GERMANTOWN, Md., Aug. 10, 2015 /PRNewswire/ -- Neuralstem, Inc. (Nasdaq: CUR) a biopharmaceutical company developing neural stem cell-derived small molecule and cell therapy treatments for central nervous system diseases, reported its financial results and business update for the three and six months ended June 30, 2015.
Neurogenic Small Molecule Program
- NSI-189 Phase II in Major Depressive Disease (MDD): Neuralstem is developing regulatory and clinical plans for a multicenter, Phase II clinical trial of NSI-189 for the treatment of MDD. Maurizio Fava, M.D., Slater Family Professor of Psychiatry at Harvard Medical School, Massachusetts General Hospital will be the principal investigator. The study is anticipated to enroll approximately 200 patients and expected to begin in the second half of 2015.
- NSI-189 for the treatment of cognitive deficit in schizophrenia: The Company plans to begin a Phase Ib clinical trial for the treatment of cognitive deficit in schizophrenia.
Cell Therapy Program
- NSI-566 spinal cord-derived stem cell therapy, under development for the treatment of ALS: In March, the company announced topline data, concluding 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 administered via 40 injections. The Company’s collaborators are currently completing a final report on the study. The Company expects to initiate a larger controlled clinical study this year.
- NSI-566 spinal cord-derived cell therapy under development for the treatment of chronic spinal cord injury (cSCI): The four-patient, stem cell transplantation Phase I safety study dosed the last patient in July. Each patient is evaluated over a 6-month post-operative observation period. The trial is being conducted at the UCSD School of Medicine, supported and funded by the UCSD Sanford Stem Cell Clinical Center.
- NSI-566 spinal cord derived stem cell therapy under development for the treatment of motor deficits in stroke: 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 is expected to commence in 2015. The trial is sponsored by Neuralstem’s wholly owned subsidiary, Suzhou Neuralstem Biopharmaceuticals Co., Ltd. (“Neuralstem China”).
Business Highlights
In May, the Company announced the appointment of Jonathan Lloyd Jones to the position of Chief Financial Officer. Mr. Lloyd Jones brings more than 25 years of corporate finance and business development experience to the company. Mr. Lloyd Jones is a Chartered Accountant and holds an MBA degree from the Wharton School of the University of Pennsylvania and a BSc from the University of Bradford.
Neuralstem was approved for listing on the NASDAQ Capital Market under the symbol “CUR.” The company’s common stock started trading on the NASDAQ on June 13, 2015.
The U.S. District Court for the District of Maryland dismissed StemCells, Inc.'s patent infringement case with prejudice in StemCells, Inc. v. Neuralstem, Inc. in favor of Neuralstem on July 22, 2015.
Results of Operations for the Second Quarter Ended June 30, 2015
Cash, cash equivalents and short-term investments on hand was approximately $23.7 million at June 30, 2015, compared to approximately $27.5 million at December 31, 2014. The decrease was primarily due to our cash used in operations partially offset by 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.
For the three months ended June 30, 2015, we reported a net loss of approximately $5.4 million or $0.06 per share, compared to a net loss of approximately $6.8 million or $0.08 per share in the comparable quarter of 2014. Our operating loss for the three months ended June 30, 2015 was approximately $5.0 million compared to a loss of approximately $3.5 million in the same quarter of 2014. The increase in operating loss was due to an approximately $1.3 million increase in research and development expenses coupled with an approximately $0.2 million increase in general and administrative expenses.
The increase in research and development expenses was primarily attributable to an increase of approximately $0.9 million in project and laboratory expenses, an increase of approximately $0.3 million in payroll and related expenses due to increased salaries and headcount and an increase of approximately $0.1 million in consulting expenses. These increased expenses are all related to the expansion of our pre-clinical and clinical trial efforts and are expected to continue into subsequent periods.
The increase in general and administrative expenses was primarily attributable to an increase in payroll and related expenses due to increased salaries and headcount.
Results of Operations for the Six Months Ended June 30, 2015
For the six months ended June 30, 2015, we reported a net loss of approximately $10.5 million or $0.12 per share, compared to a net loss of approximately $12.7 million or $0.15 per share in the comparable period of 2014. Our operating loss for the six months ended June 30, 2015 was approximately $9.6 million compared to a loss of approximately $8.7 million in the same period of 2014. The increase in operating loss was due to an approximately $2.9 million increase in research and development expenses partially offset by an approximately $1.9 million decrease in general and administrative expenses.
The increase in research and development expenses was primarily attributable to an increase of approximately $2.0 million in project and laboratory expenses, and an increase of approximately $0.6 million in payroll and related expenses due to increased salaries and headcount. These increased expenses are all related to the expansion of our pre-clinical and clinical trial efforts and are expected to continue into subsequent periods.
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