- Seasoned biotech executive and accomplished scientific leader with broad experience from early-stage company development to managing publicly traded entities -

GERMANTOWN, Md., Dec. 18, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule technologies, appointed Kenneth C. Carter, Ph.D., as the Company’s Executive Chairman of the Board to be effective on January 1, 2019. Dr. Carter will replace interim CEO, Jim Scully, who will be stepping down.

“Dr. Carter brings a wealth of drug development expertise and executive leadership having led both private and public biotechnology companies. His leadership will be invaluable to Neuralstem at a critical juncture in the Company’s evolution,” said William Oldaker, Chairman of the Board. “Our team will greatly benefit from Dr. Carter’s entrepreneurial background with development stage companies. On behalf of the Board, I would like to thank Jim for his guidance during this transition period.”

“I look forward to working with the team at Neuralstem to develop and execute on a strategic plan to deliver on promising therapies and maximize value for shareholders,” said Dr. Ken Carter.

Dr. Carter is a dynamic industry executive and scientific leader with deep experience in development-stage biotechnology companies. Over the past decade, he has helped found and lead several companies including NexImmune, Inc., an immuno-oncology company which he helped spin out from John Hopkins University and served as CEO from inception in 2011 until June 2017. He also co-founded and is currently Chairman of the Board of Noble Life Sciences, Inc, a pre-clinical contract research organization that enables translational science and product development for biotechnology and pharmaceutical companies. Dr. Carter was also co-founder and CEO of Avalon Pharmaceuticals from inception in 1999 until the Company’s merger with Clinical Data in 2009 and led Avalon’s initial public offering on the NASDAQ stock exchange in 2004. Under Dr. Carter’s leadership, Avalon developed a pipeline of cancer drug candidates based on a novel high-throughput genomic screening technology and successfully secured R&D partnerships with Merck, Novartis, Sanofi-Aventis and MedImmune.

Dr. Carter has served on numerous corporate and advisory boards including the National BIO Industry Organization, Antidote Therapeutics, Inc., Iterion Pharmaceuticals and the Maryland BioHealth Initiative (BHI). He is also an adjunct faculty member at John Hopkins University. He completed a postdoctoral fellowship in Cell Biology at the University of Massachusetts Medical School. He received his doctoral degree in Human Genetics and Cell Biology at the University of Texas Medical Branch at Galveston and his B.S. at Abilene Christian University.

Inducement Grant

In connection with Dr. Carter’s employment, on December 12, 2018, the Compensation Committee of the company’s Board of Directors approved the grant of a non-qualified inducement stock option to purchase 800,000 shares of the company’s common stock. The option has an exercise price of the $0.425 (the closing price of the common stock on the date of grant), a term of ten (10) years, and vests as follows: (i) 200,000 of the stock options vest on the effective date of employment, (ii) 100,000 of the stock options vest on the six month anniversary of the effective date of employment, (iii) 100,000 of the stock options vest on the two year anniversary of the effective date of employment, and (iv) 400,000 of the stock options vest upon the achievement of certain performance-based milestones to be agreed upon by the Company and Dr. Carter.

About Neuralstem

Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. Neuralstem’s diversified portfolio of product candidates includes its proprietary neural stem cell technology.

The Company has two lead development candidates:

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

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three, six and nine months ended March 31, June 30 and September 30, 2018, 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:
Investors:
Argot Partners (Investor Relations)
212-600-1902
neuralstem@argotpartners.com

- NSI-189 Received Orphan Designation for Treatment of Angelman Syndrome -

- Initiated Phase 2 Clinical Trial of NSI-566 for Treatment of Chronic Stroke -

- Second-Generation Neural Stem Cell Program NSI-532 Showed Positive Preclinical Results for Alzheimer’s Disease -

- Closed $2.1 Million Registered Direct Offering -

GERMANTOWN, Md., Nov. 14, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule technologies, today provided a business update and reported its financial results for the third quarter ended September 30, 2018.

“During the third quarter of 2018 we have made progress with our programs, have taken steps to strengthen the balance sheet, and, perhaps most importantly, have determined how we will focus our efforts moving forward,” said Jim Scully, Interim Chief Executive Officer of Neuralstem. “We believe that proceeds from our recent offering, combined with our efforts to reduce cash burn, will allow us to pursue key development initiatives that will be detailed in the coming weeks.”

Clinical Highlights

• In August, NSI-189 received from FDA the orphan designation for treatment of Angelman Syndrome. Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people - about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome.
  
• In July, the company announced initiation of a Phase 2 clinical trial to further evaluate NSI-566 in ischemic stroke. This follows the positive results of the open-label Phase 1 stroke study disclosed in a 2018 ISSCR (International Society for Stem Cell Research) abstract on June 23, 2018. The Phase 2 study is a randomized, double-blind, sham-surgery controlled study. It is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients with half of their body partially paralyzed. The trial is taking place at BaYi Brain Hospital in Beijing, China, and commenced on August 1, 2018.
  
• In October, the company announced publication of a manuscript in Scientific Reports showing that transplantation of NSI-532.IGF1 mitigates disease pathology and improves cognition in a mouse model of Alzheimer’s Disease. The study was performed at the University of Michigan by a team led by Dr. Eva Feldman, Director of the Program for Neurology Research and Discovery, and Research Director of the University of Michigan ALS Center of Excellence. NSI-532.IGF1 is the first candidate from the NSI-532 program, a second-generation cell therapy program which combines neural stem cells with neuroprotective proteins.

Corporate Highlights

• In October, the company completed a registered direct offering of its securities which resulted in gross proceeds to Neuralstem of $2.1 million. Neuralstem intends to use the proceeds from this offering to further its clinical and preclinical programs, and for general working capital.

Financial Results for the Quarter Ended September 30, 2018

• Cash Position and Liquidity: At September 30, 2018, cash and investments was $5.7 million as compared to $7.1 million at June 30, 2018. The $1.4 million decrease reflects a loss for the period, which was somewhat ameliorated by management’s cost reduction efforts. The company expects its existing cash, cash equivalents and short-term investments to fund its operations, based on its current operating plans, into the second quarter of 2019.
  
• Operating Loss: Operating loss for the third quarter ended September 30, 2018 was $2.1 million compared to a loss of $2.6 million for the comparable period of 2017. The reduction in loss is attributed to reduced clinical development activity and management efforts to reduce overall expenses.
  
• Net Loss: Net loss for the third quarter ended September 30, 2018 was $1.8 million, or $0.12 per share (basic), compared to a loss of $0.1 million, or $0.01 per share (basic), for the comparable period of 2017. The increase in net loss was primarily due to the non-cash gains related to the change in the fair value of our liability classified warrants in 2017, partially offset by a decrease in our operating loss.
  
• Research and Development Expenses: The $0.9 million of research and development expenses for the quarter ended September 30, 2018 represents a 35% decrease over the comparable period of 2017. This decrease was primarily attributable to a decrease in personnel and facility expenses, and a decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial.
  
• General and Administrative Expenses: The $1.2 million of general and administrative expenses for the third quarter ended September 30, 2018 represents a 2% decrease over the comparable period of 2017. This decrease was primarily attributable to lower payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a decrease in non-cash share-based compensation expense which was offset by an increase in tax and insurance expenses and consulting and professional fees.

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three, six and nine months ended March 31, June 30 and September 30, 2018, 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:
Argot Partners (Investor Relations)
212-600-1902
neuralstem@argotpartners.com

GERMANTOWN, Md., Oct. 26, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, today announced that it has entered into definitive agreements with institutional investors for the purchase of 3,000,000 shares of its common stock, at a purchase price per share of $0.70, in a registered direct offering. Additionally, Neuralstem has also agreed to issue to the investors unregistered warrants to purchase up to 3,000,000 shares of its common stock. The closing of the offering is expected to take place on or about October 29, 2018, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $0.75 per share of common stock, will be exercisable commencing six months following the issuance date and will expire five and one-half years from the issuance date.

The gross proceeds to Neuralstem, before deducting placement agent fees and other offering expenses, are expected to be $2.1 million. Neuralstem intends to use the net proceeds from this offering to further its clinical and preclinical programs, and for general working capital.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Neuralstem pursuant to a “shelf” registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission (“SEC”) on June 23, 2017 and the base prospectus contained therein (File No. 333-218608). The offering of the shares of common stock will be made only by means of a prospectus supplement and accompanying base prospectus that form a part of the registration statement.

A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at 646-975-6996 or e-mail at placements@hcwco.com.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

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

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 , 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:
Argot Partners (Investor Relations)
212-600-1902
neuralstem@argotpartners.com

NSC transplantation led to improved cognition and reduced Aβ plaque pathology

GERMANTOWN, Md., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, announced the publication of a manuscript in Scientific Reports showing that transplantation of NSI-532.IGF1, a proprietary human neural stem cell line developed by Neuralstem (US patent no 9,750,769), mitigates disease pathology and improves cognition in a mouse model of Alzheimer’s disease (AD).

The study was performed at the University of Michigan by a team led by Dr. Eva Feldman, Director of the Program for Neurology Research and Discovery, and Research Director of the University of Michigan ALS Center of Excellence. Dr. Feldman’s team grafted the neural stem cell line into APP/PS1 mice that carry genes bearing mutations associated with onset of AD in humans.

NSI-532.IGF1 was implanted adjacent to the hippocampus, a structure in the brain that is critical for memory formation, and animals were evaluated for cognitive performance along with evidence of Aβ plaque pathology, a hallmark of AD in humans. Animals receiving neural stem cell grafts showed improved cognitive performance relative to control animals in two memory tasks that are dependent on hippocampal function, and also showed a decrease in Aβ plaque pathology relative to controls.

“Our leading neural stem cell therapy product in clinical development, NSI-566, has shown promise for treatment of motor deficits across three different indications—stroke, spinal cord injury, and ALS,” said Karl Johe, PhD, Chief Scientific Officer at Neuralstem. “NSI-532.IGF1 is a second-generation cell therapy candidate that is engineered to combine neural stem cells with a neuroprotective protein, IGF-1, thereby targeting neurodegenerative conditions like AD. This preclinical study from Dr. Feldman’s team suggests that the combined properties of neural stem cells and IGF-1 may mitigate the pathology and cognitive deficits associated with Alzheimer’s disease.”

“Alzheimer’s disease is a leading cause of dementia and there are currently no treatments available that significantly alter the course of this disease,” said Dr. Feldman. “We are encouraged by the results we have seen with human neural stem cells in this established animal model and look forward to continuing this collaboration with Neuralstem.”

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

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 , 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

- Phase 2 clinical trial initiated to further evaluate NSI-566 as treatment for ischemic stroke -
- NSI-189 Granted Orphan Drug Designation for the Treatment of Angelman Syndrome -
- Jim Scully appointed interim chief executive officer -

GERMANTOWN, Md., Aug. 15, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, provides a business update and reported its financial results for the second quarter ended June 30, 2018.

“We are pleased to report a productive second quarter of 2018 as we continue to advance our pipeline of innovative neural stem cell and small molecule therapies,” said Jim Scully, interim Chief Executive Officer of Neuralstem. “We are especially excited about the advancement of our lead stem cell therapy candidate, NSI-566, into a Phase 2 trial in ischemic stroke, as well as its potential application to other areas of unmet medical need. Additionally, based on encouraging preclinical data, we look forward to exploring our small molecule NSI-189’s potential treatment applications, including Angelman Syndrome and Alzheimer’s Disease.”

Clinical Highlights

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). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

• In July, Neuralstem announced initiation of a Phase 2 clinical trial evaluating NSI-566 as a potential treatment for ischemic stroke. This trial, which will be a randomized, double-blind, controlled study, is based on the positive results from the open-label Phase 1 safety study and is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients where half of their body has been partially paralyzed. James Li, Ph.D., Executive Vice President of Asia Operations of Suzhou Neuralstem Ltd, will be managing this trial which will be taking place at Bayi Brain Hospital in Beijing, China, and commenced on August 1, 2018. In Phase 1, NSI-566 treatment of 9 chronically hemiparetic stroke patients resulted in statistically significant improvement from baseline of motor functioning and clinical status.
  
  
• In June, the Company announced the results from a study published in Cell Stem Cell that support the potential therapeutic application of transplanted NSI-566 in patients with chronic spinal cord injury (cSCI). The manuscript, entitled “A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury,” presented a detailed analysis of motor and sensory function and electrophysiology results which showed improvement in three of the four patients after NSI-566 transplantation. The study’s primary objective was to evaluate the safety of NSI-566 transplantation in subjects with stable thoracic spinal cord injury, and additional endpoints measured included changes in neurologic deficits, neurophysiology, and neuropathic pain.
  
  
• In May, the Company announced the results from a study published in the Annals of Clinical and Translational Neurology in a manuscript entitled “Long-term Phase 1/2 Intraspinal Stem Cell Transplantation Outcomes in Amyotrophic Lateral Sclerosis” that support the potential of transplanted human spinal cord-derived neural stem cells (HSSC) to stabilize functioning of ALS patients. The study evaluated the impact of HSSC transplantation on functional outcomes, as measured using the ALSFRS-R scale, and on a composite statistic that combined functional and survival outcomes. Results were evaluated against matched controls derived from two historical datasets and showed significantly better ALSFRS-R scores at 24 months, as well as the composite functional/survival score in subjects receiving HSSC. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated questionnaire that measures physical function in performing activities of daily living (ADLs).

NSI-189, is a small molecule 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.

• In August, the Company announced it had been granted orphan drug designation by the FDA for the treatment of Angelman Syndrome. In pre-clinical models, NSI-189 has demonstrated the ability to restore long term potentiation (LTP), a measure of synaptic plasticity and an in vitro biomarker of memory. Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people - about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome. The FDA's orphan-drug designation program provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation confers seven years of market exclusivity upon FDA approval, as well as other development incentives, such as tax credits related to clinical trial expenses, an exemption from the FDA-user fee and FDA assistance in clinical trial design.
  
  
• In July, the Company presented preclinical data at the Alzheimer's Association International Conference in Chicago, Illinois, demonstrating that oral administration of NSI-189 in a mouse model of Alzheimer’s Disease leads to a significant amelioration and/or improvement in cognition measures and anxiety. Results were presented in a poster titled ‘Effect of Neurogenic Compound NSI-189 on Indices of Cognition and Anxiety in a Mouse Model (5XFAD) of Alzheimer’s Disease.’ The study was carried out by Dr. Corinne Jolivalt’s laboratory at the University of California, San Diego, and found that treatment with NSI-189 significantly improved learning ability as well as retention, short-term memory and anxiety levels of mice.

Corporate Highlights

• Effective August 1, Jim Scully was appointed as interim chief executive officer by the Board of Directors. Mr. Scully succeeds Mr. Rich Daly, former Neuralstem president and chief executive officer. Mr. Scully brings to Neuralstem a wealth of experience from a range of senior executive roles in the pharmaceutical and broader healthcare industry, including leadership roles in financial and strategic planning, global business development and general management at Takeda Pharmaceuticals, Astellas Pharmaceuticals, Abbott Laboratories and Walgreens.
  
  
• Also, effective August 1, the Board of Directors appointed William Oldaker as Chairman of the Board. Mr. Oldaker has served as a director of Neuralstem since April 2007. Additionally, he is a founder and partner in the Washington, D.C. law firm, Oldaker & Willison PLLP, and is a member of the Colorado, D.C. and Iowa Bar Associations, the Bar Association for the Court of Appeals, D.C., and the Bar of the United States Supreme Court.

Financial Results for the Quarter Ended June 30, 2018

Cash Position and Liquidity: At June 30, 2018, cash and investments was $7.1 million as compared to $9.7 million at March 31, 2018. The $2.6 million decrease reflects a $0.6 million loss for the period adjusted for certain non-cash items including a $1.4 million gain related to the change in fair value of our liability classified warrants, $760,000 net cash outflows related to changes in operating assets and liabilities, and $200,000 of share-based compensation. The Company expects its existing cash, cash equivalents and short-term investments to fund its operations based on its current operating plans, into the first quarter of 2019.

Operating Loss: Operating loss for the second quarter ended June 30, 2018 was $2.0 million compared to a loss of $4.2 million for the comparable period of 2017. Operating loss for the six months ended June 30, 2018 was $4.4 million compared to a loss of $8.5 million for comparable period of 2017.

The decrease in operating loss for both the three- and six-month periods was primarily related to decreases in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, decreases in personnel, facility and related expenses due to ongoing corporate restructuring and cost reduction efforts offset by revenues from a milestone-based royalty and reimbursements under a National Institute of Health (NIH) grant.

Net Loss: Net loss for the second quarter ended June 30, 2018 was $0.6 million, or $0.04 per share (basic), compared to a loss of $4.6 million, or $0.39 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants.

Net loss for the six months ended June 30, 2018 was $2.8 million, or $0.18 per share (basic), compared to a loss of $12.2 million, or $1.06 per share (basic), for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating loss and the non-cash charges related to the change in the fair value of liability classified warrants and warrant inducement expenses in the 2017 period and a decrease in interest expense related to our long-term debt which matured in April 2017.

Research and Development Expenses: The $1.0 million of research and development expenses for the quarter ended June 30, 2018 represents a $1.6 million, or 61% decrease over the comparable period of 2017. This decrease was primarily attributable to a $710,000 decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $310,000 decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial and a $410,000 decrease in non-cash share-based compensation expense along with $90,000 of reimbursements under a NIH grant.

The $2.2 million of research and development expenses for the six months ended June 30, 2018 represents a $3.3 million, or 60% decrease over the comparable period of 2017. This decrease was primarily attributable to a $1.8 million decrease in personnel and facility expenses due to ongoing corporate restructuring and cost reduction efforts, a $540,000 decrease in clinical trial and related costs due to the completion of the NSI-189 Phase 2 clinical trial, a $720, 000 decrease in our non-cash share-based compensation expense along with $180,000 of reimbursements under a NIH grant.

General and Administrative Expenses: The $1.3 million of general and administrative expenses for the second quarter ended June 30, 2018 represents a $380,000, or 23% decrease over the comparable period of 2017. This decrease was primarily attributable to a $400,000 decrease in payroll and related expenses due to corporate restructuring and cost reduction efforts coupled with a $40,000 decrease in non-cash share-based compensation expense partially offset by a $70,000 increase in tax and insurance expenses.

The $2.4 million of general and administrative expenses for the six months ended June 30, 2018 represents a $530,000, or 18% decrease over the comparable period of 2017. This decrease was primarily attributable to a $560,000 decrease in payroll and related expenses coupled with a $40,000 decrease in consulting and professional service expenses due to corporate restructuring and cost reduction efforts partially offset by a $90,000 increase in our tax and insurance expenses.

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three months ended March 31, 2018, 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:

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

GERMANTOWN, Md., Aug. 09, 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, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to NSI-189 for the treatment of Angelman syndrome.

“Angelman Syndrome is a rare disease with significant unmet medical need, and for which there are no FDA-approved therapies,” said Jim Scully, Chief Executive Officer of Neuralstem. “Orphan drug designation is an important regulatory milestone in the development of NSI-189 and we are committed to evaluating NSI-189’s role as a treatment to improve the lives of patients with Angelman syndrome.”

In pre-clinical models, NSI-189 has demonstrated the ability to restore long term potentiation (LTP), a measure of synaptic plasticity and an in vitro biomarker of memory.

The FDA's orphan-drug designation program provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. Orphan drug designation confers seven years of market exclusivity upon FDA approval, as well as other development incentives, such as tax credits related to clinical trial expenses, an exemption from the FDA-user fee and FDA assistance in clinical trial design.

About Angelman Syndrome

Angelman Syndrome (AS) is a rare congenital genetic disorder caused by a lack of function in the UBE3A gene on the maternal 15th chromosome. It affects approximately one in 15,000 people - about 500,000 individuals globally. Symptoms of AS include developmental delay, lack of speech, seizures, and walking and balance disorders. Patients with AS may never walk or speak and require life-long care. Life expectancy is normal which places a significant burden on patients and caregivers. There are currently no FDA-approved therapies for the treatment of Angelman syndrome.

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), chronic spinal cord injury (cSCI), and traumatic brain injury (TBI). NSI-566 was shown to have restorative function in a primate paralysis model. The study was published in the peer reviewed journal Nature Medicine, and the full manuscript can be found here.

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

William Oldaker Expands Role and is Named Chairman of the Board

GERMANTOWN, Md., Aug. 06, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell and small molecule compound technologies, today announced that the Board of Directors has appointed Jim Scully as interim chief executive officer. Mr. Scully will assume the role effective immediately and succeeds Mr. Rich Daly who served as president and chief executive officer of the Company since February 2016.

“Jim’s contribution in 2018 heading up business development and as strategic advisor for Neuralstem has been extremely valuable, and we are confident that his appointment will ensure continued momentum over the near-term as our dedicated search efforts continue,” said Cristina Csimma, Chair of the Nominating Committee of Neuralstem. “Jim is an experienced pharmaceutical executive with a deep understanding of commercial, clinical development and manufacturing operations and has worked with our team to advance our Company’s efforts in China and rest-of-world.”

“I am very pleased to increase my responsibilities with Neuralstem at this important time for the company, and I look forward to working closely with the management team and the Board to unlock the full potential of the Company’s promising pipeline candidates, NSI-566 and NSI-189,” said Mr. Scully. “We continue to believe that these candidates represent innovative approaches to several unmet medical needs, and we look forward to providing further updates on our progress in executing our strategic plan.”

Mr. Scully’s experience spans multiple key strategic roles in the healthcare industry. During his decade with Takeda Pharmaceuticals, a leading global pharmaceutical company, Mr. Scully assumed roles of increasing responsibility across multiple functional areas, leading efforts in financial planning, global business development, business analytics and corporate project management. Mr. Scully has also held key roles at Astellas Pharmaceuticals, Abbott Labs, GE Healthcare and Walgreens. These roles included leadership of clinical development planning, performance analytics and partnering initiatives.

The Board of Directors also appointed William Oldaker, as Chairman. Mr. Oldaker has served as a director of Neuralstem since April 2007. He is a founder and partner in the Washington, D.C. law firm, Oldaker & Willison PLLP, and is a member of the Colorado, D.C. and Iowa Bar Associations, the Bar Association for the Court of Appeals, D.C., and the Bar of the United States Supreme Court.

“I am excited to expand my role and continue to work with the Board and the management team to execute on its exciting strategy to become a leader in CNS and neural stem cell technology,” said William Oldaker.

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-566 is a stem cell therapy being tested for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI).
  
  
• 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.

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

Neuralstem announced the positive topline results of Phase 1 stroke study in the 2018 ISSCR (International Society for Stem Cell Research) abstract on June 23, 2018.

“The Phase 2 study, which will be a randomized, double-blind, controlled study, is based on the encouraging results from the open-label Phase 1 safety study.  It is intended to further test the safety and efficacy of NSI-566 to reverse paralysis in stroke patients with half of their body partially paralyzed,” said Dr. Karl Johe, Chief Scientific Officer of Neuralstem.

The trial will be taking place at Bayi Brain Hospital in Beijing, China, commencing on August 1, 2018.  Managing the trial will be James Li, Ph.D., Executive Vice President of Asia Operations of Suzhou Neuralstem Ltd, a wholly owned subsidiary of Neuralstem, Inc., located in Suzhou, China.  Dr. Li has been made the Manager and a Registered Agent of Suzhou Neuralstem.

Neuralstem will be allocating US$3 million toward this trial.

About Ischemic Stroke

Ischemic strokes, the most common type of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain. Approximately 15 million people worldwide suffer stroke of which it is estimated that 87% of all strokes are ischemic strokes. Post-stroke motor deficits include paralysis in arms and legs and can be permanent.

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-566 is a stem cell therapy being tested for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS) and chronic spinal cord injury (cSCI). 
  
  
• 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.

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:

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

• Study evaluated the effect of oral treatment with NSI-189 in well-established 5xFAD mouse model for Alzheimer’s disease (AD)
  
• Treatment with NSI-189 restored memory retention and learning abilities in AD mice, and reduced anxiety in control and AD mice

GERMANTOWN, Md., July 23, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced the presentation of data at the Alzheimer's Association International Conference in Chicago, Illinois, demonstrating that oral administration of NSI-189 in a mouse model of Alzheimer’s Disease leads to a significant amelioration and/or improvement in cognition measures and anxiety. Results are being presented in a poster titled ‘Effect of Neurogenic Compound NSI-189 on Indices of Cognition and Anxiety in a Mouse Model (5XFAD) of Alzheimer’s Disease.’

The study was carried out by Dr. Corinne Jolivalt’s laboratory at the University of California, San Diego, and involved the oral administration of NSI-189 to mice harboring gene changes that recreate symptoms of familial Alzheimer’s disease. Animals were treated starting at 15 weeks of age, when memory defects are first beginning to appear. Key findings include:

• Treatment with NSI-189 significantly improved learning ability as well as retention as measured by a simple task (Barnes maze), and improved performance on a test of short term memory (Novel Object Recognition)
• Treatment with NSI-189 improved motor learning of AD mice as measured by performance on a Rotarod test
• NSI-189 treatment decreased anxiety levels in both AD mice and control mice as measured by an open field test

“Data from this preclinical study suggest that NSI-189 may be able to mitigate or reverse the cognitive impact of Alzheimer’s disease,” said Corinne Jolivalt, PhD, associate professor in the Department of Pathology at UC San Diego School of Medicine. “We look forward to continuing this line of inquiry to further evaluate the potential of NSI-189 in the treatment of this devastating disease.”

About Alzheimer’s disease

Alzheimer's disease is a chronic, neurodegenerative disorder that causes progressive dementia as well as a decline in other aspects of cognition which can affect a person’s ability to interact socially or function at work. There are currently an estimated 50 million people living with dementia around the world, with numbers expected to triple by 2050. The total estimated annual social and economic cost of dementia is $818 billion USD worldwide and is expected to reach a trillion in the coming years.

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

GERMANTOWN, Md., June 11, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) contract by the Department of Defense (DoD). The award of $150,000 will support the Company’s ongoing efforts to develop its NSI-566 human neural stem cell line as a candidate therapeutic for severe Traumatic Brain Injury (TBI).

It is estimated that approximately 3-5 million people in the United States have a disability resulting from TBI, with rehabilitative therapy currently serving as the primary treatment method. The research supported by the SBIR contract will facilitate the progress of Neuralstem’s ongoing collaboration with the research group of Dr. Ross Bullock, MD, Ph.D., Professor, Department of Neurological Surgery and Director, Clinical Neurotrauma at the Miami Project to Cure Paralysis. This research is intended to culminate in the filing of an IND application to conduct clinical trials in TBI.

“We are very pleased and appreciative that the DoD has chosen to fund this project,” said Rich Daly, President and CEO of Neuralstem. “Severe TBI represents a significant unmet medical need, and we are excited to continue our preclinical studies to establish the therapeutic potential of neural stem cells in this indication.”

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 with pro-cognitive activity that is in clinical development for major depressive disorder and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, diabetic neuropathy, and stroke.

• NSI-566 is a stem cell therapy in clinical testing for treatment of paralysis in stroke, Amyotrophic Lateral Sclerosis (ALS), and chronic spinal cord injury (cSCI). NSI-566 has been shown to confer neurological improvement upon transplantation to patients with spinal cord injury (Link) and confers functional benefit upon transplantation to patients with ALS (Link).

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

- Neuralstem Announces Publication of Data From First-In-Human Study of Human Neural Stem Cell Transplantation for Chronic Spinal Cord Injury -

- First cohort of four subjects with thoracic (T2-T12) ASIA-A grade spinal cord injury in the Phase I study received intraspinal injections of human spinal cord-derived neural stem cells 12-24 months after injury
- All subjects tolerated the procedure well, with no serious adverse events 18-27 months after grafting
- Analysis of motor and sensory function and electrophysiology results showed improvement in three of the four patients

GERMANTOWN, Md., June 04, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced the results from a study published in the journal Cell Stem Cell that support the potential of transplanted NSI-566, a human spinal cord-derived neural stem cell line (HSSC) to benefit patients with chronic spinal cord injury (SCI). The publication can be found here.

The manuscript entitled “A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury” has as senior author Study Principal Investigator Joseph D. Ciacci, MD, Chief of Neurosurgery at the VA San Diego Healthcare System and Professor of Surgery at UC San Diego Health. The study’s primary objective was to evaluate the safety of NSI-566 transplantation in subjects with stable thoracic spinal cord injury, but additional endpoints were also measured including changes in neurologic deficits, neurophysiology, and neuropathic pain.

Subjects were evaluated for at least 18 months and up to 27 months after implantation of neural stem cells and showed no evidence of serious adverse events, suggesting the procedure is well-tolerated. Analysis of motor and sensory function and electrophysiology results showed improvement in three of the four patients after NSI-566 transplantation,

“Stem cell therapies have tremendous potential in addressing spinal cord injury, a condition for which there are currently no treatment options that can restore lost function,” said Dr. Ciacci. “This study serves as a step in this direction, as it suggests the procedure is safe and has the potential for benefitting the patient.”

Neuralstem has initiated the second cohort trial to test safety in patients with cervical spinal cord injury patients. “These data are encouraging and suggest that human spinal cord-derived neural stem cells may provide functional benefit to patients with spinal cord injury,” said Rich Daly, Neuralstem’s Chief Executive Officer. “We look forward to seeing the impact of this procedure on subjects with cervical injuries, who are the basis for the second cohort of the trial.”

About Spinal Cord Injury

A spinal cord injury, or SCI, generally refers to any injury to the spinal cord that is caused by trauma instead of disease although in some cases, it can be the result of diseases. It is estimated that there are 12,500 new cases of SCI per year and that at any given time, there are between 240,000 and 337,000 people in the United States that are living with SCI. Chronic spinal cord injury (cSCI) generally refers to the phase beginning 6 months after the initial injury. SCIs are most often traumatic, caused by lateral bending, dislocation, rotation, axial loading, and hyperflexion or hyperextension of the cord or cauda equina. Motor vehicle accidents are the most common cause of SCIs, while other causes include falls, work-related accidents, sports injuries, and penetrations such as stab or gunshot wounds. In certain instances, SCIs can also be of a non-traumatic origin, as in the case of cancer, infection, intervertebral disc disease, vertebral injury and spinal cord vascular disease.

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), chronic spinal cord injury (cSCI), and traumatic brain injury (TBI). NSI-566 was shown to have restorative function in primate paralysis model. Highlights of this study were published in the peer reviewed journal, Nature, and the full manuscript can be found here.

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

GERMANTOWN, Md., May 29, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced that Karl Johe, PhD, Chief Scientific Officer of Neuralstem, will be providing a Company overview during the 2018 BIO International Convention in Boston, Massachusetts, on Monday, June 4, 2018 at 3:30pm ET.

A live audio webcast as well as a video recording of this presentation will be available in the Investors section of the Company's website at investor.neuralstem.com. The webcast will be archived on the Company's website for 90 days following the presentation.

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
kimberly@argotpartners.com

GERMANTOWN, Md., May 15, 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, provides a business update and reported its financial results for the first quarter ended March 31, 2018 .

“We remain committed to the development of NSI-566, our lead stem cell therapy candidate, and were pleased to complete the first surgery in the second cohort of our ongoing Phase 1 clinical trial in patients with chronic spinal cord injury,” said Rich Daly, President & Chief Executive Officer. “We anticipate initiating a clinical trial for NSI-566 in chronic stroke in China and have targeted mid-2018 to begin dosing. We continue to pursue the development of NSI-189, our lead small molecule candidate for major depressive disorder (MDD) and look forward to meeting with the U.S. Food and Drug Administration in the second half of 2018 to formulate its clinical development path. We believe that NSI-189 may offer cognitive benefits in addition to antidepressant effects, which would distinguish it from other approved treatments for MDD.”

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). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

• Neuralstem announced the results from a study published in the Annals of Clinical and Translational Neurology in a manuscript entitled “Long-term Phase 1/2 Intraspinal Stem Cell Transplantation Outcomes in Amyotrophic Lateral Sclerosis” that support the potential of transplanted human spinal cord-derived neural stem cells (HSSC) to stabilize functioning of ALS patients. The study evaluated the impact of HSSC transplantation on functional outcomes, as measured using the ALSFRS-R scale, and on a composite statistic that combined functional and survival outcomes. Results were evaluated against matched controls derived from two historical datasets and showed significantly better ALSFRS-R scores at 24 months, as well as the composite functional/survival score in subjects receiving HSSC. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated questionnaire that measures physical function in performing activities of daily living (ADLs). The manuscript was published on May 3, 2018.
  
  
• On March 28, Neuralstem completed the first surgery using NSI-566 spinal cord-derived neural stem cells in the second, cervical injury cohort of a Phase 1 clinical trial in patients with chronic spinal cord injury (cSCI). The patients in this cohort include complete injury patients with no motor or sensory function below injury. The clinical trial is being conducted at the University of California San Diego, Division of Neurosurgery. The clinical trial was expanded to include a new cohort of four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 of their spinal cord, after promising results were observed with the first cohort. The clinical trial is evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI.

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.

• In the second half of 2018, Neuralstem intends to meet with the U.S. Food and Drug Administration to discuss the clinical development path for NSI-189 in major depressive disorder.

Financial Results for the Quarter Ended March 31, 2018

Cash Position and Liquidity: Cash and investments was $9.7 million at March 31, 2018 as compared to $11.7 million at December 31, 2017. The $2.0 million decrease reflects a $2.1 million loss for the period adjusted for certain non-cash items including $240,000 of share-based compensation, $190,000 gain related to the change in fair value of our liability classified warrants and $180,000 net cash inflows related to changes in our operating assets and liabilities.

Operating Loss: Operating loss for the quarter ended March 31, 2018 was $2.3 million compared to a loss of $4.2 million for the comparable period of 2017. The decrease in operating loss for the year was primarily related to decreases in clinical trial and related costs due to the completion of the Company’s NSI-189 Phase 2 clinical trial coupled with decreases in personnel, facility and related expenses due to our ongoing corporate restructuring and cost reduction efforts.

Net Loss: Net loss for the quarter ended March 31, 2018 was $2.1 million, or $0.14 per share, compared to a loss of $7.6 million, or $0.68 per share, for the comparable period of 2017. The decrease in net loss was primarily due to a decrease in operating expenses and the non-cash charges related to the change in the fair value of the liability classified warrants and warrant inducement expenses in the 2017 period along with a decrease in interest expense related to our long-term debt which matured in April 2017.

Research and Development Expenses: The $1.2 million of research and development expenses for the quarter ended March 31, 2018 represents a $1.7 million, or 60% decrease over the comparable period of 2017. This decrease was primarily attributable to a $1.1 million decrease in clinical trial and related costs due to the completion of our NSI-189 Phase 2 clinical trial, a $200 thousand decrease in our personnel and facility expenses due to our ongoing corporate restructuring and cost reduction efforts and a $310 thousand decrease in our non-cash share-based compensation expense.

General and Administrative Expenses: The $1.2 million of general and administrative expenses for the quarter ended March 31, 2018 represents a $150 thousand, or 11% decrease over the comparable period of 2017. This decrease was primarily attributable to a $140 thousand decrease in payroll and related expenses coupled with a $50 thousand decrease in consulting and professional service expenses due to our corporate restructuring and cost reduction efforts partially offset by a $20 thousand increase in non-cash share-based compensation expense.

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 first quarter of 2019.

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 its Annual Report on Form 10-K for the year ended December 31, 2017, and its Quarterly Report on Form 10-Q for the three months ended March 31, 2018, 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

• Post-hoc comparison of combined cohorts from Phase 1 and 2 trials vs. historical controls revealed statistically significant difference in scores in functional status and in a composite statistic combining survival and functional status in subjects receiving human spinal cord-derived neural stem cells
  
• Study provides validation for additional trials to evaluate the benefit of neural stem cells in ALS patients

GERMANTOWN, Md., May 03, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced the results from a study published in the Annals of Clinical and Translational Neurology that support the potential of transplanted human spinal cord-derived neural stem cells (HSSC) to stabilize functioning of amyotrophic lateral sclerosis (ALS) patients. The publication can be found here.

The manuscript entitled “Long-term Phase 1/2 Intraspinal Stem Cell Transplantation Outcomes in Amyotrophic Lateral Sclerosis” had as senior author Study Principal Investigator Eva Feldman, MD, PhD, Russell N. DeJong Professor of Neurology at the University of Michigan. It evaluated the impact of HSSC transplantation on functional outcomes, as measured using the ALSFRS-R scale, and on a composite statistic that combined functional and survival outcomes. Results were evaluated against matched controls derived from two historical datasets and showed significantly better ALSFRS-R scores at 24 months, as well as the composite functional/survival score in subjects receiving HSSC. The ALS Functional Rating Scale-Revised (ALSFRS-R) is a validated questionnaire that measures physical function in performing activities of daily living (ADLs).

“We are looking forward to completing a larger Phase 2b/3 multicenter study,” said Dr. Feldman.

“These data are encouraging and indicate that human spinal cord-derived neural stem cells may provide functional benefit to ALS patients,” said Rich Daly, Neuralstem’s Chief Executive Officer. “We are grateful to the subjects who have participated in these trials and to the clinicians and caregivers involved in performing them. These long-term follow-up data are extremely valuable to us in designing the Company’s Phase 2b/3 clinical study to further evaluate NSI-566, Neuralstem’s cell therapy candidate, in this patient population.”

The Phase 1 and 2 open label dose escalation studies were carried out at the University of Michigan in Ann Arbor, Emory University in Atlanta, and Harvard Medical School in Boston. They enrolled a total of 30 subjects and had as their primary objective to evaluate the safety of intraspinal transplantation of HSSC, while also measuring survival and functional endpoints. Previous publications from the investigators have concluded that the treatment is safe.

About Amyotrophic Lateral Sclerosis (ALS)

ALS is a progressive disease that affects nerve cells, or neurons, in the brain and the spinal cord, leading to degeneration and eventual atrophy of the surrounding muscles. As the condition worsens, motor neurons die, and the brain can no longer control the affected muscles. In time, this causes the loss of patients' ability to speak, eat, move and breathe, eventually resulting in death. According to the ALS Association, it is estimated that more than 6,000 people in the U.S. are diagnosed with ALS each year, amounting to 15 new cases per day, totaling approximately 20,000 Americans living with the disease at any given time. There is currently no cure or treatment that that halts or reverses the progression of the disease.

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

GERMANTOWN, Md., April 11, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced Karl Johe, Ph.D, Chief Scientific Officer of Neuralstem, will be providing a clinical update at the Alliance for Regenerative Medicine 6^th Annual Cell & Gene Therapy Investor Day at the Metropolitan Club in New York, NY. The presentation is scheduled for Tuesday, April 17, 2018 at 8:55am ET.

A live audio webcast as well as a video recording of this presentation will be available in the Investors section of the Company's website at investor.neuralstem.com. The webcast will be archived on the Company's website for 90 days following the presentation.

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

GERMANTOWN, Md., April 10, 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, today announced that it completed the first surgery in the second, cervical injury cohort of a Phase 1 clinical trial in patients with chronic spinal cord injury (cSCI). NSI-566 is Neuralstem’s lead stem cell therapy candidate.

“This study involves complete injury patients with no motor or sensory function below injury. The first four paraplegic cases with thoracic injury went exceptionally well. We are excited to move forward with the next four quadriplegic cases with cervical injury,” said Karl Johe, Ph.D., the Chief Scientific Officer of Neuralstem.

Neuralstem is conducting a Phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The clinical trial is being conducted at the University of California San Diego, Division of Neurosurgery. In April 2017, the clinical trial was expanded to include a new cohort of four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 of their spinal cord, after promising results were observed with the first cohort. The clinical trial is evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. The amended protocol was approved by the U.S. Food and Drug Administration and the Institutional Review Board at the study site, University of California San Diego (UCSD) and can be found on clinicaltrials.gov (NCT01772810). The first surgery for the second cohort was completed on March 28.

According to the National Spinal Cord Injury Statistical Center at UAB, as of 2015, about 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year. Approximately, 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.

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

- 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.

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

- NSI-566 shown to have restorative function in primate paralysis model -

- NSI-566 transplantation resulted in measurable improvement in forelimb function -

GERMANTOWN, Md., March 13, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, highlighted the publication of a manuscript in Nature Medicine showing that NSI-566, Neuralstem’s lead cell therapy candidate, provided meaningful improvement in forelimb function in a non-human primate model of acute spinal cord injury. The full manuscript can be found here.

The manuscript, entitled ‘Restorative Effects of Human Neural Stem Cell Grafts on the Primate Spinal Cord,’ involved a study to evaluate the potential benefits of transplanting NSI-566 into rhesus monkeys two weeks after they received a hemisection lesion of the cervical spinal cord.

Key Findings:

• NSI-566 was observed to extend hundreds of thousands of axons long distances from the graft site which appear to form synaptic connections with host neurons, including motor neuron populations;
• Host corticospinal axons regenerate into the NSI-566 graft;
• Grafting of NSI-566 led to a measurable improvement in forelimb function in injured animals.

The study was led by researchers at the University of California San Diego School of Medicine and builds on their previous work showing that grafted NSI-566 cells promote locomotor recovery in rats subjected to severe spinal cord injury.

“This study strengthens our conviction that NSI-566 could potentially confer a benefit in patients with motor deficits from spinal injury and supports our ongoing efforts in addressing conditions involving paralysis, such as ALS and stroke," said Richard Daly, Neuralstem’s Chairman and CEO.

About NSI-566

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

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

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 (MDD) 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 ischemic 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, 2016, and Form 10-Q for the three and nine months ended September 30, 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

GERMANTOWN, Md., March 12, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced that members of the management team will participate at the following upcoming investor conferences:

• B. Riley FBR, Inc. & Co. China Healthcare Investment & Partnering Symposium in Hangzhou, China, on Saturday, March 17 at 9:00am China Standard Time. A live audio webcast of this presentation will be available in the Investors section of the Company's website at investor.neuralstem.com. The webcast will be archived on the Company's website for 90 days following the presentation.
• 15th Annual BIO Asia International Conference in Tokyo, Japan. Rich Daly, Neuralstem’s President & CEO, will participate in a panel discussion entitled, “Lessons on Biopharma Partnerships with Universities” on Tuesday, March 20 at 9:00am Japan Standard Time.
• Also at the 15th Annual BIO Asia Conference, Dr. Karl Johe, PhD, Chief Scientific Officer of Neuralstem, will provide an update on NSI-566, the Company’s lead cell therapy candidate, in a presentation on Monday, March 19 at 5:30pm Japan Standard Time.

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 (MDD) 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, 2016, and Form 10-Q for the three and nine months ended September 30, 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
kimberly@argotpartners.com

GERMANTOWN, Md., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced that Richard Daly, Chairman and CEO of Neuralstem, will participate in a panel discussion entitled, “From Research & Development to Commercial Venture: Building a Successful Biotech Company” at the Young Jewish Professionals CEO Healthcare Symposium in New York, New York, on Tuesday, February 13, 2018 at 8:30am ET.

About Neuralstem

Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need. The Company’s lead development candidate, NSI-189, is a small molecule in clinical development for major depressive disorder (MDD) 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, chronic spinal cord injury (cSCI) and Amyotrophic Lateral Sclerosis (ALS). 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, 2016, and Form 10-Q for the three and nine months ended September 30, 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

kimberly@argotpartners.com