GERMANTOWN, M.D., May 8, 2015 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments for central nervous system diseases, reported its financial results for the three months ended March 31, 2015 and provided a business and clinical update.
“Neuralstem made substantial clinical progress this quarter in both our cell therapy and small molecule programs. We announced positive top-line safety data and encouraging secondary efficacy data for our Phase II ALS clinical trial, and look forward with anticipation to the release of the comprehensive data and analysis,” said Richard Garr, Neuralstem CEO. “Additionally, as we began to prepare for the NSI-189 MDD Phase II trial, we announced a second NSI-189 indication, cognitive deficit in schizophrenia, in which we will also commence a trial in 2015.”
Neurogenic Small Molecule Program
- Regulatory and clinical preparation for NSI-189 Phase II clinical trial for the treatment of MDD. Maurizio Fava, M.D., Slater Family Professor of Psychiatry at Harvard Medical School, Massachusetts General Hospital is the principal investigator for the anticipated approximately 150-patient, multi-site clinical trial in 2015.
- Preparation for NSI-189 Phase Ib clinical trial for the treatment of cognitive deficit in schizophrenia. Cognitive deficit in schizophrenia is a prominent characteristic of the disorder that is correlated with hippocampal atrophy in this patient population.
Cell Therapy
NSI-566 spinal cord-derived stem cell therapy under development for the treatment of ALS
- Announced top-line data for the Phase II NSI-566 ALS trial. Topline data concluded that the Phase II ALS clinical trial met the primary safety endpoints and established what we believe to be the maximum safe-tolerated dose of 16 million cells delivered in 40 injections. Secondary efficacy endpoints, such as the Amyotrophic Lateral Sclerosis Functional Rating Scale, or ALSFRS, and grip strength were evaluated at nine months post-surgery to assess the potential therapeutic benefit of disease stabilization. This dose-escalating trial treated 15 ambulatory patients in five cohorts. Each of the three patients in the final cohort received a total dose of 40 injections of 400,000 cells, 20 injections each in the cervical and lumbar regions, for a total 16 million transplanted cells per patient. As a result of the clear safety and strong treatment effects, a larger Phase II efficacy trial will be commenced in 2015.
NSI-566 spinal cord-derived cell therapy under development for the treatment of chronic spinal cord injury (cSCI)
- The Phase I cSCI clinical trial is ongoing. Patients are being treated and evaluated in the Phase I trial for cSCI at the UCSD School of Medicine, supported and funded by the UCSD Sanford Stem Cell Clinical Center. The four-patient stem cell transplantation safety trial is followed by six-month post-surgery observation period. With UCSD’s collaboration, we anticipate to report top-line data in the fourth quarter of 2015.
NSI-566 spinal cord derived stem cell therapy under development for the treatment of motor deficits in stroke
- Advancement in Phase I/II ischemic stroke trial. Neuralstem continues to proceed in its collaborative Phase I/II ischemic stroke trial with BaYi Brain Hospital in Beijing. The Phase II portion of the study, a controlled proof-of-concept study, is expected to commence in 2015. The trial is sponsored by Neuralstem’s wholly-owned subsidiary, Suzhou Sun-Now Biopharmaceutical Co. Ltd. (“Neuralstem China”), which was formed to develop Neuralstem’s cell therapy products in China.
Business Highlights
Neuralstem announced the appointment of Jonathan Lloyd Jones to the position of Chief Financial Officer, effective May 18, 2015. Mr. Lloyd Jones brings to the position more than 25 years of corporate finance and business development experience. He previously served as Chief Financial Officer at Columbia Laboratories (Juniper Pharmaceuticals), CFO and VP of Corporate Development at TetraLogic, and Senior Director, Corporate Development at Genzyme Corporation (Sanofi-Aventis). Mr. Lloyd Jones is a Chartered Accountant who holds a MBA degree from the Wharton School of the University of Pennsylvania a BS from the University of Bradford.
Neuralstem’s President and CEO, Richard Garr presented an overview of the company’s cell therapy and neurogenic small molecule clinical trials at three investor conferences in the first quarter of 2015: Biotech Showcase in San Francisco, BIO CEO & Investor Conference in New York City, and Barclays Global Healthcare Conference in Miami.
In March, New Zealand issued a patent (623207) for “Methods for Treating and/or Reversing Neurodegenerative Diseases and/or Disorders.”
Results of Operations for the Quarter Ended March 31, 2015:
Cash, cash equivalents and short-term investments on hand was approximately $28.6 million at March 31, 2015, compared to approximately $27.5 million at December 31, 2014. The increase was primarily due to our raising approximately $6.0 million, net through the issuance of our common stock from warrant exercises and from the sale of our common stock largely offset by cash used in our operations.
In the quarter ended March 31, 2015, we reported a net loss of approximately $5.1 million or $0.06 per share, compared to a loss of approximately $5.9 million or $0.07 per share in the first quarter of 2014. Our operating loss in the quarter ended March 31, 2015 was approximately $4.6 million compared to a loss of $5.2 million in the same quarter of 2014. The decrease in operating loss was primarily attributable to a decrease of approximately $2.1 million in general and administrative expenses largely offset by an increase of approximately $1.6 million in research and development expenses.
The increase in research and development expenses was primarily attributable to an increase of approximately $1.2 million in project and lab expenses and an increase of approximately $0.3 million in payroll and related expenses due to increased salaries and headcount. These increased expenses are all related to a ramping-up of our pre-clinical and clinical trial efforts and are expected to continue into subsequent periods.
The decrease in general and administrative expenses was primarily attributable to a decrease of approximately $1.8 million in non-cash stock based compensation largely the result of a first quarter 2014 expense of approximately $2.0 million in non-cash stock based compensation expense related to a financial advisory and consulting services provider achieving a performance based milestone that resulted in a term extension of certain common stock purchase warrants. This was coupled with a decrease of approximately $0.5 million in legal fees resulting from insurance claims related to litigation expense. These decreases were partially offset by increases of approximately $0.1 million in each of consulting fees and payroll related expenses due to increased salaries and headcount.
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