Archive for May, 2017

$LMFA to Present at the 7th Annual LD Micro Invitational on June 6, 2017

TAMPA, Fla., May 31, 2017  — LM Funding America, Inc. (NASDAQ:LMFA) (NASDAQ:LMFAW), a specialty finance company offering unique funding solutions to community associations, has been invited to present at the 7th Annual LD Micro Invitational Investor Conference. The conference is being held on June 6-7, 2017 at the Luxe Sunset Boulevard Hotel in Los Angeles, California.

LM Funding CEO Bruce Rodgers will present on Tuesday, June 6 at 4:30 p.m. Pacific time, with one-on-one meetings held throughout the day.

LM Funding provides condominium and homeowner associations (COAs and HOAs) funding solutions to cover delinquent association dues. Management will discuss how their proprietary software allows them to scale and capitalize on the significant untapped market opportunity in the community funding market.

For additional information or to schedule a one-on-one meeting with LM Funding management, please contact your LD Micro representative or the company’s investor relations team at (949) 574-3860.

About LM Funding America
LM Funding America, Inc., together with its subsidiaries, is a specialty finance company that provides funding to nonprofit community associations (Associations) primarily located in the state of Florida, as well as in the states of Washington, Colorado and Illinois. The company offers funding to Associations by purchasing a certain portion of the associations’ rights to delinquent accounts that are selected by the Associations arising from unpaid Association assessments. It is also involved in the business of purchasing delinquent accounts on various terms tailored to suit each Association’s financial needs, including under its New Neighbor Guaranty™ program. The company was founded in 2008 and is based in Tampa, Florida. The company’s common shares and warrants trade on the NASDAQ Capital Market under the symbols “LMFA” and “LMFAW”.

Forward-Looking Statements
This press release may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995.  Words such as “anticipate,” “estimate,” “expect,” “intend,” “plan,” and “project” and other similar words and expressions are intended to signify forward-looking statements.  Forward-looking statements are not guarantees of future results and conditions but rather are subject to various risks and uncertainties.  Some of these risks and uncertainties are identified in the company’s filings with the SEC.  The occurrence of any of these risks and uncertainties could have a material adverse effect on the company’s business, financial condition, and results of operations.

Company Contact:
Bruce Rodgers
Chairman and CEO
LM Funding America, Inc.
(813) 222-8996
investors@lmfunding.com

Investor Relations Contact:
Sean Mansouri
Liolios Group, Inc.
(949) 574-3860
LMFA@liolios.com
Wednesday, May 31st, 2017 Uncategorized Comments Off on $LMFA to Present at the 7th Annual LD Micro Invitational on June 6, 2017

$AXU Reminds Shareholders of Voting Cut-Off for Upcoming Shareholders Meeting

VANCOUVER, May 31, 2017 – Alexco Resource Corp. (NYSE-MKT:AXU, TSX:AXR) would like to remind shareholders they have until 1:30 pm (Vancouver Time) on Tuesday June 6, 2017 to vote their shares for the upcoming Annual General Meeting (“Meeting”) of Alexco shareholders to be held at 1:30 pm (Vancouver Time) on Thursday, June 8, 2017.

Shareholders are urged to carefully read the information circular in connection with the Annual General meeting. A copy of the information circular in addition to other meeting materials is available on SEDAR at www.sedar.com and on Alexco’s website at www.alexcoresource.com/s/agm.asp. Management of Alexco recommends a vote FOR all proposed resolutions.

YOUR VOTE IS IMPORTANT REGARDLESS OF THE NUMBER OF SHARES YOU OWN. PLEASE VOTE TODAY.

How to Vote and Shareholder Questions

Registered Holders:  due to the essence of time, holders are asked to return their proxies using the following methods by June 6, 2017 at 1:30 p.m. (Pacific Time):

INTERNET: Vote online at www.investorvote.com using the control number located on the bottom left hand side of the proxy.
TELEPHONE: Call 1-866-732-VOTE (8683) toll free.

Beneficial Holders:  due to the essence of time holders are asked to return their voting instruction forms using the methods set out on their voting instruction form or business reply envelope, or as set out below, by June 5, 2017 at 1:30 p.m. (Pacific Time):

INTERNET: Vote online at www.proxyvote.com using the control number located on the voting instruction form.
TELEPHONE: Canada: Call 1-800-474-7493 (English) OR 1-800-474-7501 (French)
United States: Call 1-800-454-8683

Some statements (“forward-looking statements”) in this news release contain forward-looking information concerning the Company’s anticipated results and developments in the Company’s operations in future periods, made as of the date of this news release.  Forward-looking statements may include, but are not limited to, statements with respect to the timing of activities and reports.  Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking statements.  Forward-looking statements are based on certain assumptions that management believes are reasonable at the time they are made.  There can be no assurance that forward-looking statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements.  The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by applicable securities legislation.

Wednesday, May 31st, 2017 Uncategorized Comments Off on $AXU Reminds Shareholders of Voting Cut-Off for Upcoming Shareholders Meeting

$NERV Announces Amended Agreement for MIN-202 in Insomnia

Minerva to gain global strategic control over development of MIN-202 for insomnia

Janssen cash payments to Minerva of up to $70 million, including $30 million upfront

All shares in Minerva held by an affiliate of Janssen (approximately 3.9 million shares representing approximately 10% of outstanding shares) to be repurchased at par value

Minerva Phase 2 development payments totaling $13 million to be waived

WALTHAM, Mass., May 31, 2017  — Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it has entered into a binding term sheet to amend its co-development and license agreement with Janssen Pharmaceutica NV (Janssen) related to MIN-202 (JNJ 42827922), a selective orexin-2 receptor antagonist, and to repurchase all Minerva shares owned by Johnson & Johnson Innovation – JJDC, Inc. (an affiliate of Janssen).  This amendment and the stock repurchase are conditional upon the closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen and approval by the European Commission.

Under the amended agreement, Minerva will gain global strategic control of the development of MIN-202 to treat insomnia, and Janssen will forego its right to royalties on MIN-202 insomnia sales in Minerva territories.  Minerva will retain its current rights to MIN-202 as adjunctive therapy for major depressive disorder (MDD), which include an exclusive license in the European Union, Switzerland, Liechtenstein, Iceland and Norway, with royalties payable by Minerva to Janssen, and royalties on sales payable by Janssen to Minerva elsewhere worldwide.

Payments to Minerva by Janssen under this new agreement include an upfront payment of $30 million, $20 million at the start of a Phase 3 insomnia trial for MIN-202 and $20 million when 50% of the patients are enrolled in this trial.  Janssen will waive the remaining payments due from Minerva for Phase 2 development of MIN-202, which total approximately $13 million.  Minerva will assume all financial responsibility for Phase 3 development costs for MIN-202 in insomnia.  All Minerva stock currently owned by Johnson & Johnson Innovation – JJDC, Inc. totaling approximately 3.9 million shares and representing approximately 10% of total Minerva shares outstanding will be repurchased by Minerva at par value of $.0001 per share or approximately $389 in total.

“We view the new agreement with Janssen as a structure that will ensure a more focused and efficient clinical development of MIN-202 in insomnia by Minerva,” said Dr. Remy Luthringer, president and chief executive officer of Minerva.  “We look forward to continuing our collaboration with Janssen while accelerating the clinical advancement of our portfolio.  In addition, the infusion of financial resources under this agreement significantly extends Minerva’s financial runway.”

Minerva expects that these combined financial resources will support the development of MIN-101, its lead product candidate to treat negative symptoms in schizophrenia, and the development of MIN-202 in insomnia and MDD to the end of 2019.  Within that time frame, Minerva expects to generate data readouts from its planned Phase 3 trial with MIN-101 and three Phase 2b trials with MIN-202 in both indications.  Additional clinical activities planned during that period include a Phase 2 trial with MIN-117 and a Phase 1 trial with MIN-301.

About MIN-202 (JNJ 42827922)

MIN-202 is a selective orexin 2 receptor antagonist under development for the treatment of insomnia and as adjunctive therapy for MDD.  In the brain, the orexin system is involved in the control of several key functions, including metabolism and wakefulness. MIN-202 seeks to inhibit the activity of the neurons that promote wakefulness by selectively blocking the orexin 2 receptor. Rather than making an individual sleepier, blocking the orexin 2 receptor reduces the level of the neurotransmitters that signal the brain to maintain vigilance and wakefulness.

About Minerva Neurosciences

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

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended.  Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties.  Forward-looking statements include statements herein with respect to the approval by the European Commission and subsequent closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen; our ability to negotiate and execute the definitive agreements described above; the timing and results of future clinical milestones with MIN-202 in insomnia and major depressive disorder, including the timing and scope of future clinical trials and results of clinical trials with this compound; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our agreements with Janssen related to MIN-202; our ability to successfully develop and commercialize MIN-101, MIN-202, MIN-117 and MIN-301; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals.  These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, the inherent uncertainty in approval by the European Commission and subsequent closing of the pending acquisition of Actelion Ltd. by affiliates of Janssen; whether MIN-101, MIN-202, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, it will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether the results of future clinical trials of MIN-101, MIN-202, MIN-117 and MIN-301, if any, will be consistent with the results of past clinical trials; whether MIN-101, MIN-202, MIN-117 and MIN-301 will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions.  These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 4, 2017.  Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

Contact:

William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
Wednesday, May 31st, 2017 Uncategorized Comments Off on $NERV Announces Amended Agreement for MIN-202 in Insomnia

$AYA Makes Final Payment on Rational Group Deferred Purchase Price

MONTREAL, May 31, 2017  – Amaya Inc. (Nasdaq: AYA; TSX: AYA) today announced that it has made its final payment on the deferred purchase price obligation for its acquisition of the Rational Group in August 2014. Amaya used cash flow from operations to make the payment, which included the remaining balance of $47.5 million and approximately $870,000 of associated fees. As previously announced, Amaya paid $200 million of the deferred purchase price in November 2016, $75 million in February 2017 and a further $75 million in April 2017. All dollar ($) amounts are in U.S. dollars.

About Amaya

Amaya is a leading provider of technology-based products and services in the global gaming and interactive entertainment industries. Amaya ultimately owns gaming and related consumer businesses and brands including PokerStars, PokerStars Casino, BetStars, Full Tilt, StarsDraft, and the PokerStars Championship and PokerStars Festival live poker tour brands (incorporating aspects of the European Poker Tour, PokerStars Caribbean Adventure, Latin American Poker Tour and the Asia Pacific Poker Tour). These brands have more than 111 million cumulative registered customers globally and collectively form the largest poker business in the world, comprising online poker games and tournaments, sponsored live poker competitions, marketing arrangements for branded poker rooms in popular casinos in major cities around the world, and poker programming and content created for television and online audiences. Amaya, through certain of these brands, also offers non-poker gaming products, including casino, sportsbook and daily fantasy sports. Amaya, through certain of its subsidiaries, is licensed or approved to offer, or offers under third party licenses or approvals, its products and services in various jurisdictions throughout the world, including in Europe, both within and outside of the European Union, the Americas and elsewhere. In particular, PokerStars is the world’s most licensed online gaming brand, holding licenses or related operating approvals in 17 jurisdictions.

Wednesday, May 31st, 2017 Uncategorized Comments Off on $AYA Makes Final Payment on Rational Group Deferred Purchase Price

$CBIO Factor IX Recommended for Orphan Drug Designation in Europe

Positive opinion issued by EMA Committee for Orphan Medicinal Products for CB 2679d/ISU304, a next-generation Factor IX for subcutaneous prophylactic treatment of Hemophilia B

SOUTH SAN FRANCISCO, Calif., May 31, 2017 — Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan drug) designation for CB 2679d/ISU304 for the treatment of hemophilia B.

Currently approved therapies for treating hemophilia B rely on frequent intravenous infusions where adherence and convenient access to peripheral veins is difficult, often requiring the use of a central venous access devices that have associated risks of infection and thrombosis. CB 2679d, a highly potent next-generation coagulation Factor IX variant, has demonstrated, in preclinical studies, the potential to normalize human Factor IX levels with a daily subcutaneous injection.

“Obtaining orphan drug designation is an important part of our regulatory approval strategy for CB 2679d, and the receipt of the positive COMP opinion puts us one step closer to this goal,” said Nassim Usman, Ph.D., President and Chief Executive Officer of Catalyst.

Catalyst’s South Korean collaborator, ISU Abxis, plans to initiate a Phase 1/2 proof-of-concept study of CB 2679d in individuals with severe hemophilia B in June 2017 in South Korea.

About Orphan Designation
Applications for orphan designation are initially reviewed by the COMP. Positive opinions are forwarded to the European Commission, which is responsible for formally granting the orphan medicinal designation. Orphan designation in the EU is given to products that are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; where prevalence of the condition in the EU is less than 5 in 10,000; and where the product represents a significant benefit over existing treatments.

Orphan Designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Detailed information on orphan designation can be found here.

About Factor IX
CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is IND-approved in South Korea. Catalyst believes that CB 2679d/ISU304 may allow for subcutaneous prophylactic treatment of individuals with hemophilia B and maintain higher FIX activity levels than currently available products. Learn more about Factor IX.

About Hemophilia and Factor Replacement Therapy
Hemophilia, for which there is no cure, is a rare but serious bleeding disorder that results from a genetic or an acquired deficiency of a protein required for normal blood coagulation. Individuals with hemophilia suffer from spontaneous bleeding episodes as well as substantially prolonged bleeding times upon injury. Learn more about hemophilia.

About Catalyst
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. For more information, visit www.catalystbiosciences.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statement of historical facts, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d/ISU304 and development plans for this product candidate are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the anticipated granting of orphan drug designation of CB2679d/ISU304 in the EU by the European Commission, clinical trial timelines, including the anticipated initiation of a Phase 1/2 proof-of-concept study for CB 2679d/ISU304 in June of 2017, the potential uses and benefits of subcutaneously dosed CB 2679d/ISU304. Actual results or events could differ materially from the plans and expectations and projections disclosed in these forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Catalyst makes, including, but not limited to, the risk that the European Commission will not follow the recommendation of the European Medicines Agency Committee for Orphan Medicinal Products, the risk that trials and studies may be delayed and may not have satisfactory outcomes, that human trials will not replicate the results from animal studies, that potential adverse effects may arise from the testing or use of Catalyst’s products, including the generation of antibodies, the risk that costs required to develop or manufacture Catalyst’s products will be higher than anticipated, competition, and other factors described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and our other periodic reports filed with the SEC. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.

 

Contacts: 
Investors:
Fletcher Payne, CFO
Catalyst Biosciences
650.871.0761
investors@catbio.com 

Media:
Denise Powell
510.703.9491
denise@redhousecomms.com
Wednesday, May 31st, 2017 Uncategorized Comments Off on $CBIO Factor IX Recommended for Orphan Drug Designation in Europe

$MBOT Issuance of a Canadian Patent Covering a Self-Cleaning Shunt

Continues to Strengthen Global IP Portfolio for ViRob™ and TipCAT™ Technology Platforms

HINGHAM, Mass., May 31, 2017 — Microbot Medical Inc. (Nasdaq:MBOT), a medical device company specializing in the design and development of transformational micro-robotic medical technologies, announced today that the Canadian Intellectual Property Office has granted patent No. 2,803,0462, covering the Company’s Self-Cleaning Shunt (SCS™).

“This patent continues to strengthen our IP for the self-cleaning shunt platform and complements the forthcoming US patent that was allowed earlier in the year.  These and other patents in our portfolio allow us to position the Company to enter additional sizeable markets while leveraging the use of our transformational technology,” commented Harel Gadot, CEO, President and Chairman.  “We continue to make significant progress towards the development of our initial SCS product, which focuses on the Ventriculoperitoneal (VP) Shunts space.   We are addressing large unmet markets with our unique technology platforms, and as we grow our transformational micro-robotic technologies, we will continue to maintain and strengthen our IP portfolio as well.”

The patent covers an inlet head for use on shunts, such as Ventriculoperitoneal (VP) Shunts, which are implanted in Hydrocephalus patients for draining excess cerebrospinal fluid (CSF). The inlet head includes a tube with openings disposed in its wall, and a cleaning element installed inside the tube, such that mutual vibratory motion between the cleaning element and the tube, maintains the openings clear and thereby prevents shunt occlusion.  The Company has an exclusive license for the patent from the Technion – Israel Institute of Technology.

Globally, the Company now has 21 patents issued and 15 patent applications pending worldwide. The Company’s patents cover its ViRob™ and TipCAT™ technology platforms.

About Microbot Medical, Inc.

Microbot, which was founded in 2010 and commenced operations in 2011, became a NASDAQ listed company on November 28, 2016. The Company specializes in transformational micro-robotic medical technologies leveraging the natural and artificial lumens within the human body. Microbot’s current platforms, ViRob™ and TipCAT™, are comprised of two highly advanced micro-robotic technologies, from which the Company is currently developing its first two product candidates: the Self Cleaning Shunt, or SCS™, for the treatment of hydrocephalus and Normal Pressure Hydrocephalus, or NPH; and a self-propelling, semi-disposable endoscope that is being developed initially for use in colonoscopy procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com.

The ViRob™ technology is a revolutionary autonomous crawling micro-robot which can be controlled remotely or within the body.  Its miniature dimensions allow it to navigate and crawl in different spaces within the human body, including blood vessels, the digestive tract and the respiratory system.  Its unique structure gives it the ability to move in tight spaces and curved passages as well as the ability to remain within the human body for prolonged time.  To learn more about ViRob™ please visit http://www.microbotmedical.com/technology/virob/.

TipCAT™ is a transformational self-propelled, flexible, and semi-disposable endoscope providing see & treat capabilities within tubular lumens in the human body such as the colon, blood vessels, and the urinary tract.  Its locomotion mechanism is perfectly suitable to navigate and crawl through natural & artificial tubular lumens, applying the minimal necessary pressure to achieve the adequate friction required for gentle, fast, and safe advancement within the human body.  To learn more about TipCAT™ visit http://www.microbotmedical.com/technology/tipcat/.

Safe Harbor

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Microbot Medical Inc. particularly those mentioned in the cautionary statements found in Microbot Medical Inc.’s filings with the Securities and Exchange Commission. Microbot Medical disclaims any intent or obligation to update these forward-looking statements.

Investor Contacts:

Analysts and Institutional Investors
Michael Polyviou
EVC Group
mpolyviou@evcgroup.com
646-445-4800

Individual Investors
Jeremy Roe
Integra Consulting Group llc
jeremy@integracg.net
(925) 262-8305
Wednesday, May 31st, 2017 Uncategorized Comments Off on $MBOT Issuance of a Canadian Patent Covering a Self-Cleaning Shunt

$VRAY to Present at Citi’s 2017 Small & Mid Cap Conference

CLEVELAND, May 30, 2017 — ViewRay, Inc. (NASDAQ: VRAY) announced today that Chris Raanes, Chief Executive Officer, and Ajay Bansal, Chief Financial Officer, are scheduled to present at Citi’s 2017 Small & Mid Cap Conference in New York, NY.

Event:                   Citi’s 2017 Small & Mid Cap Conference
Date:                     Thursday, June 8
Time:                     9:30am ET

If interested in meeting with management at the conference please contact your Citi sales representative or The Ruth Group at bjohnston@theruthgroup.com. 

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.

Tuesday, May 30th, 2017 Uncategorized Comments Off on $VRAY to Present at Citi’s 2017 Small & Mid Cap Conference

$GLYC Announces Closing of Public Offering and Full Exercise

GlycoMimetics, Inc. (NASDAQ: GLYC) today announced the closing of its underwritten public offering of 8,050,000 shares of its common stock at a public offering price of $11.50 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,050,000 additional shares of common stock. All of the shares in the offering were offered by GlycoMimetics. The aggregate gross proceeds to GlycoMimetics from the offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $92.6 million.

Jefferies LLC and Cowen acted as joint book-running managers for the offering. SunTrust Robinson Humphrey, Inc. acted as lead manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on March 17, 2015 and declared effective by the SEC on March 24, 2015. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. The final prospectus supplement and accompanying prospectus were filed with the SEC on May 24, 2017. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at (877) 821-7388; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by phone at (631) 274-2806.

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

About GlycoMimetics, Inc.

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

 

GlycoMimetics, Inc.
Investor Contact:
Shari Annes, 650-888-0902
sannes@annesassociates.com
or
Media Contact:
Jamie Lacey-Moreira, 410-299-3310
jamielacey@presscommpr.com

Tuesday, May 30th, 2017 Uncategorized Comments Off on $GLYC Announces Closing of Public Offering and Full Exercise

$MTBC Extends Offer to New Hospital Clients of its Patient Receivables Solution

SOMERSET, NJ–(May 30, 2017) – MTBC (NASDAQ: MTBC) (NASDAQ: MTBCP), a leading provider of proprietary, cloud-based healthcare IT solutions and services, today announced that hospitals that select MTBC’s patient receivables solution by September 30, 2017 will receive a complimentary, commitment-free month of service.

A current hospital client of MTBC’s patient receivables solution explained, “MTBC is a great partner.” Marlena Kratzer, Director of Patient Accounts for Sacred Heart Hospital of Pennsylvania, continued, “They handle everything, which allows us to use our resources elsewhere.”

MTBC’s patient receivables solution leverages its proprietary technology, real-time data, and experienced professionals to empower healthcare facilities and medical practices to streamline and optimize the collection of patient balances. MTBC’s cloud-based patient receivables tools include the following:

  • Real-time eligibility and deductible details;
  • Cloud-based patient payment portal and patient smartphone app;
  • Automated telephone, text message, and email communication campaigns;
  • Secure electronic statements, together with traditional paper statement series;
  • Advanced business intelligence and analytics; and
  • Professional patient telephone support.

“As patients bear an increasing percentage of the cost for healthcare services, it’s critical that hospitals and medical practices leverage a solution that efficiently maximizes patient collections in a patient-centric manner,” said Stephen Snyder, MTBC President. He continued, “It’s our privilege to provide a variety of technology-driven solutions to thousands of healthcare providers across the country and we look forward to partnering with additional hospitals seeking a proven patient receivables solution.”

Additional information regarding MTBC is available at www.mtbc.com or by calling 866.266.6822.

About MTBC
MTBC is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers. Our integrated Software-as-a-Service (or SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

For additional information, please visit our website at www.mtbc.com.

Follow MTBC on Twitter, LinkedIn and Facebook.

SOURCE MTBC

Investor and Company Contact:
Bill Korn
Chief Financial Officer
Medical Transcription Billing, Corp.
bkorn@mtbc.com
732-873-5133

Tuesday, May 30th, 2017 Uncategorized Comments Off on $MTBC Extends Offer to New Hospital Clients of its Patient Receivables Solution

$MNKD Provides Update on Senior Management

Michael Castagna appointed Chief Executive Officer and Member of MannKind Board of Directors

VALENCIA, Calif., May 30, 2017  — MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) announced today that its Board of Directors appointed Michael Castagna, Pharm.D., as Chief Executive Officer effective May 25, 2017. Dr. Castagna replaced Matthew Pfeffer, who served as both CEO and Chief Financial Officer since January 2016 and as CFO from 2008 to 2016. To facilitate an orderly transition, Mr. Pfeffer will continue with the company in an advisory capacity until the end of July 2017.

In addition, on May 25, 2017, Dr. Castagna was appointed to the board of directors of MannKind.

Kent Kresa, Chairman of the Board, said, “The Board is extremely grateful to Matt for his committed service to the company over the past nine years. Matt successfully set the foundation for the company during its transition into a commercial entity and effectively prepared Michael to be his successor.” Mr. Kresa continued, “Michael demonstrated deep commercial expertise in his prior role as MannKind’s Chief Commercial Officer as he built the capabilities from the bottom-up necessary to position Afrezza and the company for future growth. Under Michael’s leadership, new prescriptions of Afrezza have shown a steady increase since the MannKind launch and future prospects for this innovative product are strong. The Board is excited to move forward under Michael’s leadership.”

Dr. Castagna said, “I am honored to lead MannKind into its next phase of growth. Our inhaled insulin, Afrezza, is a truly differentiated brand that will help millions of people suffering from diabetes. Our relentless focus on empowering people to conquer the daily struggle of managing their diabetes will set MannKind apart.”

Rose Alinaya, currently the company’s Senior Vice President and Principal Accounting Officer, will take over the role of Acting Chief Financial Officer until a permanent CFO is named.

Dr. Castagna said, “I am happy to have Rose in this position as I will benefit greatly from her 14 years of experience with MannKind. She will be a key asset for me as I take on my new role.”

About MannKind Corporation
MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.

Company Contact:
Rose Alinaya
Acting Chief Financial Officer
661-775-5300
ralinaya@mannkindcorp.com
Tuesday, May 30th, 2017 Uncategorized Comments Off on $MNKD Provides Update on Senior Management

$ALBO Closing of $51.9 Million Public Offering

BOSTON, May 30, 2017 — Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today the completion of its previously announced underwritten public offering of 2,200,000 shares of its common stock at a price to the public of $20.50 per share. In addition, the underwriters have exercised an option to purchase an additional 330,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares in the offering were sold by Albireo, with gross proceeds to Albireo of approximately $51.9 million and net proceeds of approximately $48.2 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Cowen and William Blair acted as joint book-running managers and representatives of the underwriters for the offering. Needham & Company and Wedbush PacGrow acted as co-managers.

The offering was made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (SEC). The final prospectus supplement and accompanying prospectus have been filed with the SEC and are available at the SEC’s website located at www.sec.gov, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at 631-274-2806, and from William Blair & Company, L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, or by telephone at 1-800-621-0687 or email at prospectus@williamblair.com.

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

About Albireo

Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 3 product candidates and one Phase 2 product candidate. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden.

Source: Albireo Pharma, Inc.

 

Investor Contact: 
Hans Vitzthum 
LifeSci Advisors, LLC. 
212-915-2568

Media Contact: 
Heather Anderson 
6 Degrees 
980-938-0260 
handerson@6degreespr.com
Tuesday, May 30th, 2017 Uncategorized Comments Off on $ALBO Closing of $51.9 Million Public Offering

$PTGX Enters into Worldwide Agreement with Janssen on IBD

– Protagonist grants Janssen exclusive, worldwide rights to PTG-200, a first-in-class oral peptide IL-23 receptor antagonist currently in pre-clinical development – Protagonist to receive a $50 million upfront payment and potentially up to an additional $940 million in development and sales milestones; double-digit tiered royalties on net sales – Protagonist and Janssen to co-fund development through Phase 2; Protagonist retains option to co-detail U.S. prescribers – Protagonist to host conference call and webcast today, May 30, at 8:00 a.m. Eastern Daylight Time

NEWARK, Calif., May 30, 2017  — Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced that the company has entered into a worldwide license and collaboration agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the co-development and commercialization of PTG-200, Protagonist’s first-in-class, oral peptide IL-23 receptor antagonist for all indications including inflammatory bowel disease (IBD). PTG-200 is expected to enter Phase 1 clinical testing in normal healthy volunteers in the second half of 2017. The agreement builds upon a Johnson & Johnson Innovation – JJDC, Inc. Series B venture financing from 2013 in support of the discovery and development of Protagonist’s pipeline of oral peptide therapeutics.

“We are very pleased to partner with Janssen, a world-leader in the development of innovative therapies for patients suffering with chronic inflammatory and immunomodulatory diseases. As an oral IL-23 receptor antagonist, PTG-200 nicely complements Janssen’s current IBD portfolio,” said Dinesh V. Patel, Ph.D., Protagonist’s President and Chief Executive Officer. “The funding provided by this transaction enables us to advance our platform and clinical pipeline of innovative peptide drugs, including our lead oral peptide alpha-4-beta-7 integrin antagonist, PTG-100, which is currently in a Phase 2b clinical trial as a potential treatment for ulcerative colitis.”

“Our oral peptide PTG-200 works by blocking the IL-23 pathway, a mechanism which has been proven by injectable antibodies, including an approved drug and others in different stages of clinical development,” said David Y. Liu, Ph.D., Protagonist’s Chief Scientific Officer and Head of R&D. “As evidenced by PTG-200, we believe our technology platform is validated in its ability to generate potential first-in-class oral peptides as the next generation of targeted therapy drugs for IBD.”

Terms of the Collaboration

Under the terms of the license and collaboration agreement, Protagonist will receive an upfront payment of $50 million from Janssen, and will also be eligible to receive up to an additional $940 million in development, regulatory, and sales milestones. The development milestones represent significant payments that Protagonist would receive upon completion of each component of the Phase 2a/2b clinical trial in Crohn’s disease if Janssen elects to retain its license following each of those events. Janssen will receive exclusive, worldwide rights to develop and commercialize PTG-200, and Protagonist will receive double-digit tiered royalties on net product sales.

Protagonist Therapeutics and Janssen will jointly conduct the development of PTG-200 through Phase 2 clinical proof-of-concept in Crohn’s disease, after which time Janssen will be responsible for development and commercialization. Per the terms of the agreement, Protagonist will have the right to co-detail PTG-200 in the United States.

The transaction is expected to close in the third quarter of 2017, subject to customary closing conditions.

Additional details regarding the collaboration can be found in Protagonist’s Form 8-K filed today with the Securities and Exchange Commission.

Conference Call and Webcast Information

Protagonist Therapeutics will host a conference call to discuss this transaction at 8:00 a.m. EDT today, May 30, 2017. The live webcast can be accessed under “Events and Presentations” in the Investors section of the company’s website at www.protagonist-inc.com. The webcast will be available for replay for 30 days on the company website. Alternatively, investors may listen to the call by dialing toll-free 844-515-9178 from locations in the United States or via toll call +1-614-999-9313 from outside the United States. Please refer to conference ID number 30341699.

About PTG-200

PTG-200 is a first-in-class oral Interleukin-23 receptor (IL-23R) antagonist being co-developed with Janssen initially for the treatment of Crohn’s disease. PTG-200 is currently in pre-clinical development studies, and is expected to enter Phase 1 clinical testing in the second half of 2017.

PTG-200 may have the potential to transform the existing IBD treatment paradigm because it is designed to offer significant advantages over injectable antibody drugs, including improved convenience, patient compliance, and the potential for improved safety and tolerability compared to currently approved injectable antibody drugs.

About Protagonist Therapeutics

Protagonist Therapeutics is a clinical-stage biopharmaceutical company with a proprietary technology platform which is utilized to discover and develop novel peptide-based drugs to address significant unmet medical needs. Its primary focus is on developing potential first-in-class oral targeted therapy-based peptide drugs that work by blocking biological pathways that are currently targeted by marketed injectable antibody drugs. Protagonist’s initial lead peptide product candidates, PTG-100 and PTG-200, are based on this approach, and the company believes these candidates have the potential to transform the existing treatment paradigm for inflammatory bowel disease (IBD), chronic gastrointestinal diseases consisting primarily of ulcerative colitis and Crohn’s disease.

PTG-100, a potential first-in-class oral peptide alpha-4-beta-7 integrin antagonist, is currently in a global Phase 2b clinical trial for treatment of moderate-to-severe ulcerative colitis.  PTG-200, a first-in-class oral Interleukin-23 receptor antagonist for potential treatment of IBD, initially Crohn’s disease, is currently in pre-clinical development and is expected to enter a Phase 1 clinical study in the second half of 2017.

In addition to PTG-100 and PTG-200, the company is developing an injectable hepcidin mimetic PTG-300 as a potential orphan drug for the treatment of rare diseases such as beta-thalassemia.  PTG-300 is currently being studied in a Phase 1 clinical trial.

Protagonist is headquartered in Newark, California with its pre-clinical and clinical staff in California, and discovery operations both in California and in Brisbane, Queensland, Australia. For further information, please visit http://www.protagonist-inc.com.

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. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our programs, the timing of our clinical trials, the potential for eventual regulatory approval and commercialization of our product candidates and our potential receipt of milestone payments and royalties under our collaboration agreement with Janssen. In some cases you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “expect,” “potential,” or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses, our reliance on third parties and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do,  and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission on May 10, 2017. 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.

Tuesday, May 30th, 2017 Uncategorized Comments Off on $PTGX Enters into Worldwide Agreement with Janssen on IBD

$SVM Declares Dividend – US$0.01 Semi-Annual, up from CAD $0.01

Trading Symbol: TSX/NYSE MKT: SVM

VANCOUVER, May 26, 2017  – Silvercorp Metals Inc. (“Silvercorp” or the “Company”) today announced that its Board of Directors declared a dividend of US$0.01 to be paid on or before June 30th, 2017 to shareholders of record at the close of business June 9th 2017

In November 2016, in light of improved operations, financial results, and a growing cash position the Company re-instated dividends, declaring a semi-annual dividend of CAD$0.01 per share (CAD$0.02 per share on an annual basis).  The Company has now decided to slightly increase the dividend by making the payment in U.S. funds rather than Canadian funds.

The dividends are considered eligible dividends for Canadian tax purposes.

The declaration and payment of future dividends is at the discretion of the Board of Directors and any future decision to pay dividends will be based on a number of factors including commodity prices, market conditions, financial results, cash flows from operations, expected cash requirements and other relevant factors.

About Silvercorp Metals Inc.

Silvercorp is a low-cost silver-producing Canadian mining company with multiple mines in China.   The Company’s vision is to deliver shareholder value by focusing on the acquisition of under developed projects with resource potential and the ability to grow organically.  For more information, please visit our website at www.silvercorpmetals.com

Friday, May 26th, 2017 Uncategorized Comments Off on $SVM Declares Dividend – US$0.01 Semi-Annual, up from CAD $0.01

$AFSI Announces Closing of $300 Million Private Placement

NEW YORK, May 26, 2017  — AmTrust Financial Services, Inc. (Nasdaq:AFSI) (the “Company” or “AmTrust”) announced today that it has closed its previously announced private placement of 24,096,384 shares of common stock at a price of $12.45 per share, resulting in gross proceeds to the Company of US$300 million.

About AmTrust Financial Services, Inc.

AmTrust Financial Services, Inc., a multinational insurance holding company headquartered in New York City, offers specialty property and casualty insurance products, including workers’ compensation, commercial automobile, general liability and extended service and warranty coverage through its primary insurance subsidiaries rated “A” (Excellent) by A.M. Best. For more information about AmTrust visit www.amtrustgroup.com.

Forward-Looking Statements

This news release contains certain forward-looking statements that are intended to be covered by the safe harbors created by the Private Securities Litigation Reform Act of 1995. When we use words such as “anticipate,” “intend,” “plan,” “believe,” “estimate,” “expect,” or similar expressions, we do so to identify forward-looking statements. Examples of forward-looking statements include the plans and objectives of management for future operations, including those relating to future growth of our business activities and availability of funds, projections of the impact of potential errors or misstatements in our financial statements, and estimates of the impact of material weaknesses in our internal control over financial reporting, and are based on current expectations that involve assumptions that are difficult or impossible to predict accurately and many of which are beyond our control. Actual results may differ materially from those expressed or implied in these statements as a result of significant risks and uncertainties, including, but not limited to, non-receipt of expected payments from insureds or reinsurers, changes in interest rates, a downgrade in the financial strength ratings of our insurance subsidiaries, the effect of the performance of financial markets on our investment portfolio, the amounts, timing and prices of any share repurchases made by us under our share repurchase program, development of claims and the effect on loss reserves, accuracy in projecting loss reserves, the cost and availability of reinsurance coverage, the effects of emerging claim and coverage issues, changes in the demand for our products, our degree of success in integrating acquired businesses, the effect of general economic conditions, state and federal legislation, regulations and regulatory investigations into industry practices, the impact of known or potential errors or misstatements in our financial statements, our ability to timely and effectively remediate the material weaknesses in our internal control over financial reporting and implement effective internal control over financial reporting and disclosure controls and procedures in the future, risks associated with conducting business outside the United States, the impact of Brexit, developments relating to existing agreements, disruptions to our business relationships with Maiden Holdings, Ltd. or National General Holdings Corp., breaches in data security or other disruptions with our technology, heightened competition, changes in pricing environments, and changes in asset valuations. Additional information about these risks and uncertainties, as well as others that may cause actual results to differ materially from those projected, is contained in our filings with the SEC, including our Annual Report on Form 10-K and our quarterly reports on Form 10-Q. The projections and statements in this news release speak only as of the date of this release and we undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

For more information, please contact:

AmTrust Financial Services, Inc.
Chaya Cooperberg
Chief Communications Officer & SVP Corporate Affairs
chaya.cooperberg@amtrustgroup.com
646.458.3332
Friday, May 26th, 2017 Uncategorized Comments Off on $AFSI Announces Closing of $300 Million Private Placement

$SENS Announces Pricing of $41 Million Underwritten Offering of Common Stock

Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the pricing of its underwritten offering of 29,078,014 shares of its common stock at a price of $1.41 per share to a group of institutional investors, including Roche Finance, Ltd., which has agreed to purchase 21,276,596 shares in the offering, and funds affiliated with New Enterprise Associates, which have agreed to purchase 7,092,198 shares in the offering. Gross proceeds to Senseonics from the offering are expected to be $41.0 million. The offering is expected to close on or about June 1, 2017, subject to customary closing conditions.

Leerink Partners LLC is acting as the sole book-running manager for the offering.

Senseonics intends to use the net proceeds from the offering to begin commercialization of Eversense in the United States, if approved, to fund continued research and development of future configurations of Eversense, and for working capital and general corporate purposes.

A shelf registration statement relating to the shares of common stock offered in the underwritten offering described above was filed with the Securities and Exchange Commission (SEC) on April 3, 2017 and declared effective by the SEC on April 17, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6132, email: syndicate@Leerink.com.

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

About Senseonics Holdings, Inc.

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation CGM system, Eversense, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics Holdings, Inc., including statements about Senseonics’ the closing of the offering, anticipated use of proceeds and other statements containing the words “expect,” “intend,” “may,” “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the underwritten offering on the anticipated terms or at all, uncertainties inherent in the expanded commercial launch of Eversense and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.

 

Senseonics Holdings, Inc.
R. Don Elsey
Chief Financial Officer
301.556.1602
don.elsey@senseonics.com

Friday, May 26th, 2017 Uncategorized Comments Off on $SENS Announces Pricing of $41 Million Underwritten Offering of Common Stock

$ECYT to Announce Updated Data on EC1456 and EC1169

WEST LAFAYETTE, Ind., May 26, 2017 — Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, today announced that two posters will be presented on its lead, clinical-stage assets, EC1456 and EC1169, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2 – 6, 2017, in Chicago.

Updated data will be presented on EC1456-01, a two part phase 1 dose escalation (Part A) and expansion (Part B) study. The presentation includes data for 87 Part A treated patients with advanced solid tumors and 6 Part B treated patients with FR-positive non-small cell lung cancer (NSCLC) as of the data cutoff on May 18, 2017. All patients were imaged to assess folate receptor expression with 99mTc-etarfolatide (FR expression not an eligibility criteria for Part A). Preliminary data from our first patient enrolled in the EC1456 ovarian surgical study, EC1456-02, will also be presented.

An update also will be provided for EC1169-01, a two-part phase 1 dose escalation (Part A) and expansion (Part B) study in patients with metastatic castration-resistant prostate cancer (mCRPC). The presentation includes data for the expansion phase (Part B) for 24 taxane-exposed mCRPC patients and 16 taxane-naïve mCRPC patients as of the data cutoff on May 15, 2017. All patients were imaged to assess PSMA expression with 99mTc-EC0652 (PSMA expression not an eligibility criteria).

The posters will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #: 2576
Title: Phase 1 dose escalation study of the folate receptor-targeted small molecule drug conjugate EC1456
Presenter: Dr. Wael Harb, Horizon Oncology Center
When: Monday, June 5, 8:00 a.m. – 11:30 a.m. CDT
Session Title: Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Abstract #: 5038
Title: Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Presenter: Dr. Michael Morris, Memorial Sloan Kettering Cancer Center
When: Monday, June 5, 1:15 p.m. – 4:45 p.m. CDT
Session Title: Poster Session: Genitourinary (Prostate) Cancer

 

About EC1456

EC1456 is an investigational therapeutic SMDC constructed of a high affinity FR-targeting ligand conjugated through a spacer and bioreleasable linker system to a potent cytotoxic microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient FR-status is determined using the investigational companion imaging agent, etarfolatide. EC1456 is currently being evaluated in a phase 1 study in patients with advanced solid tumors (Part A) and FR-positive NSCLC (Part B) (ClinicalTrials.gov Identifier: NCT01999738) and a phase 1 exploratory study in patients with ovarian cancer undergoing surgery (ClinicalTrials.gov Identifier: NCT03011320).

About EC1169

EC1169 is an investigational therapeutic SMDC constructed of a high affinity prostate specific membrane antigen (PSMA)-targeting ligand conjugated through a bioreleasable linker system to a potent microtubule inhibitor, TubBH. Patient PSMA-status is determined using the investigational companion imaging agent, EC0652. EC1169 is currently being evaluated in a phase 1 study in patients with metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02202447).

About Endocyte

Endocyte is a biopharmaceutical company and leader in developing targeted therapies for the treatment of cancer and other serious diseases.  Endocyte uses its proprietary drug conjugation technology to create novel SMDCs and companion imaging agents for personalized targeted therapies.  The company’s SMDCs actively target receptors that are over-expressed on diseased cells, relative to healthy cells.  This targeted approach is designed to enable the treatment of patients with highly active drugs at greater doses, delivered more frequently and over longer periods of time than would be possible with the untargeted drug alone.  The companion imaging agents are designed to identify patients whose disease over-expresses the target of the therapy and who are therefore more likely to benefit from treatment. For additional information, please visit Endocyte’s website at www.endocyte.com.

Endocyte Forward-Looking Statement

Certain of the statements made in this press release are forward looking, such as those relating to the company’s development programs and upcoming milestones. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trials (whether caused by competition, adverse events, patient enrollment rates, shortage of clinical trial materials, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks related to the safety and efficacy of the company’s product candidates; risks that early stage preclinical data may not be indicative of subsequent data when expanded to additional pre-clinical models or to subsequent clinical data; risks that evolving competitive activity and intellectual property landscape may impair the company’s ability to capture value for the technology; estimates of the potential markets for its product candidates; estimates of the capacity of manufacturing and other facilities required to support its product candidates; projected cash needs; and expected future revenues, operations, expenditures and cash position. More information about the risks and uncertainties faced by Endocyte, Inc. is contained in the company’s periodic reports filed with the Securities and Exchange Commission. Endocyte, Inc. 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: 
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
Friday, May 26th, 2017 Uncategorized Comments Off on $ECYT to Announce Updated Data on EC1456 and EC1169

$CFRX Initiation of Phase 2 Staph Aureus Study Evaluating CF-301

YONKERS, NY–(May 25, 2017) – ContraFect Corporation (NASDAQ: CFRX), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced the initiation of an international Phase 2 study evaluating its first-in-class lysin, CF-301, as a potential treatment of Staphylococcus aureus (Staph aureus) bacteremia including right sided endocarditis. Staph aureus bacteremia and endocarditis are serious life threatening infections, associated with substantial morbidity and mortality despite currently available conventional antibiotics. This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the potential for CF-301 to be used in addition to standard-of-care (SOC) antibiotics to significantly improve clinical success rates compared to SOC antibiotics alone. Safety, tolerability, and pharmacokinetics of CF-301 will also be evaluated in the study. The company expects to announce top line results in Q4 2018.

“We are very pleased to initiate the first clinical study of CF-301 in patients with S. aureus bacteremia. Based on the extensive amount of pre-clinical data generated, CF-301 has the potential to improve clinical outcomes for these patients by rapid bacterial killing, synergy with conventional antibiotics and clearance of biofilms that complicate Staph aureus infections, ” said Cara Cassino, M.D., EVP of Research and Development and Chief Medical Officer at ContraFect.

“We are excited about the initiation of this trial, and the promise that CF-301, and potentially other lysins in our pipeline, may offer important new advances in the treatment of bacterial infections which are a global health care threat,” said Steven C. Gilman, Ph.D., Chairman of ContraFect.

In the United States alone, there are approximately 120,000 cases annually of the bloodstream infection Staph aureus bacteremia, which causes approximately 30,000 deaths. Staph aureus bacteremia can be further complicated when the infection spreads into the heart muscle, heart valves or lining of the heart, causing endocarditis. Even with current SOC antibiotic therapy, the resulting damage to the heart muscle or heart valves could require surgery for definitive treatment to prevent stroke, heart failure or multi-organ system damage. Of further concern, drug-resistant strains of Staph aureus are now evolving additional resistance against SOC antibiotics, which may ultimately result in an increase in the number of cases and in mortality from Staph aureus bacteremia, including endocarditis.

About the Trial:

ContraFect plans to conduct the trial in approximately 70 sites worldwide including North America, South America, and Europe. A total of 115 patients are expected to be enrolled, randomized 3:2 to receive either a single dose of 0.25 mg/kg CF-301 administered via a 2 hour IV infusion in addition to SOC antibiotics or placebo plus SOC antibiotics.

The primary endpoint of the trial is early clinical response. In addition, safety, tolerability, pharmacokinetics, and a number of exploratory clinical and health resource utilization endpoints will be evaluated.

More information about the trial is available at www.clinicaltrials.gov.

About ContraFect:

ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (Methicillin-resistant Staphylococcus aureus) and influenza.

About CF-301:

CF-301 is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staphylococcus aureus (Staph aureus) bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body’s natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect. It is the first lysin to enter clinical studies in the U.S.

FORWARD-LOOKING STATEMENTS

This press release contains, and our officers and representatives may make from time to time, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding our ability to discover and develop protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, including whether CF-301 has the potential to be a first-in-class lysin therapeutic for the treatment of Staph aureus bacteremia including right sided endocarditis, whether CF-301 used in addition to SOC antibiotics can significantly improve clinical success rates compared to SOC antibiotics alone, whether CF-301 can improve clinical outcomes for patients by rapid bacterial killing, synergy with conventional antibiotics and clearance of biofilms which complicate Staph aureus infections, whether CF-301 and other lysins in our pipeline will offer important new advances in the treatment of bacterial infections which are a global health care threat, our plans to conduct the trial in approximately 70 sites worldwide including North America, South America, and Europe, our ability to enroll a total of 115 patients, whether we achieve our clinical endpoints, the announcement of top line results in Q4 2018 and our ability to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases and those detailed under the caption “Risk Factors” in ContraFect’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and its other filings with the Securities and Exchange Commission. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contact
Paul Boni
ContraFect Corporation
Tel: 914-207-2300
Email: pboni@contrafect.com

Thursday, May 25th, 2017 Uncategorized Comments Off on $CFRX Initiation of Phase 2 Staph Aureus Study Evaluating CF-301

$GSOL To Increase Amalgamation Consideration To US$20.00 Per Share

NEW YORK, May 25, 2017  — Global Sources Ltd. (NASDAQ: GSOL) (the “Company“) today announced that the Company, Expo Holdings I Ltd. (“Parent“) and Expo Holdings II Ltd., a wholly-owned subsidiary of Parent, have entered into an amendment to the previously announced Agreement and Plan of Amalgamation (as amended, the “Amended Amalgamation Agreement“) providing for an increase in the amalgamation consideration from US$18.00 per share in cash to US$20.00 per share in cash.

The revised amalgamation consideration of US$20.00 per share represents approximately a 11.1% premium over the original amalgamation consideration and approximately a 66.7% premium over the Company’s closing price of US$12.00 per share on May 22, 2017, the last trading day prior to the date that the Company entered into the original Agreement and Plan of Amalgamation, and approximately a 91.7% premium over the volume-weighted average closing prices of the shares during the 30 trading days prior to May 22, 2017.

On May 24, 2017, the Company’s Board of Directors (the “Board“) received a proposal from a third party to acquire all the outstanding common shares of the Company for US$20.00 per share in cash. On May 25, 2017, the Board received a proposal from Parent to amend the original Agreement and Plan of Amalgamation to increase the amalgamation consideration from US$18.00 per share to US$20.00 per share. The Board unanimously approved the Amended Amalgamation Agreement and the transactions contemplated by the Amended Amalgamation Agreement, and continues to recommend that the Company’s shareholders approve the Amended Amalgamation Agreement and the transactions contemplated by the Amended Amalgamation Agreement. In making its recommendation, the Board considered a number of factors and consulted with its legal and financial advisors.

The consummation of the amalgamation is subject to customary closing conditions, including the approval by the shareholders of the Company, as well as certain other customary closing conditions. The Company expects to hold a special meeting of its shareholders to consider and act upon the Amended Amalgamation Agreement and the transactions contemplated by the Amended Amalgamation Agreement as promptly as practicable. Details regarding the record date for, and the date, time and place of, the special meeting will be included in a press release when finalized.

CVCapital Securities, LLC is serving as the financial advisor to the Board. Cleary Gottlieb Steen & Hamilton LLP is serving as U.S. legal advisor to the Board, and Appleby is serving as Bermuda legal advisor to the Board.

About Global Sources

Global Sources is a leading business-to-business media company and a primary facilitator of trade with Greater China.

The core business facilitates trade between Asia and the world using English-language media such as online marketplaces (GlobalSources.com), trade shows, magazines, and apps.

More than 1.4 million international buyers, including 95 of the world’s top 100 retailers, use these services to obtain product and company information to help them source more profitably from overseas supply markets. These services also provide suppliers with integrated marketing solutions to build corporate image, generate sales leads and win orders from buyers in more than 240 countries and territories.

Now in its fifth decade, Global Sources has been publicly listed on the NASDAQ since 2000.

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27-A of the Securities Act of 1933, as amended and Section 21-E of the Securities Exchange Act of 1934, as amended. The company’s actual results could differ materially from those set forth in the forward-looking statements as a result of the risks associated with the company’s business, changes in general economic conditions, and changes in the assumptions used in making such forward-looking statements.

Press Contact Investor Contact in Asia
Camellia So Connie Lai
Tel: (852) 2555-5021 Tel: (852) 2555-4747
e-mail: GSpress@globalsources.com e-mail: investor@globalsources.com
Investor Contact in U.S.
Cathy Mattison
LHA
Tel: (1-415) 433-3777
e-mail: cmattison@lhai.com
Thursday, May 25th, 2017 Uncategorized Comments Off on $GSOL To Increase Amalgamation Consideration To US$20.00 Per Share

$BCRX Second Interim Analysis of Its APeX-1 in HAE

125 mg dose of BCX7353 showed a reduction of 73% in overall attack rate (p=0.002)

RESEARCH TRIANGLE PARK, N.C., May 25, 2017  — BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from a second interim analysis of its Phase 2 APeX-1 clinical trial in hereditary angioedema (HAE). APeX-1 is a 3-part dose ranging trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered once-daily (QD) BCX7353 for 28 days, as a preventative treatment to reduce the frequency of attacks in HAE patients. This second interim analysis evaluated data from all patients in Parts 1 and 2 of the trial. The first interim analysis evaluated data from 28 of 36 patients in Part 1.

“These data support our hypothesis regarding the initial findings seen from the first interim analysis,” said Jon Stonehouse, Chief Executive Officer & President of BioCryst. “We are delighted to see that a daily dose of 125 mg of BCX7353 results in a high level of efficacy with an improved tolerability profile compared to the 350 mg dose observed in the first interim analysis. We look forward to completing Part 3 of the trial to select appropriate doses for our pivotal program.”

This second interim analysis of pooled data from Parts 1 and 2 evaluated doses of BCX7353 125 mg (n=7), 250 mg (n=6) and 350 mg (n=18) QD versus placebo (n=20) for 28 days. The baseline attack rate was approximately 1/week. Baseline characteristics were generally well balanced between the treatment groups. Compliance with study drug dosing was excellent (≥ 98%).

The pre-specified per-protocol (PP) interim analysis included data on a total of 44 subjects with confirmed Type 1 or Type 2 HAE completing 28 days of treatment. The percentage reductions by treatment group in the mean rate of independently-adjudicated angioedema attacks for the pre-defined effective dosing period (weeks 2 through 4) in BCX7353 treated subjects were: 125 mg QD, 73% (p=0.002); 250 mg QD, 37% (p=0.128) and 350 mg QD, 58% (p=0.001) compared to placebo. In the intent-to-treat (ITT) population, corresponding reductions by treatment group were: 125 mg QD, 73% (p=0.004); 250 mg QD, 44% (p=0.090) and 350 mg QD, 45% (p=0.014) compared to placebo.

A pre-planned analysis of peripheral and abdominal attacks showed reductions in peripheral attacks of 74% (125 mg QD), 54% (250 mg QD) and 90% (350 mg QD) compared with placebo (PP analysis, weeks 2 through 4) and reductions in abdominal attacks of 72% (125 mg QD), 10% (250 mg QD) and 8% (350 mg QD) compared with placebo (PP analysis, weeks 2 through 4). Based on this distribution, it is likely that subjects in the 250 mg and 350 mg arms recorded transient abdominal adverse events (AEs) as HAE attack symptoms in their diary. In contrast, a consistent reduction in attacks regardless of anatomical location was observed in the 125 mg arm.

Oral BCX7353 once-daily for 28 days was generally safe and well tolerated in subjects with HAE. There were no serious AEs and no severe AEs. Three subjects in the BCX7353 350 mg treatment arm, two of which were previously reported, discontinued study drug before day 28. A third subject in this arm discontinued study drug due to vomiting and abdominal cramps concurrent with menses. The most common treatment-emergent adverse events were the common cold and diarrhea. The gastrointestinal AEs previously observed in the 350 mg arm were not seen at the 125 mg dose. Additionally, no significant laboratory abnormalities were observed in the two lower dose groups.

Steady state BCX7353 plasma levels and kallikrein inhibition levels in HAE subjects were similar to those seen in healthy subjects administered the same doses in a previously completed Phase 1 trial. Steady state trough drug levels (24 hours after dosing) greatly exceeded the target therapeutic range at the 250 mg and 350 mg dose levels. Trough levels for the 125 mg dose were generally within the target range.

The efficacy, safety and tolerability profile of BCX7353 observed in this interim analysis strongly supports its continued investigation as a prophylactic treatment for HAE. Enrollment into Part 3 of the trial is progressing well. Completion of Part 3 will enable a full evaluation of the dose response necessary to select doses for a pivotal program.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast today, May 25, 2017 at 9:00 a.m. Eastern Time, to discuss its APeX-1 second interim analysis and to respond to questions on the APeX-1 interim results.  To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International).  No passcode is needed for the call.  The webcast can be accessed by logging onto www.BioCryst.com.  Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst has several ongoing development programs: BCX7353 and other second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Japan, Taiwan and Korea. Post-marketing commitment development activities for RAPIVAB are ongoing, as well as activities to support regulatory approvals in other territories. For more information, please visit the Company’s website at www.BioCryst.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that developing any HAE drug candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of HAE second generation drug candidates (including APeX-1 and ZENITH-1) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the Company may not advance human clinical trials with product candidates as expected; that the FDA may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates; that BioCryst may not receive additional government funding to further support the development of galidesivir; that galidesivir development may not be successful; that BARDA and/or NIAID may further condition, reduce or eliminate future funding; that revenue from peramivir injection is unpredictable and may never result in significant revenue for the Company; that the Company may not be able to continue development of ongoing and future development programs; that such development programs may never result in future products; that actual financial results may not be consistent with expectations, including that 2017 operating expenses and cash usage may not be within management’s expected ranges.  Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.

BCRXW

CONTACT:    
Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910
Thursday, May 25th, 2017 Uncategorized Comments Off on $BCRX Second Interim Analysis of Its APeX-1 in HAE

$AERI Announces Public Offering 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 patients with 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 bookrunner for the offering.

Aerie intends to use the net proceeds of the offering for general corporate purposes, including to fund expansion of its commercialization programs in North America for both RhopressaTM and RoclatanTM, its potential preclinical and clinical activities for pipeline therapy and delivery technology opportunities, its clinical and commercialization efforts beyond North America, and its manufacturing activities, including the construction of its manufacturing plant and the addition of secondary contract manufacturers, for working capital and potentially for the expansion of its external business development programs.

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 the prospectus forming a part of the effective registration statement and a related prospectus supplement. 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 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 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 current product candidates are once-daily intraocular pressure-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (new drug application) for RhopressaTM (netarsudil ophthalmic solution) 0.02% was submitted to the U.S. Food and Drug Administration (FDA) in February 2017, and, in May 2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the RhopressaTM NDA for February 28, 2018. Aerie’s 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, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1, which is still ongoing, and Mercury 2. A RoclatanTM NDA submission is expected to take place in the first half of 2018. 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 and potential future 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 FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for our product candidates; our expectations regarding the commercialization and manufacturing of our product candidates; our expectations related to the offering discussed in this press release, including the completion, timing and size of the offering and the use of proceeds therefrom; the potential advantages of our product candidates; our plans to pursue development of additional product candidates and technologies in ophthalmology, including 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; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products or product candidates or technologies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental 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 receipt of the PDUFA goal date notification does not constitute FDA approval of the RhopressaTM NDA, and there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data, whether as a result of recommendations, if any, made by any FDA advisory committee or otherwise, that must be made or received before it will approve the NDA, if ever, or that the FDA will approve the NDA. 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, May 25th, 2017 Uncategorized Comments Off on $AERI Announces Public Offering of Common Stock

$DMRC to Present at the B. Riley & Co. 18th Annual Investor Conference, May 25

BEAVERTON, Ore., May 24, 2017 — Digimarc Corporation (NASDAQ: DMRC) has been invited to present at the 18th Annual B. Riley & Co. Investor Conference being held on May 24-25, 2017 at the Loews Santa Monica Beach Hotel in Santa Monica, CA.

Digimarc Chairman and CEO Bruce Davis is scheduled to present on Thursday, May 25 at 9:00 a.m. Pacific time and will hold one-on-one meetings with institutional investors throughout the day. The presentation will be webcast live and available for replay here.

For additional information or to schedule a one-on-one meeting with Digimarc management, please contact your B. Riley representative.

About Digimarc
Digimarc Corporation (NASDAQ: DMRC) is a pioneer in the automatic identification of everyday objects such as product packaging and virtually any media, including print, images and audio. Based on the patented Intuitive Computing Platform (ICP™), Digimarc provides innovative and comprehensive automatic recognition technologies to simplify search, and transform information discovery through unparalleled reliability, efficiency and security. Digimarc has a global patent portfolio, which includes approximately 1,100 U.S. and foreign patents and pending patent applications. These innovations include state-of-the-art identification technology, Digimarc Barcode, as well as Digimarc Discover® software for barcode scanning, image recognition, and more. Digimarc is based in Beaverton, Oregon, with technologies deployed by major retailers and consumer brands, global banks, U.S. states, film companies and professional sports franchises, among others. Visit digimarc.com and follow us @digimarc to learn more about The Barcode of Everything™.

Wednesday, May 24th, 2017 Uncategorized Comments Off on $DMRC to Present at the B. Riley & Co. 18th Annual Investor Conference, May 25

$MNGA 60% Production Rate Increase, 49% Cost Reduction

New Renewable Feedstock Significantly Reduces Waste and Downtime Increasing the Value of Gasification Units in the Industrial Gas Market

TAMPA, Florida, May 24, 2017  —

MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA), a leading clean technology company in the renewable resources and environmental solutions industries, announced today that it has transitioned to a new renewable feedstock that results in approximately a 60% increase in fuel output per minute while yielding approximately a 49% reduction in fuel production cost. The Company has a patent pending for the usage of this new feedstock in its gasification systems, which it expects will be granted.

Over the last year, the Company has conducted extensive testing of various feedstocks to improve the production of MagneGas2® and reduce production costs. After significant research and development, the MagneGas engineering team has identified a much more efficient feedstock that helps reduces the overall production costs for MagneGas2® by approximately 49%. Additionally, through the elimination of redundant processes that are not required for use of the new feedstock, gas output per minute has increased by approximately 60%. The Company strongly believes that the combination of these two improvements will result in an even more competitive product with greater margins that will be the catalyst for additional market penetration and increased gas sales.

The new renewable feedstock significantly improves the operation of the Company’s units, which translates to reduced operating costs. As a result, the Company believes MagneGas’s gasification equipment will be an even more attractive an investment opportunity for distributor and gas producers. Additionally, the improvements in production costs and increases in output should increase the market penetration of MagneGas2® due to increased supply and also facilitate sales of units to the large market of distributors seeking a viable replacement to acetylene. The Company plans to share the news of its improvements to its domestic and international contacts, several of which are in active discussions with MagneGas about purchasing gasification systems to produce MagneGas2® in their local markets.

“Our R&D team has been working diligently to develop a less expensive, more efficient way to produce MagneGas2® which has already been extensively market tested with our sales team.  We are excited to announce that we have successfully introduced a new feedstock that produces MagneGas2® more efficiently at a reduced cost. We believe that this is significant for our Company because it makes the sale of our gasification equipment more attractive to potential buyers both domestically and abroad and allows for increased market penetration of MagneGas2®.  In addition, the lower fuel cost has the potential to impact our gross margins by reducing our direct cost. I believe this is one of the most significant events that the Company has had this year and that we can expect further increases in production rates and cost reductions in the coming months,” stated Ermanno Santilli, CEO of MagneGas.

“For many years, research, development and production related expenses for MagneGas2® has been one of the most significant components of recurring operating expenses for MagneGas,” stated Scott Mahoney, CFO of MagneGas. “The Company has taken a series of steps in the past two quarters to address expense control and overall profitability outlook. We began by addressing vendors, then non-essential staffing, and now we are pleased to announce meaningful reductions to our production expenses going forward.”

“This is a powerful next step in our ability to increase market share in the industrial gases and welding supply space. This is also a critical metric for marketing and selling our equipment to established regional industrial gas distributors across the U.S.,” continued Mr. Mahoney. “We have been very successful penetrating the regional distributor market over the past 3 years.  We have existing distributor relationships in 18 states across the U.S. and we are in active discussions with a number of our partners about licensing the rights to produce MagneGas2® in their particular regions. With these new demonstrated operating efficiencies, we can better drive many of these relationships towards the purchase of MagneGas2® equipment sales in the near term.”

About MagneGas Corporation

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

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

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

FORWARD-LOOKING STATEMENTS

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

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.
Investor Contacts:
Crescendo Communications
626 RXR Plaza
Uniondale, NY 11556
T: +1-844-589-8760
mnga@crescendo-ir.com

Wednesday, May 24th, 2017 Uncategorized Comments Off on $MNGA 60% Production Rate Increase, 49% Cost Reduction

$AERI Reports Positive Roclatan™ Phase 3 Topline Efficacy

Roclatan™ Successfully Achieves Primary Efficacy Endpoint in Mercury 2 Study

Conference Call and Webcast Today, May 24, 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 patients with glaucoma and other diseases of the eye, today reported the successful primary efficacy results of the Company’s 90-day Phase 3 “Mercury 2” registration trial for its fixed-dose combination product candidate, Roclatan™. The results of Mercury 2 were consistent with the successful 90-day efficacy results from the Mercury 1 trial, a 12-month Phase 3 registration trial for Roclatan™, which reported topline efficacy findings in September 2016. Mercury 2 achieved its primary efficacy endpoint of demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa™ (netarsudil ophthalmic solution) 0.02%, and market-leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening. The IOP-lowering effect of Roclatan™ was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa™ throughout the duration of the study. The study evaluated patients with maximum baseline intraocular pressures (IOPs) ranging from above 20 to below 36 mmHg. Management will host a conference call with accompanying slides to discuss these results at 5:00 p.m. Eastern Time (ET) today. The accompanying slides are available at Aerie’s website, aeriepharma.com.

Roclatan™ Phase 3 Highlights for Mercury 2

  • Roclatan™ dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both latanoprost and Rhopressa™ 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. Roclatan™ IOP lowering exceeded that of latanoprost in a range of 1.5 to 2.4 mmHg for an average of 1.8 mmHg, and exceeded Rhopressa™ IOP lowering in a range of 2.2 to 3.3 mmHg for an average of 2.7 mmHg. Efficacy levels were consistent across the 90-day period for all arms in the study.
  • Roclatan™ reduced mean diurnal IOPs to 16 mmHg or lower in 56 percent of patients, a significantly higher percentage than observed in the two comparator arms.
  • Discontinuation rates for the 90-day period for Roclatan™ and Rhopressa™ were approximately 10 percent for each product candidate, representing the lowest discontinuation rates experienced across all Phase 3 trials of Roclatan™ and Rhopressa™.
  • The most common Roclatan™ adverse event was hyperemia, or eye redness, which was reported in nearly 55 percent of patients, was sporadic, and was scored as mild for the large majority of these patients, generally consistent with previous trials. There were no drug-related serious or systemic adverse events for any of the treatment groups.

“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan™. The topline efficacy results demonstrated in Mercury 2 are consistent with Mercury 1, confirming the potential for Roclatan™ to become the most efficacious IOP-lowering therapy to enter the market, if approved. Now that the efficacy results for both Mercury 1 and 2 have proven successful, and if the Mercury 1 12-month safety results are also successful, we expect to submit our Roclatan™ NDA (new drug application) in the first half of 2018,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

Dr. Anido continued, “In addition to the excellent efficacy observed in Mercury 2 for both Roclatan™ and Rhopressa™, we were also delighted to see relatively low discontinuation rates for the 90-day Mercury 2 trial of 9.8 percent and 10.6 percent for Roclatan™ and Rhopressa™, respectively.”

Richard A. Lewis, M.D., Aerie’s Chief Medical Officer, added, “Roclatan™ is distinguished by its ability to lower intraocular pressure to levels previously unseen with current glaucoma therapies, including market-leading latanoprost. This product holds the promise of potentially becoming the first prostaglandin fixed-dose combination available in the United States. The safety profile of Roclatan™ observed in Mercury 2 once again points to a safe and tolerable product.”

About Roclatan™

Roclatan™ is a once-daily eye drop that combines Rhopressa™, as described below, with latanoprost, a widely prescribed PGA. Based on the Company’s preclinical studies and clinical trials to date, Aerie believes that Roclatan™, 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, Roclatan™ has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product.

The first Phase 3 registration trial for Roclatan™, named Mercury 1, is a 12-month safety trial, which had a successful 90-day efficacy readout in September 2016. The 12-month safety data from this trial are expected in the third quarter of 2017. The second Phase 3 registration trial, named Mercury 2, is a 90-day efficacy trial, which just completed and is the subject of this press release. The topline 90-day efficacy readouts for both Mercury 1 and Mercury 2 demonstrated that Roclatan™ was statistically superior to each of its components, thus achieving their primary clinical endpoints. Aerie expects to submit a Roclatan™ NDA to the U.S. Food and Drug Administration (FDA) in the first half of 2018. A third Phase 3 registration trial, named Mercury 3, is expected to commence in Europe in mid-2017. Mercury 3 is not necessary for approval in the U.S., but rather to facilitate regulatory approval and commercialization in Europe.

About Rhopressa™

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

The results of two Phase 3 registration trials (Rocket 2 and Rocket 1) for Rhopressa™ were included in the NDA submission to the FDA in February 2017. There were two additional Phase 3 registration trials for Rhopressa™, named Rocket 3 and Rocket 4. Rocket 3 was a small 12-month safety-only study in Canada that was not necessary for the NDA submission and for which enrollment has been discontinued. Rocket 4, which was successfully completed in April 2017, was designed to provide adequate six-month safety data for regulatory filing purposes in Europe, and was also not necessary for the NDA submission. The 90-day efficacy results from Rocket 4 and Mercury 1, the initial Phase 3 registration trial for Aerie product candidate Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, were also included in the Rhopressa™ NDA submission as supportive. The FDA has set the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review of the Rhopressa™ NDA for February 28, 2018.

Conference Call / Webcast Information

Aerie management will host a live conference call and webcast at 5:00 p.m. ET today to discuss the Roclatan™ Phase 3 efficacy results from Mercury 2, including a review of the associated slides that are posted on Aerie’s website, 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 28687184. 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 28687184. The telephone replay will be available until June 1, 2017.

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 current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was submitted to the FDA in February 2017, and, in May 2017, the FDA set the PDUFA goal date for the completion of the FDA’s review of the Rhopressa™ NDA for February 28, 2018. Aerie’s second product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa™ and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1, which is still ongoing, and Mercury 2. A Roclatan™ NDA submission is expected to take place in the first half of 2018. 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 and potential future 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 FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for our product candidates; our expectations regarding the commercialization and manufacturing of our product candidates; the potential advantages of our product candidates; our plans to pursue development of additional product candidates and technologies in ophthalmology, including 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; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products or product candidates or technologies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental 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 2 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. The receipt of the PDUFA goal date notification does not constitute FDA approval of the Rhopressa™ NDA, and there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data, whether as a result of recommendations, if any, made by any FDA advisory committee or otherwise, that must be made or received before it will approve the NDA, if ever, or that the FDA will approve the NDA. 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, May 24th, 2017 Uncategorized Comments Off on $AERI Reports Positive Roclatan™ Phase 3 Topline Efficacy

$PBYI Receives FDA Advisory Committee Support for Neratinib

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 – 4 to recommend approval of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.

The ODAC vote was based on a review of the clinical development program that included 11 trials in breast cancer and represented approximately 2,000 patient years’ experience. The focus of the meeting was the Phase III ExteNET study, which provided one year of continuous therapy with neratinib after patients completed one year of therapy with a trastuzumab-based regimen. The study demonstrated a statistically significant 33% relative reduction of risk of invasive disease recurrence within two years after treatment.

“Despite advances in adjuvant therapy for HER2-positive breast cancer, disease recurrence remains a risk. Since there are no effective therapies for patients whose disease recurs, there is an important need for additional options to further reduce the risk of recurrence,” said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision making process.

“We appreciate the committee’s comments and the support of the many clinicians, patients and advocates who participated in today’s meeting,” Mr. Auerbach added. “We look forward to further discussion with the FDA.”

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking statements. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company’s dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company’s drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company’s products, the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, risks pertaining to securities class action, derivative and defamation lawsuits, the Company’s dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

 

Puma Biotechnology, Inc.
Alan H. Auerbach or Mariann Ohanesian, +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
or
Russo Partners
David Schull or Amiad Finkelthal, +1-212-845-4271
david.schull@russopartnersllc.com
amiad.finkelthal@russopartnersllc.com

Wednesday, May 24th, 2017 Uncategorized Comments Off on $PBYI Receives FDA Advisory Committee Support for Neratinib

$CIIX Announces New Subsidiary Chinesehempoil.com, OptHemp Product Line

SAN GABRIEL, California, May 24, 2017  —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces that Chinesehempoil.com Inc., established last month as a wholly owned subsidiary of CIIX, will officially launch its own premium hemp health product line ‘OptHemp,’ which will include the Company’s first private label product, OptHemp Ultra Premium Hemp Oil.

The OptHemp products will be available at http://www.ChineseHempOil.com, the Company’s official bi-lingual site. CIIX will use multiple sales channels to implement its sales plan including online sales, retail sales and direct marketing. As part of its plan, CIIX is close to completing construction on its first retail store, which will be among the first retail stores to offer premium hemp-based products along with other health products in San Gabriel, CA. The Company is expected to open the retail store this June in an optimal location within one of the city’s premier Chinese consumer districts.

“I am very pleased to announce the launch of our first premium OptHemp product,” says Warren Wang, founder and CEO of CIIX. “Hemp oil is believed to have positive balancing effects on the mind and body of persons using them.”

OptHemp Ultra Premium Hemp Oil, the line’s base level product, is extracted and purified with raw materials from 100% organic farms in Colorado using a supercritical CO2 extraction technology. OptHemp products are GMO-free, making them attractive to consumers concerned about product source and purity.

“We believe that the desire for better quality of life in the Chinese community, coupled with fact that the aging population continues to grow, will lead to continued growth in the alternative health sector and increased demand for natural hemp-based health products,” says Wang. CIIX is confident that its OptHemp product line will lay a solid foundation for the Company’s entrance into the legal hemp industry and the alternative health sector.”

About ChineseInvestors.com (OTCQB: CIIX)

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail and online sales of hemp-based products and other health related products.

For more information visit ChineseInvestors.com

Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom

Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh

Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom

Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1.214.636.2548

Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

Wednesday, May 24th, 2017 Uncategorized Comments Off on $CIIX Announces New Subsidiary Chinesehempoil.com, OptHemp Product Line

$KTNNF NetworkNewsWire Releases Exclusive Audio Interview with Kootenay Zinc

NEW YORK, NY–(Marketwired – May 24, 2017) – NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions for business, today announces the online availability of its interview with Kootenay Zinc Corp. (OTCQB: KTNNF) (CSE: ZNK), a mineral exploration and development company focused on discovering large-scale sedimentary-exhalative (“SEDEX“) zinc deposits in Vancouver, British Columbia.

The interview can be heard at https://www.networknewswire.com/solutions/corporate-communications/interviews/kootenay-zinc-corp-interview/

Kicking off the interview, NNW’s Stuart Smith introduces Stuart (Tookie) Angus, a current independent business advisor to the mining industry and member of Kootenay Zinc’s advisory board, who provides a run-down of the company’s operations.

Kootenay Zinc is focused on the discovery of zinc ore body near the Sullivan Mine, which was previously one of the world’s largest zinc/lead/silver deposits. In operation for 100 years, the Sullivan Mine produced over $49 billion value of metal. Now, Kootenay Zinc hopes to replicate that success.

“We are about 30 kilometers, or 18 miles, from the mine, with a current drill program underway to try and discover [an extension] for the Sullivan Mine deposit,” says Angus.

Angus next provides insight into the potential of Kootenay Zinc’s mineral property, and notes that the company is adequately financed to carry-out its current drill program. He draws a parallel with the progress of Arizona Mining, a company drilling a large deposit of the same metals in Arizona, which recently carried out a private placement financing of $110 million.

“Going back to October of 2015, [Arizona Mining] was a micro-cap company trading at approximately $0.20 a share. Last week it carried out a private placement financing at a price of $2.45 per share, when the previous closing on the stock was $1.89… that $110 million financing was a huge endorsement of that project. So there you have a huge increase in terms of percentage and absolute value for a company that is still in the exploration phase, not yet in development. That’s the kind of target Kootenay Zinc is looking for,” says Angus.

Responsible for leading this charge is a well-qualified management team, including a “top-notch” geologist and geophysicist, which consistently updates shareholders on its progress and goals for 2017.

“We have a number of different anomalies that we’re going to test. The truth serum in this business is the drill bit. We’re going to go in there and bravely drill to see if we can find what we hope is there,” Angus says in conclusion.

About Kootenay Zinc Corp.

Kootenay Zinc Corp. is a mineral exploration and development company based in Vancouver, British Columbia that is presently targeting the Sully Property. The Company is focused on discovering large-scale sedimentary-exhalative (“SEDEX“) deposits.

The Sully Property comprises 1,375 hectares located approximately 30 kilometres (18 miles) east of Kimberley, B.C., and overlies rocks of similar age and origin as those which host the world-class Sullivan deposit, owned by Teck Resources Ltd. Sullivan was discovered in 1892, and is known to be one of the largest SEDEX deposits in the world. Over its 100-year lifetime, Sullivan produced approximately 150 million tonnes of ore, including approximately three hundred million ounces of silver, eight million tonnes of zinc and eight million tonnes of lead. The equivalent level of strata as at Sullivan and that formed on the margin of that same basin are present at the Sully Property. The Company cautions that past results or discoveries on proximate land are not necessarily indicative of the results that may be achieved on the Sully Property.

For more information visit www.kootenayzinc.com

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides to users (1) access to our news aggregation and syndication servers, (2) enhanced press release services, and (3) a full array of social communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information, visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Communications Contact:
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Wednesday, May 24th, 2017 Uncategorized Comments Off on $KTNNF NetworkNewsWire Releases Exclusive Audio Interview with Kootenay Zinc

$ETRM Announces the Acquisition of the Gastric Vest System

– At 12 Months, Gastric Vest System™ Patients Demonstrated Excess Weight Loss (EWL) of 85% and Waist Circumference Reduction of 38 Centimeters – – Company to Host Conference Call Today at 10:00 AM Eastern Time –

ST. PAUL, Minn., May 23, 2017  — EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices treating obesity, metabolic diseases and other gastrointestinal disorders, announced today that it has acquired the Gastric Vest System™ (the “Gastric Vest” or “Vest”), through its acquisition of BarioSurg, Inc.

The Gastric Vest is an investigational, minimally-invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device, which wraps around the stomach and emulates the effect of conventional weight loss surgery, enables gastric volume reduction without permanently changing patient anatomy. In a pilot study conducted outside the U.S., at 12 months, Vest patients demonstrated a mean percent excess weight loss (%EWL) of 85%, an average drop in HbA1c (Hemoglobin A1c) of 2.1 points, and an average waist circumference reduction of 38 centimeters, or approximately 15 inches.

“We are excited to both incorporate BarioSurg’s Gastric Vest into our now further differentiated portfolio of medical devices for fighting obesity and related comorbidities, and to explore potential clinical opportunities to combine the Vest and vBloc Therapy®,” said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. “As we move toward building a comprehensive bariatric and metabolic continuum of care platform to effectively address unmet needs within these areas, we believe that the strong foundation we’ve built at EnteroMedics will maximize the potential for a successful approval and the subsequent commercialization of this device. We look forward to sharing more details on this morning’s conference call.”

“Based on early results, when comparing short-term %EWL, the Gastric Vest appears to perform as well as, and possibly even better than, gastric bypass and sleeve gastrectomy procedures,” stated Scott Shikora, MD, Director, Center for Metabolic and Bariatric Surgery, Brigham and Women’s Hospital, Former President of the American Society for Metabolic and Bariatric Surgery, and Chief Medical Consultant, EnteroMedics. “If the Vest continues to yield similar results to those observed to date, it will be a game changer in the field of bariatrics.”

Raj Nihalani, MD, inventor of the Gastric Vest System, Founder and Former Chief Executive Officer of BarioSurg stated: “EnteroMedics is a leader in minimally-invasive, sustainable weight loss treatment with vBloc Therapy. I look forward to joining the company and navigating a path toward potential FDA approval and eventual commercialization, while at the same time exploring ways in which the Vest may be able to be combined with vBloc Therapy to enhance patient outcomes.”

The consideration paid by EnteroMedics for BarioSurg, Inc. consists of 1.38 million unregistered shares of EnteroMedics common stock, 1.0 million unregistered shares of conditional convertible preferred stock (which will be convertible into 5.0 million unregistered shares of common stock upon the receipt of the required approval of EnteroMedics’ stockholders under NASDAQ rules), and $2.0 million in cash. The shares of common stock issued in the acquisition represent 19.99% of EnteroMedics’ outstanding common stock immediately prior to the acquisition.  EnteroMedics expects to hold a special meeting of its stockholders to seek the required approval of the conversion of the conditional convertible preferred stock in the summer of 2017.

In connection with the acquisition, EnteroMedics has appointed Dr. Nihalani as Chief Technology Officer, EnteroMedics.

Conference Call Details

A conference call will be held today at 10:00 AM Eastern Time and may be accessed by dialing (877) 280-7473 (U.S. and Canada) or (707) 287-9370 (international), and entering passcode 22469535. A replay of the call will be available from May 23 at 2:00 PM Eastern Time through May 30 at 2 PM Eastern Time by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), and entering passcode 22469535.

To access the live webcast, visit the events page of the investor relations section of EnteroMedics’ website at www.enteromedics.com. A replay of the webcast will be available immediately after the conference call.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.

About BarioSurg Inc.

BarioSurg, Inc. was founded in 2008 by Dr. Raj Nihalani.  BarioSurg was a privately held medical device company that developed the proprietary, minimally invasive and reversible device, the Gastric Vest System™ to treat obesity and related comorbidities.

Information about the vBloc® System and vBloc® Neurometabolic Therapy

vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.  You should not have an implanted vBloc® System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the vBloc System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and vBloc System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC.

Important Information
EnteroMedics intends to file a proxy statement and other relevant materials with the Securities and Exchange Commission (the “SEC”) to obtain approval from EnteroMedics’ stockholders of the conversion of the preferred stock issued to BarioSurg’s stockholders in connection with the acquisition into shares of EnteroMedics common stock (the “Stockholder Approval”). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS FILED WITH THE SEC CAREFULLY IN THEIR ENTIRETY AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE STOCKHOLDER APPROVAL. The proxy statement, any amendments or supplements to the proxy statement and other relevant documents filed by EnteroMedics with the SEC will be available free of charge through the web site maintained by the SEC at www.sec.gov or by calling the SEC at telephone number 1-800-SEC-0330. Free copies of these documents may also be obtained from EnteroMedics’ website at www.enteromedics.com or by writing to: EnteroMedics Inc., 2800 Patton Road, St. Paul, Minnesota 55113, Attention: Investor Relations.

EnteroMedics and its directors and executive officers are deemed to be participants in the solicitation of proxies from the stockholders of EnteroMedics in connection with the Stockholder Approval. Information regarding EnteroMedics’ directors and executive officers is included in EnteroMedics’ definitive proxy statement for its 2017 annual meeting of stockholders to be held on June 1, 2017, which was filed with the SEC on April 27, 2017.

Other information regarding the participants in such proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the proxy statement to be filed in connection with the Stockholder Approval.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates.  Forward-looking statements in this release include statements concerning the performance, commercialization and FDA approval of the Gastric Vest and statements about the benefits of the acquisition and the combined company’s plans, objectives, expectations and intentions with respect to future operations, products and services. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Applicable risks and uncertainties related to the acquisition include, but are not limited to, the following: the acquisition may involve unexpected costs or liabilities; the ability to recognize benefits of the acquisition; and risks that the merger disrupts current plans and operations. Additional risks and uncertainties include, among others:  our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc® System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc® System; physician adoption of our vBloc® System and vBloc® Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; the cost and management time of operating a public company; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 8, 2017 and quarterly report on Form 10-Q filed May 15, 2017. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

 

Tuesday, May 23rd, 2017 Uncategorized Comments Off on $ETRM Announces the Acquisition of the Gastric Vest System

$CYTX Logs Final 48 Week Patient Follow Up Visit in Scleroderma Trial

Topline trial results announcement expected early Q3 2017

SAN DIEGO, Calif., May 23, 2017  — Cytori Therapeutics, Inc. (NASDAQ:CYTX) (“Cytori” or the “Company”), today announced that it has now completed all 48 week follow up monitoring visits in its U.S. FDA approved Phase III STAR trial. A total of 88 subjects were enrolled and the last subject’s 48 week visit was conducted earlier this week.

STAR is a double-blind, randomized, placebo-controlled, parallel group phase III pivotal study investigating the efficacy and safety of HABEO™ Cell Therapy™on subjects with impaired hand function from scleroderma. The subjects were randomized 1:1 to either HABEO Cell Therapy or placebo. HABEO™ and placebo were administered subcutaneously in subject’s fingers. Final assessments were done at 48 weeks.  Upon unblinding and evaluation of the data, subjects who received placebo will be offered participation into the crossover portion of the protocol, using HABEO™ Cell Therapy™, should they desire treatment and continue to qualify. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov

In the United States, the scleroderma affected population appears to be approximately 184 per million, which would represent a market size of aproximately 45,000 scleroderma patients.1 Additionally, in Europe, scleroderma is estimated to have a prevalence between 31 per million and 277 per million which equates to approximately 17,000 to 149,000 scleroderma affected people in the Europe.2

About Cytori Therapeutics

Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. Cytori Nanomedicine™ is developing liposome encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, statements regarding Cytori’s conduct of its STAR phase III clinical trial,  are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: risks in the conduct of clinical trials; risks associated with potential benefits of our products; risks in the collection and results of clinical data; risks associated with development of our clinical pipeline; final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance; and other risks and uncertainties described under the “Risk Factors” section in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q.  Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.

1. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a large US managed care population.” J Rheum 2012; 38:784-6.

2. Varga, John et al. “Scleroderma: From Pathogenesis to Comprehensive Management.” 2012

Cytori Therapeutics, Inc.

Tiago Girao, 1-858-458-0900

ir@cytori.com
Tuesday, May 23rd, 2017 Uncategorized Comments Off on $CYTX Logs Final 48 Week Patient Follow Up Visit in Scleroderma Trial

$AIRI Announces 2nd Closing of Bridge Loan and Delay in Filing of Form 10-Q

HAUPPAUGE, N.Y., May 23, 2017 — Air Industries Group (NYSE MKT:AIRI) (“Air Industries” or the “Company”), an integrated manufacturer of precision equipment assemblies and components for leading aerospace and defense prime contractors, announced the second closing of an offering of Bridge Loans.

The Company closed on the sale of approximately $1,069,000 of Convertible Notes on Friday, May 19th, which yielded gross proceeds to the Company of approximately $1,038,000.  Coupled with the $3,089,000 of Bridge Notes sold on May 12th, the Company sold Bridge Notes in the aggregate principal amount of $4,158,624, from which it derived gross proceeds (net of cancellation of indebtedness totaling $1,503,288 advanced on May 2nd and May 10th by Michael and Robert Taglich) of $2,534,196.  The placement of the Bridge Loans was arranged by Taglich Brothers and Roth Capital Partners.  The net proceeds will be used for working capital, primarily to accelerate payments to the Air Industries’ suppliers.

The Company separately announced today that there will be a delay in the filing of its Form 10-Q for the three months ended March 31, 2017.  The Company anticipates filing its Form 10-Q no later than Friday, May 26, 2017.

Separately, Air Industries announced that revenues for the three months ended March 31, 2017, inclusive of revenues of approximately $416,000 — generated by AMK before its sale in January, were in excess of $16 million, approximately one million more than in the first quarter of 2016. The Company expects to report a smaller loss than that reported in the first quarter of 2016, together with positive EBITDA for the period.

ABOUT AIR INDUSTRIES GROUP

Air Industries Group (AIRI) is an integrated manufacturer of precision equipment assemblies and components for leading aerospace and defense prime contractors. Air Industries operates in three segments: Complex Machining of aircraft landing gear and flight controls, Aerostructures & Electronics, and Turbine & Engine products.

The Company uses EBITDA as a supplemental liquidity measure because management finds it useful to understand and evaluate results, excluding the impact of non-cash depreciation and amortization charges, stock based compensation expenses, and nonrecurring expenses and outlays, prior to consideration of the impact of other potential sources and uses of cash, such as working capital items. This calculation may differ in method of calculation from similarly titled measures used by other companies.

Certain matters discussed in this press release are ‘forward-looking statements’ intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace, the ability to realize firm backlog and projected backlog, cost cutting measures, potential future results and acquisitions, are examples of such forward-looking statements. The forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of projects due to variability in size, scope and duration, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Contact Information

Air Industries Group
631.881.4913
ir@airindustriesgroup.com
Tuesday, May 23rd, 2017 Uncategorized Comments Off on $AIRI Announces 2nd Closing of Bridge Loan and Delay in Filing of Form 10-Q

$GSOL Enters Into Definitive Amalgamation Agreement

NEW YORK, May 23, 2017 — Global Sources Ltd.  (NASDAQ: GSOL) (the “Company“) today announced that it has entered into an Agreement and Plan of Amalgamation (the “Amalgamation Agreement“) with Expo Holdings I Ltd. (“Parent“) and Expo Holdings II Ltd. (“Amalgamation Sub“), a wholly-owned subsidiary of Parent, pursuant to which Amalgamation Sub and the Company will be amalgamated and continue as an exempted company limited by shares registered under the laws of Bermuda (the “Amalgamated Company“), which will become a wholly-owned subsidiary of Parent (the “Amalgamation“).

Subject to the terms and conditions set forth in the Amalgamation Agreement, at the effective time of the Amalgamation, each issued and outstanding common share of the Company (each “Share“) will be automatically cancelled and converted into the right to receive an amount equal to US$18.00 (the “Amalgamation Consideration“) in cash, without interest. The Amalgamation Consideration represents a premium of 50.0% over the Company’s closing price of US$12.00 per Share on May 22, 2017, the last trading day prior to the date that the Company entered into the Amalgamation Agreement, and a premium of 72.65% to the volume-weighted average closing prices of the Shares during the 30 trading days prior to May 22, 2017.

The consummation of the Amalgamation is subject to customary closing conditions, including the approval by the shareholders of the Company, as well as certain other customary closing conditions. Mr. Merle Allan Hinrich, director and Executive Chairman of the Company, together with his wife Mrs. Miriam Hinrich, and Hinrich Investments Limited, have each entered into a voting and support agreement with Expo Holdings I Ltd. and Expo Holdings II Ltd., pursuant to which each of Mr. Merle Allan Hinrich, Mrs. Miriam Hinrich and Hinrich Investments Limited has agreed to vote all their Shares in favor of the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation. As of the date of this press release, Mr. Merle Allan Hinrich, Mrs. Miriam Hinrich and Hinrich Investments Limited beneficially own approximately 64.87% of the total issued and outstanding Shares.  If completed, the Amalgamation will result in the Company becoming a privately-held company and its Shares will no longer be listed on the NASDAQ Global Select Market.

The Company’s Board of Directors (the “Board“) unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that the Company’s shareholders approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation. The Board negotiated the terms of the Amalgamation Agreement with the assistance of its legal and financial advisors.

The Company expects to hold a special meeting of its shareholders to consider and act upon the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement as promptly as practicable. Details regarding the record date for, and the date, time and place of, the special meeting will be included in a press release when finalized.

CVCapital Securities, LLC is serving as the financial advisor to the Board. Cleary Gottlieb Steen & Hamilton LLP is serving as U.S. legal advisor to the Board, and Appleby is serving as Bermuda legal advisor to the Board.

About Global Sources

Global Sources is a leading business-to-business media company and a primary facilitator of trade with Greater China.

The core business facilitates trade between Asia and the world using English-language media such as online marketplaces (GlobalSources.com), trade shows, magazines, and apps.

More than 1.4 million international buyers, including 95 of the world’s top 100 retailers, use these services to obtain product and company information to help them source more profitably from overseas supply markets. These services also provide suppliers with integrated marketing solutions to build corporate image, generate sales leads and win orders from buyers in more than 240 countries and territories.

Now in its fifth decade, Global Sources has been publicly listed on the NASDAQ since 2000.

Safe Harbor Statement

This news release contains forward-looking statements within the meaning of Section 27-A of the Securities Act of 1933, as amended and Section 21-E of the Securities Exchange Act of 1934, as amended. The company’s actual results could differ materially from those set forth in the forward-looking statements as a result of the risks associated with the company’s business, changes in general economic conditions, and changes in the assumptions used in making such forward-looking statements.

Press Contact Investor Contact in Asia
Camellia So Connie Lai
Tel: (852) 2555-5021 Tel: (852) 2555-4747
e-mail: GSpress@globalsources.com e-mail: investor@globalsources.com
Investor Contact in U.S.
Cathy Mattison
LHA
Tel: (1-415) 433-3777
e-mail: cmattison@lhai.com
Tuesday, May 23rd, 2017 Uncategorized Comments Off on $GSOL Enters Into Definitive Amalgamation Agreement
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