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NEURALSTEM REPORTS SECOND QUARTER FINANCIAL
AND PROVIDES BUSINESS AND CLINICAL UPDATE
GERMANTOWN, MD, August 8, 2014 -- Neuralstem,
Inc. (NYSE MKT: CUR) today reported its financial results for the three months and six months ended June 30, 2014 and provided
a business and clinical update.
"We are pleased to report that 2014
has already seen the company achieve several major milestones. In late July, we completed the last of the surgeries in the NSI-566/ALS
Phase II trial. Each of the patients in the final cohort have received a total of 16 million NSI-566 neural stem cells, through
40 surgical injections of 400,000 cells per injection. The trial will conclude after an observation period of six months,"
said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer.
"Our FDA-approved NSI-566 Phase I
trial to treat chronic spinal cord injury (cSCI) is scheduled to commence in the coming weeks at the University of California,
San Diego, School of Medicine, following approval by UCSD's Institutional Review Board during the second quarter,"
said Dr. Johe. "The open-label, ascending-dose study of patients with thoracic spinal cord injuries utilizes the same proprietary
spinal platform and floating cannula developed for the ALS trials, as well as the same NSI-566 spinal cord cells. Patients in this
trial will have an American Spinal Injury Association AIS-A level of impairment (considered to be in complete paralysis) and will
be between one and two years post injury. The trial is generously supported by, and will be conducted in its entirety at, UCSD
under the guidance of Principal Investigator, Joseph Ciacci, MD."
Dr. Johe continued: "During the second
quarter, the company achieved another major milestone when data from the Ib trial of our neurogenic small molecule compound to
treat MDD was presented at two prestigious academic conferences held in June: the American Society of Clinical Psychopharmacology
(ASCP) Annual Meeting, and the International College of Neuropyschopharmacology (CINP) Annual Meeting. The extremely robust NSI-189
Phase Ib data showed statistical significance; and clinically meaningful improvement of both depression and cognitive symptoms
in the active therapy patients, compared to placebo across all clinical measurements. Further, the improvements persisted eight
weeks after 28-day treatment stopped.
"We believe the biomarker data (quantitative
EEG), which was included in the CINP conference presentation, confirms that NSI-189 is affecting key circuitry common in both mood
control and cognition, involving hippocampal neurogenesis and synaptogenesis," added Dr. Johe. "Combined with the significant
clinical improvements of the patients, these findings validate our hypothesis that NSI-189 stimulates the neurogenesis of hippocampal
stem cells, altering the fine structures within the hippocampus in a manner that is long-lasting. We are encouraged that NSI-189
may be affecting the physical structure of the human brain in these depression patients and may modify progression of cognitive
impairment diseases, as well.
"With such positive data supporting
this novel neurogenesis-based platform, we and fellow investigators, including lead study author, Dr. Maurizio Fava, Executive
Vice Chair, Department of Psychiatry, Executive Director, Clinical Trials Network and Institute, Massachusetts General Hospital,
are preparing the Phase II trial application. We plan to launch a multi-site NSI-189/Phase II MDD study late in the first quarter
of 2015. This next clinical trial will test two doses (40mg once a day and 40mg twice a day), along with a randomized, double-blinded,
placebo control group, in approximately 150 patients with confirmed diagnosis of recurrent MDD, with the aim of confirming these
extremely promising results in a larger clinical setting," concluded Dr. Johe.
"We closed the second quarter of
2014 with a cash position of nearly $30 million, which gives a solid foundation to execute on the company's business plan
through mid-2016," said Richard Garr, Neuralstem's President and CEO. "As Neuralstem's products advance
in the clinic in both cell therapy and neurogenic pharmaceuticals, we are building the infrastructure necessary to accelerate our
programs towards NSI-566 and NSI-189 commercialization. To that end, my fellow Directors and I were pleased to welcome Sandy Smith
as a Director during the second quarter. Sandy is the former President, International Group, and Executive Vice President of Genzyme
Corporation. His experience directing global commercialization for one of the world's most successful rare disease companies, where
he was directly responsible for launching 12 new products in diverse therapeutic areas, will prove invaluable as we take the company
to the next level. Sandy's appointment follows that of Catherine Sohn, PharmD, who spearheaded global commercialization at
GlaxoSmithKline, one of the world's largest pharmaceutical companies. We are already benefitting from this level of expertise
and experience being added to Neuralstem's Board. We are extremely pleased to have Sandy's and Cathy's guidance
during this time of pivotal inflection points for our product development in both the Company's cell therapy and small molecule
"During this past quarter, we further
strengthened our global IP portfolio with the issuance of a neurogenic small molecule patent, validated in 34 countries, by the
European Patent Organisation. We also received notice of issuance of the second U.S. patent for the floating spinal cannula surgical
device used in cell therapy. This brings our total patents to 87 issued and 59 pending," said Garr.
"Dr. Johe and I would like to acknowledge
with deep gratitude the brave patients and their families and caregivers who are allowing this breakthrough cell therapy and novel
neurogenic drug advancements in the clinic. We also thank our exceptional collaborators, among them: NSI-189/psychiatric/small
molecule trial consultant, Maurizio Fava, MD, NSI-566/ALS principal investigator, Eva L. Feldman, MD, PhD, and NSI-566/cSCI lead
collaborator, Martin Marsala, MD, PhD. We also want to acknowledge the leading institutions that serve as sites for this ground-breaking
work, including the University of Michigan, Emory University, Massachusetts General, and University of California, San Diego,"
Second Quarter Clinical Program and
In June, Neuralstem's NSI-189/MDD
Phase Ib data was reported at the annual meetings of both the American Society of Clinical Psychopharmacology (ASCP), and the International
College of Neuropyschopharmacology (CINP).
received issuance of EPO Patent # 2470182 (Synthesis of a Neurostimulative Piperazine), that
was validated in 34 countries: Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain,
Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Macedonia,
Malta, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia and Turkey, for a total of 35 European patents.
June, Neuralstem shares were added to the broad-market Russell 3000
Index. Annual reconstitution of Russell's U.S. indexes
captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization. Membership in the Russell
3000, which remains in place for one year, brings automatic inclusion in the large-cap Russell 1000
Index or small-cap Russell 2000
Index as well as the appropriate growth and value style indexes.
In May, Sandford Drexel Smith was appointed
to Neuralstem's Board of Directors. Mr. Smith is the former President, International Group, and Executive Vice President
of Genzyme Corporation. As President of the International Group, Mr. Smith opened markets in Latin America, China, India, Russia
and Eastern Europe, establishing more than 45 offices worldwide, and was responsible for the launch of 12 new products in diverse
therapeutic areas. He grew Genzyme's international business to $3.1 billion, or 60% of the company's total revenues.
In 2011, Genzyme was acquired by Sanofi, one of the world's largest healthcare companies.
In May, Neuralstem's President and
CEO, Richard Garr, presented a talk entitled, "Sustainable Growth of Regenerative Medicine: Ensuring Long Term Development
and Patient Access to Transformative Cell Therapies," at the World Stem Cells & Regenerative Medicine Congress, in London,
In April, the FDA-approved NSI-566 Phase
I trial to treat chronic spinal cord injury (cSCI) was approved to commence at the University of California, San Diego, School
of Medicine by its Institutional Review Board. The open-label study will enroll patients with thoracic spinal cord injuries who
have an American Spinal Injury Association AIS-A level of impairment (patients who are considered to be in complete paralysis)
and are between one and two years post injury. NSI-566/cSCI patients will also receive post-surgery immunosuppressive therapy as
tolerated for three months.
In April, NSI-566/ALS Principal Investigator,
Eva Feldman, PhD, MD, presented published Phase I data at the Keystone Symposia, "Engineering Cell Fate and Function."
Dr. Feldman took part in a workshop, organized in collaboration with California Institute for Regenerative Medicine, called "Clinical
Progress for Stem Cell Therapies."
In April, the United States Patent Office
issued Patent #8,708,962, the second U.S. patent for the floating spinal cannula and method of use, to which Neuralstem holds exclusive
Second Quarter Financial Results
For the three months ended June 30, 2014,
the Company reported a net loss of approximately $6,751,000 or $0.08 per share, compared with a net loss of approximately $6,252,000