Daily Archives: April 2, 2018

The Open Society Foundations and BRAC Sound Alarm for the Rohingya Ahead of Monsoon Season in Bangladesh

New York, April 02, 2018 (GLOBE NEWSWIRE) — George Soros and the Open Society Foundations today announced an emergency assistance fund of USD 10 million to help Rohingya people displaced from Myanmar and host communities in Bangladesh.  From April to October there is a high risk of flash floods, landslides, and cyclones in southern Bangladesh, where the Rohingya are sheltered in makeshift settlements vulnerable to water contamination and spread of disease.

The fund includes a donation of USD 8 million to BRAC, one of the largest international development and humanitarian organizations based in Bangladesh, comes after an urgent call from the United Nations for humanitarian assistance for the more than 650,000 Rohingya who since August 2017 have fled Rakhine State, Myanmar. An additional USD 2 million to other projects that support the Rohingya. The appeal also recognizes the needs of host communities, given significant strains placed on the local economy, environment, and vital resources.

“The Rohingya people have already suffered serious abuses in Myanmar, and unless exceptional measures are taken, their suffering will continue in Bangladesh when the monsoon season starts this month,” said George Soros, founder and chair of the Open Society Foundations. “The more people are moved out of harm’s way, the better the chances of the remaining ones to survive.”

“The BRAC team has been working hand in hand with the Government of Bangladesh and partner organizations, first to ensure emergency relief, and now gradually to address critical services and long-term livelihood needs in the Rohingya settlements,” said Sir Fazle Hasan Abed, founder and chairperson of BRAC. “In an environment mired in conflict, BRAC’s vision of a world free from all forms of exploitation and discrimination, remains as relevant as ever. We will continue to support the government’s efforts to ensure a safe and dignified life for the displaced Rohingya families and host communities.”

During a humanitarian crisis, the needs are manifold. Children are the most vulnerable, with a high prevalence of trauma. They require protection services and safe places to continue their schooling and development during early childhood.

BRAC has in place the largest civil society response for the Rohingya, with more than 3,200 people working on the ground. Its integrated approach includes attention to sanitation and hygiene infrastructure, health care, education, protection, livelihood security, intensive behavioral change communication and counselling, and distribution of non-food items and shelter to ensure the dignity and wellbeing of displaced families.

“I urge other philanthropies, governments, and the private sector to develop a comprehensive action plan to provide Bangladesh with major financial support, debt forgiveness, and trade concessions while continuing to call on the Myanmar government to ensure safe, voluntary, and dignified return for the Rohingya,” said Soros.

The Open Society Foundations have taken a special interest in the plight of the Rohingya people. In 2015, Soros visited camps for internally displaced Rohingya in Sittwe, the capital of Rakhine State, in Myanmar, where he was reminded of the Jewish ghetto in Budapest during World War II. Soros, who lived through the Nazi occupation and fled communism in Hungary, has long been committed to the needs of refugees.

Alissa Sadler
Open Society Foundations 
1-917-392-4245
alissa.sadler@opensocietyfoundations.org

Compuware’s New Automated Receive Order System Greatly Simplifies Ordering and Delivery of Maintenance

Represents Significant Step in the Common Install Initiative Spearheaded by Compuware in Collaboration with IBM and Other ISVs

DETROIT, April 02, 2018 (GLOBE NEWSWIRE) — In its ongoing mission to provide customers with the best possible experience across all touchpoints, Compuware today announced it has streamlined and improved the process by which customers receive Compuware mainframe product maintenance (also known as program temporary fixes or PTFs).

Compuware is now using IBM SMP/E RECEIVE ORDER functionality that enables customers to securely receive all Compuware product maintenance, individual PTFs and/or HOLDDATA directly onto their mainframes by running a simple SMP/E job.

“Compuware’s automated Receive Order system will make delivery of mainframe product maintenance easier and more efficient for systems programmers responsible for handling product maintenance activities,” said Keith Sisson, Director of Technology for Compuware. “As innovation necessarily increases and accelerates on the mainframe, system programmers require better and faster ways to respond.”

Compuware has been working collaboratively with IBM and other ISVs on a years-long Common Install Initiative intended to simplify and streamline the product installation process for all mainframe customers.

“We applaud IBM’s leadership, as the platform steward, to release the specifications for RECEIVE ORDER to provide all mainframe ISVs an equal opportunity to support this essential Common Install Initiative,” continued Sisson. “This is another significant step closer to a consistent and streamlined maintenance and installation methodology, which is great for our customers and for the mainframe ecosystem overall.”

“This is very exciting news! Compuware is a leader in the mainframe ISV community, and their participation in the Common Install Initiative will help next-generation infrastructure customers be more productive and successful. This is a win for the mainframe world,” said Cheryl Watson, noted mainframe author and consultant.

Customers who have questions about Compuware’s Receive Order system can direct them to license.support@compuware.com.

Compuware Corporation
Compuware empowers the world’s largest companies to excel in the digital economy by fully leveraging their high-value mainframe investments. We do this by delivering highly innovative solutions that uniquely enable IT professionals with mainstream skills to manage mainframe applications, data, and platform operations. Learn more at compuware.com.

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Copyright © 2018, Compuware Corporation. All rights reserved. The Compuware products and services listed within this release are trademarks or registered trademarks of Compuware Corporation.

Neuralstem Reports Year End 2017 Fiscal Results and Business Update

– Neuralstem Releases Full Data Set for NSI-189 MDD Trial Showing Patient Rated Outcome and Cognitive Benefits

– Nature Medicine Paper Demonstrates Benefit of NSI-566 on Paralysis in Non-Human Primates

GERMANTOWN, Md., April 02, 2018 (GLOBE NEWSWIRE) — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, reported its financial results for the year ended December 31, 2017.

“We remain committed to the development of NSI-566, our lead stem cell therapy candidate, and NSI-189 for major depressive disorder (MDD), which we believe offer novel modalities of treatments for patients that are not effectively treated by current therapies,” said Rich Daly, President & CEO. “We are preparing for the initiation of a clinical trial for NSI-566 in chronic stroke in China and have targeted mid-2018 to begin dosing. The recent findings of NSI-566 that were published in Nature Medicine were very encouraging, demonstrating NSI-566 led to a measurable improvement in forelimb function in injured animals. We look forward to continuing to explore its utility as a potential treatment for paralysis associated with spinal cord injuries.”

“We plan to formulate the clinical development path for NSI-189 in MDD after our meeting with the U.S. Food and Drug Administration which we expect to occur in the second half of 2018. NSI-189 may offer cognitive benefits in addition to antidepressant effects, which would distinguish it from other approved treatments,” Mr. Daly continued.

Clinical Highlights for Lead Clinical Programs

NSI-566, is a spinal cord-derived neural stem cell line that is being evaluated to treat paralysis associated with stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI).

  • The publication of a manuscript in Nature Medicine demonstrated that NSI-566 provided meaningful improvement in forelimb function in a non-human primate model following acute spinal cord injury. The study was performed at the California National Primate Research Center at University of California, Davis by Mark H. Tuszynski, MD, PhD, Professor of Neurosciences, Director of the Center for Neural Repair, an Attending Neurologist at the University of California, San Diego (UCSD). The full manuscript can be found here.
  • In March, the Journal of Neurotrauma published preclinical data on NSI-566 spinal cord-derived neural stem cells in a study entitled, “Amelioration of penetrating ballistic-like brain injury induced cognitive deficits after neuronal differentiation of transplanted human neural stem cells.” These data showed robust engraftment and long-term survival of NSI-566 post transplantation in a rat model of penetrating ballistic-like brain injury. These are the first data from the 4-year proof-of-concept research program, funded by the United States Department of Defense, for NSI-566 in traumatic brain injury. The study was led by Ross Bullock, M.D., Ph.D., The Miami Project to Cure Paralysis, University of Miami School of Medicine.

NSI-189, a benzylpiperazine-aminopyridine, in clinical development for MDD and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.

  • At the 56th American College of Neuropsychopharmacology Annual Meeting last December, additional safety, efficacy and tolerability data from an exploratory Phase 2 clinical trial examining the efficacy of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID) compared to placebo for the treatment of MDD were presented in a poster entitled, “A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189 Phosphate, a Neurogenic Compound, Among Out-Patients with Major Depressive Disorder.”  These additional results suggest that NSI-189 has antidepressant effects with cognitive benefits shown on both objective and subjective measures.
  • Last August, Neuralstem was awarded approximately a $1 million Phase 2 Small Business Innovation Research grant by the National Institutes of Health (NIH) to conduct preclinical research into the potential of NSI-189 for the prevention and treatment of diabetic neuropathy.
  • As previously announced in July 2017, NSI-189 failed to achieve statistical significance on its physician measured primary endpoint in an exploratory Phase 2 clinical trial examining the efficacy of NSI-189 at 40 mg once daily and 40 mg twice daily compared to placebo for the treatment of major depressive disorder. The study, which utilized the two-staged sequential parallel comparison design, did not meet its primary efficacy endpoint of a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS).  However, as reported in our topline results, the 40 mg QD dose was directionally positive on the MADRS and met statistical significance on several key secondary patient reported efficacy endpoints.
  • Neuralstem intends to meet with the U.S. Food and Drug Administration to discuss the clinical development path for NSI-189 in the second half of 2018.

Corporate Highlights

  • In November, the Company appointed David Recker, MD, as Chief Medical Officer. Dr. Recker has more than 20 years of experience in drug development in multiple therapeutic areas including Central Nervous System disorders and cell therapy and has been involved in numerous aspects of clinical strategy development, including product registration and marketing support, clinical trial development and execution, data interpretation, key opinion leader development and support.
  • In September, Cristina Csimma, Pharm.D, MHP, joined the board of directors. Ms. Csimma brings extensive senior leadership experience in the biopharmaceutical industry, including expertise in drug development and regulatory and commercial processes. In December, Xi Chen, Ph.D., was appointed to the Company’s Board of Directors by Tianjin, Neuralstem’s largest shareholder. Dr. Chen replaces Zhang Zhuo as the director appointee of the Series A Convertible Preferred Stock.
  • Also in September, the Company was awarded two additional patents by the United States Patent and Trademark Office.  These patents broadly protect methods for using neural stem cells to treat neurodegenerative disorders, a key component of the Company’s platform.  The first new patent, U.S. Patent No. 9,744,194, covers methods of treating neurodegenerative disorders through transplantation of neural stem cells.  The second new patent, U.S. Patent No. 9,750,769, covers neural stem cells engineered to express IGF-1, a neurotrophic molecule with broad therapeutic potential in the treatment of neurodegenerative disorders.
  • In June, Neuralstem was added to the Russell Microcap® Index as part of the FTSE’s annual reconstitution of its family of U.S. indexes.

Financial Results for the Year Ended December 31, 2017

Cash Position and Liquidity:  At December 31, 2017, cash and investments was $11.7 million as compared to $20.2 million at December 31, 2016.  The $8.5 million decrease is due to cash used in  operations and $3.8 million to pay down our long-term debt partially offset by $5.4 million of proceeds from the August 2017 public offering of common stock and warrants and $3.2 million of proceeds from the exercise of outstanding warrants.

Operating Loss: Operating loss for the year ended December 31, 2017 was $13.3 million compared to a loss of $20.6 million for the same period of 2016.  The decrease in operating loss for the year was primarily due to ongoing corporate restructuring and cost reduction efforts partially offset by increases in clinical trial expenses as the Company completed the Phase 2 clinical trial of NSI-189.

Net Loss:  Net loss for the year ended December 31, 2017 was $15.7 million, or $1.20 per share (basic), compared to a loss of $21.1 million, or $2.53 per share (basic), on a split adjusted basis for the same period of 2016.  The decrease in net loss was primarily due to a decrease in operating expenses and interest expense due to the maturity of long-term debt in April 2017 partially offset by non-cash expense related to the change in the fair value of our liability classified warrants.

R&D Expenses: The $8.1 million of research and development expenses for 2017 represents a $5.1 million, or 38% decrease over 2016 expenses. This decrease was primarily attributable to a $2.3 million decrease in personnel, facility and other expenses related to ongoing corporate restructuring and cost reduction efforts, a $2.1 million decrease in costs related to our completed NS-189 Phase 2 clinical trial and a $0.7 million decrease in non-cash stock-based compensation expense.

G&A Expenses:  The $5.5 million of general and administrative expenses for 2017 represents a $2.0 million, or 27% decrease over 2016 expenses.  This decrease was primarily attributable to a $1.2 million decrease in payroll and related expenses due to our ongoing corporate restructuring and cost reduction efforts and a $1.0 decrease in non-cash stock-based compensation expense partially coupled.

Liquidity: The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on our current operating plans, into the second quarter of 2019.

Neuralstem, Inc.
Consolidated Balance Sheets
December 31,
2017 2016
ASSETS
CURRENT ASSETS
Cash and cash equivalents $   6,674,940 $   15,194,949
Short-term investments   5,000,000   5,000,000
Trade and other receivables   312,802   10,491
Current portion of related party receivable, net of discount   58,784   53,081
Prepaid expenses   402,273   646,195
Total current assets   12,448,799   20,904,716
 
Property and equipment, net   172,886   269,557
Patents, net   883,462   990,153
Related party receivable, net of discount and current portion   365,456   424,240
Other assets   13,853   15,662
Total assets $   13,884,456 $   22,604,328
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued expenses $   875,065 $   2,343,936
Accrued bonuses   418,625   852,963
Current portion of long-term debt, net of fees and discount   –   3,705,787
Other current liabilities   220,879   430,738
Total current liabilities   1,514,569   7,333,424
       
Warrant liabilities   3,852,882   3,921,917
Other long term liabilities   1,876   18,209
Total liabilities   5,369,327   11,273,550
 
STOCKHOLDERS’ EQUITY
Preferred stock, 7,000,000 shares authorized, $0.01 par value; 1,000,000 shares issued and outstanding in both 2017 and 2016   10,000   10,000
Common stock, $0.01 par value; 300 million shares authorized, 15,160,014 and 11,032,858 shares issued and outstanding in 2017 and 2016, respectively   151,600   110,329
Additional paid-in capital   217,050,174   204,239,837
Accumulated other comprehensive income   2,631   3,905
Accumulated deficit   (208,699,276 )   (193,033,293 )
Total stockholders’ equity   8,515,129   11,330,778
Total liabilities and stockholders’ equity $   13,884,456 $   22,604,328
Neuralstem, Inc.
Consolidated Statements of Operations and Comprehensive Loss
Year Ended December 31,
2017 2016
Revenues $ 260,000 $ 16,246
Operating expenses:
Research and development costs 8,096,095 13,155,887
General and administrative expenses 5,471,010 7,497,202
Total operating expenses 13,567,105 20,653,089
Operating loss (13,307,105 ) (20,636,843 )
Other income (expense):
Interest income  70,269  58,835
Interest expense (159,066 ) (1,141,297 )
Gain on related party settlement   – 458,608
Gain (loss) from change in fair value of liability classified warrants  (1,470,174 ) 660,253
Fees related to issuance of liability classified warrants and other expenses  (799,907 ) (474,167 )
Total other income (expense)  (2,358,878 ) (437,768 )
Net loss $ (15,665,983 ) $  (21,074,611 )
Net loss per common share – basic and diluted $  (1.20 ) $  (2.53 )
Weighted average common shares outstanding – basic and diluted  13,064,422 8,345,992
Comprehensive loss:
Net loss $  (15,665,983 ) $  (21,074,611 )
Foreign currency translation adjustment (1,274 ) 834
Comprehensive loss $  (15,667,257 ) $ (21,073,777 )

About Neuralstem

Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. The Company has two lead development candidates:

  • NSI-189, is a small molecule in clinical development for major depressive disorder and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.
  • NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI).

Neuralstem’s diversified portfolio of product candidates is based on its proprietary neural stem cell technology.

Cautionary Statement Regarding Forward Looking Information

This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

Contact:

Kimberly Minarovich
Argot Partners (Investor Relations)
212-600-1902
neuralstem@argotpartners.com

National recognition makes Bau Truc pottery village tourism hub

Bau Truc village in Ninh Thuan province has attracted a growing number of visitors since the pottery art of the local Cham ethnic minority was recognized as a national intangible cultural heritage in 2017.

The Bau Truc pottery cooperative has welcomed 4,000 visitors so far this year. Its 30 member households are involved in pottery production and conduct demonstrations.

Phu Huu Minh Thuan, director of the cooperative, said: Local people are developing their pottery-making tradition and tourism at the same time. We pay attention to environmental protection and will provide hands-on experience for visitors.

Bau Truc pottery village is the only Cham pottery village in Ninh Thuan province and one of the most ancient in Southeast Asia.

Source: VOV5

China hits back with tariffs on US imports

China has imposed tariffs of up to 25% on 128 US imports, including pork and wine, after US President Donald Trump raised duties on foreign steel and aluminium imports last month.

The tariffs, affecting some 3 billion USD of imports, will kick in on Monday. Beijing said the move was to “safeguard China’s interests and balance losses caused by new US tariffs. China previously said it did not want a trade war but would not sit by if its economy is hurt. Mr Trump has insisted that “trade wars are good”, and that it should be “easy” for the US to win one.

On March 22, the US said it was planning to impose duties on up to 60 billion USD of Chinese imports and limit China’s investment in the US, in retaliation for years of alleged intellectual property theft.

Source: VOV5

Vietnam tops global stock markets in Q1

The VN-Index reached 1.17 trillion points at the close of the last session of March.

The index, which represents the Ho Chi Minh City Stock Exchange, topped the world stock markets for growth in the first quarter of 2018. Following Vietnam were Egypt and Brazil.

Vietnam’s stock market enjoyed the highest growth over the past 6 months but ranked third after Mongolia and Nigeria over the past year.

Source: VOV5

Hanoi hosts Davis Cup tennis competition

Vietnam is the No 1 seed in Group A of the Davis Cup, Asia/Oceania Zone Group III, which begins Monday in Hanoi.

The hosts, who rank 67th in the world, are in the same pool with Cambodia, Pacific Oceania and Malaysia, following a draw that was held on Sunday. Group B includes Kuwait, Jordan, Qatar, Saudi Arabia and Syria. Matches will begin at 5pm at the M? A�Anh Sports Complex from April 2-7. The top two teams in each group will take part in the semi-finals. The winners of the semifinals will be promoted to Group II for next season.

Source: VOV5