reduction with no increase in severe hypoglycemia and a slight risk of DKA.  If approved, sotagliflozin could represent a significant addition to the current standard of care and potentially allow patients with type 1 diabetes to better manage their diabetes while on insulin.”

About inTandem1

The double-blind, placebo controlled, Phase 3 study known as inTandem1 enrolled 793 patients in the United States and Canada with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%, which corresponds to an estimated average blood sugar of 154 mg/dl to 269 mg/dl (8.6 mmol/l to 15.0 mmol/l).  The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo.  Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone.  After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured.  The mean baseline A1C level at the time of randomization after the six-week optimization period was 7.6% for all three dose arms.

The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment.  The trial has a double-blind long term extension of 28-weeks, with a total treatment duration of 52-weeks. There were 268 patients in the placebo arm, 263 patients in the 200mg dose arm and 262 patients in the 400mg dose arm.  The overall mean placebo adjusted A1C reduction was 0.35% in the 200mg dose arm (p<0.001) and 0.41% in the 400mg dose arm (p<0.001).

Sotagliflozin was generally well tolerated.  Across all three dose arms (placebo, 200mg, 400mg), the incidence of treatment-emergent adverse events (AEs) were 67.5%, 67.3% and 71.0%, respectively; the incidence of serious AEs (SAEs) were 3.4%, 3.8% and 6.9%, respectively; and discontinuation due to AEs were 1.5%, 1.1% and 3.8%, respectively.  There were no reported deaths in the study.

Two primary safety concerns for patients with type 1 diabetes are severe hypoglycemia and diabetic ketoacidosis (DKA).  The number of patients with severe hypoglycemic events during the 24-week treatment period was 18 (6.7%), 11 (4.2%), and 12 (4.6%) in the placebo, 200mg and 400mg dose arms, respectively.  The number of patients with DKA events during the 24-week treatment period was 0 (0.0%), 3 (1.1%), and 8 (3.1%) in the placebo, 200mg and 400mg dose arms, respectively.

Lexicon is conducting another similar pivotal Phase 3 clinical trial predominantly in Europe (inTandem2), which is expected to report top-line results by the end of the year.  The third type 1 diabetes Phase 3 clinical trial, inTandem3, is underway globally and is studying approximately 1,400 patients treated with sotagliflozin 400mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization. Sanofi is expected to commence Phase 3 clinical trials for sotagliflozin in patients with type 2 diabetes by the end of the year.

About Sotagliflozin

Discovered using Lexicon’s unique approach to gene science, sotagliflozin is a first-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin has been shown in a Phase 2 study to improve glycemic control in people with type 1 diabetes while reducing their need for mealtime insulin.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide, royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin.  Lexicon is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States.  Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States.

Lexicon Conference Call

Lexicon management will hold a conference call and webcast to discuss the inTandem1 Phase 3 top-line results at 8:00 a.m. Eastern Time on September 9, 2016.  The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international).  The conference ID for all callers is 79513441.  Investors can access a live webcast of the call at www.lexpharma.com.  An archived version of the webcast will be available on the website through October 9, 2016.

About Lexicon

Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s and its licensees’ clinical development of and regulatory filings for sotagliflozin (LX4211) and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Friday, September 9th, 2016 Uncategorized Comments Off on $LXRX Positive TopLine Results, Phase 3 #Sotagliflozin in #Diabetes

$EARS Achieves #Midpoint, #Enrollment Phase 3 of #AM111 in Sudden #Deafness

ZUG, Switzerland, Sept. 9, 2016  — Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it has reached the midpoint for enrollment in the HEALOS Phase 3 clinical trial of AM-111 in idiopathic sudden sensorineural hearing loss, or ISSNHL, which is also known as sudden deafness.

“We are pleased to continue making progress with the Phase 3 development of AM-111 as the first specific therapeutic for acute inner ear hearing loss,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer. “HEALOS has now enrolled more than 125 patients out of the target of 255 patients, and we expect to report top-line results in the second half of next year, in line with previous guidance.”

The HEALOS trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of single-dose intratympanic administration of AM-111. The trial is being conducted in Europe and Asia and is enrolling patients who are suffering from severe to profound ISSNHL within 72 hours from onset. Patients are randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids are given as reserve therapy in case of insufficient hearing recovery by Day 7. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 28.

HEALOS is the first of two pivotal trials in Auris Medical’s Phase 3 clinical development program for AM-111. The second trial, ASSENT, was initiated in June 2016 and is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of single-dose intratympanic administration of AM-111. The trial is being conducted in the United States, Canada and South Korea and is set to enroll approximately 300 patients who are suffering from severe to profound ISSNHL within 72 hours from onset. Patients are randomized to receive AM-111 0.4 mg/mL, 0.8 mg/mL or placebo in a 1:1:1 ratio; oral corticosteroids are given as background therapy. The primary efficacy endpoint for the trial is the improvement of pure tone hearing thresholds from baseline to Day 91.

About Acute Inner Ear Hearing Loss   

Acute injury to the cochlea, e.g., from overexposure to noise, bacterial or viral infections, inflammation or vascular compromise may result in damage to inner ear hair cells and neurons and acute hearing loss. Thanks to cellular defenses and intrinsic repair mechanisms, a certain amount of hearing loss can be recovered in the subsequent days and weeks following the insult. However, the remaining hearing loss is irreversible. Acute inner ear hearing loss may be accompanied by other disorders of the inner ear such as dizziness or tinnitus, and if it develops into permanent hearing loss, it may have chronically debilitating consequences. Hearing loss may have a serious impact on professional and personal lives, e.g. through avoidance or withdrawal from social situations, reduced alertness and increased risk to personal safety, impaired memory and ability to learn new tasks, or reduced job performance and earning power. To date, there exists no treatment with proven efficacy for acute inner ear hearing loss.

About AM-111 

AM-111 contains the synthetic peptide D-JNKI-1 (D-stereoisomer of c-Jun N-terminal Kinase Inhibitor 1), a cell-penetrating inhibitor of the JNK stress kinase. JNK is activated following various types of cochlear insults (stress) that cause acute inner ear hearing loss and plays a key role in the apoptosis of cochlear hair cells and neurons as well as in inflammatory responses. By blocking JNK, AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic hearing loss. AM-111’s otoprotective effects have been demonstrated in various animal models of cochlear stress, including acute acoustic trauma, acute labyrinthitis (inflammation), drug ototoxicity (aminoglycosides), bacterial infection, cochlear ischemia and cochlear implantation trauma. Clinically, AM-111 has been evaluated in two completed trials and is currently being tested in two pivotal Phase 3 trials. It is administered intratympanically in one single dose. AM-111 has orphan drug designation from both the US Food and Drug Administration and the European Medicines Agency.

About Auris Medical

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol “EARS.”

Forward-looking Statements

This press release may contain statements that constitute “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 are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com

Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com

Friday, September 9th, 2016 Uncategorized Comments Off on $EARS Achieves #Midpoint, #Enrollment Phase 3 of #AM111 in Sudden #Deafness

$BV to Present at the $DB Technology Conference

AUSTIN, Texas, Sept. 08, 2016  — Bazaarvoice, Inc. (NASDAQ:BV), which is creating the world’s smartest network of active shoppers, brands and retailers, today announced that Jim Offerdahl, Chief Financial Officer, will present at the Deutsche Bank Technology Conference at the Encore at Wynn in Las Vegas.

The presentation is scheduled for Tuesday, September 13, 2016 at 4:50 p.m. Pacific Time, or 5:50 p.m. Central Time. A live audio webcast of the presentation, as well as a replay, will be accessible on the Investor Relations, Events & Presentations page of BV’s website at http://investors.bazaarvoice.com/.

About Bazaarvoice

Bazaarvoice is creating the world’s smartest shopper network connecting more than one-half billion consumers monthly to thousands of retailers and brands. Our network enables Bazaarvoice’s clients to engage consumers online, in-store and via mobile devices with industry leading solutions that include targeted shopper advertising and authentic consumer generated content, such as ratings and reviews, curated photos, social posts and videos. For more information, visit http://www.bazaarvoice.com.

 

Investor Relations Contact: 
Linda Wells 
Bazaarvoice, Inc. 
415-872-3612 
linda.wells@bazaarvoice.com

Media Contact: 
Andy North
Bazaarvoice, Inc. 
512-551-6502 
andy.north@bazaarvoice.com
Thursday, September 8th, 2016 Uncategorized Comments Off on $BV to Present at the $DB Technology Conference